Colposeptin (Colposeptine)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspvaginal tablets
Composition:

1 tablet contains: active ingredients: progestrin 10,00 mg, chlorohinalald 200,00 mg; Excipients: lactose monohydrate 582.00 mg, microcrystalline cellulose 300.00 mg, magnesium stearate 6.00 mg. Boric acid 100.00 mg, sodium lauryl sulfate 2.00 mg.

Description:Flat oblong tablets with beveled edges from light yellow to yellow with a brownish or pinkish hue; on the surface of the tablets, marble is allowed.
Pharmacotherapeutic group:Estrogen + antimicrobial agent - oxyquinoline
ATX: & nbsp
  • Estrogens in combination with other drugs
    • Pharmacodynamics:Colposseptin - a combined preparation containing as active ingredients promestrien and chlorohinaldol. Promestiren is a synthetic estrogen-like substance. With topical application it promotes the processes of proliferation of the vaginal epithelium, restoration of normal microflora and physiological pH in the vagina. Chlorhinaldol is an antibacterial agent from the group of 8-hydroxyquinoline derivatives. Has antimicrobial, antiprotozoal and antifungal action. Active against Gram-negative and Gram-positive bacteria (Corynebacterium diphtheria, Streptococcus pyogenes, Staphylococcus aureus, Pseudomonas aeruginosa, Proteus vulgaris, Salmonella, Shigella, Escherichia coli), manifests activity in relation to the simplest (Entamoeba histolytica, Lamblia intestinalis, Trichomonas vaginalis), as well as yeast fungi (Candida) and dermatophytes (Trichophyton, Epidermophyton, Microsporum).
    Pharmacokinetics:

    After intravaginal administration, less than 1% of the progestinriene enters the systemic circulation. Progestrin does not accumulate in organs and tissues. With topical application, systemic hormonal effects are absent, including in estrogen-dependent organs. Promestrien is dealkylated to form two monoesters (3 and 17-beta), is unchanged or partially transformed into estradiol. The period of biological decay is less than 24 hours. Absorption of chlorohinaldol from the vagina is very low. After the introduction of vaginally, chlorohinaldol was not detected in blood plasma.

    Indications:

    - Atrophic vaginitis due to estrogen deficiency.

    - Nonspecific bacterial and candidal vaginitis.

    Contraindications:

    - Diagnosed estrogen-dependent malignant neoplasms (of the breast, uterus, ovaries or vagina) or suspicion of them.

    - The period of breastfeeding.

    - Simultaneous use with spermicides (see section "Interaction with other drugs").

    - Hypersensitivity to chlorohinaldol and promerestriene, and other components of the drug.

    - Bleeding from the genital tract of an unknown etiology.

    - Pregnancy.

    - Age to 18 years.

    Pregnancy and lactation:

    Adequate and controlled studies in pregnant women have not been conducted. Given the lack of data on the penetration of active substances through the placental barrier and into breast milk, the risk to the fetus or the child can not be ruled out. The use of the drug during pregnancy and breastfeeding is contraindicated.

    Dosing and Administration:

    Introduce one tablet (previously moistened with water) into the vagina at night for 18 days. Do not interrupt treatment during menstruation.

    Side effects:

    When applying the drug, the following adverse reactions are possible: irritation of the vaginal mucosa, burning and itching in the vagina, allergic reactions.

    If any of the unwanted reactions listed in the manual is aggravated, or if you notice any other undesirable reactions not listed in the instructions, tell your doctor.

    Overdose:

    When using the drug in accordance with the instructions for medical use, an overdose is unlikely.With excessive or prolonged use of the drug, local adverse reactions may be intensified (irritation, itching and burning in the vagina).

    Interaction:

    It is not recommended to use joint application with spermicides, since it is possible to inactivate their contraceptive effect.

    Special instructions:

    Before the beginning of treatment it is necessary to undergo a clinical and gynecological examination. It is necessary to monitor the doctor throughout the treatment period.

    In case of bleeding from the vagina (unclear etiology), a survey should be conducted.

    Chlorchinaldol is a halogenated hydroxyquinoline. There are cases of cross-allergic reaction with other halogenated hydroxyquinolines - clioquinol.

    If clinical signs of infection persist after completion of treatment, a second microbiological study should be conducted to confirm the diagnosis. If unwanted reactions appear, discontinue use and consult a doctor. During treatment it is recommended to abstain from sexual intercourse. Do not use vaginal pills inside.

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

    The drug does not affect the ability to drive vehicles or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:

    Tablets are vaginal, 10 mg + 200 mg.

    Packaging:

    6 tablets per blister from PA / Al/ PE // Al/ PE. For 3 blisters together with instructions for use in a cardboard box.

    Storage conditions:

    Store at a temperature not exceeding 25 ° 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:LP-004606
    Date of registration:21.12.2017
    Expiration Date:21.12.2022
    The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel
    Manufacturer: & nbsp
    Representation: & nbspTeva Teva Israel
    Information update date: & nbsp24.01.2018
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