Active substanceClindamycinClindamycin
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  • Dosage form: & nbspCream vaginal
    Composition:

    1 g of cream contains:

    active substance: clindamycin phosphate in terms of 100% of the substance - 20 mg;

    Excipients: sodium benzoate 40 mg, castor oil 100 mg, propylene glycol 440 mg, emulsifier EM 3398 100 mg, macrogol-1500 300 mg.

    Description:

    Cream from white to white with a yellowish or kremovatym color shade.

    A weak specific odor is allowed.

    Pharmacotherapeutic group:Antibiotic-Lincosamide
    ATX: & nbsp

    J.01.F.F.01   Clindamycin

    Pharmacodynamics:

    Antibiotic group of lincosamides for vaginal use. The mechanism of action of the drug is associated with a violation of intracellular protein synthesis in the microbial cell at level 50S subunit of ribosomes.

    Clindamycin has a broad spectrum of action, bacteriostatic effect, in higher concentrations against some microorganisms - bactericidal. Active against microorganisms that cause bacterial vaginosis: Gardnerella vaginalis, Mobiluncus spp., Bacteroides spp., Mycoplasma hominis, Peptostreptococcus spp. To clindamycin are not sensitive Trichomonas vaginalis and Candida albicans.

    Pharmacokinetics:

    After a single intravaginal injection of 100 mg of clindamycin, an average of 4% of the administered dose is systemically absorbed. The maximum concentration of clindamycin in blood plasma is 20 ng / ml.

    Indications:Bacterial vaginosis caused by microorganisms that are sensitive to the drug.
    Contraindications:

    Hypersensitivity to clindamycin or lincomycin.

    Pregnancy and lactation:

    Clinical studies on the use of clindamycin in women in the first trimester pregnancy was not carried out, so the use of the drug is possible only if the expected benefit for the mother exceeds the risk to the fetus.

    Application in the II and III trimesters pregnancy is possible, as there is no adverse effect on the fetus.

    It is not known whether clindamycin with mother's milk in case of intravaginal application, therefore it is necessary to compare the benefits of using the drug during the period of breastfeeding and the possible risk for the baby.

    Dosing and Administration:

    Introduced intravaginally with the help of an applicator.

    The recommended single dose is 100 mg of clindamycin (one complete applicator), preferably at bedtime for 3-7 days.

    Instructions for using the applicator:

    Disposable applicators attached to the package are designed to accurately dispense and inject the cream of Clindacin® into the vagina.

    1. Open the tube with the cream, taking off the cap. Puncture the tuba membrane with the back of the cap. Screw the plastic applicator onto the threaded neck of the tube.

    2. Gently pushing the tube from the opposite end, gently squeeze the cream into the applicator. The applicator piston moves independently as the required volume is filled. The applicator is full when the piston comes to a stop. Unscrew the applicator and close the tube with a cap.

    3.In the supine position on your back, pull your knees to your chest. Hold the applicator horizontally, carefully enter it into the vagina as deeply as possible, trying not to cause unpleasant sensations.

    4. Slowly pressing the piston against the stop, enter the entire volume of the cream into the vagina.

    5. Carefully remove the applicator from the vagina and throw it into the garbage can.

    Side effects:

    Possible the development of allergic reactions, the appearance of irritation at the injection site, cervicitis, vaginitis, vulvovaginal candidiasis.

    Overdose:

    In case of intravaginal application of the drug, an overdose is not established.

    Interaction:

    Between clindamycin and erythromycin an antagonistic interaction was noted.

    There is cross-resistance between clindamycin and lincomycin.

    Special instructions:

    With prolonged use of the drug, excessive growth of microorganisms insensitive to it is possible, especially fungi of the genus Candida.

    Given the possibility of minimal systemic absorption of the drug (approximately 4%), it can not be ruled out that there is a diarrhea against the background of the drug. In this case, the drug should be canceled.

    It is not recommended to be used simultaneously with other intravaginal agents.

    The efficacy and safety of clindamycin for intravaginal use in children has not been established.

    Form release / dosage:

    Vaginal cream 2%.

    Packaging:

    By 20 or 40 g in an aluminum tube. Each 20 g tube, together with 3 applicators and instructions for use or a 40 g tube, together with 7 applicators and instructions for use, are placed in a pack of cardboard.

    Storage conditions:

    In the dark place at a temperature of no higher than 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:P N000956 / 01
    Date of registration:26.10.2007 / 30.12.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia
    Manufacturer: & nbsp
    Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia
    Information update date: & nbsp28.01.2018
    Illustrated instructions
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