Butoconazole: Uses, Dosage, Side Effects and More

This information is not country-specific. Please refer to the Hong Kong prescribing information.

Generic Medicine Info

Indications and Dosage

Vaginal
Vulvovaginal candidiasis

Adult: As 2% cream: Apply 1 applicator-full (approx 5 g) intravaginally as a single dose. Dosing recommendations may vary among countries and between individual products (refer to local or specific product guidelines).

Contraindications

Hypersensitivity.

Special Precautions

Consider HIV infection in sexually-active women who have difficulty eradicating recurrent vaginal yeast infections. Pregnancy and lactation.

Adverse Reactions

Gastrointestinal disorders: Abdominal pain or cramps.
Reproductive system and breast disorders: Vulvovaginal burning sensation, pruritus, swelling, and soreness; pelvic pain.

Pregnancy Category (US FDA)

Vag: C

Patient Counseling Information

May weaken latex or rubber contraceptive devices (e.g. condoms and diaphragms) which may lead to contraceptive failure; use of these products within 72 hours of therapy is not recommended. Abstain from sexual intercourse and avoid using douches or spermicide during treatment. Avoid contact with the eyes.

Monitoring Parameters

Perform appropriate microbiological studies to confirm diagnosis. If clinical symptoms persist, repeat tests to rule out pathogens or other conditions that may predispose to recurrent vaginal fungal infections.

Action

Description:
Mechanism of Action: Butoconazole is an imidazole-derived azole antifungal agent. The exact mechanism of action is unknown; however, it is presumed to inhibit ergosterol biosynthesis by interfering with 14-α demethylase, an enzyme essential for converting lanosterol to ergosterol. This inhibition damages the fungal cell membrane, thereby increasing the permeability of susceptible fungi and causing nutrient leakage.
Pharmacokinetics:
Absorption: Slowly absorbed following intravaginal administration. Time to peak plasma concentration: 12-24 hours.
Excretion: Via urine (2.7%); faeces (2.8%).

Chemical Structure

Storage

Store between 15-30°C. Avoid temperatures >30°C.

MIMS Class

Preparations for Vaginal Conditions

ATC Classification

G01AF15 - butoconazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.

References

Anon. Butoconazole. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 02/09/2024.

Brayfield A, Cadart C (eds). Butoconazole Nitrate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/09/2024.

Butoconazole. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 02/09/2024.

Butoconazole. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 02/09/2024.

Gynazole 1 Cream (Padagis Israel Pharmaceuticals Ltd). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/09/2024.

Disclaimer: This information is independently developed by MIMS based on Butoconazole from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2025 MIMS. All rights reserved. Powered by MIMS.com