Monograph Details
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Pain & Pyrexia
> Nonnarcotic analgesics
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ULTRACET |
| 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 + non-opioid analgesic. |
| Generic Name |
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Tramadol HCl 37.5mg, acetaminophen 325mg; tabs. |
| Indications |
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Short-term (≤5 days) management of acute pain. |
| Children |
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Not recommended. |
| Adults |
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2 tabs every 4–6 hours; max 8 tabs/day. Renal dysfunction (CrCl <30 mL/min): max 2 tabs every 12 hours. |
| Contraindications |
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Acute intoxication with alcohol, hypnotics, narcotics, centrally-acting analgesics, other opioids, or psychotropics. |
| Precautions |
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Do not give to opioid-dependent patients. Hepatic impairment: not recommended. Respiratory depression. Increased intracranial pressure. Head injury. Seizure disorders. Acute abdomen. Avoid abrupt cessation. Elderly. Drug abusers. Labor & delivery, pregnancy (Cat.C), nursing mothers: not recommended. |
| Interactions |
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Concomitant MAOIs, carbamazepine, alcohol: not recommended. Increased risk of seizures with MAOIs, SSRIs, tricyclics, neuroleptics, opioids, naloxone, 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. Avoid other acetaminophen-containing products. |
| Adverse Reactions |
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Somnolence, constipation, dizziness, sweating, GI upset, anorexia, dry mouth, pruritus, insomnia, prostate disorders, seizures, hepatotoxicity (overdosage). |
| How Supplied |
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Tabs—20, 100, 500 |
| Additional Resources |
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• Related Prescribing Note |
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