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Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics." It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression. other central nervous system actions, or metabolic effects may be involved. Adult obese subjects instructed in dietary management and treated with "anorectic" drugs, lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term clinical trials. IONAMINE Capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification, and caloric restriction in the management of exogenous obesity for patients with an initial body mass index >=30 kg/m2, or >=27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidem 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 Ionamin® Phentermine resin SA, generic name for the appetite suppressant Ionamin®. Ionamin® 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 Ionamin® has been indicated in the development of primary pulmonary hypertension, a rare, fatal disease of the lungs, as well as valvular heart disease. 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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! Ionamin 30mg (20 pills) 56.95 Ionamin 30mg (30 pills) 81.95 Ionamin 30mg (60 pills) 167.95 Ionamin 30mg (90 pills) 238.95 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. 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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 Order Ionamin Low As $56.95 30mg x20 pills $56.95 Free FedEx Shipping on All orders. US Pharmacy. US orders only. Secure and discreet online ordering. drugstorescripts.com Ionimine Brand Diet Pills Lose weight today with Ionamin alternative. Ionimine provides powerful weight loss results and requires no prescription. Order Ionimine and lose weight today with it. www.lab88.com More internet results for ionamine... Sponsored Results Ionamin® is a popular brand name for the weight loss diet pill phentermine. Ionamin is taken on an empty stomach 1 hour before meals. 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Our hours are now 8:00am-5:00pm EST Ionamin® IONAMIN ® (brand name Phentermine) Capsules 30mg. (Appetite Suppressant - Oral) Uses Ionamin medication is used as an appetite suppressant. It is used in conjunction with an overall diet plan to reduce weight. How to take this medication This medication is best taken on an empty stomach one hour before meals. 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. Side effects Dry mouth, sleeplessness, irritability, stomach upset or constipation may occur the first few days as your body adjusts to Ionamin. If these effects persist or become bothersome, inform your doctor. Precautions Tell your doctor your complete medical history especially if you have high blood pressure, an over-active thyroid, glaucoma, diabetes or emotional problems. Consult with your doctor if you think you are pregnant or before breast-feeding. Alcohol can increase unwanted side effects of dizziness. Limit alcohol use. Ionamin is not recommended for use in children. Consult your doctor or pharmacist for further information. Drug interactions Inform your doctor about all the medicines you use, (prescription and nonprescription) especially if you take high blood pressure medicine or MAO inhibitors (e.g., furazolidone, phenelzine, selegiline, tranylcypromine) or 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 medicine. 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. Miss 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. Keep this and all medications out of the reach of children. 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. 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What should my physician know before I take Ionamin They need to know if you have any of these conditions: heart disease diabetes glaucoma thyroid disease high blood pressure taken other medications to lose weight in the past year pregnant or trying to get pregnant breast-feeding an unusual or allergic reaction to phendimetrazine, other medications, foods, dyes, or preservatives What if I miss a dose of Ionamin If you miss a dose of Ionamin, take it as soon as you can. If it is late in the day, or near bedtime, do not take that dose. Do not take double or extra doses of Ionamin. Side effects of Ionamin Side effects of Ionamin are 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. 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What is Ionamin? · Ionamin is a sympathomimetic amine, which is similar to an amphetamine. It is also known as an "anorectic" or "anorexigenic" drug. Ionamin stimulates the central nervous system (nerves and brain), which increases your heart rate and blood pressure and decreases your appetite. · Ionamin is used as a short-term supplement to diet and exercise in the treatment of obesity. · Ionamin may also be used for purposes other than those listed in this medication guide. Who should not take Ionamin? · You cannot take Ionamin if you ·have heart disease or high blood pressure; ·have arteriosclerosis (hardening of the arteries); ·have glaucoma; ·have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), or phenelzine (Nardil) in the last 14 days; or ·have a history of drug or alcohol abuse. · Before taking this medication, tell your doctor if you have ·problems with your thyroid, ·an anxiety disorder, ·epilepsy or another seizure disorder, or ·diabetes. · You may not be able to take Ionamin, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above. · It is not known whether Ionamin will harm an unborn baby. Do not take Ionamin without first talking to your doctor if you are pregnant. · It is also not known whether Ionamin passes into breast milk. Do not take Ionamin without first talking to your doctor if you are breast-feeding a baby. How should I take Ionamin? · Take Ionamin exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you. · Take each dose with a full glass of water. · Ionamin is usually taken once or twice a day before a meal on an empty stomach. · Do not take Ionamin in the evening because it may cause insomnia. · Do not crush, chew or open any "once-daily" Ionamin tablets or capsules. Swallow them whole. · Never take more of this medication than is prescribed for you. Too much Ionamin could be very dangerous to your health. · Store Ionamin at room temperature away from moisture and heat. What happens if I miss a dose? · Take the missed dose as soon as you remember. However, if it is almost time for your next dose or if it is already evening, skip the missed dose and take only your next regularly scheduled dose. A dose taken too late in the day will cause insomnia. Do not take a double dose of this medication. What happens if I overdose? · Seek emergency medical attention. · Symptoms of a Ionamin overdose include restlessness, tremor, rapid breathing, confusion, hallucinations, panic, aggressiveness, nausea, vomiting, diarrhea, an irregular heartbeat, and seizures. What should I avoid while taking Ionamin? · Use caution when driving, operating machinery, or performing other hazardous activities. Amphetamine may cause dizziness, blurred vision, or restlessness, and it may hide the symptoms of extreme tiredness. If you experience these effects, avoid hazardous activities. · Do not take Ionamin late in the day. A dose taken too late in the day can cause insomnia. What are the possible side effects of Ionamin? · If you experience any of the following serious side effects, stop taking Ionamin and seek emergency medical attention: ·an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives); ·an irregular heartbeat or very high blood pressure (severe headache, blurred vision); or ·hallucinations, abnormal behavior, or confusion. · Other, less serious side effects may be more likely to occur. Continue to take Ionamin and talk to your doctor if you experience ·restlessness or tremor, ·nervousness or anxiety, ·headache or dizziness, ·insomnia, ·dry mouth or an unpleasant taste in your mouth, ·diarrhea or constipation, or ·impotence or changes in your sex drive. · Ionamin is habit forming. You can become physically and psychologically dependent on this medication, and withdrawal effects may occur if you stop taking it suddenly after several weeks of continuous use. Talk to your doctor about stopping this medication gradually. · 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 Ionamin? · You cannot take Ionamin if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), or phenelzine (Nardil) in the last 14 days. · Changes in insulin and other diabetes drug therapies may be necessary during treatment with Ionamin. · Ionamin may reduce the effects of guanethidine (Ismelin). This could lead to an increase in blood pressure. Tell your doctor if you are taking guanethidine. · Before taking this medication, tell your doctor if you are taking a tricyclic antidepressant such as amitriptyline (Elavil), amoxapine (Asendin), doxepin (Sinequan), nortriptyline (Pamelor), imipramine (Tofranil), clomipramine (Anafranil), protriptyline (Vivactil), or desipramine (Norpramin). 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The information provided includes the following: what is Lortab the possible side effects of Lortab what happens if you miss a dose of Lortab what happens if you overdose with Lortab the most important information about Lortab how to use Lortab other drugs that may affect Lortab what to avoid while using Lortab Generic Name: acetaminophen and hydrocodone (ah see ta MIH no fen and hye dro KOE done) Brand Names: Anexsia, Anolor DH5, Bancap HC, Dolacet, Lorcet 10/ 650, Lorcet HD, Lorcet Plus, Lortab, Lortab 10, Lortab 5/ 500, Lortab 7.5/ 500, Lortab Elixir, Norco, T-Gesic, Vicodin, Vicodin ES, Vicodin HP, Zydone What is the most important information I should know about acetaminophen and hydrocodone? • Hydrocodone is habit forming. It is possible become physically and/ or psychologically dependent on the medication. Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor. Withdrawal effects may occur if acetaminophen and hydrocodone is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose. • Avoid alcohol while taking acetaminophen and hydrocodone. Alcohol can increase drowsiness and dizziness caused by the medication, possibly resulting in unconsciousness and death. Also, acetaminophen can be damaging to the liver when taken with alcohol. • Acetaminophen and hydrocodone may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if acetaminophen and hydrocodone is taken with any of these medications. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor. • Acetaminophen and hydrocodone may cause constipation. Drink plenty of water (six to eight full glasses a day) to lessen this side effect. Increased fiber in the diet may also help to alleviate constipation. What is acetaminophen and hydrocodone? • Hydrocodone (related to codeine) is in a class of drugs called narcotic analgesics. It relieves pain. • Acetaminophen is a less potent pain reliever that increases the effects of hydrocodone. • Together, acetaminophen and hydrocodone are used to relieve moderate-to-severe pain. • Acetaminophen and hydrocodone may also be used for purposes other than those listed in this medication guide. What should I discuss with my healthcare provider before taking acetaminophen and hydrocodone? • Before taking this medication, tell your doctor if you have · a history of alcohol or drug abuse; · kidney disease; · liver disease; · asthma; · urinary retention; · an enlarged prostate; · hypothyroidism; · seizures or epilepsy; · gallbladder disease; · a head injury; or · Addison's disease. • You may not be able to take acetaminophen and hydrocodone, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above. • Acetaminophen and hydrocodone 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 or could become pregnant during treatment. • Acetaminophen and hydrocodone passes into breast milk and may affect a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. • If you are younger than 18 years of age or older than 60 years of age, you may be more likely to experience side effects from acetaminophen and hydrocodone. Your doctor may prescribe a lower dose. How should I take acetaminophen and hydrocodone? • Take acetaminophen and hydrocodone exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you. • Take each dose with a full glass of water. • Take acetaminophen and hydrocodone with food or milk if it causes stomach upset. • To ensure that you get a correct dose, measure the liquid form of acetaminophen and hydrocodone with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one. • Hydrocodone is habit forming. It is possible become physically and/ or psychologically dependent on the medication. Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor. Withdrawal effects may occur if acetaminophen and hydrocodone is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose. • Acetaminophen and hydrocodone may cause constipation. Drink plenty of water (six to eight full glasses a day) to lessen this side effect. Increased fiber in the diet may also help to alleviate constipation. • Store acetaminophen and hydrocodone at room temperature away from moisture and heat. What happens if I miss a dose? • Take the missed dose as soon as you remember. Do not take a double dose of this medication. Wait the prescribed amount of time before taking the next dose. What happens if I overdose? • Seek emergency medical attention if an overdose is suspected. • Symptoms of an acetaminophen and hydrocodone overdose may include slow breathing, seizures, dizziness, weakness, loss of consciousness, coma, confusion, tiredness, cold and clammy skin, small pupils, nausea, vomiting, and sweating. What should I avoid while taking acetaminophen and hydrocodone? • Avoid alcohol while taking acetaminophen and hydrocodone. Alcohol can increase drowsiness and dizziness caused by the medication, possibly resulting in unconsciousness and death. Also, acetaminophen can be damaging to the liver when taken with alcohol. • Acetaminophen and hydrocodone may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if acetaminophen and hydrocodone is taken with any of these medications. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor. • Use caution when driving, operating machinery, or performing other hazardous activities. Hydrocodone may cause drowsiness or dizziness. If you experience drowsiness or dizziness, avoid these activities. • Other products may also contain acetaminophen, especially over-the-counter pain, fever, cold, and allergy medications. Do not take any other products that contain acetaminophen without first talking to your doctor. Too much acetaminophen can be dangerous. What are the possible side effects of acetaminophen and hydrocodone? • If you experience any of the following serious side effects, stop taking acetaminophen and hydrocodone and seek emergency medical attention or contact your doctor immediately: · an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); · slow, weak breathing; · seizures; · cold, clammy skin; · severe weakness or dizziness; · unconsciousness; · yellowing of the skin or eyes; or · unusual fatigue, bleeding, or bruising. • Other, less serious side effects may be more likely to occur. Continue to take acetaminophen and hydrocodone and talk to your doctor if you experience · constipation; · dry mouth, nausea, vomiting, or decreased appetite; · dizziness, tiredness, or lightheadedness; · muscle twitches; · sweating; · itching; · decreased urination; or · decreased sex drive. • Hydrocodone is habit forming. It is possible become physically and/ or psychologically dependent on the medication. Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor. Withdrawal effects may occur if acetaminophen and hydrocodone is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose. • 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 acetaminophen and hydrocodone? • Do not take acetaminophen and hydrocodone if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. Dangerous side effects could result. • Acetaminophen and hydrocodone may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if acetaminophen and hydrocodone is taken with any of these medications. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor. • Other products may also contain acetaminophen, especially over-the-counter pain, fever, cold, and allergy medications. Do not take any other products that contain acetaminophen without first talking to your doctor. Too much acetaminophen can be dangerous. • Drugs other than those listed here may also interact with acetaminophen and hydrocodone. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products. Where can I get more information? • Your pharmacist has additional information about acetaminophen and hydrocodone written for health professionals that you may read. -------------------------------------------------------------------------------- In addition, the liquid contains the following inactive ingredients: citric acid anhydrous, ethyl maltol, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution, sucrose, with D&C Yellow #10 and FD&C Yellow #6 as coloring and natural and artificial flavoring. CLINICAL PHARMACOLOGY Hydrocodone is a semisynthetic narcotic analgesic and antitussive with multiple actions qualitatively similar to those of codeine. Most of these involve the central nervous system and smooth muscle. The precise mechanism of action of hydrocodone and other opiates is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system. In addition to analgesia, narcotics may produce drowsiness, changes in mood and mental clouding. The analgesic action of acetaminophen involves peripheral influences, but the specific mechanism is as yet undetermined. Antipyretic activity is mediated through hypothalamic heat regulating centers. Acetaminophen inhibits prostaglandin synthetase. Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing. Pharmacokinetics The behavior of the individual components is described below. Hydrocodone Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23.6 ± 5.2 ng/mL. Maximum serum levels were achieved at 1.3 ± 0.3 hours and the half-life was determined to be 3.8 ± 0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-(alpha)- and 6-(beta)-hydroxymetabolites. See OVERDOSAGE for toxicity information. Acetaminophen Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. See OVERDOSAGE for toxicity information. INDICATIONS AND USAGE Lortab Elixir (hydrocodone bitartrate and acetaminophen oral solution) is indicated for the relief of moderate to moderately severe pain. CONTRAINDICATIONS This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone, acetaminophen, or any other component of this product. Patients known to be hypersensitive to other opioids may exhibit cross sensitivity to hydrocodone. WARNINGS Respiratory Depression At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing. Infants may have increased sensitivity to the respiratory depressant effects of opioids (see PRECAUTIONS , Pediatric Use ). If use of Lortab Elixir in such patients is contemplated, it should be administered cautiously, in substantially reduced initial doses, by personnel experienced in administering opioids to infants, and with intensive monitoring. Head Injury and Increased Intracranial Pressure The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions, which may obscure the clinical course of patients with head injuries. Acute Abdominal Conditions The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions. PRECAUTIONS General Special Risk Patients As with any narcotic analgesic agent, Lortab Elixir should be used with caution in elderly or debilitated patients, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind. Cough Reflex Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when Lortab Elixir are used postoperatively and in patients with pulmonary disease. Information for Patients Hydrocodone, like all narcotics, may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product. Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided. Hydrocodone may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed. Physicians should instruct patients and caregivers to read the patient information leaflet, which appears as the last section of the labeling. Laboratory Tests In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests. Drug Interactions Patients receiving narcotics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and acetaminophen oral solution may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced. The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone. Drug/Laboratory Test Interactions Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid. Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether hydrocodone has a potential for carcinogenesis, mutagenesis, or impairment of fertility. Hydrocodone has not demonstrated mutagenic potential using the Ames Salmonella-Microsomal Activation test, the Basc test on Drosophila germ cells, and the Micronucleus test on mouse bone marrow. No adequate studies have been conducted in animals to determine whether acetaminophen has a potential for carcinogenesis, mutagenesis, or impairment of fertility. Acetaminophen has not demonstrated mutagenic potential using the Ames Salmonella-Microsomal Activation test, the Basc test on Drosophila germ cells, and the Micronucleus test on mouse bone marrow. Pregnancy Teratogenic Effects Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Lortab Elixir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever. These signs usually appear during the first few days of life. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal. Labor and Delivery Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (see OVERDOSAGE ). The effect of hydrocodone, if any, on the later growth, development, and functional maturation of the child is unknown. Nursing Mothers Acetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known. It is not known whether hydrocodone is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydrocodone and acetaminophen, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use Safety and effectiveness in the pediatric population below the age of two years have not been established. Use of Lortab Elixir in the pediatric population is supported by the evidence from adequate and well controlled studies of hydrocodone and acetaminophen combination products in adults with additional data which support the development of metabolic pathways in children two years of age and over (see DOSAGE AND ADMINISTRATION for pediatric dosage information). Geriatric Use Clinical studies of hydrocodone bitartrate and acetaminophen oral solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Hydrocodone and the major metabolites of acetaminophen are known to be substantially excreted by the kidney. Thus the risk of toxic reactions may be greater in patients with impaired renal function due to the accumulation of the parent compound and/or metabolites in the plasma. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Hydrocodone may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of hydrocodone bitartrate and acetaminophen oral solution and observed closely. ADVERSE REACTIONS Potential effects of high dosage are also listed in the OVERDOSAGE section. Cardio-renal: Bradycardia, cardiac arrest, circulatory collapse, renal toxicity, renal tubular necrosis, hypotension. Central Nervous System/Psychiatric: Anxiety, dizziness, drowsiness, dysphoria, euphoria, fear, general malaise, impairment of mental and physical performance, lethargy, light-headedness, mental clouding, mood changes, psychological dependence, sedation, somnolence progressing to stupor or coma. Endocrine: Hypoglycemic coma. Gastrointestinal System: Abdominal pain, constipation, gastric distress, heartburn, hepatic necrosis, hepatitis, occult blood loss, nausea, peptic ulcer, and vomiting. Genitourinary System: Spasm of vesical sphincters, ureteral spasm, and urinary retention. Hematologic: Agranulocytosis, hemolytic anemia, iron deficiency anemia, prolonged bleeding time, thrombocytopenia. Hypersensitivity: Allergic reactions. Musculoskeletal: Skeletal muscle flaccidity. Respiratory Depression: Acute airway obstruction, apnea, dose-related respiratory depression (see OVERDOSAGE ), shortness of breath. Special Senses: Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose. Skin: Cold and clammy skin, diaphoresis, pruritus, rash. DRUG ABUSE AND DEPENDENCE Controlled Substance Lortab Elixir (hydrocodone bitartrate and acetaminophen oral solution) is classified as a Schedule III controlled substance. Abuse and Dependence Hydrocodone can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore, this product should be prescribed and administered with caution appropriate to the use of other oral narcotic medications. However, psychological dependence is unlikely to develop when hydrocodone bitartrate and acetaminophen oral solution are used for a short time for the treatment of pain. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. OVERDOSAGE Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen. Signs and Symptoms Toxicity from hydrocodone poisoning includes the opioid triad of loss of consciousness, pinpoint pupils, and respiratory depression (Cheyne-Stokes respiration, cyanosis, decrease in respiratory rate and/or tidal volume). Convulsions may occur. The toxic dose of acetaminophen for adults is 10 grams. In adults, hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams, or fatalities with less than 15 grams. Early symptoms following a potentially hepatotoxic overdose of acetaminophen may include diaphoresis, general malaise, nausea, and vomiting. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Other signs and symptoms of overdose of this product include bradycardia, cold and clammy skin, extreme somnolence progressing to stupor or coma, hypoglycemic coma, hypotension, renal tubular necrosis, skeletal muscle flaccidity, thrombocytopenia. In severe overdosage, apnea; circulatory collapse; cardiac arrest; dose-dependent, potentially fatal hepatic necrosis; and death may occur. Treatment A single or multiple overdose with hydrocodone and acetaminophen is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Vomiting should be induced with syrup of ipecac, if the patient is alert (adequate pharyngeal and laryngeal reflexes). Oral activated charcoal (1 g/kg) should follow gastric emptying. The first dose should be accompanied by an appropriate cathartic. If repeated doses are used, the cathartic might be included with alternate doses as required. Hypotension is usually hypovolemic and should respond to fluids. Vasopressors and other supportive measures should be employed as indicated. A cuffed endo-tracheal tube should be inserted before gastric lavage of the unconscious patient and, when necessary, to provide assisted respiration. Meticulous attention should be given to maintaining adequate pulmonary ventilation. In severe cases of intoxication, peritoneal dialysis, or preferably hemodialysis may be considered. If hypoprothrombinemia occurs due to acetaminophen overdose, vitamin K should be administered intravenously. Naloxone, a narcotic antagonist, can reverse respiratory depression and coma associated with opioid overdose. Naloxone hydrochloride 0.4 mg to 2 mg is given parenterally. Since the duration of action of hydrocodone may exceed that of the naloxone, the patient should be kept under continuous surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. A narcotic antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression. If the dose of acetaminophen may have exceeded 140 mg/kg, acetylcysteine should be administered as early as possible. Serum acetaminophen levels should be obtained, since levels four or more hours following ingestion help predict acetaminophen toxicity. Do not await acetaminophen assay results before initiating treatment. Hepatic enzymes should be obtained initially, and repeated at 24-hour intervals. Methemoglobinemia over 30% should be treated with methylene blue by slow intravenous administration. DOSAGE AND ADMINISTRATION Dosage should be adjusted according to severity of pain and response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related. The usual adult dosage is one tablespoonful every 4 to 6 hours as needed for pain. The total daily dosage for adults should not exceed 6 tablespoonfuls. The usual dosages for children are given by the table below, and are to be given every 4 to 6 hours as needed for pain. These dosages correspond to an average individual dose of 0.27 mL/kg of Lortab Elixir (providing 0.135 mg/kg of hydrocodone bitartrate and 9 mg/kg of acetaminophen). Dosing should be based on weight whenever possible. Lortab (pronounced LOR-tab) is used to relieve moderate to moderately severe pain. You should not take Lortab Elixir if you are allergic to hydrocodone or acetaminophen. The most common side effects of Lortab Elixir are abdominal pain, dizziness, drowsiness, light-headedness, nausea, shortness of breath, unusual tiredness, and vomiting. Take this medicine as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Uses Lortab Elixir is an analgesic used to relieve moderate to moderately severe pain. Lortab Elixir is a combination product containing hydrocodone (hye-droe-KO-done) bitartrate and acetaminophen (a-seat-a-MIN-oh-fen). Hydrocodone is a narcotic pain reliever and a cough suppressant. Acetaminophen is a non-narcotic pain reliever and fever reducer. A narcotic analgesic and acetaminophen used together may provide better pain relief than either product used alone. If you have any questions, please call your doctor or pharmacist. General Cautions Do not take this drug if you have allergies or unusual reactions to narcotic pain relievers or acetaminophen because it is likely that you may also be allergic to Lortab Elixir. This product may inhibit your mental and physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while you are taking this product. This medicine may not be right for you. Check with your doctor or pharmacist, if you: are pregnant. are nursing. are taking other medications; narcotic pain relievers; allergy medicines; antidepressant medicines; acetaminophen-containing medicines or other medicines that cause central nervous system depression, including alcohol. have other medical problems: a history of drug or alcohol abuse; recent head injury; emphysema, asthma, or other chronic lung disease; liver disease, kidney disease; underactive thyroid, Addison's disease, enlarged prostate or difficulty urinating. Proper Use Take this medicine as directed by your doctor. Do not share it with anyone else. This medicine can cause drug dependence and has the potential for abuse. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If you think that this medicine is not working properly after taking it for some time, do not increase the dose. Check with your doctor or pharmacist. Dosing The dose of this medication will be different for different patients. Follow the directions provided by your doctor. The following information includes only the average doses of this medication. If your dose is different, do not change doses unless your doctor tells you to do so. BODY WEIGHT APPROXIMATE AGE DOSE Every 4 to 6 hours MAXIMUM TOTAL DAILY DOSE (6 doses per day) 12 to 15 kg 27 to 34 lbs. 2 to 3 years ? teaspoonful = 3.75 mL 4 ? teaspoonfuls = 22.5 mL 16 to 22 kg 35 to 50 lbs. 4 to 6 years 1 teaspoonful = 5 mL 6 teaspoonfuls = 30 mL 23 to 31 kg 51 to 69 lbs. 7 to 9 years 1 ? teaspoonfuls = 7.5 mL 9 teaspoonfuls = 45 mL 32 to 45 kg 70 to 100 lbs. 10 to 13 years 2 teaspoonfuls = 10 mL 12 teaspoonfuls = 60 mL 46 kg and up 101 lbs. and up 14 years to adult 1 Tablespoonful = 15 mL 6 Tablespoonfuls = 90 mL It is very important that Lortab Elixir be dosed accurately. A household teaspoon or tablespoon is not an accurate measuring device, especially when one-half or three-fourths of a teaspoonful is to be measured. Since a household teaspoon is not accurate and can be mixed-up with a tablespoon (which can cause overdosage), it is strongly recommended that you obtain and use a proper measuring device. Ask your doctor or pharmacist for help to find a dropper that can measure the needed dose properly and ask for help if you do not understand how to use the dropper. Missed Dose To avoid a possible overdose, it is important that you do not take more than a single dosage at one time, or that you don't take doses at intervals less than 4 hours apart. If you miss taking a dose of Lortab Elixir, take it as soon as you remember. However, make sure to wait at least 4 hours before taking your next dose. If you missed taking a dose, and it is almost time for your next dose, skip the missed dose and take your medicine as scheduled. Do not double the prescribed dose. Possible Side Effects Side effects you may experience include abdominal pain, constipation, difficulty urinating, dizziness, drowsiness, fear, fuzzy thinking, general feeling of discomfort or illness, light-headedness, mood changes, nausea, nervousness, rash, shortness of breath, slower reactions, unusual tiredness, and vomiting. Call your doctor if these effects continue or are bothersome. Side effects not listed above may sometimes occur. If you notice any other effects, check with your doctor. Storage Keep out of the reach of children. Store at room temperature (protect from heat, do not refrigerate). Keep in original labeled bottle. Discard medicines that are old or no longer needed. Even a single overdose of this medicine may be a life-threatening situation. If you suspect that you or someone else may have taken more than the prescribed dose of this medicine, contact your local poison control center or emergency room immediately. This medicine was prescribed for your particular condition. Do not use if for another condition or give the drug to others. This leaflet provides a summary of information about Lortab Elixir. If you have any questions or concerns, or want more information about Lortab Elixir, contact your doctor or pharmacist. Your pharmacist also has a longer leaflet about Lortab Elixir that is written for health professionals that you can ask to read. Prepared by UCB Pharma, Inc.Rev. 6E 03/2004 Current as of 05/2005 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. Combination medicines containing narcotic analgesics (nar-KOT-ik an-al-JEE-zicks) and acetaminophen (a-seat-a-MIN-oh-fen) are used to relieve pain. A narcotic analgesic and acetaminophen used together may provide better pain relief than either medicine used alone. In some cases, relief of pain may come at lower doses of each medicine. Narcotic analgesics act in the central nervous system (CNS) to relieve pain. Many of their side effects are also caused by actions in the CNS. When narcotics are used for a long time, your body may get used to them so that larger amounts are needed to relieve pain. This is called tolerance to the medicine. Also, when narcotics are used for a long time or in large doses, they may become habit-forming (causing mental or physical dependence). Physical dependence may lead to withdrawal symptoms when you stop taking the medicine. Acetaminophen does not become habit-forming when taken for a long time or in large doses, but it may cause other unwanted effects, including liver damage, if too much is taken. In the U.S., these medicines are available only with your medical doctor's or dentist's prescription. In Canada, some acetaminophen, codeine, and caffeine combinations are available without a prescription. These medicines are available in the following dosage forms: Oral Acetaminophen and Codeine Capsules (U.S.) Oral solution (U.S. and Canada) Oral suspension (U.S.) Tablets (U.S. and Canada) Acetaminophen, Codeine, and Caffeine Tablets (Canada) Dihydrocodeine, Acetaminophen, and Caffeine Capsules (U.S.) Hydrocodone and Acetaminophen Capsules (U.S.) Oral solution (U.S.) Tablets (U.S.) Oxycodone and Acetaminophen Capsules (U.S.) Oral solution (U.S.) Tablets (U.S. and Canada) Pentazocine and Acetaminophen Tablets (U.S.) Propoxyphene and Acetaminophen Tablets (U.S.) -------------------------------------------------------------------------------- Before Using This Medicine In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For narcotic analgesic and acetaminophen combinations, the following should be considered: Allergies-Tell your doctor if you have ever had any unusual or allergic reaction to acetaminophen or to a narcotic analgesic. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes. Pregnancy- For acetaminophen : Although studies on birth defects with acetaminophen have not been done in pregnant women, it has not been reported to cause birth defects or other problems. For narcotic analgesics : Although studies on birth defects with narcotic analgesics have not been done in pregnant women, they have not been reported to cause birth defects. However, hydrocodone caused birth defects in animal studies when very large doses were used. Codeine did not cause birth defects in animals, but it caused slower development of bones and other toxic or harmful effects in the fetus. Pentazocine and propoxyphene did not cause birth defects in animals. There is no information about whether dihydrocodeine or oxycodone causes birth defects in animals. Too much use of a narcotic during pregnancy may cause the fetus to become dependent on the medicine. This may lead to withdrawal side effects in the newborn baby. Also, some of these medicines may cause breathing problems in the newborn baby if taken just before or during delivery. For caffeine : Studies in humans have not shown that caffeine (contained in some of these combination medicines) causes birth defects. However, studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to those present in 12 to 24 cups of coffee a day). Breast-feeding-Acetaminophen, codeine, and propoxyphene pass into the breast milk. It is not known whether other narcotic analgesics pass into the breast milk. However, these medicines have not been reported to cause problems in nursing babies. Children-Breathing problems may be especially likely to occur when narcotic analgesics are given to children younger than 2 years of age. These children are usually more sensitive than adults to the effects of narcotic analgesics. Also, unusual excitement or restlessness may be more likely to occur in children receiving these medicines. Acetaminophen has been tested in children and has not been shown to cause different side effects or problems in children than it does in adults. Older adults-Elderly people are especially sensitive to the effects of narcotic analgesics. This may increase the chance of side effects, especially breathing problems, during treatment. Acetaminophen has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. Other medicines-Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking a narcotic analgesic and acetaminophen combination, it is especially important that your health care professional know if you are taking any of the following: Carbamazepine (e.g., Tegretol)-Propoxyphene may increase the blood levels of carbamazepine, which increases the chance of serious side effects Central nervous system (CNS) depressants or Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate]) (taken currently or within the past 2 weeks) or Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])-Taking these medicines together with a narcotic analgesic may increase the chance of serious side effects Naltrexone (e.g., Trexan)-Naltrexone keeps narcotic analgesics from working to relieve pain; people taking naltrexone should take pain relievers that do not contain a narcotic Zidovudine (e.g., AZT, Retrovir)-Acetaminophen may increase the blood levels of zidovudine, which increases the chance of serious side effects Other medical problems-The presence of other medical problems may affect the use of narcotic analgesic and acetaminophen combinations. Make sure you tell your doctor if you have any other medical problems, especially: Alcohol and/or other drug abuse, or history of, or Brain disease or head injury or Colitis or Convulsions (seizures), history of, or Emotional problems or mental illness or Emphysema, asthma, or other chronic lung disease or Hepatitis or other liver disease or Kidney disease or Underactive thyroid-The chance of serious side effects may be increased Enlarged prostate or problems with urination or Gallbladder disease or gallstones-Some of the effects of narcotic analgesics may be especially serious in people with these medical problems Heart disease-Caffeine (present in some of these combination medicines) can make some kinds of heart disease worse -------------------------------------------------------------------------------- Proper Use of This Medicine Take this medicine only as directed by your medical doctor or dentist . Do not take more of it, do not take it more often, and do not take it for a longer time than your medical doctor or dentist ordered. This is especially important for young children and elderly patients, who may be more sensitive than other people to the effects of narcotic analgesics. If too much of a narcotic analgesic is taken, it may become habit-forming (causing mental or physical dependence) or lead to medical problems because of an overdose. Taking too much acetaminophen may cause liver damage. If you think that this medicine is not working properly after you have been taking it for a few weeks, do not increase the dose . Instead, check with your medical doctor or dentist. Dosing-The dose of these medicines will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so. The number of capsules or tablets or teaspoonfuls of solution or suspension that you take depends on the strength of the medicine. For acetaminophen and codeine For oral capsule or tablet dosage form: For pain: Adults-1 or 2 capsules or tablets containing acetaminophen with 15 or 30 milligrams (mg) of codeine, or 1 capsule or tablet containing acetaminophen with 60 mg of codeine, every four hours as needed. Children-Dose must be determined by the doctor, depending on the age of the child. Most young children will receive the oral solution or suspension, rather than tablets or capsules. For oral solution or suspension dosage form: For pain: Adults-1 tablespoonful (3 teaspoonfuls) every four hours as needed. Children younger than 3 years of age-Dose must be determined by your doctor. Children 3 to 7 years of age-1 teaspoonful three or four times a day as needed. Children 7 to 12 years of age-2 teaspoonfuls three or four times a day as needed. For acetaminophen, codeine, and caffeine Lortab Addiction Information Lortab Addiction Information Lortab is an opioid. Lortab is commonly prescribed because of its analgesic, or pain relieving properties. Lortab is the brand name for the combination of acetaminophen and hydrocodone. Many studies have shown that properly managed medical use of Lortab is safe and rarely causes addiction. Taken exactly as prescribed, Lortab can be used to manage pain effectively. Lortab acts by attaching to specific proteins called opioids receptors, which are found in the brain, spinal cord, and gastrointestinal tract. When these compounds attach to certain opioids receptors in the brain and spinal cord, they can effectively change the way a person experiences pain. In addition, opioids medications can affect regions of the brain that mediate what we perceive as pleasure, resulting in the initial euphoria that many opioids produce. They can also produce drowsiness, cause constipation, and, depending upon the amount taken, depress breathing. Taking a large single dose could cause severe respiratory depression or death. Chronic use of Lortab can result in tolerance to the medication so that higher doses must be taken to obtain the same effects. Long-term use also can lead to physical dependence—the body adapts to the presence of the substance and withdrawal symptoms occur if use is reduced abruptly. Individuals taking prescribed lortab should not only be given these medications under appropriate medical supervision, but also should be medically supervised when stopping use in order to reduce or avoid withdrawal symptoms. Symptoms of withdrawal can include restlessness, muscle and bone pain, insomnia, diarrhea, vomiting, cold flashes with goose bumps (“cold turkey”), and involuntary leg movements. Individuals who become addicted to lortab can be treated. Options for effectively treating pain killer addiction to prescription opioids are drawn from research on treating heroin addiction. Prolonged use of these drugs eventually changes the brain in fundamental and long-lasting ways, explaining why people cannot just quit on their own, and why treatment is essential. In effect, drugs of abuse take over the brain's normal pleasure and motivational systems, moving drug use to the highest priority in the individual's motivational hierarchy, thereby overriding all other motivations and drives. These brain changes, then, are responsible for the compulsion to seek and use drugs that we have come to define as addiction. This is likely the state people are in when they are reportedly "doctor shopping," feigning illnesses, and stealing from pharmacies to obtain the drug. Fortunately, we have a number of effective options to treat lortab addiction to prescription opioids and to help manage the sometime severe withdrawal syndrome that accompanies sudden cessation of drug use. Typically, the patient is medically detoxified before any treatment approach is begun. Although detoxification in itself is not a treatment for pain killer addiction, it can help relieve withdrawal symptoms while the patient adjusts to being drug free. Once the patient completes detoxification, the treatment provider must then work with the patient to determine which course of treatment would best suit the needs of the patient. For free assistance online, click here.

Methocarbamol Tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts 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. Methocarbamol does not directly relax tense skeletal muscles in man. DOSAGE AND ADMINISTRATION 500 mg - Adults: initial dosage, 3 tablets q.i.d.; maintenance dosage, 2 tablets q.i.d. 750 mg - Adults: initial dosage, 2 tablets q.i.d.; maintenance dosage, 1 tablet q.4h, or 2 tablets t.i.d. Six grams a day are recommended for the first 48 to 72 hours of treatment. (For severe conditions 8 grams a day may be administered.) Thereafter, the dosage can usually be reduced to approximately 4 grams a day. HOW SUPPLIED Methocarbamol Tablets, USP 500 mg are scored, round, white tablets imprinted “DAN DAN” and “5381” supplied in bottles of 100, 500 and 1000. Robaxin is prescribed, along with rest, physical therapy, and other measures, for the relief of pain due to severe muscular injuries, sprains, and strains. -------------------------------------------------------------------------------- Most important fact about this drug Return to top Robaxin is not a substitute for the rest or physical therapy needed for proper healing. Although the drug may temporarily make an injury feel better, do not let that tempt you into pushing your recovery. Lifting or exercising too soon may further damage the muscle. -------------------------------------------------------------------------------- How should you take this medication? Return to top Take Robaxin exactly as prescribed. Do not take a larger dose or use more often than directed. --If you miss a dose... If only an hour or so has passed, take it as soon as you remember. If you do not remember until later, skip the dose and go back to your regular schedule. Do not take 2 doses at once. --Storage instructions... Store at room temperature in a tightly closed container. -------------------------------------------------------------------------------- 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 taking Robaxin. Side effects may include: Abnormal taste, allergic reaction, amnesia, blurred vision, confusion, double vision, dizziness, drop in blood pressure and fainting, drowsiness, fever, flushing, headache, hives, indigestion, insomnia, itching, light-headedness, nasal congestion, nausea, pinkeye, poor coordination, rash, seizures, slowed heartbeat, uncontrolled eye movement, vertigo, vomiting, yellow eyes and skin -------------------------------------------------------------------------------- Why should this drug not be prescribed? Return to top If you are sensitive to or have ever had an allergic reaction to Robaxin or other drugs of this type, you should not take this medication. Make sure your doctor is aware of any drug reactions you have experienced. -------------------------------------------------------------------------------- Special warnings about this medication Return to top Robaxin can cause drowsiness and dizziness. Do not drive a car or operate potentially dangerous machinery until you know how the drug affects you. Tell your doctor if you have kidney or liver disease. These conditions may affect Robaxin's effectiveness. Avoid or be careful using alcoholic beverages. Robaxin may darken urine to brown, green, or black. -------------------------------------------------------------------------------- Possible food and drug interactions when taking this medication Return to top If Robaxin is taken with certain other drugs, the effects of either can be increased, decreased, or altered. It is especially important to check with your doctor before combining Robaxin with drugs that slow the nervous system, including: Alcohol Drugs for myasthenia gravis, including Mestinon, Prostigmin, and Tensilon Narcotic pain relievers such as Percocet and Tylenol with Codeine Sleep aids such as Halcion and Seconal Tranquilizers such as Xanax and Valium -------------------------------------------------------------------------------- Special information if you are pregnant or breastfeeding Return to top There have been rare reports of harm to the developing baby following use of Robaxin during pregnancy. Pregnant women should take this drug only if the potential benefits clearly outweigh the possible risks. If you are pregnant or plan to become pregnant, inform your doctor immediately. It is not known if this drug appears in breast milk. If this medication is essential to your health, your doctor may advise you to discontinue breastfeeding your baby until your treatment is finished. If you are sensitive to or have ever had an allergic reaction to Robaxin or other drugs of this type, you should not take this medication. Make sure your doctor is aware of any drug reactions you have experienced. Special warnings about this medication Robaxin can cause drowsiness and dizziness. Do not drive a car or operate potentially dangerous machinery until you know how the drug affects you. Tell your doctor if you have kidney or liver disease. These conditions may affect Robaxin's effectiveness. Avoid or be careful using alcoholic beverages. Robaxin may darken urine to brown, green, or black. Possible food and drug interactions when taking this medication If Robaxin is taken with certain other drugs, the effects of either can be increased, decreased, or altered. It is especially important to check with your doctor before combining Robaxin with drugs that slow the nervous system, including: alcohol drugs for myasthenia gravis, including Mestinon, Prostigmin, and Tensilon narcotic pain relievers such as Percocet and Tylenol with Codeine sleep aids such as Halcion and Seconal tranquilizers such as Xanax and Valium Special information if you are pregnant or breastfeeding There have been rare reports of harm to the developing baby following use of Robaxin during pregnancy. Pregnant women should take this drug only if the potential benefits clearly outweigh the possible risks. If you are pregnant or plan to become pregnant, inform your doctor immediately. It is not known if this drug appears in breast milk. If this medication is essential to your health, your doctor may advise you to discontinue breastfeeding your baby until your treatment is finished. Recommended Dosage ADULTS - Robaxin The usual starting dose is 3 tablets taken 4 times a day. The usual long-term dose is 2 tablets taken 4 times a day. ADULTS - Robaxin 750 The usual starting dose is 2 tablets taken 4 times a day. The usual long-term dose is 1 tablet taken every 4 hours or 2 tablets taken 3 times a day. CHILDREN The safety and effectiveness of Robaxin have not been established in children. Overdosage Any drug taken in excess can have dangerous consequences. If you suspect an overdose of Robaxin, seek emergency medical treatment immediately Search Arthritis Advertisement Newsletters & RSS Email to a friend Print this Page Add to del.icio.usRelated Resources - Robaxin / Methocarbamol Robaxin (Methocarbamol) Muscle Relaxers (Muscle Relaxants) Muscle Pain Related Resources - Robaxin / Methocarbamol When Are Muscle Relaxers Prescribed For Arthritis Patients? Arthritis Drugs The Pain Quiz - Acute vs. Chronic Pain Related Resources - Robaxin / Methocarbamol Joint Pain Pain Relief The Pain Relief Quiz Most Popular Arthritis Screening Quiz Fibromyalgia Screening Quiz Rheumatoid Arthritis Screening Quiz Lupus Screening Quiz Osteoarthritis Screening Quiz Related Topics Orthopedics Senior Living Senior Health Physical Therapy Irritable Bowel / Crohn's Disease The Facts Of Robaxin (Methocarbamol) From Carol & Richard Eustice, Your Guide to Arthritis. FREE Newsletter. Sign Up Now! Robaxin (Methocarbamol) - Muscle Relaxer (Muscle Relaxant) BRAND NAME: Robaxin GENERIC DRUG NAME: Methocarbamol INDICATIONS AND USAGE: Robaxin (Methocarbamol) 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 methocarbamol has not been clearly identified, but may be related to its sedative properties. Robaxin does not directly relax tense skeletal muscles in man. CONTRAINDICATIONS: Robaxin is contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components. WARNINGS: Since methocarbamol may possess a general CNS depressant effect, patients receiving Robaxin should be cautioned about combined effects with alcohol and other CNS depressants. Safe use of Robaxin has not been established with regard to possible adverse effects upon fetal development. Sponsored Links Dog Joint Pain Relief All Natural Supplement for Pets DGP for good joint health in pets. www.doggonepain.com Rheumatoid Arthritis Free info on Rheumatoid Arthritis. We've done the work! InfoScouts.com Rheumatoid Arthritis The Spot To Find It! It Is All Here. erheumatoidarthritis.net There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, Robaxin should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards. Robaxin may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. PRECAUTIONS: Patients should be cautioned that Robaxin may cause drowsiness or dizziness, which may impair their ability to operate motor vehicles or machinery. Because Robaxin may possess a general CNS-depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants. ADVERSE REACTIONS: Adverse reactions reported coincident with the administration of methocarbamol include: Body as a whole: Anaphylactic reaction, angioneurotic edema, fever, headache Cardiovascular system: Bradycardia, flushing, hypotension, syncope, thrombophlebitis Digestive system: Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting Hemic and lymphatic system: Leukopenia Immune system: Hypersensitivity reactions Nervous system: Amnesia, confusion, Diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo Skin and special senses: Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria DRUG INTERACTIONS: Robaxin may inhibit the effect of pyridostigmine bromide. Therefore, Robaxin should be used with caution in patients with myasthenia gravis receiving anticholinesterase agents. DRUG / LABORATORY TEST INTERACTIONS: Methocarbamol may cause a color interference in certain screening tests for 5-hydroxyindoleacetic acid. CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: Long-term studies to evaluate the carcinogenic potential of Robaxin have not been performed. No studies have been conducted to assess the effect of Robaxin on mutagenesis or its potential to impair fertility. PREGNANCY: Animal reproduction studies have not been conducted with methocarbamol. It is also not known whether methocarbamol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Robaxin should be given to a pregnant woman only if clearly needed. Safe use of Robaxin has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, Robaxin should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards. NURSING MOTHERS: Methocarbamol and/or its metabolites are excreted in the milk of dogs; however, it is not known whether methocarbamol or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Robaxin is administered to a nursing woman. PEDIATRIC USE: Safety and effectiveness of Robaxin in pediatric patients below the age of 16 have not been established. OVERDOSAGE: Limited information is available on the acute toxicity of methocarbamol. Overdose of methocarbamol is frequently in conjunction with alcohol or other CNS depressants and includes the following symptoms: nausea drowsiness blurred vision hypotension seizures coma In post-marketing experience, deaths have been reported with an overdose of methocarbamol alone or in the presence of other CNS depressants, alcohol or psychotropic drugs. Management of overdose includes symptomatic and supportive treatment. Store Robaxin at controlled room temperature, between 20°C and 25°C (68°F and 77°F). Related Resources Robaxin (Methocarbamol) Muscle Relaxers (Muscle Relaxants) When Are Muscle Relaxers Prescribed For Arthritis Patients? Muscle Pain Source: U.S. Food and Drug Administration, NDA 11-011/S-070/071 Updated: May 25, 2006 Carol Eustice holds a bachelor's degree in biology and is a former registered medical technologist. She was diagnosed with rheumatoid arthritis over 30 years ago. Her husband, Richard, also has rheumatoid arthritis. Together they have nearly 50 years of combined experience living with the disease.Important disclaimer information about this About site. Related Resources - Robaxin / Methocarbamol Robaxin (Methocarbamol) Muscle Relaxers (Muscle Relaxants) Muscle Pain Related Resources - Robaxin / Methocarbamol When Are Muscle Relaxers Prescribed For Arthritis Patients? Arthritis Drugs The Pain Quiz - Acute vs. Chronic Pain Related Resources - Robaxin / Methocarbamol Joint Pain Pain Relief The Pain Relief Quiz Robaxin Injectable has a pH between 3.5 and 6.0.[1] CLINICAL PHARMACOLOGY The mechanism of action of methocarbamol in humans has not been established, but may be due to general central nervous system (CNS) depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber. Pharmacokinetics Special populations Renally impaired The clearance of methocarbamol in renally-impaired patients on maintenance hemodialysis was reduced about 40% compared to a normal population, although the mean elimination half-life in these two groups was similar (1.2 versus 1.1 hours, respectively).[2] Hepatically impaired In patients with cirrhosis secondary to alcohol abuse, the mean total clearance of methocarbamol was reduced approximately 70% compared to a normal population (11.9 L/hr), and the mean elimination half-life was extended to approximately 3.4 hours.[3] The fraction of methocarbamol bound to plasma proteins was decreased to approximately 40 to 45% compared to 46 to 50% in an age- and weight-matched normal population.[3] INDICATIONS AND USAGE The injectable form of methocarbamol 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. Methocarbamol does not directly relax tense skeletal muscles in man. CONTRAINDICATIONS Robaxin Injectable should not be administered to patients with known or suspected renal pathology. This caution is necessary because of the presence of polyethylene glycol 300 in the vehicle. A much larger amount of polyethylene glycol 300 than is present in recommended doses of Robaxin Injectable is known to have increased preexisting acidosis and urea retention in patients with renal impairment. Although the amount present in this preparation is well within the limits of safety, caution dictates this contraindication. Robaxin Injectable is contraindicated in patients hypersensitive to methocarbamol or to any of the injection components. WARNINGS Since methocarbamol may possess a general CNS depressant effect, patients receiving Robaxin Injectable should be cautioned about combined effects with alcohol and other CNS depressants. Safe use of Robaxin Injectable has not been established with regard to possible adverse effects upon fetal development. There have been very rare reports of fetal and congenital abnormalities following in utero exposure to methocarbamol.[4] Therefore, Robaxin Injectable should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see PRECAUTIONS , Pregnancy ). Use in Activities Requiring Mental Alertness Methocarbamol may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that methocarbamol therapy does not adversely affect their ability to engage in such activities.[5] PRECAUTIONS General As with other agents administered either intravenously or intramuscularly, careful supervision of dose and rate of injection should be observed. Rate of injection should not exceed 3 ml per minute--i.e., one 10 ml vial in approximately three minutes. Since Robaxin Injectable is hypertonic, vascular extravasation must be avoided. A recumbent position will reduce the likelihood of side reactions. Blood aspirated into the syringe does not mix with the hypertonic solution. This phenomenon occurs with many other intravenous preparations. The blood may be safely injected with the methocarbamol, or the injection may be stopped when the plunger reaches the blood, whichever the physician prefers. The total dosage should not exceed 30 ml (three vials) a day for more than three consecutive days except in the treatment of tetanus. Caution should be observed in using the injectable form in patients with suspected or known seizure disorders. Information for Patients Patients should be cautioned that methocarbamol may cause drowsiness or dizziness, which may impair their ability to operate motor vehicles or machinery.[5] Because methocarbamol may possess a general CNS-depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants.[5] Drug Interactions See WARNINGS and PRECAUTIONS for interaction with CNS drugs and alcohol. Methocarbamol may inhibit the effect of pyridostigmine bromide. Therefore, methocarbamol should be used with caution in patients with myasthenia gravis receiving anticholinesterase agents.[6, 7] Drug/Laboratory Test Interactions Methocarbamol may cause a color interference in certain screening tests for 5-hydroxy-indoleacetic acid (5-HIAA) using nitrosonaphthol reagent and in screening tests for urinary vanillylmandelic acid (VMA) using the Gitlow method.[8, 9] Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies to evaluate the carcinogenic potential of methocarbamol have not been performed. No studies have been conducted to assess the effect of methocarbamol on mutagenesis or its potential to impair fertility. Pregnancy Teratogenic Effects--Pregnancy Category C Animal reproduction studies have not been conducted with methocarbamol.[10] It is also not known whether methocarbamol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.[10] Robaxin Injectable should be given to a pregnant woman only if clearly needed.[10] Safe use of Robaxin Injectable has not been established with regard to possible adverse effects upon fetal development. There have been very rare reports of fetal and congenital abnormalities following in utero exposure to methocarbamol.[4] Therefore, Robaxin Injectable should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see WARNINGS ). Nursing Mothers Methocarbamol and/or its metabolites are excreted in the milk of dogs; however, it is not known whether methocarbamol or its metabolites are excreted in human milk.[11] Because many drugs are excreted in human milk, caution should be exercised when Robaxin Injectable is administered to a nursing woman.[10] Pediatric Use Safety and effectiveness of Robaxin Injectable in pediatric patients have not been established except in tetanus. See Dosage and Administration , Special Directions for Use in Tetanus , For pediatric patients . ADVERSE REACTIONS The following adverse reactions have been reported coincident with the administration of methocarbamol.[12] Some events may have been due to an overly rapid rate of intravenous injection. Body as a whole : Anaphylactic reaction, fever, headache Cardiovascular system : Bradycardia, flushing, hypotension, syncope, thrombophlebitis In most cases of syncope there was spontaneous recovery. In others, epinephrine, injectable steroids, and/or injectable antihistamines were employed to hasten recovery. Digestive system, Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting Hemic and lymphatic system : Leukopenia Nervous system : Amnesia, confusion, diplopia, dizziness or light-headedness, drowsiness, insomnia, mild muscular incoordination, nystagmus seizures (including grand mal), vertigo The onset of convulsive seizures during intravenous administration of methocarbamol has been reported in patients with seizure disorders. The psychic trauma of the procedure may have been a contributing factor. Although several observers have reported success in terminating epileptiform seizures with Robaxin® Injectable, its administration to patients with epilepsy is not recommended (see PRECAUTIONS , General ). Skin and special senses : Blurred vision, conjuctivitis with nasal congestion, metallic taste, pruritus, rash, urticaria Other : Pain and sloughing at the site of injection OVERDOSAGE Limited information is available on the acute toxicity of methocarbamol. Overdose of methocarbamol is frequently in conjunction with alcohol or other CNS depressants and includes the following symptoms: nausea, drowsiness, blurred vision, hypotension, seizures, and coma.[13-15] One adult survived the deliberate ingestion of 22 to 30 grams of methocarbamol without serious toxicity.[16] Another adult survived a dose of 30 to 50 grams.[16] The principal symptom in both cases was extreme drowsiness.[16] Treatment was symptomatic and recovery was uneventful.[16] Treatment Management of overdose includes symptomatic and supportive treatment.[16] Supportive measures include maintenance of an adequate airway, monitoring urinary output and vital signs, and administration of intravenous fluids if necessary.[16] The usefulness of hemodialysis in managing overdose is unknown.[16] DOSAGE AND ADMINISTRATION For Intravenous and Intramuscular Use Only. Total adult dosage should not exceed 30 ml (3 vials) a day for more than 3 consecutive days except in the treatment of tetanus. A like course may be repeated after a lapse of 48 hours if the condition persists. Dosage and frequency of injection should be based on the severity of the condition being treated and therapeutic response noted. For the relief of symptoms of moderate degree, 10 ml (one vial) may be adequate. Ordinarily this injection need not be repeated, as the administration of the oral form will usually sustain the relief initiated by the injection. For the severest cases or in postoperative conditions in which oral administration is not feasible, 20 to 30 ml (two to three vials) may be required. Directions for Intravenous Use Robaxin Injectable may be administered undiluted directly into the vein at a maximum rate of three ml per minute . It may also be added to an intravenous drip of Sodium Chloride Injection (Sterile Isotonic Sodium Chloride Solution for Parenteral Use) or five percent Dextrose Injection (Sterile 5 percent Dextrose Solution); one vial given as a single dose should not be diluted to more than 250 ml for I.V. infusion. AFTER MIXING WITH I.V. INFUSION FLUIDS, DO NOT REFRIGERATE. Care should be exercised to avoid vascular extravasation of this hypertonic solution, which may result in thrombophlebitis. It is preferable that the patient be in a recumbent position during and for at least 10 to 15 minutes following the injection. Directions for Intramuscular Use When the intramuscular route is indicated, not more than five ml (one-half vial) should be injected into each gluteal region. The injections may be repeated at eight hour intervals, if necessary. When satisfactory relief of symptoms is achieved, it can usually be maintained with tablets. Not Recommended for Subcutaneous Administration. Special Directions for Use in Tetanus There is clinical evidence which suggests that methocarbamol may have a beneficial effect in the control of the neuromuscular manifestations of tetanus. It does not, however, replace the usual procedure of debridement, tetanus antitoxin, penicillin, tracheotomy, attention to fluid balance, and supportive care. Robaxin Injectable should be added to the regimen as soon as possible. For adults: Inject one or two vials directly into the tubing of the previously inserted indwelling needle. An additional 10 ml or 20 ml may be added to the infusion bottle so that a total of up to 30 ml (three vials) is given as the initial dose (see PRECAUTIONS ). This procedure should be repeated every six hours until conditions allow for the insertion of a nasogastric tube. Crushed Robaxin (methocarbamol) tablets suspended in water or saline may then be given through this tube. Total daily oral doses up to 24 grams may be required as judged by patient response. For pediatric patients: A minimum initial dose of 15 mg/kg is recommended. This dosage may be repeated every six hours as indicated. The maintenance dosage may be given by injection into tubing or by I.V. infusion with an appropriate quantity of fluid. See directions for I.V. use. HOW SUPPLIED Robaxin Injectable--10 ml single dose vials in packages of 5 (NDC 0031-7409-87) and 25 (NDC 0031-7409-94). Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F). ALSO AVAILABLE Methocarbamol is also available as tablets, Robaxin® which contains 500 mg of methocarbamol per tablet and Robaxin®-750 which contains 750 mg of methocarbamol per tablet. Manufactured for A. H. Robins CO., Division of American Home Products, by ELKINS-SINN, INC., Cherry Hill, NJ 08034 Manufactured by: PHARMACEUTICAL DIVISION A. H. ROBINS COMPANY RICHMOND, VIRGINIA 23220 CI 6303-2 Revised March 5, 2001 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. Robaxin This page contains drug information on Robaxin. The information provided includes the following: what is Robaxin the possible side effects of Robaxin what happens if you miss a dose of Robaxin what happens if you overdose with Robaxin the most important information about Robaxin how to use Robaxin other drugs that may affect Robaxin what to avoid while using Robaxin Generic Name: methocarbamol (meth oh KAR ba mall) Brand Names: Robaxin, Robaxin-750 What is the most important information I should know about methocarbamol? • Use caution when driving, operating machinery, or performing other hazardous activities. Methocarbamol may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. • Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking methocarbamol. • Call your doctor immediately if you experience a rash, itching, a fever, or nasal congestion during treatment with methocarbamol. What is methocarbamol? • Methocarbamol is a muscle relaxant. It works by blocking nerve impulses (or pain sensations) that are sent to your brain. • Methocarbamol is used, along with rest and physical therapy, to treat injuries and other painful muscular conditions. • Methocarbamol is also used in the treatment of tetanus. • Methocarbamol may also be used for purposes other than those listed in this medication guide. Who should not take methocarbamol? • Before taking methocarbamol, tell your doctor if you have kidney disease, liver disease, or a seizure disorder. You may need a lower dose or special monitoring during your therapy. • It is not known whether methocarbamol will harm an unborn baby. Do not take methocarbamol without first talking to your doctor if you are pregnant. • It is also not known whether methocarbamol passes into breast milk. Do not take methocarbamol without first talking to your doctor if you are breast-feeding a baby. • Methocarbamol is not approved for use in children younger than 12 years of age. How should I take methocarbamol? • Take methocarbamol exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you. • Take each dose with a full glass of water. • Methocarbamol is usually taken three or four times a day. Follow your doctor's instructions. • Store methocarbamol at room temperature away from moisture and heat. What happens if I miss a dose? • Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication. What happens if I overdose? • Seek emergency medical attention. • Symptoms of a methocarbamol overdose include drowsiness, confusion, and unconsciousness. What should I avoid while taking methocarbamol? • Use caution when driving, operating machinery, or performing other hazardous activities. Methocarbamol may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. • Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking methocarbamol. What are the possible side effects of methocarbamol? • If you experience any of the following serious side effects, stop taking methocarbamol and seek emergency medical attention: · an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives); · a rash or itching; · a fever; or · nasal congestion. • Other, less serious side effects may be more likely to occur. Continue to take methocarbamol and talk to your doctor if you experience · drowsiness, dizziness, lightheadedness, or fainting; · headache or blurred vision; · nausea or a metallic taste in your mouth; or · brown, black, or green urine (this is not harmful). • 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 methocarbamol? • Many drugs can increase the effects of methocarbamol, which can lead to heavy sedation. Before taking this medication, tell your doctor if you are taking any of the following medicines: · antihistamines such as brompheniramine (Dimetane, Bromfed, others), chlorpheniramine (Chlor-Trimeton, Teldrin, others), azatadine (Optimine), clemastine (Tavist), and many others; · narcotics (pain killers) such as meperidine (Demerol), morphine (MS Contin, MSIR, o