Indications

Terbinafine : This cream is used to treat dermatophytes-caused onychomycosis of the toenail or fingernail (tinea unguium).

Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceus), Microsporum canis, and Epidermophyton floccosum cause fungal infections of the skin. Yeast infections of the skin, mostly caused by the Candida genus (e.g. C. Albicans). Due to Pityrosporum orbiculare, pityriasis (tinea) Versicolor develops (also known as Malassezia furfur).

Pharmacology

Terbinafine is an allylamine antifungal agent that inhibits the biosynthesis of ergosterol (an important component of fungal cell membranes) by inhibiting squalene epoxidase. This is mainly due to the increase in membrane permeability mediated by the accumulation of high concentrations of squalene, which leads to fungal cell death, rather than ergosterol deficiency. According to drug concentration and in vitro fungal species test, terbinafine hydrochloride may have fungicidal effects. However, the clinical significance of the in vitro data is unclear. In vitro and clinical infections, terbinafine has been shown to be active against most strains of the following microorganisms: Trichophyton mentagrophytes, Trichophyton, and rubrum.

Dosage & Administration

Terbinafine cream: Terbinafine cream can be applied once or twice daily. Cleanse and dry the affected areas thoroughly before the application of the terbinafine cream. Apply the cream to the affected skin and the surrounding area in a thin layer and rub it lightly. In the case of intertriginous infections (submammary, interdigital, intergluteal, inguinal) the application may be covered with a gauze strip, especially at night. The likely durations of treatment are as follows:

• Tinea corporis, cruris: 1 to 2 weeks
• Tinea pedis: 1 week
• Cutaneous candidiasis: 2 weeks
• Pityriasis Versicolor: 2 weeks

Relief of the clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks, the diagnosis should be verified.

Interaction

Terbinafine inhibits the CYP450 2D6 isozyme in vivo, according to research. Tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers, antiarrhythmics class 1C (e.g., flecainide and propafenone), and monoamine oxidase inhibitors Type B are among the drugs processed mostly by the CYP450 2D6 isozyme. Co-administration of terbinafine should be done with caution, and the dose of the 2D6-metabolized medication may need to be reduced.

Contraindications

Terbinafine creams are contra-indicated in individuals hypersensitive to terbinafine.

Side Effects

Reported adverse events included gastrointestinal symptoms (including diarrhea, indigestion, and abdominal pain), abnormal liver tests, rash, hives, itching, and dysgeusia. Generally speaking, adverse events are mild, short-lived, and do not lead to drug discontinuation. Based on the experience of terbinafine use worldwide, adverse events include terbinafine and symptomatic liver damage, rarer cases of liver failure, some leading to death or liver transplantation, severe skin reactions, severe neutrophils Cell reduction, thrombocytopenia, angioedema, and allergic reactions. (including allergic reactions). Other adverse reactions that have been reported include malaise, fatigue, vomiting, arthralgia, myalgia, and hair loss.

Pregnancy & Lactation

Terbinafine Cream: Fetal fertility and toxicity studies in animals have shown no side effects. Pregnant women have no clinical experience with terbinafine; therefore, terbinafine should not be used unless the potential benefits outweigh any potential risks. Terbinafine is excreted in human milk, therefore mothers should not receive terbinafine treatment during lactation.

Precautions & Warnings

Warning

• Terbinafine Cream: Terbinafine Cream is for external use only. Avoid contact with eyes.

Note: Terbinafine is not recommended for patients with chronic or active liver disease. Before prescribing terbinafine, the pre-existing liver disease should be assessed. Hepatotoxicity may occur in patients with or without pre-existing liver disease. It is recommended that all patients undergo serum transaminase testing (ALT and AST) before taking terbinafine tablets.

Therapeutic Class

Drugs for subcutaneous and mycoses, Topical Antifungal preparations

Storage Conditions

Store in a cool and dry place, below 30°C, and protect from light.

Generic

Terbinafine Hydrochloride

Pharmaceutical Name

Eskayef Pharmaceuticals Ltd.