Sulgin (Tablets) Instructions for Use

Marketing Authorization Holder

PharmVILAR NPO, LLC (Russia)

Manufactured By

PharmVILAR NPO, LLC (Russia)

ATC Code

A07AB03 (Sulfaguanidine)

Active Substance

Sulfaguanidine (Rec.INN registered by WHO)

Dosage Form

Sulgin

Tablets 500 mg: 10, 20, 30, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets are white or almost white, round, flat-cylindrical in shape, with a bevel and a score line.

Excipients: potato starch, calcium stearate, sodium carboxymethyl starch.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.

Clinical-Pharmacological Group

Antibacterial sulfonamide drug

Pharmacotherapeutic Group

Antidiarrheals, intestinal anti-inflammatory/antimicrobial agents; intestinal antimicrobial agents; sulfonamides

Pharmacological Action

It is a broad-spectrum antibacterial agent, a sulfonamide derivative. Sulfaguanidine is active against Gram-positive and Gram-negative microorganisms (including pathogens of intestinal infections). It is poorly absorbed from the gastrointestinal tract. It acts primarily in the intestinal lumen.

The mechanism of action is due to competitive antagonism with PABA and competitive inhibition of dihydropteroate synthase, which leads to impaired synthesis of tetrahydrofolic acid, necessary for the synthesis of purines and pyrimidines.

It inhibits the growth of Escherichia coli and reduces the synthesis of thiamine, riboflavin, and nicotinic acid in the intestine. Sulgin has a bacteriostatic effect on Streptococcus spp., Staphylococcus spp., Escherichia coli, Shigella dysenteriae, Proteus vulgaris.

Pharmacokinetics

After oral administration, Sulfaguanidine is slightly absorbed from the gastrointestinal tract, resulting in a high bacteriostatic concentration in the intestine.

Indications

Bacterial dysentery. Colitis and enterocolitis. Preparation for colon surgery.

ICD codes

Dosage Regimen

Administer orally. The dose, regimen, and duration of therapy are determined individually based on the indication and the patient’s age.

For adults: initial dose is 1-2 g ( 2-4 tablets) per administration. On the first day of treatment, administer a total of 6 g ( 12 tablets) in divided doses, with an interval of 4 hours between doses.

On the second and third days, administer 1-1.5 g ( 2-3 tablets) every 6 hours. On the fourth and fifth days, administer 1-1.5 g ( 2-3 tablets) every 8 hours.

Do not exceed the maximum single dose of 2 g ( 4 tablets). Do not exceed the maximum daily dose of 7 g ( 14 tablets).

For mild cases of the disease, the total course dose is 25-30 g. For more severe cases, the total course dose is 30-35 g.

For children aged 3 years and older: initial dose is 500 mg/kg ( 1 tablet per 10 kg of body weight) per day, divided into 3 doses with an interval of 6 hours.

Subsequent doses for children should be halved, administered at the same intervals. The total treatment duration for children is typically 5-7 days.

For preoperative bowel preparation, administer 500 mg ( 1 tablet) every 4 hours for 5 days prior to surgery. Postoperatively, resume the same regimen for an additional 5-7 days.

During the entire course of treatment, ensure adequate fluid intake ( 2-3 liters per day) to prevent crystalluria. Concurrently administer B vitamins to prevent deficiency.

Adverse Reactions

From the digestive system: often – nausea, vomiting.

From the urinary system: rarely – crystalluria.

Allergic reactions: frequency unknown – urticaria, exfoliative dermatitis.

Other: rarely – development of B vitamin deficiency, leukopenia; frequency unknown – neuritis.

Contraindications

Hypersensitivity to sulfonamides; glucose-6-phosphate dehydrogenase deficiency, nephrourolithiasis, porphyria, B₁₂-deficiency anemia, hyperbilirubinemia (in children); children under 3 years of age.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding). If use during lactation is necessary, the issue of discontinuing breastfeeding should be decided.

Pediatric Use

Contraindicated for use in children under 3 years of age.

Special Precautions

During treatment, it is necessary to maintain increased diuresis and simultaneously prescribe B vitamins. If necessary, Sulfaguanidine is used in combination with sulfonamides or antibiotics that are well absorbed from the gastrointestinal tract.

To prevent crystalluria during treatment, patients should receive plenty of fluids (2-3 liters/day).

Early discontinuation of treatment or insufficient doses may lead to the emergence of resistant strains of pathogens.

Drug Interactions

With simultaneous use, Sulfaguanidine reduces the effectiveness of oral contraceptives.

With simultaneous use, benzocaine, procaine reduce the antimicrobial activity of sulfaguanidine (as they release PABA upon hydrolysis).

With simultaneous use, NSAIDs, hypoglycemic agents (sulfonylurea derivatives), phenytoin, and indirect anticoagulants enhance the severity of sulfaguanidine’s side effects.

With simultaneous use, ascorbic acid, hexamethylenetetramine increase the risk of crystalluria.

With simultaneous use, myelotoxic agents enhance the manifestations of hematotoxicity of sulfaguanidine.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.