Active substanceSulfacetamideSulfacetamide
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  • Dosage form: & nbsptoapley eye
    Composition:On 1 ml:

    active substance: sodium sulfacetamide monohydrate - 100 mg or 200 mg;

    Excipients: sodium thiosulphate pentahydrate - 1.5 mg, hydrochloric acid 1 M solution - up 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.

    Active in a relationship 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 drug falling into the systemic circulation is not enough to develop a systemic therapeutic effect, but it is sufficient for sensitization upon repeated administration.

    When topically applied, the maximum concentration (CmOh) of sulfonamides in the cornea (about 3 mg / ml), the humidity of the anterior chamber (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 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 for the treatment of pregnant and lactating mothers as prescribed by the attending physician,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:

    1-2 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 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, itching, 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).

    Overdose:

    Data on drug overdose are absent.

    Interaction:

    Co-administration with procaine and tetracaine reduces the bacteriostatic effect of sulfacetamide.

    HThe incompatibility of sulfacetamide when it is used together with silver salts is observed.

    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 sulfanilamide, 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 in case of allergy symptoms, as well as with pain and other signs of an infectious inflammatory process, and an increase in the amount of purulent discharge.

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

    In case of development of blurring of vision after instillation it is necessary to refrain from driving and potentially hazardous activities Activities that require increased concentration and speed psychomotor reactions, to restore the clarity of vision.

    Form release / dosage:Eye drops, 10% and 20%.
    Packaging:

    5 ml, 10 ml, 15 ml in sterile polymer bottles-droppers, hermetically sealed with polymer stoppers and droppers cap screwed.

    One bottle-dropper of 5 ml, 10 ml, 15 ml together with the instruction for use is placed in a pack.

    5 ml, 3 ml, 2 ml, 1.5 ml, 1.0 ml, 0.5 ml, 0.3 ml in a disposable tube. Disposable and multi-turn, with a capping cap.

    1 cassette (5 pcs.) Or 2 cassettes (10 pcs.) A 5 ml dropper, 3 ml, 2 ml, 1.5 ml, 1.0 ml, 0.5 ml, 0.3 ml together with the instruction for use put in a pack.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years

    Use the bottle after autopsy within 14 days.

    Tube-dropper used after opening for 14 days.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-003483
    Date of registration:02.03.2016
    Expiration Date:02.03.2021
    The owner of the registration certificate:YUZHFARM, LLC YUZHFARM, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspYUZHFARM, LLCYUZHFARM, LLC
    Information update date: & nbsp10.08.2016
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