LAMISIL

What it is

Lamisil contains terbinafine hydrochloride. Each Lamisil tablet contains terbinafine hydrochloride equal to either 125 mg or 250 mg terbinafine base.

Approved indications

— Treatment in adults of ringworm (tinea corporis, tinea cruris and tinea pedis) due to infection caused by dermatophytes such as Trichophyton and Microsporum canis and Epidermophyton floccosum, where oral therapy is considered appropriate owing to the site, severity or extent of the infection, and the infection is not responsive to topical therapy. — Onychomycosis in adults (fungal infection of the nail) caused by dermatophyte fungi.

Dosing overview

For skin infections and onychomycosis, the recommended dose is 250 mg once a day. For tinea pedis (interdigital, plantar/moccasin type), likely duration of treatment is 2 to 6 weeks, and for tinea corporis and cruris, 2 to 4 weeks. For onychomycosis, for most patients the duration for successful treatment is between six weeks and three months. However, infections in the big toe, or if nail growth is very poor, treatment for up to 6 months may be necessary.

Key safety warnings

Patients taking Lamisil tablets are at risk of developing agranulocytosis, thrombocytopenia, pancytopenia and neutropenia, which are very rarely associated with terbinafine. The problem usually resolves within a few days to a week of withdrawal of Lamisil tablets. Cases of thrombotic thrombocytopenic purpura (TTP), some fatal, have been reported with terbinafine. Discontinue terbinafine if clinical symptoms and laboratory findings consistent with TTP occur. The findings of unexplained thrombocytopenia and anaemia should prompt further evaluation and consideration of the diagnosis of TTP. Serious skin reactions (for example Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms) have been very rarely reported in patients taking Lamisil tablets. Terbinafine should be used with caution in patients with pre-existing psoriasis or lupus erythematosus as precipitation and exacerbation of psoriasis and cutaneous and systemic lupus erythematosus have been reported. Very rare cases of liver failure (some leading to liver transplant or death) have been reported with the use of Lamisil tablets. Before prescribing Lamisil tablets, liver function tests should be performed since hepatotoxicity may occur in patients with and without pre-existing liver disease. Therefore periodic monitoring (after 4–6 weeks of treatment) of liver function tests is recommended.

Contraindications

Hypersensitivity to terbinafine or to any of the excipients in the formulation. Severe, chronic, or active hepatic disease.

PBS listing

PBS listings are available for Lamisil cream and gel formulations. Cream containing terbinafine hydrochloride 10 mg per g, 15 g is listed with 2 PBS items under streamlined restriction at an ex-manufacturer price of A$12.51. Gel 10 mg per g, 15 g is listed with 1 PBS item under restricted status at an ex-manufacturer price of A$13.69.

Regulatory history

Lamisil terbinafine 250 mg tablet and 125 mg tablet were first listed on the ARTG on 24 September 1993.