Adult Dosing

Vulvovaginal candidiasis

Adults, nonpregnant

• One applicatorful (5 g) as single dose intravaginally

Pediatric Dosing

• Safety and effectiveness in pediatric population have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Butoconazole is indicated for the local treatment of vulvovaginal candidiasis

• Hypersensitivity to any of the ingredients of the product

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Confirm diagnosis by KOH smears and/or cultures
• Recurrent vaginal infections may be an early sign of infection with HIV. Evaluate women at risk for HIV infection
• Intractable candidiasis may be symptom of unrecognized diabetes or reinfection. Evaluate patient carefully.

Supplemental Patient Information

• Advise patients not to use latex or rubber products such as condoms or vaginal contraceptive diaphragms within 72 hours following treatment with butoconazole

Pregnancy Category:C

Breastfeeding: Safety unknown. No published experience with butoconazole, other agents might be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 10 May 2010). Manufacturer advises caution

• Vulvovaginal burning, vulvovaginal itching, vulvovaginal soreness and swelling, pelvic or abdominal pain or cramping

• Mechanism of Action: Exact mechanism unknown. Reduces fungal cell membrane ergosterol synthesis and increases cellular permeability (azole antifungal)
• Minimal systemic absorption (5.5%)
• Metabolized by liver, CYP450: unknown
• Excreted in feces (2.8%) and urine (2.7%)
• Half-life: 21-24 hrs (plasma half-life)

US Trade Name(s)

• Gynazole-1
• Femstat 3

US Availability

Gynazole-1

• CRE: 2% (single 5 g applicator)

Femstat 3

• OTC Vaginal CRE: 2%

Canadian Trade Name(s)

• Gynazole-1

Canadian Availability

Gynazole 1

• CRE: 2% (single 5 g applicator)

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• Gynazole-1

Australian Availability

Gynazole-1

• CRE: 2% (single 5 g applicator)

[Outline]

Antimicrobials

Vaginal Agents; Anti-infectives

Infectious Disease

Vaginal Agents; Anti-infectives

Obstetrics/Gynecology

Vaginal Agents; Anti-infectives