Dosage Form: Cream
Tioconazole is indicated for the local treatment of-
- Fungal infections of skin: Dermatophyte infections including tinea corporis, tinea cruris, tinea manuum, tinea pedis, pityriasis Versicolor (tinea versicolor), dermal candidiasis.
- Erythrasma: Its activity against some Gram-positive bacteria is an added benefit in mixed infections.
- Vulvovaginal candidiasis (VVC).
Tioconazole is a topical antifungal agent. It is a broad-spectrum antifungal agent that inhibits the growth of human pathogenic yeasts. It exhibits fungicidal activity in-vitro against Candida albicans, other species of the genus Candida and against Torulopsis glabrata.
Topical: Apply & massage gently into the affected & surrounding skin area once or twice a day. In intertriginous areas, apply sparingly & smoothed in well to avoid macerating effects. Duration: 1-6 weeks.
- Adult: As 6.5% ointment: Admin intravaginally at bedtime as a single dose.
- Child: ≥12 yr Admin at bedtime as a single dose.
Route of administration: Topically.
Hypersensitivity to Cyclosporine or to any of the excipients of Cyclosporine
Tioconazole is contraindicated in individuals who have been shown to be sensitive to imidazole antifungal agents or to other components of the ointment
Burning and itching were the most frequent side effects occurring in approximately 6% and 5% of the patients respectively. There were occasional reports (less than 1%) of other side effects including irritation, discharge, vulvar edema and swelling, vaginal pain, dysuria, nocturia, dyspareunia, dryness of vaginal secretions, desquamation.
Pregnancy & Lactation:
Pregnancy category C. Tioconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, nursing should be temporarily discontinued while Tioconazole is administered.
Precautions & Warnings:
Tioconazole is intended for intravaginal administration only. Administration of Tioconazole just prior to bedtime may be preferred. The Tioconazole ointment base may interact with rubber or latex products such as condoms; therefore, use of such products within 72 hours following treatment is not recommended.
Drugs used in Vaginal and Vulval condition, Topical Antifungal preparations.
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Manufactured by: Renata Limited.