Description
Release form
Coated tablets.
Packing
50 pcs.
Pharmacological action
Sulfasalazin-EN – antimicrobial and anti-inflammatory intestinal agent.
Sulfasalazine selectively accumulates in the connective tissue of the intestine with the release of 5-aminosalicylic acid (5-ASA), possessing anti-inflammatory activity, and sulfapyridine, which has antimicrobial bacteriostatic activity against diplococci, streptococci, gonococci, E. coli.
Pharmacokinetics
About 30% of sulfasalazine in enteric coated tablets are absorbed from the small intestine, the remaining 70% are digested with intestinal microflora to form 60-80% sulfapyridine and 25% 5-ASA. Sulfasalazine reaches its maximum concentration 3-12 hours after taking enteric-coated tablets. Communication with plasma proteins of sulfasalazine – 99%, sulfapyridine – 50%, 5-ASA – 43%. Sulfapyridine is metabolized in the liver by hydroxylation to form inactive metabolites, 5-ASA by acetylation. The half-life of sulfasalazine is 5-10 hours, sulfapyridine – 6-14 hours, 5-ASA – 0.6-1.4 hours. It is excreted through the intestines – 5% sulfapyridine and 67% 5-ASA, kidneys – 75-91% of absorbed sulfasalazine (within 3 days).
Indications
ulcerative colitis (treatment of exacerbations and maintenance therapy in remission)
Crohn s disease (mild to moderate forms in the exacerbation phase)
rheumatoid arthritis
juvenile rheumatoid arthritis.
Contraindications
blood disease
porphyria
severe hepatic impairment
severe renal impairment
enzyme deficiency glucose-6-phosphate dehydrogenase
children under 5 years of age
hypersensitivity to sulfamic acid.
Composition
1 enteric-coated tablet contains: active ingredient: sulfasalazine coated with povidone (corresponding to 500 mg) sulfasalase 535,000 mg
excipients: pregelatinized starch, magnesium stearate, colloidal silicon dioxide, anhydrous.
Dosage and Administration
Inside. Adults on the first day of treatment are prescribed 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 the acute clinical symptoms of ulcerative colitis subside, sulfasalazin-EN 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 old are prescribed 500 mg 3-6 times / day. Sulfasalazine-EN should be taken after meals.
Side effects of
From the central nervous system and peripheral nervous system: headache, dizziness, tinnitus, ataxia, cramps, sleep disturbances, hallucinations, peripheral neuropathy.
From the urinary system: impaired renal function, interstitial nephritis.
From the digestive system: nausea, vomiting, diarrhea, abdominal pain, anorexia, hepatitis, pancreatitis.
From the respiratory system: interstitial pneumonitis and other lung tissue lesions.
From the hemopoietic system: anemia, leukopenia, thrombocytopenia, agranulocytosis.
From the reproductive system: transient oligospermia, infertility.
Allergic reactions: skin rash, fever, anaphylactic shock.
Others: staining of the skin, urine, soft contact lenses yellow is possible.
Storage conditions
In the dark place at a temperature of no higher than 25 ° C.
Expiration
2 years.
Deystvuyuschee substances
Sulfasalazine
Terms and conditions
prescription
dosage form
tablets
KRKA d.d. Novo mesto AO, Slovenia
