GYNO-CANDIZOL 400/MG VAGINAL OVULES 3/VAG OVULES

Indications

Approved Uses

Treatment of vulvovaginal candidiasis (Candida vulvovaginitis/yeast infection).

Dosage & Administration

Dosing by Condition

Vulvovaginal candidiasis: 400 mg vaginal ovule once daily at bedtime for 3 consecutive days (this pack provides the full course).

Initial Dose

One 400mg ovule inserted vaginally at bedtime.

Maintenance Dose

One 400mg ovule inserted intravaginally once daily at bedtime for 3 consecutive days (not a maintenance dose but a complete treatment course)

Maximum Dose

Intravaginal use: Insert 1 ovule (400 mg) once daily at bedtime for 3 consecutive days (maximum 1 ovule per 24 hours).

Dose Adjustment Notes

No dose adjustment required for renal or hepatic impairment due to minimal systemic absorption

How to Take

Insert 1 soft vaginal ovule (400 mg miconazole nitrate) high/deep into the vagina once daily at bedtime for 3 consecutive nights; insert with a finger (or applicator if supplied), wash hands before/after, and remain lying down briefly to reduce leakage.

Side Effects

Common Side Effects

Local vaginal/vulvar burning, itching, irritation, increased discharge/leakage; lower abdominal/pelvic cramps; headache (less common).

Side Effect Frequency

Vulvovaginal burning, itching or irritation (2%); cramping (2%); headache (1.3%); hives, skin rash (<0.5%).

Safety & Warnings

Contraindications

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

Warnings & Precautions

Not for oral/ophthalmic use; may damage latex condoms/diaphragms (and reduce effectiveness of some spermicides) during treatment and for a short period after; seek medical evaluation if fever, lower abdominal/pelvic pain, foul-smelling discharge, recurrent symptoms, or no improvement after 3 days/if symptoms persist beyond 7 days; use caution/monitoring if on warfarin.

Drug Interactions

Drug Interactions

Warfarin/other coumarin anticoagulants (may increase anticoagulant effect/INR); latex condoms/diaphragms and some spermicides may be compromised by the ovule base (reduced contraceptive effectiveness).

Interaction Severity

Warfarin: MAJOR/clinically significant (may increase INR/bleeding risk even with vaginal miconazole; monitor closely/avoid without medical advice). Latex condoms/diaphragms: clinically significant reduction in effectiveness (non-drug interaction).

Food Interaction

Not applicable/no clinically relevant food interactions (vaginal route).

Special Populations

Pregnancy

Effectiveness in pregnancy has not been established; vaginal imidazole derivatives are recommended for pregnant women with vulvovaginal candidiasis for 7 days of treatment

Elderly

Standard adult dosing

Storage & Patient Advice

Stopping the Medicine

Complete the full 3-day course (one 400 mg ovule nightly for 3 nights) even if symptoms improve; stop after the course is finished unless significant irritation/allergy occurs.

Patient Counseling

Use 1 ovule intravaginally at bedtime for 3 nights and complete the course; expect some leakage (use a panty liner) and avoid tampons/douching; avoid sex during treatment and note the product may weaken latex condoms/diaphragms; seek medical advice if first episode, pregnancy (especially 1st trimester), severe/recurrent symptoms, fever/pelvic pain, or no improvement within ~3 days or not resolved within ~7 days; if on warfarin, consult a clinician and monitor INR/bleeding.

Monitoring Requirements

No routine monitoring required. Patients on warfarin should monitor INR closely.

Pharmacology

Mechanism of Action

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

Duration of Effect

Symptom improvement typically occurs during therapy, but clinical/mycological cure is assessed after completion; symptoms may take up to ~7 days to fully resolve after starting treatment.

Half-Life

Not well established/clinically not meaningful for vaginal miconazole because systemic absorption is minimal; a reliable half-life is generally not provided for this route.

Bioavailability

Minimal systemic absorption after intravaginal use (generally low, often reported as <~1-2%).

Metabolism

If systemically absorbed, miconazole undergoes hepatic metabolism; it can inhibit CYP enzymes (notably CYP2C9 and CYP3A4), which is clinically relevant mainly with higher/systemic exposure or interacting drugs (e.g., warfarin).

Excretion

Minimal systemic absorption after vaginal use; any absorbed miconazole is eliminated mainly via biliary/fecal excretion as metabolites, with only a small fraction excreted in urine.

Product Information

Available Dosage Forms

For this product: vaginal ovule/soft vaginal capsule (ovule).

Generic Availability

Yes

Application

Vaginal

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 29-08-2026