Sulfasalazin (sulfasalazine) coated tablets 500 mg. №50

Description

Sulfasalazin (sulfasalazine) coated tablets 500 mg. №50

Composition

active substance: sulfasalazine;

1 tablet contains sulfasalazine 500 mg;

Excipients: povidone, pregelatinized starch, magnesium stearate, colloidal anhydrous silica, hypromellose, propylene glycol.

Dosage form

Film-coated tablets.

Main physical and chemical properties: round, brownish-yellow, slightly biconvex tablets with beveled edges, covered with a transparent colorless film coating.

Pharmacotherapeutic group

Anti-inflammatory drugs used in intestinal diseases. Aminosalicylic acid and similar agents.
ATX code A07E C01.

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.

Indications

Sulfasalazin tablets 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.

Contraindications

The drug Sulfasalazin tablets 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 dose should be adjusted according to the severity of the disease and possible side effects. Sulfasalazin tablets should be taken with food, drinking a glass of liquid. The missed dose should be taken as early as possible until there is little time left to take the next dose. In this case, the patient should take only the next scheduled dose.

The tablets should be swallowed whole, not broken or crushed.

Elderly patients: no special warnings.

• Ulcerative colitis
  Adults
  Severe: 2-4 tablets of the drug Sulfasalazine 4 times a day, can be used in combination with steroids as part of intensive care. At fast passing of tablets efficiency of drug can decrease.
  The night interval between receptions should not exceed 8 hours.
  The course of moderate severity: 2-4 tablets 4 times a day, can be used in combination with steroids.
  Mild: 2 tablets 4 times a day with or without steroids.
  Maintenance therapy: after induction of remission, gradually reduce the dose to 4 tablets per day. At this dose, the drug should be taken constantly, because if you stop treatment, even a few years after an acute attack, the risk of recurrence increases 4 times.
  Children
  The dose should be reduced in proportion to body weight.
  In case of acute attack or relapse: 40-60 mg / kg per day.
  Maintenance treatment: 20-30 mg / kg per day.
• Crohn’s disease
  In Crohn’s disease, the drug should be taken according to the same scheme as in ulcerative colitis.
• Rheumatoid arthritis
  Adults
  Patients with rheumatoid arthritis and patients who have used NSAIDs for a long time may have a sensitive stomach, so in this case, Sulfasalazine should be used according to the following recommendations. Treatment should be started with 1 tablet per day, gradually increasing the dose by 1 tablet per day per week until the dose is 1 tablet 4 times a day or 2 tablets 3 times a day depending on the tolerability and effectiveness of the drug. The effect is slow, and the pronounced effect may not be observed for 6 weeks. Improving joint mobility should be accompanied by a decrease in erythrocyte sedimentation rate and C-reactive protein levels. Concomitant use of NSAIDs and the drug Sulfasalazine is possible.
• Juvenile polyarticular or oligoarticular rheumatoid arthritis
  Children from 6 years old.
  30-50 mg / kg / day, divided into 4 equal doses. Usually the maximum daily dose is 2000 mg / day. To reduce possible gastrointestinal intolerance, the drug should be started with the planned maintenance dose and then increased by ¼ each week until the maintenance dose is reached.

Children

Studies on the safety and efficacy of sulfasalazine in the treatment of signs and symptoms of juvenile rheumatoid arthritis with polyarthritis syndrome have been reported in patients with rheumatoid arthritis aged 6 to 16 years. Extrapolation of data from adult patients with rheumatoid arthritis to children with juvenile rheumatoid arthritis with polyarthritis syndrome is based on the similarity of the disease and the effectiveness of therapy in these two groups of patients. Published research confirms the possibility of extrapolating data on the safety and efficacy of sulfasalazine in juvenile rheumatoid arthritis with polyarthritis syndrome.

A high incidence of adverse events has been reported in patients with systemic juvenile arthritis. The use of the drug in children with systemic juvenile rheumatoid arthritis often resulted in a serum-like reaction. This reaction was often severe and manifested by fever, nausea, vomiting, headache, rash, and abnormal liver function tests. Treatment with sulfasalazine in the systemic course of juvenile rheumatoid arthritis is not recommended.

Overdose

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.