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Terazol

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Terazol 3, Terazol 7

Terazol 3, Terazol 7

INDICATIONS

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 50458-535-01) 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 50458-536-01) 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 50458-531-01) with a vaginal applicator. Store at Controlled Room Temperature 15–30°C (59–86°F).

Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674 (for the Vaginal Cream) Jubilant HollisterStier General Partnership, Kirkland, Quebec, Canada H9H 4J4 (for the Vaginal Cream and Vaginal Suppositories). Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, New Jersey 08560

Last reviewed on RxList: 10/11/2013
This monograph has been modified to include the generic and brand name in many instances.

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