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 intra-vaginally 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).
Manufactured by: Janssen Ortho, LLC Manati, Puerto Rico 00674. Distributed by: ORTHO-McNEIL, PHARMACEUTICAL, INC. Raritan, New Jersey 08869. Revised October 2007. FDA revision date: 6/30/2004
Generic Name: Terconazole
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ENABLEX is a prescription medicine used in adults to treat the following symptoms due to a condition called overactive bladder:
- · having a strong need to go to the bathroom right away (also called "urgency")
- · leaks or wetting accidents (also called "urinary incontinence")
- · having to go to the bathroom too often (also called "urinary frequency")
IMPORTANT SAFETY INFORMATION
You should not take once-daily ENABLEX if you have certain types of stomach problems, glaucoma, or have trouble emptying your bladder. Side effects of ENBLEX include blurred vision, and more commonly dry mouth, constipation, indigestion, and abdominal pain. Use caution when doing certain activities until you know how ENBALEX affects you.
Terazol 3, Terazol 7
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