INDICATIONS AND USAGE
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 (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis.DOSAGE AND ADMINISTRATION
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.
DOSAGE FORMS AND STRENGTHS
Tablet, 250 mg white to yellow-tinged white circular, bi-convex, beveled tablets imprinted with "LAMISIL" in circular form on one side and code "250" on the other side.CONTRAINDICATIONS
Terbinafine is contraindicated in individuals with a history of allergic reaction to oral terbinafine because of the risk of anaphylaxis.
WARNINGS AND PRECAUTIONS
Cases of liver failure, some leading to liver transplant or death, have occurred with the use of Terbinafine in individuals with and without pre-existing liver disease.
In the majority of liver cases reported in association with Lamisil use, the patients had serious underlying systemic conditions. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease. Treatment with Terbinafine should be discontinued if biochemical or clinical evidence of liver injury develops.
Terbinafine are not recommended for patients with chronic or active liver disease. Before prescribing Terbinafine, pre-existing liver disease should be assessed. Hepatotoxicity may occur in patients with and without pre-existing liver disease. Patients prescribed Terbinafine should be warned to report immediately to their physician any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain or jaundice, dark urine or pale stools. Patients with these symptoms should discontinue taking oral terbinafine, and the patient's liver function should be immediately evaluated.Taste Disturbance Including Loss of Taste
Taste disturbance, including taste loss, has been reported with the use of Terbinafine. It can be severe enough to result in decreased food intake, weight loss, and depressive symptoms. Taste disturbance may resolve within several weeks after discontinuation of treatment, but may be prolonged (greater than one year). If symptoms of a taste disturbance occur, Terbinafine should be discontinued.Depressive Symptoms
Depressive symptoms have occurred during postmarketing use of terbinafine. Prescribers should be alert to depressive symptoms, and patients should be instructed to report depressive symptoms to their physician.