Monograph Details
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Pain & Pyrexia
> Narcotic analgesics
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IBUDONE 5/200 |
| Manufacturer |
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Kowa Pharmaceuticals America, Inc. |
| Legal Classification |
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CIII |
| Pharmacological Class |
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Opioid + NSAID. |
| Generic Name |
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Hydrocodone bitartrate 5mg, ibuprofen 200mg; tabs. |
| Also |
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• IBUDONE 10/200
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| Indications |
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Short term (generally <10 days) management of acute pain. |
| Children |
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<16yrs: not recommended. |
| Adults |
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Individualize; use lowest effective dose for shortest time. ≥16yrs: 1 tab every 4–6 hours as needed; max 5 tabs/day. |
| Contraindications |
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Aspirin allergy. Coronary artery bypass graft surgery. 3rd trimester pregnancy. |
| Precautions |
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Advanced renal disease: not recommended. Head injury. Increased intracranial pressure. Acute abdomen. Peptic ulcer. History of upper GI disease. Impaired renal, hepatic, thyroid, pulmonary, or adrenocortical function. GI or GU obstruction. Asthma. Edema. Hypertension. Heart failure. Bleeding disorders. Monitor BP, blood, and hepatic and renal function. Dehydration. Post-op (may suppress cough reflex). Drug abusers. Discontinue if hepatic dysfunction occurs. Elderly. Debilitated. Pregnancy (Cat.C). Labor & delivery, nursing mothers: not recommended. |
| Interactions |
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See Contraindications. Avoid aspirin. Alcohol, other CNS depressants potentiated. May potentiate, or be potentiated by, MAOIs (not recommended) or tricyclic antidepressants, skeletal muscle relaxants. Increases serum lithium levels. May reduce efficacy of, and increase risk of renal failure with, ACEIs, diuretics. May increase bleeding with anticoagulants. Paralytic ileus may occur with anticholinergics. May increase lithium, methotrexate toxicity. Corticosteroids increase risk of GI bleed. |
| Adverse Reactions |
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Headache, CNS depression, dizziness, GI upset/bleed, constipation, rash (discontinue if occurs), respiratory depression, anemia, mood changes, confusion, anaphylaxis; aseptic meningitis (rare); others. See literature re: risk of cardiovascular events. |
| How Supplied |
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Tabs—100 |
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