Sodium sulfacyl-SOLOPHARM 20% vial, 5ml

Composition

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1 ml contains:

Active ingredients:

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

Auxiliary substances:

sodium thiosulfate pentahydrate – 1 mg,

hydrochloric acid 1 M solution-up to pH 8.0,

d/i water – up to 1 ml

Pharmacological action

Pharmacotherapy group: Antimicrobial agent – sulfonamide. ATX: A. 07. A. B Sulfonamides Pharmacodynamics : Antimicrobial bacteriostatic agent, sulfonamide. The mechanism of action is due to competitive antagonism with paraaminobenzoic acid, inhibition of dihydropteroate synthetase, and disruption of the synthesis of tetrahydrofolic acid, which is necessary for the synthesis of purines and pyrimidines. 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. It is possible to develop resistance to sulfacetamide. Pharmacokinetics: Penetrates into the eye tissue, where it has its own specific antibacterial effect. It acts mainly topically, but part of the drug is absorbed through the inflamed conjunctiva and enters the systemic circulation. The amount of the drug entering the systemic circulation is not sufficient for the development of a systemic therapeutic effect, but it is sufficient for sensitization upon repeated use. When applied topically, the maximum concentration (Cmax) of sulfonamides in the cornea (about 3 mg/ml), anterior chamber moisture (about 0.5 mg/ml) and iris (about 0.1 mg/ml) is reached within the first 30 minutes after application. A certain amount (less than 0.5 mg/ml) is retained in the tissues of the eyeball for 3-4 hours. If the corneal epithelium is damaged, the penetration of sulfonamides increases. Sulfacetamide is metabolized in the liver by N-acetylation, the metabolites have antibacterial activity. Sulfacetamide is excreted in the kidneys by glomerular filtration.

Indications

In the complex therapy of diseases of the eyelids, conjunctiva, cornea, anterior segment of the choroid and tear ducts caused by microorganisms sensitive to sulfacetamide.

For the prevention of infectious complications in the complex therapy of burns and injuries of the visual organ.

Use during 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 is necessary to refrain from breast-feeding during the use of the drug due to the lack of relevant clinical data. It is possible to develop nuclear jaundice in newborns whose mothers took tablet forms of sulfonamides during pregnancy, so it is impossible to exclude the risk of jaundice when taking sulfonamide in the dosage form of eye drops.

Contraindications

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

Side effects

Allergic reactions, burning, lacrimation, pain, itching in the eyes, transient blurred vision after instillation, non-specific conjunctivitis, development of superinfection, severe allergic reactions to sulfonamides (Stephen-Johnson syndrome, toxic epidermolysis, lightning-fast liver necrosis, agranulocytosis, aplastic anemia). If any of the side effects listed in the instructions get worse or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

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

How to take, course of use and dosage

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 installations can be reduced as the condition improves. When treating diseases of the visual organ caused by Chlamydia trachomatis, the dosage regimen is 1 drop every 2 hours, local use of sulfonamide should be combined with systemic therapy.

Overdose

Cases of overdose of the drug are not described.

Special instructions

Patients with hypersensitivity to furosemide, thiazide diuretics, sulfonylurea, or carbonic anhydrase inhibitors may be hypersensitive to sulfacetamide.

Excessive growth of microorganisms that are insensitive to sulfonamide, as well as fungal flora, is possible.

Reduction of the antibacterial activity of sulfonamides in the presence of high concentrations of naraaminobenzoic 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 increased pain and other signs of an infectious inflammatory process, an increase in the amount of purulent discharge.

Influence on the ability to drive vehicles and mechanisms: If blurred vision develops after installation, it is necessary to refrain from driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions, until visual clarity is restored.

Storage conditions

At a temperature not exceeding 15 °C. Keep out of reach of children.

Shelf

life is 2 years. After opening the bottle – 1 month. Do not use after the expiration date!

Active ingredient

Sulfacetamide

Dosage form

eye drops