GYNO-DAKTARIN VAG CREAM

Indications

Approved Uses

Treatment of vulvovaginal candidiasis (vaginal yeast infection) due to Candida species.

Dosage & Administration

Dosing by Condition

Vulvovaginal candidiasis: Insert/apply one applicatorful (~5 g) of 2% cream intravaginally once daily at bedtime for 7 consecutive days.

Initial Dose

One applicatorful (approximately 5 g) intravaginally once daily at bedtime

Maintenance Dose

One applicatorful (approximately 5 g) intravaginally once daily at bedtime for 7 days

Maximum Dose

One applicatorful intravaginally once daily (typically at bedtime) for the labeled course (commonly 7 days for 2% cream).

Children's Dosage

Approved for use in children 12 years of age and older.

Dose Adjustment Notes

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

How to Take

At bedtime, fill the provided applicator with the 2% cream (to the marked line), insert the applicator high into the vagina as far as comfortably possible while lying on your back with knees bent, depress the plunger to deliver the dose, then withdraw; wash hands before/after use and follow the leaflet for applicator cleaning/disposal; consider a panty liner for possible leakage.

Safety & Warnings

Contraindications

Hypersensitivity to miconazole (miconazole nitrate) or to any excipient/component of the formulation.

Warnings & Precautions

May damage latex condoms/diaphragms (use alternative contraception during treatment and shortly after); discontinue if significant irritation or hypersensitivity occurs; avoid contact with eyes and do not use orally; seek medical evaluation if fever, pelvic/abdominal pain, foul-smelling discharge, symptoms persist after treatment, or recur frequently; patients on warfarin should be monitored for bleeding/INR changes.

Age Restriction

Not recommended for self-use in children <12 years; use only under medical supervision.

Drug Interactions

Drug Interactions

Warfarin/other coumarin anticoagulants (may increase anticoagulant effect/bleeding risk); consider caution with oral hypoglycemics (rarely enhanced effect).

Interaction Severity

MAJOR: Warfarin/other coumarin anticoagulants (increased INR/bleeding risk-avoid if possible or monitor INR closely). Other interactions (e.g., phenytoin, oral hypoglycemics) are theoretically possible via CYP inhibition but are generally less clinically significant with vaginal use than with systemic azoles.

Food Interaction

No restriction.

Special Populations

Children

Approved for use in children 12 years of age and older.

Elderly

Standard adult dosing.

Kidney Impairment

No adjustment needed.

Liver Impairment

No adjustment needed.

Storage & Patient Advice

Stopping the Medicine

Complete the full prescribed course even if symptoms improve earlier; seek medical advice if symptoms persist after completing therapy or recur soon after.

Patient Counseling

Use one applicatorful nightly for 7 days and complete the course even if symptoms improve or menses starts; avoid tampons, douching, and other intravaginal products during treatment; the cream can weaken latex condoms/diaphragms-avoid sex or use non-latex protection during treatment and for several days after; seek medical advice if no improvement within ~3 days, symptoms persist beyond 7 days, recur soon, or if pregnant/first episode/fever pelvic pain or foul discharge; tell your clinician if using warfarin due to bleeding risk.

Monitoring Requirements

No routine monitoring required; patients on warfarin should have INR monitored

Pharmacology

Mechanism of Action

Inhibits fungal 14α-demethylase (CYP450-dependent), blocking ergosterol synthesis and disrupting fungal cell membrane integrity/permeability.

Duration of Effect

Clinical effect is expected to build over the treatment course; symptom control may persist after completion, but there is no single fixed 'duration' beyond completing the full 7-day regimen.

Half-Life

Not clinically established/meaningful for vaginal miconazole; when measurable after systemic exposure, reported terminal t½ is ~20-25 hours.

Bioavailability

Low systemic absorption after intravaginal use (generally <2%).

Metabolism

Hepatic metabolism when systemically absorbed, primarily via CYP3A4 (and CYP2C9) inhibition/interaction potential.

Excretion

For the small absorbed fraction, elimination is mainly via feces (biliary) with minimal renal excretion.

Product Information

Available Dosage Forms

Cream (intravaginal/vaginal cream).

Composition per Dose

Each gram of cream: 20 mg miconazole nitrate (2% w/w)

Generic Availability

Yes

OTC Alternatives

Clotrimazole vaginal products (cream/tablets) and tioconazole vaginal ointment are common OTC alternatives; oral fluconazole 150 mg is an alternative where available OTC/behind-the-counter depending on local regulation.

Application

Vaginal

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