Class: Topical Preparations
Dosage Form: Cream
Description: Antifungal vaginal cream
Butoconazole nitrate…………20 mg
Butoconazole vaginal cream is indicated in treatment of vulvovaginal candidiasis caused by Candida.
Butoconazole vaginal cream is contraindicatedin patients with a history of hypersensitivity to any of the product ingredients.
Some patients may experience burning or itching sensation in the vaginal wall.
Dosage and Administration:
The recommended dose of Butoconazole is one full applicator (around 5 grams cream) intravaginally at night.
This amount of cream contains approximately 100 mg butoconazole nitrate.
Pregnancy and Lactation:
In rats administered with 6 mg/kg/day butoconazole intravaginally during the period of organogenesis, there was an increase in resorption rate and a decrease in litter size. No teratogenicity was noted.
It is not known whether this drug is excreted in human milk. Caution should be exercised when butoconazole nitrate is administered to a nursing mother.
If clinical symptoms persist, tests should be repeated to rule out other pathogens, to confirm the original diagnosis and to rule out otehr conditions that may predispose a patient to recurrent vaginal fungal infection.
Carton box containing 5 g aluminum tube of cream and plastic disposable applicator.
Store between 15-25°C.