ThromboMage
ThromboMag: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: TromboMag
ATX code: B01AC30
Active ingredient: magnesium hydroxide, acetylsalicylic acid
Manufacturer: Hemofarm, LLC (Russia)
Description and photo update: 28.11.2018
Prices in pharmacies: from 77 rubles.
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Thrombomag is an antiplatelet agent.
Release form and composition
Dosage form - film-coated tablets: round, biconvex, white (slight marbling is possible), with a line on one side; the cross section shows the core of almost white or white color (10 pcs. in blister contour packs, in a cardboard box 3 or 10 packs and instructions for the use of Thrombomag).
Composition of 1 tablet:
- active substances: acetylsalicylic acid - 75 or 150 mg, magnesium hydroxide - 15.2 or 30.39 mg;
- auxiliary components: citric acid, potato starch, corn starch, microcrystalline cellulose, magnesium stearate;
- film shell: macrogol-4000, hypromellose, talc.
Pharmacological properties
Pharmacodynamics
ThromboMag is a drug of combined composition, the antiplatelet property of which is due to acetylsalicylic acid (ASA). Its mechanism of action is explained by the ability to irreversibly inhibit the enzyme cyclooxygenase (COX-1), as a result of which the synthesis of thromboxane A2 is blocked, platelet aggregation is suppressed.
The most pronounced antiaggregatory effect is noted in platelets, since they cannot synthesize COX again. It is believed that ASA also has other mechanisms for suppressing platelet aggregation, thereby expanding the scope of its application in various vascular diseases.
In addition, ASA has antipyretic, anti-inflammatory and analgesic properties.
Magnesium hydroxide - the second active ingredient of Thrombomag - is an antacid agent that reduces the irritating effect of ASA on the gastric mucosa.
Pharmacokinetics
Once in the gastrointestinal tract, ASA is absorbed quickly and almost completely. With the simultaneous intake of food, absorption slows down. Undergoes partial metabolism during absorption.
During and after absorption, ASA is biotransformed into the main metabolite - salicylic acid, which is also metabolized under the influence of the enzyme (mainly in the liver), resulting in the formation of such metabolites as salicyluric acid, glucuronide salicylate and phenyl salicylate found in many body fluids and tissues. In women, ASA metabolism occurs more slowly (due to the lower activity of enzymes in the blood serum).
The maximum plasma concentration of ASA is reached 10–20 minutes after taking Thrombomag inside, salicylic acid - after 18–120 minutes. Acetylsalicylic and salicylic acids are highly bound to blood plasma proteins and are rapidly distributed in the body. The binding of salicylic acid to plasma proteins is non-linear and depends on the concentration. At low concentrations (0.4 mg / ml) - up to 75%.
Bioavailability of acetylsalicylic acid is 50-68%, salicylic acid - 80-100%. Salicylic acid crosses the placental barrier and into breast milk.
In newborns, pregnant women and patients with renal insufficiency, salicylates can displace bilirubin from the association with albumin and cause the development of bilirubin encephalopathy.
ASA and its metabolites are excreted mainly by the kidneys. When Trombomag is taken in low doses, the half-life (T ½) of acetylsalicylic acid from plasma is 15–20 minutes, salicylic acid is 120–180 minutes. When taking the drug in high doses due to saturation of the enzymatic systems, T ½ increases significantly.
Unlike other salicylates, non-hydrolyzed ASA does not accumulate in the blood serum when taken multiple times. With normal renal function, 80-100% of the received dose of ASA is excreted by the kidneys within 24-72 hours.
The magnesium hydroxide included in ThromboMag does not affect the bioavailability of ASA.
Indications for use
- primary prevention of cardiovascular diseases (thrombosis, acute heart failure) in patients with risk factors (arterial hypotension, obesity, hyperlipidemia, diabetes mellitus, old age, smoking);
- prevention of recurrent myocardial infarction and blood vessel thrombosis;
- prevention of thromboembolism after vascular surgery (for example, after percutaneous transluminal coronary angioplasty or coronary artery bypass grafting);
- treatment of unstable angina.
Contraindications
Absolute:
- erosive and ulcerative lesions of the gastrointestinal tract in the acute phase;
- gastrointestinal bleeding;
- tendency to bleeding (hemorrhagic diathesis, thrombocytopenia, vitamin K deficiency);
- hemorrhage in the brain;
- severe hepatic impairment (> 9 points on the Child-Pugh scale);
- severe renal failure [creatinine clearance (CC) <30 ml / min];
- deficiency of glucose-6-phosphate dehydrogenase;
- bronchial asthma caused by the intake of salicylates or non-steroidal anti-inflammatory drugs (NSAIDs);
- combination of bronchial asthma, nasal polyposis and paranasal sinuses with ASA intolerance;
- age up to 18 years;
- I and III trimesters of pregnancy;
- lactation period;
- the need for the simultaneous use of methotrexate in a weekly dose of 15 mg;
- hypersensitivity to any component of Thrombomag or other NSAIDs.
Relative:
- a history of gastrointestinal ulcer or gastrointestinal bleeding;
- liver failure (≤ 9 points on the Child - Pugh scale);
- mild to moderate renal impairment (CC> 30 ml / min);
- circulatory disorders due to chronic heart failure, atherosclerosis of the renal arteries, massive bleeding, sepsis, extensive surgical intervention;
- hyperuricemia;
- gout;
- polyposis of the nose and paranasal sinuses;
- hay fever;
- allergic reactions;
- chronic respiratory diseases;
- bronchial asthma;
- preoperative period;
- II trimester of pregnancy;
- drinking alcohol or taking ethanol-containing drugs;
- simultaneous use of the following drugs: antiplatelet drugs, thrombolytics, anticoagulants, methotrexate in a weekly dose <15 mg, NSAIDs, valproic acid, ASA derivatives in high doses, sulfonamides (including co-trimoxazole), selective serotonin reuptake inhibitors, systemic glucocorticosteroids, insulin, oral hypoglycemic agents (sulfonylurea derivatives), carbonic anhydrase inhibitors (acetazolamide), narcotic analgesics, digoxin, ibuprofen.
ThromboMag, instructions for use: method and dosage
ThromboMag tablets should be taken orally, 1-2 hours after a meal, once a day, swallowing whole with a sufficient amount of water. If necessary, the tablet can be crushed or chewed.
The drug is used for a long time, the doctor determines the duration of therapy individually.
Recommended dosage regimens for ThromboMag:
- primary prevention of cardiovascular diseases: the first day - 1 tablet containing 150 mg of ASA, then - 1 tablet each containing 75 mg of ASA;
- prevention of re-myocardial infarction and blood vessel thrombosis, prevention of thromboembolism after surgery: 1 tablet 75 or 150 mg (according to ASA);
- treatment of unstable angina pectoris: 1 tablet of 75 or 150 mg (according to ASA).
If one or more receptions are missed, Thrombomag should be taken as soon as possible. If the time for taking the next dose is approaching, then the pill should be taken at the usual time.
Side effects
Thrombomag is generally well tolerated.
Side effects are classified as follows: very common -> 10%; often -> 1% and 0.1% and 0.01% and <0.1%; very rarely - <0.01%, including isolated cases.
Possible adverse reactions:
- allergic reactions: infrequently - itchy skin, skin rash, urticaria, swelling of the nasal mucosa, rhinitis, Quincke's edema; very rarely - cardiorespiratory distress syndrome, anaphylactic shock;
- on the part of the hematopoietic system: very often - increased bleeding; rarely - anemia; very rarely - hypoprothrombinemia, leukopenia, agranulocytosis, neutropenia, aplastic anemia, eosinophilia, thrombocytopenia; in patients with severe glucose-6-phosphate dehydrogenase deficiency - hemolysis, hemolytic anemia;
- from the central nervous system: often - insomnia, headache; infrequently - drowsiness, dizziness; rarely - tinnitus, intracerebral hemorrhage;
- from the digestive system: very often - heartburn; often - nausea, vomiting; infrequently - abdominal pain, ulcers of the mucous membrane of the stomach and duodenum (including perforation), gastrointestinal bleeding; rarely - increased activity of liver enzymes; very rarely - colitis, esophagitis, irritable bowel syndrome, erosive lesions of the upper gastrointestinal tract (including with strictures), stomatitis;
- from the respiratory system: often - bronchospasm;
- others: very rarely - impaired renal function.
Overdose
Early signs of ASA overdose (salicism) develop at a plasma concentration of about 0.2 mg / ml and include ringing or tinnitus. Serious toxic effects occur at concentrations> 0.4 mg / ml.
Overdose symptoms of moderate severity: dizziness, tinnitus, hearing impairment, confusion, nausea, vomiting. Treatment includes gastric lavage, repeated intake of activated charcoal, and symptomatic therapy.
Signs of a severe overdose: fever, ketoacidosis, severe hypoglycemia, respiratory alkalosis, hyperventilation, respiratory and cardiovascular failure, coma. In this case, immediate hospitalization of the patient to a specialized department is required, where emergency care is carried out: gastric lavage, repeated intake of activated carbon, hemodialysis, alkaline and forced alkaline diuresis, restoration of the acid-base and water-electrolyte state. Further treatment is symptomatic. Alkaline diuresis is carried out until the pH value of urine reaches 7.5–8. Forced alkaline diuresis is performed when in adults the concentration of salicylates in plasma is> 500 mg / l (3.6 mmol / l). Overdose is especially dangerous in old age.
special instructions
Thrombomag should be used strictly as directed by a doctor.
The inhibitory effect of the drug on platelet aggregation persists for several days after taking it. This must be taken into account when performing a surgical intervention. A few days before surgery, the doctor compares the risk of bleeding and the risk of ischemic complications. If the risk of bleeding is high, Thrombomag is temporarily canceled.
Long-term use of ASA and / or in high doses in elderly patients is associated with an increased risk of gastrointestinal bleeding. With prolonged therapy, regular monitoring of the blood test, fecal occult blood test and the functional state of the liver is required.
In severe forms of glucose-6-phosphate dehydrogenase deficiency, Thrombomag can cause the development of hemolytic anemia and hemolysis. The risk is increased with acute infections, fever and high doses of the drug.
In low doses, ASA reduces the excretion of uric acid, which is fraught with the development of gout in predisposed patients with reduced excretion of uric acid.
Systemic glucocorticosteroids (GCS) reduce the concentration of salicylates in the blood plasma, and after their cancellation, an overdose of salicylates may develop. With their simultaneous use, the risk of damage to the mucous membrane of the gastrointestinal tract and the development of bleeding increases. The risk is also high with the combined use of antiplatelet agents, thrombolytic drugs and anticoagulants.
With the simultaneous use of methotrexate, the incidence of side effects from the hematopoietic organs increases. In the first few weeks of using Thrombomag in combination with methotrexate at a dose of <15 mg / week, a blood test should be performed every seven days. More careful monitoring of the patient's condition should be carried out with impaired renal function (even small) and in the elderly.
Ibuprofen is not recommended for patients with an increased risk of cardiovascular disease. In acetylsalicylic acid, obtained in doses <300 mg, the antiplatelet effect decreases, as a result of which the cardioprotective effects decrease. Patients who are taking ibuprofen as an analgesic should inform their doctor when prescribing Thrombomag.
Influence on the ability to drive vehicles and complex mechanisms
When using Thrombomag, caution should be exercised by vehicle drivers and persons employed in potentially hazardous industries.
Application during pregnancy and lactation
Salicylates, used in daily doses of more than 300 mg in the first trimester of pregnancy, increase the incidence of fetal developmental defects (cleft palate, heart defects). In the third trimester, ASA inhibits labor, causes increased bleeding in the mother and fetus, and closure of the arterial duct in the fetus. If the drug is taken immediately before childbirth, intracranial hemorrhage may occur, especially in premature newborns. In this regard, in the I and III trimesters of pregnancy, Thrombomag is strictly contraindicated.
In the second trimester, the use of the drug is possible only if the expected benefit is definitely higher than the potential risks. Thrombomag is prescribed in a daily dose of not more than 150 mg (according to AKC) and for a short period.
ASA and its metabolites in small amounts pass into breast milk. There is not enough clinical data to assess the degree of safety of the drug during lactation. A single intake of salicylates does not cause side effects in an infant. However, if you need to take Thrombomag for a long time, you should stop breastfeeding.
Pediatric use
Thrombomag is not used in pediatrics (for the treatment of children and adolescents under 18 years of age).
With impaired renal function
- renal failure (CC> 30 ml / min): Thrombomag tablets should be used with caution under regular monitoring of renal function;
- severe renal failure (CC <30 ml / min): the drug is contraindicated.
For violations of liver function
- liver failure (≤ 9 points on the Child-Pugh scale): Thrombomag should be used with caution under regular monitoring of liver function;
- severe hepatic impairment (> 9 points on the Child-Pugh scale): the drug is contraindicated.
Drug interactions
The antiplatelet effect of ASA is reduced by: cholestyramine, ibuprofen, systemic glucocorticosteroids and antacids containing magnesium and / or aluminum hydroxide.
ASA enhances the effect and increases the risk of toxicity when used simultaneously with methotrexate (reducing its renal clearance and displacing it from the connection with blood plasma proteins) and valproic acid (displacing it from the connection with plasma proteins).
Like other NSAIDs, in high doses, ASA can reduce the hypotensive effect of diuretics (suppressing the synthesis of renal prostaglandins and reducing the glomerular filtration rate) and antihypertensive drugs. In particular, due to the competitive blockade of prostacyclin synthesis, the drug can reduce the effect of angiotensin-converting enzyme (ACE) inhibitors.
In low doses, ASA weakens the effect of uricosuric agents (sulfinpyrazone, probenecid, benzbromarone), competitively suppressing renal tubular excretion of uric acid.
ASA enhances the action and increases the risk of developing side effects of the following drugs:
- other NSAIDs and narcotic analgesics (due to synergism of action);
- carbonic anhydrase inhibitors, for example, acetazolamide (development of severe acidosis and increased toxic effect on the central nervous system is possible);
- digoxin and lithium (their renal excretion decreases, plasma concentrations increase; plasma concentrations should be monitored and doses adjusted if necessary);
- selective serotonin reuptake inhibitors, including paroxetine and sertraline (due to synergistic action; with an increased risk of bleeding in the upper gastrointestinal tract);
- antiplatelet agents (including clopidogrel and dipyridamole), indirect anticoagulants (including ticlopidine and warfarin), heparin, thrombolytic drugs (due to the displacement of plasma proteins and synergism of the main therapeutic effects);
- oral hypoglycemic agents, which are sulfonylurea derivatives, and insulin [ASA in high daily doses (more than 2000 mg) itself has hypoglycemic properties, and also displaces sulfonylurea derivatives from the connection with plasma proteins];
- sulfonamides, including co-trimoxazole (ASA displaces them from the connection with plasma proteins and increases the concentration in the blood plasma);
- ethanol (its damaging effect on the mucous membrane of the digestive system increases, and the risk of gastrointestinal bleeding increases).
Analogs
Analogs of ThromboMag are: Cardiomagnet, Trombital, Trombital Forte, Phazostabil.
Terms and conditions of storage
Store at a temperature not exceeding 25 ° C in a place protected from moisture and light, out of reach of children.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Thrombomage
There are no reviews on Thrombomag on the network that would allow us to evaluate the effectiveness and safety of its reception.
Price for ThromboMag in pharmacies
Approximate prices for ThromboMag: 75 mg + 15.2 mg - 108–124 rubles. per pack of 30 tablets, 204-219 rubles. for a pack of 100 tablets; 150 mg + 30.39 mg - 190 rubles. for a pack of 30 tablets, 359 rubles. per pack of 100 tablets.
ThromboMag: prices in online pharmacies
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Drug name Price Pharmacy |
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ThromboMag 75 mg + 15.2 mg film-coated tablets 30 pcs. 77 RUB Buy |
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ThromboMag 75 mg + 15.2 mg film-coated tablets 100 pcs. 151 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
