LAMISIL ORAL GRANULES Rx
Generic Name and Formulations:
Terbinafine HCl 125mg, 187.5mg; per packet.
Novartis Pharmaceuticals Corp
Indications for LAMISIL ORAL GRANULES:
<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.
Chronic or active liver disease.
Onychomycosis: confirm diagnosis with nail specimen. Pre-existing hepatic disease or renal impairment (CrCl <50mL/min): not recommended. Perform LFTs prior to and periodically during treatment. Discontinue if hepatic injury, progressive skin rash (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS), taste/smell disturbances, severe neutropenia (neutrophils ≤1000 cells/mm3), thrombotic microangiopathy occurs, or if lupus erythematosus is suspected. Monitor CBCs if immunodeficient. Pregnancy (Cat.B), nursing mothers: not recommended.
Potentiated by cimetidine. Antagonized by rifampin. May potentiate drugs metabolized by CYP2D6 (eg, tricyclic antidepressants, SSRIs, beta-blockers). May be potentiated by CYP2C9 and CYP3A4 inhibitors (eg, fluconazole, ketoconazole, amiodarone). Potentiates caffeine. Antagonizes cyclosporine.
Headache, diarrhea, rash, dyspepsia, liver enzyme abnormalities, pruritus, taste disturbances, nausea, abdominal pain, flatulence, urticaria; also children: nasopharyngitis, pyrexia, cough, upper respiratory infection; rare: hepatotoxicity, depressive symptoms, smell disturbances.
Tabs—30, 100; Packets—14, 42