Magnecard tablets p/o 75mg №10×3

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Magnecard tablets 75 mg in a cell. pack No. 10×3
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White film-coated tablets with a biconvex surface, tablets with a dosage of 75 mg – round; tablets with a dosage of 150 mg – oval, with a risk. Composition One tablet contains: active ingredient – acetylsalicylic acid – 75 mg or 150 mg; excipients: magnesium hydroxide, starch 1500 (corn starch, partially pregelatinized), stearic acid, magnesium stearate, microcrystalline cellulose, opadry II (including polyvinyl alcohol, partially hydrolyzed; talc; macrogol 3350; titanium dioxide E 171). Pharmacotherapeutic group Inhibitors of platelet aggregation, excluding heparin. ATX code: B01AC06. Pharmacological properties Pharmacodynamics The mechanism of antiplatelet action of acetylsalicylic acid (ASA) is based on irreversible inhibition of cyclooxygenase (COX-1), resulting in blocking the synthesis of thromboxane A2 and suppressing platelet aggregation. This effect is long-term and usually lasts for the entire eight-day life span of the platelet. Paradoxically, acetylsalicylic acid also inhibits the formation of prostacyclin (a prostaglandin that has the ability to stimulate platelet aggregation and vasoconstriction) in endothelial cells of the walls of blood vessels. This effect is not long lasting. As soon as acetylsalicylic acid is washed out of the blood, the production of prostacyclin resumes in nucleated endothelial cells. As a result, once-daily low-dose (<300 mg/day) acetylsalicylic acid causes inhibition of thromboxane A2 in platelets without a clear reduction in prostacyclin formation. Pharmacokinetics After oral administration, ASA is rapidly and completely absorbed from the gastrointestinal tract (GIT). ASA is partially metabolized during absorption. During and after absorption, ASA is converted to the main metabolite, salicylic acid, which is metabolized mainly in the liver under the influence of enzymes to form metabolites such as phenyl salicylate, salicylate glucuronide and salicyluric acid, found in many tissues and in urine. In women, the metabolic process is slower (less enzyme activity in the blood serum). The maximum concentration of ASA in the blood plasma is reached 10-20 minutes after ingestion, salicylic acid - after 0.3-2 hours. ASA and salicylic acid bind strongly to plasma proteins (from 66% to 98% depending on the dose) and are rapidly distributed in the body. Salicylic acid crosses the placenta and is excreted in breast milk. Excretion of salicylic acid is dose-dependent, since its metabolism is limited by the capabilities of the enzymatic system. The elimination half-life ranges from 2-3 hours when ASA is used at low doses and up to 15 hours when the drug is used at high doses (usual doses of acetylsalicylic acid as an analgesic). Unlike other salicylates, non-hydrolyzed ASA does not accumulate in the blood serum with repeated administration of the drug. Salicylic acid and its metabolites are excreted by the kidneys. In patients with normal renal function, 80-100% of a single dose of the drug is excreted by the kidneys within 24-72 hours. Acetylsalicylic and salicylic acid penetrates into the cerebrospinal and synovial fluid, through the placenta and into mother's milk. Indications for use The risk on the tablet is not intended for dividing the tablet in half and does not carry a functional load. unstable angina - as part of standard therapy; acute myocardial infarction - as part of standard therapy; prevention of recurrent myocardial infarction; prevention of recurrent transient ischemic attack (TIA) and recurrent cerebral infarction; prevention of thrombosis after surgery and invasive interventions on the vessels (for example, after coronary artery bypass grafting (CABG) or primary percutaneous coronary intervention (PCI)); prevention of cardiovascular diseases in high-risk patients is possible only on prescription, if the benefit of therapy outweighs the risk of adverse events, in particular bleeding, and it is possible to diagnose occult bleeding .Note: acetylsalicylic acid in a single dose of 75-150 mg is not intended for the treatment of pain. Contraindications Hypersensitivity to acetylsalicylic acid, excipients in the composition of the drug; bronchial asthma induced by the intake of salicylates and other non-steroidal anti-inflammatory drugs (NSAIDs); erosive and ulcerative lesions of the gastrointestinal tract (in the acute stage); gastrointestinal bleeding; hemorrhagic diathesis; combined use with methotrexate at a dose of 15 mg per week or more; pregnancy (III trimester) at a daily dose of more than 150 mg; severe renal failure (creatinine clearance (CC) less than 30 ml / min); severe liver failure (class B and higher according to Child-Pugh scale); chronic heart failure III-IV functional class according to the NYHA classification. Dosage and administration Tablets should be swallowed whole with water. If desired, the tablet can be broken in half for ease of swallowing, chewed or pre-pounded. The risk on the tablet is not intended for dividing the tablet into two equal doses and does not carry a functional load. Unstable angina: 75-150 mg 1 time per day. Acute myocardial infarction: 75-150 mg 1 time per day. Prevention of recurrent myocardial infarction: 300 mg 1 time per day. once a day. Prevention of thrombosis after operations and invasive interventions on the vessels (for example, after CABG or PCI): 75-150 mg 1 time per day. In acute myocardial infarction, it is recommended to chew the first tablet and drink plenty of water. Acetylsalicylic acid at a dosage of 75 mg (150 mg) is intended for long-term use. The duration of therapy is determined by the doctor. Side effects To assess the frequency of side effects, the following gradation is used: very often -? 1/10; often - > 1/100 to < 1/10; infrequently -> 1/1000 to < 1/100; rarely -> 1/10 000 to < 1/1000; very rarely - < 1/10,000; frequency unknown - the frequency cannot be estimated from the available data. Disorders of the circulatory and lymphatic system Rare and very rare cases of severe bleeding, such as cerebral bleeding, have been observed, especially in patients with uncontrolled hypertension and / or during concomitant therapy with anticoagulant drugs, in some cases potentially life-threatening. Cases of hemolysis and hemolytic anemia have been reported in patients with severe forms of glucose-6-phosphate dehydrogenase (G6PD) deficiency. Bleeding, such as epistaxis, bleeding gums, skin bleeding, or urogenital bleeding, possibly with increased duration of bleeding. This action may be maintained for 4 to 8 days after application. Gastrointestinal disorders Common: gastrointestinal disorders such as heartburn, nausea, vomiting, abdominal pain and diarrhoea; slight blood loss from the gastrointestinal tract (microbleeding). Infrequent: ulcer of the gastrointestinal tract, which in very rare cases can lead to perforation; gastrointestinal bleeding (long-term use of the drug Magnecard can cause iron deficiency anemia due to latent blood loss from the gastrointestinal tract); gastrointestinal inflammation (if the patient has black feces (tarry stools) or hematemesis, both phenomena are signs of serious bleeding in the stomach, it is urgent to inform the attending physician about this). Nervous system disorders Headache, dizziness, hearing loss, tinnitus or confusion may be signs of an overdose. Skin and subcutaneous tissue disorders Uncommon: skin reactions (very rarely up to erythema multiforme exudative). Immune system disorders Rare: hypersensitivity reactions of the skin, respiratory tract and cardiovascular system, especially in patients with asthma. These symptoms include: hypotension, dyspnoea, rhinitis, nasal congestion, anaphylactic shock, and angioedema. Hepatobiliary disorders Very rare: Elevated liver function tests. Renal and urinary disorders Very rare: impaired renal function, acute renal failure. Metabolism Very rare: hypoglycemia; when used in small doses, acetylsalicylic acid reduces the excretion of uric acid. In predisposed patients, it can trigger an attack of gout. Interactions with other drugs With the simultaneous use of ASA, it enhances the effect of the drugs listed below; if necessary, the simultaneous appointment of ASA with the listed drugs should consider the need to reduce the dose of these drugs: methotrexate by reducing renal clearance and displacing it from its association with proteins; the combination of ASA with methotrexate is accompanied by an increased incidence of side effects from the hematopoietic organs; the use of the drug Magnecard together with methotrexate is contraindicated if the dose of the latter exceeds 15 mg per week (see section "Contraindications") and possibly with caution - at a dose of methotrexate less than 15 mg per week; heparin and indirect anticoagulants due to impaired platelet function and displacement indirect anticoagulants due to proteins; with simultaneous use with anticoagulants, thrombolytic and antiplatelet agents (ticlopidine), there is an increase in the risk of bleeding as a result of synergism of the main therapeutic effects of the drugs used; with simultaneous use with drugs that have anticoagulant, thrombolytic or antiplatelet effects, there is an increase damaging effect on the mucous membrane of the gastrointestinal tract; selective serotonin reuptake inhibitors, which can lead to an increased risk of bleeding from the upper gastrointestinal tract (synergism with ASA); digoxin due to a decrease in its renal excretion, which can lead to its overdose; hypoglycemic agents for oral administration (sulfonylurea derivatives) and insulin due to the hypoglycemic properties of ASA itself in high doses and the displacement of sulfonylurea derivatives from association with blood plasma proteins; this must be borne in mind when prescribing ASA to patients with diabetes mellitus receiving the listed drugs; when used simultaneously with valproic acid, its toxicity increases due to displacement from its association with blood plasma proteins; NSAIDs and salicylic acid derivatives in high doses (increased risk of an ulcerogenic effect and bleeding from the gastrointestinal tract as a result of synergistic action); ethanol (alcoholic beverages) (increased risk of damage to the mucous membrane of the gastrointestinal tract and prolongation of bleeding time as a result of mutual enhancement of the effects of ASA and ethanol). Simultaneous administration of ASA in high doses may weaken the effect of the drugs listed below. If it is necessary to simultaneously prescribe ASA with the listed drugs, consideration should be given to the need to adjust the dose of the following drugs: any diuretics (when used together with ASA in high doses, a decrease in glomerular filtration rate is noted as a result of a decrease in prostaglandin synthesis in the kidneys); angiotensin-converting enzyme inhibitors (ACE) (a dose-dependent decrease in glomerular filtration rate (GFR) is noted as a result of inhibition of prostaglandins that have a vasodilating effect, respectively, a weakening of the hypotensive effect. The clinical significance of a decrease in GFR is noted at a daily dose of ASA of more than 160 mg. In addition, there is a decrease in the positive cardioprotective effect of ACE inhibitors prescribed to patients for the treatment of chronic heart failure.This effect is also manifested when used in conjunction with ASA in high doses); drugs with uricosuric action - benzbromarone, probenecid (decrease in the uricosuric effect due to competitive suppression of renal tubular excretion of uric acid). When used simultaneously with ibuprofen, antagonism is noted with respect to irreversible platelet inhibition due to the action of ASA, which leads to a decrease in the cardioprotective effects of ASA. Therefore, the combination of ASA with ibuprofen is not recommended in patients with an increased risk of cardiovascular disease. With simultaneous use with systemic glucocorticosteroids (GCS) (with the exception of hydrocortisone or other GCS used for the replacement therapy of Addison's disease), there is an increase in the elimination of salicylates and, accordingly, a weakening of their action. When combining the use of GCS and salicylates, it should be remembered that during treatment, the level of salicylates in the blood is reduced, and after the abolition of GCS, an overdose of salicylates is possible. Use in pregnancy and lactation Pregnancy Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonic/fetal development. Data from epidemiological studies indicate an increased risk of miscarriage, as well as the development of heart defects and gastroschisis after the use of prostaglandin synthesis inhibitors in early pregnancy. It is assumed that the risk increases with increasing dose and duration of therapy. The experience of pregnant women with the use of acetylsalicylic acid in daily doses of 50 to 150 mg in the second and third trimesters showed no signs of a decrease in uterine tone, increased bleeding, or premature closure of the ductus arteriosus. There are no data on the effect of daily doses of acetylsalicylic acid in the range of 150 and 300 mg during pregnancy. In the I and II trimesters of pregnancy, acetylsalicylic acid can be taken in a daily dose of less than 300 mg, in short courses, only as directed by a doctor, after a thorough assessment of the benefit / risk ratio for the mother and fetus. In the third trimester of pregnancy, salicylates in high doses (more than 300 mg / day; we are talking about the usual doses of ASA from 500 mg as an anesthetic) can cause inhibition of labor, premature closure of the ductus arteriosus in the fetus, increased bleeding in the mother and fetus, and administration just before delivery can cause intracranial hemorrhage, especially in premature babies. In the III trimester of pregnancy, acetylsalicylic acid can be taken in a daily dose of less than 150 mg, in short courses, only as directed by a doctor, after a thorough assessment of the benefit / risk ratio for the mother and fetus. Reception of acetylsalicylic acid in a daily dosage of more than 150 mg in the III semester is contraindicated. Breastfeeding Acetylsalicylic acid and its metabolites pass into breast milk in small amounts. Interruption of breastfeeding is usually not required if a daily dose of up to 150 mg is used. With prolonged use of the drug or its administration in a daily dose of more than 150 mg per day, breastfeeding should be discontinued. Influence on the ability to drive a car / moving mechanisms Taking the drug Magnecard does not affect the ability to drive a car / moving mechanisms. Precautions Use with caution: for gout, hyperuricemia, because. ASA in low doses reduces the excretion of uric acid; it should be borne in mind that ASA at low doses can provoke the development of gout in predisposed patients (having reduced excretion of uric acid); with a history of ulcerative lesions of the gastrointestinal tract or gastrointestinal bleeding; with impaired liver function (below class B according to Child-Pugh scale); in case of impaired renal function (CC more than 30 ml / min), as well as circulatory disorders resulting from atherosclerosis of the renal arteries, congestive heart failure, hypovolemia, major surgery, sepsis, cases of massive bleeding, since in all in these cases, ASA may increase the risk of developing acute renal failure and impaired renal function; with bronchial asthma, chronic respiratory diseases, hay fever, nasal polyposis, drug allergies, including NSAIDs (analgesics, anti-inflammatory, antirheumatic drugs); with suspected surgical intervention (VK except for minor ones, for example, tooth extraction), since ASA can cause a tendency to develop bleeding for several days after taking the drug; with bronchial asthma, chronic respiratory diseases, hay fever, nasal polyposis, drug allergies, including NSAIDs (analgesics, anti-inflammatory, antirheumatic agents) for patients who have an acute deficiency of G6PD, acetylsalicylic acid can cause hemolysis or hemolytic anemia. Factors that may lead to an increased risk of hemolysis include, for example, a high dose, fever or acute infections; when used in combination with the following drugs (see section "Interaction with other drugs"): - with methotrexate at a dose of less than 15 mg per week; - with anticoagulant, thrombolytic or other antiplatelet agents; - with NSAIDs and salicylic acid derivatives in high doses. The following should be considered: overdose of ASA is associated with a risk of gastrointestinal bleeding; overdose is especially dangerous in elderly patients; medicines containing acetylsalicylic acid should not be prescribed to children and adolescents for the treatment of viral infections, accompanied or not accompanied by fever, without consultation doctor. Some viral diseases, especially influenza A, influenza B, and chickenpox, are at risk of developing Reye's syndrome, a very rare but life-threatening disease that requires emergency medical attention. This risk may increase with concomitant use of acetylsalicylic acid; however, a causal relationship has not been established. A sign of Reye's syndrome can be persistent vomiting in the above diseases. Considering the foregoing, children under 16 years of age are contraindicated in the use of the drug without appropriate indications (Kawasaki disease). Overdose Salicylate intoxication (develops when taking ASA at a dose of more than 100 mg / kg / day for more than 2 days) may result from prolonged use of toxic doses of the drug as part of the incorrect therapeutic use of the drug (chronic intoxication) or a single accidental or intentional use of toxic doses of the drug to an adult or a child (acute intoxication). Symptoms of chronic intoxication with salicylic acid derivatives are nonspecific and often difficult to diagnose. Mild intoxication usually develops only after repeated use of large doses of the drug and is manifested by dizziness, tinnitus, hearing loss, increased sweating, nausea and vomiting, headache and confusion. The specified symptomatology disappears after reduction of a dose of medicine. Tinnitus may occur at plasma ASA concentrations of 150 µg/mL to 300 µg/mL. More severe symptoms appear when the concentration of ASA in the blood plasma is above 300 μg / ml. The main manifestation of acute intoxication is a severe violation of the acid-base state, the manifestations of which may vary depending on the age of the patient and the severity of intoxication. In children, the most typical is the development of metabolic acidosis. Treatment of intoxication is carried out in accordance with accepted standards and depends on the severity of intoxication and the clinical picture and should be aimed mainly at accelerating the elimination of the drug and restoring the water-electrolyte balance and acid-base state. Overdose symptoms from mild to moderate severity: dizziness, tinnitus, hearing impairment, increased sweating, nausea, vomiting, headache, confusion, profuse sweating, tachypnea, hyperventilation, respiratory alkalosis. Treatment: gastric lavage, repeated intake of activated charcoal, forced alkaline diuresis, restoration of water and electrolyte balance and acid-base balance. Moderate to severe overdose symptoms: respiratory alkalosis with compensatory metabolic acidosis; hyperpyrexia (extremely high body temperature); respiratory disorders: hyperventilation, non-cardiogenic pulmonary edema, respiratory depression, asphyxia; cardiovascular system disorders: cardiac arrhythmias, arterial hypotension, depression of cardiac activity; violations of water and electrolyte balance: dehydration, impaired renal function from oliguria up to the development of renal failure, characterized by hypokalemia, hypernatremia, hyponatremia; impaired glucose metabolism: hyperglycemia, hypoglycemia (especially in children), ketoacidosis; tinnitus , deafness; gastrointestinal bleeding; hematological disorders: from inhibition of platelet aggregation to coagulopathy, prolongation of prothrombin time, hypoprothrombinemia; neurological disorders: toxic encephalopathy and CNS depression (drowsiness, confusion, coma, convulsions). Treat Use: immediate hospitalization in specialized departments for emergency therapy - gastric lavage, repeated intake of activated charcoal, forced alkaline diuresis, hemodialysis, restoration of water and electrolyte balance and acid-base status, symptomatic therapy. Upakovka10 tablets in a blister pack of PVC film and aluminum foil. 3, 6 or 10 blister packs, together with the leaflet, are placed in a pack of cardboard (No. 10x3, No. 10x6, No. 10x10). Storage conditions In a place protected from light and moisture, at a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life 2 years. Do not use the drug after the expiration date. Conditions for dispensing from pharmaciesWithout a prescription. Buy Magnecard tablets p/o 75mg No. 10x3