Gino-Pevaril

General characteristics. Structure:

Active agent: an ekonazola nitrate – 50 mg, 150 mg.

Excipients: solid fat (type A and type B).

Pharmacological properties:

Pharmacodynamics. Ekonazola nitrate possesses a broad spectrum of activity and is active concerning dermatophytes, yeast and mold mushrooms. It also has clinically significant activity against gram-positive bacteria. Ekonazola nitrate damages cellular membranes that leads to increase in permeability of a fungal cell. A target for an ekonazol are acylic groups of the unsaturated fatty acids which are a part of membrane phospholipids.

Pharmacokinetics. Ekonazola nitrate is poorly soaked up, after introduction to a vagina about 5% of the entered dose are absorbed. The maximum concentration of an ekonazol and/or its metabolites in blood are observed for 1-2 day after use and reach 15 ng/ml for suppositories with a dosage of 50 mg and 65 ng/ml for suppositories with a dosage of 150 mg. Ekonazol and/or his metabolites strongly contact serum proteins (98%). Ekonazol is exposed to active metabolism by oxidation, deamination, and O-dealkylation, its metabolites are removed by kidneys and through intestines.

Indications to use:

Gino-Pevaril is shown for treatment of vulvovaginal mycoses.

Route of administration and doses:

Intravaginalno.

Suppositories on 50 mg.

Vaginal suppository is entered deeply into a vagina, in a prone position, just before a dream within not less than 14 days. It is necessary to conduct a full course of treatment, despite disappearance of subjective symptoms (an itch, bleach).

Suppositories on 150 mg.

Vaginal suppository is entered deeply into a vagina, in a prone position, just before a dream within 3 days. In case of a recurrence or a positive take of a cultural research in 1 week after the carried-out treatment conduct the second year of treatment.

Features of use:

Drug is intended only for intravaginalny use. It is not intended for intake.

At accidental hit of drug in eyes it is necessary to wash out immediately them clear water or hydrochloric solution and, in case of need, to ask for medical care.

Simultaneous use of latex condoms or diaphragms and vaginal anti-infectious drugs can reduce efficiency of latex barrier contraceptives. For this reason Gino-Pevaril is not recommended to use along with a diaphragm or condom. The patients using spermicidal contraceptives have to consult to the doctor as the drugs accepted for intravaginalny introduction can inactivate a spermicidal contraceptive.

Gino-Pevaril it is not necessary to apply in combination with other drugs for treatment of diseases of genitalias appointed inside or outwardly.

In case of the expressed irritation or hypersensitivity treatment by Gino-Pevaril needs to be stopped.

At the patients sensitive to imidazoles, hypersensitivity and to an ekonazol to nitrate is possible.

Side effects:

At Gino-Pevaril's use it can be observed local irritation, burning sensation, an itch, an erythema, rash. Separate cases of emergence of allergic reactions, such as a Quincke's disease and a small tortoiseshell are known.

Side effects of drug are systematized on bodies and frequency of emergence with use of the following classification:

- very often (> 1/10),

- often (> 1/100, <1/10),

- infrequently (> 1/1000, <1/100),

- seldom (> 1/10000, <1/1000),

- very seldom (<1/10000), including isolated cases.

From immune system:

- very seldom: hypersensitivity.

From skin and hypodermic fabrics: 

- very seldom: Quincke's disease, small tortoiseshell, contact dermatitis, skin peeling, erythema.

The general frustration and reactions in an injection site:

- very seldom: pain, irritation and hypostasis in an injection site.

Interaction with other medicines:

Ekonazol is inhibitor of an isoenzyme CYP3A4/2C29. However, in view of that drug is poorly soaked up in a system blood stream, emergence of clinically significant interactions is improbable, though took place at reception of peroral anticoagulants. The patients accepting indirect anticoagulants, such as warfarin and аценокумарол have to be careful and watch parameters of coagulability of blood.

Contraindications:

Hypersensitivity to any of drug components.

Children's age up to 16 years.

With care:

Data on Gino-Pevaril's use for elderly persons (65 years are more senior) are insufficient.

Overdose:

So far data on overdose are not available. At accidental administration of drug inside there can be nausea, vomiting and diarrhea. In such cases if necessary it is necessary to carry out symptomatic therapy.

Storage conditions:

To store at a temperature from 15 to 30 °C . To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Suppositories of 50 mg.

On 5 suppositories in the blister from PVC and polyethylene of low density. 3 blisters place in a cardboard pack with the enclosed application instruction.

Suppositories of 150 mg.

On 3 suppositories in the blister from PVC and polyethylene of low density. 1 blister is placed in a cardboard pack with the enclosed application instruction.