Trombital tabs 75mg + 15.2mg #100

Instruction for Trombital

You can buy Trombital on this page

Trombital is an antiplatelet agent.

Release form and composition

The drug is produced in the form of film-coated tablets: biconvex, round, film shell and a core on a cross section of almost white or white [30 or 100 pcs. in a dark (amber) glass jar, sealed with a white polyethylene screw cap with a built-in removable capsule with silica gel and a ring providing control of the first opening; in a cardboard box 1 can and instructions for the use of Trombital].
1 tablet contains:
    active substances: acetylsalicylic acid - 75 mg, magnesium hydroxide - 15.2 mg;
    additional substances: potato starch, microcrystalline cellulose, corn starch, magnesium stearate;
    film shell: macrogol (polyglycol 4000), hypromellose (hydroxypropyl methylcellulose 15 cps), talc.

Pharmacodynamics

Trombital is a combined platelet aggregation inhibitor. The drug, as a result of suppression of thromboxane A2 production in platelets, reduces aggregation, platelet adhesion and thrombus formation. After a single dose, the antiplatelet effect of the drug is observed for 7 days (in men, the effect is more pronounced than in women).
Against the background of unstable angina pectoris, acetylsalicylic acid reduces mortality and the threat of myocardial infarction, it also demonstrates effectiveness in the primary prevention of cardiovascular lesions, mainly myocardial infarction in men after 40 years, and shows a good result in the secondary prevention of myocardial infarction. This active substance in the liver inhibits the production of prothrombin, promotes an increase in prothrombin time, an increase in the fibrinolytic activity of blood plasma and a decrease in the level of vitamin K-dependent coagulation factors - II, VII, IX and X. During surgical interventions, the active ingredient increases the risk of hemorrhagic complications, against the background of combined use with anticoagulants increases the likelihood of bleeding.
When used in high doses, acetylsalicylic acid also exhibits anti-inflammatory, analgesic and antipyretic effects, activates the excretion of uric acid (disrupting the process of its reabsorption in the renal tubules). In the gastric mucosa, the blockade of cyclooxygenase-1 (COX-1) causes inhibition of gastroprotective prostaglandins, which can lead to ulceration of the mucous membrane and further development of bleeding.
The magnesium hydroxide included in Trombital protects the mucous membrane of the gastrointestinal tract (GIT) from the negative effects of acetylsalicylic acid.

Pharmacokinetics

Acetylsalicylic acid is almost completely absorbed from the gastrointestinal tract. The half-life (T½) of the active substance is approximately 15 minutes, since under the action of enzymes it is rapidly hydrolyzed to salicylic acid in the blood plasma, liver and intestines. For salicylic acid, T½ is approximately 3 hours, but can increase significantly with the simultaneous use of high doses (more than 3 g) of acetylsalicylic acid due to saturation of enzyme systems. The bioavailability of acetylsalicylic acid is 70%, but this value can fluctuate significantly, due to the fact that the active substance is metabolized by presystemic hydrolysis (liver, gastrointestinal mucosa) with the participation of enzymes into salicylic acid, the bioavailability of which is 80-100%.
The applied doses of magnesium hydroxide do not affect the bioavailability of acetylsalicylic acid.

Indications for use

    primary prevention of cardiovascular lesions, including thrombosis and acute heart failure with existing risk factors (for example, arterial hypertension, hyperlipidemia, diabetes mellitus, smoking, obesity, old age);
    prevention of blood vessel thrombosis and repeated myocardial infarction;
    prevention of thromboembolism after surgical interventions on the vessels, such as coronary artery bypass grafting, percutaneous transluminal coronary angioplasty;
    unstable angina.

Contraindications

Absolute:
    gastrointestinal bleeding, erosive and ulcerative lesions of the gastrointestinal tract during an exacerbation;
    hemorrhage in the brain;
    chronic heart failure III – IV functional class according to NYHA classification (New York Association of Cardiologists);
    partial or complete combination of recurrent polyposis rhinosinusitis and bronchial asthma with intolerance to acetylsalicylic acid or any other non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (COX-2) inhibitors, including indications in history;
    bronchial asthma due to the intake of salicylates and other NSAIDs;
    predisposition to bleeding (hemorrhagic diathesis, thrombocytopenia, vitamin K deficiency);
    renal failure of severe degree with creatinine clearance (CC) below 30 ml / min;
    severe hepatic impairment (Child-Pugh grades B and C);
    deficiency of glucose-6-phosphate dehydrogenase;
    I and III trimesters of pregnancy and lactation;
    concomitant use of methotrexate at a dose of 15 mg per week or more;
    age under 18;
    hypersensitivity to any of the constituents of the drug and other NSAIDs.
Relative (take Trombital tablets with extreme caution):
    history of gastrointestinal bleeding or erosive and ulcerative gastrointestinal defects;
    impaired renal function (CC above 30 ml / min);
    hepatic impairment (class A on the Child-Pugh scale);
    diabetes;
    chronic respiratory diseases, bronchial asthma, nasal polyposis, hay fever, allergic conditions, drug allergies, including in the form of skin reactions, itching, urticaria (since acetylsalicylic acid can lead to bronchospasm, as well as provoke attacks of bronchial asthma or development of other hypersensitivity reactions);
    gout, hyperuricemia, since acetylsalicylic acid, taken in small doses, reduces the excretion of uric acid;
    II trimester of pregnancy;
    the proposed surgical intervention (including such a minor one as tooth extraction), since Trombital can cause bleeding for several days after taking it;
    elderly age;
    combined administration with the following drugs: NSAIDs and salicylic acid derivatives in high doses, digoxin, valproic acid, anticoagulants, antiplatelet / thrombolytic agents, methotrexate at a dose below 15 mg per week, insulin and oral hypoglycemic agents (sulfonylurea derivatives), selective seizure of serotonin, ethanol (including ethanol-containing drinks), ibuprofen, systemic glucocorticosteroids (GCS), lithium preparations, carbonic anhydrase inhibitors, sulfonamides, narcotic analgesics.

Trombital, instructions for use: method and dosage

Trombital tablets are taken orally with water, 1 time per day. If you find it difficult to swallow the whole tablet, you can chew it or crush it into powder beforehand.
Recommended dosage regimen of Trombital:
    cardiovascular diseases, including thrombosis and acute heart failure with existing risk factors for primary prevention: on the first day - 2 tablets, then 1 tablet per day;
    thromboembolism after surgical interventions on the vessels, repeated myocardial infarction and thrombosis of blood vessels for prevention purposes: in a daily dose of 1-2 tablets;
    unstable angina pectoris: in a daily dose of 1-2 tablets; for faster absorption, it is recommended to chew the first tablet of the drug.
Trombital is intended for long-term use, the dose of the drug and the duration of therapy are determined by the attending physician.
It is required to take the drug only in the above doses, in accordance with the indications.

Side effects

    nervous system: often - insomnia, headache; infrequently - drowsiness, dizziness; rarely - tinnitus, intracerebral hemorrhage; with an unknown frequency - hearing loss (may be a sign of an overdose of the drug);
    hematopoietic system: very often - increased bleeding (bleeding of the gums, nosebleeds, hematomas, bleeding from the urinary tract); rarely - anemia; extremely rarely - thrombocytopenia, hypoprothrombinemia, aplastic anemia, neutropenia, eosinophilia, agranulocytosis; with an unknown frequency - leukopenia; there have also been reports of serious cases of bleeding (for example, such as gastrointestinal bleeding and cerebral hemorrhage, especially in patients with hypertension who have not reached the target blood pressure and / or are receiving concomitant treatment with anticoagulants), in some cases with life-threatening character; bleeding can cause the development of acute or chronic iron deficiency / posthemorrhagic anemia (for example, due to latent bleeding) with corresponding clinical and laboratory symptoms and signs (pallor, asthenia, hypoperfusion); in patients with severe forms of glucose-6-phosphate dehydrogenase deficiency, cases of hemolysis and hemolytic anemia have been reported;
    respiratory system: often - bronchospasm;
    urinary system: with an unknown frequency - impaired renal function and acute renal failure;
    digestive system: very often - heartburn; often - vomiting, nausea; infrequently - pain in the abdomen, ulcers of the gastric mucosa and duodenal ulcer, including gastrointestinal, perforated (rarely) bleeding; rarely - increased activity of liver enzymes; extremely rare - stomatitis, erosive lesions of the upper gastrointestinal tract, strictures, esophagitis, colitis, irritable bowel syndrome; with an unknown frequency - decreased appetite, diarrhea;
    allergic reactions: often - urticaria, Quincke's edema; infrequently - anaphylactic reactions, including angioedema; with an unknown frequency - skin rash, itching, swelling of the nasal mucosa, rhinitis, cardiorespiratory distress syndrome, severe reactions, including anaphylactic shock.
In case of the appearance / aggravation of the above-described undesirable effects or the occurrence of other disorders, it is necessary to consult a specialist.

Overdose

An overdose of Trombital can be observed both after a single dose of a high dose, and with long-term treatment. With a single dose of acetylsalicylic acid at a dose below 150 mg / kg, acute poisoning is considered mild, at a dose of 150-300 mg / kg - moderate, and when used in higher doses - severe.
Symptoms of an overdose of the drug from mild to moderate severity include: visual impairment, hearing impairment, headache, tinnitus, dizziness, increased sweating, vomiting, nausea, hyperventilation, tachypnea, confusion, respiratory alkalosis. With the development of these symptoms, provocation of vomiting and forced alkaline diuresis, repeated intake of activated carbon are prescribed, and measures are taken to restore the water-electrolyte balance and acid-base state.
Symptoms of a moderate to severe Trombital overdose may include: very high body temperature (hyperpyrexia), respiratory alkalosis with compensatory metabolic acidosis, hyperventilation, respiratory depression, noncardiogenic pulmonary edema, asphyxia, decreased blood pressure, cardiac arrhythmias, collapse, cardiac depression , gastrointestinal bleeding, tinnitus, deafness, hyperglycemia, hypoglycemia (mainly in children), ketoacidosis, dehydration, impaired renal function (from oliguria to renal failure, characterized by hyper- and hyponatremia, hypokalemia), depression of the central nervous system (drowsiness, convulsions, confusion, coma), toxic encephalopathy, hematological disorders (from suppression of platelet aggregation to coagulopathy, hypoprothrombinemia, prolongation of prothrombin time).
In case of moderate / severe overdose, immediate hospitalization is required for emergency therapy. Gastric lavage, repeated administration of activated charcoal and laxatives are performed, with a salicylate content of more than 500 mg / l - alkalinization of urine, carried out by intravenous (i / v) infusion of sodium bicarbonate (88 meq in 5% glucose solution at a dose of 1 l, at a rate of 10 –15 ml / kg / h). Induction of diuresis is performed and the volume of circulating blood is restored (by two- or three-fold intravenous infusion of sodium bicarbonate in the same dose). It should be borne in mind that intensive intravenous infusion of fluid in elderly patients can cause pulmonary edema in them. Acetazolamide is not recommended for alkalinizing urine, since it can provoke acidemia and increase the toxic effect of salicylates.
When performing alkaline diuresis, it is required to achieve pH values ​​between 7.5 and 8. Hemodialysis is prescribed when the plasma concentration of salicylates in the blood is over 1000 mg / l, and in patients with chronic poisoning - 500 mg / l or less if indicated (progressive deterioration, refractory acidosis, renal failure, pulmonary edema, severe central nervous system damage). Against the background of pulmonary edema, artificial ventilation of the lungs is carried out with a mixture enriched with oxygen, with cerebral edema - hyperventilation and osmotic diuresis.
The threat of chronic intoxication is aggravated in the elderly when using Trombital for several days at a dose of more than 100 mg / kg per day. In patients of this age group, the level of salicylates in plasma should be periodically set, since they do not always have the initial symptoms of salicilism, such as visual impairment, tinnitus, nausea, vomiting, general malaise, headache, dizziness.

Special instructions

Trombital should be taken as directed by your doctor.
In the case of taking acetylsalicylic acid in doses exceeding therapeutic ones, the risk of developing gastrointestinal bleeding is aggravated.
While taking acetylsalicylic acid during and / or after surgery, bleeding of varying severity may develop. In patients receiving acetylsalicylic acid in low doses, a few days before elective surgery, it is required to assess the threat of bleeding in comparison with the threat of ischemic complications. With a significant risk of bleeding, the drug should be temporarily discontinued.
With the simultaneous use of Trombital with alcohol, the risk of defects in the gastrointestinal mucosa and lengthening of bleeding time increases.
During the period of long-term drug therapy, a general blood test and fecal occult blood test should be performed periodically.

Influence on the ability to drive vehicles and complex mechanisms

During therapy with acetylsalicylic acid preparations, patients who drive vehicles or other complex and potentially dangerous equipment should be careful.

Application during pregnancy and lactation

In the I and III trimesters of pregnancy, taking Trombital is contraindicated, since it has a teratogenic effect. In the first trimester of pregnancy, the use of the drug can lead to the appearance in the fetus of cleavage of the upper palate, and in the third trimester - to inhibition of labor (suppression of the synthesis of prostaglandins), hyperplasia of the pulmonary vessels and hypertension in the pulmonary circulation, premature closure of the ductus arteriosus in the fetus.
Salicylic acid crosses the placental barrier. In the second trimester of pregnancy, taking the drug is possible only if the expected benefit to the mother significantly exceeds the possible threat to the fetus.
Acetylsalicylic acid, like its metabolites, passes into breast milk. During the period of use of Trombital, breastfeeding should be discontinued.

Childhood use

Trombital is contraindicated in patients under 18 years of age.

With impaired renal function

In the presence of severe renal failure (CC less than 30 ml / min), the use of Trombital is contraindicated, with mild to moderate degree (CC more than 30 ml / min), it should be used with caution.

For violations of liver function

In severe liver dysfunctions (classes B and C on the Child-Pugh scale), the use of an antiplatelet agent is contraindicated. Patients with class A hepatic impairment on the Child-Pugh scale should use Trombital with caution.

Use in the elderly

Elderly patients during the period of treatment with Trombital should be careful, because with prolonged use of acetylsalicylic acid in low doses as an antiplatelet agent, the risk of gastrointestinal bleeding is aggravated.

Drug interactions

When used in combination, acetylsalicylic acid enhances the effect of the following drugs / substances due to the development of the following effects:
    digoxin - its renal excretion decreases;
    methotrexate - renal clearance decreases, and this substance is displaced from the connection with proteins; this combination leads to an increase in the incidence of adverse reactions from the hematopoietic organs;
    antidiabetic oral agents (sulfonylurea derivatives) and insulin - acetylsalicylic acid in high doses exhibits a hypoglycemic effect; sulfonylurea derivatives are displaced from the bond with blood plasma proteins;
    heparin and indirect anticoagulants - platelet function is impaired, indirect anticoagulants are displaced from the connection with plasma proteins;
    valproic acid - this substance is displaced from the connection with plasma proteins;
    narcotic analgesics, other NSAIDs, thrombolytic, antiplatelet and anticoagulant drugs (ticlopidine) - caution should be exercised with this combination.
When acetylsalicylic acid is combined with certain drugs / substances, the following effects may be observed:
    barbiturates and lithium salts - the plasma concentration of these agents increases;
    ibuprofen - the cardioprotective effects of acetylsalicylic acid are reduced when it is used in doses up to 300 mg due to the weakening of the antiplatelet effect; in the presence of an increased risk of cardiovascular disease, this combination is not recommended;
    anticoagulants, thrombolytics, antiplatelet agents - the risk of bleeding is aggravated;
    GCS, ethanol and ethanol-containing drugs - the negative effect on the gastrointestinal mucosa increases, and the threat of gastrointestinal bleeding increases;
    systemic GCS - the elimination of salicylates is enhanced, and their effect is weakened; after the cancellation of the use of systemic corticosteroids, the risk of overdose of salicylates increases;
    ethanol - the toxic effect of this substance on the central nervous system increases;
    cholestyramine, antacids - absorption of acetylsalicylic acid decreases;
    uricosuric drugs (probenicid, benzbromarone) - their effect is weakened as a result of competitive suppression of renal tubular excretion of uric acid;
    angiotensin-converting enzyme inhibitors - there is a dose-dependent decrease in the glomerular filtration rate due to inhibition of prostaglandins, which exhibit a vasodilating effect and, as a result, a decrease in the hypotensive effect;
    diuretics (when combined with acetylsalicylic acid in high doses) - a decrease in the glomerular filtration rate is possible due to a decrease in the production of prostaglandins in the kidneys.

Terms and conditions of storage

Store out of the reach of children at a temperature not exceeding 25 ° C.
Shelf life is 2 years.

Reviews about Trombital

Reviews of Trombital are overwhelmingly positive. Patients note the effectiveness of the antiplatelet agent when used for the prevention of cardiovascular diseases, repeated attacks of myocardial infarction and thromboembolism after surgical interventions on the vessels, as well as for the prevention of angina attacks. According to reviews, after treatment with the drug, a stable positive result is observed. Also, patients note the complete identity of this drug with a foreign Cardiomagnet, but at the same time, the price of the Russian drug is slightly lower than that of its analogue, which is important for patients during long-term therapy.
The disadvantages of the remedy include a large list of contraindications and adverse reactions. To reduce unwanted effects from the digestive tract, many patients recommend taking Trombital after meals.

Terms of sell

You don't need to have a prescription to buy Trombital.