Tioconazole interacts with 14-α demethylase, a cytochrome P-450 enzyme that converts lanosterol to ergosterol, an essential component of the yeast membrane. In this way, tioconazole inhibits ergosterol synthesis, resulting in increased cellular permeability. Tioconazole may also inhibit endogenous respiration, interact with membrane phospholipids, inhibit the transformation of yeasts to mycelial forms and the uptake of purine, impair triglyceride and/or phospholipid biosynthesis, and inhibit the movement of calcium and potassium ions across the cell membrane by blocking the ion transport pathway known as the Gardos channel.

Tioconazole is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As Tioconazole has been shown to be effective only for candidal vulvovaginitis, the diagnosis should be confirmed by KOH smears and/or cultures. Other pathogens commonly associated with vulvovaginitis should be ruled out by appropriate methods.

Studies have shown that women taking oral contraceptives have a cure rate similar to those not taking such agents when treated with Tioconazole.

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.

Vaginal candidiasis:

• Adult: As 6.5% ointment: Admin intravaginally at bedtime as a single dose.
• Child: ≥12 yr Admin at bedtime as a single dose.

Tioconazole is contraindicated in individuals who have been shown to be sensitive to imidazole antifungal agents or to other components of the ointment.

Occasional local transient & mild irritation; if hypersensitivity reaction develop, treatment should be discontinued & appropriate therapy should be instituted.

Not for ophthalmic use.

Use in Special Populations

Safety and effectiveness in pregnant and diabetic patients have not been established

Pregnancy & Lactation

Pregnancy Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.