Active substanceMetronidazoleMetronidazole
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  • Dosage form: & nbspgspruce for external use
    Composition:

    1 gram of gel contains:

    Active substance: metronidazole - 10.0 mg.

    Excipients: disodium edetate 0.50 mg, carbomer 940 10.0 mg, methyl parahydroxybenzoate 0.32 mg, sodium hydroxide 1.27 mg, propyl parahydroxybenzoate 0.40 mg, propylene glycol 50.0 mg, purified water - sk. required up to 1 g.

    Description:ABOUTUnconventional gel from colorless to yellow.
    Pharmacotherapeutic group:Antimicrobial and antiprotozoal drug
    ATX: & nbsp

    P.01.A.B   Nitroimidazole derivatives

    P.01.A.B.01   Metronidazole

    Pharmacodynamics:

    Antiprotozoal and antimicrobial drug, a derivative of 5-nitroimidazole. The mechanism of action is the biochemical reduction of the 5-nitro group of metronidazole by intracellular transport proteins of anaerobic microorganisms and protozoa. The reduced 5-nitro group of metronidazole reacts with the DNA of a cell of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria.

    Active with respect to Trichomonas vaginalis, as well as Gram-negative anaerobes Bacteroides spp. (incl. Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp. and some Gram-positive microorganisms (sensitive strains Eubacterium spp., Clostridium spp., Peptococcus spp., Peptostreptococcus spp.). The MIC for these strains is 0.125-6.25 μg / ml.

    With external application has anti-acne action, the mechanism of which is precisely unknown (not related to the action on the mite Demodex folliculorum, found in the hair follicles and the secretion of the sebaceous glands, and any influence on the production of this secret).

    Metronidazole for external use may have antioxidant activity.It is established that it significantly reduces the production of active oxygen, hydroxyl radicals and hydrogen peroxide by neutrophils, which are potential oxidants capable of causing tissue damage at the site of inflammation. Metronidazole for external use is ineffective against telangiectasias seen in rosacea.

    Metronidazole is insensitive to aerobic microorganisms and facultative anaerobes, but in the presence of mixed flora (aerobes and anaerobes) metronidazole acts synergistically with antibiotics effective against conventional aerobes.

    Pharmacokinetics:

    Absorption is minimal, after external application in the serum only trace amounts of the drug are detected. Sucked metronidazole passes through the placenta and the blood-brain barrier (BBB). FROMmOh - up to 66 ng / ml (when applying 1 g of gel equivalent to 7.5 mg of metronidazole).

    Indications:

    Pink acne (including post-steroids), acne vulgaris, infectious skin diseases, trophic ulcers of the lower extremities (against varicose veins, diabetes mellitus), flaccid wounds, bedsores, burns, eczema, seborrhoeic eczema, oily seborrhea, seborrheic dermatitis , hemorrhoids, fissures of the anus.

    Contraindications:

    Hypersensitivity to the components of the drug, as well as to a derivative of nitroimidazole.

    Pregnancy and lactation:

    It is not recommended to prescribe the drug to pregnant women in the first trimester of pregnancy.

    During the lactation period, if the drug is to be prescribed, the question of stopping breastfeeding should be resolved.

    Dosing and Administration:

    For external use.

    Apply to the pre-cleaned skin with a thin layer 2 times a day, in the morning and in the evening, for 3-9 weeks. If necessary, an occlusive bandage is applied. The average duration of treatment is 3-4 months, the therapeutic effect is usually observed after 3 weeks of treatment.

    Side effects:

    With local application, the concentration of metronidazole in the blood is very low, so the risk of developing systemic side effects is small.

    Rarely can be observed: allergic reactions (skin rash, itching, urticaria); hyperemia, peeling and burning of the skin, lacrimation (if the gel is applied close to the eyes).

    Overdose:

    Cases of drug overdose in the recommended doses for this method of administration were not observed.

    Interaction:With simultaneous application increases the effect of warfarin and other indirect anticoagulants (increases prothrombin time).
    Special instructions:Do not apply on the mucous membrane of the eyes or near the eyes (may cause lacrimation). In case of contact with the gel, they should be washed immediately with plenty of water.
    Effect on the ability to drive transp. cf. and fur:

    The drug does not affect the ability to drive and maintain moving mechanical equipment.

    Form release / dosage:

    Gel for external use, 1%.

    Packaging:

    By 30 grams into an aluminum tube, the neck of which is sealed with an aluminum membrane and with a screw cap made of polyethylene with a lip for perforating the membrane. One tube in a cardboard box together with instructions for use.

    By 30 grams into a plastic laminated tube, the neck of which is sealed with aluminum foil, laminated with polyethylene and with a screw cap made of polypropylene with a projection (or without a lip) for perforating the foil. One tube in a cardboard box together with instructions for use.

    Storage conditions:

    At a temperature of no higher than 30 ° C. Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N011666 / 02
    Date of registration:21.02.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:Unik Pharmaceutical Laboratories Unik Pharmaceutical Laboratories India
    Manufacturer: & nbsp
    Representation: & nbsp"UNIC PHARMACEUTICAL LABORATORY (branch of the company" JB Chemicals and Pharmaceuticals Ltd. ")""UNIC PHARMACEUTICAL LABORATORY (branch of the company" JB Chemicals and Pharmaceuticals Ltd. ")"India
    Information update date: & nbsp11.05.2018
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