Monograph Details
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Pain & Pyrexia
> Nonnarcotic analgesics
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ULTRAM |
| Manufacturer |
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Ortho-McNeil Pharmaceuticals, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Opioid. |
| Generic Name |
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Tramadol HCl 50mg; scored tabs. |
| Also |
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• ULTRAM ER
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| Indications |
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Moderate to moderately severe pain. |
| Children |
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<16 years: not recommended. |
| Adults |
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≥16 years: 50–100mg every 4–6 hours; max 400mg/day. Or, 25mg in AM on 1st day, increase by 25mg every 3 days (ie, to 25mg four times daily), then increase by 50mg every 3 days (ie, to 50mg four times daily), then increase to 50–100mg every 4–6 hours; max 400mg/day. >75 years: max 300mg/day. Renal dysfunction (CrCl <30mL/min): max 100mg every 12 hours. Cirrhosis: max 50mg every 12 hours. |
| Contraindications |
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Acute intoxication with alcohol, hypnotics, narcotics, centrally-acting analgesics, other opioids, or psychotropic drugs. |
| Precautions |
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Do not give to opioid-dependent patients. Respiratory depression. Increased intracranial pressure. Head injury. Seizure disorders. Acute abdomen. Renal or hepatic impairment. Suicidal ideation. Drug abusers. Avoid abrupt cessation. Elderly (esp. >75 years). Labor & delivery, pregnancy (Cat.C), nursing mothers: not recommended. |
| Interactions |
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Concomitant MAOIs, carbamazepine, alcohol: not recommended. May potentiate seizure risk with MAOIs, SSRIs, neuroleptics, opioids, naloxone, tricyclics, others that lower seizure threshold. Potentiation with alcohol, other CNS depressants; reduce dose. May be potentiated by CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine, amitriptyline). May potentiate digoxin, warfarin. May be affected by CYP3A4 inhibitors (eg, ketoconazole, erythromycin) or CYP3A4 inducers (rifampin, St. John's Wort). |
| Adverse Reactions |
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Dizziness, GI upset, constipation, headache, somnolence, pruritus, CNS stimulation, asthenia, sweating, dry mouth, seizures, anaphylaxis. |
| How Supplied |
ER tabs—30, 90
Tabs—100, 500 |
| Additional Resources |
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• Related Prescribing Note |
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