MYCOHEAL 400/MG VAGINAL SUPP 3/SUPP

Indications

Approved Uses

Vulvovaginal candidiasis (vaginal yeast infection; moniliasis).

Dosage & Administration

Dosing by Condition

Vulvovaginal candidiasis: 400 mg intravaginally once daily at bedtime for 3 consecutive days.

Initial Dose

One 400mg suppository intravaginally at bedtime.

Maintenance Dose

400mg intravaginally once daily for 3 days

Maximum Dose

Vaginal use: Insert 1 vaginal suppository (400 mg) intravaginally once daily at bedtime; maximum 1 suppository in 24 hours. Use for 3 consecutive nights per labeled regimen unless otherwise directed by a clinician.

Children's Dosage

Not approved for use in pre-pubertal children; use in adolescents post-puberty under medical supervision

How to Take

Insert 1 suppository (400 mg) high into the vagina once daily at bedtime for 3 consecutive days; wash hands before and after use; insert with finger (applicator only if supplied).

Side Effects

Common Side Effects

Local vaginal/vulvar burning, itching, irritation, and abdominal/pelvic cramps; headache can occur.

Side Effect Frequency

Common: local vaginal burning/irritation/itching and vulvovaginal discomfort; abdominal/pelvic cramps may occur. Rare/uncommon: hypersensitivity reactions (rash, urticaria); headache is reported but not a typical prominent reaction for vaginal products.

Safety & Warnings

Contraindications

Hypersensitivity to miconazole nitrate (or other imidazole antifungals) or to any excipient in the suppository.

Warnings & Precautions

For vaginal use only; avoid contact with eyes and do not ingest. If symptoms do not improve within 3 days or persist beyond 7 days, or if recurrent infections occur, seek medical evaluation. The suppository base may weaken latex condoms/diaphragms-use alternative contraception during treatment (and for several days after). Avoid tampons, douching, and intravaginal spermicides during treatment. If using warfarin/coumarins, monitor INR/bleeding closely.

Age Restriction

Not recommended under 12 years

Drug Interactions

Drug Interactions

Warfarin/coumarin anticoagulants: potential increased anticoagulant effect/bleeding risk-avoid if possible or monitor INR closely; other systemic interactions (e.g., phenytoin, sulfonylureas) are primarily relevant to oral/systemic miconazole and are not routinely expected with vaginal use but use caution in high-risk patients.

Interaction Severity

MAJOR: Warfarin/other coumarin anticoagulants-may increase anticoagulant effect/bleeding risk; monitor INR/bleeding. Other interactions are generally unlikely with vaginal use but caution is warranted with narrow-therapeutic-index CYP2C9 substrates.

Food Interaction

No restriction.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Safe

Children

Not approved for use in pre-pubertal children; use in adolescents post-puberty under medical supervision

Elderly

Standard adult dosing

Kidney Impairment

No adjustment needed

Storage & Patient Advice

Stopping the Medicine

Complete the full 3-day course (one 400 mg vaginal suppository nightly for 3 nights) even if symptoms improve; seek medical advice if symptoms persist/return.

Patient Counseling

Insert 1 suppository high in the vagina at bedtime for 3 nights and complete the course; avoid tampons/douching/other vaginal products during treatment; the product may weaken latex condoms/diaphragms-use non-latex/alternative contraception during treatment (and for several days after per labeling); seek medical advice if not improved within 3 days, not resolved within 7 days, recurrent infections, pregnancy, or if on warfarin/anticoagulants; store below 30°C.

Monitoring Requirements

No routine monitoring; monitor INR if patient is on warfarin

Pharmacology

Mechanism of Action

Inhibits fungal lanosterol 14α-demethylase (CYP450), decreasing ergosterol synthesis and disrupting cell membrane integrity/permeability.

Onset of Action

Symptom improvement is typically expected within 1-3 days of starting treatment.

Duration of Effect

Clinical symptom improvement is usually seen during the 3-day course, but full resolution may take up to 7 days; reassess if symptoms persist beyond 7 days or recur.

Half-Life

Unknown / not clinically applicable for vaginal use (systemic half-life not well established due to minimal absorption).

Metabolism

Hepatic metabolism (primarily via CYP-mediated oxidative pathways) to inactive metabolites; however, systemic exposure after vaginal use is minimal.

Product Information

Available Dosage Forms

Vaginal suppository (100 mg, 200 mg, 1200 mg), Vaginal cream (2%, 4%)

Composition per Dose

Each vaginal suppository: 400mg miconazole nitrate

OTC Alternatives

Other OTC intravaginal azoles for VVC include clotrimazole and tioconazole (and other miconazole regimens/forms where available).

Application

Vaginal

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