MONISTAT 5
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MONISTAT 5 (MONISTAT 5).
Miconazole inhibits fungal cytochrome P450 14α-demethylase, blocking ergosterol synthesis and disrupting fungal cell membrane integrity.
| Metabolism | Primarily hepatic via CYP450 enzymes; minimal systemic absorption after vaginal application. |
| Excretion | Primarily fecal (90%) as unchanged drug; renal excretion minimal (<1%). |
| Half-life | Terminal half-life approximately 24 hours; supports once-daily dosing. |
| Protein binding | 98.7% bound to plasma proteins, mainly albumin. |
| Volume of Distribution | Vd approximately 0.7 L/kg, reflecting distribution into tissues. |
| Bioavailability | Vaginal: approximately 5-10% systemically absorbed. |
| Onset of Action | Vaginal: symptomatic relief within 24 hours. |
| Duration of Action | Duration of therapy is 5 days for vaginal candidiasis; clinical cure rate >80%. |
Miconazole nitrate 100 mg vaginal suppository inserted once daily at bedtime for 3 days; or 200 mg vaginal suppository once daily at bedtime for 3 days; or 1200 mg vaginal suppository as a single dose.
| Dosage form | TAMPON |
| Renal impairment | No dose adjustment required for impaired renal function. |
| Liver impairment | No dose adjustment required for mild to moderate hepatic impairment; use caution in severe hepatic impairment due to potential for increased systemic absorption. |
| Pediatric use | Not indicated for pediatric patients; safety and efficacy in children have not been established. |
| Geriatric use | No dose adjustment required; use standard adult dosing for uncomplicated vulvovaginal candidiasis. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MONISTAT 5 (MONISTAT 5).
| Breastfeeding | Miconazole is minimally absorbed into systemic circulation after vaginal use; excretion into breast milk is negligible. Considered compatible with breastfeeding. No M/P ratio available due to undetectable levels. Avoid application to breast area. |
| Teratogenic Risk | Miconazole (active ingredient in MONISTAT 5) is classified as FDA Pregnancy Category C. Limited human data; in animal studies, embryotoxicity was observed at maternally toxic doses. Intravaginal administration results in minimal systemic absorption, likely low risk for major malformations. Use only if clearly needed, especially during first trimester. |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to miconazole or any component of the formulation.
| Precautions | For intravaginal use only. Discontinue if irritation or hypersensitivity occurs. Use with caution in patients with known hypersensitivity to azole antifungals. Do not use during menstruation. If symptoms persist beyond 7 days, reevaluate diagnosis. |
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| Fetal Monitoring | No specific fetal monitoring required for short-term vaginal use. Monitor for signs of local irritation or allergic reaction. In complicated cases (e.g., recurrent infections), consider glucose testing for diabetes. |
| Fertility Effects | No known adverse effects on fertility. Miconazole does not significantly alter hormonal balance or reproductive function when used topically. |