Acecardol tablets p / o 100mg, No. 30

Prevention of acute myocardial infarction in the presence of risk factors (for example, diabetes mellitus, hyperlipidemia, arterial hypertension, obesity, smoking, old age) and repeated myocardial infarction.

Unstable angina.

Prevention of stroke (including in patients with transient cerebrovascular accident).

Prevention of thromboembolism after surgery and invasive interventions on the vessels (for example, coronary artery bypass grafting, endarterectomy of the carotid arteries, arteriovenous bypass grafting, angioplasty of the carotid arteries).

Prevention of deep vein thrombosis and thromboembolism of the pulmonary artery and its branches (for example, with prolonged immobilization as a result of major surgery)

The tablets should be taken orally, before meals, with plenty of liquid. The drug is intended for long-term use. The duration of therapy is determined by the attending physician.

Prophylaxis for suspected acute myocardial infarction: 100-200 mg / day or 300 mg every other day (the first tablet must be chewed for rapid absorption).

Prevention of new-onset acute myocardial infarction in the presence of risk factors: 100 mg / day or 300 mg every other day.

Prevention of recurrent myocardial infarction. Unstable angina. Prevention of stroke and transient cerebrovascular accident. Prevention of thromboembolic complications after surgery or invasive studies: 100 - 300 mg / day.

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

1 ACEKARDOL tablet contains - 100 mg of acetylsalicylic acid (active ingredient).

Excipients: povidone, corn starch, milk sugar (lactose), microcrystalline cellulose, magnesium stearic acid (magnesium stearate), talc, acetylphthalyl cellulose, titanium dioxide, castor oil.

Hypersensitivity to ASA, to excipients of the drug and other NSAIDs.

Erosive and ulcerative lesions, gastrointestinal bleeding, hemorrhagic diathesis, bronchial asthma induced by the intake of salicylates and NSAIDs, Fernand-Vidal triad (combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and ASA intolerance), combined use with methotrexatom 15 mg per week or more pregnancy (I and III trimester) and lactation Age up to 18 years.

Use with caution
for gout;
hyperuricemia;
a history of: ulcerative lesions of the gastrointestinal tract or gastrointestinal bleeding, renal and hepatic failure, bronchial asthma, chronic respiratory diseases, hay fever, nasal polyposis, allergic reactions to other drugs;
in the second trimester of pregnancy; in combination with methotrexate at a dose of less than 15 mg per week;
deficiency of vitamin K and glucose-6-phosphate dehydrogenase.

Trade name: Acecardol

International non-proprietary name:

acetylsalicylic acid

Dosage form:

enteric-coated tablets

Composition of the preparation:

1 ACEKARDOL tablet contains 50, 100 or 300 mg of acetylsalicylic acid (active ingredient).

Excipients: povidone, corn starch, milk sugar (lactose), microcrystalline cellulose, magnesium stearic acid (magnesium stearate), talc, acetylphthalyl cellulose, titanium dioxide, castor oil.

Description: White or almost white, round biconvex film-coated tablets.

ATX code [N02BA01]

Pharmacological properties

Pharmacodynamics

The mechanism of action of acetylsalicylic acid (ASA) is based on irreversible inhibition of cyclooxygenase, as a result of which the synthesis of thromboxane A2 is blocked and platelet aggregation is suppressed. 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, antipyretic effects.

Pharmacokinetics

After oral administration, acetylsalicylic acid is absorbed in the upper part of the small intestine. The maximum concentration in blood plasma is observed on average 3 hours after taking the drug inside. Acetylsalicylic acid undergoes partial metabolism in the liver with the formation of less active metabolites. It is excreted by the kidneys, both in unchanged form and in the form of metabolites; the half-life for acetylsalicylic acid is about 15 minutes, for metabolites - about 3 hours.

Indications for use

Prevention of acute myocardial infarction in the presence of risk factors (for example, diabetes mellitus, hyperlipidemia, arterial hypertension, obesity, smoking, old age) and repeated myocardial infarction.

Unstable angina.

Prevention of stroke (including in patients with transient cerebrovascular accident).

Prevention of thromboembolism after surgery and invasive interventions on the vessels (for example, coronary artery bypass grafting, endarterectomy of the carotid arteries, arteriovenous bypass grafting, angioplasty of the carotid arteries).

Prevention of deep vein thrombosis and thromboembolism of the pulmonary artery and its branches (for example, with prolonged immobilization as a result of major surgery)

Contraindications

Hypersensitivity to ASA, to excipients of the drug and other NSAIDs.

Erosive and ulcerative lesions, gastrointestinal bleeding, hemorrhagic diathesis, bronchial asthma induced by the intake of salicylates and NSAIDs, Fernand-Vidal triad (combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and ASA intolerance), combined use with methotrexatom 15 mg per week or more pregnancy (I and III trimester) and lactation Age up to 18 years.

Use with caution
for gout;
hyperuricemia;
a history of: ulcerative lesions of the gastrointestinal tract or gastrointestinal bleeding, renal and hepatic failure, bronchial asthma, chronic respiratory diseases, hay fever, nasal polyposis, allergic reactions to other drugs;
in the second trimester of pregnancy; in combination with methotrexate at a dose of less than 15 mg per week;
deficiency of vitamin K and glucose-6-phosphate dehydrogenase.

Pregnancy use

The use of large doses of salicylates in the first 3 months of pregnancy is associated with an increased incidence of fetal defects (cleft palate, heart defects). In the second trimester of pregnancy, salicylates can be prescribed only with a rigorous assessment of the risks and benefits.

In the last trimester of pregnancy, salicylates in a high dose (more than 300 mg / day) cause inhibition of labor, premature closure of the ductus arteriosus in the fetus, increased bleeding in the mother and fetus, and administration just before childbirth can cause intracranial hemorrhage, especially in premature infants. salicylates are contraindicated in the last trimester of pregnancy.

Application 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 termination of breastfeeding. However, with prolonged use of the drug or prescribing it in a high dose, breastfeeding should be stopped immediately.

Method of administration and dosage

The tablets should be taken orally, before meals, with plenty of liquid. The drug is intended for long-term use. The duration of therapy is determined by the attending physician.

Prophylaxis for suspected acute myocardial infarction: 100-200 mg / day or 300 mg every other day (the first tablet must be chewed for rapid absorption).

Prevention of new-onset acute myocardial infarction in the presence of risk factors: 100 mg / day or 300 mg every other day.

Prevention of recurrent myocardial infarction. Unstable angina. Prevention of stroke and transient cerebrovascular accident. Prevention of thromboembolic complications after surgery or invasive studies: 100 - 300 mg / day.

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

Side effect

Allergic reactions: urticaria, Quincke's edema.

Immune system: anaphylactic reactions.

Gastrointestinal tract: nausea, heartburn, vomiting, pain in the abdomen, ulcers of the mucous membrane of the stomach and duodenum, including perforation, gastrointestinal bleeding, increased activity of 'liver' enzymes.

Respiratory system: bronchospasm

Hematopoietic system: increased bleeding, anemia (rare).

Central nervous system: dizziness, tinnitus

Overdose

Overdose symptoms of moderate severity: nausea, vomiting, tinnitus, hearing impairment, dizziness, confusion.

Treatment: dose reduction.

Severe overdose symptoms: Fever, hyperventilation, ketoacidosis, respiratory alkalosis, coma, cardiovascular and respiratory failure, severe hypoglycemia.

Treatment: immediate hospitalization in specialized departments for emergency treatment of gastric lavage, determination of acid-base balance, alkaline and forced alkaline diuresis, hemodialysis, administration of solutions, activated carbon, symptomatic therapy. When carrying out alkaline diuresis, it is necessary to achieve pH values ??between 7.5 and 8. Forced alkaline diuresis should be carried out when the concentration of salicylates in plasma is more than 500 mg / l (3.6 mmol / l) in adults and 300 mg / l (2, 2 mmol / l) in children.

Interaction with other medicinal products. With the simultaneous use of ASA enhances the effect of the following drugs:

• methotrexate by reducing renal clearance and displacing it from the connection with proteins;

• heparin and indirect anticoagulants due to dysfunction of platelets and displacement of indirect anticoagulants from the connection with proteins;

• thrombolytic and antiplatelet drugs (ticlopidine);

• digoxin due to a decrease in its renal excretion;

• hypoglycemic agents (insulin and sulfonylurea derivatives) due to the hypoglycemic properties of ASA itself in high doses and displacement of sulfonylurea derivatives from their association with proteins

• valproic acid due to its displacement from the connection with proteins;

• An additive effect is observed with the simultaneous administration of ASA with alcohol;

• ASA weakens the effect of uricosuric drugs (benzbromarone) due to competitive tubular elimination of uric acid;

• By enhancing the elimination of salicylates, systemic glucocorticosteroids (HSC) weaken their effect.

special instructions

The drug should be used after a doctor's prescription. 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 drugs (eg, skin reactions, itching, urticaria). ASA can cause bleeding of varying degrees of severity during and after surgery. The combination of ASA with anticoagulants, thrombolytics and antiplatelet drugs is accompanied by an increased risk of bleeding. ASA in low doses can provoke the development of gout in susceptible individuals (with reduced excretion of uric acid).The combination of ASA with methotrexate is accompanied by an increased incidence of side effects from the hematopoietic organs.

High doses of ASA have a hypoglycemic effect, which must be borne in mind when prescribing it to patients with diabetes mellitus receiving hypoglycemic drugs. With the combined appointment 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.

The combination of ASA with ibuprofen is not recommended, since the latter impairs the beneficial effect of Acecardol on life expectancy. Increasing the dose of ASA is associated with the risk of gastrointestinal bleeding. Overdose is especially dangerous in elderly patients. When ASA is combined with alcohol, the risk of damage to the mucous membrane of the gastrointestinal tract and lengthening of bleeding time is increased.

Influence on the ability to drive a car / mechanisms: Not observed.

Release form

Enteric-coated tablets, 50, 100 and 300 mg each.

Storage conditions

In a dry, dark place at a temperature not exceeding 25 ? C. Keep out of the reach of children.

Expiration date 3 years. Do not use after the expiration date printed on the package.