Sulfacil Sodium Renewal 20% Eye Drops

Indications

Sodium sulfacil Renewal is indicated for use in adults and children aged from 2 months to 18 years. In combination therapy for diseases of the eyelids, conjunctiva, cornea, anterior segment of the vascular membrane, and tear ducts caused by microorganisms sensitive to sulfacetamide. For the prevention of infectious complications in combination therapy for burns and injuries of the visual organs. Sodium sulfacil Renewal is indicated for use in adults and children aged from 2 months to 18 years. In combination therapy for diseases of the eyelids, conjunctiva, cornea, anterior segment of the vascular membrane, and tear ducts caused by microorganisms sensitive to sulfacetamide. For the prevention of infectious complications in combination therapy for burns and injuries of the visual organs.

Method of application and doses

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 instillations may be reduced as the condition improves. When treating eye diseases caused by Chlamydia trachomatis, the dosing regimen is 1 drop every 2 hours; local application of sulfanilamide should be combined with systemic therapy.

Instructions for using the dropper tube with a valve:
Method of application and doses
1. Turn the valve and open the dropper tube (make sure that the solution is at the bottom of the dropper tube).
2. Squeeze the dropper tube and instill the required amount of the medication into the eye(s).
3. Press the valve and close the dropper tube after each procedure.

Instructions for using the dropper tube with a screw cap:
Screw the cap tightly
The tip will pierce the dropper tube
Open the dropper tube
Squeeze the dropper tube
Tightly close the screw cap
1. Screw the cap of the dropper tube tightly until it stops.
2. The tip under the cap will pierce the top of the dropper tube.
3. Open the dropper tube carefully, avoiding touching the tip of the dropper tube with your fingers.
4. Squeeze the dropper tube, holding it between the thumb and index finger of one hand. Instill the required amount of the medication into the conjunctival sac of the eye. Avoid contact of the tip of the open dropper tube with the surface of the eye and hands.
5. After use, tightly close the screw cap clockwise.

Composition per 1 ml
Active ingredient:
sulfacetamide - 200 mg
Excipients:
sodium thiosulfate - 1 mg
hydrochloric acid - up to pH 8.5 (1 M solution of hydrochloric acid)
water for injections - up to 1 ml

Description of the dosage form

Transparent colorless or slightly colored liquid.

Contraindications

Increased sensitivity to the components of the drug, age under 2 months.

Special instructions

Patients with increased sensitivity to furosemide, thiazide diuretics, sulfonylurea derivatives, or carbonic anhydrase inhibitors may have increased sensitivity to sulfacetamide.
Excessive growth of microorganisms resistant to sulfanilamide, as well as fungal flora, is possible.
There is a reduction in the antibacterial activity of sulfanilamides in the presence of high concentrations of PAEC with a large amount of purulent discharge. Therapy should be discontinued if symptoms of allergy appear, as well as in case of increased pain and other signs of an infectious process, or an increase in purulent discharge.
Use within 30 days after opening.

Section: Side Effects

Adverse reactions are distributed by system-organ classes according to MedDRA.
Disorders of the immune system: allergic reactions, development of superinfection, severe allergic reactions to sulfonamides (Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant liver necrosis, agranulocytosis, aplastic anemia).
Disorders of the eye: burning, tearing, stinging, itching in the eyes, transient blurring of vision after instillation, nonspecific conjunctivitis.

Overdose

There is no data on the overdose of the drug.

Interaction

Sulfacetamide enhances the effect of indirect anticoagulants. Co-administration with benzocaine, procaine, and tetracaine reduces the bacteriostatic effect of sulfacetamide. Incompatibility of sulfacetamide is observed when it is used together with silver salts. Simultaneous administration with chloramphenicol increases the risk of side effects from the latter. Diphenylhydantoin, para-aminosalicylic acid (PAS), and salicylates increase the toxicity of sulfacetamide.

Pharmacodynamics

Antimicrobial bacteriostatic agent, sulfanilamide. The mechanism of action is due to competitive antagonism with para-aminobenzoic acid and inhibition of dihydropteroate synthase, disrupting 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 perfringens, Bacillus anthracis, Corynebacterium diphtheriae, Yersinia pestis, Chlamydia spp, Actinomyces israelii, Toxoplasma gondii.

Pharmacokinetics

Absorption
It penetrates the eye tissues, where it exerts its specific antibacterial effect. It acts predominantly locally, but a portion of the drug is absorbed through the inflamed conjunctiva and enters the systemic bloodstream. The amount of the drug that enters the systemic circulation is insufficient to develop a systemic therapeutic effect, but it is enough to cause sensitization upon repeated administration.
With local application, the maximum concentration (Cmax) of sulfanilamides in the cornea (about 3 mg/ml), aqueous humor (about 0.5 mg/ml), and iris (about 0.1 mg/ml) is reached within the first 30 minutes after application. Some amount (less than 0.5 mg/ml) remains in the tissues of the eyeball for 3-4 hours. In cases of corneal epithelial damage, the penetration of sulfanilamides is enhanced.
Biotransformation
Sulfacetamide is metabolized in the liver by N-acetylation, and the metabolites possess antibacterial activity. Excretion occurs through glomerular filtration.