miconazole nitrate
Femizol-M, Fungoid tincture, Lotrimin AF, Micatin, Monistat 3, Monistat 7, Monistat-Derm, Ony-Clear, Tetterine

Available forms
Available by prescription only
Cream: 2%
Vaginal cream: 2%
Vaginal suppositories: 1,200 mg
Available without a prescription
Cream: 2%
Ointment: 2%
Powder: 2%
Solution: 2%
Spray: 2%
Vaginal cream: 2%
Vaginal suppositories: 100 mg, 200 mg

Indications and dosages
 Cutaneous or mucocutaneous fungal infections caused by susceptible organisms. Topical use. Adults and children: Apply to affected areas b.i.d. for 2 to 4 weeks.
 Treatment of pityriasis (tinea versicolor). Topical use. Adults and children older than age 2: Apply cream to affected area once daily.
Vaginal use
Adults: Insert 1,200-mg suppository h.s. for 1 day, or 200-mg suppository h.s. for 3 days, or 100-mg suppository or one applicatorful of vaginal cream h.s. for 7 days.

Pharmacodynamics
Antifungal action: Miconazole is fungistatic and fungicidal, depending on drug concentration, in Aspergillus flavus, Candida albicans, C. parapsilosis, C. tropicalis, Coccidioides immitis, Cryptococcus neoformans, Curvularia, Histoplasma capsulatum, Microsporum canis, Paracoccidioides brasiliensis, Pseudallescheria boydii, Sporothrix schenckii, dermatophytes, and some gram-positive bacteria. Miconazole causes thickening of the fungal cell wall, altering membrane permeability; it also may kill the cell by interference with peroxisomal enzymes, causing accumulation of peroxide within the cell wall. It attacks virtually all pathogenic fungi.

Pharmacokinetics
Absorption: A small amount of drug is systemically absorbed after vaginal administration.
Distribution: Unknown.
Metabolism: Metabolized in the liver, predominantly to inactive metabolites.
Excretion: Elimination is triphasic; terminal half-life is about 24 hours.

Contraindications and precautions
Topical form is contraindicated in patients hypersensitive to drug. Use cautiously in patients with hepatic insufficiency.

Interactions
Drug-drug. Amphotericin B: May antagonize effects of amphotericin B. Monitor patient carefully.
Benzodiazepines: Increases benzodiazepine effects. Consider lower benzodiazepine dose.
HMG-CoA reductase inhibitors: Increases risk of rhabdomyolysis. Use together cautiously.
Phenytoin: Increases phenytoin levels. Monitor phenytoin levels.
Tacrolimus: Increases risk of tacrolimus toxicity. Monitor tacrolimus levels and patient symptoms.
Vinca alkaloids: Increases risk of vinca alkaloid toxicity. Avoid use together.
Warfarin: Increases anticoagulant effect. Monitor PT and INR.

Adverse reactions
CNS: headache.
GU: vulvovaginal burning, pruritus, or irritation with vaginal cream; pelvic cramps.
Skin: irritation, burning, maceration, allergic contact dermatitis.

Effects on lab test results
None reported.

Overdose and treatment
No information available.

Special considerations
• Clean affected area before applying cream. After application, massage area gently until cream disappears.
• Continue topical therapy for at least 1 month; improvement should begin in 1 to 2 weeks. If no improvement occurs by 4 weeks, reevaluate diagnosis.
• Insert vaginal applicator high into vagina, except in pregnancy.
Pregnant patients
• The 7-day vaginal treatment is preferred in pregnant women.
Breast-feeding patients
• Safety hasn’t been established in breast-feeding women.
Pediatric patients
• Safety in children younger than age 1 hasn’t been established.

Patient education
• Teach patient the symptoms of fungal infection, and explain treatment rationale.
• Encourage patient to adhere to prescribed regimen and follow-up visits and to report adverse effects.
• Teach patient correct procedure for intravaginal or topical applications.
• To prevent vaginal reinfection, teach correct perineal hygiene and recommend that patient abstain from sexual intercourse during therapy.

Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE THREATENING.
◆ Canada only
◇ Unlabeled clinical use