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Free FedEx overnight delivery on all orders. Save now and on all your refills. Cost plus a small processing fee. Diethylpropion HCl CR 75mg (Gen.Tenuate Dospan) (30 - 24 hr. tabs) 19.88 Diethylpropion HCl CR 75mg (Gen.Tenuate Dospan) (60 - 24 hr. tabs) 38.88 Diethylpropion HCl CR 75mg (Gen.Tenuate Dospan) (90 - 24 hr. tabs) 56.88 Tenuate Dospan 75mg (30 - 24 hr. tabs) 48.88 Tenuate Dospan 75mg (60 - 24 hr. tabs) 88.88 Tenuate Dospan 75mg (90 - 24 hr. tabs) 128.88 IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug. APPETITE SUPPRESSANTS - ORAL COMMON BRAND NAME(S): Fastin, Ionamin, Plegine, Prelu-2, Sanorex, Tenuate USES: This medication is used in combination with a diet plan to help you reduce weight. HOW TO USE: This medication is best taken on an empty stomach one hour before meals. Sustained-release or long acting products must be swallowed whole. Crushing or chewing them will destroy the long action and may cause increased side effects. Because this medication may cause sleeplessness, avoid taking a dose late in the day. Take this medication as prescribed. Do not take it more often or longer than directed. It is usually taken for 8 to 12 weeks. Use in combination with other appetite suppressant medicine is generally not recommended. Consult your doctor before such use. SIDE EFFECTS: Blurred vision, dizziness, dry mouth, sleeplessness, irritability, stomach upset or constipation may occur the first few days as your body adjusts to the medication. If these effects persist or become bothersome, inform your doctor. Notify your doctor if you experience: chest pain, nervousness, pounding heart, difficulty urinating, mood changes, breathing difficulties, swelling. If this medication makes you dizzy or lightheaded, avoid driving or engaging in activities requiring alertness. If you notice other effects not listed above, contact your doctor or pharmacist. PRECAUTIONS: Tell your doctor your complete medical history, especially if you have: high blood pressure, an over-active thyroid, glaucoma, diabetes, emotional problems. This medication can be habit forming and must be used with caution. Alcohol can increase unwanted side effects of dizziness. Limit alcohol use. This drug is not recommended for use in children. Consult your doctor or pharmacist for further information. This medication should be used only when clearly needed during pregnancy. Discuss the risk and benefits with your doctor. This drug may be excreted into breast milk. You may have to stop nursing or stop using this drug. Consult your doctor before breast-feeding. DRUG INTERACTIONS: Inform your doctor about all the medicines you use, (prescription and nonprescription) especially if you take: high blood pressure medicine, MAO inhibitors (e.g., furazolidone, linezolid, phenelzine, selegiline, tranylcypromine), any other weight loss medicine. Avoid "stimulant" drugs that may increase your heart rate such as decongestants or caffeine. Decongestants are commonly found in over-the-counter cough-and-cold medicines. Do not start or stop any medicine without doctor or pharmacist approval. OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include restlessness, fever, fast breathing, dizziness, confusion, hallucinations, panic or paranoid, drowsiness, convulsions, unconsciousness, unusually fast or slow heart beat, headache, nausea/vomiting, diarrhea, stomach pain, pale or flushing, chest pain, sweating, muscle weakness, agitation, large pupils, or delusions. NOTES: Appetite suppressants are not a substitute for proper diet. For maximum effects, this must be used in conjunction with a diet and exercise program. Do not share this medication with others. MISSED DOSE: If you miss a dose, do not double the next dose. Instead, skip the missed dose and resume your usual dosing schedule. STORAGE: Store at room temperature away from sunlight and moisture. Do not store in the bathroom. Health News Is Prescription Tenuate® right for you? by Sally LoBriglio We have discussed lots of topics in the ConsumerHealthDigest.com weight loss forum—diet, exercise, stress, anxiety, pms, menopause, depression, diabetes, high blood pressure, heart disease. But one topic that is sure to turn up week after week is appetite suppression. So many people just cannot gain control over their appetite, and we now know that more than just will-power is required to fight the battle of the bulge –and win. Unfortunately, human beings have been hard-wired with large appetites for the purpose of increasing the chance of survival in ancient times. In times of scarcity, this trait was necessary for the survival of our ancestors. However, in modern times, where most of us encounter an excess of accessible, relatively inexpensive, calorically dense foods, this trait causes considerably more harm than good. Large appetites, combined with the excess accessibility of inexpensive, calorically dense foods, unfortunately for us, is a formula for disaster. Obesity has reached epidemic proportions in the U.S. and continues to grow in size and severity. And we know that obesity leads to cardiovascular disease, hypertension, and diabetes, as well as a number of other serious health conditions which can have drastic implications. So what can we do on our end to silence the call of our ravenous, often out of control appetites and finally put an end to weight gain? In light of the recent obesity epidemic, a number of products have appeared on the market aimed at weight loss and appetite suppression. These products include vitamin, mineral, and herbal supplements, as well as prescription pharmaceutical medications which can only be obtained under a doctor’s recommendation. A solution may now be available for you. By using an appetite suppressant, and finding ways to restore normal, balanced eating habits, it may be possible to lose weight as well as the stress of dieting through willpower alone, and get your life back on track. Prescription Drug Tenuate® Diethylpropion hydrochloride, generic name for the appetite suppressant Tenuate®. Tenuate® is indicated only for the short-term (few weeks) management of obesity. Tolerance to the appetite suppressant effects usually develops within a few weeks, at which time the drug will become ineffective and use should be discontinued. Caution should be used, as Tenuate® has been implicated in increasing seizures in epileptic patients. It may also cause a symptomatic heart disease such as heart rhythm disturbances. Tenuate® is related chemically and pharmacologically to the amphetamines. The use of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. Discontinued use may result in withdrawal-like symptoms including extreme fatigue and depression. Side effects may also include skin abnormalities, insomnia, irritability, hyperactivity, personality changes, and psychosis. Are there alternatives? Non-Prescription All Natural Appetite Suppressants What makes a non-prescription appetite suppressant product so appealing? Is it the all natural and non-physically addictive properties? Prescription products pose the risk for too many potential side effects and drug interactions. The elite non-prescription products contain thermogenic ingredients which support weight loss through not only one, but dual mechanisms: 1: suppress the appetite 2: increase metabolic rate and the number of calories burned You might not need to resort to prescription strength drugs to achieve your weight loss goals. All natural supplements can support a safe and effective weight loss regimen. Natural supplements give you an excellent alternative to prescription strength appetite suppression drugs. These products have limited side effects, less drug interactions, and are less expensive than alot of the prescription strength appetite suppressants available on the market today. Unlike prescription appetite suppressants, alternative therapies can be used with a greater amount of safety and ease. What is the best all natural appetite suppressant on the market today? We reviewed over 50 different all natural appetite suppressants on the market today. At the conclusion of our research, we found Lipovarin™, manufactured by Sterling Grant Laboratories, demonstrates overall safety and effective weight loss results at a reasonable cost. That is why we have rated it Consumer Health Digest's Best Buy! Buy Here Product Name Lipovarin™ ThermaLean-RX™ Leptoprin-SF™ Manufacturer Sterling Grant Laboratories MedaBiotics AG Waterhouse Lowest Price Found $49.97 $49.99 $153.00 Overall Score 96/100 94/100 91/100 CHD Product Rating Results Lipovarin™ ThermaLean-RX™ Leptoprin-SF™ Total Score 96pts 94pts 91pts Rate It Rate It Rate It Buy TenuateTenuate is an appetite suppressant used to treat obesity during the first few weeks of a weight-loss program. It is helpful for weight-loss while you are learning new ways to eat and to exercise. Drug Dosage Quantity Price Buy Diethylpropion [Tenuate] 75mg 30 tablets $119.00 Diethylpropion [Tenuate] 75mg 60 tablets $159.00 Diethylpropion [Tenuate] 75mg 90 tablets $189.00 DISCLAIMER This information is not intended to substitute for professional medical advice. Be sure to contact your physician, pharmacist or other health care provider for more information about this medication. Diethylpropion HCl CR 75mg (Gen.Tenuate Dospan) (30 - 24 hr. tabs) 27.94 Diethylpropion HCl CR 75mg (Gen.Tenuate Dospan) (60 - 24 hr. tabs) 45.94 Diethylpropion HCl CR 75mg (Gen.Tenuate Dospan) (90 - 24 hr. tabs) 64.94 Tenuate Dospan 75mg (30 - 24 hr. tabs) 41.94 Tenuate Dospan 75mg (60 - 24 hr. tabs) 78.94 Tenuate Dospan 75mg (90 - 24 hr. tabs) 112.94 IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug. APPETITE SUPPRESSANTS - ORAL COMMON BRAND NAME(S): Fastin, Ionamin, Plegine, Prelu-2, Sanorex, Tenuate USES: This medication is used in combination with a diet plan to help you reduce weight. HOW TO USE: This medication is best taken on an empty stomach one hour before meals. Sustained-release or long acting products must be swallowed whole. Crushing or chewing them will destroy the long action and may cause increased side effects. Because this medication may cause sleeplessness, avoid taking a dose late in the day. Take this medication as prescribed. Do not take it more often or longer than directed. It is usually taken for 8 to 12 weeks. Use in combination with other appetite suppressant medicine is generally not recommended. Consult your doctor before such use. SIDE EFFECTS: Blurred vision, dizziness, dry mouth, sleeplessness, irritability, stomach upset or constipation may occur the first few days as your body adjusts to the medication. If these effects persist or become bothersome, inform your doctor. Notify your doctor if you experience: chest pain, nervousness, pounding heart, difficulty urinating, mood changes, breathing difficulties, swelling. If this medication makes you dizzy or lightheaded, avoid driving or engaging in activities requiring alertness. If you notice other effects not listed above, contact your doctor or pharmacist. PRECAUTIONS: Tell your doctor your complete medical history, especially if you have: high blood pressure, an over-active thyroid, glaucoma, diabetes, emotional problems. This medication can be habit forming and must be used with caution. Alcohol can increase unwanted side effects of dizziness. Limit alcohol use. This drug is not recommended for use in children. Consult your doctor or pharmacist for further information. This medication should be used only when clearly needed during pregnancy. Discuss the risk and benefits with your doctor. This drug may be excreted into breast milk. You may have to stop nursing or stop using this drug. Consult your doctor before breast-feeding. DRUG INTERACTIONS: Inform your doctor about all the medicines you use, (prescription and nonprescription) especially if you take: high blood pressure medicine, MAO inhibitors (e.g., furazolidone, linezolid, phenelzine, selegiline, tranylcypromine), any other weight loss medicine. Avoid "stimulant" drugs that may increase your heart rate such as decongestants or caffeine. Decongestants are commonly found in over-the-counter cough-and-cold medicines. Do not start or stop any medicine without doctor or pharmacist approval. OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include restlessness, fever, fast breathing, dizziness, confusion, hallucinations, panic or paranoid, drowsiness, convulsions, unconsciousness, unusually fast or slow heart beat, headache, nausea/vomiting, diarrhea, stomach pain, pale or flushing, chest pain, sweating, muscle weakness, agitation, large pupils, or delusions. NOTES: Appetite suppressants are not a substitute for proper diet. For maximum effects, this must be used in conjunction with a diet and exercise program. Do not share this medication with others. MISSED DOSE: If you miss a dose, do not double the next dose. Instead, skip the missed dose and resume your usual dosing schedule. STORAGE: Store at room temperature away from sunlight and moisture. Do not store in the bathroom. BONTRIL, PHENDIMETRAZINE $15 MERIDIA $93 ADIPEX $49 DIDREX $40 XENICAL $56 PHENTERMINE $12 TENUATE, DIETHYLPROPION $41 IONAMIN $56 www.frontierpharmacies.com All Prescriptions filled by a U.S. Licensed Pharmacy Drug Strength Quantity Price Status Pharmacy Info TENUATE 25 mg 90 * $59.00 In Stock TENUATE 75 mg 30 * $45.00 In Stock TENUATE 75 mg 60 * $90.00 In Stock TENUATE 75 mg 90 * $149.00 In Stock * indicates generic Additional Information Why is this medication prescribed Diethylpropion decreases appetite. It is used on a short-term basis (a few weeks), in combination with diet, to help you lose weight. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information. What other information should I know Keep all appointments with your doctor. Your doctor may order certain tests to check your response to diethylpropion. Diethylpropion may affect blood sugar levels of diabetic patients and may cover up some signs and symptoms of hypoglycemia (low blood sugar). If you notice a change in the results of your urine or blood sugar tests, check with your doctor. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. In case of emergency overdose In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911. ________________ Tenuate Sales Tenuate Sales - check out our low prices Tenuate Sales works hard to deliver to you the lowest possible prices available online for the prescription medication tenuate. You'll be glad you visited because the prices are rock bottom for this incredibly popular weight loss medication! Featured Pharmacy - Worldwide Shipping - LOW price Active Medicinal Ingredients: Tenuate Brand Names: Tenuate Notes: The substance tenuate helps overweight individuals lose weight, in conjunction with a weight loss plan and good exercise program. Tenuate activates in your body by suppressing your appetite, making you feel less hunger. Tenuate is intended as a short-term supplement to a good diet and exercise program for the treatment of obesity. This medicine is an appetite suppressant used along with diet, exercise, and behavior therapy for the short-term management of obesity. Diethylpropion HCl CR 75mg (Gen.Tenuate Dospan) (30 - 24 hr. tabs) 27.98 Diethylpropion HCl CR 75mg (Gen.Tenuate Dospan) (60 - 24 hr. tabs) 45.98 Diethylpropion HCl CR 75mg (Gen.Tenuate Dospan) (90 - 24 hr. tabs) 64.98 Tenuate Dospan 75mg (30 - 24 hr. tabs) 41.98 Tenuate Dospan 75mg (60 - 24 hr. tabs) 78.98 Tenuate Dospan 75mg (90 - 24 hr. tabs) 112.98 IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug. COMMON BRAND NAME(S): Fastin, Ionamin, Plegine, Prelu-2, Sanorex, Tenuate USES: This medication is used in combination with a diet plan to help you reduce weight. HOW TO USE: This medication is best taken on an empty stomach one hour before meals. Sustained-release or long acting products must be swallowed whole. Crushing or chewing them will destroy the long action and may cause increased side effects. Because this medication may cause sleeplessness, avoid taking a dose late in the day. Take this medication as prescribed. Do not take it more often or longer than directed. It is usually taken for 8 to 12 weeks. Use in combination with other appetite suppressant medicine is generally not recommended. Consult your doctor before such use. SIDE EFFECTS: Blurred vision, dizziness, dry mouth, sleeplessness, irritability, stomach upset or constipation may occur the first few days as your body adjusts to the medication. If these effects persist or become bothersome, inform your doctor. Notify your doctor if you experience: chest pain, nervousness, pounding heart, difficulty urinating, mood changes, breathing difficulties, swelling. If this medication makes you dizzy or lightheaded, avoid driving or engaging in activities requiring alertness. If you notice other effects not listed above, contact your doctor or pharmacist. PRECAUTIONS: Tell your doctor your complete medical history, especially if you have: high blood pressure, an over-active thyroid, glaucoma, diabetes, emotional problems. This medication can be habit forming and must be used with caution. Alcohol can increase unwanted side effects of dizziness. Limit alcohol use. This drug is not recommended for use in children. Consult your doctor or pharmacist for further information. This medication should be used only when clearly needed during pregnancy. Discuss the risk and benefits with your doctor. This drug may be excreted into breast milk. You may have to stop nursing or stop using this drug. Consult your doctor before breast-feeding. DRUG INTERACTIONS: Inform your doctor about all the medicines you use, (prescription and nonprescription) especially if you take: high blood pressure medicine, MAO inhibitors (e.g., furazolidone, linezolid, phenelzine, selegiline, tranylcypromine), any other weight loss medicine. Avoid "stimulant" drugs that may increase your heart rate such as decongestants or caffeine. Decongestants are commonly found in over-the-counter cough-and-cold medicines. Do not start or stop any medicine without doctor or pharmacist approval. OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include restlessness, fever, fast breathing, dizziness, confusion, hallucinations, panic or paranoid, drowsiness, convulsions, unconsciousness, unusually fast or slow heart beat, headache, nausea/vomiting, diarrhea, stomach pain, pale or flushing, chest pain, sweating, muscle weakness, agitation, large pupils, or delusions. NOTES: Appetite suppressants are not a substitute for proper diet. For maximum effects, this must be used in conjunction with a diet and exercise program. Do not share this medication with others. MISSED DOSE: If you miss a dose, do not double the next dose. Instead, skip the missed dose and resume your usual dosing schedule. STORAGE: Store at room temperature away from sunlight and moisture. Do not store in the bathroom. TENUATE® (diethylpropion hydrochloride) is a sympathomimetic amine, which is similar to an amphetamine. It is also known as an "anorectic" or an "anorexigenic" drug. Tenuate stimulates the central nervous system (nerves and brain), which increases your heart rate and blood pressure and decreases your appetite. Tenuate is used as a short-term supplement to diet and exercise in the treatment of obesity. Trusted Online Drug Store is dedicated to making your prescription order as easy, quick and private as possible. 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Our hours are now 8:00am-5:00pm EST Tenuate® Uses This medicine is an appetite suppressant used along with diet, exercise, and behavior therapy for the short-term management of obesity. How To Take This Medication Follow the directions for using this medicine provided by your doctor. Take this medicine about 30 minutes to 1 hour before meals. Take your last dose of the day at least 4 to 6 hours before bedtime. Side Effects Side effects, that may go away during treatment, include restlessness, nervousness, difficulty sleeping, or dry mouth. If they continue or are bothersome, check with your doctor. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. Precautions Do not exceed the recommended dose or take this medicine for longer than prescribed without checking with your doctor. Exceeding the recommended dose or taking this medicine for longer than prescribed may cause serious side effects. Keep all doctor and laboratory appointments while you are using this medicine. Before you begin taking any new medicine, either prescription or over-the-counter, check with your doctor or pharmacist. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to this medicine. Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using this medicine. For women: this medicine is excreted in breast milk. If you are or will be breast-feeding while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby. If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose include restlessness, tremor, rapid breathing, nausea, vomiting, diarrhea, and stomach cramps. Drug Interactions Some medicines or medical conditions may interact with this medicine. Inform your doctor or pharmacist of all prescription and over-the-counter medicine that you are taking. Do not use this medicine if you are also taking guanadrel, guanethidine, furazolidone, or monoamine oxidase inhibitors (MAOIs). Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding. Use of this medicine is not recommended if you have a history of heart disease, high blood pressure, hyperthyroidism, glaucoma, atherosclerosis, or brain or spinal cord disorders. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine. Notes Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children. Missed Dosage If you miss a dose of this medicine, take it as soon as possible. If it is after 4 pm, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Storage Store this medicine at room temperature in a tightly-closed container, away from heat and light. Tenuate, an appetite suppressant, is prescribed for short-term use (a few weeks) as part of an overall diet plan for weight reduction. It is available in two forms: immediate-release tablets (Tenuate) and controlled-release tablets (Tenuate Dospan). Tenuate should be used with a behavior modification program. -------------------------------------------------------------------------------- Tenuate will lose its effectiveness within a few weeks. When this begins to happen, you should discontinue the medicine rather than increase the dosage. -------------------------------------------------------------------------------- How should you take this medication? Return to top Take this medication exactly as prescribed. Tenuate may be habit-forming and can be addicting. If you are taking Tenuate Dospan (the controlled release formulation), do not crush or chew the tablets. Swallow the medication whole. --If you miss a dose... If you are taking the immediate-release form of Tenuate, go back to your regular schedule at the next meal. If you are taking Tenuate Dospan, take the missed dose as soon as you remember. If you do not remember until the next day, skip the dose. Never take 2 doses at once. --Storage instructions... Store at room temperature in a tightly closed container. Protect from excessive heat. -------------------------------------------------------------------------------- What side effects may occur? Return to top Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue using Tenuate. Side effects may include: Abdominal discomfort, abnormal redness of the skin, anxiety, blood pressure elevation, blurred vision, breast development in males, bruising, changes in sex drive, chest pain, constipation, depression, diarrhea, difficulty with voluntary movements, dizziness, drowsiness, dryness of the mouth, feelings of discomfort, feelings of elation, feeling of illness, hair loss, headache, hives, impotence, inability to fall or stay asleep, increased heart rate, increased seizures in epileptics, increased sweating, increased volume of diluted urine, irregular heartbeat, jitteriness, menstrual upset, muscle pain, nausea, nervousness, overstimulation, painful urination, palpitations, pupil dilation, rash, restlessness, shortness of breath or labored breathing, stomach and intestinal disturbances, tremors, unpleasant taste, vomiting -------------------------------------------------------------------------------- Why should this drug not be prescribed? Return to top If you are sensitive to or have ever had an allergic reaction to Tenuate or other appetite suppressants, you should not take this medication. Make sure your doctor is aware of any drug reactions you have experienced. Do not take this drug if you have severe hardening of the arteries, an overactive thyroid, glaucoma, or severe high blood pressure, or if you are agitated, have a history of drug abuse or are taking an MAO inhibitor (antidepressant drug such as Nardil) or have taken one within the last 14 days. -------------------------------------------------------------------------------- Special warnings about this medication Return to top Tenuate or Tenuate Dospan may impair your ability to engage in potentially hazardous activities. Therefore, make sure you know how you react to this medication before you drive, operate dangerous machinery, or do anything else that requires alertness or concentration. If you have heart disease or high blood pressure, use caution when taking this medication. This drug may increase convulsions in some epileptics. Your doctor should monitor you carefully if you have epilepsy. Psychological dependence has occurred while taking this drug. Talk with your doctor if you find you are relying on this drug to maintain a state of well-being. The abrupt withdrawal of this medication following prolonged use at high doses may result in extreme fatigue, mental depression, and sleep disturbances. -------------------------------------------------------------------------------- Possible food and drug interactions when taking this medication Return to top Tenuate or Tenuate Dospan may interact with alcohol unfavorably. Do not drink alcohol while taking this medication. If Tenuate or Tenuate Dospan is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important that you consult your doctor before combining Tenuate with the following: Blood pressure medications such as Ismelin Insulin Phenothiazine drugs such as the major tranquilizer Thorazine -------------------------------------------------------------------------------- Special information if you are pregnant or breastfeeding Return to top The effects of Tenuate or Tenuate Dospan during pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, inform your doctor immediately. This drug appears in breast milk. If the medication is essential to your health, your doctor may advise you to discontinue breastfeeding until your treatment is finished. The usual dosage is one 25-milligram tablet taken 3 times a day, 1 hour before meals; you may take 1 tablet in the middle of the evening, if you want, to overcome night hunger. 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SOMA (WATSON BRAND) Soma Indications This medicine is used with rest and physical therapy to treat acute, painful muscle conditions Contraindications Do not take this medication if - you are allergic to any ingredient of this medicine ... more Soma Tablets (carisoprodol) Tablets, USP DESCRIPTION `SOMA' (carisoprodol) Tablets, USP is available as 350 mg round, white tablets. Chemically, carisoprodol is N-isopropyl-2- methyl-2-propyl-1,3-propanediol dicarbamate. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is very slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. The molecular formula is C 12 H 24 N 2 O 4 , with a molecular weight of 260.33. The structural formula is: Other ingredients: alginic acid, magnesium stearate, potassium sorbate, starch, tribasic calcium phosphate. ACTIONS Carisoprodol produces muscle relaxation in animals by blocking interneuronal activity in the descending reticular formation and spinal cord. The onset of action is rapid and effects last four to six hours. INDICATIONS Carisoprodol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Carisoprodol does not directly relax tense skeletal muscles in man. CONTRAINDICATIONS Acute intermittent porphyria as well as allergic or idiosyncratic reactions to carisoprodol or related compounds. WARNINGS Idiosyncratic Reactions --On very rare occasions, the first dose of carisoprodol has been followed by idiosyncratic symptoms appearing within minutes or hours. Symptoms reported include: extreme weakness, transient quadriplegia, dizziness, ataxia, temporary loss of vision, diplopia, mydriasis, dysarthria, agitation, euphoria, confusion, and disorientation. Symptoms usually subside over the course of the next several hours. Supportive and symptomatic therapy, including hospitalization, may be necessary. Usage in Pregnancy and Lactation --Safe usage of this drug in pregnancy or lactation has not been established. Therefore, use of this drug in pregnancy, in nursing mothers, or in women of childbearing potential requires that the potential benefits of the drug be weighed against the potential hazards to mother and child. Carisoprodol is present in breast milk of lactating mothers at concentrations two to four times that of maternal plasma. This factor should be taken into account when use of the drug is contemplated in breast-feeding patients. Usage in Children --Because of limited clinical experience, `SOMA' is not recommended for use in patients under 12 years of age. Potentially Hazardous Tasks --Patients should be warned that this drug may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a motor vehicle or operating machinery. Additive Effects --Since the effects of carisoprodol and alcohol or carisoprodol and other CNS depressants or psychotropic drugs may be additive, appropriate caution should be exercised with patients who take more than one of these agents simultaneously. Drug Dependence --In dogs, no withdrawal symptoms occurred after abrupt cessation of carisoprodol from dosages as high as 1 gm/kg/day. In a study in man, abrupt cessation of 100 mg/kg/day (about five times the recommended daily adult dosage) was followed in some subjects by mild withdrawal symptoms such as abdominal cramps, insomnia, chilliness, headache, and nausea. Delirium and convulsions did not occur. In clinical use, psychological dependence and abuse have been rare, and there have been no reports of significant abstinence signs. Nevertheless, the drug should be used with caution in addiction-prone individuals. PRECAUTIONS Carisoprodol is metabolized in the liver and excreted by the kidney; to avoid its excess accumulation, caution should be exercised in administration to patients with compromised liver or kidney function. ADVERSE REACTIONS Central Nervous System --Drowsiness and other CNS effects may require dosage reduction. Also observed: dizziness, vertigo, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, and insomnia. (See also Idiosyncratic Reactions under "Warnings." ) Allergic or Idiosyncratic --Allergic or idiosyncratic reactions occasionally develop. They are usually seen within the period of the first to fourth dose in patients having had no previous contact with the drug. Skin rash, erythema multiforme, pruritus, eosinophilia, and fixed drug eruption with cross reaction to meprobamate have been reported with carisoprodol. Severe reactions have been manifested by asthmatic episodes, fever, weakness, dizziness, angioneurotic edema, smarting eyes, hypotension, and anaphylactoid shock. (See also Idiosyncratic Reactions under "Warnings." ) In case of allergic or idiosyncratic reactions to carisoprodol, discontinue the drug and initiate appropriate symptomatic therapy, which may include epinephrine, antihistamines, and in severe cases corticosteroids. In evaluating possible allergic reactions, also consider allergy to excipients (information on excipients is available to physicians on request). Cardiovascular --Tachycardia, postural hypotension, and facial flushing. Gastrointestinal --Nausea, vomiting, hiccup, and epigastric distress. Hematologic --Leukopenia, in which other drugs or viral infection may have been responsible, and pancytopenia, attributed to phenylbutazone, have been reported. No serious blood dyscrasias have been attributed to carisoprodol. DOSAGE AND ADMINISTRATION The usual adult dosage of `SOMA' (carisoprodol) Tablets, USP is one 350 mg tablet, three times daily and at bedtime. Usage in patients under age 12 is not recommended. OVERDOSAGE Overdosage of carisoprodol has produced stupor, coma, shock, respiratory depression, and, very rarely, death. The effects of an overdosage of carisoprodol and alcohol or other CNS depressants or psychotropic agents can be additive even when one of the drugs has been taken in the usual recommended dosage. Any drug remaining in the stomach should be removed and symptomatic therapy given. Should respiration or blood pressure become compromised, respiratory assistance, central nervous system stimulants, and pressor agents should be administered cautiously as indicated. Carisoprodol is metabolized in the liver and excreted by the kidney. Although carisoprodol overdosage experience is limited, the following types of treatment have been used successfully with the related drug meprobamate: diuresis, osmotic (mannitol) diuresis, peritoneal dialysis, and hemodialysis (carisoprodol is dialyzable). Careful monitoring of urinary output is necessary and caution should be taken to avoid overhydration. Observe for possible relapse due to incomplete gastric emptying and delayed absorption. Carisoprodol can be measured in biological fluids by gas chromatography (Douglas, J. F. et al.: J Pharm Sci 58: 145, 1969). HOW SUPPLIED `SOMA' (carisoprodol) Tablets, USP 350 mg: Round, convex, white tablets, inscribed with `SOMA' on one side and 37-WALLACE 2001 on the other side, are available in bottles of 100 (NDC 0037-2001-01) and 500 (NDC 0037-2001-03), and unit-dose packages of 100 (NDC 0037-2001-85). PRODUCT PHOTO(S): NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size. The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis. The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you. The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products. Are your Dyslexic? Great info on Dyslexia diagnosis, symptoms & treatments. infoscouts.com Lorazepam-Reviewed Is Lorazepam the right prescription medicine for you? Find out. ConsumerHealthDigest.com "Are you dizzy ?" You may have Labyrinthitis Find treatment and remedy options InfoForYourHealth.com Soma (Carisoprodol) on Sale Now 90 tabs $84, 180 tabs just $159. Free FedEx. Order online now. ApexOnlinePharmacy.com. www.apexonlinepharmacy.com (sponsored listing) Soma Premium tickets - lower prices. 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La aspirin actъa reduciendo las substancias en el cuerpo que causan dolor e inflamaciуn. S... Soma Compound La aspirin estб en la clase de drogas llamada salicilatos. Aspirin actъa reduciendo sustancias en el cuerpo que causan inflamaciуn y dolor. Se usa pa... aspirin y carisoprodol La aspirin estб en la clase de drogas llamada salicilatos. Aspirin actъa reduciendo sustancias en el cuerpo que causan inflamaciуn y dolor. Se usa pa... Vanadom Carisoprodol es un relajante para los mъsculos. Йste actъa bloqueando los impulsos de los nervios (o sensaciones de dolor) que se mandan al cerebro. aspirin/carisoprodol/codeine La aspirin estб en la clase de drogas llamada salicilatos. La aspirin actъa reduciendo las substancias en el cuerpo que causan dolor e inflamaciуn. S... carisoprodol Carisoprodol es un relajante para los mъsculos. Йste actъa bloqueando los impulsos de los nervios (o sensaciones de dolor) que se mandan al cerebro. PDR Drug information for Soma Compound w/Codeine Tablets (carisoprodol, aspirin and codeine phosphate tablets, USP) carisoprodol 200 mg + aspirin 325 mg + codeine phosphate 16 mg--Warning: May be habit-forming TABLETS DESCRIPTION `Soma' Compound with Codeine is a combination product containing carisoprodol, a centrally-acting muscle relaxant, plus aspirin, an analgesic with antipyretic and anti-inflammatory properties and codeine phosphate, a centrally-acting narcotic analgesic. It is available as a two-layered, white and yellow, oval-shaped tablet for oral administration. Each tablet contains carisoprodol 200 mg, aspirin 325 mg, and codeine phosphate 16 mg. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate. Its empirical formula is C 12 H 24 N 2 O 4 , with a molecular weight of 260.33. The structural formula is: Other ingredients: croscarmellose sodium, D&C Yellow #10, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, povidone, sodium metabisulfite, starch, stearic acid. CLINICAL PHARMACOLOGY Carisoprodol: Carisoprodol is a centrally-acting muscle relaxant that does not directly relax tense skeletal muscles in man. The mode of action of carisoprodol in relieving acute muscle spasm of local origin has not been clearly identified, but may be related to its sedative properties. In animals, carisoprodol has been shown to produce muscle relaxation by blocking interneuronal activity and depressing transmission of polysynaptic neurons in the spinal cord and in the descending reticular formation of the brain. The onset of action is rapid and lasts four to six hours. Carisoprodol is metabolized in the liver and is excreted by the kidneys. It is dialyzable by peritoneal and hemodialysis. Aspirin: Aspirin is a non-narcotic analgesic with anti-inflammatory and antipyretic activity. Inhibition of prostaglandin biosynthesis appears to account for most of its anti-inflammatory and for at least part of its analgesic and antipyretic properties. Aspirin is rapidly absorbed and almost totally hydrolyzed to salicylic acid following oral administration. Although aspirin has a half-life of only about 15 minutes, the apparent biologic half-life of salicylic acid in the therapeutic plasma concentration range is between 6 and 12 hours. Salicylic acid is eliminated by renal excretion and by biotransformation to inactive metabolites. Clearance of salicylic acid in the high-dose range is sensitive to urinary pH (see Drug Interactions ) and is reduced by renal dysfunction. Codeine Phosphate: Codeine phosphate is a centrally-acting narcotic-analgesic. Its actions are qualitatively similar to morphine, but its potency is substantially less. Clinical studies have shown that combining aspirin and codeine produces a significant additive effect in analgesic efficacy. INDICATIONS AND USAGE `Soma' Compound with Codeine is indicated as an adjunct to rest, physical therapy, and other measures for the relief of pain, muscle spasm, and limited mobility associated with acute, painful musculoskeletal conditions when the additional action of codeine is desired. CONTRAINDICATIONS Acute intermittent porphyria; bleeding disorders; allergic or idiosyncratic reactions to carisoprodol, aspirin, codeine, or related compounds. WARNINGS On very rare occasions, the first dose of carisoprodol has been followed by idiosyncratic reactions, with symptoms appearing within minutes or hours. These may include extreme weakness, transient quadriplegia, dizziness, ataxia, temporary loss of vision, diplopia, mydriasis, dysarthria, agitation, euphoria, confusion, and disorientation. Although symptoms usually subside over the course of the next several hours, discontinue `Soma' Compound with Codeine and initiate appropriate supportive and symptomatic therapy, which may include epinephrine and/or antihistamines. In severe cases, corticosteroids may be necessary. Severe reactions have been manifested by asthmatic episodes, fever, weakness, dizziness, angioneurotic edema, smarting eyes, hypotension, and anaphylactoid shock. The effects of carisoprodol with agents such as alcohol, other CNS depressants, or psychotropic drugs may be additive. Appropriate caution should be exercised with patients who take one or more of these agents simultaneously with Soma Compound with Codeine. Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. PRECAUTIONS General: To avoid excessive accumulation of carisoprodol, aspirin, or their metabolites, use `Soma' Compound with Codeine with caution in patients with compromised liver or kidney function, or in elderly or debilitated patients (see CLINICAL PHARMACOLOGY ). Use with caution in patients with history of gastritis or peptic ulcer, in patients on anticoagulant therapy, and in addiction-prone individuals. Information for Patients: Caution patients that this drug may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a motor vehicle or operating machinery. Caution patients with a predisposition for gastrointestinal bleeding that concomitant use of aspirin and alcohol may have an additive effect in this regard. Caution patients that dosage of medications used for gout, arthritis, or diabetes may have to be adjusted when aspirin is administered or discontinued (see Drug Interactions ). Each enteric, film-coated, controlled-release tablet contains paroxetine hydrochloride equivalent to paroxetine as follows: 12.5 mg-yellow, 25 mg-pink, 37.5 mg-blue. One layer of the tablet consists of a degradable barrier layer and the other contains the active material in a hydrophilic matrix. Inactive ingredients consist of hypromellose, polyvinylpyrrolidone, lactose monohydrate, magnesium stearate, colloidal silicon dioxide, glyceryl behenate, methacrylic acid copolymer type C, sodium lauryl sulfate, polysorbate 80, talc, triethyl citrate, and 1 or more of the following colorants: Yellow ferric oxide, red ferric oxide, D&C Red No. 30, D&C Yellow No. 6, D&C Yellow No. 10, FD&C Blue No. 2. CLINICAL PHARMACOLOGY Pharmacodynamics: The efficacy of paroxetine in the treatment of major depressive disorder, panic disorder, social anxiety disorder, and premenstrual dysphoric disorder (PMDD) is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin (5-hydroxy-tryptamine, 5-HT). Studies at clinically relevant doses in humans have demonstrated that paroxetine blocks the uptake of serotonin into human platelets. In vitro studies in animals also suggest that paroxetine is a potent and highly selective inhibitor of neuronal serotonin reuptake and has only very weak effects on norepinephrine and dopamine neuronal reuptake. In vitro radioligand binding studies indicate that paroxetine has little affinity for muscarinic, alpha 1 -, alpha 2 -, beta-adrenergic-, dopamine (D 2 )-, 5-HT 1 -, 5-HT 2 -, and histamine (H 1 )-receptors; antagonism of muscarinic, histaminergic, and alpha 1 -adrenergic receptors has been associated with various anticholinergic, sedative, and cardiovascular effects for other psychotropic drugs. Because the relative potencies of paroxetine's major metabolites are at most 1/50 of the parent compound, they are essentially inactive. Pharmacokinetics: Tablets of PAXIL CR contain a degradable polymeric matrix (GEOMATRIX™) designed to control the dissolution rate of paroxetine over a period of approximately 4 to 5 hours. In addition to controlling the rate of drug release in vivo, an enteric coat delays the start of drug release until tablets of PAXIL CR have left the stomach. Paroxetine hydrochloride is completely absorbed after oral dosing of a solution of the hydrochloride salt. In a study in which normal male and female subjects (n = 23) received single oral doses of PAXIL CR at 4 dosage strengths (12.5 mg, 25 mg, 37.5 mg, and 50 mg), paroxetine C max and AUC 0-inf increased disproportionately with dose (as seen also with immediate-release formulations). Mean C max and AUC 0-inf values at these doses were 2.0, 5.5, 9.0, and 12.5 ng/mL, and 121, 261, 338, and 540 ng·hr./mL, respectively. T max was observed typically between 6 and 10 hours post-dose, reflecting a reduction in absorption rate compared with immediate-release formulations. The mean elimination half-life of paroxetine was 15 to 20 hours throughout this range of single doses of PAXIL CR. The bioavailability of 25 mg PAXIL CR is not affected by food. During repeated administration of PAXIL CR (25 mg once daily), steady state was reached within 2 weeks (i.e., comparable to immediate-release formulations). In a repeat-dose study in which normal male and female subjects (n = 23) received PAXIL CR (25 mg daily), mean steady state C max , C min , and AUC 0-24 values were 30 ng/mL, 20 ng/mL, and 550 ng·hr./mL, respectively. Based on studies using immediate-release formulations, steady-state drug exposure based on AUC 0-24 was several-fold greater than would have been predicted from single-dose data. The excess accumulation is a consequence of the fact that 1 of the enzymes that metabolizes paroxetine is readily saturable. In steady-state dose proportionality studies involving elderly and nonelderly patients, at doses of the immediate-release formulation of 20 mg to 40 mg daily for the elderly and 20 mg to 50 mg daily for the nonelderly, some nonlinearity was observed in both populations, again reflecting a saturable metabolic pathway. In comparison to C min values after 20 mg daily, values after 40 mg daily were only about 2 to 3 times greater than doubled. Social Anxiety Disorder: Usual Initial Dosage: PAXIL CR should be administered as a single daily dose, usually in the morning, with or without food. The recommended initial dose is 12.5 mg/day. Patients were dosed in a range of 12.5 mg to 37.5 mg/day in the clinical trial demonstrating the effectiveness of PAXIL CR in the treatment of social anxiety disorder. If the dose is increased, this should occur at intervals of at least 1 week, in increments of 12.5 mg/day, up to a maximum of 37.5 mg/day. Patients should be cautioned that PAXIL CR should not be chewed or crushed, and should be swallowed whole. Maintenance Therapy: There is no body of evidence available to answer the question of how long the patient treated with PAXIL CR should remain on it. Although the efficacy of PAXIL CR beyond 12 weeks of dosing has not been demonstrated in controlled clinical trials, social anxiety disorder is recognized as a chronic condition, and it is reasonable to consider continuation of treatment for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment. nsure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion, or in symptomatic patients. Activated charcoal should be administered. Due to the large volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be of benefit. No specific antidotes for paroxetine are known. A specific caution involves patients taking or recently having taken paroxetine who might ingest excessive quantities of a tricyclic antidepressant. In such a case, accumulation of the parent tricyclic and an active metabolite may increase the possibility of clinically significant sequelae and extend the time needed for close medical observation (see PRECAUTIONS -- Drugs Metabolized by Cytochrome P 450 IID 6 ). In managing overdosage, consider the possibility of multiple-drug involvement. The physician should consider contacting a poison control center for additional information on the treatment of any overdose. Telephone numbers for certified poison control centers are listed in the Physicians' Desk Reference (PDR). DOSAGE AND ADMINISTRATION Major Depressive Disorder: Usual Initial Dosage: PAXIL CR should be administered as a single daily dose, usually in the morning, with or without food. The recommended initial dose is 25 mg/day. Patients were dosed in a range of 25 mg to 62.5 mg/day in the clinical trials demonstrating the effectiveness of PAXIL CR in the treatment of major depressive disorder. As with all drugs effective in the treatment of major depressive disorder, the full effect may be delayed. Some patients not responding to a 25-mg dose may benefit from dose increases, in 12.5-mg/day increments, up to a maximum of 62.5 mg/day. Dose changes should occur at intervals of at least 1 week. Patients should be cautioned that PAXIL CR should not be chewed or crushed, and should be swallowed whole. Maintenance Therapy: There is no body of evidence available to answer the question of how long the patient treated with PAXIL CR should remain on it. It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Whether the dose of an antidepressant needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown. Systematic evaluation of the efficacy of immediate-release paroxetine hydrochloride has shown that efficacy is maintained for periods of up to 1 year with doses that averaged about 30 mg, which corresponds to a 37.5-mg dose of PAXIL CR, based on relative bioavailability considerations (see CLINICAL PHARMACOLOGY -- Pharmacokinetics ). Panic Disorder: Usual Initial Dosage: PAXIL CR should be administered as a single daily dose, usually in the morning. Patients should be started on 12.5 mg/day. Dose changes should occur in 12.5-mg/day increments and at intervals of at least 1 week. Patients were dosed in a range of 12.5 to 75 mg/day in the clinical trials demonstrating the effectiveness of PAXIL CR. The maximum dosage should not exceed 75 mg/day. Patients should be cautioned that PAXIL CR should not be chewed or crushed, and should be swallowed whole. Maintenance Therapy: Long-term maintenance of efficacy with the immediate-release formulation of paroxetine was demonstrated in a 3-month relapse prevention trial. In this trial, patients with panic disorder assigned to immediate-release paroxetine demonstrated a lower relapse rate compared to patients on placebo. Panic disorder is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment. Switching Patients to or From a Monoamine Oxidase Inhibitor: At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with PAXIL CR. Similarly, at least 14 days should be allowed after stopping PAXIL CR before starting an MAOI. Discontinuation of Treatment With PAXIL CR: Symptoms associated with discontinuation of immediate-release paroxetine hydrochloride or PAXIL CR have been reported (see PRECAUTIONS ). Patients should be monitored for these symptoms when discontinuing treatment, regardless of the indication for which PAXIL CR is being prescribed. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate. GEOMATRIX is a trademark of Jago Pharma, Muttenz, Switzerland. PRODUCT PHOTO(S): NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size. The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis. Premenstrual Dysphoric Disorder: Usual Initial Dosage: PAXIL CR should be administered as a single daily dose, usually in the morning, with or without food. PAXIL CR may be administered either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment. The recommended initial dose is 12.5 mg/day. In clinical trials, both 12.5 mg/day and 25 mg/day were shown to be effective. Dose changes should occur at intervals of at least 1 week. Patients should be cautioned that PAXIL CR should not be chewed or crushed, and should be swallowed whole. Maintenance/Continuation Therapy: The effectiveness of PAXIL CR for a period exceeding 3 menstrual cycles has not been systematically evaluated in controlled trials. However, women commonly report that symptoms worsen with age until relieved by the onset of menopause. Therefore, it is reasonable to consider continuation of a responding patient. Patients should be periodically reassessed to determine the need for continued treatment. Never let your child stop taking an antidepressant without first talking to his or her healthcare provider. Stopping an antidepressant suddenly can cause other symptoms. There are Benefits and Risks When Using Antidepressants Antidepressants are used to treat depression and other illnesses. Depression and other illnesses can lead to suicide. In some children and teenagers, treatment with an antidepressant increases suicidal thinking or actions. It is important to discuss all the risks of treating depression and also the risks of not treating it. You and your child should discuss all treatment choices with your healthcare provider, not just the use of antidepressants. Other side effects can occur with antidepressants (see section below). Of all the antidepressants, only fluoxetine (Prozac®) * has been FDA approved to treat pediatric depression. For obsessive compulsive disorder in children and teenagers, FDA has approved only fluoxetine (Prozac®) * , ser-traline (Zoloft®) * , fluvoxamine, and clomipramine (Anafranil®) * . Your healthcare provider may suggest other antidepressants based on the past experience of your child or other family members. Is this all I need to know if my child is being prescribed an antidepressant? No. This is a warning about the risk for suicidality. Other side effects can occur with antidepressants. Be sure to ask your healthcare provider to explain all the side effects of the particular drug he or she is prescribing. Also ask about drugs to avoid when taking an antidepressant. Ask your healthcare provider or pharmacist where to find more information. *The following are registered trademarks of their respective manufacturers: Prozac®/Eli Lilly and Company; Zoloft®/Pfizer Pharmaceuticals; Anafranil®/Mallinckrodt Inc. This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants. The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you. The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products. Bipolar Disorder Special Populations: Treatment of Pregnant Women During the Third Trimester: Neonates exposed to PAXIL CR and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS ). When treating pregnant women with paroxetine during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering paroxetine in the third trimester. Dosage for Elderly or Debilitated Patients, and Patients With Severe Renal or Hepatic Impairment: The recommended initial dose of PAXIL CR is 12.5 mg/day for elderly patients, debilitated patients, and/or patients with severe renal or hepatic impairment. Increases may be made if indicated. Dosage should not exceed 50 mg/day. Paroxetine is extensively metabolized after oral administration. The principal metabolites are polar and conjugated products of oxidation and methylation, which are readily cleared. Conjugates with glucuronic acid and sulfate predominate, and major metabolites have been isolated and identified. Data indicate that the metabolites have no more than 1/50 the potency of the parent compound at inhibiting serotonin uptake. The metabolism of paroxetine is accomplished in part by cytochrome P 450 IID 6 . Saturation of this enzyme at clinical doses appears to account for the nonlinearity of paroxetine kinetics with increasing dose and increasing duration of treatment. The role of this enzyme in paroxetine metabolism also suggests potential drug-drug interactions (see PRECAUTIONS ). Approximately 64% of a 30-mg oral solution dose of paroxetine was excreted in the urine with 2% as the parent compound and 62% as metabolites over a 10-day post-dosing period. About 36% was excreted in the feces (probably via the bile), mostly as metabolites and less than 1% as the parent compound over the 10-day post-dosing period. Drug Interactions: Clinically important interactions may occur when certain drugs are administered concomitantly with aspirin or aspirin-containing drugs. Oral Anticoagulants -- By interfering with platelet function or decreasing plasma prothrombin concentration, aspirin enhances the potential for bleeding in patients on anticoagulants. Methotrexate -- aspirin enhances the toxic effects of this drug. Probenecid and Sulfinpyrazone -- large doses of aspirin reduce the uricosuric effect of both drugs. Renal excretion of salicylate may also be reduced. Oral Antidiabetic Drugs -- enhancement of hypoglycemia may occur. Antacids -- to the extent that they raise urinary pH, antacids may substantially decrease plasma salicylate concentrations; conversely, their withdrawal can result in a substantial increase. Ammonium Chloride -- this and other drugs that acidify a relatively alkaline urine can elevate plasma salicylate concentrations. Ethyl Alcohol -- enhanced aspirin-induced fecal blood loss has been reported. Corticosteroids -- salicylate plasma levels may be decreased when adrenal corticosteroids are given, and may be increased substantially when they are discontinued. Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term studies have been done with `Soma' Compound with Codeine. Pregnancy--Teratogenic Effects: Pregnancy Category C. Adequate animal reproduction studies have not been conducted with `Soma' Compound with Codeine. It is also not known whether `Soma' Compound with Codeine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. `Soma' Compound with Codeine should be given to a pregnant woman only if clearly needed. Studies in rodents have shown salicylates to be teratogenic when given in early gestation, and embryocidal when given in later gestation in doses considerably greater than usual therapeutic doses in humans. Studies in women who took aspirin during pregnancy have not demonstrated an increased incidence of congenital abnormalities in the offspring. Labor and Delivery: Ingestion of aspirin near term or prior to delivery may prolong delivery or lead to bleeding in mother, fetus, or neonate. Nursing Mothers: Carisoprodol is excreted in human milk in concentrations two-to-four times that in maternal plasma. Aspirin is excreted in human milk in moderate amounts and can produce a bleeding tendency in nursing infants. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness in children below the age of twelve have not been established. ADVERSE REACTIONS If severe reactions occur, discontinue `Soma' Compound with Codeine and initiate appropriate symptomatic and supportive therapy. The following side effects which have occurred with the administration of the individual ingredients alone may also occur with the combination. Carisoprodol: Central Nervous System --Drowsiness is the most frequent complaint and along with other CNS effects may require dosage reduction. Observed less frequently are dizziness, vertigo and ataxia. Tremor, agitation, irritability, headache, depressive reactions, syncope, and insomnia have been infrequent or rare. Idiosyncratic --Idiosyncratic reactions are very rare. They are usually seen within the period of the first to fourth dose in patients having had no previous contact with the drug (see WARNINGS ). Allergic --Skin rash, erythema multiforme, pruritus, eosinophilia, and fixed drug eruptions with cross-reaction to meprobamate have been reported. If allergic reactions occur, discontinue `Soma' Compound with Codeine and treat symptomatically. In evaluating possible allergic reactions, also consider allergy to excipients (information on excipients is available to physicians on request). Cardiovascular --Tachycardia, postural hypotension, and facial flushing. Gastrointestinal --Nausea, vomiting, epigastric distress and hiccup. Hematologic --No serious blood dyscrasias have been attributed to carisoprodol alone. Leukopenia and pancytopenia have been reported, very rarely, in situations in which other drugs or viral infections may have been responsible. Aspirin: The most common adverse reactions associated with the use of aspirin have been gastrointestinal, including nausea, vomiting, gastritis, occult bleeding, constipation and diarrhea. Gastric erosion, angioedema, asthma, rash, pruritus and urticaria have been reported less commonly. Tinnitus is a sign of high serum salicylate levels (see OVERDOSAGE ). Aspirin Intolerance --Allergic type reactions in aspirin-sensitive individuals may involve the respiratory tract or the skin. Symptoms of the former range from rhinorrhea and shortness of breath to severe asthma, and the latter may consist of urticaria, edema, rash, or angioedema (giant hives). These may occur independently or in combination. Codeine Phosphate: Nausea, vomiting, constipation, miosis, sedation, and dizziness have been reported. DRUG ABUSE AND DEPENDENCE Controlled Substance: Schedule C-III (see PRECAUTIONS ).

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Drug Interactions: Tramadol can impair thinking and the physical abilities required for driving or operating machinery. Tramadol should be avoided in patients intoxicated with alcohol, hypnotics, and narcotics. Large doses of tramadol administered with alcohol or anesthetic agents can impair breathing. Tramadol can increase the risk of seizure in epileptic patients, especially with simultaneous use of tricyclic antidepressants, such as Elavil. No dosage adjustment or reduction is necessary in healthy elderly patients 65-75 years of age. Patients over the age of 75 years, and those with liver and kidney dysfunction may need lower dosages. The safety of tramadol in children has not been established. Tramadol may rarely be habit forming. Tramadol should be avoided in patients with a history of opiate addiction or hypersensitivity to opiate medications. Pregnancy: The safety of tramadol during pregnancy has not been established. Nursing Mothers: The safety of tramadol in nursing mothers has not been established. Side Effects: Tramadol is generally well tolerated and side effects are usually transient. Commonly reported side effects include nausea, constipation, dizziness, headache, drowsiness, and vomiting. Less commonly reported side effects include itching, sweating, dry mouth, diarrhea, rash, visual disturbances, and vertigo. Related Links on MedicineNet.com Page 2 of this Article The Doctor's Response Information on this web site is provided for informational purposes only and is not a substitute for professional medical advice. You should not use the information on this web site for diagnosing or treating a medical or health condition. You should carefully read all product packaging. If you have or suspect you have a medical problem, promptly contact your professional healthcare provider. Statements and information regarding dietary supplements have not been evaluated or approved by the Food and Drug Administration. Please consult your healthcare provider before beginning any course of supplementation or treatment. Rapid Ultram Detox Confidential, painless and safe. Financing available; call us today! www.detox911.com Buy Ultram at Wholesale Smart shoppers buy Ultram at wholesale prices. No membership. www.pillsavers.com Chemical formula C16H25NO2 Molecular weight 263.4 g/mol Bioavailability 68-72% Increases with repeated dosing. Metabolism Hepatic demethylated & glucuronidated Elimination half-life 5-7 hours Excretion Renal Pregnancy category C (USA) C (Australia) Legal status Schedule 4 (Australia) Routes of administration Oral, IV, IM Tramadol (INN) (IPA: [?tr?m?d?l]) is an atypical opioid which is a centrally acting analgesic, used for treating moderate to severe pain. It is a synthetic agent, unrelated to other opioids, and appears to have actions on the GABAergic, noradrenergic and serotonergic systems. Tramadol was developed by the German pharmaceutical company Grunenthal GmbH and marketed under the trade name Tramal. Grunenthal has also cross licensed the drug to many other pharmaceutical companies that market it under various names, some of which are listed below. Tramadol is available in both injectable (intravenous and/or intramuscular) and oral preparations. It is usually marketed as the hydrochloride salt (tramadol hydrochloride). Dosages vary depending on the degree of pain experienced by the patient. Tramadol is approximately 10% as potent as morphine, when given by the IV/IM route. Oral doses range from 50–400 mg daily, with up to 600 mg daily when given IV/IM. Tramadol has a limited popularity as a recreational drug, and is referred to as "Tram-Tram" amongst users. Mechanism of action The mechanism of action of tramadol has yet to be fully elucidated, but it is believed to work through modulation of the GABAergic, noradrenergic and serotonergic systems. The contribution of non-opioid activity is demonstrated by the analgesic effects of tramadol not being fully antagonised by the ?-opioid receptor antagonist naloxone. Tramadol is marketed as a racemic mixture with a weak affinity for the ?-opioid receptor (approximately 1/6000th that of morphine). The (+)-enantiomer is approximately four times more potent than the (-)-enantiomer in terms of ?-opioid receptor affinity and 5-HT reuptake, whereas the (-)-enantiomer is responsible for noradrenaline reuptake effects (Shipton, 2000). These actions appear to produce a synergistic analgesic effect, with (+)-tramadol exhibiting 10-fold higher analgesic activity than (-)-tramadol (Goeringer et al., 1997). The serotonergic modulating properties of tramadol mean that it has the potential to interact with other serotonergic agents. There is an increased risk of serotonin syndrome when tramadol is taken in combination with serotonin reuptake inhibitors (e.g. SSRIs), since these agents not only potentiate the effect of 5-HT but also inhibit tramadol's metabolism. Metabolism Tramadol undergoes hepatic metabolism via the cytochrome P450 isozyme CYP2D6, being O- and N-demethylated to 5 different metabolites. Of these, M1 is the most significant since it has 200 times the ?-affinity of (+)-tramadol, and furthermore has an elimination half-life of 9 hours compared to 6 hours for tramadol itself. In the 6% of the population who have slow CYP2D6 activity, there is therefore a slightly reduced analgesic effect. Phase II hepatic metabolism renders the metabolites water-soluble and they are renally excreted. Thus reduced doses may be used in renal and hepatic impairment. Adverse effects The most commonly reported adverse drug reactions are nausea, vomiting and sweating. Drowsiness is reported, although it is less of an issue compared to other opioids. Respiratory depression, a common side effect of most opioids, is not clinically significant in normal doses. By itself, it does not increase the seizure threshold, though it may do if used in combination with SSRIs, tricyclic antidepressants, or in patients with epilepsy. Dependence Some controversy exists regarding the dependence liability of tramadol. Grunenthal has promoted it as an opioid with a low risk of dependence compared to traditional opioids, claiming little evidence of such dependence in clinical trials. They offer the theory that since the M1 metabolite is the principal agonist at ?-opioid receptors, the delayed agonist activity reduces dependence liability. The noradrenaline reuptake effects may also play a role in reducing dependence. Despite these claims it is apparent, in community practice, that dependence to this agent does occur. This would be expected since analgesic and dependence effects mediated by the same ?-opioid receptor. However, this dependence liability is considered relatively low by health authorities, such that tramadol is classified as a Schedule 4 Prescription Only Medicine in Australia, rather than as a Schedule 8 Controlled Drug like other opioids (Rossi, 2004). Similarly, tramadol is not currently scheduled by the U.S. DEA, unlike other opioid analgesics. Nevertheless, the Prescribing Information for Ultram warns that tramadol "may induce psychic and physical dependence of the morphine-type." Proprietary preparations Grunenthal, which still owns the patent to tramadol, has cross-licensed the agent to various pharmaceutical companies internationally. Thus tramadol is marketed under many trade names including: Adolonta, Contramal, Crispin, Nobligan, Siverol, Tiparol, Toplagic, Tradol, Tradolan, Tralgit, Tramacet, Tramadin, Tramal, Tramahexal, Tramazac, Ultracet, Ultram, Zamadol and Zydol. Abuse Late reports of abuse have been encountered in the United Kingdom through stolen prescriptions. The drug has been discovered to be sold for around ?4-5.00 a gram. It is either snorted, injected or taken oraly per two 50mg capsules, also poured into 1g capsules and taken as a "shot". Usually followed by an increased dose due to metabolic variation. References Goeringer KE, Logan BK, Christian GD. Identification of tramadol and its metabolites in blood from drug-related deaths and drug-impaired drivers. J Anal Toxicol 1997;21(7):529-37. PMID 9399121 Rossi S, editor. Australian Medicines Handbook 2004 (AMH). Adelaide: Australian Medicines Handbook; 2004. ISBN 0-9578521-4-2. Shipton EA. Tramadol – present and future. Anaesth Intensive Care 2000;28(4):363-74. PMID 10969362 Ultram – U.S. Prescribing Information McDiarmid T. What is the addiction risk associated with tramadol? Jour Fam Prac. January 2005 Vol. 54, No. 1 This entry is from Wikipedia, the leading user-contributed encyclopedia. It may not have been reviewed by professional editors (see full disclaimer) Donate to Wikimedia Tramadol Overnight All Orders - Free FedEx Shipping Fast & Discreet US Pharmacy 1-800# www.BestNetPharmacies.com Ultram 50mg $50 (200) Generic Ultram Low Prices MediSave Canada Pharmacy. www.MediSave.ca Mentioned In ultram is mentioned in these AnswerPages: List of drugs: U SOS (video game) chlorprothixene levomepromazine perphenazine postherpetic neuralgia Restless legs syndrome chlorpromazine selective serotonin reuptake inhibitor obsessive-compulsive disorder CanadaPharmacy.com The #1 Canadian Mail Order Pharmacy Over 500,000 Clients 1-800-891-0844 www.CanadaPharmacy.com Order Ultram Cheap 100% FDA approved. 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Why is this medication prescribed? Tramadol is used to relieve moderate to moderately severe pain. It also may be used to treat pain caused by surgery and chronic conditions such as cancer or joint pain. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information. How should this medicine be used? Tramadol comes as a tablet to take by mouth. It usually is taken every 4-6 hours as needed. It may be taken with or without food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tramadol exactly as directed. Tramadol can be habit-forming. Do not take a larger dose, take it more often, or for a longer period than your doctor tells you to. What special precautions should I follow? Before taking tramadol, tell your doctor and pharmacist if you are allergic to tramadol, codeine, or any other drugs. tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially other pain relievers; carbamazepine (Tegretol); MAO inhibitors [phenelzine (Nardil) or tranylcypromine (Parnate)]; medications for depression; quinidine; sleeping pills; tranquilizers; and vitamins. tell your doctor if you have or have ever had kidney or liver disease, a history of seizures, or a history of alcohol or drug abuse. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking tramadol, call your doctor. if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking tramadol. you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you. remember that alcohol can add to the drowsiness caused by this drug. What should I do if I forget a dose? Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. What side effects can this medication cause? Although side effects from tramadol are not common, they can occur. Tell your doctor if any of these symptoms are severe or do not go away: If you experience any of the following symptoms, call your doctor immediately: fast heartbeat redness, swelling, and itching of the face numbness or tingling of the hands and feet difficulty breathing changes in urination seizures What storage conditions are needed for this medicine? Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication. In case of emergency/overdose In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911. What other information should I know? Keep all appointments with your doctor. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug. HOW TO USE: Take this medication by mouth as prescribed. It is usually taken every 4 to 6 hours as needed. Use this medication exactly as prescribed. Do not increase your dose, use it more frequently or use it for a longer period of time than prescribed because this drug can be habit-forming. Also, if used for an extended period of time, do not suddenly stop using this drug without your doctor's approval. When used for extended periods, this medication may not work as well and may require different dosing. Consult your doctor if the medication stops working well. SIDE EFFECTS: This medication may cause dizziness, weakness, incoordination, nausea or vomiting, stomach upset, constipation, headache, drowsiness, anxiety, irritability, dry mouth, or increased sweating. If any of these effects persist or worsen, inform your doctor. Notify your doctor if you develop any of these serious effects while taking this medication: chest pain, rapid heart rate, skin rash or itching, mental confusion, disorientation, seizures, tingling of the hands or feet, trouble breathing. In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, breathing trouble. If you notice other effects not listed above, contact your doctor or pharmacist. PRECAUTIONS: Tell your doctor your medical history, especially of: kidney disease, liver disease, seizure disorder, lung disease, history of drug or alcohol dependency, any allergies you may have. Limit alcohol as it may add to the dizziness or drowsiness effects caused by the medication. Because this drug may make you dizzy/drowsy, use caution performing tasks requiring alertness such as driving. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Tramadol is excreted into breast milk. Because the effects on a nursing infant are not known, consult your doctor before breast- feeding. DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription medications you may use, especially of: carbamazepine, narcotic pain relievers (e.g., codeine), drugs used to aid sleep, antidepressants (e.g., SSRI-types such as fluoxetine or fluvoxamine), MAO inhibitors (e.g., furazolidone, linezolid, phenelzine, procarbazine, selegiline, tranylcypromine), psychiatric medicine (e.g., nefazodone), "triptan"-type drugs, anti-anxiety drugs (e.g., diazepam), sibutramine. Also, report use of certain antihistamines (e.g., diphenhydramine) which are also present in many cough-and-cold products. Do not start or stop any medicine without doctor or pharmacist approval. OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include cold and clammy skin, low body temperature, slowed breathing, slowed heartbeat, drowsiness, dizziness, lightheadedness, deep sleep, loss of consciousness, or seizures. MISSED DOSE: If you miss a dose, take it as soon as remembered; do not take it if it is near the time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. STORAGE: Store this medication at room temperature between 59 and 86 degrees F (15 to 30 degrees C) away from heat and light. Do not store in the bathroom. Keep this and all medications out of the reach of children. Ultram tramadol (TRAM a dol) Ultram, Ultram ER What is the most important information I should know about Ultram? • You should not take Ultram if you have ever been addicted to drugs or alcohol. • Take Ultram exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor. Do not take more than 300 milligrams of Ultram in one day. • Do not stop using this medication suddenly without talking to your doctor. You may need to gradually reduce the dose. Withdrawal symptoms may occur when you stop using Ultram. Withdrawal symptoms include anxiety, sweating, nausea, diarrhea, tremors, chills, hallucinations, trouble sleeping, or breathing problems. Call your doctor at once if you have any of these withdrawal symptoms after you stop using Ultram. • Do not crush the Ultram tablet. This medicine is for oral (by mouth) use only. Powder from a crushed tablet should not be inhaled or diluted with liquid and injected into the body. Using this medicine by inhlation or injection can cause life-threatening side effects, overdose, or death. • Seizures (convulsions) have occurred in some people taking Ultram. You may be more likely to have a seizure while taking Ultram if you have a history of seizures or head injury, a metabolic disorder, or if you are taking certain medicines such as antidepressants, muscle relaxers, or medicine for nausea and vomiting. • Seek emergency medical attention if you think you have used too much of this medicine. A Ultram overdose can be fatal. Symptoms of a Ultram overdose may include drowsiness, shallow breathing, slow heartbeat, extreme weakness, cold or clammy skin, feeling light-headed, fainting, or coma. • While you are taking Ultram, do not drink alcohol or use drugs that make you sleepy (such as cold medicine, other pain medications, muscle relaxants, and medicine for seizures, depression or anxiety). These drugs may slow your breathing or increase drowsiness when used together with Ultram. • Ultram can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. What is Ultram? • Ultram is a narcotic pain reliever. • Ultram is used to treat moderate to severe pain. Ultram extended-release is used to treat moderate to severe chronic pain when treatment is needed around the clock. • Ultram may also be used for purposes other than those listed in this medication guide. What should I discuss with my healthcare provider before taking Ultram? • You should not take Ultram if you have ever been addicted to drugs or alcohol. • Do not take Ultram if you are intoxicated (drunk), or if you have recently used any of the following drugs: · alcohol; · narcotic pain medicine; · sedatives or tranquilizers (such as Valium); · medicine for depression or anxiety; · medicine for mental illness (such as bipolar disorder, schizophrenia); or · street drugs. • Seizures have occurred in some people taking Ultram. Your risk of a seizure may be higher if you have any of these conditions: · a history of drug or alcohol addiction; · a history of epilepsy or other seizure disorder; · a history of head injury; or · a metabolic disorder. • Talk with your doctor about your individual risk of having a seizure from this medicine. • Before taking Ultram, tell your doctor if you have: · kidney disease; · liver disease; · a stomach disorder; or · a history of depression, mental illness, or suicide attempt. • If you have any of these conditions, you may not be able to use Ultram, or you may need a dosage adjustment or special tests during treatment. • FDA pregnancy category C. This medication may be harmful to an unborn baby. Ultram may also cause serious or fatal side effects in a newborn if the mother uses the medication during pregnancy or labor. Tell your doctor if you are pregnant or plan to become pregnant during treatment. • Ultram can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. • Older adults may be more sensitive to the effects of Ultram. If you are over 65, your doctor may recommend a lower dose. • Ultram should not be given to a child younger than 16 years of age. How should I take Ultram? • Take Ultram exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor. Do not take more than 300 milligrams of Ultram in one day. • Take each dose with a full glass of water. • Ultram can be taken with or without food, but take it the same way each time. • Do not crush the Ultram tablet. This medicine is for oral (by mouth) use only. Powder from a crushed tablet should not be inhaled or diluted with liquid and injected into the body. Using this medicine by inhlation or injection can cause life-threatening side effects, overdose, or death. • Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time. • If you use the Ultram extended-release tablet, the tablet shell may pass into your stools (bowel movements). This is normal and does not mean that you are not receiving enough of the medicine. • Ultram may be habit-forming. Tell your doctor if you feel the medicine is not working as well in relieving your pain. Do not change your dose without talking to your doctor. • Do not stop using this medication suddenly without talking to your doctor. You may need to gradually reduce the dose. Withdrawal symptoms may occur when you stop using Ultram. Withdrawal symptoms include anxiety, sweating, nausea, diarrhea, tremors, chills, hallucinations, trouble sleeping, or breathing problems. Call your doctor at once if you have any of these withdrawal symptoms after you stop using Ultram. • Store Ultram at room temperature away from moisture and heat. What happens if I miss a dose? • Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose. What happens if I overdose? • Seek emergency medical attention if you think you have used too much of this medicine. A Ultram overdose can be fatal. • Symptoms of a Ultram overdose may include drowsiness, shallow breathing, slow heartbeat, extreme weakness, cold or clammy skin, feeling light-headed, fainting, or coma. What should I avoid while taking Ultram? • Do not drink alcohol while you are taking Ultram. Alcohol may cause a dangerous decrease in your breathing when used together with Ultram. • Avoid using drugs that make you sleepy (such as cold medicine, other pain medications, muscle relaxants, and medicine for seizures, depression or anxiety). These drugs may slow your breathing or increase drowsiness when used together with Ultram. • Ultram can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. What are the possible side effects of Ultram? • Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. • Stop using Ultram and call your doctor at once if you have any of these serious side effects: · seizure (convulsions); · a red, blistering, peeling skin rash; or · shallow breathing, weak pulse. • Continue taking Ultram and talk to your doctor if you have any of these less serious side effects: · dizziness, drowsiness, weakness; · nausea, vomiting, constipation, loss of appetite; · blurred vision; · flushing (redness, warmth, or tingly feeling); or · sleep problems (insomnia). • Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. What other drugs will affect Ultram? • You may be more likely to have a seizure (convulsions) if you take Ultram while you are using certain other medicines. Do not take Ultram without telling your doctor if you also use any of the following: · an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam); or · an antidepressant such as amitriptyline (Elavil), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor); paroxetine (Paxil), or sertraline (Zoloft). • Before taking Ultram, tell your doctor if you also use: · carbamazepine (Tegretol); · warfarin (Coumadin); · digoxin (Lanoxin, Lanoxicaps); · ketoconazole (Nizoral); · erythromycin (E-Mycin, E.E.S., Ery-Tab); · rifampin (Rifadin, Rimactane, Rifater); · St. John's wort; · quinidine (Quinaglute, Quinadex, Cardioquin, Quinora); or · drugs that make you sleepy (such as cold medicine, other pain medications, muscle relaxants, and medicine for seizures, depression or anxiety). • If you are using any of these drugs, you may not be able to use Ultram or you may need dosage adjustments or special tests during treatment. • There may be other drugs not listed that can affect Ultram. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Do not exceed the recommended dose or take this medicine for longer than prescribed. If you experience difficulty breathing or tightness of chest; swelling of eyelids, face, or lips; or develop a rash or hives, tell your doctor immediately. Do not take any more of this medicine unless your doctor tells you to do so. Avoid alcohol while you are using this medicine. This medicine will add to the effects of alcohol and other depressants. Do not drive, operated machinery, or do anything else that could be dangerous until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. Before you begin taking any new medicine, either prescription or over-the-counter, check with your doctor or pharmacist. For women: if you plan on becoming pregnant, discuss with your doctor the benefits and risks of using this medicine during pregnancy. This medicine is excreted in breast milk. Do not breast-feed while taking this medicine. If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include cold and clammy skin, low body temperature, slowed breathing, slowed heartbeat, drowsiness, dizziness, lightheadedness, seizures, deep sleep, and loss of consciousness. Tramadol hydrochloride tablets) Ultram is a prescription medication indicated for the management of moderate to moderately severe pain. Ultram was approved March 3, 1995 by FDA Name : Ultram (Tramadol hydrochloride tablets) is a centrally acting analgesic. Ultram is a prescription medication used to treat pain. Ultram received U.S. Food and Drug Administration (FDA) approval in March 1995. Tramadol, the main ingredient in Ultram, has been prescribed for more than 55 million patients worldwide and more than 21 million patients in the United States. What should I discuss with my doctor before taking Ultram? Do not take Ultram without first talking to your doctor if you Seizures have been reported as a rare side effect of treatment with Ultram. The risk of seizures may be increased in patients who have any of the conditions or are taking any of the medications listed below: have a history of seizures or epilepsy have a head injury have a metabolic disorder have a central nervous system infection are experiencing alcohol or drug withdrawal are taking a tricyclic antidepressant such as amitriptyline (Elavil), nortriptyline (Pamelor), doxepin (Sinequan), imipramine (Tofranil), clomipramine (Anafranil), and others... are taking a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) are taking a psychiatric medication such as chlorpromazine (Thorazine), fluphenazine (Prolixin), haloperidol (Haldol), loxapine (Loxitane), mesoridazine (Serentil), perphenazine (Trilafon), thioridazine (Mellaril), thiothixene (Navane), and others... are taking a selective serotonin reuptake inhibitor (SSRI) such as fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or citalopram (Celexa) are taking a narcotic pain reliever such as codeine, fentanyl (Duragesic), hydromorphone (Dilaudid), meperidine (Demerol), hydrocodone (Vicodin, Lorcet, Lortab, others), morphine (MS Contin, MSIR, RMS, Roxanol, others), oxycodone (Roxicodone, Percocet, Percodan, others), propoxyphene (Darvon, Darvocet, others), and others... are taking promethazine (Phenergan) or prochlorperazine (Compazine) are taking sibutramine (Meridia) are taking bupropion (Wellbutrin, Zyban) are taking cyclobenzaprine (Flexeril) Before taking Ultram, tell your doctor if you have kidney disease liver disease history of alcohol or drug dependence You may not be able to take Ultram, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above. Ultram is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. It is also not known whether Ultram passes into breast milk. Do not take Ultram without first talking to your doctor if you are breast-feeding a baby. If you are over 75 years of age, you may be more likely to experience side effects from Ultram. The maximum daily dose of Ultram for people over 75 years of age is 300 mg. Ultram is not approved by the FDA for use by children younger than 16 years of age Warnings Do not drink alcohol don't use sedatives, tranquilizers, antihistamines, or narcotic pain relievers while taking Ultram. Use caution when driving, operating machinery, or performing other hazardous activities. Ultram may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. 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Alprazolam is a short-acting drug in the benzodiazepine class used to treat anxiety disorders and as an adjunctive treatment for depression. Alprazolam was invented by Pfizer and is marketed under the trade name Xanax. Its patent expired in September 1993. Pharmacology Alprazolam is a triazolobenzodiazepine, that is, a benzodiazepine with a triazolo-ring attached to its structure. Alprazolam binds to the GABAA subtype of the GABA receptor, increasing inhibitory effects of GABA within the central nervous system. The binding site for benzodiazepines is distinct from the binding site for barbiturates and GABA on the GABA receptor. Unlike other benzodiazepines, alprazolam may also have some antidepressant activity, although clinical evidence of this is lacking. Pharmacokinetics The mechanism of action is not fully understood; However, Alprazolam is readily absorbed from the gastrointestinal tract. The peak plasma concentration is achieved in 1-2 hours. Most of the drug is bound to plasma protein, mainly albumin. Alprazolam is hydroxylated in the liver to ?-hydroxyalprazolam, which is also pharmacologically active. This and other metabolites are later excreted in urine as glucuronides. Some of the drug is also excreted in unchanged form. Indications alprazolam 2mg tablet bottleThe main medical uses for alprazolam include: Treatment of panic disorder, with or without agoraphobia. Alprazolam is very effective in preventing panic attacks. However, despite its efficacy, many psychiatrists are reluctant to use alprazolam for this condition because of the possibility of dependence and interdose ("breakthrough") anxiety due to its short-acting nature. An extended-release formulation of alprazolam known as Xanax XR® was introduced in 2001 and is often preferred. Treatment of panic attacks. Alprazolam is taken as needed (PRN); 4 to 6 doses per day are the acceptable limit. If dependence seems to develop and/or the limit is exceeded, therapy may be reconsidered and/or discontinued. Long-term treatment of severe generalized anxiety disorders. Alprazolam may be used for long-term treatment of anxiety if other therapies either do not work or are contraindicated. Duration of therapy in this case is often four months or longer. The decision to use alprazolam for this purpose must be carefully made by a specialized psychiatrist, taking into account the individual's suffering, quality of life, loss of social performance and risk of dependence. Adjunctive treatment of depression. SSRIs (e.g. sertraline or fluoxetine) are often co-administered with alprazolam at the outset of long-term SSRI anxiety treatment in order to counteract the initial anxiogenic (anxiety-producing) effects of SSRI treatment. Tricyclic antidepressants and buspirone are also used with alprazolam in refractory (resistant) cases of generalized anxiety disorder. Other uses. Alprazolam may be used by specialists to treat severe cases of Borderline Personality Disorder. Some studies have shown positive results. [edit] Availability Alprazolam is generally sold in generic form in the United States. It is also sold under many other brand names, depending on the country: Xanax® - United States, Australia, United Kingdom, Turkey, Portugal, Ireland, Greece, Hungary, Belgium, Croatia, Switzerland, Netherlands, Italy, New Zealand, Pakistan Xanax XR® - (an extended release formulation) United States, Israel[1] Frontal® - Brazil Frontal XR® - (an extended release formulation) Brazil Apraz® - Brazil Aceprax® - Uruguay Sedipral® - Paraguay Helex® - Slovenia, Croatia Niravam® - (formulary that dissolves on the tongue) United States Apo-Alpraz® - Canada (also made by other companies under different names) Xanor® - Finland, Philippines, South Africa, Sweden, Norway, Austria Kalma® - Australia Ralozam® - Australia Zamhexal® - Australia Alplax® - Argentina Alviz® - Indonesia Alzolam® - India, Malaysia Alprax® - India Tranax® - India Alpralid® - Israel Restyl® - Bahrain, Cyprus, Egypt, India, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, Republic of Yemen, Saudi Arabia, Syria, United Arab Emirates Tranquinal® - Ecuador, Peru Trankimazin® - Spain Tafil® - Costa Rica, Denmark, El Salvador, Germany, Guatemala, Honduras, Mexico, Nicaragua, Panama, Venezuela Tafil AP® - (an extended release formulation) Mexico Constan® - Japan Solanax® - Japan Zolarem® - Bahrain, Benin, Burkina-Faso, Cyprus, Egypt, Ethiopia, Gambia, Ghana, Guinea, Iran, Iraq, Israel, Ivory Coast, Jordan, Kenya, Kuwait, Lebanon, Liberia, Libya, Malawi, Mali, Mauritania, Mauritius, Morocco, Niger, Nigeria, Oman, Qatar, Republic of Yemen, Saudi Arabia, Senegal, Seychelles, Sierra-Leone, South Africa, Sudan, Syria, Tanzania, Tunia, Uganda, United Arab Emirates, Zambia, Zimbabwe Zoldac® - Benin, Burkina-Faso, Ethiopia, Gambia, Ghana, Guinea, India, Ivory Coast, Kenya, Liberia, Malawi, Mali, Mauritania, Mauritius, Morocco, Niger, Nigeria, Senegal, Seychelles, Sierra-Leone, South Africa, Sudan, Tanzania, Tunia, Uganda, Zambia, Zimbabwe Calmax® - Ireland Frontin® - Slovakia and possibly other European countries Prazolex® - Romania Kinax® (???) - Taiwan Manorest® - Sri Lanka Ksalol® - Serbia [edit] Packaging Appearance is generally as follows in the United States. Alprazolam Inscriptions on tablet vary depending on manufacturer. .25 mg White oval tablet scored .5 mg Peach oval tablet scored (.5 mg Alprazolam may also be found in White round tablet scored) 1 mg Blue oval tablet scored 2 mg White rectangle multi-scored tablet. May also be called a Xanax XR® .5 mg White pentagonal tablet Imprinted "X /0.5" 1 mg Yellow square tablet Imprinted "X / 1" 2 mg Blue round tablet Imprinted "X / 2" 3 mg Green triangular tablet Imprinted "X / 3" Side effects Common side effects of alprazolam can include: Somnolence (drowsiness) Euphoria Confusion Less common side effects can include: Fatigue Headache Rare side effects can include: Sleep apnea Hypoventilation (Respiratory depression) Blurred vision Difficulty in depth perception Slurred speech or dysarthria Changes in personality Confusion Disorientation Amnesia (memory impairment) Vivid dreams and/or nightmares Jaundice Tachycardia Bradycardia Changes in plasma cortisol and ACTH levels Blood dyscrasias Decreased salivation Increased salivation Diarrhea Constipation Nausea Elevated hepatic (liver) enzymes Incontinence Rare paradoxical side effects can include: Nervousness Anxiety Agitation Rage Insomnia Muscle spasms and rigidity Paradoxical side effects are usually a result of too high a dose (sometimes deliberate) and/or combination with alcohol. Adjusting the dosage usually causes them to cease. Long-term treatment with alprazolam may lead to physical and/or psychological dependence. Users often develop a tolerance to the drug's sedative effects, though tolerance to its anxiolytic efficacy rarely develops when used at theraputic dosage levels. There is now a general consensus among many psychiatrists that alprazolam (a so-called 'high-potency' benzodiazepine) poses a particularly high risk for misuse, abuse and dependence. Withdrawal after long-term treatment should be done slowly over a period of weeks (or even months) to avoid serious withdrawal symptoms such as agitation, panic attacks, rebound anxiety, muscle cramps and seizures. Some patients may benefit from a substitution with diazepam or clonazepam as these drugs remain in the bloodstream longer and have a somewhat lower risk of dependency. Contraindications Use of alprazolam should be avoided in individuals with the following conditions: Myasthenia gravis Acute intoxication with alcohol, narcotics, or other psychoactive substances Ataxia Severe hypoventilation Acute narrow-angle glaucoma Severe liver deficiencies (e.g. hepatitis and cirrhosis) Severe sleep apnea Hypersensitivity or allergy to any drug in the benzodiazepine class Patients at a High Risk for Abuse and Dependence At a particularly high risk for misuse, abuse, and dependence are: Patients with a history of alcohol or drug abuse and/or dependence Emotionally unstable patients Patients with severe personality disorders Patients with chronic pain or other physical disorders Patients from the aforementioned group should be monitored very closely during therapy for signs of abuse and development of dependence. Discontinue therapy if any of these signs are noted. Long-term therapy in these patients is not recommended. alprazolam 2mg tabletsAlprazolam, like all benzodiazepines, has the potential for abuse, especially in individuals prone to addiction. Although it is not manufactured illegally, it is often diverted to the black market. The state of relaxation, anxiolysis, disinhibition and euphoria induced by benzodiazepines is the main reason for their illicit use. Injecting alprazolam is highly dangerous. When crushed in water, it will not dissolve, potentially causing severe damage to arteries. While it is somewhat soluble in alcohol, the combination of the two, particularly when injected, can easily cause a serious (and potentially fatal) overdose. Alprazolam is sometimes used with other recreational drugs to relieve the panic or distress of dysphoric reactions to psychedelics such as LSD and also to promote sleep in the "come-down" period following use of recreational drugs with stimulant or insomniac properties (such as LSD, cocaine, amphetamines, DXM, and MDMA). It is also often used in conjunction with marijuana or heroin to potentiate the relaxing effect. Alprazolam is often combined with the drug Methadone to produce a unique, Heroin-like "high". It is also sometimes used by heroin addicts to suppress withdrawal symptoms. Insufflating alprazolam is another popular recreational method of administration. This method is short-acting, lasting anywhere from 30 minutes to 1 hour. Because of fillers, snorting the drug causes moderate nasal inflammation. Users should be very careful when snorting Alprazolam, as when up to 4mg has been insufflated, rare side-effects are more likely to become present. The three dominant ones being 'memory loss', 'loss of motor-function', and 'slurred speech'. [citation needed] Legal status In the United States, alprazolam is a prescription drug and is assigned to Schedule IV of the Controlled Substances Act by the Drug Enforcement Administration. Internationally, alprazolam is included under the United Nations Convention on Psychotropic Substances[3]. Alprazolam is a short-acting drug in the benzodiazepine class used to treat anxiety disorders and as an adjunctive treatment for depression. Alprazolam was invented by Pfizer and is marketed under the trade name Xanax. Its patent expired in September 1993. Pharmacology Alprazolam is a triazolobenzodiazepine, that is, a benzodiazepine with a triazolo-ring attached to its structure. Alprazolam binds to the GABAA subtype of the GABA receptor, increasing inhibitory effects of GABA within the central nervous system. The binding site for benzodiazepines is distinct from the binding site for barbiturates and GABA on the GABA receptor. Unlike other benzodiazepines, alprazolam may also have some antidepressant activity, although clinical evidence of this is lacking. Pharmacokinetics The mechanism of action is not fully understood; However, Alprazolam is readily absorbed from the gastrointestinal tract. The peak plasma concentration is achieved in 1-2 hours. Most of the drug is bound to plasma protein, mainly albumin. Alprazolam is hydroxylated in the liver to ?-hydroxyalprazolam, which is also pharmacologically active. This and other metabolites are later excreted in urine as glucuronides. Some of the drug is also excreted in unchanged form. alprazolam 2mg tablet bottleThe main medical uses for alprazolam include: Treatment of panic disorder, with or without agoraphobia. Alprazolam is very effective in preventing panic attacks. However, despite its efficacy, many psychiatrists are reluctant to use alprazolam for this condition because of the possibility of dependence and interdose ("breakthrough") anxiety due to its short-acting nature. An extended-release formulation of alprazolam known as Xanax XR® was introduced in 2001 and is often preferred. Treatment of panic attacks. Alprazolam is taken as needed (PRN); 4 to 6 doses per day are the acceptable limit. If dependence seems to develop and/or the limit is exceeded, therapy may be reconsidered and/or discontinued. Long-term treatment of severe generalized anxiety disorders. Alprazolam may be used for long-term treatment of anxiety if other therapies either do not work or are contraindicated. Duration of therapy in this case is often four months or longer. The decision to use alprazolam for this purpose must be carefully made by a specialized psychiatrist, taking into account the individual's suffering, quality of life, loss of social performance and risk of dependence. Adjunctive treatment of depression. SSRIs (e.g. sertraline or fluoxetine) are often co-administered with alprazolam at the outset of long-term SSRI anxiety treatment in order to counteract the initial anxiogenic (anxiety-producing) effects of SSRI treatment. Tricyclic antidepressants and buspirone are also used with alprazolam in refractory (resistant) cases of generalized anxiety disorder. Other uses. Alprazolam may be used by specialists to treat severe cases of Borderline Personality Disorder. Some studies have shown positive results. Availability Alprazolam is generally sold in generic form in the United States. It is also sold under many other brand names, depending on the country: Xanax® - United States, Australia, United Kingdom, Turkey, Portugal, Ireland, Greece, Hungary, Belgium, Croatia, Switzerland, Netherlands, Italy, New Zealand, Pakistan Xanax XR® - (an extended release formulation) United States, Israel[1] Frontal® - Brazil Frontal XR® - (an extended release formulation) Brazil Apraz® - Brazil Aceprax® - Uruguay Sedipral® - Paraguay Helex® - Slovenia, Croatia Niravam® - (formulary that dissolves on the tongue) United States Apo-Alpraz® - Canada (also made by other companies under different names) Xanor® - Finland, Philippines, South Africa, Sweden, Norway, Austria Kalma® - Australia Ralozam® - Australia Zamhexal® - Australia Alplax® - Argentina Alviz® - Indonesia Alzolam® - India, Malaysia Alprax® - India Tranax® - India Alpralid® - Israel Restyl® - Bahrain, Cyprus, Egypt, India, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, Republic of Yemen, Saudi Arabia, Syria, United Arab Emirates Tranquinal® - Ecuador, Peru Trankimazin® - Spain Tafil® - Costa Rica, Denmark, El Salvador, Germany, Guatemala, Honduras, Mexico, Nicaragua, Panama, Venezuela Tafil AP® - (an extended release formulation) Mexico Constan® - Japan Solanax® - Japan Zolarem® - Bahrain, Benin, Burkina-Faso, Cyprus, Egypt, Ethiopia, Gambia, Ghana, Guinea, Iran, Iraq, Israel, Ivory Coast, Jordan, Kenya, Kuwait, Lebanon, Liberia, Libya, Malawi, Mali, Mauritania, Mauritius, Morocco, Niger, Nigeria, Oman, Qatar, Republic of Yemen, Saudi Arabia, Senegal, Seychelles, Sierra-Leone, South Africa, Sudan, Syria, Tanzania, Tunia, Uganda, United Arab Emirates, Zambia, Zimbabwe Zoldac® - Benin, Burkina-Faso, Ethiopia, Gambia, Ghana, Guinea, India, Ivory Coast, Kenya, Liberia, Malawi, Mali, Mauritania, Mauritius, Morocco, Niger, Nigeria, Senegal, Seychelles, Sierra-Leone, South Africa, Sudan, Tanzania, Tunia, Uganda, Zambia, Zimbabwe Calmax® - Ireland Frontin® - Slovakia and possibly other European countries Prazolex® - Romania Kinax® (???) - Taiwan Manorest® - Sri Lanka Ksalol® - Serbia Packaging Appearance is generally as follows in the United States. Alprazolam Inscriptions on tablet vary depending on manufacturer. .25 mg White oval tablet scored .5 mg Peach oval tablet scored (.5 mg Alprazolam may also be found in White round tablet scored) 1 mg Blue oval tablet scored 2 mg White rectangle multi-scored tablet. May also be called a "bar". Xanax XR® .5 mg White pentagonal tablet Imprinted "X /0.5" 1 mg Yellow square tablet Imprinted "X / 1" 2 mg Blue round tablet Imprinted "X / 2" 3 mg Green triangular tablet Imprinted "X / 3" Side effects Sleep apnea Hypoventilation (Respiratory depression) Blurred vision Difficulty in depth perception Slurred speech or dysarthria Changes in personality Confusion Disorientation Amnesia (memory impairment) Vivid dreams and/or nightmares Jaundice Tachycardia Bradycardia Changes in plasma cortisol and ACTH levels Blood dyscrasias Decreased salivation Increased salivation Diarrhea Constipation Nausea Elevated hepatic (liver) enzymes Incontinence Rare paradoxical side effects can include: Nervousness Anxiety Agitation Rage Insomnia Muscle spasms and rigidity Paradoxical side effects are usually a result of too high a dose (sometimes deliberate) and/or combination with alcohol. Adjusting the dosage usually causes them to cease. Long-term treatment with alprazolam may lead to physical and/or psychological dependence. Users often develop a tolerance to the drug's sedative effects, though tolerance to its anxiolytic efficacy rarely develops when used at theraputic dosage levels. There is now a general consensus among many psychiatrists that alprazolam (a so-called 'high-potency' benzodiazepine) poses a particularly high risk for misuse, abuse and dependence. Withdrawal after long-term treatment should be done slowly over a period of weeks (or even months) to avoid serious withdrawal symptoms such as agitation, panic attacks, rebound anxiety, muscle cramps and seizures. Some patients may benefit from a substitution with diazepam or clonazepam as these drugs remain in the bloodstream longer and have a somewhat lower risk of dependency. Contraindications Use of alprazolam should be avoided in individuals with the following conditions: Myasthenia gravis Acute intoxication with alcohol, narcotics, or other psychoactive substances Ataxia Severe hypoventilation Acute narrow-angle glaucoma Severe liver deficiencies (e.g. hepatitis and cirrhosis) Severe sleep apnea Hypersensitivity or allergy to any drug in the benzodiazepine class [edit] Patients at a High Risk for Abuse and Dependence At a particularly high risk for misuse, abuse, and dependence are: Patients with a history of alcohol or drug abuse and/or dependence Emotionally unstable patients Patients with severe personality disorders Patients with chronic pain or other physical disorders Patients from the aforementioned group should be monitored very closely during therapy for signs of abuse and development of dependence. Discontinue therapy if any of these signs are noted. Long-term therapy in these patients is not recommended. alprazolam 2mg tabletsAlprazolam, like all benzodiazepines, has the potential for abuse, especially in individuals prone to addiction. Although it is not manufactured illegally, it is often diverted to the black market. The state of relaxation, anxiolysis, disinhibition and euphoria induced by benzodiazepines is the main reason for their illicit use. Injecting alprazolam is highly dangerous. When crushed in water, it will not dissolve, potentially causing severe damage to arteries. While it is somewhat soluble in alcohol, the combination of the two, particularly when injected, can easily cause a serious (and potentially fatal) overdose. Alprazolam is sometimes used with other recreational drugs to relieve the panic or distress of dysphoric reactions to psychedelics such as LSD and also to promote sleep in the "come-down" period following use of recreational drugs with stimulant or insomniac properties (such as LSD, cocaine, amphetamines, DXM, and MDMA). It is also often used in conjunction with marijuana or heroin to potentiate the relaxing effect. Alprazolam is often combined with the drug Methadone to produce a unique, Heroin-like "high". It is also sometimes used by heroin addicts to suppress withdrawal symptoms. Insufflating alprazolam is another popular recreational method of administration. This method is short-acting, lasting anywhere from 30 minutes to 1 hour. Because of fillers, snorting the drug causes moderate nasal inflammation. Users should be very careful when snorting Alprazolam, as when up to 4mg has been insufflated, rare side-effects are more likely to become present. The three dominant ones being 'memory loss', 'loss of motor-function', and 'slurred speech'. [citation needed] Legal status In the United States, alprazolam is a prescription drug and is assigned to Schedule IV of the Controlled Substances Act by the Drug Enforcement Administration. Internationally, alprazolam is included under the United Nations Convention on Psychotropic Substances[3]. The ability of alprazolam to induce human hepatic enzyme systems has not yet been determined. However, this is not a property of benzodiazepines in general. Further, alprazolam did not affect the prothrombin or plasma warfarin levels in male volunteers administered sodium warfarin orally. In vitro, alprazolam is bound (80 percent) to human serum protein. Changes in the absorption, distribution, metabolism and excretion of benzodiazepines have been reported in a variety of disease states including alcoholism, impaired hepatic function and impaired renal function. Changes have also been demonstrated in geriatric patients. A mean half-life of alprazolam of 16.3 hours has been observed in healthy elderly subjects (range: 9.0-26.9 hours, n=16) compared to 11.0 hours (range: 6.3-15.8 hours, n=16) in healthy adult subjects. In patients with alcoholic liver disease the half-life of alprazolam ranged between 5.8 and 65.3 hours (mean: 19.7 hours, n=17) as compared to between 6.3 and 26.9 hours (mean=11.4 hours, n=17) in healthy subjects. In an obese group of subjects the half-life of alprazolam ranged between 9.9 and 40.4 hours (mean=21.8 hours, n=12) as compared to between 6.3 and 15.8 hours (mean=10.6 hours, n=12) in healthy subjects. Because of its similarity to other benzodiazepines, it is assumed that alprazolam undergoes transplacental passage and that it is excreted in human milk. INDICATIONS AND USAGE XANAX Tablets (alprazolam) are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of six months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or 'lump in throat'); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or `mind going blank' because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to XANAX. XANAX is also indicated for the treatment of panic disorder, with or without agoraphobia. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R criteria for panic disorder (see CLINICAL STUDIES ). Panic disorder is an illness characterized by recurrent panic attacks. The panic attacks, at least initially, are unexpected. Later in the course of this disturbance certain situations, eg, driving a car or being in a crowded place, may become associated with having a panic attack. These panic attacks are not triggered by situations in which the person is the focus of others' attention (as in social phobia). The diagnosis requires four such attacks within a four week period, or one or more attacks followed by at least a month of persistent fear of having another attack. The panic attacks must be characterized by at least four of the following symptoms: dyspnea or smothering sensations; dizziness, unsteady feelings, or faintness; palpitations or tachycardia; trembling or shaking; sweating; choking; nausea or abdominal distress; depersonalization or derealization; paresthesias; hot flashes or chills; chest pain or discomfort; fear of dying; fear of going crazy or of doing something uncontrolled. At least some of the panic attack symptoms must develop suddenly, and the panic attack symptoms must not be attributable to some known organic factors. Panic disorder is frequently associated with some symptoms of agoraphobia. Demonstrations of the effectiveness of XANAX by systematic clinical study are limited to four months duration for anxiety disorder and four to ten weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to eight months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient. CONTRAINDICATIONS XANAX Tablets are contraindicated in patients with known sensitivity to this drug or other benzodiazepines. XANAX may be used in patients with open angle glaucoma who are receiving appropriate therapy, but is contraindicated in patients with acute narrow angle glaucoma. XANAX is contraindicated with ketoconazole and itraconazole, since these medications significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP 3A) (see WARNINGS and PRECAUTIONS - Drug Interactions ). WARNINGS Dependence and withdrawal reactions, including seizures: Certain adverse clinical events, some life-threatening, are a direct consequence of physical dependence to XANAX. These include a spectrum of withdrawal symptoms; the most important is seizure (see DRUG ABUSE AND DEPENDENCE ). Even after relatively short-term use at the doses recommended for the treatment of transient anxiety and anxiety disorder (ie, 0.75 to 4.0 mg per day), there is some risk of dependence. Spontaneous reporting system data suggest that the risk of dependence and its severity appear to be greater in patients treated with doses greater than 4 mg/day and for long periods (more than 12 weeks). However, in a controlled postmarketing discontinuation study of panic disorder patients, the duration of treatment (three months compared to six months) had no effect on the ability of patients to taper to zero dose. In contrast, patients treated with doses of XANAX greater than 4 mg/day had more difficulty tapering to zero dose than those treated with less than 4 mg/day. The importance of dose and the risks of XANAX as a treatment for panic disorder: Because the management of panic disorder often requires the use of average daily doses of XANAX above 4 mg, the risk of dependence among panic disorder patients may be higher than that among those treated for less severe anxiety. Experience in randomized placebo-controlled discontinuation studies of patients with panic disorder showed a high rate of rebound and withdrawal symptoms in patients treated with XANAX compared to placebo treated patients. Relapse or return of illness was defined as a return of symptoms characteristic of panic disorder (primarily panic attacks) to levels approximately equal to those seen at baseline before active treatment was initiated. Rebound refers to a return of symptoms of panic disorder to a level substantially greater in frequency, or more severe in intensity than seen at baseline. Withdrawal symptoms were identified as those which were generally not characteristic of panic disorder and which occurred for the first time more frequently during discontinuation than at baseline. In a controlled clinical trial in which 63 patients were randomized to XANAX and where withdrawal symptoms were specifically sought, the following were identified as symptoms of withdrawal: heightened sensory perception, impaired concentration, dysosmia, clouded sensorium, paresthesias, muscle cramps, muscle twitch, diarrhea, blurred vision, appetite decrease and weight loss. Other symptoms, such as anxiety and insomnia, were frequently seen during discontinuation, but it could not be determined if they were due to return of illness, rebound or withdrawal. In a larger database comprised of both controlled and uncontrolled studies in which 641 patients received XANAX, discontinuation-emergent symptoms which occurred at a rate of over 5% in patients treated with XANAX and at a greater rate than the placebo treated group were as follows: From the studies cited, it has not been determined whether these symptoms are clearly related to the dose and duration of therapy with XANAX in patients with panic disorder. In two controlled trials of six to eight weeks duration where the ability of patients to discontinue medication was measured, 71%-93% of XANAX treated patients tapered completely off therapy compared to 89%-96% of placebo treated patients. In a controlled postmarketing discontinuation study of panic disorder patients, the duration of treatment (three months compared to six months) had no effect on the ability of patients to taper to zero dose. Seizures attributable to XANAX were seen after drug discontinuance or dose reduction in 8 of 1980 patients with panic disorder or in patients participating in clinical trials where doses of XANAX greater than 4 mg/day for over 3 months were permitted. Five of these cases clearly occurred during abrupt dose reduction, or discontinuation from daily doses of 2 to 10 mg. Three cases occurred in situations where there was not a clear relationship to abrupt dose reduction or discontinuation. In one instance, seizure occurred after discontinuation from a single dose of 1 mg after tapering at a rate of 1 mg every three days from 6 mg daily. In two other instances, the relationship to taper is indeterminate; in both of these cases the patients had been receiving doses of 3 mg daily prior to seizure. The duration of use in the above 8 cases ranged from 4 to 22 weeks. There have been occasional voluntary reports of patients developing seizures while apparently tapering gradually from XANAX. The risk of seizure seems to be greatest 24-72 hours after discontinuation (see DOSAGE AND ADMINISTRATION for recommended tapering and discontinuation schedule). The medical event voluntary reporting system shows that withdrawal seizures have been reported in association with the discontinuation of XANAX. In most cases, only a single seizure was reported; however, multiple seizures and status epilepticus were reported as well. Ordinarily, the treatment of status epilepticus of any etiology involves use of intravenous benzodiazepines plus phenytoin or barbiturates, maintenance of a patent airway and adequate hydration. For additional details regarding therapy, consultation with an appropriate specialist may be considered. Early morning anxiety and emergence of anxiety symptoms between doses of XANAX have been reported in patients with panic disorder taking prescribed maintenance doses of XANAX. These symptoms may reflect the development of tolerance or a time interval between doses which is longer than the duration of clinical action of the administered dose. In either case, it is presumed that the prescribed dose is not sufficient to maintain plasma levels above those needed to prevent relapse, rebound or withdrawal symptoms over the entire course of the interdosing interval. In these situations, it is recommended that the same total daily dose be given divided as more frequent administrations (see DOSAGE AND ADMINISTRATION ). Risk of dose reduction: Withdrawal reactions may occur when dosage reduction occurs for any reason. This includes purposeful tapering, but also inadvertent reduction of dose (eg, the patient forgets, the patient is admitted to a hospital, etc.). Therefore, the dosage of XANAX should be reduced or discontinued gradually (see DOSAGE AND ADMINISTRATION ). XANAX Tablets are not of value in the treatment of psychotic patients and should not be employed in lieu of appropriate treatment for psychosis. Because of its CNS depressant effects, patients receiving XANAX should be cautioned against engaging in hazardous occupations or activities requiring complete mental alertness such as operating machinery or driving a motor vehicle. For the same reason, patients should be cautioned about the simultaneous ingestion of alcohol and other CNS depressant drugs during treatment with XANAX. Benzodiazepines can potentially cause fetal harm when administered to pregnant women. If XANAX is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Because of experience with other members of the benzodiazepine class, XANAX is assumed to be capable of causing an increased risk of congenital abnormalities when administered to a pregnant woman during the first trimester. Because use of these drugs is rarely a matter of urgency, their use during the first trimester should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug. Alprazolam interaction with drugs that inhibit metabolism via cytochrome P450 3A: The initial step in alprazolam metabolism is hydroxylation catalyzed by cytochrome P450 3A (CYP 3A). Drugs that inhibit this metabolic pathway may have a profound effect on the clearance of alprazolam. Consequently, alprazolam should be avoided in patients receiving very potent inhibitors of CYP 3A. With drugs inhibiting CYP 3A to a lesser but still significant degree, alprazolam should be used only with caution and consideration of appropriate dosage reduction. For some drugs, an interaction with alprazolam has been quantified with clinical data; for other drugs, interactions are predicted from in vitro data and/or experience with similar drugs in the same pharmacologic class. The following are examples of drugs known to inhibit the metabolism of alprazolam and/or related benzodiazepines, presumably through inhibition of CYP 3A. Potent CYP 3A inhibitors: Azole antifungal agents --Although in vivo interaction data with alprazolam are not available, ketoconazole and itraconazole are potent CYP 3A inhibitors and the coadministration of alprazolam with them is not recommended. Other azole-type antifungal agents should also be considered potent CYP 3A inhibitors and the coadministration of alprazolam with them is not recommended (see CONTRAINDICATIONS ). Drugs demonstrated to be CYP 3A inhibitors on the basis of clinical studies involving alprazolam (caution and consideration of appropriate alprazolam dose reduction are recommended during coadministration with the following drugs): Nefazodone --Coadministration of nefazodone increased alprazolam concentration two-fold. Fluvoxamine --Coadministration of fluvoxamine approximately doubled the maximum plasma concentration of alprazolam, decreased clearance by 49%, increased half-life by 71%, and decreased measured psychomotor performance. Cimetidine --Coadministration of cimetidine increased the maximum plasma concentration of alprazolam by 86%, decreased clearance by 42%, and increased half-life by 16%. Other drugs possibly affecting alprazolam metabolism: Other drugs possibly affecting alprazolam metabolism by inhibition of CYP 3A are discussed in the PRECAUTIONS section (see PRECAUTIONS -- Drug Interactions ). PRECAUTIONS General: If XANAX Tablets are to be combined with other psychotropic agents or anticonvulsant drugs, careful consideration should be given to the pharmacology of the agents to be employed, particularly with compounds which might potentiate the action of benzodiazepines (see DRUG INTERACTIONS ). As with other psychotropic medications, the usual precautions with respect to administration of the drug and size of the prescription are indicated for severely depressed patients or those in whom there is reason to expect concealed suicidal ideation or plans. It is recommended that the dosage be limited to the smallest effective dose to preclude the development of ataxia or oversedation which may be a particular problem in elderly or debilitated patients. (See DOSAGE AND ADMINISTRATION .) The usual precautions in treating patients with impaired renal, hepatic or pulmonary function should be observed. There have been rare reports of death in patients with severe pulmonary disease shortly after the initiation of treatment with XANAX. A decreased systemic alprazolam elimination rate (eg, increased plasma half-life) has been observed in both alcoholic liver disease patients and obese patients receiving XANAX (see CLINICAL PHARMACOLOGY ). Episodes of hypomania and mania have been reported in association with the use of XANAX in patients with depression. Alprazolam has a weak uricosuric effect. Although other medications with weak uricosuric effect have been reported to cause acute renal failure, there have been no reported instances of acute renal failure attributable to therapy with XANAX. Information for Patients: For all users of XANAX: To assure safe and effective use of benzodiazepines, all patients prescribed XANAX should be provided with the following guidance. In addition, panic disorder patients, for whom doses greater than 4 mg/day are typically prescribed, should be advised about the risks associated with the use of higher doses. Inform your physician about any alcohol consumption and medicine you are taking now, including medication you may buy without a prescription. Alcohol should generally not be used during treatment with benzodiazepines. Not recommended for use in pregnancy. Therefore, inform your physician if you are pregnant, if you are planning to have a child, or if you become pregnant while you are taking this medication. Inform your physician if you are nursing. Until you experience how this medication affects you, do not drive a car or operate potentially dangerous machinery, etc. Do not increase the dose even if you think the medication "does not work anymore" without consulting your physician. Benzodiazepines, even when used as recommended, may produce emotional and/or physical dependence. Do not stop taking this medication abruptly or decrease the dose without consulting your physician, since withdrawal symptoms can occur. Additional advice for panic disorder patients: The use of XANAX at doses greater than 4 mg/day, often necessary to treat panic disorder, is accompanied by risks that you need to carefully consider. When used at doses greater than 4 mg/day, which may or may not be required for your treatment, XANAX has the potential to cause severe emotional and physical dependence in some patients and these patients may find it exceedingly difficult to terminate treatment. In two controlled trials of six to eight weeks duration where the ability of patients to discontinue medication was measured, 7 to 29% of patients treated with XANAX did not completely taper off therapy. In a controlled postmarketing discontinuation study of panic disorder patients, the patients treated with doses of XANAX greater than 4 mg/day had more difficulty tapering to zero dose than patients treated with less than 4 mg/day. In all cases, it is important that your physician help you discontinue this medication in a careful and safe manner to avoid overly extended use of XANAX. In addition, the extended use at doses greater than 4 mg/day appears to increase the incidence and severity of withdrawal reactions when XANAX is discontinued. These are generally minor but seizure can occur, especially if you reduce the dose too rapidly or discontinue the medication abruptly. Seizure can be life-threatening. Laboratory Tests: Laboratory tests are not ordinarily required in otherwise healthy patients. Drug Interactions: The benzodiazepines, including alprazolam, produce additive CNS depressant effects when co-administered with other psychotropic medications, anticonvulsants, antihistaminics, ethanol and other drugs which themselves produce CNS depression. The steady state plasma concentrations of imipramine and desipramine have been reported to be increased an average of 31% and 20%, respectively, by the concomitant administration of XANAX Tablets in doses up to 4 mg/day. The clinical significance of these changes is unknown. Drugs that inhibit alprazolam metabolism via cytochrome P450 3A: The initial step in alprazolam metabolism is hydroxylation catalyzed by cytochrome P450 3A (CYP 3A). Drugs which inhibit this metabolic pathway may have a profound effect on the clearance of alprazolam (see CONTRAINDICATIONS and WARNINGS for additional drugs of this type). Drugs demonstrated to be CYP 3A inhibitors of possible clinical significance on the basis of clinical studies involving alprazolam (caution is recommended during coadministration with alprazolam): Fluoxetine--Coadministration of fluoxetine with alprazalom increased the maximum plasma concentration of alprazolam by 46%, decreased clearance by 21%, increased half-life by 17%, and decreased measured psychomotor performance. Propoxyphene--Coadministration of propoxyphene decreased the maximum plasma concentration of alprazolam by 6%, decreased clearance by 38%, and increased half-life by 58%. Oral Contraceptives--Coadministration of oral contraceptives increased the maximum plasma concentration of alprazolam by 18%, decreased clearance by 22%, and increased half-life by 29%. Drugs and other substances demonstrated to be CYP 3A inhibitors on the basis of clinical studies involving benzodiazepines metabolized similarly to alprazolam or on the basis of in vitro studies with alprazolam or other benzodiazepines (caution is recommended during coadministration with alprazolam): Available data from clinical studies of benzodiazepines other than alprazolam suggest a possible drug interaction with alprazolam for the following: diltiazem, isoniazid, macrolide antibiotics such as erythromycin and clarithromycin, and grapefruit juice. Data from in vitro studies of alprazolam suggest a possible drug interaction with alprazolam for the following: sertraline and paroxetine. Data from in vitro studies of benzodiazepines other than alprazolam suggest a possible drug interaction for the following: ergotamine, cyclosporine, amiodarone, nicradipine, and nifedipine. Caution is recommended during the coadministration of any of these with alprazolam (see WARNINGS ). Drug/Laboratory Test Interactions: Although interactions between benzodiazepines and commonly employed clinical laboratory tests have occasionally been reported, there is no consistent pattern for a specific drug or specific test. Carcinogenesis, Mutagenesis, Impairment of Fertility: No evidence of carcinogenic potential was observed during 2-year bioassay studies of alprazolam in rats at doses up to 30 mg/kg/day (150 times the maximum recommended daily human dose of 10 mg/day) and in mice at doses up to 10 mg/kg/day (50 times the maximum recommended daily human dose). Alprazolam was not mutagenic in the rat micronucleus test at doses up to 100 mg/kg, which is 500 times the maximum recommended daily human dose of 10 mg/day. Alprazolam also was not mutagenic in vitro in the DNA Damage/Alkaline Elution Assay or the Ames Assay. Alprazolam produced no impairment of fertility in rats at doses up to 5 mg/kg/day, which is 25 times the maximum recommended daily human dose of 10 mg/day. Pregnancy: Teratogenic Effects: Pregnancy Category D: (See WARNINGS Section). Nonteratogenic Effects: It should be considered that the child born of a mother who is receiving benzodiazepines may be at some risk for withdrawal symptoms from the drug during the postnatal period. Also, neonatal flaccidity and respiratory problems have been reported in children born of mothers who have been receiving benzodiazepines. Labor and Delivery: XANAX has no established use in labor or delivery. Nursing Mothers: Benzodiazepines are known to be excreted in human milk. It should be assumed that alprazolam is as well. Chronic administration of diazepam to nursing mothers has been reported to cause their infants to become lethargic and to lose weight. As a general rule, nursing should not be undertaken by mothers who must use XANAX. Pediatric Use: Safety and effectiveness of XANAX in individuals below 18 years of age have not been established. Geriatric Use: The elderly may be more sensitive to the effects of benzodiazepines. They exhibit higher plasma alprazolam concentrations due to reduced clearance of the drug as compared with a younger population receiving the same doses. The smallest effective dose of XANAX should be used in the elderly to preclude the development of ataxia and oversedation (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION ). ADVERSE REACTIONS Side effects to XANAX Tablets, if they occur, are generally observed at the beginning of therapy and usually disappear upon continued medication. In the usual patient, the most frequent side effects are likely to be an extension of the pharmacological activity of alprazolam, eg, drowsiness or light-headedness. The data cited in the two tables below are estimates of untoward clinical event incidence among patients who participated under the following clinical conditions: relatively short duration (ie, four weeks) placebo-controlled clinical studies with dosages up to 4 mg/day of XANAX (for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety) and short-term (up to ten weeks) placebo-controlled clinical studies with dosages up to 10 mg/day of XANAX in patients with panic disorder, with or without agoraphobia. These data cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice where patient characteristics, and other factors often differ from those in clinical trials. These figures cannot be compared with those obtained from other clinical studies involving related drug products and placebo as each group of drug trials are conducted under a different set of conditions. Comparison of the cited figures, however, can provide the prescriber with some basis for estimating the relative contributions of drug and non-drug factors to the untoward event incidence in the population studied. Even this use must be approached cautiously, as a drug may relieve a symptom in one patient but induce it in others. (For example, an anxiolytic drug may relieve dry mouth [a symptom of anxiety] in some subjects but induce it [an untoward event] in others.) Additionally, for anxiety disorders the cited figures can provide the prescriber with an indication as to the frequency with which physician intervention (eg, increased surveillance, decreased dosage or discontinuation of drug therapy) may be necessary because of the untoward clinical event. In addition to the relatively common (ie, greater than 1%) untoward events enumerated in the table above, the following adverse events have been reported in association with the use of benzodiazepines: dystonia, irritability, concentration difficulties, anorexia, transient amnesia or memory impairment, loss of coordination, fatigue, seizures, sedation, slurred speech, jaundice, musculoskeletal weakness, pruritus, diplopia, dysarthria, changes in libido, menstrual irregularities, incontinence and urinary retention. PANIC DISORDER Treatment-Emergent Symptom Incidence * XANAX PLACEBO Number of Patients % of Patients Reporting: In addition to the relatively common (ie, greater than 1%) untoward events enumerated in the table above, the following adverse events have been reported in association with the use of XANAX: seizures, hallucinations, depersonalization, taste alterations, diplopia, elevated bilirubin, elevated hepatic enzymes, and jaundice. There have also been reports of withdrawal seizures upon rapid decrease or abrupt discontinuation of XANAX Tablets (see WARNINGS ). To discontinue treatment in patients taking XANAX, the dosage should be reduced slowly in keeping with good medical practice. It is suggested that the daily dosage of XANAX be decreased by no more than 0.5 mg every three days (see DOSAGE AND ADMINISTRATION ). Some patients may benefit from an even slower dosage reduction. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. Panic disorder has been associated with primary and secondary major depressive disorders and increased reports of suicide among untreated patients. Therefore, the same precaution must be exercised when using doses of XANAX greater than 4 mg/day in treating patients with panic disorders as is exercised with the use of any psychotropic drug in treating depressed patients or those in whom there is reason to expect concealed suicidal ideation or plans. As with all benzodiazepines, paradoxical reactions such as stimulation, increased muscle spasticity, sleep disturbances, hallucinations and other adverse behavioral effects such as agitation, rage, irritability, and aggressive or hostile behavior have been reported rarely. In many of the spontaneous case reports of adverse behavioral effects, patients were receiving other CNS drugs concomitantly and/or were described as having underlying psychiatric conditions. Should any of the above events occur, alprazolam should be discontinued. Isolated published reports involving small numbers of patients have suggested that patients who have borderline personality disorder, a prior history of violent or aggressive behavior, or alcohol or substance abuse may be at risk for such events. Instances of irritability, hostility, and intrusive thoughts have been reported during discontinuation of alprazolam in patients with post-traumatic stress disorder. Laboratory analyses were performed on patients participating in the clinical program for XANAX. The following incidences of abnormalities shown below were observed in patients receiving XANAX and in patients in the corresponding placebo group. Few of these abnormalities were considered to be of physiological signficance. When treatment with XANAX is protracted, periodic blood counts, urinalysis and blood chemistry analyses are advisable. Minor changes in EEG patterns, usually low-voltage fast activity have been observed in patients during therapy with XANAX and are of no known signficance. Post Introduction Reports: Various adverse drug reactions have been reported in association with the use of XANAX since market introduction. The majority of these reactions were reported through the medical event voluntary reporting system. Because of the spontaneous nature of the reporting of medical events and the lack of controls, a causal relationship to the use of XANAX cannot be readily determined. Reported events include: liver enzyme elevations, hepatitis, hepatic failure, Stevens-Johnson syndrome, hyperprolactinemia, gynecomastia and galactorrhea. DRUG ABUSE AND DEPENDENCE Physical and Psychological Dependence: Withdrawal symptoms similar in character to those noted with sedative/hypnotics and alcohol have occurred following discontinuance of benzodiazepines, including XANAX. The symptoms can range from mild dysphoria and insomnia to a major syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors and convulsions. Distinguishing between withdrawal emergent signs and symptoms and the recurrence of illness is often difficult in patients undergoing dose reduction. The long term strategy for treatment of these phenomena will vary with their cause and the therapeutic goal. When necessary, immediate management of withdrawal symptoms requires re-institution of treatment at doses of XANAX sufficient to suppress symptoms. There have been reports of failure of other benzodiazepines to fully suppress these withdrawal symptoms. These failures have been attributed to incomplete cross-tolerance but may also reflect the use of inadequate dosing regimen of the substituted benzodiazepine or the effects of concomitant medications. While it is difficult to distinguish withdrawal and recurrence for certain patients, the time course and the nature of the symptoms may be helpful. A withdrawal syndrome typically includes the occurrence of new symptoms, tends to appear toward the end of taper or shortly after discontinuation, and will decrease with time. In recurring panic disorder, symptoms similar to those observed before treatment may recur either early or late, and they will persist. While the severity and incidence of withdrawal phenomena appear to be related to dose and duration of treatment, withdrawal symptoms, including seizures, have been reported after only brief therapy with XANAX at doses within the recommended range for the treatment of anxiety (eg, 0.75 to 4 mg/day). Signs and symptoms of withdrawal are often more prominent after rapid decrease of dosage or abrupt discontinuance. The risk of withdrawal seizures may be increased at doses above 4 mg/day (see WARNINGS ). Patients, especially individuals with a history of seizures or epilepsy, should not be abruptly discontinued from any CNS depressant agent, including XANAX. It is recommended that all patients on XANAX who require a dosage reduction be gradually tapered under close supervision (see WARNINGS and DOSAGE AND ADMINISTRATION ). Psychological dependence is a risk with all benzodiazepines, including XANAX. The risk of psychological dependence may also be increased at doses greater than 4 mg/day and with longer term use, and this risk is further increased in patients with a history of alcohol or drug abuse. Some patients have experienced considerable difficulty in tapering and discontinuing from XANAX, especially those receiving higher doses for extended periods. Addiction-prone individuals should be under careful surveillance when receiving XANAX. As with all anxiolytics, repeat prescriptions should be limited to those who are under medical supervision. Controlled Substance Class: Alprazolam is a controlled substance under the Controlled Substance Act by the Drug Enforcement Administration and XANAX Tablets have been assigned to Schedule IV. OVERDOSAGE Manifestations of alprazolam overdosage include somnolence, confusion, impaired coordination, diminished reflexes and coma. Death has been reported in association with overdoses of alprazolam by itself, as it has with other benzodiazepines. In addition, fatalities have been reported in patients who have overdosed with a combination of a single benzodiazepine, including alprazolam, and alcohol; alcohol levels seen in some of these patients have been lower than those usually associated with alcohol-induced fatality. The acute oral LD 50 in rats is 331-2171 mg/kg. Other experiments in animals have indicated that cardiopulmonary collapse can occur following massive intravenous doses of alprazolam (over 195 mg/kg; 975 times the maximum recommended daily human dose of 10 mg/day). Animals could be resuscitated with positive mechanical ventilation and the intravenous infusion of norepinephrine bitartrate. Animal experiments have suggested that forced diuresis or hemodialysis are probably of little value in treating overdosage. General Treatment of Overdose: Overdosage reports with XANAX Tablets are limited. As in all cases of drug overdosage, respiration, pulse rate, and blood pressure should be monitored. General supportive measures should be employed, along with immediate gastric lavage. Intravenous fluids should be administered and an adequate airway maintained. If hypotension occurs, it may be combated by the use of vasopressors. Dialysis is of limited value. As with the management of intentional overdosing with any drug, it should be borne in mind that multiple agents may have been ingested. Flumazenil, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdosage. Patients treated with flumazenil should be monitored for re-sedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert including CONTRAINDICATIONS , WARNINGS and PRECAUTIONS should be consulted prior to use. DOSAGE AND ADMINISTRATION Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who require doses greater than 4 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects. Anxiety disorders and transient symptoms of anxiety: Treatment for patients with anxiety should be initiated with a dose of 0.25 to 0.5 mg given three times daily. The dose may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses. The lowest possible effective dose should be employed and the need for continued treatment reassessed frequently. The risk of dependence may increase with dose and duration of treatment. In elderly patients, in patients with advanced liver disease or in patients with debilitating disease, the usual starting dose is 0.25 mg, given two or three times daily. This may be gradually increased if needed and tolerated. The elderly may be especially sensitive to the effects of benzodiazepines. If side effects occur at the recommended starting dose, the dose may be lowered. In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction. Panic disorder: The successful treatment of many panic disorder patients has required the use of XANAX at doses greater than 4 mg daily. In controlled trials conducted to establish the efficacy of XANAX in panic disorder, doses in the range of 1 to 10 mg daily were used. The mean dosage employed was approximately 5 to 6 mg daily. Among the approximately 1700 patients participating in the panic disorder development program, about 300 received XANAX in dosages of greater than 7 mg/day, including approximately 100 patients who received maximum dosages of greater than 9 mg/day. Occasional patients required as much as 10 mg a day to achieve a successful response. Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Thereafter, the dose can be increased at intervals equal to at least 5 times the elimination half-life (about 11 hours in young patients, about 16 hours in elderly patients). Longer titration intervals should probably be used because the maximum therapeutic response may not occur until after the plasma levels achieve steady state. Dose should be advanced until an acceptable therapeutic response (ie, a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained. For patients receiving doses greater than 4 mg/day, periodic reassessment and consideration of dosage reduction is advised. In a controlled postmarketing dose-response study, patients treated with doses of XANAX greater than 4 mg/day for three months were able to taper to 50% of their total maintenance dose without apparent loss of clinical benefit. Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided. (See WARNINGS , PRECAUTIONS , DRUG ABUSE AND DEPENDENCE ). The following regimen is one that follows the principles outlined above: Treatment may be initiated with a dose of 0.5 mg three times daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg per day. Slower titration to the dose levels greater than 4 mg/day may be advisable to allow full expression of the pharmacodynamic effect of XANAX. To lessen the possibility of interdose symptoms, the times of administration should be distributed as evenly as possible throughout the waking hours, that is, on a three or four times per day schedule. The necessary duration of treatment for panic disorder patients responding to XANAX is unknown. After a period of extended freedom from attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena. In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reduced by no more than 0.5 mg every three days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Rx only PRODUCT PHOTO(S): NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size. The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis. ANIMAL STUDIES When rats were treated with alprazolam at 3, 10, and 30 mg/kg/day (15 to 150 times the maximum recommended human dose) orally for 2 years, a tendency for a dose related increase in the number of cataracts was observed in females and a tendency for a dose related increase in corneal vascularization was observed in males. These lesions did not appear until after 11 months of treatment. CLINICAL STUDIES Anxiety Disorders: XANAX Tablets were compared to placebo in double blind clinical studies (doses up to 4 mg/day) in patients with a diagnosis of anxiety or anxiety with associated depressive symptomatology. XANAX was significantly better than placebo at each of the evaluation periods of these four week studies as judged by the following psychometric instruments: Physician's Global Impressions, Hamilton Anxiety Rating Scale, Target Symptoms, Patient's Global Impressions and Self-Rating Symptom Scale. Panic Disorder: Support for the effectiveness of XANAX in the treatment of panic disorder came from three short-term, placebo-controlled studies (up to 10 weeks) in patients with diagnoses closely corresponding to DSM-III-R criteria for panic disorder. The average dose of XANAX was 5-6 mg/day in two of the studies, and the doses of XANAX were fixed at 2 and 6 mg/day in the third study. In all three studies, XANAX was superior to placebo on a variable defined as "the number of patients with zero panic attacks" (range, 37-83% met this criterion), as well as on a global improvement score. In two of the three studies, XANAX was superior to placebo on a variable defined as "change from baseline on the number of panic attacks per week" (range, 3.3-5.2), and also on a phobia rating scale. A subgroup of patients who were improved on XANAX during short-term treatment in one of these trials was continued on an open basis up to eight months, without apparent loss of benefit. The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you. The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products Avoid Dangerous Statins Use a Natural Cholesterol Remedy Safely Drop 30 Points, Guaranteed! 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