MICONAZOLE 7
Clinical safety rating: safe
Warfarin metabolism is inhibited increasing INR For topical use only not for ophthalmic use.
Imidazole antifungal agent that inhibits fungal cytochrome P450 14α-demethylase, thereby blocking ergosterol synthesis and disrupting fungal cell membrane integrity.
| Metabolism | Hepatic metabolism primarily via oxidation and glucuronidation. CYP3A4 is the major enzyme involved. |
| Excretion | Primarily fecal (~50%) and renal (~<1% unchanged) |
| Half-life | Terminal half-life 24-30 hours; prolonged in hepatic impairment |
| Protein binding | 88-93% bound to albumin and alpha-1-acid glycoprotein |
| Volume of Distribution | ~1400 L (20 L/kg), indicating extensive tissue binding |
| Bioavailability | Vaginal: ~1-2% systemic absorption; oral: <1% |
| Onset of Action | Vaginal cream: relief within 1-3 days; 7-day regimen |
| Duration of Action | Vaginal cream: clinical effect persists for ~7 days after last dose |
Apply 200 mg (one full applicator) intravaginally once daily at bedtime for 7 days.
| Dosage form | CREAM |
| Renal impairment | No dose adjustment required for any degree of renal impairment. |
| Liver impairment | No formal guidelines; use with caution in severe hepatic impairment (Child-Pugh class C) due to limited data. |
| Pediatric use | Not recommended for pediatric patients; safety and efficacy have not been established. |
| Geriatric use | No dose adjustment required; same as standard adult dosing. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Warfarin metabolism is inhibited increasing INR For topical use only not for ophthalmic use.
| FDA category | Human |
| Breastfeeding | Topical vaginal miconazole is minimally absorbed systemically. No data on presence in human milk or effects on breastfed infant. The M/P ratio is unknown but likely low due to low systemic absorption. The manufacturer recommends caution; however, use is generally considered compatible with breastfeeding. Avoid application to breast area. |
| Teratogenic Risk |
■ FDA Black Box Warning
None.
| Common Effects | vaginal yeast infections |
| Serious Effects |
["Hypersensitivity to miconazole or any component of the formulation.","Not for use in patients with hepatic impairment (systemic use)."]
| Precautions | ["For vaginal use only; not for oral or ophthalmic use.","May cause local irritation or burning sensation.","Discontinue if hypersensitivity or irritation occurs.","Use during pregnancy only if clearly needed (Category C)."] |
Loading safety data…
| FDA Pregnancy Category C. No well-controlled studies in pregnant women. Miconazole 7 (miconazole nitrate) is a topical azole antifungal. Systemic absorption after vaginal administration is minimal (approximately 1-2%). Available data from retrospective cohort studies and case reports do not suggest an increased risk of major birth defects or miscarriage when used topically during pregnancy. However, due to limited data, avoid use in the first trimester unless clearly needed. Second and third trimester use is generally considered safe, but with caution. |
| Fetal Monitoring | No specific maternal or fetal monitoring is required beyond routine obstetric care. If used during pregnancy, monitor for local irritation or allergic reaction. For systemic absorption concerns, no monitoring is indicated due to negligible absorption. |
| Fertility Effects | No known adverse effects on fertility in animal studies or human reports. Topical miconazole is not expected to impair fertility due to minimal systemic exposure. No effect on ovulation or reproductive function documented. |