Terazol (Terconazole Vaginal) - Indications and Dosage

INDICATIONS AND USAGE

TERAZOL^® 7 (terconazole) Vaginal Cream 0.4%, TERAZOL^® 3 (terconazole) Vaginal Cream 0.8% and TERAZOL^® 3 (terconazole) Vaginal Suppositories 80 mg are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As these products are effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.

DOSAGE AND ADMINISTRATION

TERAZOL^® 7 (terconazole) Vaginal Cream 0.4%

One full applicator (5 g) of TERAZOL 7 Vaginal Cream (20 mg terconazole) should be administered intravaginally once daily at bedtime for seven consecutive days.

TERAZOL^® 3 (terconazole) Vaginal Cream 0.8%

One full applicator (5 g) of TERAZOL 3 Vaginal Cream (40 mg terconazole) should be administered intravaginally once daily at bedtime for three consecutive days.

TERAZOL^® 3 (terconazole) Vaginal Suppositories 80 mg

One TERAZOL 3 Vaginal Suppository (80 mg terconazole) should be administered intravaginally once daily at bedtime for three 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 these products is not affected by menstruation.

HOW SUPPLIED

TERAZOL^® 7 (terconazole) Vaginal Cream 0.4% is available in 45g (NDC 0062-5350-01) tubes with an ORTHO* Measured-Dose Applicator. Store at Controlled Room Temperature 15–30°C (59–86°F).

TERAZOL^® 3 (terconazole) Vaginal Cream 0.8% is available in 20g (NDC 0062-5356-01) tubes with an ORTHO* Measured-Dose Applicator. Store at Controlled Room Temperature 15–30°C (59–86°F).

TERAZOL^® 3 (terconazole) Vaginal Suppositories 80 mg are available as 2.5g, elliptically-shaped white to off-white suppositories in packages of three (NDC 0062-5351-01) with a vaginal applicator. Store at Controlled Room Temperature 15–30°C (59–86°F).

*Trademark

Manufactured by:

Janssen Ortho, LLC

Manati, Puerto Rico 00674

Distributed by:

ORTHO-McNEIL (logo)

ORTHO-McNEIL PHARMACEUTICAL, INC.
Raritan, New Jersey 08869

© OMP 1998

Printed in U.S.A.

Revised October 2007