Monograph Details
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Pain & Pyrexia
> Nonnarcotic analgesics
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ULTRAM ER |
| 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 100mg, 200mg, 300mg; ext-rel tabs. |
| Also |
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• ULTRAM
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| Indications |
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Moderate to moderately severe chronic pain when continuous analgesia is needed for an extended period of time. |
| Children |
<18 years: not recommended.
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| Adults |
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≥18 years: initially 100mg once daily, then may increase by 100mg every 5 days; max 300mg/day. Renal dysfunction (CrCl <30mL/min) or severe hepatic impairment: not recommended. |
| 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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