GYNO-MIKOZAL 400/MG VAGINAL OVULES 3\VAG OVULES

Indications

Approved Uses

Vulvovaginal candidiasis (Candida vulvovaginitis/“vaginal yeast infection”).

Dosage & Administration

Dosing by Condition

Vulvovaginal candidiasis: 1 ovule (miconazole nitrate 400 mg) intravaginally once daily at bedtime for 3 consecutive days.

Initial Dose

One 400mg vaginal ovule inserted intravaginally at bedtime

Maximum Dose

Vaginal use: Insert 1 ovule (400 mg) intravaginally once daily at bedtime. Maximum: 1 ovule per 24 hours for this strength unless directed by a clinician.

Dose Adjustment Notes

No dose adjustment is required in renal or hepatic impairment for vaginal use due to minimal systemic absorption.

How to Take

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

Safety & Warnings

Contraindications

Hypersensitivity to miconazole/other imidazole antifungals or to any excipient in the ovule.

Driving Warning

Safe

Drug Interactions

Food Interaction

No food interactions (not applicable for intravaginal administration).

Special Populations

Elderly

Standard adult dosing.

Kidney Impairment

No adjustment needed

Liver Impairment

No adjustment needed

Storage & Patient Advice

Stopping the Medicine

Complete the full prescribed 3‑ovule (3‑day) course even if symptoms improve earlier.

Pharmacology

Mechanism of Action

Azole antifungal that inhibits ergosterol synthesis by inhibiting fungal 14-α-demethylase (CYP51), disrupting cell membrane integrity and increasing permeability.

Half-Life

Not well established/clinically not meaningful after vaginal administration due to minimal systemic absorption; systemic half-life is not reliably defined for this route.

Protein Binding

High protein binding (approximately 90% or higher) for the systemically absorbed fraction.

Product Information

Available Dosage Forms

Vaginal pessary/ovule (this product’s dosage form per SFDA: pessary).

Composition per Dose

Each vaginal ovule: 400mg miconazole nitrate

Generic Availability

Yes

OTC Alternatives

Other OTC intravaginal azoles such as clotrimazole (e.g., 500 mg single-dose pessary or 1%/2% cream regimens) or other miconazole vaginal products of different strengths/durations (where available).

Application

Vaginal

Legal Disclaimer - Al Mujtama Pharmacy The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment. Al Mujtama Pharmacy assumes no legal or medical liability for: Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist Any discrepancy between the information provided and the product's package insert or SFDA guidelines Any misuse of medication resulting from personal interpretation of the content displayed Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication. By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation. Your health is a trust - always consult your doctor first.