Indications

Terbifin Tablet: Dermatophyte infections of the nails, ringworm infections (including tinea pedis, crusis and corporis) where oral therapy is appropriate (due to site, severity, and extent).

Terbifin Cream: Dermatophyte infections of the skin and hair, pityriasis (tinea) versicolor, and yeast infections of the skin.

Other uses:

>Non-dermatophyte nail infections

>Systemic mycoses with dimorphic and rare mold fungi.

Pharmacology

Terbinafine, an antifungal Allylamine, inhibits the formation of Ergosterol (an important component of fungi cell membranes) by inhibiting the Squalene Epoxidase enzyme. This causes fungal cell death mostly due 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 value of in vitro data, on the other hand, remains unknown. Terbinafine has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections: Trichophyton Mentagrophyte, and Trichophyton rubrum.

Dosage and Administration

Terbinafine tablet:

For the treatment of fingernail onychomycosis: Terbinafine 250 mg (one tablet), once daily for 6 weeks.

For the treatment of toenail onychomycosis: Terbinafine 250 mg (one 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 the outgrowth of healthy nails.

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

Hypersensitivity to Terbinafine or any of the excipients contained in the tablet or cream.

Side effects

Terbifin® Tablet:

Abdominal discomfort, anorexia, nausea, diarrhea, headache, rash, and urticaria occasionally with arthralgia or myalgia. Less frequently taste disturbance. Rarely liver toxicity, photosensitivity, serious skin reactions, etc.

Terbifin® Cream:

Redness, itching, or stinging; rarely allergic reactions.

Pregnancy & Lactation

Use in pregnancy and lactation:

Pregnancy category B. Treatment with Terbinafine is not recommended in nursing mothers.

Use in Children: Terbifine cream appears to be an effective and well-tolerated treatment of tinea corpses and tinea cruris in children.

Use in Elderly: Terbinafine appears to be safe for the elderly. The dose should be reduced by half if significant hepatic or renal impairment is present.

Precautions & Warnings

Warnings:

Good general hygiene is necessary in conjunction with the use of Terbinafine in order to prevent reinfection (e.g. from underwear, socks, shoes, etc.).

Precautions:

Terbifin® cream is for external use only. Contact with eyes should be avoided.

Therapeutic Class

Drugs for subcutaneous and mycoses, Topical Antifungal preparations

Storage Conditions

Store below 30o C and dry place, protect from light. Keep out of the reach of children.

Generic

Terbinafine Hydrochloride

Pharmaceutical Name

Aristopharma Ltd.