Zazole (Terconazole Vaginal) - Indications and Dosage

INDICATIONS AND USAGE

Zazole^® Vaginal Cream 0.4% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As Zazole^® Vaginal Cream 0.4% is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.

DOSAGE AND ADMINISTRATION

One full applicator (5 g) of Zazole^® Vaginal Cream 0.4% (20 mg terconazole) should be administered intravaginally once daily at bedtime for seven consecutive days. Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures and other pathogens commonly associated with vulvovaginitis ruled out. The therapeutic effect of Zazole^® Vaginal Cream 0.4% is not affected by menstruation.

HOW SUPPLIED

Zazole^® Vaginal Cream 0.4% (terconazole vaginal cream 0.4%) is available in the following size:

NDC 0462-0346-46 45 gram tubes with a measured dose applicator.

Store at 20°-25°C (68°-77°F)[see USP Controlled Room Temperature].

PharmaDerm^®
a division of Altana Inc
Duluth, GA 30096 USA
www.pharmaderm.com

I8346B
R3/06
#299