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%. |
| Molecular Weight | 270.37 |
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 | Limited human data; animal studies not suggestive of harm. Generally considered safe if benefit outweighs risk. |
| 2nd trimester | No evidence of fetal harm; use if clinically indicated. |
| 3rd trimester | Avoid high-dose or prolonged use near term due to theoretical risk of premature closure of ductus arteriosus, but low-dose topical use is considered safe. |
Clinical note
Comprehensive clinical and safety monograph for MONISTAT 5 (MONISTAT 5).
| Placental transfer | Placental transfer is minimal after topical vaginal administration; systemic absorption is very low (approximately 1-3%). |
| Breastfeeding | Minimal systemic absorption after vaginal use; considered compatible with breastfeeding. No known adverse effects in nursing infants. |
■ 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. |
| Food/Dietary | No clinically significant food interactions. Avoid alcohol during treatment as it may increase risk of adverse effects (e.g., nausea, vomiting) per general azole precaution, though specific data with topical miconazole is limited. |
| Clinical Pearls |
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| Lactation Rating |
| L1 (Safe) |
| 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. |
| 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. |
| MONISTAT 5 (miconazole nitrate 100 mg vaginal suppositories) is indicated for vulvovaginal candidiasis. Unlike single-dose regimens, the 5-day course is preferred for pregnant patients or for recurrent infections. Miconazole has activity against Gram-positive bacteria, providing empirical coverage for mixed infections. Caution in patients with hypersensitivity to azole antifungals. Avoid concurrent use of diaphragm or condom for 3 days post-treatment due to potential interaction with latex. |
| Patient Advice | Insert one suppository high into the vagina at bedtime for 5 consecutive nights even if symptoms improve. · Do not use tampons, douches, spermicides, or other vaginal products during treatment. · Discontinue and consult doctor if abdominal pain, fever, or foul-smelling discharge occurs. · Avoid sexual intercourse during treatment; condoms and diaphragms may be weakened by the medication. · Complete the full course to ensure eradication; symptoms typically resolve by 3 days but finish all doses. |