Gyno-Pevaryl^® (Suppositories) Instructions for Use

Marketing Authorization Holder

Johnson & Johnson, LLC (Russia)

Manufactured By

Xian-Janssen Pharmaceutical, Ltd. (China)

ATC Code

G01AF05 (Econazole)

Active Substance

Econazole (Rec.INN registered by WHO)

Dosage Forms

	Gyno-Pevaryl®	Vaginal suppositories 50 mg: 15 pcs.
		Vaginal suppositories 150 mg: 3 pcs.

Dosage Form, Packaging, and Composition

Vaginal suppositories from white to almost white, torpedo-shaped, with a fatty odor.

Excipients: hard fat (type A and B).

3 pcs. – blisters (1) – carton packs.

Vaginal suppositories from white to almost white, torpedo-shaped, with a fatty odor.

Excipients: hard fat (type A and B).

5 pcs. – blisters (3) – carton packs.

Clinical-Pharmacological Group

A drug with antifungal action for topical use in gynecology

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Econazole nitrate has a broad spectrum of action and is active against dermatophytes, yeasts, and molds. It also has clinically significant activity against gram-positive bacteria. Econazole nitrate damages cell membranes, leading to increased permeability of the fungal cell. The target for econazole is the acyl groups of unsaturated fatty acids that are part of membrane phospholipids.

Pharmacokinetics

Econazole nitrate is poorly absorbed; after intravaginal administration, about 5% of the administered dose is absorbed. The C_max of econazole and/or its metabolites in the blood is observed on days 1-2 after application and reaches 15 ng/ml for suppositories with a dosage of 50 mg and 65 ng/ml for suppositories with a dosage of 150 mg.

Econazole and/or its metabolites are strongly bound to serum proteins (98%). Econazole undergoes active metabolism by oxidation, deamination, and O-dealkylation; its metabolites are excreted by the kidneys and through the intestines.

Indications

• Treatment of vulvovaginal mycoses.

ICD codes

Dosage Regimen

Intravaginally.

Suppositories 50 mg

The vaginal suppository is inserted deep into the vagina, in a lying position, immediately before bedtime for at least 14 days. It is necessary to complete the full course of treatment, despite the disappearance of subjective symptoms (itching, leucorrhea).

Suppositories 150 mg

The vaginal suppository is inserted deep into the vagina, in a lying position, immediately before bedtime for 3 days.

In case of recurrence or a positive culture result 1 week after the completed treatment, a second course of treatment is carried out.

Adverse Reactions

When using Gyno-Pevaryl^®, local irritation, burning sensation, itching, erythema, and rash may very rarely occur. Isolated cases of allergic reactions, such as angioedema and urticaria, have been reported.

Contraindications

• Hypersensitivity to any component of the drug;
• Children under 16 years of age.

With caution. Data on the use of Gyno-Pevaryl^® in elderly persons (over 65 years of age) are insufficient.

Use in Pregnancy and Lactation

Pregnancy

Gyno-Pevaryl^® can be absorbed from the vagina into the systemic circulation, so it should not be used during the first trimester of pregnancy unless the doctor decides that treatment with this drug is important for the patient’s health. During the second and third trimesters of pregnancy, Gyno-Pevaryl^® can be used if its potential benefit to the woman outweighs the possible risk to the fetus.

Lactation

It is not known whether econazole nitrate passes into breast milk. The drug should be used with caution during breastfeeding.

Pediatric Use

Contraindicated in children under 16 years of age.

Geriatric Use

Since data on the use of Gyno-Pevaryl^® in elderly persons (over 65 years of age) are insufficient, the drug should be used with caution.

Special Precautions

Concomitant use of latex condoms or diaphragms and vaginal anti-infective drugs may reduce the effectiveness of latex barrier contraceptives. For this reason, Gyno-Pevaryl^® is not recommended for use simultaneously with a diaphragm or condom. Patients using spermicidal contraceptives should consult their doctor, as drugs prescribed for intravaginal administration may inactivate the spermicidal contraceptive.

Gyno-Pevaryl^® should not be used in combination with other drugs for the treatment of genital diseases, administered orally or externally.

In case of severe irritation, treatment with Gyno-Pevaryl^® should be discontinued.

In patients sensitive to imidazoles, hypersensitivity to econazole nitrate is possible. The drug is not intended for oral administration.

Effect on the ability to drive vehicles and operate machinery.

Does not affect the ability to drive vehicles and operate machinery.

Overdose

There is no information on overdose to date. If the drug is accidentally ingested, nausea, vomiting, and diarrhea may occur. In such cases, symptomatic therapy should be carried out if necessary.

Drug Interactions

Appropriate studies have not been conducted. Given the chemical similarity of econazole to imidazole derivatives, there is a possibility of competitive interaction of econazole nitrate with substances metabolized by CYP3A4/2C29 enzymes. However, considering that the drug is poorly absorbed into the systemic circulation, the occurrence of clinically significant interactions is unlikely. Patients taking oral anticoagulants such as warfarin and acenocoumarol should exercise caution and monitor blood coagulation parameters.

Storage Conditions

Store the drug at a temperature between 15°C and 30°C (86°F). Keep out of reach of children.

Shelf Life

Shelf life – 5 years. Do not use after the expiration date.

Dispensing Status

The drug is dispensed by prescription.

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.