Sulfacyl (Drops) Instructions for Use

Instructions
Dosage forms

ATC Code

S01AB04 (Sulfacetamide)

Active Substance

Sulfacetamide (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug with antimicrobial action for topical use in ophthalmology

Pharmacotherapeutic Group

Drugs used in ophthalmology; antimicrobials; sulfonamides

Pharmacological Action

An antibacterial agent for topical use in ophthalmology, a derivative of sulfanilamide. It has a broad spectrum of antimicrobial action. It has a bacteriostatic effect.

The mechanism of action is associated with competitive antagonism with PABA and competitive inhibition of dihydropteroate synthase, which leads to a disruption in 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 perfringens, Bacillus anthracis, Corynebacterium diphtheriae, Yersinia pestis, Chlamydia spp., Actinomyces israelii, Toxoplasma gondii.

The development of resistance to sulfacetamide is possible.

Pharmacokinetics

When applied topically, it penetrates into the tissues and fluids of the eye. It is absorbed into the systemic circulation through the inflamed conjunctiva.

Sulfacetamide is metabolized in the liver by N-acetylation; metabolites have antibacterial activity.

Excretion of sulfacetamide occurs in the kidneys by glomerular filtration.

Indications

In the complex therapy of diseases of the eyelids, conjunctiva, cornea, anterior segment of the vascular membrane and lacrimal ducts caused by microorganisms sensitive to sulfacetamide. Prevention of infectious complications in the complex therapy of burns and injuries of the visual organs. Prevention of blennorrhea in newborns.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
A54.3	Gonococcal eye infection
H01.0	Blepharitis
H04.3	Acute and unspecified inflammation of lacrimal passages
H04.4	Chronic inflammation of lacrimal passages
H10.2	Other acute conjunctivitis
H10.4	Chronic conjunctivitis
H10.5	Blepharoconjunctivitis
H16	Keratitis
H20.0	Acute and subacute iridocyclitis (anterior uveitis)
H20.1	Chronic iridocyclitis
P39.1	Neonatal conjunctivitis and dacryocystitis
S05	Injury of eye and orbit
T26	Thermal and chemical burns confined to the eye and its adnexa
Z29.2	Other prophylactic chemotherapy (administration of antibiotics for prophylactic purposes)

ICD-11 code	Indication
1A72.4	Gonococcal eye infection
9A01.3	Infectious blepharitis
9A02.Z	Inflammatory disorders of eyelid, unspecified
9A11.Z	Disorders of the lacrimal passages, unspecified
9A1Z	Diseases of the lacrimal system, unspecified
9A60.4	Blepharoconjunctivitis
9A60.Z	Conjunctivitis, unspecified
9A71	Infectious keratitis
9A7Z	Diseases of the cornea, unspecified
9A96.Y	Other specified anterior uveitis
9A96.Z	Anterior uveitis, unspecified
KA65.0	Conjunctivitis or dacryocystitis of newborn
NA06.Z	Injury of eye and orbit, unspecified
NE00	Burn of eye and adnexa
QC05.Y	Other specified prophylactic measures

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

For the treatment of infectious eye diseases, instill 2-3 drops into the lower conjunctival sac of each affected eye. Apply drops 5-6 times daily at approximately regular intervals.

Increase the frequency of instillation during the initial, acute phase of infection as directed by a physician. Gradually reduce the frequency of application as clinical symptoms improve.

For the prevention of blennorrhea in newborns, administer 2 drops into each eye immediately after birth. Instill a second dose of 2 drops into each eye after a 2-hour interval.

Prior to instillation, ensure the dropper tip and solution are not contaminated. Avoid direct contact between the dropper tip and the eye, eyelids, or any other surface.

If using other topical ophthalmic agents, maintain an interval of at least 15 minutes between applications. Apply eye ointments after the instillation of drops.

Do not wear soft contact lenses during the course of treatment with sulfacetamide sodium. The duration of treatment is determined by the physician based on the clinical response and severity of the infection.

Discontinue use and consult a physician immediately if symptoms worsen, or if severe irritation, pain, or signs of an allergic reaction develop.

Adverse Reactions

Possible allergic reactions, burning, lacrimation, pain, itching in the eyes, transient blurred vision after instillation, nonspecific conjunctivitis, development of superinfection, severe allergic reactions to sulfonamides (Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant liver necrosis, agranulocytosis, aplastic anemia).

Contraindications

Hypersensitivity to sulfacetamide and other sulfonamide drugs; children under 2 months of age – depending on the dosage form.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, it should be used only after consultation with a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.

Pediatric Use

It is possible to use in children according to indications, in doses and dosage forms appropriate for age. It is necessary to strictly follow the instructions in the sulfacetamide drug leaflets regarding contraindications for the use of specific sulfacetamide dosage forms in children of different ages.

Special Precautions

Patients who are hypersensitive to furosemide, thiazide diuretics, sulfonylurea, or carbonic anhydrase inhibitors may have increased sensitivity to sulfacetamide.

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

A decrease in the antibacterial activity of sulfonamides is noted in the presence of high concentrations of para-aminobenzoic acid in the presence of a large amount of purulent discharge.

It is necessary to discontinue therapy if symptoms of allergy appear, as well as if pain and other signs of an infectious process intensify, and purulent discharge increases.

Effect on the ability to drive vehicles and mechanisms

During the use of sulfacetamide, patients should exercise caution when driving vehicles and mechanisms, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Sulfacetamide enhances the effect of indirect anticoagulants.

When used concomitantly with benzocaine, procaine, and tetracaine, the bacteriostatic effect of sulfacetamide is reduced.

Sulfacetamide for topical use is incompatible with silver salts.

When used concomitantly with chloramphenicol, the risk of side effects of the latter increases.

Concomitant use of diphenylhydantoin, PAS, salicylates increases the toxicity of sulfacetamide.

Storage Conditions

Store at 2°C (36°F) to 15°C (59°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Sulfacyl-sodium [Belmedpreparaty RUP (Republic of Belarus)]
Eye drops 20%: 5 ml bottle with dropper cap

Marketing Authorization Holder

Belmedpreparaty RUP (Republic of Belarus)

Dosage Form

Sulfacyl-sodium

Eye drops 20%: 5 ml bottle with dropper cap

Dosage Form, Packaging, and Composition

Eye drops as a clear, slightly yellowish solution.

	1 ml
Sulfacetamide sodium (as monohydrate)	200 mg

Excipients: sodium thiosulfate pentahydrate, purified water.

5 ml – glass bottles (1) complete with a dropper cap – cardboard packs.

Sulfacyl-sodium [Vips-Med, LLC (Russia)]
Eye drops 20%: 5 ml or 10 ml dropper bottle, 1 or 50 pcs.

Marketing Authorization Holder

Vips-Med, LLC (Russia)

Dosage Form

Sulfacyl-sodium

Eye drops 20%: 5 ml or 10 ml dropper bottle, 1 or 50 pcs.

Dosage Form, Packaging, and Composition

Eye drops 20% clear, colorless or slightly colored.

	1 ml
Sulfacetamide	200 mg

10 ml – polymer dropper bottles (1) – cardboard packs.
5 ml – polymer dropper bottles (1) – cardboard packs.
10 ml – polymer dropper bottles (50) – cardboard boxes.
5 ml – polymer dropper bottles (50) – cardboard boxes.

Sulfacyl-sodium [Lekko, CJS (Russia)]
Eye drops 20%: dropper bottle 5 ml or 10 ml

Marketing Authorization Holder

Lekko, CJS (Russia)

Dosage Form

Sulfacyl-sodium

Eye drops 20%: dropper bottle 5 ml or 10 ml

Dosage Form, Packaging, and Composition

Eye drops 20% as a clear, colorless or slightly yellowish liquid.

	1 ml
Sulfacetamide sodium monohydrate	200 mg

Excipients: sodium thiosulfate pentahydrate – 1.5 mg, hydrochloric acid 1M – to pH 7.5-8.5, purified water – to 1 ml.

5 ml – dropper bottles (1) – cardboard packs.
10 ml – dropper bottles (1) – cardboard packs.

Sulfacyl-sodium [Moscow Endocrine Plant FSUE (Russia)]
Eye drops 200 mg/1 ml: 1.5 ml dropper tubes 2 pcs., 5 ml dropper bottle 1 pc.

Marketing Authorization Holder

Moscow Endocrine Plant FSUE (Russia)

Dosage Form

Sulfacyl-sodium

Eye drops 200 mg/1 ml: 1.5 ml dropper tubes 2 pcs., 5 ml dropper bottle 1 pc.

Dosage Form, Packaging, and Composition

Eye drops as a clear, colorless or slightly colored liquid.

	1 ml
Sulfacetamide	200 mg

Excipients: sodium thiosulfate, hydrochloric acid 1M, purified water.

1.5 ml – polymer dropper tubes (2) – cardboard packs.
5 ml – polymer dropper bottles (1) – cardboard packs.

Sulfacyl-sodium [Sintez PJSC (Russia)]
Eye drops 20%: dropper bottle 5 ml or 10 ml

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Form

Sulfacyl-sodium

Eye drops 20%: dropper bottle 5 ml or 10 ml

Dosage Form, Packaging, and Composition

Eye drops 20% as a clear, colorless or slightly colored liquid.

	1 ml
Sulfacetamide	200 mg

Excipients: sodium thiosulfate, 1M hydrochloric acid solution, purified water.

5 ml – polymer dropper bottles (1) – cardboard packs.
10 ml – polymer dropper bottles (1) – cardboard packs.

Sulfacyl-sodium [Slavic Pharmacy, LLC (Russia)]
Eye drops 20%: dropper bottle 5 ml or 10 ml

Marketing Authorization Holder

Slavic Pharmacy, LLC (Russia)

Dosage Form

Sulfacyl-sodium

Eye drops 20%: dropper bottle 5 ml or 10 ml

Dosage Form, Packaging, and Composition

Eye drops 20% as a clear, colorless or slightly yellowish liquid.

	1 ml
Sulfacetamide sodium	200 mg

Excipients: sodium thiosulfate – 1.5 mg, hydrochloric acid 1M – to pH 7.7-8.7, purified water – to 1 ml.

5 ml – polymer dropper bottles (1) – cardboard boxes.
10 ml – polymer dropper bottles (1) – cardboard boxes.

Sulfacyl-sodium [YUGPHARM, LLC (Russia)]
Eye drops 10%: 5 ml, 10 ml, or 15 ml dropper bottle; 0.3 ml, 0.5 ml, 1 ml, 1.5 ml, 2 ml, 3 ml, or 5 ml dropper tube, 5 or 10 pcs.
Eye drops 20%: 5 ml, 10 ml, or 15 ml dropper bottle; 0.3 ml, 0.5 ml, 1 ml, 1.5 ml, 2 ml, 3 ml, or 5 ml dropper tube, 5 or 10 pcs.

Marketing Authorization Holder

YUGPHARM, LLC (Russia)

Dosage Forms

	Sulfacyl-sodium	Eye drops 10%: 5 ml, 10 ml, or 15 ml dropper bottle; 0.3 ml, 0.5 ml, 1 ml, 1.5 ml, 2 ml, 3 ml, or 5 ml dropper tube, 5 or 10 pcs.
		Eye drops 20%: 5 ml, 10 ml, or 15 ml dropper bottle; 0.3 ml, 0.5 ml, 1 ml, 1.5 ml, 2 ml, 3 ml, or 5 ml dropper tube, 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Eye drops as a colorless or slightly yellowish, clear solution.

	1 ml
Sulfacetamide sodium	100 mg

Excipients: sodium thiosulfate pentahydrate – 1.5 mg, hydrochloric acid solution 1 M – to pH 7.7-8.7, purified water – to 1 ml.

5 ml – dropper bottles (1) – cardboard packs.
10 ml – dropper bottles (1) – cardboard packs.
15 ml – dropper bottles (1) – cardboard packs.
0.3 ml – dropper tubes (5) – packages (1) – cardboard packs.
0.3 ml – dropper tubes (5) – packages (2) – cardboard packs.
0.5 ml – dropper tubes (5) – packages (1) – cardboard packs.
0.5 ml – dropper tubes (5) – packages (2) – cardboard packs.
1 ml – dropper tubes (5) – packages (1) – cardboard packs.
1 ml – dropper tubes (5) – packages (2) – cardboard packs.
1.5 ml – dropper tubes (5) – packages (1) – cardboard packs.
1.5 ml – dropper tubes (5) – packages (2) – cardboard packs.
2 ml – dropper tubes (5) – packages (1) – cardboard packs.
2 ml – dropper tubes (5) – packages (2) – cardboard packs.
3 ml – dropper tubes (5) – packages (1) – cardboard packs.
3 ml – dropper tubes (5) – packages (2) – cardboard packs.
5 ml – dropper tubes (5) – packages (1) – cardboard packs.
5 ml – dropper tubes (5) – packages (2) – cardboard packs.

Eye drops as a colorless or slightly yellowish, clear solution.

	1 ml
Sulfacetamide sodium	200 mg

Excipients: sodium thiosulfate pentahydrate – 1.5 mg, hydrochloric acid solution 1 M – to pH 7.7-8.7, purified water – to 1 ml.

Sulfacyl sodium [Alvils, LLC (Russia)]
Eye drops 20%: dropper tube 1, 5, or 10 ml

Marketing Authorization Holder

Alvils, LLC (Russia)

Dosage Form

Sulfacyl sodium

Eye drops 20%: dropper tube 1, 5, or 10 ml

Dosage Form, Packaging, and Composition

Eye drops 20% transparent, colorless or slightly colored.

	1 ml
Sulfacetamide	200 mg

1 ml – polyethylene dropper tubes (1) – cardboard packs.
5 ml – polyethylene dropper tubes (1) – cardboard packs.
10 ml – polyethylene dropper tubes (1) – cardboard packs.

Sulfacyl sodium [Dalkhimpharm, JSC (Russia)]
Eye drops 20%: 5 ml or 10 ml bottle or dropper bottle

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Sulfacyl sodium

Eye drops 20%: 5 ml or 10 ml bottle or dropper bottle

Dosage Form, Packaging, and Composition

Eye drops transparent, colorless or with a yellowish tint.

	1 vial
Sodium sulfacetamide monohydrate	200 mg

Excipients: sodium thiosulfate pentahydrate – 1 mg, 1 M hydrochloric acid solution – to pH 7.5 – 8.7, water for injections – to 1 ml.

Theoretical osmolarity – 1722 mOsm/l

5 ml – dropper bottles or vials – cardboard packs.
10 ml – dropper bottles or vials – cardboard packs.

Sulfacyl sodium [Obnovlenie Pfc, JSC (Russia)]
Eye drops 20%: dropper bottle 5 ml or 10 ml

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Sulfacyl sodium

Eye drops 20%: dropper bottle 5 ml or 10 ml

Dosage Form, Packaging, and Composition

Eye drops 20% transparent, colorless or slightly colored.

	1 ml
Sulfacetamide	200 mg

5 ml – polymer dropper bottles (1) – cardboard packs.
10 ml – polymer dropper bottles (1) – cardboard packs.

Sulfacyl sodium Renewal [Obnovlenie Pfc, JSC (Russia)]
Eye drops 20%: 1 ml, 1.5 ml, 2 ml, or 2.5 ml dropper tube 2 pcs.; 5 ml, 10 ml, 15 ml, 20 ml, or 25 ml 1 pc.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Sulfacyl sodium Renewal

Eye drops 20%: 1 ml, 1.5 ml, 2 ml, or 2.5 ml dropper tube 2 pcs.; 5 ml, 10 ml, 15 ml, 20 ml, or 25 ml 1 pc.

Dosage Form, Packaging, and Composition

Eye drops transparent colorless or slightly colored.

	1 ml
Sulfacetamide	200 mg

Excipients: sodium thiosulfate – 1 mg, hydrochloric acid (1M hydrochloric acid solution) – to pH 8.5, water for injections – to 1 ml.

1 ml – dropper tubes with valves (2) – cardboard packs.
1.5 ml – dropper tubes with valves (2) – cardboard packs.
2 ml – dropper tubes with valves (2) – cardboard packs.
2.5 ml – dropper tubes with valves (2) – cardboard packs.
5 ml – polyethylene dropper tubes (1) – cardboard packs.
10 ml – polyethylene dropper tubes (1) – cardboard packs.
15 ml – polyethylene dropper tubes (1) – cardboard packs.
20 ml – polyethylene dropper tubes (1) – cardboard packs.
25 ml – polyethylene dropper tubes (1) – cardboard packs.

Sulfacyl sodium solution 20% [Slavic Pharmacy, LLC (Russia)]
Eye drops 20%: bottle or bottle-dropper 5 ml or 10 ml

Marketing Authorization Holder

Slavic Pharmacy, LLC (Russia)

Dosage Form

Sulfacyl sodium solution 20%

Eye drops 20%: bottle or bottle-dropper 5 ml or 10 ml

Dosage Form, Packaging, and Composition

Eye drops transparent, colorless or slightly colored.

	1 ml
Sulfacetamide	200 mg

5 ml – bottles (1) with a dropper cap – cardboard packs.
10 ml – bottles (1) with a dropper cap – cardboard packs.
5 ml – plastic dropper bottles (1) – cardboard packs.
10 ml – plastic dropper bottles (1) – cardboard packs.

Sulfacyl sodium solution bufus [Obnovlenie Pfc, JSC (Russia)]
Eye drops 20%: dropper bottle 5 ml or 10 ml

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Sulfacyl sodium solution bufus

Eye drops 20%: dropper bottle 5 ml or 10 ml

Dosage Form, Packaging, and Composition

Eye drops 20%	1 ml
Sulfacetamide	200 mg

5 ml – polymer dropper bottles (1) – cardboard packs.
10 ml – polymer dropper bottles (1) – cardboard packs.

Sulfacyl sodium-DIA [Diafarm, JSC (Russia)]
Eye drops 20%: dropper bottle 5 ml or 10 ml

Marketing Authorization Holder

Diafarm, JSC (Russia)

Dosage Form

Sulfacyl sodium-DIA

Eye drops 20%: dropper bottle 5 ml or 10 ml

Dosage Form, Packaging, and Composition

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

	1 ml
Sodium sulfacetamide monohydrate	200 mg

Excipients: sodium thiosulfate pentahydrate – 1.5 mg, 1M hydrochloric acid solution* (to pH 7.7-8.7), purified water – to 1 ml.
* 1M hydrochloric acid solution is obtained from concentrated hydrochloric acid and purified water.

5 ml – polyethylene dropper bottles (1) – cardboard packs.
10 ml – polyethylene dropper bottles (1) – cardboard packs.

Sulfacyl sodium-DIA [Diafarm, JSC (Russia)]
Eye drops 10%: dropper bottle 5 ml or 10 ml

Marketing Authorization Holder

Diafarm, JSC (Russia)

Dosage Form

Sulfacyl sodium-DIA

Eye drops 10%: dropper bottle 5 ml or 10 ml

Dosage Form, Packaging, and Composition

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

	1 ml
Sodium sulfacetamide monohydrate	100 mg

Excipients: sodium thiosulfate pentahydrate – 1.5 mg, 1M hydrochloric acid solution* (to pH 7.7-8.7), purified water – to 1 ml.

5 ml – polyethylene dropper bottles (1) – cardboard packs.
10 ml – polyethylene dropper bottles (1) – cardboard packs.

* 1M hydrochloric acid solution is obtained from concentrated hydrochloric acid and purified water.

Sulfacyl sodium-SOLOpharm [Grotex, LLC (Russia)]
Eye drops 20%: dropper tubes 0.5 ml 5 pcs., bottle 5 ml 1 pc.

Marketing Authorization Holder

Grotex, LLC (Russia)

Dosage Form

Sulfacyl sodium-SOLOpharm

Eye drops 20%: dropper tubes 0.5 ml 5 pcs., bottle 5 ml 1 pc.

Dosage Form, Packaging, and Composition

Eye drops in the form of a transparent, colorless or slightly colored liquid.

	1 ml
Sodium sulfacetamide monohydrate (in terms of sodium sulfacetamide)	200 mg

Excipients: sodium thiosulfate pentahydrate – 1 mg, 1M hydrochloric acid solution – to pH 8.0, water for injections – to 1 ml.

0.5 ml – dropper tubes (3 pcs.) – cardboard packs – Over-the-Counter
0.5 ml – dropper tubes (5 pcs.) – cardboard packs – Over-the-Counter
1 ml – dropper tubes (3 pcs.) – cardboard packs – Over-the-Counter
1 ml – dropper tubes (5 pcs.) – cardboard packs – Over-the-Counter
5 ml – dropper bottle – cardboard packs – Over-the-Counter
5 ml – bottles – cardboard packs – Over-the-Counter

Sulfacyl-sodium-MEZ [Moscow Endocrine Plant FSUE (Russia)]
Eye drops 10%: dropper tube 1.5 ml, 2 ml or 5 ml, dropper bottle 5 ml or 10 ml, bottle 5 ml.

Marketing Authorization Holder

Moscow Endocrine Plant FSUE (Russia)

Dosage Form

Sulfacyl-sodium-MEZ

Eye drops 10%: dropper tube 1.5 ml, 2 ml or 5 ml, dropper bottle 5 ml or 10 ml, bottle 5 ml.

Dosage Form, Packaging, and Composition

Eye drops	1 ml
Sulfacetamide	100 mg

1.5 ml – polymer dropper tubes (1) – cardboard packs.
1.5 ml – polymer dropper tubes (2) – cardboard packs.
1.5 ml – polymer dropper tubes (4) – cardboard packs.
1.5 ml – polymer dropper tubes (5) – cardboard packs.
1.5 ml – polymer dropper tubes (10) – cardboard packs.
2 ml – polymer dropper tubes (1) – cardboard packs.
2 ml – polymer dropper tubes (2) – cardboard packs.
2 ml – polymer dropper tubes (4) – cardboard packs.
2 ml – polymer dropper tubes (5) – cardboard packs.
2 ml – polymer dropper tubes (10) – cardboard packs.
5 ml – polymer dropper tubes (1) – cardboard packs.
5 ml – polymer dropper tubes (2) – cardboard packs.
5 ml – polymer dropper tubes (4) – cardboard packs.
5 ml – polymer dropper tubes (5) – cardboard packs.
5 ml – polymer dropper tubes (10) – cardboard packs.
5 ml – polymer dropper bottles (1) – cardboard packs.
5 ml – polymer dropper bottles (2) – cardboard packs.
10 ml – polymer dropper bottles (1) – cardboard packs.
10 ml – polymer dropper bottles (2) – cardboard packs.
5 ml – glass bottles (1) with a dropper cap – cardboard packs.
5 ml – glass bottles (5) with a dropper cap – PVC contour packaging (1) – cardboard packs.

Medixlife (Author)

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