Mesalazine

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Available since: 2019-09-19

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Clinical Pharmacology

Anti-inflammatory agent with a predominant localization of action in the intestine. Mesalazine (5-aminosalicylic acid) inhibits the activity of neutrophilic lipoxygenase and the synthesis of arachidonic acid metabolites (prostaglandins and leukotrienes), which are mediators of inflammation. Inhibits migration, degranulation, phagocytosis of neutrophils, as well as the secretion of immunoglobulins by lymphocytes. Mesalazine has antioxidant properties by binding to free oxygen radicals.

Pharmacokinetics

After oral administration, mesalazine is slowly released from the dosage form in the distal small intestine and in the large intestine. Plasma protein binding is 43%. Metabolized in the intestinal mucosa and in the liver to form N-acetyl-5-ASA. T1 / 2 is 0.5-2 hours. Mesalazine is excreted in the urine, mainly in the acetylated form.

Indications

Nonspecific ulcerative colitis, Crohn's disease (prevention and treatment of exacerbations).

Mesalazine is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Pentasa	Ferring	Germany	granules
Salofalk	Dr. Falk	Germany	suspension
Salofalk	Dr. Falk	Germany	rectal suppositories
Salofalk	Dr. Falk	Germany	pills
Pentasa	Ferring	Germany	pills
Kansalazin	Canonpharma	Russia	pills
Mezavant	Cosmo	Italy	pills
Salofalk	Dr. Falk	Germany	granules
Mesacol	Sun Pharmaceutical Industries Ltd	India	pills
Pentasa	Ferring	Germany	rectal suppositories

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Dosage and Administration

The contents of one reservoir are administered rectally 1 time per day before bedtime (it is recommended to first clean the intestines). The daily dose is 30-50 mg / kg. The maximum daily dose is 3 g.

For the prevention of relapse, oral Salofalk is recommended in the form of pills at a dose of 15–30 mg / kg / day. The daily dose should be divided into 2 doses.

Adverse reactions

From the digestive tract: diarrhea, nausea, abdominal pain, flatulence, loss of appetite, vomiting, increased levels of liver enzymes in the blood, hepatitis.

From the side of the central nervous system: headache, depression, dizziness, insomnia, malaise, paresthesias, convulsions, tremor, tinnitus.

Hypersensitivity Reactions: skin rash, pruritus, erythema, fever, bronchospasm, pericarditis and myocarditis, acute pancreatitis, interstitial nephritis, nephrotic syndrome. Individual cases of allergic alveolitis and pancolitis have been observed. Under certain conditions, mesalazine and drugs with a similar chemical structure can lead to the development of a syndrome similar to that of systemic lupus erythematosus.

Other side effects: rarely - tachycardia, hypertension or hypotension, chest pain, shortness of breath; myalgia, arthralgia. In some cases, proteinuria, hematuria, crystalluria, oliguria, anuria were observed; anemia, leukopenia, agranulocytosis, thrombocytopenia, hypoprothrombinemia; decrease in production of tear fluid, alopecia.

Contraindications

Carefully: pregnancy (I term), mild to moderate renal / hepatic insufficiency, lung diseases (especially bronchial asthma).

Drug interactions

With simultaneous appointment, it is possible to enhance the action of coumarin anticoagulants, increase the toxicity of methotrexate, reduce the diuretic effect of spironolactone and furosemide, reduce the effectiveness of probenecid and rifampicin. Enhances the hypoglycemic effect of oral antidiabetic agents - sulfonylurea derivatives.

Pregnancy and Lactation

In pregnancy, suspected pregnancy, pregnancy planning, breastfeeding should consult with your doctor. The drug should not be used in the last 4 weeks of pregnancy.

Salofalk can be used during pregnancy only in cases where the potential benefit of its use for the mother outweighs the possible risk to the fetus.

When breastfeeding use rectal forms of the drug should not be - the active substance and its metabolites can penetrate into breast milk. If necessary, the appointment of Salofalk during lactation should decide on the termination of breastfeeding.

Special instructions

Salofalk is recommended to use only under the supervision of a physician. Before treatment, during therapy (14 days after its start and then every 4 weeks), as well as after the end of therapy (every 3 months), blood and urine tests should be performed. To monitor kidney function, it is recommended to determine the level of urea and serum creatinine, the study of urine sediment.