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AS-thrombin 100 mg No. 30 tablet p.o. solution/intestinal

Instructions for the use of the drug for specialists AS-TROMBIN Trade name AS-thrombin International nonproprietary name Acetylsalicylic acid Dosage form Enteric-coated tablets of 50 mg, 100 mg Composition One tablet contains the active substance - acetylsalicylic acid 50 mg, 100 mg, excipients : lactose, microcrystalline cellulose, talc, shell: propylene glycol, hydroxypropyl methylcellulose phthalate, titanium dioxide. Description Tablets are white, round, with a biconvex surface, coated. Pharmacotherapeutic group Anticoagulants. Platelet aggregation inhibitors (excluding heparin). ATC code B01AC06 Pharmacological properties Pharmacokinetics The enteric coating does not allow the absorption of acetylsalicylic acid in the stomach. The maximum concentration of the drug in the blood is observed on average 3 hours after taking the drug orally. Binding to plasma proteins is 80-85%, the degree of binding decreases to 50% with increasing doses of acetylsalicylic acid. Distributed into most tissues and body fluids. Penetrates the blood-brain barrier. Metabolized in the liver by hydrolysis to form salicylic acid, followed by conjugation with glycine or glucuronide. It is excreted by the kidneys mainly in the form of salicylic acid. Pharmacodynamics Antiplatelet agent. Reduces blood clotting due to a decrease in platelet aggregation by suppressing the synthesis of thromboxane A2 in them. The use of the drug, starting with a dose of 50 mg, leads to a long-term decrease by 90-95% in the concentration of thromboxane A2 and its metabolites in the blood serum. A decrease in the thromboxane content in platelets leads to irreversible suppression of aggregation and slightly dilates blood vessels. Increases the fibrinolytic activity of plasma, reduces the concentration of vitamin K-dependent blood coagulation factors (II, VIII, IX, X). Indications for use - primary prevention of myocardial infarction (reducing the risk of myocardial infarction in patients with coronary heart disease) - secondary prevention of myocardial infarction - prevention of ischemic cerebrovascular accidents - prevention of thrombosis and embolism, incl. in patients with an increased risk of their occurrence (after surgery on the heart and blood vessels, coronary artery bypass surgery) Method of administration and dosage Orally 50-100 mg 1 time per day. The dosage of the drug and duration of use are determined by the doctor. The tablets should be taken without chewing, with a small amount of liquid. Side effects - headache, dizziness, reversible visual impairment, tinnitus - bronchospasm, skin rash, Quincke's edema - anemia, thrombocytopenia, leukopenia - nausea, vomiting, diarrhea, erosive and ulcerative lesions of the gastrointestinal tract - renal dysfunction, prolongation menstruation - increased symptoms of congestive heart failure Contraindications - increased sensitivity to acetylsalicylic acid and its derivatives - erosive and ulcerative lesions of the gastrointestinal tract in the acute phase - increased bleeding, bleeding disorders, hemophilia, hemorrhagic diathesis - portal hypertension, venous congestion - hypothrombinemia, vitamin K deficiency - severe liver and kidney dysfunction - "aspirin" triad, "aspirin" asthma - glucose-6-phosphate dehydrogenase deficiency - pregnancy, lactation - childhood and adolescence up to 18 years - dissecting aortic aneurysm - heart failure Drug interactions AS - thrombin enhances the effect of other non-steroidal anti-inflammatory drugs, heparin, indirect anticoagulants, platelet aggregation inhibitors, uricosuric drugs (probenicide, sulfinpyrazone), narcotic analgesics, oral hypoglycemic agents, methotrexate. Simultaneous use with glucocorticoids increases the risk of erosive and ulcerative lesions of the gastrointestinal tract. AS-thrombin weakens the effect of diuretics, antihypertensive drugs, as well as anti-gout drugs that promote the excretion of uric acid, increases the concentration of digoxin, barbiturates and lithium salts in the blood plasma. Caffeine and antihistamines increase the risk of side effects of AS - thrombin. Special instructions Use with caution in patients with liver and kidney diseases, bronchial asthma, erosive and ulcerative lesions and a history of bleeding from the gastrointestinal tract. With increased bleeding or with simultaneous anticoagulant therapy, AC-thrombin, even in small doses, reduces the excretion of uric acid from the body, which can cause an acute attack of gout in predisposed patients. When carrying out long-term therapy and/or using AS-thrombin in high doses, it is necessary to regularly conduct blood tests and examine stool for occult blood. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms Caution is required when using the drug for vehicle drivers and people whose profession is associated with increased concentration. Overdose Overdose is unlikely due to the low content of acetylsalicylic acid in the drug. Symptoms: nausea, vomiting, tinnitus, general malaise. Treatment: provocation of vomiting, administration of activated carbon and laxatives. Release form and packaging Enteric-coated tablets, 50 mg, 100 mg, No. 10 in blister, 3 blisters in a cardboard box with instructions for use. Storage conditions Store in a dry place, protected from light, at a temperature not exceeding +25°C. Keep out of the reach of children! Shelf life: 3 years Do not use the drug after the expiration date indicated on the package. Conditions for dispensing from pharmacies Without a prescription, Republic of Kazakhstan, Almaty, st. Dzhandosova 184 "g", tel. 55-47-13, 29-57-55.

AS-thrombin instructions for use (tablets)

special instructions

AS-thrombin 100 mg tablets are not suitable for use as an anti-inflammatory/analgesic/antipyretic.

Recommended for use by adults and adolescents over 16 years of age.

AC-thrombin is contraindicated for use in children and adolescents under 16 years of age, since acetylsalicylic acid acts as a factor provoking the development of Reye's syndrome (acute hepatic encephalopathy).

The risk of developing hemorrhages increases, particularly during or after surgery (even in the case of minor procedures, such as tooth extraction).

Temporary cessation of therapy may be necessary.

AS-thrombin 100 mg tablets are not recommended for menorrhagia as it may increase menstrual bleeding.

AS-thrombin 100 mg tablets should be used with caution in cases of hypertension, as well as in the case of a history of gastrointestinal ulcers, hemorrhagic episodes and taking anticoagulant therapy.

Patients should report any unusual bleeding events to their doctor.

If gastric or intestinal bleeding develops, therapy should be discontinued.

Caution should be exercised when taking acetylsalicylic acid in patients with moderate renal insufficiency or hepatic insufficiency (contraindicated in severe cases), as well as in patients with dehydration, since taking NSAIDs may lead to deterioration of renal function.

In patients with mild to moderate liver failure, liver function tests should be measured on a regular basis.

Acetylsalicylic acid can provoke bronchospasm and asthma attacks, as well as other hypersensitivity reactions.

Risk factors include: asthma, hay fever, nasal polyposis and chronic respiratory diseases.

The same applies to patients with allergic reactions to other components (eg skin reactions, itching, urticaria).

Serious skin reactions, including Steven-Jones syndrome, have been reported in association with the use of acetylsalicylic acid.

AC-thrombin tablets should be discontinued at the first appearance of skin rash, mucosal ulcers, or other hypersensitivity reactions.

Cases of gastrointestinal bleeding and perforation may be fatal when taking NSAIDs in sensitive elderly patients, including acetylsalicylic acid.

If prolonged therapy is necessary, the patient should be examined on a regular basis.

Concomitant use with AC-thrombin 100 mg tablets of other drugs that damage hemostasis (including anti-coagulants such as warfarin, thrombolytics and antiplatelet agents, anti-inflammatory drugs and selective serotonin reuptake inhibitors) is not recommended until strictly necessary, since they may increase the risk of hemorrhage.

If taking these combinations cannot be avoided, careful monitoring for signs of bleeding is necessary.

Caution should be exercised when taken with drugs that may increase the risk of ulcers, such as oral corticosteroids, selective serotonin reuptake inhibitors, and deferasirox.

Taking acetylsalicylic acid in low doses reduces the excretion of uric acid.

In view of this fact, patients with a tendency to decrease uric acid excretion may develop an attack of gout.

When taken in doses above therapeutic doses, AC-thrombin tablets may potentiate the hypoglycemic effect of sulfonylureas and insulin.

Taking acetylsalicylic acid is contraindicated in late pregnancy, as well as during lactation.

AS-thrombin tablets contain lactose monohydrate.

Patients with rare hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption are contraindicated to take this drug.

AS-thrombin tablets contain propylene thicol, which causes skin irritation.

Pregnancy

Low doses (up to 100 mg/day)

Clinical studies show that doses up to 100 mg/day for limited obstetric use are safe.

Doses 100 - 500 mg/day

Clinical experience with doses ranging from 100 mg/day to 500 mg/day is limited.

Therefore, the recommendations below for this dose range should be followed.

Doses from 500 mg/day and above

Suppression of prostaglandin synthesis may adversely affect pregnancy and/or embryonic/fetal development.

Data from epidemiological studies indicate an increased risk of miscarriage and cardiac malformations, gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy.

The absolute risk of developing cardiovascular disease increased from less than 1% to approximately 1.5%.

The risk likely increases with increasing dose and duration of therapy.

If acetylsalicylic acid is used by a woman planning a pregnancy or during the first and second trimesters of pregnancy, it is necessary to take minimal doses of acetylsalicylic acid, and the duration of therapy should be as short as possible.

Taking prostaglandin inhibitors during the third trimester of pregnancy may have the following effects:

fetus: cardio- and pulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
renal dysfunction, which may progress to renal failure with oligohydroamniosis.

mother and newborn:

it is possible to prolong bleeding time and develop an antiplatelet effect when taking very low doses;

inhibition of uterine contractions, which leads to prolonged labor.

Therefore, taking acetylsalicylic acid at a dose of 100 mg/day or higher during the third trimester is contraindicated.

Lactation

Contraindicated.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

The impact has not been established.