Monograph Details
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Infections & Infestations
> Fungal infections
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NIZORAL TABLETS |
| Manufacturer |
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Janssen Pharmaceutica Products, LP |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Azole. |
| Generic Name |
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Ketoconazole 200mg. |
| Indications |
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Susceptible systemic fungal infections or refractory cutaneous dermatophyte infections. |
| Children |
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Usually not recommended. >2 years: see literature. |
| Adults |
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Initially 200mg daily; max 400mg daily. |
| Contraindications |
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Concomitant cisapride, triazolam. |
| Precautions |
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Not for fungal meningitis. Monitor hepatic function before and during therapy. Discontinue if hepatoxicity occurs. Achlorhydria (may impair absorption). History of hepatic dysfunction. Allergy. Children. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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See Contraindications. Serious cardiac effects with cisapride. Potentiates triazolam, midazolam, possibly oral anticoagulants, oral hypoglycemics. Avoid antacids, anticholinergics, H2 blockers within 2 hrs after ketoconazole. Avoid rifampin, isoniazid. Monitor phenytoin, cyclosporine, tacrolimus, methylprednisolone, digoxin. Caution with other hepatically metabolized drugs. |
| Adverse Reactions |
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Hepatotoxicity, anaphylaxis, urticaria, nausea, vomiting, abdominal pain, pruritus; hormonal effects (at higher doses). |
| How Supplied |
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Tabs–100 |
| Additional Resources |
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• Related Prescribing Note |
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