GYNAZOLE-1 Cream (2021)

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1. Description

GYNAZOLE-1 Butoconazole Nitrate Vaginal Cream USP, 2% contains butoconazole nitrate 2%, an imidazole derivative with antifungal activity. Its chemical name is (±)- 1-[4-(p-chlorophenyl)- 2- [(2,6-dichlorophenyl) ...

2. Clinical Pharmacology

Following vaginal administration of butoconazole nitrate vaginal cream, 2% to 3 women, 1.7% (range 1.3-2.2%) of the dose was absorbed on average. Peak plasma levels (13.6-18.6 ng radioequivalents/mL of ...

3. Indications and Usage

GYNAZOLE-1 Butoconazole Nitrate Vaginal Cream USP, 2% is indicated for the local treatment of vulvovaginal candidiasis (infections caused by <em>Candida</em>). The diagnosis should be confirmed by KOH ...

4. Contraindications

GYNAZOLE-1 Butoconazole Nitrate Vaginal Cream USP, 2% is contraindicated in patients with a history of hypersensitivity to any of the components of the product.

5. Warnings

This cream contains mineral oil. Mineral oil may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms; therefore, use of such products within 72 hours following treatment ...

6.1. General

If clinical symptoms persist, tests should be repeated to rule out other pathogens, to confirm the original diagnosis, and to rule out other conditions that may predispose a patient to recurrent vaginal ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Long term studies in animals have not been performed to evaluate the carcinogenic potential of this drug. Mutagenicity Butoconazole nitrate was not mutagenic when tested in the Ames bacterial ...

6.7. Pregnancy

Category C. In pregnant rats administered 6 mg/kg/day of butoconazole nitrate intravaginally during the period of organogenesis, there was an increase in resorption rate and decrease in litter size; however, ...

6.9. Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when butoconazole nitrate is administered to a nursing woman.

6.10. Pediatric Use

Safety and effectiveness in children have not been established.

7. Adverse Reactions

Of the 314 patients treated with GYNAZOLE-1 Butoconazole Nitrate Vaginal Cream USP, 2% for 1 day in controlled clinical trials, 18 patients (5.7%) reported complaints such as vulvar/vaginal burning, itching, ...

10. Dosage and Administration

The recommended dose of GYNAZOLE-1 Butoconazole Nitrate Vaginal Cream USP, 2% is one applicatorful of cream (approximately 5 grams of the cream) intravaginally. This amount of cream contains approximately ...

11. How Supplied

GYNAZOLE-1 Butoconazole Nitrate Vaginal Cream USP, 2% is available in cartons containing one single-dose prefilled disposable applicator (NDC 45802-396-01).

12. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Avoid heat above 30°C (86°F).

13. Clinical Studies

<u>Vulvovaginal Candidiasis:</u> Two studies were conducted that compared 2% butoconazole nitrate cream with clotrimazole tablets. There were 322 enrolled patients, 161 received 2.0% butoconazole vaginal ...