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Pronunciation:

(byoo toe KOE na zole)

U.S. Brand Names:

Gynazole-1®; Mycelex®-3 [OTC]

Synonyms:

Butoconazole Nitrate

Generic Available:

Canadian Brand Names:

Femstat® One

Use:

Local treatment of vulvovaginal candidiasis

Pregnancy Risk Factor:

C (use only in 2nd or 3rd trimester)

Pregnancy Implications:

There are 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:

If irritation or sensitization occurs, discontinue use. Contains mineral oil which may weaken latex or rubber products (condoms, vaginal contraceptive diaphragms); do not use these products within 72 hours of treatment. HIV infection should be considered in sexually-active women with difficult to eradicate recurrent vaginal yeast infections. OTC product is not for use in women with a first-time vaginal yeast infection. Safety and efficacy in females <12 years have not been established.

Adverse Reactions:

Frequency not defined.

Gastrointestinal: Abdominal pain or cramping

Genitourinary: Pelvic pain; vulvar/vaginal burning, itching, soreness, and swelling

Drug Interactions:

No data reported

Stability:

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:

Femstat®-3 [OTC]: Insert 1 applicatorful (~5 g) intravaginally at bedtime for 3 consecutive days

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)

Patient Education:

May cause burning or stinging on application; dispose of applicator after use. If symptoms of vaginitis persist, contact prescriber. Do not use OTC product if you have abdominal pain, fever, or foul-smelling discharge. Contact prescriber if infection does not clear within 3 days. Do not use tampons while using this medication. This medication contains mineral oil, which may cause damage to condoms or diaphragms; use another method of birth control during treatment. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.

Nursing Implications:

May cause burning or stinging on application; if symptoms of vaginitis persist, contact physician

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 anytime 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:

Cream, vaginal, as nitrate:

Mycelex®-3: 2% (5 g) [prefilled applicator], (20 g) [with disposable applicator]

Gynazole-1®: 2% (5 g) [prefilled applicator]

International Brand Names:

Femstal® (MX); Femstat® (AR, EC); Femstat® One (CA); Gynomyk® (BE, FR, LU, NL)

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