Aspirin cardio, 100 mg 28 pcs

Pharmgroup:

NSAIDs.

Pharmic action:

The mechanism of antiplatelet action of acetylsalicylic acid (ASA) is based on irreversible inhibition of cyclooxygenase (COX-1), resulting in blocked synthesis of thromboxane A2 and suppressed platelet aggregation.

The antiplatelet effect is most pronounced in platelets, as they are unable to re-synthesize cyclooxygenase. It is believed that ASA has other mechanisms to inhibit platelet aggregation, which expands the field of its use in various vascular diseases.

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

Indications

– Primary prevention of acute myocardial infarction in the presence of risk factors (eg, diabetes, hyperlipidemia, 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 stroke);
– Prevention of transient cerebrovascular disorders;
– Prevention of thromboembolism after surgical and invasive interventions on the vessels (e.g. coronary artery bypass grafting, carotid endarterectomy, arterio-venous bypass grafting, angioplasty and stenting of the coronary arteries, carotid angioplasty).br> – Prevention of deep vein thrombosis and thromboembolism of the pulmonary artery and its branches (including, in case of prolonged immobilization as a result of extensive surgical intervention).

Active ingredient

Composition

1 tablet:

– acetylsalicylic acid 100 mg or 300 mg;

accompanies:

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,

triethylcitrate 0.800 mg or 2.240 mg.

How to take, the dosage

Tablets of the drug ASPIRIN CARDIO should preferably be taken before meals with plenty of fluids. Tablets ASPIRIN CARDIO are taken once a day. ASPIRIN CARDIO is intended 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 pectoris: 100-300 mg/day.

– Unstable angina (if acute myocardial infarction is suspected):The initial dose of Aspirin Cardio 100-300 mg (the first tablet should be chewed for faster absorption) should be taken as soon as possible after the patient is suspected of developing an acute myocardial infarction. A dose of 200-300 mg/day should be maintained for the next 30 days after the development of myocardial infarction. After 30 days, appropriate therapy should be administered to prevent recurrent myocardial infarction.

– Prevention of stroke and transient impairment of cerebral circulation:100-300 mg/day.

– Prevention of thromboembolism after surgery and invasive vascular interventions: 100-300 mg/day.

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

What to do if you miss one or more doses of the medication:

Take the missed tablet as soon as you remember it and continue as usual. To avoid doubling your dose, do not take the missed tablet if you are approaching the time for the next tablet.

Particular effects of Aspirin Cardio when first taken and when discontinued:

There were no particular effects of the drug when first taken or when discontinued.

Interaction

When concomitant use of ASA increases the effect of the following drugs; if concomitant administration of ASA with the following drugs is necessary, consideration should be given to the need to reduce the dose of these drugs:

Methotrexate due to decreased renal clearance and its displacement from protein binding; combination of Asc and methotrexate is accompanied by increased frequency of hematopoietic side effects; Aspirin® Cardio should not be used with methotrexate if the latter dose exceeds 15 mg per week (see

Heparin and indirect anticoagulants due to disruption of platelet function and displacement of indirect anticoagulants from protein binding

In concomitant use with anticoagulants, thrombolytics and antiplatelet agents (ticlopidine) there is an increased risk of bleeding due to synergy of the main therapeutic effects of the drugs used;

When used concomitantly with drugs with anticoagulant, thrombolytic or antiplatelet agents, an increased damaging effect on the mucosa of the gastrointestinal tract is noted;

Selective serotonin reuptake inhibitors, which may increase the risk of upper gastrointestinal tract bleeding (synergism with ASA)

-Hypoglycemic agents for oral administration (sulfonylurea derivatives) and insulin due to hypoglycemic properties of ASA itself at high doses and displacement of sulfonylurea derivatives from plasma protein binding; this should be kept in mind when prescribing ASA for patients with diabetes mellitus who are receiving the above medications. -Simultaneous use with valproic acid increases its toxicity due to displacement from plasma protein binding;

Drugs and salicylic acid derivatives at high doses (increased risk of ulcerogenic effects and gastrointestinal bleeding due to synergistic action);

-Ethanol (alcoholic beverages) (increased risk of gastrointestinal mucosal damage and prolongation of bleeding time due to mutual amplification of the effects of ASA and ethanol).

The concomitant administration of ASA in high doses may weaken the effects of the drugs listed below. If concomitant administration of ASA with the drugs listed below is necessary, the need to adjust the dose of the drugs listed below should be considered:

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

-angiotensin-converting enzyme (ACE) inhibitors (there is a dose-dependent decrease of glomerular filtration rate (GFR) as a result of inhibition of prostaglandins that have a vasodilator effect, respectively, weakening of hypotensive effect. Clinical significance of decreased aEF is noted in daily dose of ASA more than 160 mg. In addition, there is a decrease of the positive cardioprotective effect of ACE inhibitors prescribed for patients with chronic heart failure. This effect is also manifested when used together with high doses of ASA);

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

In concomitant use with ibuprofen, antagonism to irreversible platelet inhibition due to the action of ASA is noted, which leads to a decrease in the cardioprotective effects of ASA. Therefore, it is not recommended to combine ASA with ibuprofen in patients with an increased risk of cardiovascular disease.

In concomitant use with systemic glucocorticosteroids (GCS) (with the exception of hydrocortisone or other GCS used for substitution therapy of Addison’s disease) an increased elimination of salicylates and correspondingly weakening of their action is noted. When combined use of GCS and salicylates it should be remembered that during treatment the level of salicylates in blood is decreased, and after withdrawal of GCS an overdose of salicylates is possible.

Special Instructions

Aspirin Cardio should be used as prescribed by your doctor.

ASA may cause bronchospasm, as well as bronchial asthma attacks and other hypersensitivity reactions. Risk factors include a history of bronchial asthma, hay fever, nasal polyposis, chronic respiratory disease, and allergic reactions to other medications (e.g., skin reactions, itching, urticaria).

The inhibitory effect of ASA on platelet aggregation persists for several days after administration, and therefore the risk of bleeding during surgery or in the postoperative period may increase. If it is necessary to absolutely exclude bleeding during surgical intervention it is necessary to discontinue use of ASA in preoperative period if possible.

Excessive dosing of ASA 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 may cause hemolysis and hemolytic anemia. Factors that may increase the risk of hemolysis include fever, acute infections, and high doses of the drug.

Impact on ability to drive/running machinery

The use of Aspirin®Cardio does not affect the ability to drive/running machinery.

Contraindications

– Hypersensitivity to acetylsalicylic acid, excipients in the preparation Aspirin Cardio and other NSAIDs
– Bronchial asthma, induced by taking salicylates and other NSAIDs; combination of bronchial asthma, recurrent polyposis of the nose and sinuses and ASA intolerance
– Gastrointestinal erosive-ulcerative lesions (acute stage)
– Gastrointestinal bleeding
– Hemorrhagic diathesis
– Concomitant use with methotrexate at a dose of 15 mg per week or more
– Concomitant use with ASCs
– Ingestion of umbilical cord blood in the stomach.
– Pregnancy (I and III trimester) and lactation
– Child and adolescent age (under 18)
– Severe renal insufficiency (creatinine clearance (CK) less than 30 ml/min).)
– Expressed hepatic insufficiency (class B or higher according to Child-Pugh scale)
– Chronic heart failure III-IV functional class according to NYHA classification

With caution:
With gout, hyperuricemia, as.к. In low doses of ASA it decreases excretion of uric acid; it should be taken into account that low doses of ASA can provoke the development of gout in predisposed patients (with decreased excretion of uric acid)./p>

Have a history of gastrointestinal ulcers or gastrointestinal bleeding

Hepatic impairment (below Child-Pugh class B).

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

In bronchial asthma, chronic respiratory diseases, hay fever, nasal polyposis, drug allergies, including the NSAID group (analgesics, anti-inflammatory, anti-rheumatic agents)

In the second trimester of pregnancy

In anticipated surgical procedures (including minor ones, such as tooth extraction), since ASA may cause a tendency to develop bleeding for several days after taking the drug

When Aspirin Cardio is used in conjunction with the following medications (see See section “Interaction with other medicinal products”):

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

Side effects

Gastrointestinal system disorders: most frequently nausea, heartburn, vomiting, abdominal pain; rarely – gastric and duodenal ulcers; very rarely – perforative gastric and duodenal ulcers, gastrointestinal bleeding (with corresponding clinical symptoms and laboratory changes), transient liver dysfunction with increased activity of “liver” transaminases.

With the hematopoietic system: administration of ASA is accompanied by an increased risk of bleeding due to the inhibitory effect of ASA on platelet aggregation. Increased incidence of perioperative (intra- and postoperative) bleeding, hematomas (bruises), nosebleeds, bleeding gums, bleeding from the urinary tract are registered. There are reports about serious cases of bleeding, which include gastrointestinal bleeding and cerebral hemorrhage (especially in patients with arterial hypertension who have not reached the target blood pressure (BP) and/or receiving concomitant therapy with anticoagulants), which in some cases may be life-threatening (see section “Special indications”).

Bleeding may lead to the development of acute or chronic post-hemorrhagic/iron deficiency anemia (e.g., due to hidden bleeding) with corresponding 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 associated laboratory and clinical manifestations, such as asthmatic syndrome (bronchospasm), mild to moderate skin, respiratory reactions, Gastrointestinal and cardiovascular reactions, including symptoms such as skin rash, pruritus, urticaria, Quincke’s edema, rhinitis, nasal mucosal edema, cardio-respiratory distress syndrome, and severe reactions, including anaphylactic shock.

Central nervous system (CNS) disorders: there have been reports of dizziness, decreased hearing, headache, tinnitus, which may be a sign of overdose of the drug (see section “Overdose”).

Urinary system disorders: there are reports of cases of renal dysfunction and acute renal failure.

Overdose

Salicylate intoxication (developed when ASA is taken at doses greater than 100 mg/kg/day for more than 2 days) can result from long-term use of toxic doses of the drug as part of a therapeutic misuse of the drug (chronic intoxication) or a single accidental or intentional ingestion of a toxic dose of the drug by an adult or child (acute intoxication).

The 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, decreased hearing, increased sweating, nausea and vomiting, headache and confusion. The above symptoms disappear after reducing the dose of the drug. Tinnitus may occur at plasma ASA concentrations of 150 to 300 mcg/mL. More severe symptoms occur at plasma concentrations of ASA above 300 mcg/ml.

The main manifestation of acute intoxication is a severe disorder of acid-base status, which manifestations 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. The treatment of intoxication is carried out in accordance with accepted standards and depends on the severity of intoxication and clinical picture, and should be aimed mainly at accelerating drug elimination and restoring water-electrolyte balance and acid-base state.

The symptoms of overdose are mild to moderate in severity:

Dizziness, tinnitus, impaired hearing, increased sweating, nausea, vomiting, headache, confusion, profuse sweating, tachypnea, hyperventilation, respiratory alkalosis.

Treatment: gastric lavage, repeated administration of activated charcoal, forced alkaline diuresis, restoration of water-electrolyte balance and acid-base balance.

The symptoms of overdose from moderate to severe:
– respiratory alkalosis with compensatory metabolic acidosis;
– hyperpyrexia (extremely high body temperature);
– respiratory disorders: hyperventilation, noncardiogenic pulmonary edema, respiratory depression, asphyxia;
– disorders of the cardiovascular system: cardiac rhythm disorders, arterial hypotension, depressed cardiac activity;
– disorders of the water-electrolyte balance: dehydration, impaired renal function from oliguria up to the development of renal failure, characterized by hypokalemia, hypernatriemia, hyponatremia;
– disorders of 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 depression of CNS function (drowsiness, confusion, coma, seizures).

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

Pregnancy use

Inhibition of prostaglandin synthesis may have adverse effects on pregnancy and fetal development.
Use of high doses of salicylates (more than 300 mg/day; we are talking about the usual doses of ASA from 500 mg as a pain reliever) in the first trimester of pregnancy is associated with an increased frequency of fetal defects (cleft palate, heart defects). Prescribing salicylates in the first trimester of pregnancy is contraindicated.

In the third trimester of pregnancy, salicylates at high doses (over 300 mg/day; we are talking about the usual doses of ASA from 500 mg as an analgesic) may cause inhibition of labor, premature closure of the fetal arterial duct, increased bleeding in mother and fetus, and administration just before delivery may cause intracranial hemorrhage, especially in premature babies. Prescribing salicylates in the third trimester of pregnancy is contraindicated.

In the second trimester of pregnancy, salicylates may be prescribed only after a strict assessment of risk and benefit to the mother and fetus, preferably in doses no higher than 150 mg/day and for short periods of time.

The use during lactation:

Salicylates and their metabolites penetrate into breast milk in small amounts. Occasional use of salicylates during lactation is not accompanied by the development of adverse reactions in the baby and does not require discontinuation of breastfeeding. However, if the drug is used for a long time or if it is prescribed in a high dose, breastfeeding should be stopped immediately.

Similarities