Sulfacil (sulfacetamide) eye drops 30% 10 ml. vial

Description

Sulfacil (sulfacetamide) eye drops 30% 10 ml. vial

Composition

active substance: sulfacetamide;

1 ml of drops contains sulfacil sodium 200 mg or 300 mg in terms of 100% of the substance;

Excipients: sodium thiosulfate; 1 M hydrochloric acid solution to pH 8.0; water for injections.

Dosage form

Eye drops.

Main physical and chemical properties: clear colorless or slightly yellowish liquid.

Pharmacotherapeutic group

Means used in ophthalmology. Sulfanilamides.
ATX Code S01A B04.

Pharmacological properties

Sulfacil has a bacteriostatic effect against gram-positive and gram-negative bacteria – streptococci, pneumococci, gonococci, Escherichia coli, chlamydia, actinomycetes. The mechanism of action of the drug is due to competitive antagonism with paraaminobenzoic acid (PABX) and competitive inhibition of dihydropteroate synthetase, which leads to disruption of the synthesis of tetrahydrofolic acid required for the synthesis of purine and pyrimidine bases. As a result, the synthesis of nucleic acids (DNA and RNA) of bacterial cells is disrupted and their reproduction is inhibited.

Indication

Infectious and inflammatory eye diseases caused by bacteria sensitive to the drug: conjunctivitis, blepharitis, purulent corneal ulcers.

Contraindication

History of hypersensitivity to the components of the drug and sulfonamides.

Use during pregnancy or breastfeeding

There have been no animal studies on the ophthalmic use of sulphonamides. Nuclear jaundice can occur in newborns as a result of a pregnant woman taking oral sulfonamides. There are no adequate and well-controlled studies of ophthalmic sulfonamides in pregnant women, and it is unknown whether sulfanilamides may harm the fetus when administered to pregnant women. This drug can be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Breastfeeding period
Systemic administration of sulfonamides may lead to nuclear jaundice in infants whose mothers take sulfonamides during lactation. Due to the possibility of developing nuclear jaundice in newborns, the decision to prescribe sulfonamides in the form of eye drops to breastfeeding women should be made taking into account the risk / benefit ratio.

Method of application and dosage

• Adults use a solution of Sulfacil 300 mg / ml 2 – 3 drops in the affected eye 5 – 6 times a day (every 4 – 5 hours).
• Children over 2 months of age should use a solution of Sulfacil 200 mg / ml 1 – 2 drops in the affected eye 4 – 5 times a day.

The course of treatment is determined by the doctor depending on the nature and severity of the disease. The average course is 7 – 10 days.

Children

The safety and efficacy of Sulfacil, eye drops 200 mg / ml, in children under 2 months of age have not been established.

Overdose

With frequent use of the drug may be redness, itching, swelling of the eyelids, significant irritation of the mucous membrane of the eye. In this case, treatment is continued with a solution of Sulfacil lower concentration, if necessary, cancel the drug and prescribe symptomatic treatment.

Side effects

Bacterial and fungal corneal ulcers have been reported during treatment with sulfonamide ophthalmic drugs.

Reactions such as local irritation, tingling and burning have been reported most frequently. Reactions including nonspecific conjunctivitis, conjunctival hyperemia, secondary infection, and allergic reactions have been reported less frequently.

Rare deaths due to severe reactions to sulfonamides have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatonecrosis, agranulocytosis, aplastic anemia, and other blood disorders.