Gynoconazole (Suppositories) Instructions for Use

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

G01AF05 (Econazole)

Active Substance

Econazole (Rec.INN WHO registered)

Dosage Forms

	Gynoconazole	Vaginal suppositories 50 mg: from 1 to 100 pcs.
		Vaginal suppositories 150 mg: from 1 to 100 pcs.

Dosage Form, Packaging, and Composition

Vaginal suppositories from white to almost white, torpedo-shaped, with a fatty odor; a longitudinal section of the suppository may show an air core and a funnel-shaped depression.

Excipients: hard fat (Witepsol grade H15, Suppocire grade NA15) – 890 mg, hard fat (Witepsol grade W35, Suppocire grade NAS50) – 1760 mg.

From 1 to 10 pcs. – contour cell packaging (from 1 to 10 pcs.) – cardboard packs.

Vaginal suppositories from white to almost white, torpedo-shaped, with a fatty odor; a longitudinal section of the suppository may show an air core and a funnel-shaped depression.

Excipients: hard fat (Witepsol grade H15, Suppocire grade NA15) – 857 mg, hard fat (Witepsol grade W35, Suppocire grade NAS50) – 1693 mg.

From 1 to 10 pcs. – contour cell packaging (from 1 to 10 pcs.) – cardboard packs.

Clinical-Pharmacological Group

A drug with antifungal action for topical use in gynecology

Pharmacotherapeutic Group

Antimicrobial agents and antiseptics used in gynecology; antimicrobial agents and antiseptics, except combinations with corticosteroids; imidazole derivatives

Pharmacological Action

Antifungal agent for topical and external use. Econazole is an imidazole derivative and has fungicidal and bactericidal action.

It inhibits the synthesis of ergosterol, which regulates the permeability of the microorganism cell wall. It is active against dermatophytes, yeasts, and molds: Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, Candida albicans, Torulopsis, Rhodotorula, Malassezia furfur (Pityrosporum orbiculare), which causes pityriasis versicolor, Corynebacterium, Epidermophyton floccosum, Aspergillus, Cladosporium, Scopulariopsis brevicautus and some gram-positive bacteria (streptococci, staphylococci and Nocardia minutissima).

Pharmacokinetics

When applied to the skin, systemic absorption is minimal and practically insignificant. Therapeutic concentrations are achieved in the epidermis (including the stratum corneum), as well as in the dermis.

With topical application, absorption is insignificant. After intravaginal administration, about 5% of the administered dose is absorbed. The C_max of econazole and/or its metabolites in blood plasma is observed on days 1-2 after application.

The binding of econazole and/or its metabolites to plasma proteins is 98%. Econazole undergoes active metabolism by oxidation, deamination, and O-dealkylation. Metabolites are excreted through the kidneys and through the intestines.

Indications

For topical use: vulvovaginal mycoses, fungal balanitis.

For external use: fungal infections of the skin, hair (including those complicated by superinfection with gram-positive bacteria); erythrasma; pityriasis versicolor; skin infections caused by gram-positive microorganisms.

ICD codes

Dosage Regimen

Select the appropriate suppository strength (50 mg or 150 mg) based on the prescribed therapeutic course.

For the 50 mg suppository: administer one suppository intravaginally at bedtime for 14 consecutive days.

For the 150 mg suppository: administer one suppository intravaginally at bedtime for 3 consecutive days.

Thoroughly wash and dry hands before handling the suppository. Remove the suppository from its individual blister packaging immediately before use.

Assume a reclining position. Insert the suppository deeply into the vagina using the finger or an applicator. Remain recumbent for a period after insertion to facilitate melting and absorption.

Complete the full prescribed course of treatment, even if symptoms resolve earlier, to prevent recurrence.

For external application to treat concomitant vulvar infections: apply a thin layer of an appropriate econazole topical cream to the affected area once or twice daily, as directed.

Concurrent treatment of the sexual partner with a suitable topical antifungal agent is mandatory to prevent reinfection.

Avoid contact with eyes and mucous membranes. Do not use intravaginal suppositories during menstruation. Use sanitary napkins to protect clothing from potential staining by the suppository base.

Adverse Reactions

Local reactions irritation, burning, itching, dry skin, pain, discomfort, swelling, erythema; with prolonged use – hypopigmentation, skin atrophy.

General reactions with intravaginal use – pelvic muscle spasm, headache.

Contraindications

Hypersensitivity to econazole; children and adolescents under 18 years of age (depending on the dosage form).

Econazole should not be applied to damaged skin areas.

Use in Pregnancy and Lactation

Use during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus. If use during lactation is necessary, the issue of discontinuing breastfeeding should be considered.

Pediatric Use

Use in children is possible according to indications, in recommended doses and dosage forms. It is necessary to strictly follow the instructions in the econazole drug leaflets regarding contraindications for the use of specific econazole dosage forms in children.

Special Precautions

When used externally in patients with eczema, anti-eczema therapy should be carried out before starting treatment. If there is no effect from the therapy within the recommended time frame, the diagnosis must be verified.

In vulvovaginal mycoses, treatment of the sexual partner is mandatory.

Avoid getting econazole preparations into the eyes, on mucous membranes, and on open wounds.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.