GYNO-MIKOZAL 200/MG VAGINAL OVULES 7\VAG OVULES

Indications

Approved Uses

Treatment of vulvovaginal candidiasis (Candida vulvovaginitis/“vaginal thrush”).

Dosage & Administration

Dosing by Condition

Vulvovaginal candidiasis: One suppository (miconazole nitrate, 200 mg) is inserted intravaginally once daily at bedtime for three consecutive days.

Initial Dose

One 200mg vaginal ovule inserted deep into the vagina at bedtime

Maintenance Dose

One suppository (miconazole nitrate, 200 mg) is inserted intravaginally once daily at bedtime for three consecutive days.

Maximum Dose

amount_per_administration: 1
unit: ovule
strength_per_unit: 200 mg
route: intravaginal
frequency: once daily (at bedtime)
max_frequency: do not exceed 1 ovule per 24 hours, for 3 consecutive days

Dose Adjustment Notes

No adjustment needed for renal or hepatic impairment for vaginal use due to minimal systemic absorption.

How to Take

Wash hands before and after use. Insert 1 ovule (pessary) high into the vagina (using a finger; applicator only if supplied) while lying on your back with knees bent; preferably at bedtime to reduce leakage. A panty liner may be used to protect clothing.

Side Effects

Common Side Effects

Local vaginal/vulvar burning, itching, irritation, and increased vaginal discharge; abdominal/pelvic cramps can occur. Headache is less common but possible.

Side Effect Frequency

Common: local vulvovaginal burning/itching/irritation; abdominal/pelvic cramping; headache. Less common/rare: hypersensitivity reactions (e.g., rash/urticaria/contact dermatitis) and very rare severe allergic reactions (e.g., anaphylaxis).

Safety & Warnings

Contraindications

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

Warnings & Precautions

Avoid eye contact; stop and seek advice if severe irritation/allergy occurs; may weaken latex condoms/diaphragms during treatment; if symptoms persist beyond 7 days, recur frequently, or if fever/abdominal pain/foul-smelling discharge occurs, seek medical evaluation; if on warfarin/coumarins, consider INR monitoring.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Warfarin/other coumarin anticoagulants (↑INR/bleeding risk); consider monitoring-other systemic CYP interactions are unlikely with vaginal use but caution is reasonable with narrow-therapeutic-index drugs.

Food Interaction

No restriction.

Alcohol Interaction

Safe

Special Populations

Pregnancy

Effectiveness in pregnancy has not been established.

Breastfeeding

Caution; it is not known whether miconazole is excreted in human milk.

Elderly

Standard adult dosing

Kidney Impairment

No adjustment needed.

Liver Impairment

No dose adjustment needed for vaginal use.

Storage & Patient Advice

Stopping the Medicine

Complete the full prescribed 7‑day course even if symptoms improve earlier.

Patient Counseling

Use 1 ovule nightly at bedtime for 3 nights and complete the course even if symptoms improve. Avoid tampons, douching, and other intravaginal products during treatment. The base may weaken latex condoms/diaphragms-use alternative contraception during treatment (and for several days after).

Monitoring Requirements

No routine monitoring; INR monitoring required if patient is on warfarin

Pharmacology

Mechanism of Action

Inhibits fungal 14α-lanosterol demethylase (CYP51), reducing ergosterol synthesis and disrupting fungal cell membrane integrity/permeability.

Duration of Effect

Clinical improvement often begins within a few days, but the full intended treatment duration is 7 days and the course should be completed for maximal cure and to reduce relapse.

Bioavailability

Minimal systemic absorption after intravaginal use (approximately 1-2% reported in references).

Excretion

Any absorbed fraction is metabolized and eliminated mainly via feces with a smaller urinary component; only very small amounts are recovered in urine/feces after vaginal use.

Product Information

Available Dosage Forms

For this product: vaginal ovule/pessary (200 mg) in a blister pack of 7 for vaginal use.

Composition per Dose

Each vaginal ovule: 200mg miconazole nitrate

Generic Availability

Yes

OTC Alternatives

Other OTC intravaginal azoles such as clotrimazole vaginal tablets/cream or other miconazole vaginal products (where available).

Application

Vaginal

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