Ulcerative colitis - in the phase of exacerbation and prevention of relapse. Leśniowski and Crohn's disease - in the phase of exacerbation.
Composition:
1 tabl enteral contains 250 mg or 500 mg of mesalazine.
Action:
Salicylic acid derivative (5-ASA) with local anti-inflammatory effect on mucosa and submucosa of the intestine. The mechanism of action is not fully explained. It probably inhibits lipoxygenase, affects the concentration of prostaglandin in the intestinal mucosa and traps free oxygen radicals. Thanks to the insoluble coating, mesalazine is released only in the small intestine and the colon. Absorption of mesalazine is greatest in the proximal sections and the smallest in the sections of the intestines. Mesalazine is metabolised prior to the transition to systemic circulation, both in the intestinal mucosa and in the liver, to N-acetyl-5-aminosalicylic acid, which is pharmacologically inactive. Binding to mesalazine and metabolite plasma proteins is 43% and 78%, respectively. Mesalazine and its metabolite are excreted mainly via faeces and urine.
Contraindications:
Hypersensitivity to salicylic acid, its derivatives and other components of the preparation. Severe kidney or liver problems. Peptic ulcer of the stomach and duodenum. Hemorrhagic diathesis.
Precautions:
Before and during drug administration, blood tests should be performed (smear morphology, liver function parameters such as ALT or AST, serum creatinine) and in the urine (strip test and urine sediment). It is recommended to perform the tests on day 14 after the start of treatment, and then 2-3 times at intervals of 4 weeks. If the results are correct, tests should be performed every 3 months. In case of additional symptoms of the disease, the tests should be carried out immediately. Caution should be exercised when using the drug in patients with impaired liver function. The preparation should not be given to patients with impaired renal function. If the kidney function worsens during the use period, the neurotoxic effects of mesalazine should be suspected. Patients with lung disease, especially with asthma, require follow-up during treatment. Patients with hypersensitivity to sulfasalazine preparations should only start treatment under close medical supervision. If symptoms of intolerance occur, such as cramps, sharp stomach pain, fever, acute headache or rash, stop taking the medicine immediately. In rare cases, in patients with a removed segment of intestine or after surgery in the vicinity of the passage of the small intestine into the thick, with ileocecal valve removal, due to the accelerated transport through the intestine, the tablets were excreted in the faeces in insoluble form. It should not be given to children under 6 years of age due to lack of data on efficacy and safety in this age group.
Pregnancy and lactation:
It may be used during pregnancy and breastfeeding only if the expected benefits outweigh the potential risks.
Side effects:
Rare: nausea, abdominal pain, diarrhea, bloating, vomiting, pain and dizziness. Very rare: peripheral neuropathy, impaired renal function (including acute and chronic interstitial nephritis, renal failure), allergic skin reactions, drug-induced fever, bronchospasm, pericarditis, myocarditis, allergic alveolitis, acute pancreatitis, syndrome systemic lupus erythematosus, generalized colitis, muscle and joint pain, blood dysrhythmia (aplastic anemia, agranulocytosis, pancytopenia, neutropenia, leukopenia, thrombocytopenia), hepatitis, hepatic function abnormalities (increase in ALT and AST and parameters indicating cholestasis) , cholestatic hepatitis, alopecia, oligospermia (reversible).
Dosage:
Orally.Adults. Ulcerative colitis: in acute conditions of 1.5-3 g per day in 3 doses; in preventing relapse of the disease / in long-term treatment 1.5 g daily in 3 doses.Crohn's disease: in acute conditions, 1.5-4.5 g per day in 3 doses. If the recommended dose is more than 1.5 g per day, use 500 mg.Children ≥6 years (The dose should be determined individually). In acute inflammatory conditions (regarding both indications) initially 30-50 mg / kg / day; the maximum dose is 75 mg / kg / day; The total dose should not exceed 4 g daily. In the long-term treatment of ulcerative colitis, initially 15-30 mg / kg / day; The total dose should not exceed 2 g daily. For children weighing ≤40 kg, the recommended dose may be half of the adult dose, while adults with a body weight of> 40 kg may use the recommended dose for adults. In preventing the recurrence of ulcerative colitis, the dose can usually be reduced to 1.5 g / day (adults and adolescents weighing> 40 kg). Treatment of acute conditions of ulcerative colitis or Crohn's disease usually lasts 8-12 weeks. The drug should be taken for 1 hour before a meal. The tablets should be swallowed whole without chewing them with plenty of liquid.
(C)
