Classes
DEA Class; Rx
Common Brand Names; Oravig
- Antifungals
miconazole topical (Rx, OTC)
- Classes: Antifungals, Topical
miconazole vaginal (Rx, OTC)
- Classes: Antifungals, Vaginal
Description
Imidazole antifungal; used topically, as a bioadhesive buccal tablet, and intravaginally for various fungal infections.
Indications
Indicated for local treatment of oropharyngeal candidiasis
Orphan designation for treatment of fungal otitis externa (otomycosis)
For Vulvovaginal Candidiasis
Contraindications
Hypersensitivity to miconazole or other components
Milk protein allergy
Adverse Effects
- 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)
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
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.
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.
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.
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.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Miconazole
buccal tablet
- 50mg
cream/aerosol powder & spray/tincture
- 2%
vaginal cream
- 2%
- 4%
vaginal suppository
- 100mg
- 200mg
- 1200mg
