Cardiomagnet - instructions for use, dose, side effects, contraindications

Active substanceAcetylsalicylic acid + Magnesium hydroxideAcetylsalicylic acid + Magnesium hydroxide

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Dosage form: & nbspfilm coated tablets

Composition:

One tablet contains

Active substances:

Acetylsalicylic acid 75 mg / 150 mg

Magnesium hydroxide 15.2 mg / 30.39 mg

Excipients:

Corn starch 9.5 mg / 19.0 mg

Cellulose microcrystalline 12.5 mg / 25.0 mg

Magnesium stearate 150 μg / 305 μg

Potato starch 2.0 mg / 4.0 mg

Shell

Hypromellose (methyl-hydroxypropyl cellulose 15) 460 μg / 1.2 mg

Propylene glycol 90 μg / 240 μg

Talc 280 μg / 720 μg

Description:

Film-coated tablets containing 75 mg / 15.2 mg of acetylsalicylic acid and magnesium hydroxide, respectively: tablets covered with a film shell, white in the form of a stylized "heart"

Film-coated tablets containing 150 mg / 30.39 mg of acetylsalicylic acid and magnesium hydroxide, respectively: tablets, film-coated, white, oval in shape with a risk on one side.

Pharmacotherapeutic group:Antiaggregant agent

ATX: & nbsp

N.02.B.A.51 Acetylsalicylic acid in combination with other drugs, excluding psycholeptics

Pharmacodynamics:

The mechanism of action of acetylsalicylic acid (ASA) is based on the irreversible inhibition of cyclooxygenase (COX-1), which blocks the synthesis of thromboxane A₂ and aggregation of platelets is suppressed. It is believed that ASA has other mechanisms for suppressing platelet aggregation, which expands its use in various vascular diseases. ASA also has an anti-inflammatory, analgesic, antipyretic effect.

Magnesium hydroxide, which is part of the Cardiomagnet, protects the mucous membrane of the gastrointestinal tract from the effects of acetylsalicylic acid.

Pharmacokinetics:

ASA is absorbed from the gastrointestinal tract almost completely. The half-life of ASA is about 15 minutes, because with the participation of enzymes ASA is rapidly hydrolyzed into salicylic acid (SC) in the intestine, liver and blood plasma. The half-life of SC is about 3 hours, but it can significantly increase with simultaneous administration of large doses of ASA (more than 3.0 g) as a result of saturation of enzyme systems.

Bioavailability of ASA is about 70%, but this value largely fluctuates, as ASA undergoes pre-systemic hydrolysis (gastrointestinal mucosa, liver) in SC under the action of enzymes. Bioavailability of SC is 80-100%.

The doses of magnesium hydroxide used do not affect the bioavailability of acetylsalicylic acid.

Indications:

Primary prevention of cardiovascular diseases, such as thrombosis and acute heart failure in the presence of risk factors (for example, diabetes, hyperlipidemia, hypertension, obesity, smoking, old age). Prevention of repeated myocardial infarction and thrombosis of blood vessels.

Prevention of thromboembolism after surgical interventions on vessels (aortocoronary bypass, percutaneous transluminal coronary angioplasty).

Unstable angina.

Contraindications:

Hypersensitivity to ASA, excipients and other NSAIDs, hemorrhage in the brain; propensity to bleed (insufficiency of vitamin K, thrombocytopenia, hemorrhagic diathesis); bronchial asthma,induced by the intake of salicylates and NSAIDs; erosive-ulcerative lesion of the gastrointestinal tract (in the phase of exacerbation); gastrointestinal bleeding; severe renal failure (creatinine clearance less than 10 ml / min.); pregnancy (I and III trimesters); lactation period; deficiency of glucose-6-phosphate dehydrogenase; simultaneous reception with methotrexate (more than 15 mg per week); children's age till 18 years.

Carefully:

With gout, hyperuricemia, history of ulcerative lesions of the gastrointestinal tract or gastrointestinal bleeding, renal and / or hepatic insufficiency, bronchial asthma, hay fever, nasal polyposis, allergic conditions, in the second trimester of pregnancy.

Pregnancy and lactation:

The use of large doses of salicylates in the first 3 months of pregnancy is associated with an increased incidence of fetal developmental defects.

In the second trimester of pregnancy, salicylates can be administered only in the light of a strict assessment of the risk and benefit.

In the last trimester of pregnancy, salicylates in high dose (more than 300 mg / day) cause inhibition of labor, premature closure of the arterial duct in the fetus,increased bleeding in the mother and fetus, and the appointment immediately before childbirth can cause intracranial hemorrhage, especially in premature infants. The appointment of salicylates in the last trimester of pregnancy is contraindicated.

Available clinical data are not sufficient to determine whether or not the drug can be used during breastfeeding. Before the appointment of acetylsalicylic acid during breastfeeding, the potential benefit of therapy with a drug regarding the potential risk to infants should be assessed.

Dosing and Administration:

The tablets are swallowed whole, washed down with water. If desired, the tablet can be broken in half, chewed or pre-grated.

Primary prevention of cardiovascular diseases, such as thrombosis and acute heart failure in the presence of risk factors (for example, diabetes mellitus, hyperlipidemia, hypertension, obesity, smoking, old age)

1 tablet Cardiomagnet containing ASA in a dose of 150 mg in the first day, then 1 tablet of Cardiomagnesium containing ACA in a dose of 75 mg once a day.

Prevention of repeated myocardial infarction and thrombosis of blood vessels

1 tablet Cardiomagnet containing ASA in a dose of 75 - 150 mg once a day.

Prevention of thromboembolism after surgical interventions on vessels (coronary artery bypass grafting, percutaneous transluminal coronary angioplasty)

1 tablet Cardiomagnet containing ASA in a dose of 75 - 150 mg once a day.

Unstable angina

1 tablet Cardiomagnet containing ASA in a dose of 75-150 mg once a day.

Side effects:

The incidence of adverse reactions listed below was determined as follows:

-Often ≥ 1/10;

-frequently> 1/100, <1/10;

sometimes> 1/1000, <1/100;

- often> 1/10 000, <1/1000;

-very rare <1/10 000, including individual messages.

Allergic reactions: Urticaria (often), Quincke's swelling (often).

The immune system: anaphylactic reactions (sometimes).

Gastrointestinal tractNausea (often), heartburn (very often), vomiting (often), pain in the abdomen, the gastric mucosa and duodenal ulcers (sometimes), including perforation (rare), gastrointestinal bleeding (sometimes) increased activity of "liver" enzymes (rarely), stomatitis (very rarely), esophagitis (very rarely),erosive lesions of the upper gastrointestinal tract (very rarely), strictures (very rarely), colitis (very rarely), irritable bowel syndrome (very rare).

Respiratory system: bronchospasm (often)

Hemopoietic system: very bleeding (very often), anemia (rarely), hypoprothrombinemia (very rarely), thrombocytopenia (very rare), neutropenia, aplastic anemia (very rare), eosinophilia (very rarely), agranulocytosis (very rare).

central nervous system: dizziness (sometimes), headache (often), insomnia (often), drowsiness (sometimes), tinnitus, intracerebral haemorrhage (rarely).

Overdose:

Symptoms of an overdose of moderate severity: nausea, vomiting, tinnitus, hearing impairment, dizziness, confusion.

Treatment: rinse the stomach, take Activated carbon. Treatment is symptomatic.

Symptoms of a severe overdose: fever, hyperventilation, ketoacidosis, respiratory alkalosis, coma, cardiovascular and respiratory failure, severe hypoglycemia.

Treatment: immediate admission to specialized emergencytherapy - gastric lavage, determination of acid-base balance, alkaline and forced alkaline diuresis, hemodialysis, administration of solutions, Activated carbon, symptomatic therapy. For alkaline diuresis, it is necessary to achieve pH values between 7.5 and 8. The forced alkaline diuresis should be performed when the concentration of salicylates in the 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 the simultaneous use of ASA enhances the effect of the following drugs:

- Methotrexate by reducing renal clearance and displacing it from the bond with proteins;

- heparin and indirect anticoagulants due to impaired platelet function and displacement of indirect anticoagulants from binding to proteins;

- thrombolytic and antiplatelet agents and anticoagulant drugs (ticlopidine);

- Digoxin due to a decrease in its renal excretion;

- hypoglycemic agents for oral administration (sulfonylurea derivatives) and insulin due to hypoglycemic properties of the ASA itself at high doses and displacement of the sulfonylurea derivatives from binding to plasma proteins;

- Valproic acid due to its displacement from the bond with proteins.

Simultaneous use of ASA with ibuprofen leads to a decrease in the cardioprotective effects of ASA.

Additive effect is observed with simultaneous reception of ASA with ethanol (alcohol).

ASA weakens the effect of uricosuric agents (benzbromarone) due to competitive tubular elimination of uric acid.

Strengthening the elimination of salicylates, systemic glucocorticosteroids (GCS) weakens their effect.

Antacids and colestramine reduce the absorption of the drug.

Special instructions:

The drug should be used after the appointment of a doctor.

ASA can provoke bronchospasm, as well as cause seizures of bronchial asthma and other reactions of hypersensitivity. Risk factors are the availability of a history of asthma, hay fever, nasal polyposis, chronic diseases of the respiratory system as well as of allergic reactions to other drugs (e.g., skin reactions, pruritus, urticaria).

ASA can cause bleeding of varying severity during and after surgical interventions. A few days before the planned surgical intervention, the risk of developingbleeding compared with the risk of developing ischemic complications in patients taking low-dose ASA. If the risk of developing bleeding is significant, ASA should be temporarily discontinued.

The combination of ASA with anticoagulants, thrombolytic and antiplatelet drugs is accompanied by an increased risk of bleeding.

ASA in low doses can provoke the development of gout in predisposed patients (having decreased uric acid excretion).

The combination of ASA with methotrexate is accompanied by an increased incidence of side effects from the hematopoiesis.

High doses of ASA have a hypoglycemic effect, which must be borne in mind when prescribing it to patients with diabetes mellitus receiving hypoglycemic agents for ingestion and insulin.

When combined use of systemic glucocorticosteroids (GCS) and salicylates should be remembered that during treatment, the concentration of salicylates in the blood is reduced, and after the abolition of systemic glucocorticosteroids (SCS), an overdose of salicylates is possible.

The combination of ASA with ibuprofen in patients with an increased risk of cardiovascular disease is not recommended: with simultaneouswith the use of ibuprofen, there is a decrease in the antiplatelet effect of ASA in doses up to 300 mg, which leads to a decrease in the cardioprotective effects of ASA.

Exceeding the dose of ASA above the recommended therapeutic doses is associated with a risk of gastrointestinal bleeding. With prolonged use of low doses of ASA as an aggressive therapy, caution is necessary in elderly patients due to the risk of developing gastrointestinal bleeding. With the simultaneous administration of ASA with alcohol, the risk of damage to the mucous membrane of the gastrointestinal tract and prolongation of bleeding time are increased.

Effect on the ability to drive transp. cf. and fur:During the period of treatment with ASA, caution should be exercised when driving vehicles and engaging in potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:

Film coated tablets 75 mg +15.2 mg and 150 mg + 30.39 mg.

Packaging:For 30 or 100 tablets in glass bottles of brown, sealed with a screw cap of white color (made of polyethylene), with a built-in removable cap with a seal,to which is attached a ring for tearing off the sealing gasket, providing control of the first opening. Each label is labeled. One bottle with instructions for use is placed in a cardboard box.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the end of the period shelf life.

Terms of leave from pharmacies:Without recipe

Registration number:П N013875 / 01

Date of registration:25.12.2007 / 07.10.2016

Expiration Date:Unlimited

The owner of the registration certificate:Takeda Pharmaceuticals, LLCTakeda Pharmaceuticals, LLC Russia

Manufacturer: & nbsp