Butoconazole

Mechanism-of-action classes: 14-alpha Demethylase Inhibitors; Ergosterol Synthesis Inhibitors.

• GYNAZOLE • 1 ® Butoconazole Nitrate Vaginal Cream USP, 2% is indicated for the local treatment of vulvovaginal candidiasis (infections caused by Candida ). The diagnosis should be confirmed by KOH smears and/or cultures (see CLINICAL STUDIES ).ICD-10: B37.9

• 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.contraindicated

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 100 mg of butoconazole nitrate.

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 with GYNAZOLE•1 ® Butoconazole Nitrate Vaginal Cream USP, 2% is not recommended. Recurrent vaginal yeast infections, especially those that are difficult to eradicate, can be an early sign of infection with the human immunodeficiency virus (HIV) in women who are considered at risk for HIV infection.

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, soreness and swelling, pelvic or abdominal pain or cramping, or a combination of two or more of these symptoms. In 3 patients (1%) these complaints were considered treatment-related. Five of the 18 patients reporting adverse events discontinued the study because of them.

Pregnancy:

• May 18, 2012ANDAANDA200923Padagis Israel

1. 1Anxiety240%
2. 2Depression240%
3. 3Exposure During Pregnancy240%
4. 4Abdominal Pain120%
5. 5Attention Deficit/hyperactivity Disorder120%
6. 6Cerebrovascular Disorder120%
7. 7Congenital Flat Feet120%
8. 8Convulsion120%
9. 9Deep Vein Thrombosis120%
10. 10Developmental Delay120%
11. 11Developmental Hip Dysplasia120%
12. 12Flatulence120%
13. 13Fungal Infection120%
14. 14Hyperkinesia120%
15. 15Joint Contracture120%

The 4 most recently updated of 4 ClinicalTrials.gov registrations naming Butoconazole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations
  Completed · Interventional · 611 enrolled · Padagis LLC
  NCT01039584updated 2023-07-12
• Efficacy and Safety of Different Doses of Venus Association in Patients With Vulvovaginal Candidiasis.
  Withdrawn · Phase 2 · Interventional · 0 enrolled · EMS
  NCT05031481updated 2022-08-10
• Vaginal Infection Study 2
  Completed · Phase 3 · Interventional · 843 enrolled · Lumara Health, Inc.
  NCT00694928updated 2012-03-05
• Vaginal Infection Study
  Completed · Phase 3 · Interventional · 1,443 enrolled · Lumara Health, Inc.
  NCT00616330updated 2012-03-05

Frequently asked questions

How does Butoconazole work?

Mechanism-of-action classes: 14-alpha Demethylase Inhibitors; Ergosterol Synthesis Inhibitors.

What is Butoconazole used for?

According to FDA labeling, Butoconazole carries indications including: GYNAZOLE • 1 ® Butoconazole Nitrate Vaginal Cream USP, 2% is indicated for the local treatment of vulvovaginal candidiasis (infections caused by Candida ). The diagnosis should be confirmed by KOH smears and/or cultures (see CLINICAL STUDIES ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Butoconazole?

Butoconazole is classified as Imidazole derivatives, Azole Antifungal, 14-alpha Demethylase Inhibitors, Ergosterol Synthesis Inhibitors, Decreased Cell Membrane Integrity.

What are the brand names for Butoconazole?

Butoconazole is marketed under brand names including Gynazole-1.

What are the contraindications for Butoconazole?

Butoconazole labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.