Kansalazin tabs 500mg #50

Instruction for Kansalazin

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Release form and composition

    prolonged-action tablets: biconvex, round, white with a gray tint or almost white, slight inclusions are possible (10 or 15 pcs. in blister strip packaging, in a cardboard bundle 1, 3, 5, 6, 9 or 10 packs of 10 pcs. either 2, 4 or 6 packs of 15 pcs.);
Each pack also contains instructions for the use of Kansalazin.
1 tablet of prolonged action contains:
    active substance: mesalazine - 500 mg;
    additional components: colloidal silicon dioxide, calcium hydrogen phosphate dihydrate, sodium alginate, copovidone, magnesium stearate, microcrystalline cellulose.

Pharmacodynamics

Mesalazine, the active substance of Kansalazin, has an anti-inflammatory effect. It inhibits the production of arachidonic acid metabolites - leukotrienes and prostaglandins, inhibits the activity of neutrophilic lipoxygenase, and prevents leukocyte chemotaxis. The substance helps to slow the migration, degranulation and phagocytosis of neutrophils, as well as the production of immunoglobulins by lymphocytes. Kansalazin exhibits an antibacterial effect in relation to some cocci and E. coli (manifested in the colon).
Mesalazine exhibits antioxidant properties by binding to oxygen radicals and destroying them. The effect of the drug after oral administration or rectal administration is mainly due to local exposure in contact with inflamed intestinal tissue.
Kansalazin is characterized by good tolerance. The drug in the form of tablets of prolonged action reduces the risk of relapse in Crohn's disease, especially in patients with ileitis and with a long duration of the disease.

Pharmacokinetics

About 30–50% of an oral dose of mesalazine is absorbed predominantly in the small intestine. With rectal administration, the release of the active substance proceeds in the colon and rectum. Metabolic transformation occurs in the intestinal mucosa and in the liver by acetylation and to a small extent with the help of enterobacteria with the formation of the main metabolite - N-acetyl-5-aminosalicylic acid. As a result, the plasma level of the drug is relatively low. Mesalazine binds to plasma proteins by 43%, and its main metabolite - by 73–83%.
Mesalazine, as well as its metabolites, does not pass through the blood-brain barrier, however, it penetrates in the form of a metabolite into breast milk (0.1% of the dose). After oral administration of Kansalazin in a daily dose of 1500 mg, cumulative properties were revealed in healthy volunteers. The drug accumulates against a background of chronic renal failure (CRF). Mesalazine and its metabolites are excreted from the body by the kidneys and intestines.

Indications for use

Sustained-release tablets Kansalazin are recommended for use in the prevention and treatment of exacerbations of ulcerative colitis and Crohn's disease.

Contraindications

Absolute:
    peptic ulcer of the stomach and duodenum (during exacerbation - for suppositories);
    severe violations of the liver and / or kidneys;
    hemorrhagic diathesis (with a predisposition to bleeding - for suppositories);
    blood diseases - for tablets;
    age up to 18 years - for suppositories; age up to 12 years, as well as body weight less than 50 kg - for tablets;
    lactation - for tablets;
    the last 2–4 weeks of pregnancy - for tablets;
    hypersensitivity to any of the components of the drug and other derivatives of salicylic acid.
Relative (treatment with Kansalazin should be carried out with caution):
    glucose-6-phosphate dehydrogenase deficiency;
    impaired liver and / or kidney function;
    I trimester of pregnancy - for tablets;
    respiratory dysfunction (especially the presence of bronchial asthma) - for suppositories.

Instructions for use: method and dosage

Kansalazin tablets are taken orally after a meal, without breaking or chewing, swallowing whole and drinking plenty of fluids. The daily dose of the drug is selected individually and is divided into several doses.
Recommended daily doses of Kansalazin, depending on the indications and age of the patients:
    ulcerative colitis (period of exacerbation), Crohn's disease (stage of exacerbation and maintenance treatment): adults - up to 4000 mg (up to 8 tablets), adolescents over 12 years old with a body weight of at least 50 kg - 20-30 mg / kg;
    ulcerative colitis (maintenance therapy): adults - 2000 mg (4 tablets), adolescents over 12 years old with a body weight of at least 50 kg - 20-30 mg / kg.

Side effects

    cardiovascular system: pain behind the sternum, palpitations, shortness of breath, increase / decrease in blood pressure (BP), tachycardia;
    digestive system: loss of appetite, nausea, heartburn, vomiting, abdominal pain, diarrhea, increased activity of hepatic transaminases, pancreatitis, hepatitis;
    nervous system: dizziness, tinnitus, headache, tremor, polyneuropathy, depression;
    urinary system: anuria, proteinuria, crystalluria, oliguria, hematuria, nephrotic syndrome;
    hematopoietic organs: hypoprothrombinemia, anemia (megaloblastic, aplastic, hemolytic), leukopenia, thrombocytopenia, agranulocytosis;
    allergic reactions: itching, skin rash, dermatosis, bronchospasm;
    others: weakness, decreased production of tear fluid, lupus-like syndrome, photosensitivity, alopecia, mumps, oligospermia.

Overdose

With a single dose below 150 mg / kg, an overdose of mild severity is observed, 150-300 mg / kg - moderate, more than 300 mg / kg - severe.
Signs of an overdose of Kansalazin of mild to moderate severity may include symptoms of salicylism: general malaise, dizziness, tinnitus, severe headache, visual impairment, nausea, vomiting, fever (poor prognostic sign in adults). Against the background of severe intoxication, the following symptoms may appear: drowsiness, anuria, convulsions, bleeding, confused consciousness, collapse, central hyperventilation of the lungs, respiratory alkalosis, metabolic acidosis. Initially, central hyperventilation of the lungs causes the development of respiratory alkalosis, manifested in the form of cold, sticky sweat, shortness of breath, suffocation, cyanosis; with increased intoxication, respiratory paralysis and dissociation of oxidative phosphorylation are aggravated, which leads to respiratory acidosis.
In case of chronic overdose, plasma levels of mesalazine detected poorly correlate with the severity of intoxication. The threat of chronic intoxication is aggravated in elderly patients while taking Kansalazin for several days at a daily dose of more than 100 mg / kg. In elderly people and children, the initial symptoms of salicylism are not always manifested, therefore, it is recommended to periodically determine the content of salicylates in the blood. With moderate / severe poisoning, the salicylate level is more than 70 mg%, with extremely severe, prognostically unfavorable - more than 100 mg%. If moderate intoxication is established, the patient needs hospitalization for 24 hours. In this condition, they provoke vomiting, prescribe activated charcoal and laxatives, and constantly monitor the acid-base composition of the blood (CBS) and electrolyte balance. Sodium bicarbonate, a solution of sodium citrate or sodium lactate are administered depending on the state of metabolism.
An increase in reserve alkalinity leads to increased elimination of mesalazine as a result of alkalization of urine. When salicylates are more than 40 mg%, urine acidity is reduced by alkalization, carried out by intravenous infusion of sodium bicarbonate - 88 mEq in 1 liter of 5% dextrose solution at a rate of 10-15 ml / h / kg. In order to restore the volume of circulating blood (BCC) and the induction of diuresis in the same doses and dilution, sodium bicarbonate is administered 2-3 times. In elderly patients, caution is required, since they have an intensive fluid infusion can provoke pulmonary edema. For alkalization of urine, it is not recommended to use acetazolamide, because it can cause acidemia and aggravate the toxic effect of salicylates.
Hemodialysis is recommended when the level of salicylates is more than 100-130 mg%, and against chronic poisoning - 40 mg% or less, in the presence of indications such as progressive deterioration, refractory acidosis, severe damage to the central nervous system, renal failure and edema lungs. If pulmonary edema develops, mechanical ventilation (IVL) is prescribed with a mixture enriched with oxygen.

Special instructions

Before the start of the course, during the treatment with Kansalazin and after its cancellation, it is advisable to conduct a general blood test and urinalysis, monitor the excretory function of the kidneys and indicators of the functional state of the liver - the activity of alanine aminotransferase (ALT) and aspartate aminotransferase (ACT), as well as the plasma level of creatinine in the blood. Control examinations are recommended, as a rule, to be carried out 14 days after the start of therapy and subsequently 2-3 times with an interval of 4 weeks. If the test results do not go beyond the norm, then the survey data can be carried out every 3 months. With the development of additional symptoms, urgent control tests are needed.
In patients related to slow acetylators, the risk of adverse reactions is increased, staining of urine and tears in yellow-orange color, staining of soft contact lenses may be noted.
Rectal suppositories are not recommended for patients with functional renal impairment. If a deterioration in kidney activity is detected during therapy, the possible nephrotoxic effect of mesalazine should be considered.
Patients with impaired lung function (especially those suffering from asthma) when using suppositories need careful monitoring.
Persons with established hypersensitivity to sulfasalazine-containing products can only start Kansalazin therapy under strict medical supervision. In case of signs of acute intolerance, which may include acute pain and cramping in the abdomen, severe headaches, fever and skin rashes, the use of the drug should be stopped immediately.
If the patient has missed the next pill, the missed dose must be taken at any time or along with the next dose. If several doses are missed, it is necessary, without stopping therapy, to obtain specialist advice.

Influence on the ability to drive vehicles and complex mechanisms

Patients driving vehicles or servicing other complex and moving mechanisms are advised to refrain from performing these activities during treatment with Kansalazin due to the possible occurrence of adverse reactions (dizziness and others).

Pregnancy and lactation

It was found that mesalazine crosses the placental barrier, but since the experience of its use in pregnant women is limited, it is not possible to assess the risk of possible adverse events during treatment with the drug during pregnancy. In studies on animals in which the drug was used orally, no adverse effects were found on pregnancy, embryo / fetus development, and childbirth.
Therapy in pregnant women is possible only if the expected benefit to the mother significantly exceeds the possible threat to the health of the fetus. In the last 2–4 weeks of pregnancy, taking Kansalazin tablets is contraindicated.
Mesalazine is excreted in breast milk in significantly lower concentrations compared to those in a woman's blood plasma, however, acetyl-mesalazine (its main metabolite) is excreted in similar or higher concentrations. If you need to use Kansalazin during lactation, you must stop breast-feeding.

Use in childhood

Rectal suppositories Kansalazin is contraindicated for patients under the age of 18 years, prolonged-release tablets - for patients under 12 years of age, and also with a body weight of less than 50 kg.

With impaired renal function

In the presence of a severe degree of renal failure, the use of Kansalazin is contraindicated, with a mild to moderate degree, it is recommended to use the drug with caution.

With impaired liver function

In the presence of a severe degree of liver failure, the use of Kansalazin is contraindicated, with a mild to moderate degree, use the drug with caution.

Drug interaction

    sulfonylurea derivatives: their hypoglycemic effect is enhanced;
    sulfonamides, furosemide, rifampicin, spironolactone: their activity decreases;
    uricosuric drugs (tubular secretion blockers): their effectiveness increases;
    methotrexate: the risk of its toxic effects is exacerbated;
    glucocorticosteroids: their ulcerogenic effect increases;
    anticoagulants: their therapeutic effect is enhanced;
    thioguanine, azathioprine, 6-mercaptopurine: there may be an increase in the myelosuppressive effect of these substances;
    warfarin (indirect anticoagulant): it is possible to weaken its anticoagulant effect (with this combination, prothrombin time should be monitored);
    cyanocobalamin: its absorption slows down.

Terms and conditions of storage

Keep out of reach of children, protected from moisture and light (for tablets), at a temperature not exceeding 25 ° C.
Shelf life is 3 years.

Reviews

Reviews of Kansalazin on medical sites are quite rare and mainly relate to tablets of prolonged action. Patients mainly note the effectiveness of the drug in the treatment of exacerbations of ulcerative colitis and Crohn's disease. Use Kansalazin is recommended only as prescribed by the doctor and in the dosages prescribed by him.

Terms of sell

You don't need a prescription to buy Kansalazin.