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

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.