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TERBEZID
TERBIZED 1% CREAM
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Composition
Each uncoated tablet of Terbized contains:
Terbinafine Hydrochloride B.P.
equivalent to Terbinafine 250 mg
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Indications
Terbinafine hydrochloride is an allylamine antifungal given by mouth in the treatment of dermatophyte infections of the skin caused by 3 genera - Epidermophyton spp. , Microsporum spp. and Trichophyton spp.,such as tinea corporis, tinea cruris and tinea pedis and also for the dermatophyte infection of nail (Onychomycosis).
Dosage and Administration
The duration and treatment varies according to the indication and the severity of the infection.Terbinaf,ine 250 mg as the hydrochloride is given once daily by mouth .Likely duration of treatment is as follows :
Skin Infections : Tinea corporis / cruris : 2 to 4 weeks
Tinea pedis : 2 to 6 weeks
Nail Infections : Onychomycosis : 6 to 12 weeks
CONTRAINDICATION
Hypersensitivity to Terbinafine hydrochloride or any of the components of the formulation.
WARNINGS & PRECAUTIONS
Warnings: Terbinafine should be discontinued if clinical and biochemical evidence of hepatotoxicity develops; it should also be discontinued if any progressive skin rash occurs.
Precautions: Terbinafine should be used with caution in patients with hepatic impairment and liver dysfunction.It should be used with caution in patients with psoriasis as very rare cases of exacerbation of psoriasis have been reported.
DRUG INTERACTIONS
Plasma concentration of terbinafine may be increased by drugs that inhibit its metabolism by cytochrome P450, such as cimetidine, and decreased by drugs that include cytochrome P450, such as rifampicin. Menstrual disturbances including breakthrough bleeding have been reported in patients taking oral contraceptives and terbinafine.
PREGNANCY AND LACTATION
Pregnancy: Safety in pregnancy has not been demonstrated.
Lactation: Terbinafine is excreted in breast milk and therefore it is not recommended for use by nursing mothers.
UNDESIRABLE EFFECTS
The most frequent adverse effect following oral administration of Terbinafine hydrochloride are gastrointestinal disturbances such as nausea, diarrhoea, and mild abdominal pain. Loss or disturbance of taste may occur and occasionally may be severe enough to lead to anorexia and weight loss.Other frequent adverse effects include headache or urticaria sometimes with arthralgia or myalgia. Other rare adverse effects include malaise, fatigue, and alopecia.
PHARMACOLOGICAL ACTION
Terbinafine is an allylamine derivative reported to have a broad spectrum of antifungal activity. It is considered to act through inhibition of fungal sterol synthesis. Terbinafine is fungicidal against dermatophytes and some yeast.
PHARMACOKINETICS
Terbinafine hydrochloride is well absorbed from the gastrointestinal tract. The bioavaibility is about 40% because of first-pass hepatic metabolism. Mean peak plasma concentration of about 1 µg per mL are reported within 2 hours of a single oral dose of 250 mg. Steady state concentrations are about 25% higher than those seen after a single dose and are reached in 10 to 14 days. Terbinafine is extensively bound to plasma proteins. Terbinafine is distributed into the stratum corneum of the skin, the nail plate, and hair where it reaches concentrations considerably higher than those found in plasma. It appears in breast milk. Less than 5% of a topical dose of terbinafine hydrochloride is absorbed.
Terbinafine is metabolised in the liver to inactive metabolites which are excreted mainly in the urine. A plasma elimination half-life varying from 11 to 36 hours has been reported and a terminal elimination half-life of up to 400 hours in patients receiving prolonged therapy, probably representing elimination from skin and adipose tissue. Fungicidal concentrations in nails are maintained for several weeks after therapy is discontinued. The elimination rate may be altered in patients with liver disease or kidney disease.
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STORAGE INSTRUCTION
Store below 25°C in a dry place, protected from light.
Presentation
A Blister containing 4 tablet is packed in a Primary Carton along with the Pack Insert.
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