Antifungal Terbinafine HCL Active Pharmaceutical Ingredient CAS 78628-80-5

Antifungal Terbinafine HCL Active Pharmaceutical Ingredient CAS 78628-80-5

Introduction

Terbinafine hydrochloride, is an antifungal developed by Novartis and Omega Pharma. It is highly hydrophobic and tends to accumulate in hair, skin, nails, and fatty tissue.

It is on the WHO Model List of Essential Medicines, the most important medications needed in a basic health system

Medical uses

• Terbinafine is mainly effective on the dermatophyte group of fungi.
• As a 1% cream or powder, it is used topically for superficial skin infections such as jock itch (tinea cruris), athlete's foot (tinea pedis), and other types of ringworm (tinea corporis).
• Terbinafine cream works in about half the time required by other antifungals.
• Oral 250-mg tablets are often prescribed for the treatment of onychomycosis, a fungal nail infection, typically by a dermatophyte or Candida species. 
• Terbinafine hydrochloride may induce or exacerbate subacute cutaneous lupus erythematosus. Persons with lupus erythematosus should first discuss possible risks with their doctor before initiation of therapy.

FDA approval
Terbinafine first became available in Europe in 1991 and in the United States in 1996. The U.S. Food and Drug Administration has approved the first generic versions of prescription Lamisil (terbinafine hydrochloride) tablets.

The remaining patent or exclusivity for Lamisil expired on June 30, 2007.

On September 28, 2007, the FDA stated that Lamisil (terbinafine hydrochloride, by Novartis AG) is a new treatment approved for use by children age four and up. 

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