Generic

Terbinafine Hydrochloride

Indications

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

Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), 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, an antifungal Allylamine, inhibits the production of Ergosterol (an important component of fungi cell membranes) by inhibiting the Squalene Epoxidase enzyme. This causes fungal cell death largely owing to increased membrane permeability caused by high levels of Squalene buildup, rather than Ergosterol insufficiency. Terbinafine hydrochloride may be fungicidal depending on the medication concentration and the fungus species tested in vitro. The clinical relevance of in vitro findings, on the other hand, remains uncertain. In vitro and in clinical infections, Terbinafine has been found to be effective against most strains of the following microorganisms: Tricophyton Mentagrophyte and Trichophyton Rubrum.

Dosage & Administration

Terbinafine tablet: Terbinafine 250 mg (one tablet) once day for 6 weeks for the treatment of finger nail onychomycosis.

Terbinafine 250 mg (one pill) once day for 12 weeks to treat toenail onychomycosis.

After mycological cure and therapy discontinuation, the best clinical impact is evident after a few months. This has to do with the time it takes for a healthy nail to grow out.

Terbinafine cream is a cream that can be used once or twice a day. Before using the terbinafine cream, carefully clean and dry the afflicted areas. Apply a small coating of the cream to the afflicted skin and the surrounding region and gently massage it in. The application may be covered with a gauze strip in the event of intertriginous infections (submammary, interdigital, intergluteal, inguinal), especially at night. The following are the expected treatment durations:

• 1 to 2 weeks for tinea corporis and cruris
• 1 week Tinea Pedis
• 2 weeks for cutaneous candidiasis
• 2 weeks for Pityriasis versicolor
• Clinical symptoms are generally relieved within a few days. The risk of recurrence is increased by irregular therapy or early treatment termination. After two weeks, if there are no indications of improvement, the diagnosis should be confirmed.

Interaction

In vivo studies have shown that terbinafine is an inhibitor of the CYP450 2D6 isozyme. Drugs predominantly metabolized by the CYP450 2D6 isozyme include the following drug classes: tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers, antiarrhythmics class 1C (e.g., flecainide and propafenone) and monoamine oxidase inhibitors Type B. Co-administration of terbinafine should be done with careful monitoring and may require a reduction in dose of the 2D6-metabolized drug.

Contraindications

Terbinafine tablets and cream are not recommended for people who are hypersensitive to terbinafine.

Side Effect

Gastrointestinal symptoms (including diarrhea, dyspepsia, and stomach discomfort), liver test abnormalities, rashes, urticaria, itching, and taste changes are among the side effects described. In general, the side effects were minor and transitory, and they did not necessitate stopping the medication. Idiosyncratic and symptomatic hepatic damage, and more infrequently, instances of liver failure, some resulting to death or liver transplant, significant skin responses, severe neutropenia, thrombocytopenia, angioedema, and allergic reactions, according to international experience with terbinafine usage (including anaphylaxis).

Pregnancy & Lactation

Terbinafine tablet: No appropriate and well-controlled trials in pregnant women have been conducted. Terbinafine should not be started during pregnancy since animal reproduction studies are not necessarily predictive of human response, and onychomycosis therapy can be postponed until after the pregnancy has finished. Terbinafine is found in the breast milk of nursing women after oral dosing. Terbinafine is not advised for use in breastfeeding mothers.

Terbinafine cream has been shown to have no negative effects on foetal toxicity and fertility in animals. There is no clinical experience with terbinafine in pregnant women; thus, terbinafine should not be used unless the possible benefits outweigh the potential risks. Terbinafine is secreted in breast milk, thus women who are breastfeeding should avoid terbinafine therapy.

Precautions & Warnings

Terbinafine pills: The use of terbinafine tablets for the treatment of onychomycosis in persons with and without preexisting liver disease has resulted in rare occurrences of liver failure, some of which have resulted in death or liver transplantation.

In individuals with current or chronic liver disease, the severity of hepatic events and/or their prognosis may be worse. If you have biochemical or clinical signs of liver damage, you should stop using terbinafine pills. Only a few cases of severe skin reactions have been reported (e.g., Stevens-Johnson Syndrome and toxic epidermal necrolysis). If you get a persistent rash on your skin.

Terbinafine cream should only be used on the outside of the body. Avoid coming into contact with the eyes.

Terbinafine is not advised for people with active or chronic liver disease. Pre-existing liver disease should be evaluated before Terbinafine is prescribed. Hepatotoxicity can affect people with or without a history of liver disease. Before using terbinafine pills, all patients should have their serum transaminase (ALT and AST) levels tested.

Therapeutic Class

Drugs for subcutaneous and mycoses, Topical Antifungal preparations

Storage Conditions

Keep it below 30°C. Do not allow yourself to get frozen.

Pharmaceutical Name

Eskayef Pharmaceuticals Ltd.