Monograph Details
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Infections & Infestations
> Fungal infections
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LAMISIL ORAL GRANULES |
| Manufacturer |
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Novartis Pharmaceuticals Corp |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Allylamine. |
| Generic Name |
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Terbinafine (as HCl) 125mg, 187.5mg; per packet. |
| Also |
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• LAMISIL TABLETS
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| Indications |
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Tinea capitis. |
| Children |
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<4yrs: not recommended. Sprinkle granules on pudding or other soft, non-acidic food and swallow (do not chew); do not use applesauce or fruit-based foods. ≥4yrs: Take once daily for 6 weeks. <25kg: 125mg/day. 25–35kg: 187.5mg/day. >35kg: 250mg/day. |
| Adults |
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Not applicable. |
| Precautions |
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Onychomycosis: confirm diagnosis with nail specimen. Do baseline liver function test. Pre-existing hepatic disease or renal impairment (CrCl <50mL/min): not recommended. Discontinue if hepatobiliary dysfunction, progressive skin rash (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis), or severe neutropenia occurs. Monitor CBCs if immunodeficient. Pregnancy (Cat.B), nursing mothers: not recommended. |
| Interactions |
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Potentiated by cimetidine. Antagonized by rifampin. May potentiate drugs metabolized by CYP2D6. May be potentiated by CYP2C9 and CYP3A4 inhibitors (eg, fluconazole, ketoconazole, amiodarone). Monitor cyclosporine. |
| Adverse Reactions |
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GI disturbances, liver test abnormalities, rash, pruritus, taste disturbances, urticaria; also children: nasopharyngitis, headache, pyrexia, cough, upper respiratory infection; rare: hepatotoxicity, liver failure, lupus erythematosus. |
| How Supplied |
Tabs—30, 100
Packets—14, 42 |
| Additional Resources |
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• Related Prescribing Note |
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