Composition, form of production and packaging
? The tablets covered with a film shell of white color, in the form of the stylized "heart".
1 tab.
acetylsalicylic acid 75 mg
magnesium hydroxide 15.2 mg
Excipients: corn starch - 9.5 mg, microcrystalline cellulose - 12.5 mg, magnesium stearate - 150 Ојg, potato starch - 2.0 mg.
Sheath composition: hypromellose (methyl hydroxypropylcellulose 15) - 460 Ојg, propylene glycol - 90 Ојg, talc - 280 Ојg.
30 pcs. - bottles of brown glass (1) - packs of cardboard.
100 pieces. - bottles of brown glass (1) - packs of cardboard.
? The tablets, covered with a film shell of white color, are oval in shape with a risk on one side.
1 tab.
acetylsalicylic acid 150 mg
magnesium hydroxide 30.39 mg
Excipients: corn starch - 19.0 mg, microcrystalline cellulose - 25.0 mg, magnesium stearate - 305 Ојg, potato starch - 4.0 mg.
Sheath composition: hypromellose (methylhydroxypropyl cellulose 15) - 1.2 mg, propylene glycol 240 Ојg, talc - 720 Ојg.
30 pcs. - bottles of brown glass (1) - packs of cardboard.
100 pieces. - bottles of brown glass (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
PHARMACHOLOGIC EFFECT
NSAIDs, antiplatelet agent. At the core of the mechanism of action of acetylsalicylic acid is the irreversible inhibition of the enzyme COX-1, which blocks the synthesis of thromboxane A 2 and suppresses the aggregation of platelets. It is believed that acetylsalicylic acid has other mechanisms for suppressing platelet aggregation, which expands its use in various vascular diseases. Acetylsalicylic acid also has an anti-inflammatory, analgesic and 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
Suction
After taking the drug inside, acetylsalicylic acid is absorbed from the digestive tract almost completely.
Bioavailability of acetylsalicylic acid is about 70%, but this value is characterized by a significant individual variability due to presystemic hydrolysis in the mucous membranes of the gastrointestinal tract and in the liver with the formation of salicylic acid under the action of enzymes. The bioavailability of salicylic acid is 80-100%.
Metabolism and excretion
T 1/2 acetylsalicylic acid is about 15 min. with the participation of enzymes, it quickly hydrolyzes into salicylic acid in the intestine, liver and blood plasma. T 1/2salicylic acid - about 3 hours, but when taking acetylsalicylic acid in high doses (> 3 g), this figure can significantly increase as a result of saturation of enzyme systems.
Magnesium hydroxide (in the applied doses) does 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;
- prophylaxis of thromboembolism after surgical interventions on vessels (coronary artery bypass grafting, percutaneous transluminal coronary angioplasty);
unstable angina.
DOSING MODE
Tablets should be swallowed whole, washed down with water. If desired, the tablet can be broken in half, chewed or pre-grated.
For 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, elderly age) appoint 1 tab. Cardiomagnet containing acetylsalicylic acid in a dose of 150 mg in the first day, then 1 tab. Cardiomagnet, containing acetylsalicylic acid in a dose of 75 mg 1 time / day.
For the prevention of repeated myocardial infarction and blood vessel thrombosis appoint 1 tab. Cardiomagnet, containing acetylsalicylic acid in a dose of 75-150 mg 1 time / day.
For prophylaxis of thromboembolism after surgical interventions on vessels (aortocoronary shunting, percutaneous transluminal coronary angioplasty) appoint 1 tab.Cardiomagnet, containing acetylsalicylic acid in a dose of 75-150 mg 1 time / day.
With unstable angina, appoint 1 tab. Cardiomagnet, containing acetylsalicylic acid in a dose of 75-150 mg 1 time / day.
SIDE EFFECT
The incidence of adverse reactions listed below was determined as follows: very often (? 1/10); often (> 1/100, <1/10); sometimes (> 1/1000, <1/100); rarely (> 1/10 000, <1/1000); very rarely (<1/10 000, including individual messages).
Allergic reactions: often - hives, swelling of Quincke; sometimes anaphylactic reactions.
From the side of the digestive system: very often - heartburn; often - nausea, vomiting; Sometimes - pain in the abdomen, ulcers of the gastric mucosa and duodenal ulcers, gastrointestinal bleeding; rarely - perforation of the stomach or duodenal ulcer, increased activity of liver enzymes; very rarely - stomatitis, esophagitis, erosive lesions of the upper gastrointestinal tract, stricture, colitis, irritable bowel syndrome.
From the respiratory system: often - bronchospasm.
On the part of the hematopoiesis system: very often - increased bleeding; rarely anemia; very rarely - hypoprothrombinemia, thrombocytopenia, neutropenia, aplastic anemia, eosinophilia, agranulocytosis.
From the side of the central nervous system: sometimes - dizziness, drowsiness; often - headache, insomnia; rarely - a noise in the ears, an intracerebral hemorrhage.
CONTRAINDICATIONS
- hemorrhage in the brain;
- tendency to bleeding (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 hemorrhage;
- renal failure of severe degree (CC <10 ml / min);
- deficiency of glucose-6-phosphate dehydrogenase;
- simultaneous reception with methotrexate (> 15 mg per week);
- I and III trimesters of pregnancy;
- the period of lactation (breastfeeding);
- children and adolescence under 18;
- Hypersensitivity to acetylsalicylic acid, excipients of the drug and other NSAIDs.
With caution should prescribe the drug for gout, hyperuricemia, the presence of an anamnesis of gastrointestinal lesions or bleeding from the gastrointestinal tract, with renal and / or liver failure, bronchial asthma, hay fever, nasal polyposis, allergic conditions, in the second trimester of pregnancy.
PREGNANCY AND LACTATION
The use of salicylates in high doses in the first trimester 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 third trimester of pregnancy, high-dose salicylates (> 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 hemorrhages, especially in premature infants. The appointment of salicylates in the III trimester of pregnancy is contraindicated.
Available clinical data are not sufficient to determine whether or not the drug can be used during breastfeeding. Before prescribing acetylsalicylic acid during breastfeeding, the potential benefit of therapy with a drug regarding the potential risk to infants should be assessed.
APPLICATION FOR FUNCTIONS OF THE LIVER
The drug is contraindicated in severe renal failure (CC less than 10 ml / min); with renal failure should be used with caution.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With liver failure should be used with caution.
APPLICATION FOR CHILDREN
Contraindicated in children and adolescents under 18 years.
SPECIAL INSTRUCTIONS
Take the drug Cardiomagnesium should be after the appointment of a doctor.
Acetylsalicylic acid can provoke bronchospasm, as well as cause attacks of bronchial asthma and other reactions of hypersensitivity. Risk factors are the presence of bronchial asthma in history, hay fever, nasal polyposis, chronic diseases of the respiratory system, as well as allergic reactions (for example, skin reactions, pruritus, urticaria) to other drugs.
Acetylsalicylic acid can cause bleeding of varying severity during and after surgical interventions.
A few days before the planned surgery, the risk of bleeding should be assessed compared with the risk of developing ischemic complications in patients taking low doses of acetylsalicylic acid. If the risk of bleeding is significant, the intake of acetylsalicylic acid should be temporarily discontinued.
The combination of acetylsalicylic acid with anticoagulants, thrombolytics and antiplatelet drugs is accompanied by an increased risk of bleeding.
The intake of acetylsalicylic acid in low doses can provoke the development of gout in predisposed individuals (having decreased uric acid excretion).
The combination of acetylsalicylic acid with methotrexate is accompanied by an increased incidence of side effects from the hematopoiesis.
Acetylsalicylic acid in high doses has 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 GCS and salicylates should be remembered that during treatment, the concentration of salicylates in the blood is reduced, and after the abolition of systemic SCS, an overdose of salicylates is possible.
It is not recommended to combine acetylsalicylic acid with ibuprofen in patients with an increased risk of cardiovascular disease: when combined with ibuprofen, a decrease in the antiplatelet effect of acetylsalicylic acid in doses up to 300 mg is observed, which leads to a decrease in the cardioprotective effects of acetylsalicylic acid.
Exceeding the dose of acetylsalicylic acid with more recommended therapeutic doses is associated with a risk of gastrointestinal bleeding.
With long-term use of acetylsalicylic acid in low doses as antiplatelet therapy, caution is needed in elderly patients in connection with the risk of developing gastrointestinal bleeding.
With the simultaneous administration of acetylsalicylic acid with ethanol, the risk of damage to the mucosa of the gastrointestinal tract and prolonging the time of bleeding is increased.
Impact on the ability to drive vehicles and manage mechanisms
During treatment with acetylsalicylic acid, patients should be careful when driving vehicles and engaging in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.
OVERDOSE
Symptoms of an overdose of moderate severity: nausea, vomiting, tinnitus, hearing impairment, dizziness, confusion.
Treatment: should wash the stomach, prescribe activated charcoal, carry out symptomatic therapy.
Symptoms of a severe overdose: fever, hyperventilation, ketoacidosis, respiratory alkalosis, coma, cardiovascular and respiratory failure, severe hypoglycemia.
Treatment: immediate hospitalization in specialized departments for emergency therapy - gastric lavage, determination of acid-base balance, alkaline and forced alkaline diuresis, hemodialysis, administration of saline solutions, activated charcoal, symptomatic therapy. When carrying out 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.
DRUG INTERACTION
With the simultaneous use of acetylsalicylic acid 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 disruption of 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 (derivatives of sulfonylureas) and insulin (due to hypoglycemic properties of acetylsalicylic acid itself in high doses and displacement of sulfonylurea derivatives from binding to plasma proteins);
- Valproic acid (due to its displacement from the bond with proteins).
Simultaneous use of acetylsalicylic acid with ibuprofen leads to a decrease in the cardioprotective effects of acetylsalicylic acid.
Additive effect is observed with simultaneous administration of acetylsalicylic acid with ethanol (alcohol).
Acetylsalicylic acid weakens the effect of uricosuric agents (benzbromarone) due to competitive tubular elimination of uric acid.
By enhancing the elimination of salicylates, systemic GCSs weaken their action.
Antacids and colestramine, when used at the same time, reduce the absorption of Cardiomagnesium.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a place protected from light and inaccessible to children at a temperature of no higher than 25 В° C. Shelf life - 3 years. Do not use after the expiration date.
