Terbinafine hydrochloride is a synthetic allylamine antifungal, which is fungicidal against dermatophytes, mold fungi, and some yeasts.

Description

Terbinafine hydrochloride is a synthetic allylamine antifungal, which is fungicidal against dermatophytes, mold fungi, and some yeasts. Terbinafine interferes with fungal ergosterol biosynthesis by inhibiting squalene epoxidase in the cell membrane. This leads to a deficiency of ergosterol and an intracellular accumulation of squalene, thus disrupting fungal membrane function and cell wall synthesis resulting in fungal cell death. Terbinafine does not inhibit cytochrome P450 activity and is weakly bound to hepatic cytochrome P450 enzymes. Terbinafine is distributed into the stratum corneum of the skin, the nail plate, and hair in higher concentration than found in plasma.

Presentation

    Terbifin Tablet: Each tablet contains Terbinafine Hydrochloride INN equivalent to Terbinafine 250 mg.
    Terbifin Cream: Each gram contains Terbinafine Hydrochloride INN 10 mg.

Indications

    Terbifin Tablet: Dermatophyte infections of the nails, and ringworm infections (including tinea pedis, crisis, 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.

Dosage & Administration

    Terbifin Tablet:

    Indications

    Daily Dosage

    Duration

    Fingernail Onychomycosis

    250 mg daily

    6 weeks

    Toenail Onychomycosis

    250 mg daily

    12 weeks

    Tinea Pedis

    250 mg daily

    2-6 weeks

    Tinea Cruris

    250 mg daily

    2-4 weeks

    Tinea Corporis

    250 mg daily

    4 weeks

    Child: Usually for 2 weeks, Tinea Capitis, over 1 year, body weight 10-20 kg, 62.5 mg once daily; body weight 20-40 kg, 125 mg once daily; body weight over 40 kg, 250 mg once daily.

    Terbifin Cream: Applied once or twice daily in

    Indications

    Duration

    Tinea Corporis, Cruris

    1-2 weeks

    Tinea Pedis

    1 week

    Cutaneous Candidiasis

    2 weeks

    Pityriasis (Tinea) Versicolor

    2 weeks

    Application of Terbifin Cream

    Clean and dry the affected areas thoroughly before application of Terbifin®. Apply the cream to the affected skin and surrounding area in a thin layer and rub it lightly. In case of intertriginous infections (submammary, interdigital, intergluteal inguinal) the application may be covered with a gauze strip, especially at night. Wash hands thoroughly after application.

Contrainidications

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

Warning & Precautions

    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.

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.

     

Drug interaction

    The plasma concentration of Terbinafine is increased by Rifampicin and decreased by Cimetidine. 

Use in special groups

    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 corposis 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.

Packing

    Terbifin® Tablet: Each box contains 12 tablets in Alu-Alu blister pack.
    Terbifin® Cream: Each Tube contains 10g cream.