Aspirin cardio, pills 100mg, 28pcs

Composition

of 1 tab. :

– acetylsalicylic acid 100 mg or 300 mg;

excipients:

cellulose, powder 10 mg or 30 mg,

corn starch 10 mg or 30 mg;

shell:

methacrylic acid and ethyl acrylate copolymer 1: 1 (Eudragit L30D) 7,857 mg or 27,709 mg,

polysorbate 80 0.186 mg or 0.514 mg,

sodium lauryl sulfate 0.057 mg or 0.157 mg,

talc 8,100 mg or 22,380 mg,

triethyl citrate 0,800 mg or 2,240 mg

Composition

.

Pharmaceutical action:

 The mechanism of antiplatelet action of acetylsalicylic acid (ASA) is based on irreversible inhibition of cyclooxygenase (COX-1), which blocks the synthesis of thromboxane a2 and suppresses platelet aggregation.

The antiplatelet effect is most pronounced in platelets, since they are not able to re-synthesize cyclooxygenase. It is believed that ASA has other mechanisms for suppressing platelet aggregation, which expands the scope of its application in various vascular diseases.

ASA also has anti-inflammatory, analgesic and antipyretic effects.

Indications

-Primary prevention of acute myocardial infarction in the presence of risk factors (for example, diabetes mellitus, hyperlipidemia, arterial hypertension, obesity, smoking, old age) and recurrent myocardial infarction;- Unstable angina (including suspected acute myocardial infarction) and stable angina;- Stroke prevention (including in patients with transient cerebrovascular accident);- Prevention of transient cerebral circulatory disorders;- Prevention of thromboembolism after operations and invasive vascular interventions (for example, aorto-coronary bypass surgery, carotid artery endarterectomy, arteriovenous bypass surgery, angioplasty and stenting of the coronary arteries, carotid artery angioplasty)- Prevention of deep vein thrombosis and thromboembolism of the pulmonary artery and its branches (including long-term immobilization as a result of extensive surgical intervention).

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 high doses of salicylates (more than 300 mg / day; we are talking about the usual doses of ASA from 500 mg as an analgesic) in the first trimester of pregnancy is associated with an increased frequency of fetal developmental defects (cleavage of the upper palate, heart defects). The use 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 the usual doses of ASA from 500 mg as an analgesic) can cause inhibition of labor, premature closure of the arterial duct in the fetus, increased bleeding in the mother and fetus, and use immediately before delivery can cause intracranial hemorrhages, especially in premature babies. The use of salicylates in the third trimester of pregnancy is contraindicated.

In the second trimester of pregnancy, salicylates can be prescribed only taking into account a strict assessment of the risk and benefit to the mother and fetus, preferably in doses not exceeding 150 mg/day and for a short time.

Use during lactation:

Salicylates and their metabolites pass into breast milk in small amounts. 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, if the drug is used for a long time or is prescribed in a high dose, breast-feeding should be stopped immediately.

Contraindications

– Hypersensitivity to acetylsalicylic acid, auxiliary substances in the composition of the drug Aspirin cardio and other NSAIDs – asthma induced by ingestion of salicylates and other NSAIDs; the combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance of ask – Erosive-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 (I and III trimester) and lactation – childhood and adolescence (up to 18 years)- Severe renal insufficiency (creatinine clearance (CC) less than 30 ml / min)- Severe hepatic insufficiency (class B and higher on the Child-Pugh scale) – Chronic heart failure of functional class III-IV according to the NYHA classification

With caution: For gout, hyperuricemia, because ASA in low doses reduces the excretion of uric acid; it should be borne in mind that ASA in low doses can provoke the development of gout in predisposed patients (with reduced uric acid excretion)

If there is a history of ulcerative lesions of the gastrointestinal tract or gastrointestinal bleeding

With impaired liver function (below Child-Pugh class B)

In cases of impaired renal function (creatinine clearance greater than 30 ml / min), as well as in cases of circulatory disorders resulting from atherosclerosis of the renal arteries, congestive heart failure, hypovolemia, extensive surgery, sepsis, cases of massive bleeding, since in all these cases, ASA can increase the risk of acute renal failure and impaired renal function.

For bronchial asthma, chronic respiratory diseases, hay fever, nasal polyposis, drug allergies, including NSAID groups (analgesics, anti-inflammatory drugs, antirheumatic drugs)

In the second trimester of pregnancy

In case of intended surgical intervention (including minor ones, for example, tooth extraction), since ASA can cause a tendency to develop bleeding within a few days after taking the drug When combined with Aspirin cardio with the following medications (see the section “Interaction with other medications”):

– with methotrexate at a dose of less than 15 mg per week; – with anticoagulants, thrombolytics or other antiplatelet agents – with NSAIDs and salicylic acid derivatives in large doses; – with digoxin; – with hypoglycemic agents for oral use (sulfonylurea derivatives) and insulin;- with valproic acid; – with alcohol (alcoholic beverages in particular);- with selective serotonin reuptake inhibitors; – with ibuprofen.

Side effects

From the digestive system: nausea, heartburn, vomiting, abdominal pain are most often noted; rarely – ulcers of the gastric and duodenal mucosa; very rarely-perforated ulcers of the gastric and duodenal mucosa, gastrointestinal bleeding (with corresponding clinical symptoms and laboratory changes), transient liver function disorders with increased activity of “liver” transaminases.

From the hematopoietic system: use of ASA is associated with an increased risk of bleeding due to the inhibitory effect of ASA on platelet aggregation. There was an increase in the frequency of perioperative (intra – and postoperative) bleeding, hematomas (bruises), nosebleeds, bleeding gums, and bleeding from the genitourinary tract. There are reports of serious cases of bleeding, which include gastrointestinal bleeding and brain hemorrhage (especially in patients with hypertension who have not reached the target blood pressure (BP) values and/or are receiving concomitant therapy with anticoagulants), which in some cases can be life-threatening (see the section “Special instructions”).

Bleeding can lead to the development of acute or chronic post-hemorrhagic / iron-deficient anemia (for example, due to latent bleeding) with appropriate clinical and laboratory signs and symptoms (asthenia, pallor, hypoperfusion).

There are reports of cases of hemolysis and hemolytic anemia in patients with severe forms of glucose-6-phosphate dehydrogenase deficiency.

Allergic reactions: hypersensitivity reactions with appropriate laboratory and clinical manifestations, such as asthmatic syndrome (bronchospasm), mild to moderate reactions from the skin, respiratory tract, gastrointestinal tract and cardiovascular system, including symptoms such as skin rash, pruritus, urticaria, angioedema, rhinitis, nasal mucosa edema, cardio-respiratory distress syndrome, as well as severe reactions, including anaphylactic shock.

From the central nervous system (CNS): there are reports of dizziness, hearing loss, headache, tinnitus, which may be a sign of an overdose of the drug (see the section “Overdose”).

From the urinary system: there are reports of cases of impaired renal function and acute renal failure.

Interaction

When used concomitantly, ASA enhances the effect of the drugs listed below; if it is necessary to simultaneously prescribe ASA with the listed drugs, the need to reduce the dose of these drugs should be considered. :

-methotrexate due to a decrease in renal clearance and its displacement from protein binding; the combination of ASA with methotrexate is accompanied by an increased frequency of side effects from the hematopoietic system; the use of Aspirin® Cardio together with methotrexate is contraindicated if the dose of the latter exceeds 15 mg per week (see the section “Contraindications”) and possibly with caution-if the dose of methotrexate is less than 15 mg per week;

heparin and indirect anticoagulants due to dysfunction of platelets, and displacing anticoagulants from the blood;

-with the simultaneous use of anticoagulants, thrombolytic and antiplatelet drugs (tiklopidin) refers to the increase risk of bleeding as a result of the synergy of the main therapeutic effects of the drugs used;

-with simultaneous use with drugs with anticoagulant, thrombolytic or antiplatelet action has increased, as has damaging effects on the mucous membrane of the gastrointestinal tract;

-selective inhibitors of serotonin reuptake, which may lead to increased risk of bleeding from the upper gastrointestinal tract (synergy with ASA)

-digoxin due to a decrease in its renal excretion, which can lead to overdose

-hypoglycemic agents for oral use (of sulfonylureas) and insulin due to the hypoglycemic properties of the ASA in high doses and displacement of sulfonylureas from the blood plasma of the blood; this must be borne in mind when assigning ask patients with diabetes mellitus receiving these drugs

-while the use of valproic acid increases its toxicity due to displacement from plasma proteins of the blood;

-NSAIDs and derivatives of salicylic acid in high doses (increasing the risk of ulcerogenic effect and bleeding from the gastrointestinal tract as a result of synergistic action);

Ethanol (alcoholic beverages) (increased risk of damage to the mucosa of the gastrointestinal tract and prolonged bleeding time due to cross-amplification effects of ASC and ethanol).

Concomitant use 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, the need for dose adjustment of the following drugs should be considered:

-any diuretics (when combined with ASA in high doses, a decrease in the glomerular filtration rate is noted as a result of a decrease in prostaglandin synthesis in the kidneys);

-angiotensin converting enzyme (ACE) inhibitors (a dose-dependent decrease in the glomerular filtration rate (GFR) is noted as a result of inhibition of prostaglandins with vasodilating effects, respectively, a weakening of the hypotensive effect. The clinical significance of GFR reduction 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 together with ASA in large doses);

– drugs with uricosuric action-benzbromarone, probenecid (decrease in the uricosuric effect due to competitive suppression of renal tubular uric acid excretion).

When used concomitantly with ibuprofen, there is antagonism against irreversible platelet suppression 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 diseases.

When used concomitantly with systemic glucocorticosteroids (corticosteroids) (with the exception of hydrocortisone or other corticosteroids 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. With the combined use of corticosteroids and salicylates, it should be remembered that during treatment, the level of salicylates in the blood is reduced, and after the withdrawal of corticosteroids, an overdose of salicylates is possible.

How to take, course of use and dosage

ASPIRIN CARDIO tablets should preferably be taken before meals, washed down with plenty of fluids. ASPIRIN CARDIO tablets are taken once a day. ASPIRIN CARDIO is designed for long-term use. The duration of therapy is determined by the doctor.

– Primary prevention of acute myocardial infarction in the presence of risk factors: 100 mg/day or 300 mg every other day.

– Prevention of recurrent heart attack, stable and unstable angina: 100-300 mg / day.

– Unstable angina (if acute myocardial infarction is suspected):the initial dose of Aspirin cardio 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 acute myocardial infarction is suspected. 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 vascular interventions: 100-300 mg / day.

– Prevention of deep vein thrombosis and pulmonary embolism and its branches: 100-200 mg/day or 300 mg every other day.

Actions if you miss taking one or more doses of the drug:

Take the missed pill as soon as you think about it and continue taking it as usual. To avoid doubling the dose, do not take a missed pill if the time for taking the next pill is approaching.

Features of the action of the drug Aspirin cardio at the first intake and when it is canceled:

There were no specific effects of the drug during the first use and its cancellation.

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 improper therapeutic use of the drug (chronic intoxication) or a single accidental or intentional intake of a toxic dose of the drug by an adult or child (acute intoxication).

Symptoms of chronic intoxication with salicylic acid derivatives are non-specific 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. These symptoms disappear after reducing the dose of the drug. Tinnitus can occur when the concentration of ASA in the blood plasma is from 150 to 300 mcg / ml. More severe symptoms occur when the concentration of ASA in the blood plasma is higher than 300 mcg / 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 development of metabolic acidosis is most typical. 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.

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 use of activated charcoal, forced alkaline diuresis, restoration of water-electrolyte balance and acid-base state.

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; – disorders of the cardiovascular system: cardiac arrhythmias, hypotension, cardiac depression; – disorders of the water-electrolyte balance: dehydration, impaired renal function from oliguria 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 suppression of CNS function (drowsiness, confusion, coma, convulsions).

Treatment: immediate hospitalization in specialized departments for emergency therapy-gastric lavage, repeated intake of activated charcoal, forced alkaline diuresis, hemodialysis, restoration of water-electrolyte balance and acid-base state, symptomatic therapy.

Special instructions

Aspirin cardio should be used as directed by your doctor.

ASA can provoke bronchospasm, as well as cause attacks of bronchial asthma and other hypersensitivity reactions. Risk factors include a history of bronchial asthma, hay fever, nasal polyposis, chronic respiratory diseases, and allergic reactions to other medications (for example, skin reactions, pruritus, and urticaria).

The inhibitory effect of ASA on platelet aggregation persists for several days after use, and therefore, there may be an increased risk of bleeding during surgery or in the postoperative period. If it is necessary to absolutely exclude bleeding during surgery, it is necessary, if possible, to completely abandon the use of ASA in the preoperative period.

Excess of the ASA dose is associated with the risk of gastrointestinal bleeding.

Overdose is especially dangerous in elderly patients.

In severe forms of glucose-6-phosphate dehydrogenase deficiency, ASA can cause hemolysis and hemolytic anemia. Factors that may increase the risk of developing hemolysis include fever, acute infections, and high doses of the drug.

Influence on the ability to drive a car/ moving mechanisms

Taking Aspirin®Cardio does not affect the ability to drive a car or move machinery.

Product Form

Enteric coated Aspirin cardio tablets

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

5 years

Active ingredient

Acetylsalicylic acid

Dosage form

Tablets

Purpose

For adults who are only pregnant in the second trimester as prescribed by a doctor

Indications

Angina pectoris, Prevention of heart attacks and strokes, Cerebral circulation disorders, Prevention of thrombosis