Preparation
Terbiderm 250 mg Tablet: Each Tablet contains Terbinafine Hydrochloride BP equivalent to
Terbinafine 250 mg Terbiderm 1% Cream: Each gram cream contains Terbinafine Hydrochloride BP 10 mg.
Therapeutic Class
Synthetic allylamine antifungal
Indication
Terbiderm tablet: Terbiderm tablet is indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).
Terbiderm cream: Fungal infection of the skin caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. Yeast infections of the skin, principally those caused by the genus Candida (e.g. C. albicans), Pityriasis (tinea) versicolor due to Pityrosporum orbiculare (also known as Malassezia furfur).
Contraindication
Terbiderm tablet and cream are contraindicated in individuals with hypersensitivity to Terbinafine or to any other ingredients of the formulation.
Dosage & Administration
Terbiderm Tablet: The usual oral dose isTerbinafine 250 mg daily for 2 to 12 weeks depending upon the infection- Fingernail Onychomycosis: Terbinafine 250 mg, once daily for 6 weeks Toenail Onychomycosis: Terbinafine 250 mg, once daily for 12 weeks
Terbiderm Cream: Terbinafine cream can be applied once or twice daily. Cleanse and dry the affected areas thoroughly before application of the terbinafine cream. Apply the cream to the affected skin and the surrounding area in a thin layer and rub in 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 pedis for 1 week,
- Tinea corporis & Tinea cruris 2 - 4 weeks,
- Cutaneous candidiasis 2 weeks &
- Pityriasis versicolor 2 weeks.
Side Effect
Most common side effects of Terbiderm tablet are headache, diarrhea, rash, dyspepsia, liver enzyme abnormalities, pruritus, taste disturbance, nausea, abdominal pain and flatulence. Occasionally may cause severe liver toxicity, change in taste or loss of taste, serious skin or allergic reactions etc.
Precaution
Terbiderm Tablet is not recommended for patients with chronic or active liver disease.
Terbiderm cream is for external use only. Contact with the eyes should be avoided.
Drug 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. There is no known drug interaction when Terbinafine is taken topically.
Use Children
The safety and efficacy of Terbiderm Tablet has not been established in pediatric patients with Onychomycosis.
Use Pregnancy Lactation
Terbiderm is a USFDA ‘Pregnancy Category B’ drug. It is recommended that Terbinafine not to be initiated during pregnancy unless the benefit outweighs the risk to the fetus.
Use in Lactation After oral administration, terbinafine is present in the breast milk of nursing mothers. Treatment with terbinafine is not recommended in nursing mothers
Packaging
Terbiderm Tablet: Each box contains 1 x 10’s Tablets in blister pack. Terbiderm Cream: Each pack has a tube containing 10 gm of the cream.
Storage
Store below 30ºC. Keep all medicine out of the reach of children and away from light.
