Active substanceSulfacetamideSulfacetamide
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  • Dosage form: & nbspeye drops
    Composition:

    Composition for 1 ml.
    Active substance:
    Sulfacetamide sodium monohydrate - 200.00 mg
    Excipients:
    Sodium thiosulphate pentahydrate 1.5 mg
    Hydrochloric acid 1 M solution to pH 7.5-8.5
    Purified water - up to 1.0 ml.

    Description:Transparent colorless or with a yellowish tinge of 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 perstis, Chlamydia spp., Actinomyces israelii, Toxoplasha 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.

    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 occurs 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 Chlamidia tracho­matis, dosing regimen - 1 drop every 2 hours, topical application of sulfonamide should be combined with systemic therapy.

    Bury in a conjunctival bag for 1-2 drops 5-6 times a day. For the prevention of blennery in newborns - 2 drops in each conjunctival sac immediately after birth and 2 drops - after 2 hours.

    Side effects:

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

    If any of the side effects indicated in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

    Overdose:

    Data on drug overdose are absent.

    Interaction:

    Sulfacetamide enhances the effect of anticoagulants of indirect action. Combined use with benzocaine, procaine and tetracaine reduces the bacteriostatic effect of sulfacetamide. 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. Diphenine, para-aminosalicylic acid (PASC), salicylates increase the toxicity of sulfacetamide.

    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 of sulfonamides 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 symptoms of allergy, as well as with pain and other signs of infection, increased purulent discharge.

    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 vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions before the restoration of vision clarity.

    Form release / dosage:

    Eye drops 20%.

    Packaging:

    To 5 ml, 10 ml to the bottles - droppers from high-density polyethylene with a screw neck, a stopper-dropper from low-density polyethylene or a nozzle-dispenser made of high-density polyethylene, and a screw cap with a control ring of the first opening of low pressure polyethylene, or polypropylene .

    On the bottle-dropper stick the label self-adhesive.

    1 bottle-dropper along with the instruction for use is placed in a pack of cardboard.

    Storage conditions:

    Store in original packaging at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use the drug after the expiration date.

    The opened bottle-dropper should not be stored for more than 30 days.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-004611
    Date of registration:25.12.2017
    Expiration Date:25.12.2022
    The owner of the registration certificate:LEKKO, ZAO LEKKO, ZAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp24.01.2018
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