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Ultram 50mg 180 tabs $112 90 tabs $82, 30 tabs $46 Fed Ex overnight, US FDA approved first-dose.com Discount Ultram Online Brand Name Pills- Discount Prices Free Shipping With Every Order! www.PillsBargain.com Drug Class And Mechanism: Tramadol is an effective pain reliever (analgesic). Its mode of action resembles that of narcotics, but it has significantly less potential for abuse and addiction than the narcotics. Tramadol is as effective as narcotics in relieving pain but does not depress respiration, a side effect of most narcotics. Tramadol is not a nonsteroidal antiinflammatory drug (NSAID), and does not have the increased risk of stomach ulceration and internal bleeding that can occur with the use of NSAIDs. Storage: Store at room temperature, sealed container. Prescribed For: Tramadol is used in the management of moderate to moderately severe pain. Dosing: May be taken with or without food. Drug Interactions: Tramadol can impair thinking and the physical abilities required for driving or operating machinery. Tramadol should be avoided in patients intoxicated with alcohol, hypnotics, and narcotics. Large doses of tramadol administered with alcohol or anesthetic agents can impair breathing. Tramadol can increase the risk of seizure in epileptic patients, especially with simultaneous use of tricyclic antidepressants, such as Elavil. No dosage adjustment or reduction is necessary in healthy elderly patients 65-75 years of age. Patients over the age of 75 years, and those with liver and kidney dysfunction may need lower dosages. The safety of tramadol in children has not been established. Tramadol may rarely be habit forming. Tramadol should be avoided in patients with a history of opiate addiction or hypersensitivity to opiate medications. Pregnancy: The safety of tramadol during pregnancy has not been established. Nursing Mothers: The safety of tramadol in nursing mothers has not been established. Side Effects: Tramadol is generally well tolerated and side effects are usually transient. Commonly reported side effects include nausea, constipation, dizziness, headache, drowsiness, and vomiting. Less commonly reported side effects include itching, sweating, dry mouth, diarrhea, rash, visual disturbances, and vertigo. Related Links on MedicineNet.com Page 2 of this Article The Doctor's Response Information on this web site is provided for informational purposes only and is not a substitute for professional medical advice. You should not use the information on this web site for diagnosing or treating a medical or health condition. You should carefully read all product packaging. If you have or suspect you have a medical problem, promptly contact your professional healthcare provider. Statements and information regarding dietary supplements have not been evaluated or approved by the Food and Drug Administration. Please consult your healthcare provider before beginning any course of supplementation or treatment. Rapid Ultram Detox Confidential, painless and safe. Financing available; call us today! www.detox911.com Buy Ultram at Wholesale Smart shoppers buy Ultram at wholesale prices. No membership. www.pillsavers.com Chemical formula C16H25NO2 Molecular weight 263.4 g/mol Bioavailability 68-72% Increases with repeated dosing. Metabolism Hepatic demethylated & glucuronidated Elimination half-life 5-7 hours Excretion Renal Pregnancy category C (USA) C (Australia) Legal status Schedule 4 (Australia) Routes of administration Oral, IV, IM Tramadol (INN) (IPA: [?tr?m?d?l]) is an atypical opioid which is a centrally acting analgesic, used for treating moderate to severe pain. It is a synthetic agent, unrelated to other opioids, and appears to have actions on the GABAergic, noradrenergic and serotonergic systems. Tramadol was developed by the German pharmaceutical company Grunenthal GmbH and marketed under the trade name Tramal. Grunenthal has also cross licensed the drug to many other pharmaceutical companies that market it under various names, some of which are listed below. Tramadol is available in both injectable (intravenous and/or intramuscular) and oral preparations. It is usually marketed as the hydrochloride salt (tramadol hydrochloride). Dosages vary depending on the degree of pain experienced by the patient. Tramadol is approximately 10% as potent as morphine, when given by the IV/IM route. Oral doses range from 50–400 mg daily, with up to 600 mg daily when given IV/IM. Tramadol has a limited popularity as a recreational drug, and is referred to as "Tram-Tram" amongst users. Mechanism of action The mechanism of action of tramadol has yet to be fully elucidated, but it is believed to work through modulation of the GABAergic, noradrenergic and serotonergic systems. The contribution of non-opioid activity is demonstrated by the analgesic effects of tramadol not being fully antagonised by the ?-opioid receptor antagonist naloxone. Tramadol is marketed as a racemic mixture with a weak affinity for the ?-opioid receptor (approximately 1/6000th that of morphine). The (+)-enantiomer is approximately four times more potent than the (-)-enantiomer in terms of ?-opioid receptor affinity and 5-HT reuptake, whereas the (-)-enantiomer is responsible for noradrenaline reuptake effects (Shipton, 2000). These actions appear to produce a synergistic analgesic effect, with (+)-tramadol exhibiting 10-fold higher analgesic activity than (-)-tramadol (Goeringer et al., 1997). The serotonergic modulating properties of tramadol mean that it has the potential to interact with other serotonergic agents. There is an increased risk of serotonin syndrome when tramadol is taken in combination with serotonin reuptake inhibitors (e.g. SSRIs), since these agents not only potentiate the effect of 5-HT but also inhibit tramadol's metabolism. Metabolism Tramadol undergoes hepatic metabolism via the cytochrome P450 isozyme CYP2D6, being O- and N-demethylated to 5 different metabolites. Of these, M1 is the most significant since it has 200 times the ?-affinity of (+)-tramadol, and furthermore has an elimination half-life of 9 hours compared to 6 hours for tramadol itself. In the 6% of the population who have slow CYP2D6 activity, there is therefore a slightly reduced analgesic effect. Phase II hepatic metabolism renders the metabolites water-soluble and they are renally excreted. Thus reduced doses may be used in renal and hepatic impairment. Adverse effects The most commonly reported adverse drug reactions are nausea, vomiting and sweating. Drowsiness is reported, although it is less of an issue compared to other opioids. Respiratory depression, a common side effect of most opioids, is not clinically significant in normal doses. By itself, it does not increase the seizure threshold, though it may do if used in combination with SSRIs, tricyclic antidepressants, or in patients with epilepsy. Dependence Some controversy exists regarding the dependence liability of tramadol. Grunenthal has promoted it as an opioid with a low risk of dependence compared to traditional opioids, claiming little evidence of such dependence in clinical trials. They offer the theory that since the M1 metabolite is the principal agonist at ?-opioid receptors, the delayed agonist activity reduces dependence liability. The noradrenaline reuptake effects may also play a role in reducing dependence. Despite these claims it is apparent, in community practice, that dependence to this agent does occur. This would be expected since analgesic and dependence effects mediated by the same ?-opioid receptor. However, this dependence liability is considered relatively low by health authorities, such that tramadol is classified as a Schedule 4 Prescription Only Medicine in Australia, rather than as a Schedule 8 Controlled Drug like other opioids (Rossi, 2004). Similarly, tramadol is not currently scheduled by the U.S. DEA, unlike other opioid analgesics. Nevertheless, the Prescribing Information for Ultram warns that tramadol "may induce psychic and physical dependence of the morphine-type." Proprietary preparations Grunenthal, which still owns the patent to tramadol, has cross-licensed the agent to various pharmaceutical companies internationally. Thus tramadol is marketed under many trade names including: Adolonta, Contramal, Crispin, Nobligan, Siverol, Tiparol, Toplagic, Tradol, Tradolan, Tralgit, Tramacet, Tramadin, Tramal, Tramahexal, Tramazac, Ultracet, Ultram, Zamadol and Zydol. Abuse Late reports of abuse have been encountered in the United Kingdom through stolen prescriptions. The drug has been discovered to be sold for around ?4-5.00 a gram. It is either snorted, injected or taken oraly per two 50mg capsules, also poured into 1g capsules and taken as a "shot". Usually followed by an increased dose due to metabolic variation. References Goeringer KE, Logan BK, Christian GD. Identification of tramadol and its metabolites in blood from drug-related deaths and drug-impaired drivers. J Anal Toxicol 1997;21(7):529-37. PMID 9399121 Rossi S, editor. Australian Medicines Handbook 2004 (AMH). Adelaide: Australian Medicines Handbook; 2004. ISBN 0-9578521-4-2. Shipton EA. Tramadol – present and future. 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Do not take more than 300 milligrams of Ultram in one day. • Do not stop using this medication suddenly without talking to your doctor. You may need to gradually reduce the dose. Withdrawal symptoms may occur when you stop using Ultram. Withdrawal symptoms include anxiety, sweating, nausea, diarrhea, tremors, chills, hallucinations, trouble sleeping, or breathing problems. Call your doctor at once if you have any of these withdrawal symptoms after you stop using Ultram. • Do not crush the Ultram tablet. This medicine is for oral (by mouth) use only. Powder from a crushed tablet should not be inhaled or diluted with liquid and injected into the body. Using this medicine by inhlation or injection can cause life-threatening side effects, overdose, or death. • Seizures (convulsions) have occurred in some people taking Ultram. 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What is Ultram? • Ultram is a narcotic pain reliever. • Ultram is used to treat moderate to severe pain. Ultram extended-release is used to treat moderate to severe chronic pain when treatment is needed around the clock. • Ultram may also be used for purposes other than those listed in this medication guide. What should I discuss with my healthcare provider before taking Ultram? • You should not take Ultram if you have ever been addicted to drugs or alcohol. • Do not take Ultram if you are intoxicated (drunk), or if you have recently used any of the following drugs: · alcohol; · narcotic pain medicine; · sedatives or tranquilizers (such as Valium); · medicine for depression or anxiety; · medicine for mental illness (such as bipolar disorder, schizophrenia); or · street drugs. • Seizures have occurred in some people taking Ultram. 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Do not use this medication without telling your doctor if you are breast-feeding a baby. • Older adults may be more sensitive to the effects of Ultram. If you are over 65, your doctor may recommend a lower dose. • Ultram should not be given to a child younger than 16 years of age. How should I take Ultram? • Take Ultram exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor. Do not take more than 300 milligrams of Ultram in one day. • Take each dose with a full glass of water. • Ultram can be taken with or without food, but take it the same way each time. • Do not crush the Ultram tablet. This medicine is for oral (by mouth) use only. Powder from a crushed tablet should not be inhaled or diluted with liquid and injected into the body. Using this medicine by inhlation or injection can cause life-threatening side effects, overdose, or death. • Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time. • If you use the Ultram extended-release tablet, the tablet shell may pass into your stools (bowel movements). This is normal and does not mean that you are not receiving enough of the medicine. • Ultram may be habit-forming. Tell your doctor if you feel the medicine is not working as well in relieving your pain. Do not change your dose without talking to your doctor. • Do not stop using this medication suddenly without talking to your doctor. You may need to gradually reduce the dose. Withdrawal symptoms may occur when you stop using Ultram. Withdrawal symptoms include anxiety, sweating, nausea, diarrhea, tremors, chills, hallucinations, trouble sleeping, or breathing problems. Call your doctor at once if you have any of these withdrawal symptoms after you stop using Ultram. • Store Ultram at room temperature away from moisture and heat. What happens if I miss a dose? • Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose. What happens if I overdose? • Seek emergency medical attention if you think you have used too much of this medicine. A Ultram overdose can be fatal. • Symptoms of a Ultram overdose may include drowsiness, shallow breathing, slow heartbeat, extreme weakness, cold or clammy skin, feeling light-headed, fainting, or coma. What should I avoid while taking Ultram? • Do not drink alcohol while you are taking Ultram. Alcohol may cause a dangerous decrease in your breathing when used together with Ultram. • Avoid using drugs that make you sleepy (such as cold medicine, other pain medications, muscle relaxants, and medicine for seizures, depression or anxiety). These drugs may slow your breathing or increase drowsiness when used together with Ultram. • Ultram can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. What are the possible side effects of Ultram? • Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. • Stop using Ultram and call your doctor at once if you have any of these serious side effects: · seizure (convulsions); · a red, blistering, peeling skin rash; or · shallow breathing, weak pulse. • Continue taking Ultram and talk to your doctor if you have any of these less serious side effects: · dizziness, drowsiness, weakness; · nausea, vomiting, constipation, loss of appetite; · blurred vision; · flushing (redness, warmth, or tingly feeling); or · sleep problems (insomnia). • Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. What other drugs will affect Ultram? • You may be more likely to have a seizure (convulsions) if you take Ultram while you are using certain other medicines. Do not take Ultram without telling your doctor if you also use any of the following: · an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam); or · an antidepressant such as amitriptyline (Elavil), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor); paroxetine (Paxil), or sertraline (Zoloft). • Before taking Ultram, tell your doctor if you also use: · carbamazepine (Tegretol); · warfarin (Coumadin); · digoxin (Lanoxin, Lanoxicaps); · ketoconazole (Nizoral); · erythromycin (E-Mycin, E.E.S., Ery-Tab); · rifampin (Rifadin, Rimactane, Rifater); · St. John's wort; · quinidine (Quinaglute, Quinadex, Cardioquin, Quinora); or · drugs that make you sleepy (such as cold medicine, other pain medications, muscle relaxants, and medicine for seizures, depression or anxiety). • If you are using any of these drugs, you may not be able to use Ultram or you may need dosage adjustments or special tests during treatment. • There may be other drugs not listed that can affect Ultram. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Do not exceed the recommended dose or take this medicine for longer than prescribed. If you experience difficulty breathing or tightness of chest; swelling of eyelids, face, or lips; or develop a rash or hives, tell your doctor immediately. Do not take any more of this medicine unless your doctor tells you to do so. Avoid alcohol while you are using this medicine. This medicine will add to the effects of alcohol and other depressants. Do not drive, operated machinery, or do anything else that could be dangerous until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. Before you begin taking any new medicine, either prescription or over-the-counter, check with your doctor or pharmacist. For women: if you plan on becoming pregnant, discuss with your doctor the benefits and risks of using this medicine during pregnancy. This medicine is excreted in breast milk. Do not breast-feed while taking this medicine. If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include cold and clammy skin, low body temperature, slowed breathing, slowed heartbeat, drowsiness, dizziness, lightheadedness, seizures, deep sleep, and loss of consciousness. Tramadol hydrochloride tablets) Ultram is a prescription medication indicated for the management of moderate to moderately severe pain. Ultram was approved March 3, 1995 by FDA Name : Ultram (Tramadol hydrochloride tablets) is a centrally acting analgesic. Ultram is a prescription medication used to treat pain. Ultram received U.S. Food and Drug Administration (FDA) approval in March 1995. Tramadol, the main ingredient in Ultram, has been prescribed for more than 55 million patients worldwide and more than 21 million patients in the United States. What should I discuss with my doctor before taking Ultram? Do not take Ultram without first talking to your doctor if you Seizures have been reported as a rare side effect of treatment with Ultram. The risk of seizures may be increased in patients who have any of the conditions or are taking any of the medications listed below: have a history of seizures or epilepsy have a head injury have a metabolic disorder have a central nervous system infection are experiencing alcohol or drug withdrawal are taking a tricyclic antidepressant such as amitriptyline (Elavil), nortriptyline (Pamelor), doxepin (Sinequan), imipramine (Tofranil), clomipramine (Anafranil), and others... are taking a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) are taking a psychiatric medication such as chlorpromazine (Thorazine), fluphenazine (Prolixin), haloperidol (Haldol), loxapine (Loxitane), mesoridazine (Serentil), perphenazine (Trilafon), thioridazine (Mellaril), thiothixene (Navane), and others... are taking a selective serotonin reuptake inhibitor (SSRI) such as fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or citalopram (Celexa) are taking a narcotic pain reliever such as codeine, fentanyl (Duragesic), hydromorphone (Dilaudid), meperidine (Demerol), hydrocodone (Vicodin, Lorcet, Lortab, others), morphine (MS Contin, MSIR, RMS, Roxanol, others), oxycodone (Roxicodone, Percocet, Percodan, others), propoxyphene (Darvon, Darvocet, others), and others... are taking promethazine (Phenergan) or prochlorperazine (Compazine) are taking sibutramine (Meridia) are taking bupropion (Wellbutrin, Zyban) are taking cyclobenzaprine (Flexeril) Before taking Ultram, tell your doctor if you have kidney disease liver disease history of alcohol or drug dependence You may not be able to take Ultram, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above. Ultram is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. It is also not known whether Ultram passes into breast milk. Do not take Ultram without first talking to your doctor if you are breast-feeding a baby. If you are over 75 years of age, you may be more likely to experience side effects from Ultram. The maximum daily dose of Ultram for people over 75 years of age is 300 mg. Ultram is not approved by the FDA for use by children younger than 16 years of age Warnings Do not drink alcohol don't use sedatives, tranquilizers, antihistamines, or narcotic pain relievers while taking Ultram. Use caution when driving, operating machinery, or performing other hazardous activities. Ultram may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. You should avoid combining it with other drugs that also increase the risk of seizures such as cyclobenzaprine (Flexeril), promethazine (Phenergan), and haloperidol (Haldol). Tell your doctor about all medicines that you are taking, and do not take any other prescription or over-the-counter medicines, including herbal products, without first talking to your doctor during treatment with Ultram. Remember, keep Tramadol and all other medications out of the reach of children, never share your medications with others, and use this medication only for the indication prescribed Featured Items RX-Simple is your dedicated online pharmacy. We have worked on the OP market for more then 5 years and we have served thousands of customers. Our primary goal is to be prompt and timely in delivery of every of your orders. All medications you can buy from our site are exactly as stated, the quality medications as claimed. These are high-quality genuine medications from their respective manufacturers. 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Sells Tramadol,famous FDA approved brand name and, generic medications with or without prescription, high quality, low prices, secure ordering, free shipping. DRUG CLASS AND MECHANISM: Tramadol is an effective pain reliever (analgesic). Its mode of action resembles that of narcotics, but it has significantly less potential for abuse and addiction than the narcotics. Tramadol is as effective as narcotics in relieving pain but does not depress respiration, a side effect of most narcotics. Tramadol is not a nonsteroidal antiinflammatory drug (NSAID), and does not have the increased risk of stomach ulceration and internal bleeding that can occur with the use of NSAIDs. DRUG INTERACTIONS: Tramadol can impair thinking and the physical abilities required for driving or operating machinery. Tramadol should be avoided in patients intoxicated with alcohol, hypnotics, and narcotics. Large doses of tramadol administered with alcohol or anesthetic agents can impair breathing. Tramadol can increase the risk of seizure in epileptic patients, especially with simultaneous use of tricyclic antidepressants, such as Elavil. No dosage adjustment or reduction is necessary in healthy elderly patients 65-75 years of age. Patients over the age of 75 years, and those with liver and kidney dysfunction may need lower dosages. The safety of tramadol in children has not been established. Tramadol may rarely be habit forming. Tramadol should be avoided in patients with a history of opiate addiction or hypersensitivity to opiate medications. I was in a really hepeless state when I first was given Tramadol. Other medicaments were ineffective and I was in pain very often. One day I found Tramadol gives the best result in traumatic pain. I ask the doctor for this medicine and since then I take 200 mg dose daily. I must be carefull because it may staggers, so it's better for me to stay in bed for a while. I am really happy taking Tramadol which alleviates my pain a lot! Richard from U.K. I think that Tramadol is the best medicament for everyone who suffers and it always appeases a pain. I decided to buy Tramadol because I had a long-drawn-out pain, which made me crazy. I had tried many times different pills, I had ever known about, but none of them gave the result as I needed. PillsBargain offers Tramadol and other prescription drugs. Shop conveniently, privately and safely for FDA approved prescription medications. Free FedEx 3-day express on all orders. Cheap Tramadol 50mg 120 Ct. $78.99, Soma & More... Save 75%+. Order Online, Toll-Free, 1-888 LOOK-NICE, COD, Fedex Overnight, Lowest Prices! FDA approved! M.D. Consult, Membership Fees Waived. Fast delivery from USA Licensed Dr./Pharmacy. Courteous Staff, Discreet Shipping. Saturday deliveries, Order by 1 Tramadol (Generic Ultram) Directions Follow the directions for using this medicine provided by your doctor. STORE THIS MEDICINE at room temperature, away from heat and light. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do NOT take 2 doses at once. Tramadol - Side Effects SIDE EFFECTS, that may go away during treatment, include dizziness, nausea, drowsiness, dry mouth, constipation, headache, or sweating. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience skin rash, itching, seizures, or hallucinations. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. Tramadol - Precautions DO NOT EXCEED THE RECOMMENDED DOSE OR TAKE THIS MEDICINE for longer than prescribed. IF YOU EXPERIENCE difficulty breathing or tightness of chest; swelling of eyelids, face, or lips; or develop a rash or hives, tell your doctor immediately. Do not take any more of this medicine unless your doctor tells you to do so. AVOID ALCOHOL while you are using this medicine. This medicine will add to the effects of alcohol and other depressants. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. THIS MEDICINE IS EXCRETED IN BREAST MILK. DO NOT BREAST-FEED while taking this medicine. Tramadol - Notes Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this product out of the reach of children. If using this medicine for an extended period of time, obtain refills before your supply runs out. Tramadol (INN) (IPA: [E?trA¦mE™dE’l]) is an atypical opioid which is a centrally acting analgesic, used for treating moderate to severe pain. It is a synthetic agent, unrelated to other opioids, and appears to have actions on the GABAergic, noradrenergic and serotonergic systems. Tramadol was developed by the German pharmaceutical company GrA?nenthal GmbH and marketed under the trade name Tramal. GrA?nenthal has also cross licensed the drug to many other pharmaceutical companies that market it under various names, some of which are listed below. Tramadol is available in both injectable (intravenous and/or intramuscular) and oral preparations. It is usually marketed as the hydrochloride salt (tramadol hydrochloride). Dosages vary depending on the degree of pain experienced by the patient. Tramadol is approximately 10% as potent as morphine, when given by the IV/IM route. Oral doses range from 50a€“400 mg daily, with up to 600 mg daily when given IV/IM. Tramadol is used to relieve moderate to moderately severe pain. It may be used to treat pain caused by surgery and chronic conditions such as cancer or joint pain. Tramadol is in a class of medications called opiate (narcotic) analgesics. It works by decreasing the body's sense of pain. Commonly reported side effects include nausea, constipation, dizziness, headache, drowsiness, and vomiting. Less commonly reported side effects include itching, sweating, dry mouth, diarrhea, rash, visual disturbances, and vertigo. 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. TRAMADOL - ORAL (TRAH-muh-dall) COMMON BRAND NAME(S): Ultram USES: Tramadol is used for pain relief. HOW TO USE: Take this medication by mouth as prescribed. It is usually taken every 4 to 6 hours as needed. Use this medication exactly as prescribed. Do not increase your dose, use it more frequently or use it for a longer period of time than prescribed because this drug can be habit-forming. Also, if used for an extended period of time, do not suddenly stop using this drug without your doctor's approval. When used for extended periods, this medication may not work as well and may require different dosing. Consult your doctor if the medication stops working well. SIDE EFFECTS: This medication may cause dizziness, weakness, incoordination, nausea or vomiting, stomach upset, constipation, headache, drowsiness, anxiety, irritability, dry mouth, or increased sweating. If any of these effects persist or worsen, inform your doctor. Notify your doctor if you develop any of these serious effects while taking this medication: chest pain, rapid heart rate, skin rash or itching, mental confusion, disorientation, seizures, tingling of the hands or feet, trouble breathing. In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, breathing trouble. If you notice other effects not listed above, contact your doctor or pharmacist. PRECAUTIONS: Tell your doctor your medical history, especially of: kidney disease, liver disease, seizure disorder, lung disease, history of drug or alcohol dependency, any allergies you may have. Limit alcohol as it may add to the dizziness or drowsiness effects caused by the medication. Because this drug may make you dizzy/drowsy, use caution performing tasks requiring alertness such as driving. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Tramadol is excreted into breast milk. Because the effects on a nursing infant are not known, consult your doctor before breast- feeding. DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription medications you may use, especially of: carbamazepine, narcotic pain relievers (e.g., codeine), drugs used to aid sleep, antidepressants (e.g., SSRI-types such as fluoxetine or fluvoxamine), MAO inhibitors (e.g., furazolidone, linezolid, phenelzine, procarbazine, selegiline, tranylcypromine), psychiatric medicine (e.g., nefazodone), "triptan"-type drugs, anti-anxiety drugs (e.g., diazepam), sibutramine. Also, report use of certain antihistamines (e.g., diphenhydramine) which are also present in many cough-and-cold products. Do not start or stop any medicine without doctor or pharmacist approval. OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include cold and clammy skin, low body temperature, slowed breathing, slowed heartbeat, drowsiness, dizziness, lightheadedness, deep sleep, loss of consciousness, or seizures. NOTES: Do not share this medication with others. MISSED DOSE: If you miss a dose, take it as soon as remembered; do not take it if it is near the time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. STORAGE: Store this medication at room temperature between 59 and 86 degrees F (15 to 30 degrees C) away from heat and light. Do not store in the bathroom. Keep this and all medications out of the reach of children. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/ or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist. tramadol Drug information Generic Name: tramadol (TRAM a dol) Brand Names: Ultram, Ultram ER What is the most important information I should know about tramadol? • You should not take tramadol if you have ever been addicted to drugs or alcohol. • Take tramadol exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor. Do not take more than 300 milligrams of tramadol in one day. • Do not stop using this medication suddenly without talking to your doctor. You may need to gradually reduce the dose. Withdrawal symptoms may occur when you stop using tramadol. Withdrawal symptoms include anxiety, sweating, nausea, diarrhea, tremors, chills, hallucinations, trouble sleeping, or breathing problems. Call your doctor at once if you have any of these withdrawal symptoms after you stop using tramadol. • Do not crush the tramadol tablet. This medicine is for oral (by mouth) use only. Powder from a crushed tablet should not be inhaled or diluted with liquid and injected into the body. Using this medicine by inhlation or injection can cause life-threatening side effects, overdose, or death. • Seizures (convulsions) have occurred in some people taking tramadol. You may be more likely to have a seizure while taking tramadol if you have a history of seizures or head injury, a metabolic disorder, or if you are taking certain medicines such as antidepressants, muscle relaxers, or medicine for nausea and vomiting. • Seek emergency medical attention if you think you have used too much of this medicine. A tramadol overdose can be fatal. Symptoms of a tramadol overdose may include drowsiness, shallow breathing, slow heartbeat, extreme weakness, cold or clammy skin, feeling light-headed, fainting, or coma. • While you are taking tramadol, do not drink alcohol or use drugs that make you sleepy (such as cold medicine, other pain medications, muscle relaxants, and medicine for seizures, depression or anxiety). These drugs may slow your breathing or increase drowsiness when used together with tramadol. • Tramadol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. What is tramadol? • Tramadol is a narcotic pain reliever. • Tramadol is used to treat moderate to severe pain. Tramadol extended-release is used to treat moderate to severe chronic pain when treatment is needed around the clock. • Tramadol may also be used for purposes other than those listed in this medication guide. What should I discuss with my healthcare provider before taking tramadol? • You should not take tramadol if you have ever been addicted to drugs or alcohol. • Do not take tramadol if you are intoxicated (drunk), or if you have recently used any of the following drugs: · alcohol; · narcotic pain medicine; · sedatives or tranquilizers (such as Valium); · medicine for depression or anxiety; · medicine for mental illness (such as bipolar disorder, schizophrenia); or · street drugs. • Seizures have occurred in some people taking tramadol. Your risk of a seizure may be higher if you have any of these conditions: · a history of drug or alcohol addiction; · a history of epilepsy or other seizure disorder; · a history of head injury; or · a metabolic disorder. • Talk with your doctor about your individual risk of having a seizure from this medicine. • Before taking tramadol, tell your doctor if you have: · kidney disease; · liver disease; · a stomach disorder; or · a history of depression, mental illness, or suicide attempt. • If you have any of these conditions, you may not be able to use tramadol, or you may need a dosage adjustment or special tests during treatment. • FDA pregnancy category C. This medication may be harmful to an unborn baby. Tramadol may also cause serious or fatal side effects in a newborn if the mother uses the medication during pregnancy or labor. Tell your doctor if you are pregnant or plan to become pregnant during treatment. • Tramadol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. • Older adults may be more sensitive to the effects of tramadol. If you are over 65, your doctor may recommend a lower dose. • Tramadol should not be given to a child younger than 16 years of age. How should I take tramadol? • Take tramadol exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor. Do not take more than 300 milligrams of tramadol in one day. • Take each dose with a full glass of water. • Tramadol can be taken with or without food, but take it the same way each time. • Do not crush the tramadol tablet. This medicine is for oral (by mouth) use only. Powder from a crushed tablet should not be inhaled or diluted with liquid and injected into the body. Using this medicine by inhlation or injection can cause life-threatening side effects, overdose, or death. • Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time. • If you use the tramadol extended-release tablet, the tablet shell may pass into your stools (bowel movements). This is normal and does not mean that you are not receiving enough of the medicine. • Tramadol may be habit-forming. Tell your doctor if you feel the medicine is not working as well in relieving your pain. Do not change your dose without talking to your doctor. • Do not stop using this medication suddenly without talking to your doctor. You may need to gradually reduce the dose. Withdrawal symptoms may occur when you stop using tramadol. Withdrawal symptoms include anxiety, sweating, nausea, diarrhea, tremors, chills, hallucinations, trouble sleeping, or breathing problems. Call your doctor at once if you have any of these withdrawal symptoms after you stop using tramadol. • Store tramadol at room temperature away from moisture and heat. What happens if I miss a dose? • Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose. What happens if I overdose? • Seek emergency medical attention if you think you have used too much of this medicine. A tramadol overdose can be fatal. • Symptoms of a tramadol overdose may include drowsiness, shallow breathing, slow heartbeat, extreme weakness, cold or clammy skin, feeling light-headed, fainting, or coma. What should I avoid while taking tramadol? • Do not drink alcohol while you are taking tramadol. Alcohol may cause a dangerous decrease in your breathing when used together with tramadol. • Avoid using drugs that make you sleepy (such as cold medicine, other pain medications, muscle relaxants, and medicine for seizures, depression or anxiety). These drugs may slow your breathing or increase drowsiness when used together with tramadol. • Tramadol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. What are the possible side effects of tramadol? • Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. • Stop using tramadol and call your doctor at once if you have any of these serious side effects: · seizure (convulsions); · a red, blistering, peeling skin rash; or · shallow breathing, weak pulse. • Continue taking tramadol and talk to your doctor if you have any of these less serious side effects: · dizziness, drowsiness, weakness; · nausea, vomiting, constipation, loss of appetite; · blurred vision; · flushing (redness, warmth, or tingly feeling); or · sleep problems (insomnia). • Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. What other drugs will affect tramadol? • You may be more likely to have a seizure (convulsions) if you take tramadol while you are using certain other medicines. Do not take tramadol without telling your doctor if you also use any of the following: · an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam); or · an antidepressant such as amitriptyline (Elavil), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor); paroxetine (Paxil), or sertraline (Zoloft). • Before taking tramadol, tell your doctor if you also use: · carbamazepine (Tegretol); · warfarin (Coumadin); · digoxin (Lanoxin, Lanoxicaps); · ketoconazole (Nizoral); · erythromycin (E-Mycin, E.E.S., Ery-Tab); · rifampin (Rifadin, Rimactane, Rifater); · St. John's wort; · quinidine (Quinaglute, Quinadex, Cardioquin, Quinora); or · drugs that make you sleepy (such as cold medicine, other pain medications, muscle relaxants, and medicine for seizures, depression or anxiety). • If you are using any of these drugs, you may not be able to use tramadol or you may need dosage adjustments or special tests during treatment. • There may be other drugs not listed that can affect tramadol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Where can I get more information? • Your pharmacist has more information about tramadol written for health professionals that you may read. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. ULTRAM tablets contain 50 mg of tramadol hydrochloride and are white in color. Inactive ingredients in the tablet are corn starch, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, titanium dioxide and wax. CLINICAL PHARMACOLOGY Pharmacodynamics ULTRAM is a centrally acting synthetic opioid analgesic. Although its mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: binding of parent and M1 metabolite to µ-opioid receptors and weak inhibition of reuptake of norepinephrine and serotonin. Opioid activity is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to µ-opioid receptors. In animal models, M1 is up to 6 times more potent than tramadol in producing analgesia and 200 times more potent in µ-opioid binding. Tramadol-induced analgesia is only partially antagonized by the opiate antagonist naloxone in several animal tests. The relative contribution of both tramadol and M1 to human analgesia is dependent upon the plasma concentrations of each compound (see CLINICAL PHARMACOLOGY , Pharmacokinetics ). Tramadol has been shown to inhibit reuptake of norepinephrine and serotonin in vitro , as have some other opioid analgesics. These mechanisms may contribute independently to the overall analgesic profile of ULTRAM. Analgesia in humans begins approximately within one hour after administration and reaches a peak in approximately two to three hours. Apart from analgesia, ULTRAM administration may produce a constellation of symptoms (including dizziness, somnolence, nausea, constipation, sweating and pruritus) similar to that of other opioids. In contrast to morphine, tramadol has not been shown to cause histamine release. At therapeutic doses, ULTRAM has no effect on heart rate, left-ventricular function or cardiac index. Orthostatic hypotension has been observed. Pharmacokinetics The analgesic activity of ULTRAM is due to both parent drug and the M1 metabolite (see CLINICAL PHARMACOLOGY , Pharmacodynamics ). Tramadol is administered as a racemate and both the [-] and [+] forms of both tramadol and M1 are detected in the circulation. Tramadol is well absorbed orally with an absolute bioavailability of 75%. Tramadol has a volume of distribution of approximately 2.7L/kg and is only 20% bound to plasma proteins. Tramadol is extensively metabolized by a number of pathways, including CYP2D6 and CYP3A4, as well as by conjugation of parent and metabolites. One metabolite, M1, is pharmacologically active in animal models. The formation of M1 is dependent upon CYP2D6 and as such is subject to inhibition, which may affect the therapeutic response (see PRECAUTIONS , Drug Interactions ). Tramadol and its metabolites are excreted primarily in the urine with observed plasma half-lives of 6.3 and 7.4 hours for tramadol and M1, respectively. Linear pharmacokinetics have been observed following multiple doses of 50 and 100 mg to steady-state. Absorption: Racemic tramadol is rapidly and almost completely absorbed after oral administration. The mean absolute bioavailability of a 100 mg oral dose is approximately 75%. The mean peak plasma concentration of racemic tramadol and M1 occurs at two and three hours, respectively, after administration in healthy adults. In general, both enantiomers of tramadol and M1 follow a parallel time course in the body following single and multiple doses although small differences (~ 10%) exist in the absolute amount of each enantiomer present. Steady-state plasma concentrations of both tramadol and M1 are achieved within two days with q.i.d. dosing. There is no evidence of self-induction (see Figure 1 and Food Effects: Oral administration of ULTRAM with food does not significantly affect its rate or extent of absorption, therefore, ULTRAM can be administered without regard to food. Distribution: The volume of distribution of tramadol was 2.6 and 2.9 liters/kg in male and female subjects, respectively, following a 100 mg intravenous dose. The binding of tramadol to human plasma proteins is approximately 20% and binding also appears to be independent of concentration up to 10 µg/mL. Saturation of plasma protein binding occurs only at concentrations outside the clinically relevant range. Metabolism: Tramadol is extensively metabolized after oral administration. Approximately 30% of the dose is excreted in the urine as unchanged drug, whereas 60% of the dose is excreted as metabolites. The remainder is excreted either as unidentified or as unextractable metabolites. The major metabolic pathways appear to be N - and O - demethylation and glucuronidation or sulfation in the liver. One metabolite ( O -desmethyltramadol, denoted M1) is pharmacologically active in animal models. Formation of M1 is dependent on CYP2D6 and as such is subject to inhibition, which may affect the therapeutic response (see PRECAUTIONS , Drug Interaction ). Approximately 7% of the population has reduced activity of the CYP2D6 isoenzyme of cytochrome P-450. These individuals are "poor metabolizers" of debrisoquine, dextromethorphan, tricyclic antidepressants, among other drugs. Based on a population PK analysis of Phase I studies in healthy subjects, concentrations of tramadol were approximately 20% higher in "poor metabolizers" versus "extensive metabolizers," while M1 concentrations were 40% lower. Concomitant therapy with inhibitors of CYP2D6 such as fluoxetine, paroxetine and quinidine could result in significant drug interactions. In vitro drug interaction studies in human liver microsomes indicate that inhibitors of CYP2D6 such as fluoxetine and its metabolite norfluoxetine, amitriptyline and quinidine inhibit the metabolism of tramadol to various degrees, suggesting that concomitant administration of these compounds could result in increases in tramadol concentrations and decreased concentrations of M1. The full pharmacological impact of these alterations in terms of either efficacy or safety is unknown. Concomitant use of SEROTONIN re-uptake INHIBITORS and MAO INHIBITORS may enhance the risk of adverse events, including seizure (see WARNINGS ) and serotonin syndrome. Elimination: Tramadol is eliminated primarily through metabolism by the liver and the metabolites are eliminated primarily by the kidneys. The mean terminal plasma elimination half-lives of racemic tramadol and racemic M1 are 6.3 ± 1.4 and 7.4 ± 1.4 hours, respectively. The plasma elimination half-life of racemic tramadol increased from approximately six hours to seven hours upon multiple dosing. Special Populations Renal: Impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite, M1. In patients with creatinine clearances of less than 30 mL/min, adjustment of the dosing regimen is recommended (see DOSAGE AND ADMINISTRATION ). The total amount of tramadol and M1 removed during a 4-hour dialysis period is less than 7% of the administered dose. Hepatic: Metabolism of tramadol and M1 is reduced in patients with advanced cirrhosis of the liver, resulting in both a larger area under the concentration time curve for tramadol and longer tramadol and M1 elimination half-lives (13 hrs. for tramadol and 19 hrs. for M1). In cirrhotic patients, adjustment of the dosing regimen is recommended (see DOSAGE AND ADMINISTRATION ). Geriatric: Healthy elderly subjects aged 65 to 75 years have plasma tramadol concentrations and elimination half-lives comparable to those observed in healthy subjects less than 65 years of age. In subjects over 75 years, maximum serum concentrations are elevated (208 vs. 162 ng/mL) and the elimination half-life is prolonged (7 vs. 6 hours) compared to subjects 65 to 75 years of age. Adjustment of the daily dose is recommended for patients older than 75 years (see DOSAGE AND ADMINISTRATION ). Gender: The absolute bioavailability of tramadol was 73% in males and 79% in females. The plasma clearance was 6.4 mL/min/kg in males and 5.7 mL/min/kg in females following a 100 mg IV dose of tramadol. Following a single oral dose, and after adjusting for body weight, females had a 12% higher peak tramadol concentration and a 35% higher area under the concentration-time curve compared to males. The clinical significance of this difference is unknown. Clinical Studies ULTRAM has been given in single oral doses of 50, 75 and 100 mg to patients with pain following surgical procedures and pain following oral surgery (extraction of impacted molars). In single-dose models of pain following oral surgery, pain relief was demonstrated in some patients at doses of 50 mg and 75 mg. A dose of 100 mg ULTRAM tended to provide analgesia superior to codeine sulfate 60 mg, but it was not as effective as the combination of aspirin 650 mg with codeine phosphate 60 mg. ULTRAM has been studied in three long-term controlled trials involving a total of 820 patients, with 530 patients receiving ULTRAM. Patients with a variety of chronic painful conditions were studied in double-blind trials of one to three months duration. Average daily doses of approximately 250 mg of ULTRAM in divided doses were generally comparable to five doses of acetaminophen 300 mg with codeine phosphate 30 mg (TYLENOL® with Codeine #3) daily, five doses of aspirin 325 mg with codeine phosphate 30 mg daily, or two to three doses of acetaminophen 500 mg with oxycodone hydrochloride 5 mg (TYLOX®) daily. Titration Trials In a randomized, blinded clinical study with 129 to 132 patients per group, a 10-day titration to a daily ULTRAM dose of 200 mg (50 mg q.i.d.), attained in 50 mg increments every 3 days, was found to result in fewer discontinuations due to dizziness or vertigo than titration over only 4 days or no titration. In a second study with 54 to 59 patients per group, patients who had nausea or vomiting when titrated over 4 days were randomized to re-initiate ULTRAM therapy using slower titration rates. A 16-day titration schedule, starting with 25 mg qAM and using additional doses in 25 mg increments every third day to 100 mg/day (25 mg q.i.d.), followed by 50 mg increments in the total daily dose every third day to 200 mg/day (50 mg q.i.d.), resulted in fewer discontinuations due to nausea or vomiting and fewer discontinuations due to any cause than did a 10-day titration schedule. Tramadol is extensively metabolized after oral administration. Approximately 30% of the dose is excreted in the urine as unchanged drug, whereas 60% of the dose is excreted as metabolites. The remainder is excreted either as unidentified or as unextractable metabolites. The major metabolic pathways appear to be N - and O - demethylation and glucuronidation or sulfation in the liver. One metabolite ( O -desmethyltramadol, denoted M1) is pharmacologically active in animal models. Formation of M1 is dependent on CYP2D6 and as such is subject to inhibition, which may affect the therapeutic response (see PRECAUTIONS , Drug Interaction ). Approximately 7% of the population has reduced activity of the CYP2D6 isoenzyme of cytochrome P-450. These individuals are "poor metabolizers" of debrisoquine, dextromethorphan, tricyclic antidepressants, among other drugs. Based on a population PK analysis of Phase I studies in healthy subjects, concentrations of tramadol were approximately 20% higher in "poor metabolizers" versus "extensive metabolizers," while M1 concentrations were 40% lower. Concomitant therapy with inhibitors of CYP2D6 such as fluoxetine, paroxetine and quinidine could result in significant drug interactions. In vitro drug interaction studies in human liver microsomes indicate that inhibitors of CYP2D6 such as fluoxetine and its metabolite norfluoxetine, amitriptyline and quinidine inhibit the metabolism of tramadol to various degrees, suggesting that concomitant administration of these compounds could result in increases in tramadol concentrations and decreased concentrations of M1. The full pharmacological impact of these alterations in terms of either efficacy or safety is unknown. Concomitant use of SEROTONIN re-uptake INHIBITORS and MAO INHIBITORS may enhance the risk of adverse events, including seizure (see WARNINGS ) and serotonin syndrome. ULTRAM has been given in single oral doses of 50, 75 and 100 mg to patients with pain following surgical procedures and pain following oral surgery (extraction of impacted molars). In single-dose models of pain following oral surgery, pain relief was demonstrated in some patients at doses of 50 mg and 75 mg. A dose of 100 mg ULTRAM tended to provide analgesia superior to codeine sulfate 60 mg, but it was not as effective as the combination of aspirin 650 mg with codeine phosphate 60 mg. ULTRAM has been studied in three long-term controlled trials involving a total of 820 patients, with 530 patients receiving ULTRAM. Patients with a variety of chronic painful conditions were studied in double-blind trials of one to three months duration. Average daily doses of approximately 250 mg of ULTRAM in divided doses were generally comparable to five doses of acetaminophen 300 mg with codeine phosphate 30 mg (TYLENOL® with Codeine #3) daily, five doses of aspirin 325 mg with codeine phosphate 30 mg daily, or two to three doses of acetaminophen 500 mg with oxycodone hydrochloride 5 mg (TYLOX®) daily. A slight, but statistically significant, increase in two common murine tumors, pulmonary and hepatic, was observed in a mouse carcinogenicity study, particularly in aged mice. Mice were dosed orally up to 30 mg/kg (90 mg/m 2 or 0.36 times the maximum daily human dosage of 246 mg/m 2 ) for approximately two years, although the study was not done with the Maximum Tolerated Dose. This finding is not believed to suggest risk in humans. No such finding occurred in a rat carcinogenicity study (dosing orally up to 30 mg/kg, 180 mg/m 2 , or 0.73 times the maximum daily human dosage). Tramadol was not mutagenic in the following assays: Ames Salmonella microsomal activation test, CHO/HPRT mammalian cell assay, mouse lymphoma assay (in the absence of metabolic activation), dominant lethal mutation tests in mice, chromosome aberration test in Chinese hamsters, and bone marrow micronucleus tests in mice and Chinese hamsters. Weakly mutagenic results occurred in the presence of metabolic activation in the mouse lymphoma assay and micronucleus test in rats. Overall, the weight of evidence from these tests indicates that tramadol does not pose a genotoxic risk to humans. No effects on fertility were observed for tramadol at oral dose levels up to 50 mg/kg (300 mg/m 2 ) in male rats and 75 mg/kg (450 mg/m 2 ) in female rats. These dosages are 1.2 and 1.8 times the maximum daily human dosage of 246 mg/m 2 , respectively. Pregnancy, Teratogenic Effects: Pregnancy Catogery C Tramadol has been shown to be embryotoxic and fetotoxic in mice, (120 mg/kg or 360 mg/m 2 ), rats (>/=25 mg/kg or 150 mg/m 2 ) and rabbits (>/=75 mg/kg or 900 mg/m 2 ) at maternally toxic dosages, but was not teratogenic at these dose levels. These dosages on a mg/m 2 basis are 1.4, >/=0.6, and >/=3.6 times the maximum daily human dosage (246 mg/m 2 ) for mouse, rat and rabbit, respectively. No drug-related teratogenic effects were observed in progeny of mice (up to 140 mg/kg or 420 mg/m 2 ), rats (up to 80 mg/kg or 480 mg/m 2 ) or rabbits (up to 300 mg/kg or 3600 mg/m 2 ) treated with tramadol by various routes. Embryo and fetal toxicity consisted primarily of decreased fetal weights, skeletal ossification and increased supernumerary ribs at maternally toxic dose levels. Transient delays in developmental or behavioral parameters were also seen in pups from rat dams allowed to deliver. Embryo and fetal lethality were reported only in one rabbit study at 300 mg/kg (3600 mg/m 2 ), a dose that would cause extreme maternal toxicity in the rabbit. The dosages listed for mouse, rat and rabbit are 1.7, 1.9 and 14.6 times the maximum daily human dosage (246 mg/m 2 ), respectively 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. 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Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products. 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. Abnormal dreams; appetite decreased; back pain; bladder pain; blistering, crusting, irritation, itching, or reddening of skin; bloody or cloudy urine; body aches or pain; change in hearing; clamminess; cold flu-like symptoms; confusion; cough producing mucus; cracked, dry, scaly skin; decreased interest in sexual intercourse; difficult, burning, or painful urination; difficulty breathing; difficulty in moving; disturbance in attention; ear congestion; ear drainage; earache or pain in ear; excessive gas; fall; false or unusual sense of well-being; feeling hot; feeling jittery; flushing or redness of the skin; general feeling of bodily discomfort; goosebumps; headache, severe and throbbing; hoarseness; hot flashes; inability to have or keep an erection; itching, pain, redness, swelling, tenderness, warmth on skin; joint sprain; joint stiffness; joint swelling; loss in sexual ability, desire, drive, or performance; loss of voice; lower back or side pain; muscle aching or cramping; muscle injury; muscle pain or stiffness; muscle spasms or twitching; nasal congestion; neck pain; night sweats; pain; pain in limb; pain or tenderness around eyes and cheekbones; pain, swelling, or redness in joints; skin discoloration; swelling; swelling of hands, ankles, feet, or lower legs; tightness of chest; trouble in holding or releasing urine; troubled breathing; trouble in sleeping; weight increased or decreased Abdominal fullness; abnormal or decreased touch sensation; blisters under the skin; bloating; blood in urine; blood pressure increased; blurred vision; chest pain or discomfort; change in walking and balance; chills; convulsions (seizures); darkened urine; difficult urination; dizziness or lightheadedness when getting up from a lying or sitting position; fainting; fast heartbeat; frequent urge to urinate; gaseous abdominal pain; heart rate increased; indigestion; irregular heartbeat; loss of memory; numbness and tingling of face, fingers, or toes; numbness, tingling, pain, or weakness in hands or feet; pain in arms, legs, or lower back, especially pain in calves and/or heels upon exertion; pain or discomfort in arms, jaw, back or neck; pains in stomach, side, or abdomen, possibly radiating to the back; pale bluish-colored or cold hands or feet; recurrent fever; seeing, hearing, or feeling things that are not there; severe cramping; severe nausea; severe redness, swelling, and itching of the skin; shortness of breath; sweats; trembling and shaking of hands or feet; trouble performing routine tasks; weak or absent pulses in legs; yellow eyes or skin This medicine will add to the effects of alcohol and other CNS depressants (medicine that causes drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with your medical doctor or dentist before taking any of the medicines listed above while you are using this medicine . This medicine may cause some people to become drowsy, dizzy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert . Dizziness, lightheadedness, or fainting may occur , especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Nausea or vomiting may occur, especially after the first couple of doses. This effect may go away if you lie down for awhile. However, if nausea or vomiting continues, check with your medical doctor or dentist. Lying down for a while may also help relieve some other side effects, such as dizziness or lightheadedness, that may occur. Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine. Taking tramadol together with medicines that are used during surgery or dental or emergency treatments may cause increased side effects. If you think you or someone else may have taken an overdose of tramadol, get emergency help at once . Signs of an overdose include convulsions (seizures) and pinpoint pupils of the eyes.

tramadol Drug information Generic Name: tramadol (TRAM a dol) Brand Names: Ultram, Ultram ER What is the most important information I should know about tramadol? • You should not take tramadol if you have ever been addicted to drugs or alcohol. • Take tramadol exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor. Do not take more than 300 milligrams of tramadol in one day. • Do not stop using this medication suddenly without talking to your doctor. You may need to gradually reduce the dose. Withdrawal symptoms may occur when you stop using tramadol. Withdrawal symptoms include anxiety, sweating, nausea, diarrhea, tremors, chills, hallucinations, trouble sleeping, or breathing problems. Call your doctor at once if you have any of these withdrawal symptoms after you stop using tramadol. • Do not crush the tramadol tablet. This medicine is for oral (by mouth) use only. Powder from a crushed tablet should not be inhaled or diluted with liquid and injected into the body. Using this medicine by inhlation or injection can cause life-threatening side effects, overdose, or death. • Seizures (convulsions) have occurred in some people taking tramadol. You may be more likely to have a seizure while taking tramadol if you have a history of seizures or head injury, a metabolic disorder, or if you are taking certain medicines such as antidepressants, muscle relaxers, or medicine for nausea and vomiting. • Seek emergency medical attention if you think you have used too much of this medicine. A tramadol overdose can be fatal. Symptoms of a tramadol overdose may include drowsiness, shallow breathing, slow heartbeat, extreme weakness, cold or clammy skin, feeling light-headed, fainting, or coma. • While you are taking tramadol, do not drink alcohol or use drugs that make you sleepy (such as cold medicine, other pain medications, muscle relaxants, and medicine for seizures, depression or anxiety). These drugs may slow your breathing or increase drowsiness when used together with tramadol. • Tramadol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. What is tramadol? • Tramadol is a narcotic pain reliever. • Tramadol is used to treat moderate to severe pain. Tramadol extended-release is used to treat moderate to severe chronic pain when treatment is needed around the clock. • Tramadol may also be used for purposes other than those listed in this medication guide. What should I discuss with my healthcare provider before taking tramadol? • You should not take tramadol if you have ever been addicted to drugs or alcohol. • Do not take tramadol if you are intoxicated (drunk), or if you have recently used any of the following drugs: · alcohol; · narcotic pain medicine; · sedatives or tranquilizers (such as Valium); · medicine for depression or anxiety; · medicine for mental illness (such as bipolar disorder, schizophrenia); or · street drugs. • Seizures have occurred in some people taking tramadol. Your risk of a seizure may be higher if you have any of these conditions: · a history of drug or alcohol addiction; · a history of epilepsy or other seizure disorder; · a history of head injury; or · a metabolic disorder. • Talk with your doctor about your individual risk of having a seizure from this medicine. • Before taking tramadol, tell your doctor if you have: · kidney disease; · liver disease; · a stomach disorder; or · a history of depression, mental illness, or suicide attempt. • If you have any of these conditions, you may not be able to use tramadol, or you may need a dosage adjustment or special tests during treatment. • FDA pregnancy category C. This medication may be harmful to an unborn baby. Tramadol may also cause serious or fatal side effects in a newborn if the mother uses the medication during pregnancy or labor. Tell your doctor if you are pregnant or plan to become pregnant during treatment. • Tramadol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. • Older adults may be more sensitive to the effects of tramadol. If you are over 65, your doctor may recommend a lower dose. • Tramadol should not be given to a child younger than 16 years of age. How should I take tramadol? • Take tramadol exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor. Do not take more than 300 milligrams of tramadol in one day. • Take each dose with a full glass of water. • Tramadol can be taken with or without food, but take it the same way each time. • Do not crush the tramadol tablet. This medicine is for oral (by mouth) use only. Powder from a crushed tablet should not be inhaled or diluted with liquid and injected into the body. Using this medicine by inhlation or injection can cause life-threatening side effects, overdose, or death. • Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time. • If you use the tramadol extended-release tablet, the tablet shell may pass into your stools (bowel movements). This is normal and does not mean that you are not receiving enough of the medicine. • Tramadol may be habit-forming. Tell your doctor if you feel the medicine is not working as well in relieving your pain. Do not change your dose without talking to your doctor. • Do not stop using this medication suddenly without talking to your doctor. You may need to gradually reduce the dose. Withdrawal symptoms may occur when you stop using tramadol. Withdrawal symptoms include anxiety, sweating, nausea, diarrhea, tremors, chills, hallucinations, trouble sleeping, or breathing problems. Call your doctor at once if you have any of these withdrawal symptoms after you stop using tramadol. • Store tramadol at room temperature away from moisture and heat. What happens if I miss a dose? • Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose. What happens if I overdose? • Seek emergency medical attention if you think you have used too much of this medicine. A tramadol overdose can be fatal. • Symptoms of a tramadol overdose may include drowsiness, shallow breathing, slow heartbeat, extreme weakness, cold or clammy skin, feeling light-headed, fainting, or coma. What should I avoid while taking tramadol? • Do not drink alcohol while you are taking tramadol. Alcohol may cause a dangerous decrease in your breathing when used together with tramadol. • Avoid using drugs that make you sleepy (such as cold medicine, other pain medications, muscle relaxants, and medicine for seizures, depression or anxiety). These drugs may slow your breathing or increase drowsiness when used together with tramadol. • Tramadol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. What are the possible side effects of tramadol? • Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. • Stop using tramadol and call your doctor at once if you have any of these serious side effects: · seizure (convulsions); · a red, blistering, peeling skin rash; or · shallow breathing, weak pulse. • Continue taking tramadol and talk to your doctor if you have any of these less serious side effects: · dizziness, drowsiness, weakness; · nausea, vomiting, constipation, loss of appetite; · blurred vision; · flushing (redness, warmth, or tingly feeling); or · sleep problems (insomnia). • Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. What other drugs will affect tramadol? • You may be more likely to have a seizure (convulsions) if you take tramadol while you are using certain other medicines. Do not take tramadol without telling your doctor if you also use any of the following: · an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam); or · an antidepressant such as amitriptyline (Elavil), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor); paroxetine (Paxil), or sertraline (Zoloft). • Before taking tramadol, tell your doctor if you also use: · carbamazepine (Tegretol); · warfarin (Coumadin); · digoxin (Lanoxin, Lanoxicaps); · ketoconazole (Nizoral); · erythromycin (E-Mycin, E.E.S., Ery-Tab); · rifampin (Rifadin, Rimactane, Rifater); · St. John's wort; · quinidine (Quinaglute, Quinadex, Cardioquin, Quinora); or · drugs that make you sleepy (such as cold medicine, other pain medications, muscle relaxants, and medicine for seizures, depression or anxiety). • If you are using any of these drugs, you may not be able to use tramadol or you may need dosage adjustments or special tests during treatment. • There may be other drugs not listed that can affect tramadol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Where can I get more information? • Your pharmacist has more information about tramadol written for health professionals that you may read. TRAMADOL HYDROCHLORIDE Manufacturer: Ortho-McNeil Prescribing Information DESCRIPTION ULTRAM® (tramadol hydrochloride tablets) is a centrally acting analgesic. The chemical name for tramadol hydrochloride is (±) cis -2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is: The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. ULTRAM tablets contain 50 mg of tramadol hydrochloride and are white in color. Inactive ingredients in the tablet are corn starch, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, titanium dioxide and wax. CLINICAL PHARMACOLOGY Pharmacodynamics ULTRAM is a centrally acting synthetic opioid analgesic. Although its mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: binding of parent and M1 metabolite to µ-opioid receptors and weak inhibition of reuptake of norepinephrine and serotonin. Opioid activity is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to µ-opioid receptors. In animal models, M1 is up to 6 times more potent than tramadol in producing analgesia and 200 times more potent in µ-opioid binding. Tramadol-induced analgesia is only partially antagonized by the opiate antagonist naloxone in several animal tests. The relative contribution of both tramadol and M1 to human analgesia is dependent upon the plasma concentrations of each compound (see CLINICAL PHARMACOLOGY , Pharmacokinetics ). Tramadol has been shown to inhibit reuptake of norepinephrine and serotonin in vitro , as have some other opioid analgesics. These mechanisms may contribute independently to the overall analgesic profile of ULTRAM. Analgesia in humans begins approximately within one hour after administration and reaches a peak in approximately two to three hours. Apart from analgesia, ULTRAM administration may produce a constellation of symptoms (including dizziness, somnolence, nausea, constipation, sweating and pruritus) similar to that of other opioids. In contrast to morphine, tramadol has not been shown to cause histamine release. At therapeutic doses, ULTRAM has no effect on heart rate, left-ventricular function or cardiac index. Orthostatic hypotension has been observed. Pharmacokinetics The analgesic activity of ULTRAM is due to both parent drug and the M1 metabolite (see CLINICAL PHARMACOLOGY , Pharmacodynamics ). Tramadol is administered as a racemate and both the [-] and [+] forms of both tramadol and M1 are detected in the circulation. Tramadol is well absorbed orally with an absolute bioavailability of 75%. Tramadol has a volume of distribution of approximately 2.7L/kg and is only 20% bound to plasma proteins. Tramadol is extensively metabolized by a number of pathways, including CYP2D6 and CYP3A4, as well as by conjugation of parent and metabolites. One metabolite, M1, is pharmacologically active in animal models. The formation of M1 is dependent upon CYP2D6 and as such is subject to inhibition, which may affect the therapeutic response (see PRECAUTIONS , Drug Interactions ). Tramadol and its metabolites are excreted primarily in the urine with observed plasma half-lives of 6.3 and 7.4 hours for tramadol and M1, respectively. Linear pharmacokinetics have been observed following multiple doses of 50 and 100 mg to steady-state. Absorption: Racemic tramadol is rapidly and almost completely absorbed after oral administration. The mean absolute bioavailability of a 100 mg oral dose is approximately 75%. The mean peak plasma concentration of racemic tramadol and M1 occurs at two and three hours, respectively, after administration in healthy adults. In general, both enantiomers of tramadol and M1 follow a parallel time course in the body following single and multiple doses although small differences (~ 10%) exist in the absolute amount of each enantiomer present. Steady-state plasma concentrations of both tramadol and M1 are achieved within two days with q.i.d. dosing. There is no evidence of self-induction (see Figure 1 and Table 1 below). Figure 1: Mean Tramadol and M1 Plasma Concentration Profiles after a Single 100 mg Oral Dose and after Twenty-Nine 100 mg Oral Doses of Tramadol HCl given TRAMADOL HYDROCHLORIDE Manufacturer: Ortho-McNeil Prescribing Information DESCRIPTION ULTRAM® (tramadol hydrochloride tablets) is a centrally acting analgesic. The chemical name for tramadol hydrochloride is (±) cis -2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is: The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. ULTRAM tablets contain 50 mg of tramadol hydrochloride and are white in color. Inactive ingredients in the tablet are corn starch, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, titanium dioxide and wax. CLINICAL PHARMACOLOGY Pharmacodynamics ULTRAM is a centrally acting synthetic opioid analgesic. Although its mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: binding of parent and M1 metabolite to µ-opioid receptors and weak inhibition of reuptake of norepinephrine and serotonin. Opioid activity is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to µ-opioid receptors. In animal models, M1 is up to 6 times more potent than tramadol in producing analgesia and 200 times more potent in µ-opioid binding. Tramadol-induced analgesia is only partially antagonized by the opiate antagonist naloxone in several animal tests. The relative contribution of both tramadol and M1 to human analgesia is dependent upon the plasma concentrations of each compound (see CLINICAL PHARMACOLOGY , Pharmacokinetics ). Tramadol has been shown to inhibit reuptake of norepinephrine and serotonin in vitro , as have some other opioid analgesics. These mechanisms may contribute independently to the overall analgesic profile of ULTRAM. Analgesia in humans begins approximately within one hour after administration and reaches a peak in approximately two to three hours. Apart from analgesia, ULTRAM administration may produce a constellation of symptoms (including dizziness, somnolence, nausea, constipation, sweating and pruritus) similar to that of other opioids. In contrast to morphine, tramadol has not been shown to cause histamine release. At therapeutic doses, ULTRAM has no effect on heart rate, left-ventricular function or cardiac index. Orthostatic hypotension has been observed. Pharmacokinetics The analgesic activity of ULTRAM is due to both parent drug and the M1 metabolite (see CLINICAL PHARMACOLOGY , Pharmacodynamics ). Tramadol is administered as a racemate and both the [-] and [+] forms of both tramadol and M1 are detected in the circulation. Tramadol is well absorbed orally with an absolute bioavailability of 75%. Tramadol has a volume of distribution of approximately 2.7L/kg and is only 20% bound to plasma proteins. Tramadol is extensively metabolized by a number of pathways, including CYP2D6 and CYP3A4, as well as by conjugation of parent and metabolites. One metabolite, M1, is pharmacologically active in animal models. The formation of M1 is dependent upon CYP2D6 and as such is subject to inhibition, which may affect the therapeutic response (see PRECAUTIONS , Drug Interactions ). Tramadol and its metabolites are excreted primarily in the urine with observed plasma half-lives of 6.3 and 7.4 hours for tramadol and M1, respectively. Linear pharmacokinetics have been observed following multiple doses of 50 and 100 mg to steady-state. Absorption: Racemic tramadol is rapidly and almost completely absorbed after oral administration. The mean absolute bioavailability of a 100 mg oral dose is approximately 75%. The mean peak plasma concentration of racemic tramadol and M1 occurs at two and three hours, respectively, after administration in healthy adults. In general, both enantiomers of tramadol and M1 follow a parallel time course in the body following single and multiple doses although small differences (~ 10%) exist in the absolute amount of each enantiomer present. Steady-state plasma concentrations of both tramadol and M1 are achieved within two days with q.i.d. dosing. There is no evidence of self-induction (see Figure 1 and Table 1 below). Figure 1: Mean Tramadol and M1 Plasma Concentration Profiles after a Single 100 mg Oral Dose and after Twenty-Nine 100 mg Oral Doses of Tramadol HCl given INDICATIONS AND USAGE ULTRAM is indicated for the management of moderate to moderately severe pain in adults. CONTRAINDICATIONS ULTRAM should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids. ULTRAM is contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. ULTRAM may worsen central nervous system and respiratory depression in these patients. WARNINGS Seizure Risk Seizures have been reported in patients receiving ULTRAM within the recommended dosage range. Spontaneous post-marketing reports indicate that seizure risk is increased with doses of ULTRAM above the recommended range. Concomitant use of ULTRAM increases the seizure risk in patients taking: Selective serotonin reuptake inhibitors (SSRI antidepressants or anorectics), Tricyclic antidepressants (TCAs), and other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.), or Other opioids. Administration of ULTRAM may enhance the seizure risk in patients taking: MAO inhibitors (see also WARNINGS - Use with MAO Inhibitors), Neuroleptics, or Other drugs that reduce the seizure threshold. Risk of convulsions may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections). In ULTRAM overdose, naloxone administration may increase the risk of seizure. Anaphylactoid Reactions Serious and rarely fatal anaphylactoid reactions have been reported in patients receiving therapy with ULTRAM. When these events do occur it is often following the first dose. Other reported allergic reactions include pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis and Stevens-Johnson syndrome. Patients with a history of anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive ULTRAM (see CONTRAINDICATIONS ). Respiratory Depression Administer ULTRAM cautiously in patients at risk for respiratory depression. In these patients alternative non-opioid analgesics should be considered. When large doses of ULTRAM are administered with anesthetic medications or alcohol, respiratory depression may result. Respiratory depression should be treated as an overdose. If naloxone is to be administered, use cautiously because it may precipitate seizures (see WARNINGS , Seizure Risk and OVERDOSAGE ). Interaction With Central Nervous System (CNS) Depressants ULTRAM should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers or sedative hypnotics. ULTRAM increases the risk of CNS and respiratory depression in these patients. Increased Intracranial Pressure or Head Trauma ULTRAM should be used with caution in patients with increased intracranial pressure or head injury. The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, and may be markedly exaggerated in these patients. Additionally, pupillary changes (miosis) from tramadol may obscure the existence, extent, or course of intracranial pathology. Clinicians should also maintain a high index of suspicion for adverse drug reaction when evaluating altered mental status in these patients if they are receiving ULTRAM. (See Respiratory Depression .) Use in Ambulatory Patients ULTRAM may impair the mental and or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using this drug should be cautioned accordingly. Use With MAO Inhibitors and Serotonin Re-uptake Inhibitors Use ULTRAM with great caution in patients taking monoamine oxidase inhibitors. Animal studies have shown increased deaths with combined administration. Concomitant use of ULTRAM with MAO inhibitors or SSRI's increases the risk of adverse events, including seizure and serotonin syndrome. Withdrawal Withdrawal symptoms may occur if ULTRAM is discontinued abruptly. (See DRUG ABUSE AND DEPENDENCE .) These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations. Clinical experience suggests that withdrawal symptoms may be relieved by tapering the medication. Physical Dependence and Abuse ULTRAM may induce psychic and physical dependence of the morphine-type (µ-opioid) (see DRUG ABUSE AND DEPENDENCE ). ULTRAM should not be used in opioid-dependent patients. ULTRAM has been shown to reinitiate physical dependence in some patients that have been previously dependent on other opioids. Dependence and abuse, including drug-seeking behavior and taking illicit actions to obtain the drug, are not limited to those patients with prior history of opioid dependence. Risk of Overdosage Serious potential consequences of overdosage with ULTRAM (tramadol hydrochloride tablets) are central nervous system depression, respiratory depression and death. In treating an overdose, primary attention should be given to maintaining adequate ventilation along with general supportive treatment (see OVERDOSAGE ). PRECAUTIONS Acute Abdominal Conditions The administration of ULTRAM may complicate the clinical assessment of patients with acute abdominal conditions. Use in Renal and Hepatic Disease Impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite, M1. In patients with creatinine clearances of less than 30 mL/min, dosing reduction is recommended (see DOSAGE AND ADMINISTRATION ). Metabolism of tramadol and M1 is reduced in patients with advanced cirrhosis of the liver. In cirrhotic patients, dosing reduction is recommended (see DOSAGE AND ADMINISTRATION ). With the prolonged half-life in these conditions, achievement of steady-state is delayed, so that it may take several days for elevated plasma concentrations to develop. Information for Patients ULTRAM may impair mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. ULTRAM should not be taken with alcohol containing beverages. ULTRAM should be used with caution when taking medications such as tranquilizers, hypnotics or other opiate containing analgesics. The patient should be instructed to inform the physician if they are pregnant, think they might become pregnant, or are trying to become pregnant (see PRECAUTIONS , Labor and Delivery ). The patient should understand the single-dose and 24-hour dose limit and the time interval between doses, since exceeding these recommendations can result in respiratory depression, seizures and death. Drug Interactions In vitro studies indicate that tramadol is unlikely to inhibit the CYP3A4-mediated metabolism of other drugs when tramadol is administered concomitantly at therapeutic doses. Tramadol does not appear to induce its own metabolism in humans, since observed maximal plasma concentrations after multiple oral doses are higher than expected based on single-dose data. Tramadol is a mild inducer of selected drug metabolism pathways measured in animals. Use With Carbamazepine Patients taking carbamazepine may have a significantly reduced analgesic effect of ULTRAM. Because carbamazepine increases tramadol metabolism and because of the seizure risk associated with tramadol, concomitant administration of ULTRAM and carbamazepine is not recommended. Use With Quinidine Tramadol is metabolized to M1 by CYP2D6. Quinidine is a selective inhibitor of that isoenzyme, so that concomitant administration of quinidine and ULTRAM results in increased concentrations of tramadol and reduced concentrations of M1. The clinical consequences of these findings are unknown. In vitro drug interaction studies in human liver microsomes indicate that tramadol has no effect on quinidine metabolism. Use With Inhibitors of CYP2D6 In vitro drug interaction studies in human liver microsomes indicate that concomitant administration with inhibitors of CYP2D6 such as fluoxetine, paroxetine, and amitriptyline could result in some inhibition of the metabolism of tramadol. Use With Cimetidine Concomitant administration of ULTRAM with cimetidine does not result in clinically significant changes in tramadol pharmacokinetics. Therefore, no alteration of the ULTRAM dosage regimen is recommended. Use With MAO Inhibitors Interactions with MAO Inhibitors , due to interference with detoxification mechanisms, have been reported for some centrally acting drugs (see WARNINGS , Use With MAO Inhibitors ). Use With Digoxin and Warfarin Post-marketing surveillance has revealed rare reports of digoxin toxicity and alteration of warfarin effect, including elevation of prothrombin times. Carcinogenesis, Mutagenesis, Impairment of Fertility A slight, but statistically significant, increase in two common murine tumors, pulmonary and hepatic, was observed in a mouse carcinogenicity study, particularly in aged mice. Mice were dosed orally up to 30 mg/kg (90 mg/m 2 or 0.36 times the maximum daily human dosage of 246 mg/m 2 ) for approximately two years, although the study was not done with the Maximum Tolerated Dose. This finding is not believed to suggest risk in humans. No such finding occurred in a rat carcinogenicity study (dosing orally up to 30 mg/kg, 180 mg/m 2 , or 0.73 times the maximum daily human dosage). Tramadol was not mutagenic in the following assays: Ames Salmonella microsomal activation test, CHO/HPRT mammalian cell assay, mouse lymphoma assay (in the absence of metabolic activation), dominant lethal mutation tests in mice, chromosome aberration test in Chinese hamsters, and bone marrow micronucleus tests in mice and Chinese hamsters. Weakly mutagenic results occurred in the presence of metabolic activation in the mouse lymphoma assay and micronucleus test in rats. Overall, the weight of evidence from these tests indicates that tramadol does not pose a genotoxic risk to humans. No effects on fertility were observed for tramadol at oral dose levels up to 50 mg/kg (300 mg/m 2 ) in male rats and 75 mg/kg (450 mg/m 2 ) in female rats. These dosages are 1.2 and 1.8 times the maximum daily human dosage of 246 mg/m 2 , respectively. Pregnancy, Teratogenic Effects: Pregnancy Catogery C Tramadol has been shown to be embryotoxic and fetotoxic in mice, (120 mg/kg or 360 mg/m 2 ), rats (>/=25 mg/kg or 150 mg/m 2 ) and rabbits (>/=75 mg/kg or 900 mg/m 2 ) at maternally toxic dosages, but was not teratogenic at these dose levels. These dosages on a mg/m 2 basis are 1.4, >/=0.6, and >/=3.6 times the maximum daily human dosage (246 mg/m 2 ) for mouse, rat and rabbit, respectively. No drug-related teratogenic effects were observed in progeny of mice (up to 140 mg/kg or 420 mg/m 2 ), rats (up to 80 mg/kg or 480 mg/m 2 ) or rabbits (up to 300 mg/kg or 3600 mg/m 2 ) treated with tramadol by various routes. Embryo and fetal toxicity consisted primarily of decreased fetal weights, skeletal ossification and increased supernumerary ribs at maternally toxic dose levels. Transient delays in developmental or behavioral parameters were also seen in pups from rat dams allowed to deliver. Embryo and fetal lethality were reported only in one rabbit study at 300 mg/kg (3600 mg/m 2 ), a dose that would cause extreme maternal toxicity in the rabbit. The dosages listed for mouse, rat and rabbit are 1.7, 1.9 and 14.6 times the maximum daily human dosage (246 mg/m 2 ), respectively. Non-teratogenic Effects Tramadol was evaluated in peri- and post-natal studies in rats. Progeny of dams receiving oral (gavage) dose levels of 50 mg/kg (300 mg/m 2 or 1.2 times the maximum daily human tramadol dosage) or greater had decreased weights, and pup survival was decreased early in lactation at 80 mg/kg (480 mg/m 2 or 1.9 and higher the maximum daily human dose). There are no adequate and well-controlled studies in pregnant women. ULTRAM should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonatal seizures, neonatal withdrawal syndrome, fetal death and still birth have been reported during post-marketing. Labor and Delivery ULTRAM

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