Active substanceSulfacetamideSulfacetamide
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  • Dosage form: & nbsp
    Eye drops.
    Composition:
    1 ml of the preparation contains:

    Active substance:

    Sulfacetamide sodium monohydrate
    (in terms of sodium sulfacetamide) 200 mg

    Excipients:

    Sodium thiosulfate pentahydrate 1 mg

    1M hydrochloric acid solution to pH 8.0

    Water for injections up to 1 ml
    Description:Transparent colorless or colored liquid.
    Pharmacotherapeutic group:Antimicrobial agent - sulfonamide.
    ATX: & nbsp

    A.07.A.B   Sulfonamides

    Pharmacodynamics:
    Antimicrobial bacteriostatic agent, sulfanilamide. The mechanism of action caused by a competitive antagonism with para-aminobenzoic acid, inhibition digidropteroatsintetazy, tetrahydrofolic acid synthesis disorder necessary for the synthesis of purines and pyrimidines.
    It is active against Gram-positive and Gram-negative cocci, Escherichia coli, Shigella spp., Vibrio cholerae, Clostridium perfringers, Bacillus anthracis, Corynebacterium diphtheriae, Yersinia pestis, Chlamydia spp., Actinomyces israelii, Toxoplasma gondii.
    Possible development of resistance to sulfacetamide.
    Pharmacokinetics:
    Penetrates into the eye tissue, where it exerts its specific antibacterial effect. Acts mainly locally, but part of the drug is absorbed through the inflamed conjunctiva and enters the systemic circulation. The amount of the drug falling into the systemic circulation is not enough to develop a systemic therapeutic effect, but it is sufficient for sensitization upon repeated administration. With topical application, the maximum concentration (Cmax) of sulfonamides in the cornea (about 3 mg / ml), the anterior chamber humidity (about 0.5 mg / ml) and the iris (about 0.1 mg / ml) is achieved in the first 30 minutes after application.Some amount (less than 0.5 mg / ml) is stored in the tissues of the eyeball for 3-4 hours. If the epithelium of the cornea is damaged, the penetration of sulfonamides is enhanced.
    Sulfacetamide is metabolized in the liver by N-acetylation, metabolites have antibacterial activity.
    Excretion of sulfacetamide occurs in the kidneys by glomerular filtration.
    Indications:In the complex therapy of diseases of the eyelids, conjunctiva, cornea, anterior section of the choroid and lacrimal ducts caused by microorganisms sensitive to sulfacetamide. For the prevention of infectious complications in the complex therapy of burns and injuries to the organ of vision.
    Contraindications:Individual hypersensitivity to the components of the drug, children's age (up to 2 months).
    Pregnancy and lactation:
    The use of the drug during pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus. It should refrain from breastfeeding during the period of use of the drug because of the lack of relevant clinical data.
    Perhaps the development of nuclear jaundice in newborns,whose mothers took the tablet form of sulfonamides during pregnancy, therefore it is impossible to exclude the risk of jaundice when taking sulfanilamide in the drug form of eye drops.
    Dosing and Administration:1 to 2 drops in the conjunctival sac 6-8 times a day (every 2-3 hours). The course of treatment is 7-10 days. The number of installations can be reduced as the state improves. When treating the diseases of the organ of vision caused by Chlamydia trachomatis, the dosing regimen is 1 drop every 2 hours, the local application of sulfonamide should be combined with systemic therapy.
    Side effects:
    Allergic reactions, burning, lacrimation, aching, itching in the eyes, transient blurred vision after instillation, nonspecific conjunctivitis, development of superinfection, severe allergic reactions to sulfonamides (Stephen-Johnson syndrome, toxic epidermolysis, fulminant liver necrosis, agranulocytosis, aplastic anemia).
    If any of the side effects indicated in the manual are aggravated or you notice any other side effects not listed in the instructions, inform your doctor.
    Overdose:Cases of drug overdose are not described.
    Interaction:Sulfacetamide enhances the effect of anticoagulants of indirect action. Combined use with procaine. tetracaine, benzocaine reduces the bacteriostatic effect of sulfacetamide. Diphenine, para-aminosalicylic acid (PASC), salicylates increase its toxicity. Incompatible with the salts of silver.
    Special instructions:
    Patients with hypersensitivity to furosemide, thiazide diuretics, sulfonylureas or carbonic anhydrase inhibitors may have increased sensitivity to sulfacetamide.
    Possible excessive growth of microorganisms, insensitive to sulfanilamide, as well as fungal flora.
    Reduction of the antibacterial activity of sulfonamides in the presence of high concentrations of nanoaminobenzoic acid in the presence of a large amount of purulent discharge.
    It is necessary to stop therapy with sulfonamides in case of allergy symptoms, as well as with pain and other signs of an infectious inflammatory process, and an increase in purulent discharge.
    Effect on the ability to drive transp. cf. and fur:If blurred vision develops after installation, it is necessary to refrain from driving vehicles andoccupations of potentially hazardous activities requiring an increased concentration of attention and speed of psychomotor reactions, until the recovery of vision clarity.
    Form release / dosage:Eye drops 20%.
    Packaging:
    By 0.5 or 1 ml in a tube of droppers from low-density polyethylene or polypropylene. For 3 or 5 tubes in a laminated package or without it, together with instructions for use in a pack of cardboard.
    5 ml per bottle with a dropper of low-density polyethylene and a lid with a control of the first opening or a flask-dropper made of high-density polyethylene, complete with a cap screwed and stopper-dropper. 1 bottle with instructions for use in a pack of cardboard.
    Storage conditions:At a temperature not higher than 15 ° ะก. Keep out of the reach of children.
    Shelf life:
    2 years.
    After opening the bottle - 1 month. Do not use after the expiration date!
    Terms of leave from pharmacies:Without recipe
    Registration number:LP-003062
    Date of registration:29.06.2015
    The owner of the registration certificate:GROTEKS, LLC GROTEKS, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp03.09.2015
    Illustrated instructions
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