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Tramadol is a prescription medication used to treat moderate to moderately severe pain in adults. Tramadol belongs to a group of drugs called opioid analgesics, white oval pill with 377, which work by blocking pain signals in the body. This medication comes in immediate release tablet and that can be taken up to 6 times a day, with or without food. Tramadol also comes in extended-release tablet and capsule forms and are taken once a day, with or without food.

If you are a consumer or patient please visit this version. Dosage and Administration 2. Warnings and Precautions 5. Tramadol hydrochloride tablets are an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate 1. Limitations of Use 1.

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MAOI Interaction Inform patients not to take tramadol hydrochloride tablets while using any drugs that inhibit monoamine oxidase.

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Learn about the medical, dental, pharmacy, behavioral, and voluntary benefits your employer may offer. Keep this medicine where others cannot get to it. Tramadol should not be given to a child younger than 12 years old, or anyone younger than 18 years old who recently had surgery to remove the tonsils or adenoids. Ultram ER should not be given to anyone younger than 18 years old. Taking tramadol during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Fatal side effects may occur if you use also use alcohol or other drugs that cause drowsiness or slow breathing. Tramadol is an pain medicine similar to an opioid. Tramadol is used to treat moderate to severe pain. The extended-release form of tramadol is for around-the-clock treatment of pain.

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Take tramadol hydrochloride tablets exactly as prescribed by your healthcare provider. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions 5. Tell your doctor if you are breastfeeding or plan to breastfeed. Use of cytochrome P 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol hydrochloride tablets require careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1. There is a relationship between increasing tramadol plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression. Do not chew, divide, or break tramadol extended-release forms. The concomitant use of tramadol hydrochloride tablets and CYP2D6 inhibitors may result in an increase in the plasma concentration of tramadol and a decrease in the plasma concentration of M1, particularly when an inhibitor is added after a stable dose of tramadol hydrochloride tablets is achieved. In animal studies, pregnant animals were given this medication and had some babies born with problems. Because carbamazepine increases tramadol metabolism and because of the seizure risk associated with tramadol, concomitant administration of tramadol hydrochloride tablets and carbamazepine is not recommended. When taking tramadol hydrochloride tablets: Do not change your dose. Tramadol hydrochloride tablets expose users to the risks of addiction, abuse and misuse, which can lead to overdose and death. Examples: Macrolide antibiotics e. Cytochrome P 3A4 Interaction The concomitant use of tramadol hydrochloride tablets with cytochrome P 3A4 inhibitors, such as macrolide antibiotics e.

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Concentration—Adverse Reaction Relationships There is a relationship between increasing tramadol plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression. Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting tramadol hydrochloride tablets or when the dosage is increased, and that it can occur even at recommended dosages. Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. Hyperalgesia and Allodynia Inform patients and caregivers not to increase opioid dosage without first consulting a clinician. Severe hepatic impairment: Recommended dose is 50 mg every 12 hours. Tramadol hydrochloride tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. Updated: May 22, Macrolide antibiotics e. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate For patients on tramadol hydrochloride tablets who are physically opioid-dependent, initiate the taper by a small enough increment, e. Approval: 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 tramadol hydrochloride tablets therapy using slower titration rates.