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

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Brand : GYNO MIKOZAL

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

18.25

Sku : I-002740
Key features
GYNO-MIKOZAL 400 mg vaginal ovules (pessary) contain miconazole nitrate as the active antifungal ingredient. As an imidazole (azole) antifungal, miconazole inhibits fungal 14-α-demethylase (CYP51), reducing ergosterol synthesis and disrupting fungal cell membrane integrity and permeability. It is indicated for the treatment of vulvovaginal candidiasis (vaginal yeast infection). Available OTC in a pack of three vaginal ovules.
- Brand: GYNO MIKOZAL
- Active Ingredient: MICONAZOLE NITRATE
- Strength: 400mg
- Dosage Form: Pessary
- Pack Size: 3 Units
- Route: Vaginal use
- Prescription Status: OTC
- Therapeutic Class: Genitourinary
- Pharmacological Group: Gynecological Anti-infectives
- Drug Class: Imidazole Antifungal
- Manufacturer: Gulf Pharmaceutical Industries (Julphar)
- Country of Origin: United Arab Emirates
- SFDA Registration No.: 2909222663
- Shelf Life: 48 months
- Storage: store below 30°c
- Application: Vaginal

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Description

Specification

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).