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Acetylsalicylic acid + Magnesium hydroxide

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2019-09-19
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Clinical Pharmacology

Reduces aggregation, platelet adhesion and thrombus formation by suppressing the synthesis of thromboxane A2 in platelets. 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 myocardial infarction in unstable angina, is effective in primary prevention of diseases of the cardiovascular system, especially myocardial infarction in men older than 40 years, and in secondary prevention of myocardial infarction.

Suppresses the synthesis of prothrombin in the liver and increases the prothrombin time. Increases plasma fibrinolytic activity 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 therapy with anticoagulants.

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

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

COX-1 blockade in the gastric mucosa leads to inhibition of gastroprotective prostaglandins, which may lead to ulceration of the mucous membrane and subsequent bleeding.

Magnesium hydroxide, which is part of the drug Trombital, protects the gastrointestinal mucosa from the effects 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 mellitus, hyperlipidemia, arterial hypertension, obesity, smoking, old age);

- prevention of recurrent myocardial infarction and thrombosis of blood vessels;

- prevention of thromboembolism after surgical interventions on the vessels (coronary artery bypass surgery, percutaneous transluminal coronary angioplasty);

- unstable angina.

Composition

On one pill:

Active ingredients: acetylsalicylic acid - 75.00 mg, magnesium hydroxide - 15.20 mg.

Excipients: microcrystalline cellulose - 12.07 mg, corn starch - 9.50 mg, potato starch - 2.00 mg, magnesium stearate - 0.15 mg.

Shell: hypromellose (hydroxypropyl methylcellulose 15 cP) - 0.60 mg, macrogol (polyglycol 4000) - 0.12 mg, talc - 0.36 mg.

Acetylsalicylic acid + Magnesium hydroxide is marketed under different brands and generic names, and comes in different dosage forms:

Brand nameManufacturerCountryDosage form
Trombital Pharmstandard Russia pills
Trombital Forte Pharmstandard Russia pills
Cardiomagnyl Takeda GmbH Russia pills
Cardiomagnyl Takeda GmbH Japan pills

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Acetylsalicylic acid + Magnesium hydroxide

Dosage and Administration

The drug is taken orally, 1 time / day, drinking water. The tablet can be swallowed whole, chew or pre-grind.

Primary prevention of cardiovascular diseases such as thrombosis and acute heart failure with risk factors (for example, diabetes mellitus, hyperlipidemia, arterial hypertension, obesity, smoking, old age): Take 2 pills of the Trombital preparation on the first day, then 1 tablet each 1 time / day

Prevention of recurrent myocardial infarction and thrombosis of blood vessels: 1-2 pills of the drug Trombital 1 time / day.

Prevention of thromboembolism after surgical interventions on the vessels (coronary artery bypass surgery, percutaneous transluminal coronary angioplasty): 1-2 pills of the drug Trombital 1 time / day.

Unstable angina: 1-2 pills of the drug Trombital 1 time / day. For faster absorption, it is recommended to chew the first pill.

The drug is intended for long-term use. The duration of treatment and the dose of the drug Trombital is determined by the doctor.

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

Adverse reactions

Categorization of the frequency of adverse events: 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 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.

On the part of the hematopoietic system: very often - increased bleeding (hematomas, nosebleeds, bleeding gums, bleeding from the urinary tract); rarely - anemia; very rarely - hypoprothrombinemia, thrombocytopenia, neutropenia, aplastic anemia, eosinophilia, agranulocytosis; frequency is unknown - leukopenia. There are reports of serious cases of bleeding, which include gastrointestinal bleeding and bleeding in the brain (especially in patients with arterial hypertension who have not reached the target values ​​of blood pressure and / or receiving concomitant anticoagulant therapy), which in some cases may be life-threatening . Bleeding can lead to the development of acute or chronic post-hemorrhagic / iron deficiency anemia (for example, due to latent bleeding) with relevant clinical and laboratory signs and symptoms (asthenia, pallor, hypoperfusion). There are reports of cases of hemolysis and hemolytic anemia in patients with severe deficiency of glucose-6-phosphate dehydrogenase.

Allergic reactions: often - urticaria, angioedema; infrequently - anaphylactic reactions, including angioedema; frequency is unknown - skin rash, itching, rhinitis, swelling of the nasal mucosa, cardio-respiratory distress syndrome, as well as severe reactions, including anaphylactic shock.

On the part of the nervous system: often - headache, insomnia; infrequently - dizziness, drowsiness; rarely - tinnitus, intracerebral hemorrhage; frequency is unknown - a decrease in hearing, which may be a sign of overdose of the drug (see section "Overdose").

On the part of the respiratory system: often - bronchospasm.

On the part of the digestive system: very often - heartburn; often - nausea, vomiting; infrequently - pain in the abdomen, ulcers of the mucous membrane of the stomach and duodenum, including perforating (rarely), gastrointestinal bleeding; rarely - increased activity of liver enzymes; very rarely - stomatitis, esophagitis, erosive lesions of the upper GI tract, strictures, irritable bowel syndrome, colitis; frequency is unknown - loss of appetite, diarrhea.

On the part of the urinary system: the frequency is unknown - impaired renal function and acute renal failure.

If the side effects indicated above are noted, or they are aggravated, or any other side effects appear, the patient should inform the doctor.

Contraindications

- hypersensitivity to acetylsalicylic acid, excipients of the drug and other NSAIDs;

- cerebral hemorrhage;

- tendency to bleeding (vitamin K deficiency, thrombocytopenia, hemorrhagic diathesis);

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

- gastrointestinal bleeding;

- bronchial asthma induced by salicylates and other NSAIDs;

- complete or incomplete combination of asthma, recurrent nasal polyposis and paranasal sinuses with intolerance to acetylsalicylic acid or other NSAIDs, including COX-2 inhibitors (including in history);

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

- I and III trimesters of pregnancy;

- breastfeeding period;

- deficiency of glucose-6-phosphate dehydrogenase;

- severe renal failure (CC less than 30 ml / min);

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

- chronic heart failure III and IV FC on
NYHA classifications;

- children's age up to 18 years.

Carefully

With gout, hyperuricemia, because Acetylsalicylic acid in small doses reduces the excretion of uric acid.

In the presence of a history of ulcerative lesions of the gastrointestinal tract or gastrointestinal bleeding.

When liver failure (class A on a scale of Child-Pugh).

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

With bronchial asthma, chronic diseases of the respiratory system, hay fever, nasal polyposis, allergic conditions, drug allergies.

In the II trimester of pregnancy.

With diabetes.

In elderly patients.

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

When taken simultaneously with the following drugs (see the section "Drug Interactions"):

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

- with anticoagulants, thrombolytic or antiplatelet agents;

- With NSAIDs and salicylic acid derivatives in high doses;

- with digoxin;

- with hypoglycemic agents for internal use (sulfonylurea derivatives) and insulin;

- with valproic acid;

-with alcohol (alcoholic beverages in particular);

- with selective serotonin reuptake inhibitors;

- with ibuprofen;

- with lithium preparations;

- with systemic GKS;

- with ethanol;

- with narcotic analgesics;

- with sulfonamides;

- with carbonic anhydrase inhibitors.

Drug interactions

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

- methotrexate due to a decrease in renal clearance and its displacement from the association with proteins, the combination of acetylsalicylic acid with methotrexate is accompanied by an increased incidence of side effects from the blood-forming organs;

- narcotic analgesics, other NSAIDs;

- Heparin and indirect anticoagulants due to dysfunction of platelets and the displacement of indirect anticoagulants due to the blood plasma proteins;

- thrombolytic, antiplatelet and anticoagulant drugs (ticlopidine);

- digoxin due to a decrease in its renal excretion;

- hypoglycemic agents for oral administration (sulfonylurea derivatives) and insulin due to the hypoglycemic properties of acetylsalicylic acid itself in high doses and forcing out sulfonylurea derivatives from their association with plasma proteins;

- valproic acid due to its displacement from the connection with 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 accompanied by an increased risk of bleeding.

Simultaneous administration with acetylsalicylic acid increases the concentration of barbiturates and lithium salts in the blood plasma.

Intensifying the elimination of salicylates, systemic corticosteroids weaken their action.

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

At the same time taking acetylsalicylic acid with ethanol there is an increase in the toxic effect of ethanol on the central nervous system.

Acetylsalicylic acid reduces the effect of uricosuric drugs - benzbromaron, probenecid (reduction urikozuricheskogo effect due to competitive suppressing renal tubular excretion of uric acid), ACE inhibitors (marked dose-dependent decrease in glomerular filtration rate by inhibiting prostaglandins possessing vasodilating action, and accordingly attenuation of the hypotensive action ), diuretics (when used together with acetylsalicylic acid in high doses, There is a decrease in glomerular filtration rate as a result of a decrease in prostaglandin synthesis in the kidneys).

Antacids and colestyramine reduce the absorption of acetylsalicylic acid.

If the patient uses the above or other medications (including non-prescription), before taking the drug Trombital should consult with your doctor.

Pregnancy and Lactation

Trombital is contraindicated for use in the first and third trimesters of pregnancy, because has a teratogenic effect - when applied in the first trimester of pregnancy, the upper palate splits in the fetus; in the third trimester, it causes inhibition of labor activity (suppression of prostaglandin synthesis), premature closure of the ductus arteriosus, hyperplasia of the pulmonary vessels and hypertension in the small circulation.

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

Salicylic acid penetrates the placental barrier.

Acetylsalicylic acid and its metabolites are excreted in breast milk. At the time of treatment, breastfeeding should be discontinued.

Special instructions

The drug should be used as prescribed by a doctor.

Acetylsalicylic acid can provoke a bronchospasm, and also cause attacks of bronchial asthma and other hypersensitivity reactions. Risk factors are a history of bronchial asthma, allergic conditions, hay fever, nasal polyposis, chronic diseases of the respiratory system, and allergic reactions to other drugs (eg, 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 to 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 stopped.

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 trigger the development of gout in susceptible patients (with reduced uric acid excretion).

Caution should be exercised when using the drug in patients with hepatic insufficiency (class A on the Child-Pugh scale), with renal insufficiency (CC more than 30 ml / min).

The combination of acetylsalicylic acid with methotrexate is accompanied by an increased incidence of side effects from the hematopoietic system.

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 oral administration (sulfonylurea derivatives) and insulin.

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

A combination of acetylsalicylic acid and ibuprofen is not recommended in patients with an increased risk of cardiovascular diseases: while using ibuprofen, there is a decrease in the antiaggregant effect of acetylsalicylic acid in doses up to 300 mg, which leads to a decrease in cardioprotective effects of acetylsalicylic acid.

Care must be taken when taking the drug with narcotic analgesics, NSAIDs and salicylic acid derivatives in high doses.

Excess therapeutic doses of acetylsalicylic acid are associated with the risk of gastrointestinal bleeding.

Caution must be exercised when using the drug in the presence of a history of ulcerative lesions of the gastrointestinal tract or gastrointestinal bleeding.

With long-term use of acetylsalicylic acid in low doses as an antiplatelet therapy, care must be taken in elderly patients because of the risk of gastrointestinal bleeding.

Care should be taken with simultaneous use of the drug with digoxin (due to a decrease in its renal excretion), valproic acid (due to its displacement from the association with plasma proteins), lithium preparations (due to an increase in their concentration in the blood plasma), sulfonamides, carbonic anhydrase inhibitors, selective serotonin reuptake inhibitors.

While taking acetylsalicylic acid with alcohol increases the risk of damage to the gastrointestinal mucosa and lengthening the time of bleeding.

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

Influence on ability to drive vehicles and mechanisms

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

Overdosage

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 is of moderate severity, and when used in higher doses, severe.

Mild to moderate overdose symptoms: dizziness, tinnitus, hearing loss, blurred vision, increased sweating, nausea, vomiting, headache, confusion, tachypnea, hyperventilation, respiratory alkalosis.

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

Symptoms of moderate to severe overdose: respiratory alkalosis with compensatory metabolic acidosis; hyperpyrexia (extremely high body temperature); respiratory disorders - hyperventilation, non-cardiogenic pulmonary edema, respiratory depression, asphyxia; disorders of the cardiovascular system - cardiac arrhythmias,
decrease in blood pressure, cardiac depression, collapse; violations of water and electrolyte balance - dehydration, impaired renal function from oliguria until the development of renal failure, characterized by hypokalemia, hypernatremia, hyponatremia; violation of glucose metabolism - hyperglycemia, hypoglycemia (especially in children), ketoacidosis; tinnitus, deafness; gastrointestinal bleeding; hematological disorders - from inhibition of platelet aggregation to coagulopathy, prolongation of prothrombin time, hypoprothrombinemia; neurological disorders - toxic encephalopathy and central nervous system function depression (drowsiness, confusion, coma, convulsions).

Treatment: immediate hospitalization in specialized departments for emergency treatment - gastric lavage, repeated administration of activated carbon and laxatives, alkalization of urine (indicated with salicylates above 500 mg / l, provided by IV infusion of sodium bicarbonate - 88 meq in 1 l 5% glucose solution, at a rate of 10-15 ml / kg / h), restoration of BCC and induction of diuresis (achieved by the introduction of sodium bicarbonate in the same dose and dilution, repeat 2-3 times); It should be borne in mind that intensive fluid infusion in elderly patients can lead to pulmonary edema. The use of acetazolamide for alkalinization of urine is not recommended (it can cause acidemia and increase the toxic effect of salicylates). When conducting alkaline diuresis, it is necessary to achieve pH values ​​between 7.5 and 8. Hemodialysis is indicated when the level of salicylates in the blood plasma is more than 1000 mg / l, and in patients with chronic poisoning - 500 mg / l and lower if indicated (refractory acidosis, progressive deterioration of , severe CNS damage, pulmonary edema, and renal failure). In case of pulmonary edema, a ventilator is shown with a mixture enriched with oxygen in the positive end-expiratory pressure mode; 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 salicilism (nausea, vomiting, tinnitus, blurred vision, dizziness, headache, general malaise) are not always noticeable, therefore it is advisable to periodically determine the content of salicylates in the blood plasma

  • Brand name: Trombital
  • Active ingredient: Acetylsalicylic acid + Magnesium hydroxide
  • Dosage form: pills, film coated white or almost white, round, biconvex; in cross section, the core is white or almost white.
  • Manufacturer: Pharmstandard

Studies and clinical trials of Acetylsalicylic acid + Magnesium hydroxide (Click to expand)

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