Active substanceClindamycinClindamycin
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  • Dosage form: & nbspgel for external use
    Composition:

    1 g of gel contains:

    active substance: clindamycin (in the form of clindamycin phosphate) 10 mg;

    Excipients: carbomer 8.0 mg, macrogol 100.0 mg, propylene glycol 50.0 mg, allantoin 2.0 mg, methyl parahydroxybenzoate 3.0 mg, sodium hydroxide to pH 5.3-5.7, water to 1000 mg.

    Description:

    A thick clear colorless gel.

    Pharmacotherapeutic group:Antibiotic-Lincosamide
    ATX: & nbsp

    J.01.F.F.01   Clindamycin

    Pharmacodynamics:

    Clindamycin phosphate is a semisynthetic antibiotic from the group of lincosamides, is a phosphate ester of clindamycin, a derivative of lincomycin.

    Clindamycin is inactive in vitro, but on the surface of the skin, under the influence of hydrolases undergoes rapid hydrolysis into the active form - clindamycin.

    Clindamycin acts bacteriostatically on Gram-positive aerobic bacteria, as well as on many anaerobic bacteria.

    Clindamycin in conditions in vitro inhibits the growth of all colonies Propionibacterium acnes. Inhibits the synthesis of proteins in a microbial cell due to interaction with 50Ssubunits of the ribosomes.

    Clindamycin, inhibiting reproduction Propionibacterium acnes, reduces the release of fatty acids, which in turn inhibits chemotaxis and this leads to the suppression of inflammatory processes.

    Pharmacokinetics:

    Clindamycin rapidly accumulates in comedones, where it exhibits antibacterial activity. The average concentration of antibiotic in the contents of comedones after application of the gel is significantly higher than the minimum inhibitory concentration for all strains Propionibacterium acnes - causative agent of acne. After applying the clindamycin gel to the skin in the blood plasma and urine, very low concentrations of clindamycin are detected.

    Indications:Klindatop is intended for the treatment of mild to moderate forms of acne.
    Contraindications:

    Hypersensitivity to the components of the drug, hypersensitivity to lincomycin in history, Crohn's disease, ulcerative and pseudomembranous (antibiotic-associated) colitis (including in the anamnesis).

    Children under 12 years.

    Carefully:Pregnancy, lactation.
    Pregnancy and lactation:

    Use in pregnancy and lactation is possible only if the potential benefit to the mother exceeds the potential risk to the fetus and the baby.

    Dosing and Administration:

    Outwardly.

    Gel a thin layer applied to the affected area of ​​the previously cleaned and dried skin 2-3 times a day. In the treatment of acne may take 12 weeks, before the full effectiveness of the drug will become apparent.

    Side effects:

    Allergic reactions (including skin rash, urticaria).

    Irritation (at the application site), contact dermatitis.

    Burning, itching, dry skin, erythema, scaling.

    With resorption, there is a possibility of development of systemic side effects, incl. in rare cases - pseudomembranous enterocolitis.

    Overdose:

    Data on overdose are absent.

    Interaction:

    Incompatible with aminoglycosides, ampicillin, calcium gluconate and magnesium sulfate.

    It shows antagonism with erythromycin.

    May enhance the effect of muscle relaxants, disrupting neuromuscular transmission.

    Incompatible with solutions containing a complex of B vitamins.

    Special instructions:

    It is necessary to avoid long-term use, as this increases the incidence of side effects and the resistance of bacteria to clindamycin may develop.

    Clindamycin, used externally, is absorbed into the body only to a small extent. In patients who have a history of colitis caused by the use of antibiotics, ulcerative and inflammatory bowel disease, Crohn's disease, it is necessary to consider the risk of developing possible undesirable side effects from the digestive system before beginning therapy.

    The use of clindamycin (as well as other antibiotics) orally or parenterally in a number of cases is associated with the development of pseudomembranous colitis. Pseudomembranous colitis can appear both on the background of long-term use, and 2-3 weeks after cessation of treatment; is manifested by diarrhea, leukocytosis, fever, abdominal pain (sometimes accompanied by discharge with mucous masses of blood and mucus).If these phenomena occur in mild cases, it is sufficient to cancel the treatment and apply ion-exchange resins (colestramine, colestipol), in severe cases, compensation for loss of fluid, electrolytes and protein, the appointment of vancomycin inwards or metronidazole is indicated. Do not use drugs that inhibit the intestinal motility.

    Clindamycin may exhibit cross-resistance to lincomycin and erythromycin.

    Avoid contact with the eyes and mucous membranes of the nose and mouth, as well as the wound skin surface.

    In case of accidental contact with the eyes or mucous membranes, rinse them with plenty of cold water.

    After prolonged use clindamycin may be present in serum and urine in small concentrations.

    Long-term treatment with clindamycin in elevated doses can lead to an increase in insensitive flora.

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

    Data on the adverse effects of the drug on the ability to control vehicles and mechanisms are not available.

    Form release / dosage:

    Gel for external use, 1%.

    Packaging:

    For 15 g or 30 g of gel in sealed aluminum tubes with a protective membrane and a varnished inner surface.

    The tube is placed in a cardboard box together with instructions for use.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Do not store in the refrigerator and do not freeze.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Shelf life after the first opening of the package is 12 months.

    Do not use after expiry date.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-001432
    Date of registration:12.01.2012 / 24.10.2013
    Expiration Date:12.01.2017
    The owner of the registration certificate:VALEANT, LLC VALEANT, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspVALEANT LLC VALEANT LLC Russia
    Information update date: & nbsp28.01.2018
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