Atsetylsalytsylovaya acid, [magnesium hydroxide] | Thrombital Forte tablets are covered.pl.ob. 150 mg + 30.39 mg 30 pcs.

film release

film-coated tablets

Pharmacological action

Pharmacotherapeutic group:

Antiplatelet agent

ATX:

N.02.BA51 Acetylsalicylic acid in combination with other drugs, excluding psycholeptics

Pharmacodynamics:

Reduces aggregation platelet 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 mortality and the risk of developing myocardial infarction with unstable angina, is effective in the primary prevention of diseases of the cardiovascular system, especially myocardial infarction in men over 40, and in the secondary prevention of myocardial infarction.

Suppresses the synthesis of prothrombin in the liver and increases prothrombin time. It 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 surgical interventions, increases the risk of bleeding during anticoagulant therapy.

Acetylsalicylic acid in high doses also has an anti-inflammatory, analgesic, antipyretic effect.

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 lead to ulceration of the mucous membrane and subsequent bleeding.

Magnesium hydroxide, which is part of the drug Thrombital Forte, protects the mucous membrane of the gastrointestinal tract from exposure to acetylsalicylic acid.

Pharmacokinetics:

Acetylsalicylic acid is almost completely absorbed from the gastrointestinal tract. The half-life of acetylsalicylic acid is about 15 minutes, because with the participation of enzymes, acetylsalicylic acid is rapidly hydrolyzed to salicylic acid in the intestines, liver and blood plasma.

The half-life of salicylic acid is about 3 hours, but it can increase significantly with the simultaneous administration of large doses of acetylsalicylic acid (more than 3.0 g) as a result of saturation of the enzyme systems.

The bioavailability of acetylsalicylic acid is 70%, but this value varies significantly, since acetylsalicylic acid undergoes presystem hydrolysis (gastrointestinal mucosa, liver) to salicylic acid by enzymes. The bioavailability of salicylic acid is 80-100%.

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

Indications

Primary prevention of cardiovascular disease 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 cardiovascular disease: recurrent myocardial infarction, blood vessel thrombosis.

Prevention of thromboembolism after vascular surgery (e.g., coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, etc.).

Unstable angina pectoris (including suspected acute myocardial infarction).

Contraindications

- Hypersensitivity to acetylsalicylic acid, excipients and other non-steroidal anti-inflammatory drugs (NSAIDs)

- cerebral hemorrhage

- tendency to bleed (vitamin K deficiency, platelet hemorrhagic diathesis)

- erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase)

- gastrointestinal bleeding

- bronchial asthma induced by taking salicylates and other NSAIDs

- a combination of bronchial asthma, non-relapsing neurocorticosis,

acids - simultaneous administration of methotrexate at a dose of 15 mg per week or more

- pregnancy (I and III trimesters)

- lactation period

- glucose-6-phosphate dehydrogenase deficiency

- severe renal residual (creatinine clearance (CC) less than 30 ml / min)

- severe liver failure (class B and C on the Child-Pugh scale)

- chronic heart failure III and IV functional class according to NYHA classification

- children under 18 years of age.

Precautions:

For gout, hyperuricemia, since acetylsalicylic acid in small doses reduces uric acid excretion.

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

With liver failure (class A on the Child-Pugh scale).

In renal failure (CC more than 30 ml / min).

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

With diabetes.

In elderly patients.

In the second trimester of pregnancy.

With the proposed surgical intervention (including minor ones, for example, tooth extraction), as acetylsalicylic acid may cause a tendency to develop bleeding within a few days after taking the drug.

When taken concurrently with the following drugs (see Interaction with other drugs):

- with methotrexate at a dose of less than 15 mg per week

- with anticoagulants, thrombolytic or antiplatelet agents

- with NSAIDs and high-dose salicylic acid derivatives

- with digoxin

- with hypoglycemic agents for oral administration (sulfonylureas) and insulin

- with valproic acid

- with alcohol (alcoholic beverages in particular)

- with selective ing serotonin reuptake inhibitors

- with ibuprofen,

- with narcotic analgesics,

- with sulfonamides (including co-trimoxazole),

- with carbonic anhydrase inhibitors (acetazolamide),

- with lithium,

- with systemic glucocorticosteroids.

Use during pregnancy and lactation

The drug Trombital Forte is contraindicated for use in the I and III trimesters of pregnancy, because has a teratogenic effect - when used in the first trimester of pregnancy, the fetus splits the upper palate, in the III trimester - it causes inhibition of labor (suppression of prostaglandin synthesis), premature closure of the ductus arteriosus in the fetus, pulmonary vascular hyperplasia and hypertension in the pulmonary circulation.

Taking the drug in the second trimester is possible only if the potential benefit to the mother outweighs the risk to the fetus.

Acetylsalicylic acid and its metabolites pass into breast milk. Breastfeeding should be discontinued during treatment.

Special instructions

The drug should be used as directed by a doctor.

Trombital Forte tablets are film-coated, have no risks and are not intended to be divided, so if your doctor recommended lowering 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 cause bronchospasm, and also cause attacks of bronchial asthma and other hypersensitivity reactions. Risk factors are a history of bronchial asthma, hay fever, nasal polyposis, chronic diseases of the respiratory system, as well as allergic reactions to other drugs (for example, skin reactions, itching, urticaria).

Acetylsalicylic acid can cause bleeding of varying severity during and after surgical interventions. A few days before the planned surgical intervention, 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, acetylsalicylic acid should be temporarily discontinued. The combination of acetylsalicylic acid with anticoagulants, thrombolytics and antiplatelet drugs are associated with an increased risk of bleeding.

Acetylsalicylic acid in low doses can trigger the development of gout in susceptible patients (with decreased uric acid excretion). The combination of acetylsalicylic acid with methotrexate is accompanied by an increased incidence of side effects from the blood forming organs.

High doses of acetylsalicylic acid have a hypoglycemic effect, which must be borne in mind when prescribing it to patients with diabetes mellitus receiving hypoglycemic agents for oral administration 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 abolition 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 disease: with simultaneous use 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.

An increase in the dose of acetylsalicylic acid over therapeutic doses is associated with a risk of gastrointestinal bleeding.

With prolonged use of low doses of acetylsalicylic acid as antiplatelet therapy, caution should be exercised in elderly patients due to the risk of gastrointestinal bleeding.

While taking acetylsalicylic acid with alcohol, the risk of damaging the mucous membrane of the gastrointestinal tract and prolonging bleeding time is increased.

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

Impact on the ability to drive transp. Wed and fur .:

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

Composition

Composition per tablet:

Active ingredients:

acetylsalicylic acid - 150.00 mg,

magnesium hydroxide - 30.39 mg.

Excipients:

microcrystalline cellulose - 24.15 mg,

corn starch - 19.00 mg,

potato starch - 4.00 mg,

magnesium stearate - 0.30 mg.

Shell:

hypromellose (hydroxypropyl methylcellulose 15 cPs) - 1.20 mg, macrogol (polyglycol 4000) - 0.24 mg, talc - 0.72 mg.

Dosage and administration

The drug is taken orally, washed down with water. The pill can be swallowed whole chew or pre-grind.

The drug is intended for prolonged use. The duration of treatment with Trombital Forte is determined by the doctor. 1 tablet of Thrombital Forte contains 150 mg of acetylsalicylic acid. If necessary, according to the doctorӳ decision, it is possible to reduce the daily dose of acetylsalicylic acid to 75 mg (see section Special Instructions).

Primary prevention of cardiovascular diseases such as thrombosis and acute heart failure in the presence of risk factors (e.g. diabetes, hyperlipidemia, hypertension, obesity, smoking, old age) - 1 tablet once a day.

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

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

Unstable angina (including suspected development of acute myocardial infarction) - 1 tablet once a day.

In case of unstable angina pectoris with suspected development of acute myocardial infarction, the first tablet must be chewed for faster absorption.

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

Side effects

The following adverse events are distributed according to the frequency of occurrence according to the following gradation: very often (with a frequency of more than 1/10), often (with a frequency of at least 1/100, but less than 1/10), infrequently (with with a frequency of at least 1/1000, but less than 1/100), rarely (with a frequency of at least 1/10000, but less than 1/1000), very rarely (with a frequency of less than 1/10000), including individual messages.

From the blood and lymphatic system: very often - increased bleeding (hematomas, nosebleeds, bleeding gums, urogenital bleeding) 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 cerebral hemorrhage (especially in patients with arterial hypertension who have not reached the target blood pressure figures and / or receiving concomitant therapy with anticoagulant drugs), which in some cases can be life-threatening character. Bleeding can lead to the development of acute or chronic posthemorrhagic / iron deficiency anemia (for example, due to occult bleeding) with the corresponding clinical and laboratory signs and symptoms (asthenia, pallor, hypoperfusion). There are reports of cases of hemolysis and hemolytic anemia in patients with severe glucose-6-phosphate dehydrogenase deficiency.

Allergic reactions: often - urticaria, Quincke's edema infrequently - anaphylactic reactions, including angioedema, unknown frequency - skin rash, pruritus, rhinitis, swelling of the nasal mucosa, cardio-respiratory distress syndrome, as well as severe reactions, including anaphylactic shock.

From the side of the nervous system: 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 section Overdose).

From the respiratory system, chest and mediastinal organs: often - bronchospasm.

From the gastrointestinal tract: very often - heartburn often - nausea, vomiting infrequently - pain in the abdomen, ulcers of the mucous membrane of the stomach and duodenum, including perforated (rare), gastrointestinal bleeding rarely - increased liver activity enzymes are very rare - stomatitis, esophagitis, erosive lesions of the upper gastrointestinal tract, stricture, irritable bowel syndrome, colitis unknown frequency - decreased appetite, diarrhea.

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

If you have any side effects that are indicated in the instructions, or they are exacerbated, or you notice any other side effects that are not listed in the instructions, inform your doctor.

Drug interaction

With the simultaneous use of acetylsalicylic acid enhances the action of the following drugs:

- methotrexate by reducing renal clearance and displacing it from the connection with proteins, the combination of acetylsalicylic acid with methotrexate is accompanied by an increased incidence of side effects from the hematopoietic organs

- narcotic analgesics, other NSAIDs

- heparin and indirect anticoagulants due to impaired platelet function and the displacement of indirect anticoagulants from plasma antagonists, preparations (ticlopidine)

- digoxin due to a decrease in its renal excretion

- hypoglycemic agents for oral administration ( roizvodnye sulfonylurea) insulin and hypoglycemic due to properties of the acetylsalicylic acid in high doses and displacement of sulfonylurea derivatives due to plasma proteins

- valproic acid due to displacement from its connection with blood plasma proteins. The 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 administration with acetylsalicylic acid increases the concentration of barbiturates and lithium salts in blood plasma.

Strengthening the elimination of salicylates, systemic glucocorticosteroids weaken their effect.

Glucocorticosteroids, ethanol and ethanol-containing drugs increase the negative effect on the mucous membrane of the gastrointestinal tract and increase the risk of gastrointestinal bleeding.

With the simultaneous administration of acetylsalicylic acid with ethanol, an increase in the toxic effect of ethanol on the central nervous system is observed. Acetylsalicylic acid weakens the effect of uricosuric drugs - benzbromaron, probenicide (a decrease in the uricosuric effect due to competitive suppression of renal tubular excretion by uric acid), angiotensin-converting enzyme inhibitors (a dose-dependent decrease in glomerular filtration as a result of inhibition of prostaglandin is observed, which has a action), diuretics (when combined with acetylsalicylo Howl acid in high doses, a decrease in glomerular filtration rate due to a decrease in the synthesis of prostaglandins in the kidneys). Antacids and colestyramine reduce the absorption of acetylsalicylic acid.

If you are using the above or other medications (including over-the-counter), consult your doctor before using Trombital Forte.

Overdose

May occur after a single dose of a 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 when higher doses are used, severe.

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

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

Symptoms of moderate to severe overdose:

- respiratory alkalosis with compensatory metabolic acidosis

- hyperpyrexia (extremely high body temperature)

- respiratory failure: hyperventilation, non-cardiogenic pulmonary edema, respiratory depression, cardiac arrhythmia - srdl : cardiac arrhythmias, decreased blood pressure, inhibition of cardiac activity,

collapse - impaired water-electrolyte balance: dehydration, impaired renal function from oliguria up to renal failure, characterized by hypokalemia, hypernatremia, hyponatremia

- impaired glucose metabolism: hyperglycemia, hypoglycemia (especially in children), ketoacidosis

- tinnitus, deafness

- gastrointestinal bleeding

- hematologic disorders: from inhibition of platelet aggregation to coagulopathy, neuroprotection, neuroprotection, neuroprotection, neuroprotection, neuroprotection, neuroprotection, neuroprotection, neuroprotection, neuroprotection, coagulopathy, neuroprotection, coagulopathy, disorders: toxic encephalopathy and inhibition of central nervous system function (drowsiness, confusion, coma, convulsions).

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

Acetosolamide is not recommended for alkalization of urine (it can cause acidemia and increase the toxic effect of salicylates). When carrying out alkaline diuresis, it is necessary to achieve pH values ​​between 7.5 and 8.

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

In case of pulmonary edema, mechanical ventilation of the lungs with an oxygen enriched mixture is shown in the positive pressure mode at the end of exhalation. Hyperventilation and osmotic diuresis are used to treat cerebral edema.

The greatest risk of developing chronic intoxication is observed in elderly people with a dose of more than 100 mg / kg / day for several days.

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

Storage Conditions

At a temperature not exceeding 25 РC.

Keep out of the reach and sight of children.

Expiration

2 years.

Active ingredient

Acetylsalicylic acid, [Magnesium hydroxide]

Terms leave through pharmacies

without prescription

Dosage form

tablet

Appointment

Adults

Indications

Indications

Preventing heart attacks and strokes, to prevent thrombosis