Sulfacyl sodium eye drops 20% 10ml


Chemical properties

Sulfacetamide is an antimicrobial bacteriostatic agent, an intermediate product in the synthesis of streptocide . The composition of medications includes sodium sulfacetamide .

According to its physical properties, it is a white, fine-crystalline powder, has no specific odor, and has a bitter taste. Very soluble in water, practically insoluble in ether and ethyl alcohol, chloroform and acetone . Molecular weight = 214.3 grams per mole.

Available in the form of eye drops, ointments, solutions for intramuscular and intravenous administration.

Pharmacodynamics and pharmacokinetics

Sulfacetamide inhibits the production of dihydrofolic acid , as it enters into a competitive interaction with para-aminobenzoic acid during the synthesis of folate . Harmful microorganisms lose their ability to grow and reproduce. The substance is active against gram-negative and gram-positive microorganisms: Bacillus anthracis, Clostridium perfringens, Corynebacterium diphtheriae, Chlamydia, Toxoplasma gondii, Corynebacterium diphtheriae, Escherichia coli, Vibrio cholerae, Yersinia pestis, Actinomyces israelii., Shigella spp.

When instilled into the eyes, the product penetrates well into the fluids and tissues of the eye and is able to be absorbed into the systemic bloodstream through the inflamed tissues of the conjunctiva. The half-life is about 10 hours

Sulfacyl sodium eye drops 20% 10ml

Compound

Active substance: sodium sulfacetamide monohydrate - 200 mg. Excipients: sodium thiosulfate pentahydrate - 1.5 mg, hydrochloric acid 1M - up to pH 7.5-8.5, purified water - up to 1 ml.

Pharmacokinetics

When applied topically, it penetrates into the tissues and fluids of the eye.
Absorbed into the systemic circulation through the inflamed conjunctiva. Sulfacetamide is metabolized in the liver by N-acetylation, the metabolites have antibacterial activity.

Excretion of sulfacetamide occurs in the kidneys by glomerular filtration.

Indications for use

In the complex treatment of diseases of the eyelids, conjunctiva, cornea, anterior segment of the choroid and lacrimal ducts caused by microorganisms sensitive to sulfacetamide.
For the prevention of infectious complications in the complex treatment 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).

Directions for use and doses

1-2 drops into 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 condition improves. When treating diseases of the organ of vision caused by Chlamydia trachomatis, the dosage regimen is 1 drop every 2 hours; local use of sulfonamide must be combined with systemic therapy.

Instill 1-2 drops into the conjunctival sac 5-6 times a day.

To prevent blenorrhea in newborns, take 2 drops into each conjunctival sac immediately after birth and 2 drops after 2 hours.

Storage conditions

Store in original packaging at a temperature not exceeding 25 °C.
Keep out of the reach of children.

Best before date

2 years.
Do not use the drug after the expiration date. Store an opened dropper bottle for no more than 30 days.

special instructions

Patients with hypersensitivity to furosemide, thiazide diuretics, sulfonylureas or carbonic anhydrase inhibitors may have increased sensitivity to sulfacetamide.
Excessive growth of microorganisms that are insensitive to sulfanilamide, as well as fungal flora, is possible.

Reduced 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 if allergy symptoms appear, as well as if pain and other signs of an infectious process increase, or if there is an increase in purulent discharge.

Description

A drug with antimicrobial action for topical use in ophthalmology.

Dosage form

Eye drops 20% in the form of a transparent, colorless or slightly yellowish liquid.

Pharmacodynamics

Antibacterial agent for topical use in ophthalmology, sulfanilamide derivative.
Has a wide spectrum of antimicrobial action. Has a bacteriostatic effect. The mechanism of action is associated with competitive antagonism with PABA and competitive inhibition of dihydropteroate synthetase, which leads to disruption of the synthesis of tetrahydrofolic acid, necessary for the synthesis of purines and pyrimidines. Sulfacetamide 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.

Resistance to sulfacetamide may develop.

Side effects

Burning, lacrimation, pain, itching in the eyes, allergic reactions, transient blurred 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 listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Use during pregnancy and breastfeeding

There is no sufficient experience with use during pregnancy and breastfeeding.
It is possible to use sulfacetamide for the treatment of pregnant and nursing mothers as prescribed by the attending physician, if the expected therapeutic effect exceeds the risk of developing possible side effects. Sulfonamides cross the placenta and into breast milk. It is possible to develop kernicterus in newborns whose mothers took tablet forms of sulfonamides during pregnancy, so it is impossible to exclude the risk of developing jaundice when taking sulfonamide in the dosage form of eye drops.

Interaction

  • Sulfacetamide enhances the effect of indirect anticoagulants.
  • Combined use with benzocaine, procaine and tetracaine reduces the bacteriostatic effect of sulfacetamide.
  • Incompatibility of sulfacetamide is observed when used in combination with silver salts.
  • Co-administration with chloramphenicol increases the risk of side effects of the latter.
  • Diphenine, para-aminosalicylic acid (PAS), and salicylates increase the toxicity of sulfacetamide.

Overdose

There are no data on drug overdose.

Impact on the ability to drive vehicles and operate machinery

If blurred vision develops after instillation, it is necessary to refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions until vision clarity is restored.

Indications for use

Sodium sulfacetamide is prescribed topically (eye drops):

  • for the treatment of conjunctivitis , purulent ulcers of the cornea;
  • for blepharitis ;
  • for the prevention and treatment of newborns with blenorrhea ;
  • for chlamydial and gonorrheal eye diseases in adult patients.

Injections of the drug are used for pneumonia , urinary tract infections, and purulent tracheobronchitis .

Sulfacyl sodium 20% 5ml eye drops

pharmachologic effect

Antibacterial agent for topical use in ophthalmology, sulfanilamide derivative.
Has a wide spectrum of antimicrobial action. Has a bacteriostatic effect. The mechanism of action is associated with competitive antagonism with PABA and competitive inhibition of dihydropteroate synthetase, which leads to disruption of the synthesis of tetrahydrofolic acid, necessary for the synthesis of purines and pyrimidines. Sulfacetamide is active against gram-positive and gram-negative bacteria (including pathogenic cocci, Escherichia coli), Chlamydia spp., Actinomyces spp.

Composition and release form Sulfacyl sodium 20% 5ml eye drops

Drops - 1 ml:

  • Active substance: sulfacetamide - 200 m; g
  • Excipients: sodium thiosulfate - 1 mg; hydrochloric acid (1 M solution of hydrochloric acid) - up to pH 8.5; water for injection - up to 1 ml.

Eye drops 20%.

1 ml, 1.5 ml, 2 ml in a dropper tube with a valve or 5 ml, 10 ml in a dropper tube with a screw neck made of polymer materials.

Dropper tubes with a screw neck are sealed with screw caps made of polymer materials.

2 dropper tubes of 1 ml, 1.5 ml, 2 ml or 1 dropper tube of 5 ml, 10 ml with instructions for use are placed in a cardboard pack.

Description of the dosage form

Transparent colorless or slightly colored liquid.

Directions for use and doses

Locally.

To treat conjunctivitis in children and adults, instill 1-2 drops into the conjunctival sac every hour, and 5-6 times a day for the next 3-4 days. For the treatment of blepharitis in children and adults, the frequency of instillations in the first days is up to 6-8 times and decreases to 3-4 times a day as the condition improves, the duration of treatment is 3-5 days.

For the treatment of purulent corneal ulcers as part of complex therapy in the form of instillations 5-6 times a day, for 5-7 days.

To prevent blennorrhea in newborns, 2 drops into each conjunctival sac immediately after birth and 2 drops after 2 hours during the day, for the treatment of blennorrhea - into each conjunctival sac, 2 drops every 1-2 hours on the first day, then every 3 hours, treatment duration is two weeks.

When treating gonorrheal and chlamydial eye diseases in adults as part of complex therapy, 1-2 drops 5-6 times a day, for 4-6 weeks. If the dynamics are positive during the treatment, the number of instillations of drops is reduced in each subsequent week.

Pharmacodynamics

Antimicrobial bacteriostatic agent, sulfanilamide. The mechanism of action is due to competitive antagonism with para-aminobenzoic acid and inhibition of dihydropteroate synthetase, disruption of the synthesis of tetrahydrofolic acid, necessary for the synthesis of purines and pyrimidines.

Active against gram-positive and gram-negative cocci, Escherichia coli, Shigella spp., Vibrio cholerae, Clostridium perfringens, Bacillus anthracis, Corynebacterium diphtheriae, Yersinia pestis, Chlamydia spp., Actinomyces israelii, Toxoplasma gondii.

Pharmacokinetics

When applied topically, the maximum concentration (Cmax) of sulfonamides in the cornea (about 3 mg/ml), anterior chamber fluid (about 0.5 mg/ml) and iris (about 0.1 mg/ml) is achieved within the first 30 minutes after application. A certain amount (less than 0.5 mg/ml) remains in the tissues of the eyeball for 3-4 hours. When the corneal epithelium is damaged, the penetration of sulfonamides increases.

Indications for use Sulfacyl sodium 20% 5ml eye drops

As part of complex therapy. Conjunctivitis and blepharitis in children and adults, purulent corneal ulcer, prevention and treatment of blenorrhea in newborns, gonorrheal and chlamydial eye diseases in adults.

Contraindications

Hypersensitivity to the components of the drug.

Use of Sulfacyl sodium 20% 5ml eye drops during pregnancy and breastfeeding

There is no sufficient experience with the use of the drug during pregnancy and breastfeeding. It is possible to use sulfacetamide for the treatment of pregnant and nursing mothers as prescribed by the attending physician, if the expected therapeutic effect exceeds the risk of developing possible side effects.

special instructions

Patients with hypersensitivity to furosemide, thiazide diuretics, sulfonylureas or carbonic anhydrase inhibitors may have increased sensitivity to sulfacetamide. After opening, use within 14 days.

Overdose

There are no data on drug overdose.

Side effects Sulfacyl sodium 20% 5ml eye drops

Burning, lacrimation, pain, itching in the eyes, transient blurred vision after instillation, allergic reactions.

Drug interactions

Combined use with procaine and tetracaine reduces the bacteriostatic effect. Incompatibility with silver salts.

Reviews

The most common reviews are for eye drops with Sulfacetamide. The reviews are generally good, and adverse reactions occur quite rarely.

“... I treat conjunctivitis with these drops, they always help. To prevent my eyes from being constantly red from irritation, I use it once before bed, it suits me”; “... The child had dacryocystitis, these drops were prescribed, but they were not effective for us. I had to replace it with others, more expensive. And so – they have a convenient bottle, and they cost pennies”; “... Sulfacetamide helped my daughter, who is 2 years old. They instilled them 3 times a day, and added chloramphenicol. The conjunctivitis went away in 5 days.”

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