Sulfasalazin (sulfasalazin) coated tablets 500 mg. №50


Induction and maintenance of remission in ulcerative colitis; treatment of Crohn’s disease in the active stage. Treatment of rheumatoid arthritis in adults in case of lack of efficacy of non-steroidal anti-inflammatory drugs (NSAIDs). Treatment of juvenile articular or oligoscopic rheumatoid arthritis.



Composition and form of release
Active ingredient: sulfasalazine (500 mg).
Sulfasalazine is produced in tablet form.
Pharmacological properties
It is an anti-inflammatory agent used for bowel diseases. It has an immunosuppressive effect – it suppresses the proliferation of killer cells, the transformation of lymphocytes. Locally inhibits cyclooxygenase, lipoxygenase in the intestinal wall, preventing the formation of leukotrienes, prostaglandins, and other inflammatory mediators.
Sulfasalazine shown:

  • for the induction and maintenance of remission in ulcerative colitis;
  • for the treatment of active Crohn’s disease;
  • for the treatment of rheumatoid arthritis in case of insufficient effectiveness of NSAIDs;
  • for the treatment of juvenile polyarticular / oligosarticular rheumatoid arthritis.

The drug Sulfasalazine is not used:

  • with intolerance to the components;
  • with intestinal obstruction;
  • with obstruction of the urinary tract;
  • with porphyria;
  • with severe renal dysfunction (GFR less than 30 ml / minute / 1.7 Zm2);
  • with severe liver dysfunction;
  • in the presence of severe asthma attacks, urticaria, rhinitis, and other manifestations of allergy caused by the intake of acetylsalicylic acid, other NSAIDs in history;
  • children under 6 years old.

Application during pregnancy and lactation
There is no data on the risk of teratogenic effects. The likelihood of negative effects on the fetus during pregnancy is low.
Since the harmful effect is not completely excluded, the drug is used during pregnancy if absolutely necessary.
Sulfasalazine passes into breast milk.
Method of administration and dosage
The drug Sulfasalazine is used internally (whole) during meals with water.
The tablets should be swallowed, not broken or crumbled.
The standard dose for moderate or severe Crohn’s disease, ulcerative colitis is 2-4 tablets 4 times a day, the night interval between doses should not exceed 8 hours.
The standard dose for mild Crohn’s disease, ulcerative colitis is 2 tablets 4 times a day.
The standard maintenance dose (after induction of remission) is 4 tablets per day.
Dosing for children with an acute attack – 40-60 mg / kg / day, maintenance – 20-30 mg / kg / day.
Symptoms: vomiting, abdominal pain, drowsiness, convulsions, kidney dysfunction, methemoglobinemia, sulfhemoglobinemia.
In case of an overdose, gastric lavage (or stimulation of vomiting) is performed, laxatives and infusion therapy are prescribed.
Side effects:

  • Hematological disorders: macrocytosis, pancytopenia, agranulocytosis, aplastic anemia, megaloblastic anemia, hypoprothrombinemia, purpura, methemoglobinemia, congenital neutropenia, myelodysplastic syndrome.
  • Immune disorders: epidermal necrolysis, anaphylaxis, erythema multiforme, interstitial lung disease, exfoliative dermatitis, drug rash with eosinophilia, DRESS syndrome, serum sickness, pneumonitis with / without eosinophilia, fibrosing alveolitis, vasculitis, pleuriditis without tamponade, periarteritis nodosa, hepatitis, liver necrosis with / without immune complexes, lupus-like syndrome, fulminant hepatitis, Much-Habermann syndrome, photosensitivity, rhabdomyolysis, arthralgia, alopecia, periorbital edema, hypersensitivity reactions.
  • Gastrointestinal disorders: hepatitis, pancreatitis, liver failure, impaired absorption of folic acid, bloody diarrhea, stomatitis, impaired absorption of digoxin, diarrhea, neutropenic enterocolitis, abdominal pain, exacerbation of ulcerative colitis.
  • Mental Disorders: Depressive Syndrome.
  • Neurological disorders: dysgeusia, seizures, transverse myelitis, transverse lesion of the posterior cord of the spinal cord, meningitis, cauda equina syndrome, encephalopathy, Guillain-Barré syndrome, peripheral neuropathy, dizziness, depression of mental functions, hearing loss, dysosmia, insomnia, hallucinations, tinnitus, drowsiness.
  • Genitourinary disorders: nephrotic syndrome, toxic nephropathy with anuria / oliguria, nephritis, hematuria, urinary tract infections, crystalluria, hemolytic uremic syndrome, proteinuria, interstitial nephritis.
  • Others: discoloration of the skin, alopecia, erythema, facial edema, discoloration of urine, pseudomonucleosis.

Storage conditions and periods
Store Sulfasalazine at temperatures up to + 25 ° C for no more than 5 years.