Vagistat-1
INDICATIONS
VAGISTAT-1 is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As VAGISTAT-1 has been shown to be effective only for candidal vulvovaginitis, the diagnosis should be confirmed by KOH smears and/or cultures. Other pathogens commonly associated with vulvovaginitis should be ruled out by appropriate methods.
Studies have shown that women taking oral contraceptives have a cure rate similar to those not taking such agents when treated with VAGISTAT-1.
Safety and effectiveness in pregnant and diabetic patients have not been established (see PRECAUTIONS).
DOSAGE AND ADMINISTRATION
VAGISTAT-1 has been found to be effective as a single- dose treatment for vulvovaginal candidiasis. Using the prefilled applicator, insert one applicator- full intravaginally. Administration of VAGISTAT-1 just prior to bedtime may be preferred.
HOW SUPPLIED
VAGISTAT-1 is supplied in a ready-to-use, prefilled, single-dose vaginal applicator (NDC 0087-0657-40). Each applicator-full will deliver approximately 4.6 grams of VAGISTAT-1 containing 65 mg of tioconazole per gram of ointment.
Storage: Store at controlled room temperature 15°-30° C (59°-86° F).
WARNING: Manufactured with 1,1,1-trichloroethane, a substance which harms public health and environment by destroying ozone in the upper atmosphere.
Generic Name: Tioconazole
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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.
Vagistat-1
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