Trombital Forte pills 150mg+30.39mg, 100pcs

Composition

Composition per tablet:

Active ingredients:  

acetylsalicylic acid – 150.00 mg,

magnesium hydroxide-30.39 mg.

Auxiliary substances:

microcrystalline cellulose – 24.15 mg,

corn starch-19.00 mg,

potato starch-4.00 mg,

magnesium stearate-0.30 mg.

Shell:  hypromellose (hydroxypropylmethylcellulose 15 sPz) – 1.20 mg, macrogol (polyglycol 4000) – 0.24 mg, talc-0.72 mg

Pharmacological action

Reduces platelet aggregation, adhesion and thrombosis by suppressing the synthesis of thromboxane A2 in platelets. The antiplatelet effect persists for 7 days after a single dose (more pronounced in men than in women).

Acetylsalicylic acid reduces the mortality and risk of myocardial infarction in unstable angina, is effective in the primary prevention of diseases of the cardiovascular system, especially myocardial infarction in men over 40 years of age, and in the secondary prevention of myocardial infarction.

Inhibits the synthesis of prothrombin in the liver and increases the prothrombin time. Increases the fibrinolytic activity of blood plasma and reduces the concentration of vitamin K-dependent coagulation factors (II, VII, IX, X). Increases the risk of hemorrhagic complications during surgery, increases the risk of bleeding during anticoagulant therapy.

Acetylsalicylic acid in high doses also has anti-inflammatory, analgesic, and antipyretic effects.

In high doses, acetylsalicylic acid stimulates the excretion of uric acid (disrupts its reabsorption in the renal tubules).

Blockade of cyclooxygenase-1 in the gastric mucosa leads to inhibition of gastroprotective prostaglandins, which can cause ulceration of the mucous membrane and subsequent bleeding.

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

Indications

Prevention of cardiovascular diseases: recurrent myocardial infarction, blood vessel thrombosis. Primary prevention of cardiovascular diseases such as thrombosis and acute heart failure in the presence of risk factors (for example, diabetes mellitus, hyperlipidemia, arterial hypertension, obesity, smoking, old age). Prevention of thromboembolism after vascular surgery (for example, coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, etc. ). Unstable angina (including suspected acute myocardial infarction).

Contraindications

• Hypersensitivity to acetylsalicylic acid, auxiliary substances of the drug and other nonsteroidal anti-inflammatory drugs (NSAIDs);
• bleeding in the brain;
• a tendency to bleeding (vitamin K, thrombocytopenia, hemorrhagic diathesis);
• erosive-ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation);
• gastrointestinal bleeding;
• asthma induced by ingestion of salicylates and other NSAIDs;
• the combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses with intolerance to acetylsalicylic acid;
• concomitant use of methotrexate in a dose of 15 mg per week or more;
• pregnancy (I and III trimester);
• lactation;
• deficiency of glucose-6-phosphate dehydrogenase;
• severe renal insufficiency (creatinine clearance (CC) of less than 30 ml/min);
• severe liver failure (class b and C according to child-Pugh);
• chronic heart failure III and IV functional class NYHA classification;
• children up to age 18 years.

With caution:

For gout, hyperuricemia, as acetylsalicylic acid in small doses reduces the excretion of uric acid.

If there is a history of ulcerative lesions of the gastrointestinal tract or gastrointestinal bleeding.

In case of hepatic insufficiency (Child-Pugh class A).

In case of renal insufficiency (creatinine clearance more than 30 ml / min).

For bronchial asthma, chronic respiratory diseases, hay fever, nasal polyposis, allergic conditions, drug allergies.

With diabetes mellitus.

In elderly patients.

In the second trimester of pregnancy.

If surgery is considered (including minor ones, such as tooth extraction), acetylsalicylic acid may cause a tendency to develop bleeding within a few days after taking the drug.

When taken concomitantly with the following medications (see section “Interaction with other medications”):

• with methotrexate at a dose of less than 15 mg per week;
• with anticoagulants, thrombolytic or antiplatelet drugs;
• NSAIDs and derivatives of salicylic acid in high doses;
• digoxin;
• with hypoglycemic agents for oral use (sulfonylureas) and insulin;
• with valproic acid,
• alcohol (alcohol in particular);
• with selective inhibitors of serotonin reuptake;
• with ibuprofen,
• with narcotic analgesics,
• with sulfonamides (including co-trimoxazole),
• with carbonic anhydrase inhibitors (acetazolamide),
• with lithium,
• systemic corticosteroids.

Side effects

The adverse events listed below are distributed by frequency according to the following gradation: very common (with a frequency of more than 1/10), common (with a frequency of at least 1/100, but less than 1/10), infrequent (with a frequency of at least 1/1000, but less than 1/100), rare (with a frequency of at least 1/10000, but less than 1/1000), very rare (with a frequency of less than 1/10000), including individual reports.

Blood and lymphatic system disorders:  very often-increased bleeding (hematomas, nosebleeds, bleeding gums, bleeding from the genitourinary tract); rarely-anemia; very rarely-hypoprothrombinemia, thrombocytopenia, neutropenia, aplastic anemia, eosinophilia, agranulocytosis; unknown frequency-leukopenia.

There are reports of serious cases of bleeding, which include gastrointestinal bleeding and brain hemorrhage (especially in patients with hypertension who have not reached the target blood pressure values and/or are receiving concomitant therapy with anticoagulants), which in some cases can be life-threatening.

Bleeding can lead to the development of acute or chronic post-hemorrhagic / iron-deficient anemia (for example, due to latent bleeding) with appropriate clinical and laboratory signs and symptoms (asthenia, pallor, hypoperfusion). Hemolysis and hemolytic anemia have been reported in patients with severe glucose-6-phosphate dehydrogenase deficiency.

Allergic reactions:  often – urticaria, angioedema; infrequently –anaphylactic reactions, including angioedema; unknown frequency – skin rash, pruritus, rhinitis, nasal mucosal edema, cardio-respiratory distress syndrome, as well as severe reactions, including anaphylactic shock.

Nervous system disorders:  often – headache, insomnia; infrequently-dizziness, drowsiness; rarely-tinnitus, intracerebral hemorrhage; unknown frequency-hearing loss, which may be a sign of an overdose of the drug (see the section “Overdose”).

Respiratory, thoracic and mediastinal disorders:  often –bronchospasm.

From the gastrointestinal tract:  very often – heartburn; often – nausea, vomiting; infrequently – abdominal pain, ulcers of the gastric and duodenal mucosa, including perforated (rarely), gastrointestinal bleeding; rarely-increased activity of “liver” enzymes; very rarely – stomatitis, esophagitis, erosive lesions of the upper gastrointestinal tract, strictures, irritable bowel syndrome, colitis; unknown frequency – decreased appetite, diarrhea.

From the urinary system: unknown frequency-impaired renal function and acute renal failure.

If you experience any of the side effects listed in the instructions, or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

When used concomitantly, acetylsalicylic acid enhances the effect of the following medications: :

• methotrexate by reducing renal clearance and ousting him from the blood, the combination of acetylsalicylic acid with methotrexate is accompanied by increased incidence of side effects from the digestive blood;
• narcotic analgesics, other NSAIDs;
• heparin and indirect anticoagulants due to dysfunction of platelets, and displacing anticoagulants from plasma proteins of the blood;
• thrombolytic, antiplatelet and anticoagulant drugs (ticlopidine);
• digoxin due to a decrease in its renal excretion;
• hypoglycemic agents for oral use (sulfonylureas) and insulin due to the hypoglycemic properties of the acetylsalicylic acid in high doses and displacement of sulfonylureas from the blood plasma of the blood;
• valproic acid due to displacement from its Association with blood plasma proteins. Simultaneous use of acetylsalicylic acid with ibuprofen leads to a decrease in the cardioprotective effects of acetylsalicylic acid.

The combination of acetylsalicylic acid with anticoagulants, thrombolytics and antiplatelet agents is associated with an increased risk of bleeding. Simultaneous use with acetylsalicylic acid increases the concentration of barbiturates and lithium salts in the blood plasma.

By increasing the elimination of salicylates, systemic glucocorticosteroids weaken their effect.

Glucocorticosteroids, ethanol and ethanol-containing drugs increase the negative impact on the gastrointestinal mucosa and increase the risk of gastrointestinal bleeding.

When taking acetylsalicylic acid with ethanol at the same time, an increase in the toxic effect of ethanol on the central nervous system is observed.

Acetylsalicylic acid reduces the effect of uricosuric medicines benzbromarone, of probenecid (decrease uricosuric effect due to competitive suppression of renal tubular excretion of uric acid), inhibitors of angiotensin converting enzyme (marked dose-dependent decrease in glomerular filtration rate as a result of inhibition of prostaglandins, which has vasodilating effect, and, consequently, the attenuation of the hypotensive effect), diuretics (combined with acetylsalicylic acid in high doses there is a decrease in glomerular filtration rate due to the reduction of prostaglandin synthesis in the kidneys). Antacids and colestyramine reduce the absorption of acetylsalicylic acid.

How to take, course of use and dosage

The drug is taken orally, washed down with water. The tablet can be swallowed whole, chewed or pre-ground.

The drug is intended for long-term use. The duration of treatment with Trombital Forte is determined by the doctor. 1 tablet of Trombital Forte contains 150 mg of acetylsalicylic acid. If necessary, according to the doctor’s decision, it is possible to reduce the daily dose of acetylsalicylic acid to 75 mg (see the section “Special instructions”).

Primary prevention of cardiovascular diseases, such as thrombosis and acute heart failure in the presence of risk factors (for example, diabetes mellitus, hyperlipidemia, arterial hypertension, obesity, smoking, old age) – 1 tablet 1 time a day.

Prevention of cardiovascular diseases: repeated myocardial infarction, blood vessel thrombosis-1 tablet 1 time a day.

Prevention of thromboembolism after vascular surgery (for example, coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, etc. ) – 1 tablet 1 time a day.

Unstable angina (including suspected acute myocardial infarction) – 1 tablet 1 time a day.

In unstable angina, if acute myocardial infarction is suspected, the first tablet should be chewed for faster absorption.

Use the drug only according to the indications, the method of use and in the doses indicated in the instructions.

Overdose

It may occur after a single large dose or with prolonged use of the drug. If a single dose of acetylsalicylic acid is less than 150 mg/kg, acute poisoning is considered mild,150-300 mg/kg – moderate, and with higher doses – severe.

Symptoms of overdose from mild to moderate severity: dizziness, tinnitus, hearing loss, visual impairment, increased sweating, nausea, vomiting, headache, confusion, tachypnea, hyperventilation, respiratory alkalosis.

Treatment: provocation of vomiting, repeated use of activated charcoal, forced alkaline diuresis, restoration of water-electrolyte balance and acid-base state.

Moderate to severe overdose symptoms:

• respiratory alkalosis with compensatory metabolic acidosis;
• or hyperpyrexia (extremely high body temperature);
• respiratory: hyperventilation, nicardipine pulmonary edema, respiratory depression, apnea;
• disorders of the cardiovascular system: arrhythmias, lowering blood pressure, depression of cardiac activity, collapse;
• violations of water-electrolyte balance: dehydration, impaired renal function from oliguria up to the development of renal failure, characterized by hypokalemia, with hypernatremia, hyponatremia;
• the violation of the metabolism of glucose: hyperglycemia, hypoglycemia (especially in children), ketoacidosis.
• noise in the ears, deafness;
• gastrointestinal bleeding;
• hematological disorders: from the inhibition of platelet aggregation to coagulopathy, prolongation of prothrombin time, hypoprothrombinemia;
• neurological disorders: toxic encephalopathy and inhibition of the function of the Central nervous system (drowsiness, confusion, coma, convulsions).

Treatment: immediate hospitalization in specialized departments for emergency therapy – gastric lavage, repeated intake of activated charcoal and laxatives, alkalinization of urine (indicated at salicylate levels above 500 mg/l, provided by intravenous infusion of sodium bicarbonate – 88 meq in 1 liter of 5% glucose solution, at a rate of 10-15 ml/kg/h), restoration of circulating blood volume and induction of diuresis (achieved by use of sodium bicarbonate in the same dose and dilution, repeated 2-3 times); keep in mind that intensive fluid infusions in elderly patients can lead to pulmonary edema.

It is not recommended to use acetosolamide for alkalinization of urine (it can cause acidemia and increase the toxic effect of salicylates). When performing alkaline diuresis, it is necessary to achieve pH values between 7.5 and 8.

Hemodialysis is indicated when the level of salicylates in blood plasma is more than 1000 mg / l, and in patients with chronic poisoning-500 mg/l or lower if there are indications (refractory acidosis, progressive deterioration of the condition, severe damage to the central nervous system, pulmonary edema and renal failure).

With pulmonary edema, artificial ventilation of the lungs with a mixture enriched with oxygen is indicated in the positive pressure mode at the end of exhalation; hyperventilation and osmotic diuresis are used to treat brain edema. The greatest risk of developing chronic intoxication is observed in the elderly when taking more than 100 mg / kg / day for several days.

In children and elderly patients, the initial signs of salicylism (nausea, vomiting, tinnitus, visual impairment, dizziness, headache, general malaise) are not always noticeable, so it is advisable to periodically determine the content of salicylates in blood plasma.

Special instructions

The drug should be used as directed by a doctor.

Tablets of the drug Trombital Forte are film-coated, have no risks and are not intended for division, so if the doctor recommends reducing the daily dose of acetylsalicylic acid to 75 mg, then you need to switch to taking another drug containing 75 mg of acetylsalicylic acid in 1 tablet.

Acetylsalicylic acid can provoke bronchospasm, as well as cause asthma attacks and other hypersensitivity reactions. Risk factors include a history of bronchial asthma, hay fever, nasal polyposis, chronic respiratory diseases, and allergic reactions to other medications (for example, skin reactions, pruritus, and urticaria).

Acetylsalicylic acid can cause bleeding of varying severity during and after surgery. A few days before the planned surgical intervention, the risk of bleeding should be evaluated in comparison with the risk of ischemic complications in patients taking low doses of acetylsalicylic acid. If the risk of bleeding is significant, acetylsalicylic acid should be temporarily discontinued.

The combination of acetylsalicylic acid with anticoagulants, thrombolytics and antiplatelet drugs is associated with an increased risk of bleeding.

Acetylsalicylic acid in low doses can provoke the development of gout in predisposed patients (with reduced uric acid excretion). The combination of acetylsalicylic acid with methotrexate is accompanied by an increased frequency of side effects from the hematopoietic system.

High doses of acetylsalicylic acid have a hypoglycemic effect, which should be taken into account when prescribing it to patients with diabetes mellitus receiving hypoglycemic agents for oral use and insulin.

With the combined use of systemic glucocorticosteroids and salicylates, it should be remembered that during treatment, the concentration of salicylates in the blood is reduced, and after the withdrawal of systemic glucocorticosteroids, an overdose of salicylates is possible.

The combination of acetylsalicylic acid with ibuprofen is not recommended in patients with an increased risk of cardiovascular diseases: when used simultaneously with ibuprofen, there is a decrease in the antiplatelet effect of acetylsalicylic acid in doses up to 300 mg, which leads to a decrease in the cardioprotective effects of acetylsalicylic acid.

Increasing the dose of acetylsalicylic acid above therapeutic doses is associated with the risk of gastrointestinal bleeding.

When taking long-term low-dose acetylsalicylic acid as antiplatelet therapy, caution should be exercised in elderly patients due to the risk of gastrointestinal bleeding.

Concomitant use of acetylsalicylic acid with alcohol increases the risk of damage to the gastrointestinal mucosa and prolongation of bleeding time.

With prolonged use of the drug, a general blood test and a fecal occult blood test should be performed periodically.

During treatment with acetylsalicylic acid preparations, care should be taken when driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Film-coated tablets

Storage conditions

At a temperature not exceeding 25 °C.

Shelf

life is 2 years.

Active ingredient

: Acetylsalicylic acid, [Magnesium hydroxide]

Dosage form

Tablets

Purpose

For adults

Indications

Prevention of thrombosis, Prevention of heart attacks and strokes