Aspirin Cardio Coated Tablets 300mg N20
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Description
Round biconvex pills of white color; in cross section, a homogeneous mass of white color surrounded by a white shell.
Active ingredients
Acetylsalicylic acid
Release form
Pills
Composition
1 tablet of the drug ASPIRIN CARDIO contains acetylsalicylic acid 100 mg or 300 mg as an active substance; excipients: cellulose, powder 10 mg or 30 mg, corn starch 10 mg or 30 mg; enteric coating: methacrylic acid and ethyl acrylate copolymer (1: 1) 7.857 mg or 21.709 mg, polysorbate 80 0.186 mg or 0.514 mg, sodium lauryl sulfate 0577 mg or 0.157 mg, talc 8.100 mg or 22.380 mg, triethyl citrate 0.800 mg or 2.240 mg .
Pharmacological effect
The mechanism of the antiplatelet action of acetylsalicylic acid (ASK) is based on the irreversible inhibition of cyclooxygenase (COX-1), as a result of which thromboxane A2 synthesis is blocked and platelet aggregation is inhibited. Antiplatelet effect is most pronounced in platelets, as they are not able to re-synthesize cyclooxygenase. It is believed that ASA has other mechanisms for the suppression of platelet aggregation, which expands the scope of its application in various vascular diseases. ASA also has anti-inflammatory, analgesic and antipyretic effects.
Pharmacokinetics
After oral administration, ASA is rapidly and completely absorbed from the gastrointestinal tract (GIT). ASK is partially metabolized during absorption. During and after absorption, ASK is converted to the main metabolite - salicylic acid, which is metabolized mainly in the liver under the influence of enzymes with the formation of such metabolites as phenyl salicylate, glucuronide salicylate and salicyuric acid, found in many tissues and in urine. In women, the metabolic process is slower (lower serum enzyme activity). The maximum concentration of ASA in the blood plasma is reached 10-20 minutes after ingestion, 2 salicylic acid - after 0.3-2 hours. Due to the fact that the pills are coated with an acid-resistant coating, ASA is not released in the stomach (the shell effectively blocks the dissolution of the drug in the stomach), but in the alkaline environment of the duodenum.Thus, the absorption of ASA in the form of enteric-coated pills is delayed by 3-6 hours compared with conventional (without such a shell) pills. ASK 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. The elimination of salicylic acid is dose-dependent, since its metabolism is limited by the capabilities of the enzymatic system. The half-life is from 2-3 hours with the use of ASA in low doses and up to 15 hours with the use of the drug in high doses (usual doses of acetylsalicylic acid as an analgesic). Unlike other salicylates, with repeated use of the drug, non-hydrolyzed ASA does not accumulate in the blood serum. 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 eliminated by the kidneys within 24-72 hours.
Indications
Primary prevention of acute myocardial infarction with risk factors (for example, diabetes mellitus, hyperlipidemia, arterial hypertension, obesity, smoking, old age) and repeated myocardial infarction; • Unstable stenocardia (including suspected acute myocardial infarction) and stable angina pectoris; • Prevention of stroke (including in patients with transient cerebral circulation); • Prevention of transient cerebral circulation; • Prevention of thromboembolism after operations and invasive interventions on vessels (for example, coronary artery bypass surgery, carotid artery endarterectomy, arteriovenous bypass surgery, angioplasty and coronary artery stenting, angioplasty of the carotid arteries) • Thrombosis prevention of deep coronary arteries, carotid angioplasty of carotid arteries • Prevention of thrombosis of deep coronary arteries, carotid angioplasty of carotid arteries with prolonged immobilization as a result of extensive surgical intervention).
Contraindications
Hypersensitivity to acetylsalicylic acid, excipients in the composition of the drug and other NSAIDs • Bronchial asthma, induced by the intake of salicylates and other NSAIDs; combination of bronchial asthma,recurrent nasal polyposis and paranasal sinuses and ASK intolerance • Erosive and ulcerative lesions of the gastrointestinal tract (in acute stage) • Gastrointestinal bleeding • Hemorrhagic diathesis • Combined use with methotrexate at 15 mg per week or more • Pregnancy (I) trimester) and lactation period • Child and adolescence (up to 18 years) • Severe renal failure (creatinine clearance (CC) less than 30 ml / min.) • Severe hepatic insufficiency (class B and higher on the Child-Pugh scale) • Chronic I am heart failure III-IV functional class NYHA classification
Precautionary measures
With gout, hyperuricemia, because ASC in low doses reduces the excretion of uric acid; It should be borne in mind that low-dose ASA may trigger the development of gout in susceptible patients (with reduced uric acid excretion) • If you have a history of ulcers of the gastrointestinal tract or gastrointestinal bleeding • If the liver function is dysfunctional (lower than grade B) Child-Pugh scale) • In renal dysfunction (CC more than 30 ml / min), as well as circulatory disorders resulting from atherosclerosis of the renal arteries, congestive heart failure, hypovolemia, extensive hir rgicheskogo intervention, sepsis cases of major bleeding, as in all these cases, the ASA may increase the risk of acute renal failure and renal dysfunction. • With bronchial asthma, chronic respiratory diseases, hay fever, nasal polyposis, drug allergies, including NSAIDs (analgesics, anti-inflammatory, antirheumatic drugs) • In the second trimester of pregnancy • With suspected surgical intervention (including minor, for example, extraction of a tooth ), because ASA can cause bleeding to develop within a few days after taking the drug • When used in combination with the following drugs (see section l interaction with other drugs): - with methotrexate at least 15 mg per week; - with anticoagulant, thrombolytic or other antiplatelet agents - with NSAIDs and derivatives of salicylic acid in large doses; - with digoxin;- with oral hypoglycemic agents (sulfonylurea derivatives) and insulin; - with valproic acid; - with alcohol (alcoholic beverages in particular); - with selective serotonin reuptake inhibitors; - with ibuprofen.
Use during pregnancy and lactation
Inhibition of prostaglandin synthesis can have a negative effect on pregnancy and the development of the embryo or fetus. The use of large doses of salicylates (more than 300 mg / day; we are talking about the usual doses of ASA from 500 mg as an anesthetic) in the first trimester of pregnancy is associated with an increased frequency of fetal developmental defects (splitting of the upper palate, heart defects). The appointment of salicylates in the first trimester of pregnancy is contraindicated. In the third trimester of pregnancy, salicylates in a high dose (more than 300 mg / day; we are talking about usual doses of ASA from 500 mg as an anesthetic) can cause inhibition of labor, premature closure of the arterial duct in the fetus, increased bleeding in the mother and fetus, and Administration immediately before delivery may cause intracranial hemorrhage, especially in premature babies. The appointment of salicylates in the third trimester of pregnancy is contraindicated. In the II trimester of pregnancy, salicylates can be prescribed only with a rigorous assessment of the risk and benefits for the mother and fetus, preferably in doses not higher than 150 mg / day and not for long. Use during lactation Salicylates and their metabolites in small amounts into breast milk. Accidental intake of salicylates during lactation is not accompanied by the development of adverse reactions in the child and does not require discontinuation of breastfeeding. However, with prolonged use of the drug or the appointment of a high dose of breastfeeding should be immediately stopped.
Dosage and administration
Tablets drug Aspirin Cardio preferably taken before meals, drinking plenty of fluids. Aspirin CARDIO pills are taken 1 time per day. Aspirin CARDIO is intended for long-term use. The duration of therapy is determined by the doctor. Primary prevention of acute myocardial infarction with risk factors: 100 mg / day or 300 mg every other day.Prevention of recurrent infarction, stable and unstable angina: 100-300 mg / day. Unstable angina (with suspected acute myocardial infarction): an initial dose of 100-300 mg (the first tablet must be chewed for faster absorption) should be taken by the patient as soon as possible after the development of an acute myocardial infarction. In the next 30 days after the development of myocardial infarction, a dose of 200-300 mg / day should be maintained. After 30 days, appropriate therapy should be prescribed to prevent recurrent myocardial infarction. Prevention of stroke and transient cerebrovascular accident: 100-300 mg / day. Prevention of thromboembolism after surgery and invasive interventions on the vessels: 100-300 mg / day. 5 Prevention of deep vein thrombosis and pulmonary thromboembolism and its branches: 100-200 mg / day or 300 mg every other day. Actions to skip taking one or more doses of the drug: Take the missed pill as soon as you remember it and continue to take it as usual. To avoid doubling the dose, do not take the missed pill if the next pill is coming. Peculiarities of the drug action at the first dose and when it is canceled: There were no specific effects of the drug at the first dose and its cancellation.
Side effects
On the part of the digestive system: the most common nausea, heartburn, vomiting, abdominal pain; rarely, ulcers of the mucous membrane of the stomach and duodenum; very rarely - perforated ulcers of the mucous membrane of the stomach and duodenum, gastrointestinal bleeding (with appropriate clinical symptoms and laboratory changes), transient disorders of liver function with increased activity of hepatic transaminases. On the part of the hematopoietic system: the appointment of ASA is accompanied by an increased risk of bleeding due to the inhibitory effect of ASA on platelet aggregation. An increase in the frequency of perioperative (intra- and postoperative) bleeding, hematomas (bruises), nasal bleeding, bleeding of the gums, bleeding from the urinary tract was recorded. There are reports of severe bleeding,which include gastrointestinal bleeding and bleeding in the brain (especially in hypertensive patients who have not reached the target blood pressure (BP) and / or receiving concomitant anticoagulant therapy), which in some cases may be life-threatening (see section Special instructions). Bleeding can lead to the development of acute or chronic post-hemorrhagic / iron deficiency anemia (for example, due to latent bleeding) with relevant clinical and laboratory signs and symptoms (asthenia, pallor, hypoperfusion). There are reports of hemolysis and hemolytic anemia in patients with severe deficiency of glucose-6-phosphate dehydrogenase. Allergic reactions: hypersensitivity reactions with appropriate laboratory and clinical manifestations, such as asthma syndrome (bronchospasm), mild to moderate reactions of the skin, respiratory tract, gastrointestinal tract and cardiovascular system, including symptoms such as skin rash , pruritus, urticaria, angioedema, rhinitis, swelling of the nasal mucosa, cardio-respiratory distress syndrome, as well as severe reactions, including anaphylactic shock. On the part of the central nervous system (CNS): there are reports of cases of dizziness, hearing loss, headache, tinnitus, which may be a sign of overdose of the drug (see the section Overdose). 6 From the urinary system: there are reports of cases of development of renal dysfunction and acute renal failure.
Overdose
Salicylate intoxication (developed 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 improper therapeutic use of the drug (chronic intoxication) or a single accidental or intentional reception of a toxic dose of the drug adults or children (acute intoxication). The symptoms of chronic intoxication with salicylic acid derivatives are not specific and are often difficult to diagnose. Mild severity 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 indicated symptoms disappear after reducing the dose of the drug.Tinnitus can occur when plasma concentrations of ASA are from 150 to 300 µg / ml. More severe symptoms occur 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 can 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 excretion of the drug and the restoration of water-electrolyte balance and acid-base status. • Mild to moderate overdose symptoms: Dizziness, tinnitus, hearing loss, increased sweating, nausea, vomiting, headache, confusion, profuse sweating, tachypnea, hyperventilation, respiratory alkalosis. Treatment: gastric lavage, repeated administration of activated carbon, forced alkaline diuresis, restoration of water-electrolyte balance and acid-base state. • Symptoms of overdose from moderate to severe: - respiratory alkalosis with compensatory metabolic acidosis; - hyperpyrexia (extremely high body temperature); - Respiratory disorders: hyperventilation, non-cardiogenic pulmonary edema, respiratory depression, asphyxia; - disorders of the cardiovascular system: cardiac arrhythmias, arterial hypotension, cardiac depression; - violations of water and electrolyte balance: dehydration, impaired renal function from oliguria until 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 central nervous system function depression (drowsiness, confusion, coma, convulsions).Treatment: immediate hospitalization in specialized departments for emergency treatment - gastric lavage, repeated administration of activated carbon, forced alkaline diuresis, hemodialysis, restoration of water-electrolyte balance and acid-base status, symptomatic therapy.
Interaction with other drugs
With simultaneous use of ASA enhances the effect of the following drugs; if necessary, simultaneous prescription of ASA with the listed funds should consider the need to reduce the dose of these drugs: • methotrexate by reducing renal clearance and displacing it from the association with proteins; the combination of ASA with methotrexate is accompanied by an increased incidence of side effects from the blood-forming organs; use of the drug Aspirin Cardio together with methotrexate is contraindicated if the dose of the latter exceeds 15 mg per week (see section Contraindications) and possibly with caution when the dose of methotrexate is less than 15 mg per week; • heparin and indirect anticoagulants due to dysfunction of platelets and the displacement of indirect anticoagulants due to the association with proteins; • with simultaneous use with anticoagulants, thrombolytic and antiplatelet agents (ticlopidine), there is an increased risk of bleeding as a result of synergism of the main therapeutic effects of the drugs used; • at simultaneous use with the drugs possessing anticoagulant, thrombolytic or antiagregantny action strengthening of the damaging effect on a mucous membrane of a digestive tract is noted; • selective serotonin reuptake inhibitors, which may increase the 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 of • hypoglycemic oral preparations (sulfonylurea derivatives) and insulin due to the hypoglycemic properties of the ASA itself in high doses and the displacement of sulfonylurea derivatives from the association with 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 the displacement of blood plasma from its association with proteins; • NSAIDs and salicylic acid derivatives in high doses (increased risk of ulcerogenic effects 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 prolonged bleeding time as a result of the mutual enhancement of the effects of ASA and ethanol). The simultaneous administration of ASA in high doses may weaken the effect of the medicines listed below. If necessary, simultaneous prescription of ASA with the listed drugs should consider the need for dose adjustment of the following agents: • any diuretics (when used together with ASA in high doses, a decrease in glomerular filtration rate is observed as a result of a decrease in prostaglandin synthesis in the kidneys); • angiotensin-converting enzyme (ACE) inhibitors (a dose-dependent decrease in glomerular filtration rate (GFR) is observed as a result of inhibition of prostaglandins with vasodilating action, respectively, a decrease in hypotensive action. The clinical value of a decrease in GFR is observed with a daily dose of ASC more than 160 mg. In addition, a decrease in positive cardioprotective effect of ACE inhibitors assigned to patients for the treatment of chronic heart failure. This effect is also when combined with ASA in high doses); • drugs with uricosuric action - benzbromarone, probenecid (reduction of the uricosuric effect due to competitive suppression of renal tubular excretion of uric acid). With simultaneous use with ibuprofen, antagonism is observed with respect to irreversible inhibition of platelets caused by the action of ASA, which leads to a decrease in the cardioprotective effects of ASA. Therefore, the combination of ASA with ibuprofen in patients with an increased risk of cardiovascular diseases is not recommended. With simultaneous use with systemic glucocorticosteroids (GCS) (with the exception of hydrocortisone or another GCS used for replacement therapy for Addison's disease), an increase in the elimination of salicylates and, accordingly, a weakening of their action is noted.With the combined use of GCS and salicylates, it should be remembered that during treatment the level of salicylates in the blood is lowered, and after GCS is canceled, an overdose of salicylates is possible.
special instructions
The drug should be used as prescribed by a doctor. • ASA can provoke bronchospasm, as well as trigger asthma attacks and other hypersensitivity reactions. Risk factors are a history of bronchial asthma, hay fever, nasal polyposis, chronic diseases of the respiratory system, as well as allergic reactions to other drugs (eg, skin reactions, itching, urticaria). • The inhibitory effect of ASK on platelet aggregation persists for several days after administration, and therefore, there may be an increased risk of bleeding during surgery or in the postoperative period. If necessary, the absolute exclusion of bleeding during surgery is necessary, if possible, to completely abandon the use of ASA in the preoperative period. • Excessive doses of ASA are associated with the risk of gastrointestinal bleeding. • Overdose is especially dangerous in elderly patients. 9 • In severe forms of deficiency of glucose-6-phosphate dehydrogenase, ASA can cause hemolysis and hemolytic anemia. Factors that may increase the risk of hemolysis are fever, acute infections and high doses of the drug. Influence on the ability to drive a car / moving machinery Taking Aspirin Cardio does not affect the ability to drive a car / driving gear.
Storage conditions
At a temperature not higher than 25 ° С. Keep out of the reach of children!