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Miconazole

    Brands

    DEA Class; Rx

    Common Brand Names; Oravig

    • Antifungals

    miconazole topical (Rx, OTC)

    Brand and Other Names: Desenex, Fungoid Tincture, Monistat Derm, Micatin, Zeasorb-AF, Cavilon Antifungal Cream
    • Classes: Antifungals, Topical

    miconazole vaginal (Rx, OTC)

    Brand and Other Names: Monistat-1 Combination Pack, Monistat-3 Combination Pack, Monistat-7 Combination Pack, Monistat-7 Vaginal Cream, Monistat-7 Vaginal Suppositories, Vagistat-3 Combination Pack, Femizol M
    • Classes: Antifungals, Vaginal

    Imidazole antifungal; used topically, as a bioadhesive buccal tablet, and intravaginally for various fungal infections.

    Indicated for local treatment of oropharyngeal candidiasis

    Orphan designation for treatment of fungal otitis externa (otomycosis)

    For Vulvovaginal Candidiasis

    Hypersensitivity to miconazole or other components

    Milk protein allergy

    • Diarrhea (6%)
    • Nausea (4.6%)
    • Headache (5%)
    • Dysgeusia (2.9%)
    • Upper abdominal pain (2.5%)
    • Vomiting (2.5%)
    • Irritation
    • Burning
    • Maceration
    • Allergic contact dermatitis
    • Irritation, burning, maceration, allergic contact dermatitis (all rare)
    • Irritation
    • Burning
    • Maceration
    • Allergic contact dermatitis
    • Irritation, burning, maceration, allergic contact dermatitis (all rare)

    Monitor closely in patients with history or allergic reaction to other azole antifungals; discontinue immediately at first sign of hypersensitivity

    No formal drug interaction studies have been performed with miconazole buccal administration

    Coadministration of miconazole (topical, intravaginal, oral administration) with warfarin has resulted in enhancement of anticoagulant effect; closely monitor for evidence of bleeding, prothrombin time, and INR

    Known CYP2C9 and CYP3A4 inhibitor; although the systemic absorption is minimal and plasma concentrations are substantially lower than when given IV, the potential for interaction with drugs metabolized via CYP2C9 and CYP3A4 (eg, oral hypoglycemics, phenytoin, ergot alkaloids) cannot be ruled out

    There are no available data on therapy use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; based on findings from animal data, therapy may cause fetal harm when administered to pregnant women

    There is no available information on presence of drug in human milk, effects on breastfed child, or on milk production

    Adults

    50 mg/day PO; 1 applicatorful (100 or 200 mg miconazole/5 g cream) intravaginally/day; 1 suppository (100, 200, or 1,200 mg) intravaginally/day. Maximum dosage not available for topical products.

    Geriatric

    50 mg/day PO; 1 applicatorful (100 or 200 mg miconazole/5 g cream) intravaginally/day; 1 suppository (100, 200, or 1,200 mg) intravaginally/day. Maximum dosage not available for topical products.

    Adolescents

    16 to 17 years: 50 mg/day PO; 1 applicatorful (100 or 200 mg miconazole/5 g cream) intravaginally/day; 1 suppository (100, 200, or 1,200 mg) intravaginally/day. Maximum dosage not available for topical products.
    13 to 15 years: Safety and efficacy of oral formulation have not been established; however, 50 mg/day PO has been used off-label. 1 applicatorful (100 or 200 mg miconazole/5 g cream) intravaginally/day; 1 suppository (100, 200, or 1,200 mg) intravaginally/day. Maximum dosage not available for topical products.

    Children

    12 years: 1 applicatorful (100 or 200 mg miconazole/5 g cream) intravaginally/day; 1 suppository (100, 200, or 1,200 mg) intravaginally/day. Maximum dosage not available for topical products. Safety and efficacy of oral formulation have not been established.
    2 to 11 years: Maximum dosage not available for topical products. Safety and efficacy of other formulations have not been established.
    1 year: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Miconazole

    buccal tablet

    • 50mg

    cream/aerosol powder & spray/tincture

    • 2%

    vaginal cream

    • 2%
    • 4%

    vaginal suppository

    • 100mg
    • 200mg
    • 1200mg