Active substanceSulfacetamideSulfacetamide
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  • Dosage form: & nbspeye drops
    Composition:

    Composition per ml:

    Active substance: sodium sulfacetamide - 200 mg;

    Excipients: sodium thiosulfate - 1.5 mg, hydrochloric acid 1 M solution - to pH 7.7-8.7, purified water - up to 1 ml.

    Description:Transparent colorless or slightly yellowish liquid.
    Pharmacotherapeutic group:Antimicrobial agent, sulfonamide
    ATX: & nbsp

    A.07.A.B   Sulfonamides

    Pharmacodynamics:

    Antimicrobial bacteriostatic agent, sulfanilamide. The mechanism of action is associated with competitive antagonism with PABA and inhibition of dihydropteroate synthetase, which leads to a disruption in the synthesis of dihydrofolic acid and, ultimately, its active metabolite of tetrahydrofolic acid, 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 perfringens, Bacillus antracis, Corynebacterium diphteriae, 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. Operates predominantly topically, but part of the drug is absorbed through Inflamed conjunctiva and enters the systemic circulation. The amount of the preparation, entering the systemic circulation is not sufficient to develop a systemic therapeutic effect, but sufficient for sensitization upon repeated administration. When topically applied, the maximum concentration (Cm(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 the 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 organs of vision.

    Contraindications:

    Individual hypersensitivity to the components of the drug, children's age (up to 2 months).

    Pregnancy and lactation:

    Sufficient experience in use during pregnancy, breast-feeding is not. It is possible to use sulfacetamide to treat pregnant and lactating mothers as prescribed by the doctor if the expected curative effect exceeds the risk of possible side effects. Sulfonamides penetrate the placenta and into breast milk.

    Perhaps the development of nuclear jaundice in newborns whose mothers took tablets of sulfanilamides during pregnancy, so it is impossible to exclude the risk of jaundice when taking sulfanilamide in the form of a drug eye drops.

    Dosing and Administration:

    Buried in the conjunctival bag for 1-2 drops 6-8 times a day (every 2-3 hours). The course of treatment is 7-10 days. The number of instillations can be reduced as the state improves. When carrying out therapy for eye diseases caused by Chlamydia trachomatis, dosing regimen - 1 drop every 2 hours, topical application of sulfonamide should be combined with systemic therapy.

    Side effects:

    Allergic reactions, burning, lacrimation, stinging, itching in the eyes, transient blurring of vision after instillation, nonspecific conjunctivitis, development of superinfection, severe allergic reactions to sulfonamides (Stephen-Johnson syndrome, toxic epidermolysis, fulminant liver necrosis, agranulocytosis, aplastic anemia).

    Overdose:

    Data on drug overdose are absent.

    Interaction:

    Co-administration with procaine and tetracaine reduces bacteriostaticeffect of sodium sulfacil. The incompatibility of sulfacetamide is observed when it is used together with silver salts. Simultaneous administration with chloramphenicol increases the risk of side effects of the latter.

    Special instructions:

    Patients who are hypersensitive to furosemide, thiazide diuretics, sulfonylureas or carbonic anhydrase inhibitors may have increased sensitivity to sulfacetamide.

    Possible excessive growth of microorganisms, insensitive to sulfacetamide, as well as fungal flora.

    Reduction of antibacterial activity in the presence of high concentrations of para-aminobenzoic acid in the presence of a large amount of purulent discharge. It is necessary to stop therapy if allergy symptoms appear, as well as pain and other signs of an infectious and inflammatory process increase, and the amount of purulent discharge increases.

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

    In the case of fogging of vision after instillation, it is necessary to refrain from driving and practicing potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions, until the recovery of vision clarity.

    Form release / dosage:Eye drops 20%.
    Packaging:

    To 5, 10 ml in sterile polymer bottles-droppers, hermetically sealed by polymer stoppers, droppers and lids.

    To 5, 10 ml in sterile polymer bottles-droppers, manufactured by technologies "blow-fill-seal" "blow-fill-seal-sealing" on the production line Botellpack, hermetically sealed with screw caps.

    For 1 polymer bottle-dropper along with the instruction for medical use is 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:

    2 years.

    The bottle-dropper should be used after opening for 30 days.

    Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-004276
    Date of registration:28.04.2017
    Expiration Date:28.04.2022
    The owner of the registration certificate:SLAVYANSKAYA APTEKA, LLC SLAVYANSKAYA APTEKA, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp23.05.2017
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