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standards of non-Merck sources.
Pronunciation
(byoo toe KOE na zole)
U.S. Brand Names
Index Terms
Generic Available
No
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Local treatment of vulvovaginal candidiasis
Pregnancy Risk Factor
C (use only in 2nd or 3rd trimester)
Pregnancy Considerations
No adequate and well-controlled studies have been conducted in pregnant women. However, butoconazole has been used during pregnancy. Use should be limited to the 2nd or 3rd trimesters only.
Lactation
Excretion in breast milk unknown/use caution
Contraindications
Hypersensitivity to butoconazole or any component of the formulation
Warnings/Precautions
Concerns related to adverse effects:
• Irritation: If irritation or sensitization occurs, discontinue use.
Special populations:
• Pediatrics: Safety and efficacy have not been established in females <12 years of age.
Dosage form specific issues:
• Petrolatum-based: Contains mineral oil which may weaken latex or rubber products (condoms, vaginal contraceptive diaphragms); do not use these products within 72 hours of treatment.
• OTC product: Not for use in women with a first-time vaginal yeast infection.
Other warnings/precautions:
• HIV infection consideration: HIV infection should be considered in sexually-active women with difficult to eradicate recurrent vaginal yeast infections.
Adverse Reactions
Frequency not defined.
Gastrointestinal: Abdominal pain or cramping
Genitourinary: Pelvic pain; vulvar/vaginal burning, itching, soreness, and swelling
Drug Interactions
There are no known significant interactions.
Storage
Store at 15°C to 30°C (59°F to 86°F).
Mechanism of Action
Increases cell membrane permeability in susceptible fungi (Candida)
Pharmacodynamics/Kinetics
Absorption: 2%
Metabolism: Not reported
Time to peak: 12-24 hours
Dosage
Adults: Female: Gynazole-1®: Insert 1 applicatorful (?5 g) intravaginally as a single dose; treatment may need to be extended for up to 6 days in pregnant women (use in pregnancy during 2nd or 3rd trimester only)
Additional Information
Gynazole-1®: This product is delivered in a base allowing the active ingredient to remain vaginally for 4 days. It is associated with less leakage and can therefore be applied at any time during the day or night (per product information, Gynazole-1®).
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
None reported
Mental Health: Effects on Psychiatric Treatment
None reported
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, vaginal, as nitrate:
Gynazole-1®: 2% (5 g) [prefilled applicator]
Pricing: U.S. (www.drugstore.com)
Cream (Gynazole-1)
2% (5.8): $68.94
International Brand Names
Lexi-Comp.com
Last full review/revision December 2008
Content last modified December 2008
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