Description
release form
enteric-coated prolonged-release tablets.
Packaging
60 pcs
Indications
Induction of remission according to clinical and endoscopic indicators in patients with mild or moderate ulcerative colitis.
Maintenance of remission in patients with ulcerative colitis.
Contraindications
Hypersensitivity to salicylates (including mesalazine) or any auxiliary component of the drug.
Severe renal impairment (GFR <30 ml / min / 1.73 m2). Severe impairment of liver function. Children under 18 years of age (due to a lack of data on the safety and effectiveness of the drug in this category of patients). Precautions Mild or moderate renal impairment. Chronic dysfunction of the lungs (bronchial asthma). Diseases predisposing to the development of myo- or pericarditis. The drug is prescribed with caution to patients who are allergic to sulfasalazine, due to possible cross-sensitivity to mesalazine. Use during pregnancy and lactation Pregnancy Limited data on the use of mesalazine during pregnancy do not indicate an increased risk of congenital malformations. Mesalazine crosses the placental barrier, but the concentration of the substance in the tissues of the fetus is much lower than when used in therapeutic doses in adults. Animal studies have not revealed adverse effects of mesalazine on pregnancy, embryo / fetus development, childbirth, and postnatal development of offspring. Mesalazine should be used during pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus. Caution should be exercised when prescribing high doses of the drug. Lactation period Mesalazine is excreted in breast milk in a small amount, and the metabolite N-acetyl-5-aminosalicylic acid is in a higher concentration. During lactation, mesalazine should be used with caution and only if the possible benefit to the mother outweighs the potential risk to the baby. In infants, cases of sporadic diarrhea have been described. Ability to conceive Available data do not indicate a lasting effect of mesalazine on the ability of men to conceive. Special instructions It is advisable to regularly conduct a general blood test (before, during, and after treatment) and urine, and monitor the excretory function of the kidneys. Patients who are slow acetylators have an increased risk of side effects. Staining of urine and tears in yellow-orange color, staining of soft contact lenses may be observed. If you miss the drug, the missed dose should be taken at any time or along with the next dose. If several doses are missed, then, without stopping treatment, consult a doctor. If you suspect the development of acute intolerance syndrome, mesalazine must be canceled. Composition 1 tablet contains: Active ingredient: mesalazine 1200 mg. Excipients: Tablet core: sodium carmellose (7MF) – 11.3 mg, sodium carmellose (7HXF) – 38.7 mg, carnauba wax – 5.0 mg, stearic acid – 10.0 mg, colloidal silicon dioxide -2 , 0 mg, sodium carboxymethyl starch (type A) – 30.0 mg, talc – 11.0 mg, magnesium stearate – 14.0 mg. Tablet shell: talc – 17.8 mg, methacrylic acid and methyl methacrylate copolymer [1: 1] – 16.0 mg, methacrylic acid and methyl methacrylate copolymer [1: 2] -16.0 mg, triethyl citrate – 3.2 mg, titanium dioxide – 6, 0 mg, iron dye oxide red – 3.0 mg, macrogol 6000 – 1.0 mg. Dosage and administration The drug Lisinopril-Teva is taken orally once a day, regardless of the meal time, preferably at the same time of day. The dose is selected individually. With arterial hypertension, patients not receiving other antihypertensive drugs use 5 mg per day. In the absence of a therapeutic effect, the dose is increased every 2-3 days by 5 mg to a dose of 20-40 mg / day (increasing the dose above 40 mg / day usually does not lead to a further decrease in blood pressure). Average daily maintenance dose of 20 mg. The maximum daily dose is 40 mg. The therapeutic effect usually develops after 2-4 weeks from the start of treatment, which should be considered when increasing the dose. With insufficient effect, simultaneous use of the drug with other antihypertensive drugs is possible. If the patient has received pre-treatment with diuretics, then the intake of these drugs must be stopped 2-3 days before the start of the drug Lisinopril-Teva. If this is not possible, then the initial dose of Lisinopril-Teva should not exceed 5 mg per day. In this case, after taking the first dose, medical monitoring is recommended for several hours (the maximum effect is achieved after about 6 hours), since a marked decrease in blood pressure may occur. In case of renovascular hypertension associated with increased RAAS activity, it is also advisable to use a low initial dose of 2.5 mg per day in dynamics, under enhanced medical supervision (control of blood pressure, renal function, serum potassium). A maintenance dose, continuing strict medical supervision, should be determined depending on the dynamics of blood pressure. In chronic heart failure, the initial dose of 2.5 mg per day, the dose is gradually increased (by no more than 10 mg, with an interval of at least 2 weeks), depending on blood pressure. The maximum daily dose is 20 mg. In the early treatment of acute myocardial infarction on the first day, the dose is 5 mg, then 5 mg every other day, 10 mg after two days and then 10 mg per day as maintenance therapy. In patients with acute myocardial infarction, the drug should be used for at least 6 weeks. At the beginning of treatment or during the first 3 days after myocardial infarction in patients with low systolic blood pressure (120 mm Hg or lower), a lower dose of Lisinopril-Teva is used – 2.5 mg. If the systolic blood pressure is lower than or equal to 100 mm Hg the drug Lisinopril-Teva is not recommended. With concomitant renal failure (CC less than 80 ml / min. ) an appropriate dose adjustment should be made. In diabetic nephropathy in patients with type 1 diabetes mellitus, the drug Lisinopril-Teva is used at a dose of 10 mg per day. If necessary, the dose can be increased to 20 mg per day in order to achieve diastolic blood pressure below 75 mm RT. Art. in the sitting position. For patients with type 2 diabetes mellitus, the drug Lisinopril-Teva is used in the same dose in order to achieve a diastolic blood pressure below 90 mm Hg. in the sitting position. QC (ml / min.) Initial dose (mg / day) 30-80 5-10 10-29 2.5-5 less than 10 (including patients on hemodialysis) 2.5 In renal failure and in patients on hemodialysis, the initial dose is set depending on the CC.food Time. Tablets should not be crushed or chewed and should be swallowed whole. Adults, including the elderly (over 65 years) Induction of remission: 2.4 – 4.8 g (2 – 4 tablets) 1 time per day. For patients who are not sensitive to the minimum dose, the recommended maximum daily dose is 4.8 g. When taking the maximum dose (4.8 g / day), the treatment effect should be evaluated after 8 weeks. Maintenance of remission: 2.4 g (2 tablets) 1 time per day. Children and adolescents under 18 years of age: Due to the lack of safety and efficacy data, Mesavant is not recommended for children under 18 years of age. Special studies of the use of the drug Mesavant in patients with impaired liver or kidney function have not been conducted. Side effects of the Digestive system: nausea, vomiting, heartburn, diarrhea, loss of appetite, abdominal pain, increased activity of hepatic transaminases, hepatitis, pancreatitis. From the CCC side: palpitations, tachycardia, increase or decrease in blood pressure, pain behind the sternum, shortness of breath. From the nervous system: headache, tinnitus, dizziness, polyneuropathy, tremor, depression. From the urinary system: proteinuria, hematuria, oliguria, anuria, crystalluria, nephrotic syndrome. Allergic reactions: skin rash, itching, dermatosis, bronchospasm. From the hemopoietic organs: anemia (hemolytic, megaloblastic, aplastic), leukopenia, agranulocytosis, thrombocytopenia, hypoprothrombinemia. Other: weakness, mumps, photosensitivity, lupus-like syndrome, oligospermia, alopecia, decreased production of lacrimal fluid. Drug Interactions Clinical studies in healthy adults did not reveal clinically significant interactions of the drug Mesavant with the 4 most commonly used antibiotics (amoxicillin, ciprofloxacin, metronidazole and sulfamethoxazole). Nevertheless, there is evidence of the interaction of other mesalazine-containing drugs with drugs: It is recommended to use mesalazine with caution along with drugs that have a nephrotoxic effect, including non-steroidal anti-inflammatory drugs (NSAIDs) and azathioprine, as this may increase the risk of adverse events from the kidneys. Mesalazine inhibits thiopurinmethyl transferase activity. Caution is advised to take mesalazine concomitantly with azathioprine or mercaptopurine, as this may increase the risk of impaired blood cell composition. The use of mesalazine together with anticoagulants of the coumarin group, for example, warfarin, may be accompanied by a decrease in the activity of the latter. If necessary, the use of such a combination should be carefully monitored prothrombin time. overdose Mezavant preparation is an aminosalicylate signs of salicylate intoxication include tinnitus, vertigo, headache, confusion, drowsiness, pulmonary edema, dehydration on the background of increased sweating and diarrhea, diarrhea, and diarrhea. , hyperthermia. For acute overdose, standard methods of treatment for acute salicylate intoxication should be used. Hypoglycemia and impaired water-electrolyte balance should be corrected by appropriate therapy. Adequate kidney function should be maintained. Active ingredient Mesalazine Kosmo S.p.A., Italy
