Aspirin cardio tab. p / o ksh / sol. 100mg No. 28

Release form, composition and packaging

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Enteric-coated tablets, white, round, biconvex

cross-section - a homogeneous mass of white, surrounded by a white shell.

1 tab.

acetylsalicylic acid 100 mg

cellulose, powder - 10 mg, corn starch - 10 mg.

The composition of the enteric shell: copolymer of methacrylic acid and ethyl acrylate (1: 1) - 7.857 mg, polysorbate 80 - 0.186 mg, sodium lauryl sulfate - 0.057 mg, talc - 8.1 mg, triethyl citrate - 0.8 mg.

10 pieces.

- blisters (2) - cardboard packs.

14 pcs.

- blisters (2) - cardboard packs.

14 pcs.

- blisters (4) - cardboard packs.

14 pcs.

- blisters (7) - cardboard packs.

pharmachologic effect

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

The antiplatelet effect is most pronounced in platelets, because

they are unable to re-synthesize COX.

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.

Pharmacokinetics

Absorption After oral administration, ASA is rapidly and completely absorbed from the gastrointestinal tract. ASA is partially metabolized during absorption. During and after absorption, ASA is converted into the main metabolite - salicylic acid. Due to the fact that the tablets are coated with an acid-resistant coating, ASA is released not in the stomach, but in the alkaline environment of the duodenum. Cmax of ASA in blood plasma is achieved approximately 2-7 hours after taking the tablets, thus, the absorption of ASA in the form of enteric-coated tablets is slowed down compared to the usual (without an enteric coating). When taken simultaneously with food, a slowdown in the absorption of ASA is noted without affecting the degree of absorption. Lower absorption rate of enteric-coated ASA tablets,does not affect the exposure of ASA in blood plasma and its ability to inhibit platelet aggregation during long-term therapy with low doses of the drug. Nevertheless, in order to ensure maximum stability of Aspirin® Cardio tablets in the stomach, it is recommended to take the drug 30 minutes before a meal with plenty of liquid (see section Dosage regimen"). According to pharmacokinetic data, there are no clinically significant deviations in the concentration-dose curve when taking ASA at a dose of 100 mg to 500 mg. Distribution ASA and salicylic acid bind to a large extent with blood plasma proteins and are rapidly distributed in the body. Salicylic acid crosses the placental barrier, excreted in breast milk. Metabolism The main metabolite of ASA is salicylic acid.The metabolism of salicylic acid is carried out in the liver with the formation of salicyrulic acid, phenolic glucuronide of salicylic acid, salicylglucuronide and gentisuric acid. Elimination The elimination of salicylic acid is dose-dependent, since its metabolism is limited by the capabilities of the enzymatic system. T1 / 2 ranges from 2-3 hours when using ASA in low doses and up to 15 hours when using the drug in high doses (usual doses of acetylsalicylic acid as an analgesic). Salicylic acid and its metabolites are excreted by the kidneys.T1 / 2 ranges from 2-3 hours when using ASA in low doses and up to 15 hours when using the drug in high doses (usual doses of acetylsalicylic acid as an analgesic). Salicylic acid and its metabolites are excreted by the kidneys.T1 / 2 ranges from 2-3 hours when using ASA in low doses and up to 15 hours when using the drug in high doses (usual doses of acetylsalicylic acid as an analgesic). Salicylic acid and its metabolites are excreted by the kidneys.

Indications for use

- primary 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 pectoris (including suspected development of acute myocardial infarction) and stable angina pectoris

- stroke prevention (including in patients with transient cerebrovascular accident)

- prevention

Name ENG

ASPIRIN CARDIO

Clinical and pharmacological group

Antiplatelet agent

ATX code

Acetylsalicylic acid

Dosage

100mg

Structure

1 tablet contains acetylsalicylic acid 100 mg

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 repeated myocardial infarction

unstable angina (including suspected development of acute myocardial infarction) and stable angina

stroke prevention (including in patients with transient cerebrovascular accident)

prevention of transient disorders of cerebral circulation

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 and stenting of the coronary arteries, angioplasty of the carotid arteries)

prevention of deep vein thrombosis and thromboembolism of the pulmonary artery and its branches (including with prolonged immobilization as a result of extensive surgical intervention).

Contraindications

hypersensitivity to acetylsalicylic acid, excipients in the drug and other NSAIDs

bronchial asthma induced by the intake of salicylates and other NSAIDs

a combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and ASA intolerance

erosive and ulcerative lesions of the gastrointestinal tract in the acute phase

gastrointestinal bleeding

hemorrhagic diathesis

severe renal impairment

severe liver dysfunction

chronic heart failure III-IV FC according to NYHA classification

combined use with methotrexate at a dose of 15 mg per week or more

I and III trimesters of pregnancy

lactation period (breastfeeding)

children and adolescents up to 18 years of age (due to the lack of data on efficacy and safety).,

Carefully:

hypersensitivity to analgesics, anti-inflammatory drugs, antirheumatic drugs, as well as allergic reactions to other substances

a history of ulcerative lesions of the gastrointestinal tract, incl.

a history of chronic and recurrent gastrointestinal lesions or gastrointestinal bleeding

with gout, hyperuricemia

with impaired liver function

with impaired renal function

with circulatory disorders resulting from atherosclerosis of the renal arteries, congestive heart failure, hypovolemia, extensive surgery, sepsis, cases of massive bleeding

with bronchial asthma, chronic respiratory diseases, hay fever, nasal polyposis, chronic diseases of the respiratory system, as well as allergic reactions to other drugs (for example, skin reactions, itching, urticaria)

with severe forms of glucose-6-phosphate dehydrogenase deficiency

in the II trimester of pregnancy

with the proposed surgical intervention (including minor, for example, tooth extraction)

when used in combination with the following drugs:

- with methotrexate at a dose of less than 15 mg per week

- with anticoagulant, thrombolytic or other antiplatelet agents

- with NSAIDs (including ibuprofen, naproxen)

- 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.

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 5 years

INN / Active ingredient

acetylsalicylic acid

Specifications

Category

Anticoagulants

Scope of the drug

Heart, vessels, blood

Release form

Tablet

Manufacturer country

Germany

Package quantity, pcs

28

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Bayer

The amount of the dosage form in the primary package

14 pcs.

Primary packaging type

Blister

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Antiplatelet agent

Anatomical and therapeutic characteristics

B01AC06 Acetylsalicylic acid

Dosage form

Enteric-coated tablets

Dosage (volume) of the substance in the preparation

acetylsalicylic acid 100 mg

Expiration date in days

1825

Package weight, g

twenty

Mode of application

:

Aspirin cardio is prescribed by mouth. For prophylaxis with suspected acute myocardial infarction, the recommended dose is 100-200 mg / day or 300 mg every other day. The first tablet is recommended to be chewed for faster absorption. For the prevention of new-onset acute myocardial infarction in the presence of risk factors, the recommended dose is 100 mg / day or 300 mg every other day. For the prevention of recurrent myocardial infarction, with unstable angina pectoris, for the prevention of stroke, transient cerebrovascular accident and thromboembolic complications after surgical interventions on the vessels, the drug is prescribed at a dose of 100-300 mg / day. For the prevention of deep vein thrombosis and thromboembolism of the pulmonary artery and its branches, the recommended dose of the drug is 100-200 mg / day or 300 mg every other day.Aspirin Cardio is intended for long-term use, the duration of therapy is set individually. Aspirin Cardio tablets are taken before meals with plenty of liquid.

Information on technical characteristics, delivery set, country of manufacture "