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12.1 Mechanism of Action Terbinafine is an allylamine antifungal [see ] .

Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. Terbinafine tablets are an allylamine antifungal indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).

• Prior to administering, evaluate patients for evidence of chronic or active liver disease. • Fingernail onychomycosis: One tablet, once daily for 6 weeks. • Toenail onychomycosis: One tablet, once daily for 12 weeks. 2.1 Assessment Prior to Initiation Before administering terbinafine tablets, evaluate patients for evidence of chronic or active liver disease [see (4) and ]. 2.2 Dosage Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks. Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks. The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

Common (greater than 2% of patients treated with terbinafine tablets) reported adverse events include headache, diarrhea, rash, dyspepsia, liver enzyme abnormalities, pruritus, taste disturbance, nausea, abdominal pain, and flatulence. To report SUSPECTED , contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequently reported adverse events observed in the 3 U.S./Canadian placebo-controlled trials are listed in the Table 1. The adverse events reported encompass gastrointestinal symptoms (including diarrhea, dyspepsia, and abdominal pain), liver test abnormalities, rashes, urticaria, pruritus, and taste disturbances. Changes in the ocular lens and retina have been reported following the use of terbinafine tablets in controlled trials. The clinical significance of these changes is unknown. In general, the adverse events were mild, transient, and did not lead to discontinuation from study participation. Table 1. Most frequently reported adverse events observed in the 3 U.S./Canadian placebo-controlled trials Adverse Event Discontinuation Terbinafine Tablets (%) n=465 Placebo (%) n=137 Terbinafine Tablets (%) n=465 Placebo (%) n=137 * Liver enzyme abnormalities greater than or equal to 2 times the upper limit of normal range. Headache 12.9 9.5 0.2 0 Gastrointestinal Symptoms: Diarrhea Dyspepsia Abdominal Pain Nausea Flatulence 5.6 4.3 2.4 2.6 2.2 2.9 2.9 1.5 2.9 2.2 0.6 0.4 0.4 0.2 0 0 0 0 0 0 Dermatological Symptoms: Rash Pruritus Urticaria 5.6 2.8 1.1 2.2 1.5 0 0.9 0.2 0 0.7 0 0 Liver Enzyme Abnormalities* 3.3 1.4 0.2 0 Taste Disturbance 2.8 0.7 0.2 0 Visual Disturbance 1.1 1.5 0.9 0 6.2 Postmarketing Experience The following adverse events have been identified during post-approval use of terbinafine tablets. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure....

Terbinafine tablets are contraindicated in patients with: • Chronic or active liver disease [see ] • History of allergic reaction to oral terbinafine because of the risk of anaphylaxis [see ] • Chronic or active liver disease. (4) • History of allergic reaction to oral terbinafine because of the risk of anaphylaxis. (4)