Expiration date: 05/2025

Release form and composition:

1 tablet contains:

sulfasalazine 500 mg

Tablets, film-coated brownish-yellow, round, biconvex, with a beveled edge are allowed inclusions.

Excipients: gelatinized starch, magnesium stearate, silicon oxide colloidal anhydrous.The composition of the shell: hypromellose, propylene glycol.

10 PCs. - packaging sells contoured (5) - packs of cardboard.

Pharmacological action: Sulfasalazine selectively accumulates in the connective tissue of the intestine with the release of 5-aminosalicylic acid, which has anti-inflammatory activity, and sulfapyridine, which has an antimicrobial effect.

Pharmacokinetics:absorption of Sulfasalazine is poorly absorbed in the intestine (not more than 10%). Is subjected to cleavage by intestinal microflora with the formation of 60-80% of sulfapyridine and 25% of 5-aminosalicylic acid (5-ASA).RASPREDELENIYa plasma protein is: for sulfasalazina - 99% for sulfapyridine - 50%, 5-ask - 43%.Metabolism liver sulfapiridin biotransformiroetsa mainly by acetylation, 5-ASA by acetylation. Breeding T1/2 sulfasalazine is 5-10 h, sulfapyridine - 6-14 h, 5-ASA - 0.6-1.4 h. The feces derived 5% of sulfapiridina and 67% 5-ask 75-91% sulfasalazine excreted by the kidneys within 3 days.

Indications:

• ulcerative colitis (treatment of exacerbations and maintenance therapy in remission)
• Crohn's disease (mild and moderate forms in the acute phase)
• rheumatoid arthritis
• juvenile rheumatoid arthritis.

Dosage regimen: Adults on the first day of treatment is prescribed at a dose of 500 mg 4 times/day on the 2nd day - 1 g 4 times/day on the 3rd and subsequent days - 1.5-2 g 4 times/day. After subsiding acute clinical symptoms of ulcerative colitis, the drug is prescribed in a maintenance dose of 500 mg 3-4 times/day for several months.Children aged 5-7 years are prescribed 250-500 mg 3-6 times/day, children over 7 years - 500 mg 3-6 times/day.The drug should be taken after meals.

Side effects: CNS and peripheral nervous system: headache, dizziness, tinnitus, ataxia, convulsions, sleep disorders, hallucinations, peripheral neuropathy.From the urinary system: renal dysfunction, interstitial nephritis.From the digestive system: nausea, vomiting, diarrhea, abdominal pain, anorexia, hepatitis, pancreatitis.Respiratory system: interstitial pneumonitis and other lesions of the lung tissue.From the hematopoietic system: anemia, leukopenia, thrombocytopenia, agranulocytosis.From the reproductive system: transient oligospermia, infertility.Allergic reactions: skin rash, fever, anaphylactic shock.Other: possible yellow skin, urine, soft contact lenses.

Contraindications:

• blood diseases
• porphyria
• severe liver function disorders
• severe renal dysfunction
• deficiency of the enzyme glucose-6-phosphate dehydrogenase
• children up to 5 years
• increased sensitivity to sulfonamides and derivatives of salicylic acid.

Pregnancy and lactation: the Use of Sulfasalazine during pregnancy is possible only for strict indications in the minimum effective dose. If the course of the disease allows, it is recommended to cancel the drug in the III trimester of pregnancy.If necessary, the use of the drug during lactation should decide on the termination of breastfeeding.

Special instructions: With caution, the drug should be prescribed to patients with impaired liver and/or kidney function, patients with bronchial asthma, allergic reactions.During the use of the drug, it is recommended to use an increased amount of liquid.

Overdose: Symptoms: nausea, vomiting, abdominal pain, dizziness.Treatment: gastric lavage, forced diuresis symptomatic therapy.

Drug interaction: While the use of Sulfasalazine reduces the absorption of folic acid and digoxin.With the simultaneous use of Sulfasalazine enhances the action of anticoagulants and sulfonylurea derivatives.With the simultaneous use of Sulfasalazine and antibiotics may reduce the effectiveness of Sulfasalazine, because antibiotics have a depressing effect on the intestinal flora.

Terms and conditions of storage: the Drug should be stored out of reach of children at a temperature not exceeding 25°C. do Not use the drug after the expiration date indicated on the package.