Sulfacetamide sodium

I N S T R U C T I O N for medical use of the medicinal product SULFACIL SODIUM (SULFACYL SODIUM)

Composition:

active substance: 1 ml of solution contains 300 mg of sodium sulfacetamide;

excipients: sodium thiosulfate, water for injections, hydrochloric acid (for pH adjustment).

Pharmaceutical form. Eye drops.

Main physicochemical properties: colorless or slightly colored clear liquid.

Pharmacotherapeutic group. Agents used in ophthalmology. Sulfonamides.

ATC code S01AB04.

Pharmacological Properties.

Pharmacodynamics.

An antimicrobial agent of the sulfonamide group. Exerts a bacteriostatic effect against gram-positive and gram-negative bacteria – streptococci, pneumococci, gonococci, Escherichia coli. The mechanism of action is related to competitive antagonism with para-aminobenzoic acid and competitive inhibition of dihydropteroate synthase, leading to disruption of tetrahydrofolic acid synthesis, which is essential for the synthesis of purines and pyrimidines. As a result, synthesis of nucleic acids (DNA, RNA) in bacterial cells is impaired and their replication is inhibited.

Pharmacokinetics.

When instilled onto the conjunctiva, the drug penetrates into the ocular media, where it exerts its specific antibacterial effect. It acts predominantly locally, although a portion of the drug is absorbed through the inflamed conjunctiva and enters the systemic circulation.

Clinical characteristics.

Indications. Infectious and inflammatory eye diseases caused by microflora sensitive to the drug (conjunctivitis, keratitis, blepharitis, corneal ulcers, ophthalmia neonatorum).

Contraindications. Hypersensitivity to the components of the drug and other sulfonamides.

Interaction with other medicinal products and other types of interactions. When used concomitantly with procaine, dicaine, or anestezin, the bacteriostatic effect decreases; diphenyl and salicylates enhance the toxicity of "Sodium sulfacetamide"; when used with indirect-acting anticoagulants, their specific activity increases. "Sodium sulfacetamide" is incompatible with silver salt preparations when applied locally.

Special precautions.

For topical use only! Rare fatal cases have been reported as a result of severe reactions to sulfonamides, including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood disorders.

Sensitization may occur when sulfonamides are administered repeatedly, regardless of the route of administration. Hypersensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. The drug must be discontinued at the first sign of hypersensitivity, skin rash, or other serious reactions.

Prolonged use of topical antibacterial agents may lead to overgrowth of pathogenic microorganisms, including fungi, and to the development of bacterial resistance to sulfonamides. The efficacy of sulfonamides is reduced in the presence of high concentrations of para-aminobenzoic acid in purulent exudate.

Sensitization may occur upon repeated administration of sulfonamides or as a result of cross-sensitivity between different sulfonamides.

At the first signs of increased sensitivity, increased purulent discharge, or worsening of inflammation or pain, the patient should discontinue the drug and consult a physician.

Patients with known hypersensitivity to furosemide, thiazide diuretics (hydrochlorothiazide), sulfonamide-derived drugs (glibenclamide), or carbonic anhydrase inhibitors (diamox) may be at increased risk of hypersensitivity to sodium sulfacetamide.

During treatment with this drug, it is advisable to avoid wearing contact lenses. Otherwise, contact lenses should be removed before instillation and not reinserted earlier than 15 minutes after administration of the drug.

Use during pregnancy or breastfeeding. Animal studies on the ophthalmic use of sulfonamide drugs have not been conducted. Nuclear jaundice may occur in newborns as a result of oral sulfonamide use by pregnant or breastfeeding women. There are no adequate and well-controlled studies on the use of ocular sulfonamide drugs in pregnant women, and it is unknown whether sulfonamides may cause harm to the fetus when administered during pregnancy. Sodium sulfacetamide should be used during pregnancy or breastfeeding only if prescribed by a physician and if the expected therapeutic benefit outweighs the potential risk of adverse reactions.

Ability to affect reaction speed when driving or operating machinery. Not studied.

As with other topically applied ophthalmic drugs, transient blurred vision or other visual disturbances may affect the ability to drive or operate machinery. If blurred vision occurs after instillation, the patient should wait until vision clears before driving or operating machinery.

Dosage and Administration.

For adults, instill 2–3 drops of the medicinal product into the affected eye 5–6 times daily. The duration of treatment is determined individually by a physician; on average, it lasts 7–10 days.

Children. Safety and efficacy of 30% Sodium Sulfacetamide ophthalmic drops in children have not been established.

Overdose. Significant irritation of the ocular mucous membrane may occur; in such cases, discontinue the medicinal product immediately. If necessary, symptomatic treatment should be administered.

Adverse reactions.

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

The most commonly reported reactions were local irritation, stinging, and burning. Less frequently reported reactions included nonspecific conjunctivitis, conjunctival hyperemia, secondary infection, and allergic reactions.

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

In individual cases, irritation of ocular tissues may occur (redness, itching, eyelid swelling, burning sensation).

Shelf life. 2 years.

After opening the bottle – 20 days.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging, protected from light, at a temperature between 2 and 8 °C.

Keep out of reach of children.

Packaging.

10 ml of 30 % solution in a plastic bottle. One bottle per cardboard box.

Prescription category. Prescription only.

Manufacturer. LLC "FZ "STADA", Ukraine.

Manufacturer's address and place of business.

37, Kyivska Street, Bila Tserkva, Kyiv region, 09100, Ukraine.