VAGISTAT-1 (tioconazole 6.5%) is a single dose treatment for recurrent vaginal yeast infections which is available over-the-counter.

Composition:   VAGISTAT-1 (tioconazole 6.5%) is formulated in a base of white petrolatum and magnesium aluminum silicate with butylated hydroxyanisole (BHA) added as a preservative. Each applicatorful of VAGISTAT-1 provides approximately 4.6 grams of ointment containing 300 mg of tioconazole.

  VAGISTAT-1 is indicated for the treatment of recurrent vaginal yeast infections (candidiasis) previously diagnosed by a physician. If this is the first time vaginal itch and discomfort have been present, a doctor should be consulted. If you have had a doctor diagnose a vaginal yeast infection before and have the same symptoms now, use this ointment as directed.

Studies have shown that women taking oral contraceptives have cure rates similar to those not taking such agents when treated with VAGISTAT-1.

Safety and effectiveness in pregnant and diabetic patients have not been established.

Contraindications:   VAGISTAT-1 is contraindicated in individuals who have been shown to be sensitive to imidazole antifungal agents or to other components of the ointment.



There are no adequate and well-controlled studies in pregnant women. VAGISTAT-1 (tioconazole 6.5%) should be used during pregnancy only if the physician believes the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, nursing should be temporarily discontinued while VAGISTAT-1 is administered.

Pediatric Use:

Safety and effectiveness in children have not been established.


Adverse Reactions:   The incidence of Adverse Reactions to VAGISTAT-1 is based on clinical trials involving 1000 patients. Burning and itching were the most frequent side effects occurring in approximately 6% and 5% of patients, respectively. In most instances these did not interfere with the course of therapy.

There were occasional reports (less than 1%) of other side effects including irritation, discharge, vulvar swelling, vaginal pain, dysuria, (pain on urination), nocturia, (nighttime urination), dyspareunia, (painful intercourse), dryness of vaginal secretions, desquamation, (peeling skin), and burning sensation.

In two clinical trials involving 1060 patients which supported the Rx to OTC switch, the most frequently reported side effects were vaginitis (5%), headache (5%), infection (3%), and abdominal pain (2%). There were also occasional reports (less than 2%) of pharyngitis, rhinitis, vulvovaginal disorder, rash and dysuria.

Dosage And Administration:   Administration of VAGISTAT-1 just prior to bedtime is recommended. Open the foil packet just before use. Remove the applicator and plunger from the foil packet. The applicator is prefilled with VAGISTAT-1 vaginal ointment. While firmly holding the blue-capped end of the applicator, push the tip of the plunger into the base of the applicator. REMOVE BLUE CAP (underlined) from the top of the applicator using a pull-twist action. Lie on your back with your knees bent. Gently insert applicator into the vagina as far as it will go comfortably. Push the plunger into the applicator until it will go no further. Withdraw the applicator and plunger and dispose of it in the wastebasket. Do not flush.

How Supplied:   VAGISTAT-1 is supplied in a ready-to-use, prefilled, single-dose vaginal applicator. Each applicatorful will deliver approximately 4.6 grams of VAGISTAT-1 containing 65 mg of tioconazole per gram of ointment.

Store at controlled room temperature 15°-30°C (59°-86°F).


NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug' identity should be verified by chemical analysis.