KEPTAFINE TABLET
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KEPTAFINE TABLET

January 5, 2016

COMPOSITION:
Terbinafine Hydrochloride Eq. to Terbinafine …………………250 mg in BETACYCLODEXTRIN

CATEGORY: Antifungal (Fungistatic & Fungicidal)

INDICATIONS:
For fungal infections such as Onychomycosis, Tinea cruris, Tinea corporis, Tinea pedis, Tinea captitis

DOSAGE:
• Usual Adult Dose for Onychomycosis – Fingernail
Tablets: 250 mg orally once a day for 6 weeks
The optimal clinical effect is observed some months after mycological cure and completion of treatment. This is related to the time required for outgrowth of healthy nail.
• Usual Adult Dose for Onychomycosis – Toenail
Tablets: 250 mg orally once a day for 12 weeks
The optimal clinical effect is observed some months after mycological cure and completion of treatment. This is related to the time required for outgrowth of healthy nail.
• Usual Adult Dose for Tinea Capitis
Oral granules: 250 mg orally once a day for 6 weeks
Some evidence suggests that a longer duration of therapy (e.g., 6 to 8 weeks) or higher dosage may be necessary when tinea capitis is caused by Microsporum canis.

• Usual Adult Dose for Cutaneous Candidiasis
• Tablets: 250 mg orally once a day for 2 to 4 weeks
• Usual Adult Dose for Tinea Corporis
• Tablets: 250 mg orally once a day for 2 to 4 weeks
• Usual Adult Dose for Tinea Cruris
• Tablets: 250 mg orally once a day for 2 to 4 weeks
• Usual Adult Dose for Tinea Pedis
• Tablets: 250 mg orally once a day for 2 to 6 weeks

CONTRAINDICATIONS
Terbinafine tablets are contraindicated in individuals with hypersensitivity to Terbinafine or to any other ingredients of the formulation

ADVERSE REACTIONS
The adverse events reported encompass gastrointestinal symptoms (including diarrhea, dyspepsia, and abdominal pain), liver test abnormalities, rashes, urticaria, pruritus, and taste disturbances. In general, the adverse events were mild, transient, and did not lead to discontinuation from study participation.