Gino-Pevaril® (Gyno-Pevaryl®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceEconazoleEconazole
Similar drugsTo uncover
  • Gino-Pevaril®
    suppositories the vagina. 
    Johnson & Johnson, LLC     Russia
  • Ifenek
    solution externally 
    Italfarmaco SpA     Italy
  • Ifenek
    powder externally 
    Italfarmaco SpA     Italy
  • Ifenek
    suppositories the vagina. 
    Italfarmaco SpA     Italy
  • Ifenek
    cream externally 
    Italfarmaco SpA     Italy
  • Ecodax®
    cream externally 
    Unik Pharmaceutical Laboratories     India
    • Dosage form: & nbspVaginal suppositories
    Composition:

    1 suppository vaginal contains:

    Active substance: econazole nitrate - 50 mg, 150 mg

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

    Description:

    Suppositories from white to almost white, torpedo-shaped.

    Pharmacotherapeutic group:Antifungal agent
    ATX: & nbsp

    G.01.A.F.05   Econazole

    Pharmacodynamics:

    Econazole nitrate has a wide spectrum of action and is active against dermatophytes, yeasts and mold fungi. It also has clinically significant activity against gram-positive bacteria. Econazole nitrate damages the cell membranes, which leads to an increase in the permeability of the fungal cell. The target for econazole is acyle groups unsaturated fatty acids, which are part of membrane phospholipids.

    Pharmacokinetics:

    Econazole nitrate is poorly absorbed, after injection into the vagina about 5% of the administered dose is absorbed.Maximum concentrations of econazole and / or its metabolites in the blood are observed 1-2 days 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.

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

    Indications:

    Gino-Pevaril® is indicated for the treatment of vulvovaginal mycoses.

    Contraindications:

    Hypersensitivity to any of the components of the drug.

    Children under 16 years old

    Carefully:Data on the use of Gino-Pevaril in elderly people (over 65) are not sufficient.
    Pregnancy and lactation:

    Pregnancy

    Gino-Pevaril® can be absorbed from the vagina into the systemic bloodstream, so it should not be used during the first trimester of pregnancy, unless the doctor decides that treatment with this drug is important to the patient's health. During the second and third trimesters of pregnancy, Gno-Pevaril® can be used if its potential benefit to a woman exceeds the possible risk to the fetus.

    Lactation

    It is not known whether econazole nitrate penetrates breast milk. During breastfeeding, the drug should be used with caution.

    Dosing and Administration:

    Intravaginal.

    Suppositories of 50 mg

    The vaginal suppository is injected deep into the vagina, in the supine position, just before bedtime for at least 14 days. It is necessary to conduct a full course of treatment, despite the disappearance of subjective symptoms (itching, burning).

    Suppositories of 150 mg

    The vaginal suppository is injected deep into the vagina, in the supine position, just before bedtime for 3 days.

    In case of a relapse or positive result of culture 1 week after the treatment, a second course of treatment is performed.

    Side effects:

    When applying Gino-Pevaril, local irritation, burning sensation, itching, erythema, rash can be observed. There are some cases of allergic reactions, such as angioedema and urticaria.

    Side effects of the drug are systematized according to the organs and frequency of occurrence using the following classification: very often (≥1/10), often (≥1/100, <1/10), infrequently (≥ 1/1000, <1/100), rarely (≥ 1/10000, <1/1000), very rarely (<1/10000), including isolated cases.

    From the immune system:

    Very rarely: hypersensitivity.

    From the skin and subcutaneous tissues:

    Very rarely: angioedema, hives, contact dermatitis, skin peeling, erythema.

    General disorders and reactions at the site of administration:

    Very rarely: pain, irritation and swelling at the injection site.

    Overdose:

    Up to now, there is no information on overdose. If the drug is taken orally, nausea, vomiting, and diarrhea may occur. In such cases, if necessary, should be symptomatic therapy.

    Interaction:

    Econazole is an inhibitor of the isoenzyme CYP3A4 / 2C29. However, taking into account that the drug is slightly absorbed into the systemic significant interactions are unlikely, although there was a case of taking oral anticoagulants. Patients taking indirect anticoagulants, such as warfarin and acenocoumarol, should be careful and monitor the parameters of blood coagulability.

    Special instructions:

    The drug is intended for intravaginal use only. Not is intended for oral administration.

    In case of accidental contact with the eyes, immediately wash them with clean water or brine and, if necessary, seek medical help. Simultaneous use of latex condoms or diaphragms and vaginal anti-infective drugs may reduce the effectiveness of latex barrier contraceptives. For this reason, it is not recommended to use Gino-Pevaril® at the same time as the diaphragm or condom. Patients who use spermicidal contraceptives should consult their physician, since drugs taken for intravaginal administration can inactivate the spermicidal contraceptive.

    Gino-Pevaril® should not be used in combination with other drugs for the treatment of genital diseases, appointed internally or externally.

    In case of severe irritation or hypersensitivity, treatment with Gino-Pevaril should be stopped.

    Patients sensitive to imidazoles may also have an increased sensitivity to econazole nitrate.

    Effect on the ability to drive transp. cf. and fur:

    Does not affect the ability to drive vehicles.

    Form release / dosage:

    Suppositories 50 mg, 150 mg.

    Packaging:

    Suppositories 50 mg.

    For 5 suppositories in a blister of PVC and polyethylene lowth density. 3 blisters are placed in a cardboard box with a nested instruction for use.

    Suppositories 150 mg.

    By 3 suppositories in a blister of PVC and low density polyethylene. 1 blister is placed in a cardboard box with a nested instruction for use.

    Storage conditions:

    Store at temperatures between 15 and 30 ° C. Keep out of the reach of children.

    Shelf life:

    3 years. Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N013579 / 01
    Date of registration:25.01.2008 / 02.12.2009
    Expiration Date:Unlimited
    The owner of the registration certificate:Johnson & Johnson, LLC Johnson & Johnson, LLC Russia
    Manufacturer: & nbsp
    CILAG, AG Switzerland
    Representation: & nbspJohnson & Johnson LLC Johnson & Johnson LLC Russia
    Information update date: & nbsp17.04.2017
    Illustrated instructions
      Instructions
      Up