Active substanceSulfadiazineSulfadiazine
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    cream externally 
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    ointment externally 
    GRINDEX, JSC     Latvia
  • Dosage form: & nbsp
    Ointment for external use 1%.
    Composition:
    In 1 g of ointment contains:
    active ingredient: silver sulfadiazine -10 mg;
    auxiliary substances: Vaseline oil - 230 mg; propylene glycol 100 mg; cetostearyl alcohol - 60 mg; glyceryl monostearate 40-55 - 30 mg; polysorbate-80 - 20 mg; methylparahydroxybenzoate 0.80 mg; propyl parahydroxybenzoate 0.20 mg; purified water - up to 1 g.
    Description:Ointment is white or almost white, with a characteristic odor.
    Pharmacotherapeutic group:Antimicrobial agent, sulfonamide.
    ATX: & nbsp

    J.01.E   Sulfonamides and trimethoprim

    Pharmacodynamics:Sulfadiazine - a broad-spectrum antimicrobial bactericide that belongs to the group of sulfonamides. The drug is active against Gram-positive and Gram-negative bacteria Escherichia coli, Proteus spp., Staphylococcus spp., Klebsiella spp.
    The bactericidal properties of the ointment are due to the activity of silver ions, which are released in the wound as a result of the dissociation of the silver sulfadiazine salt; the release of silver ions is progressively (moderate dissociation), ensuring the consistency of the antimicrobial effect. The bactericidal activity of silver ions is supplemented by the bacteriostatic effect of sulfadiazine (also released during the dissociation of the silver sulfadiazine salt).
    The drug is characterized by moderate osmotic activity and does not possess necrolytic properties.
    Pharmacokinetics:
    When applied to the wound surface, approximately 10% of sulfadiazine and 1% of silver are absorbed into the peripheral and systemic bloodstream. Application to the extensive wound surface is accompanied by an increase in the concentration of sulfadiazine in the blood to 10-20 μg / ml.
    Indications:Treatment of infected burn wounds, pressure sores, abrasions, skin ulcers, transplanted skin areas; as well as to prevent their infection.
    Contraindications:Pregnancy, lactation, children under 1 year; expressed deficiency of glucose-6-phosphate dehydrogenase and hypersensitivity to sulfanilamide preparations. The drug should not be used to treat deep purulent wounds and burns with excessive exudation.
    Carefully:Renal / hepatic insufficiency, deficiency of glucose-6-phosphate dehydrogenase (risk of hemolysis development).
    Dosing and Administration:Outwardly. After surgical treatment of the wound and removal of necrotic tissue on the damaged surface, apply a thin layer (2-4 mm) of ointment (under the dressing or open method) 1-2 times a day.
    The application of the ointment on the skin is painless, ointment does not spoil clothes and underwear. The maximum single dose is 300 g. The treatment period is individual and depends on the nature of the disease and the effectiveness of the treatment used, in general cases lasts up to 3 weeks.
    If you forgot to apply the drug
    If you forget to use the drug, use as quickly as possible and continue to use as usual. Do not use a double dose if the previous time of the drug was missed.
    If you feel that the effect of the drug is too strong or weak, tell the doctor or pharmacist about it.

    Precautions for use
    In the treatment of patients with hepatic and / or renal insufficiency, it is necessary to regularly monitor the concentration of sulfanilamides in the plasma. Silver salts reacting with air oxygen, metals and other chemical components, especially with catalyzing thermal effects, darken, so the drug should be stored in a closed container and away from heat sources. Parts of the body treated with the drug are recommended to protect from direct sunlight.
    Side effects:
    Burning and itching at the application site, skin pigmentation disorder, skin allergic reactions, skin necrosis, erythema multiforme, interstitial nephritis, leukopenia, which is characterized mainly by a decrease in the number of neutrophils. The maximum decrease in the number of leukocytes is observed for 2-4 days after the start of treatment; the normalization of the number of leukocytes is observed for 2-4 days, while the continued treatment with the drug does not affect the recovery of the number of leukocytes.
    With long-term use on large wound surfaces: systemic side effects, characteristic of sulfanilamide, drugs, including. violation of hematopoiesis (agranulocytosis, aplastic and hemolytic anemia, thrombocytopenia, leukopenia), skin and allergic reactions, incl. Stevens-Johnson syndrome and exfoliative dermatitis; dyspepsia, hepatitis, hepatocellular necrosis, dysfunction of the central nervous system and toxic nephrosis.
    The degree of absorption of the drug depends on the size of the burn surface and the degree of tissue damage.
    Overdose:
    With prolonged treatment of extensive burns, sulfonamides can achieve the same plasma concentrations as in systemic treatment,which determines the symptoms of an overdose: nausea, impaired liver function, crystalluria, impaired renal function, and leukopenia. Treatment is symptomatic.
    Interaction:Active substance ointment sulfadiazine silver can inactivate enzyme preparations used to clean the wound, so the simultaneous use of these drugs is undesirable.
    Special instructions:Drugs should not be disposed of in sewers or together with household waste. Consult a pharmacist about how to destroy medicines that are no longer used. These measures help to protect the environment.
    Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
    Form release / dosage:
    Ointment for external use 1%.
    Packaging:
    50 g in an aluminum tube with an inner surface lacquered, with a protective aluminum membrane on the neck and a cone-shaped device for puncturing the membrane in a screwed-in Bushon made of plastic.The tube together with the instruction for use is placed in a pack of cardboard box.
    For hospitals 800 g in a plastic jar closed with a screw cap inner liner of cardboard laminated with a surface. Banks with instructions for use are placed in a group package.
    Storage conditions:Store the ointment in tubes at a temperature of no higher than 25 ° C. Ointment in sealed cans stored protected from light at a temperature not higher than 25 ° C. Do not freeze. Keep out of the reach of children.
    Shelf life:
    2 years.
    Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:Without recipe
    Registration number:П N010985 / 01
    Date of registration:01.03.2010
    The owner of the registration certificate:GRINDEX, JSC GRINDEX, JSC Latvia
    Manufacturer: & nbsp
    Representation: & nbspGrindeks Rus, Open CompanyGrindeks Rus, Open CompanyRussia
    Information update date: & nbsp27.08.2015
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