Thrombo ASS, enteric-pills 100mg 28pcs

Composition

Active ingredient: Acetylsalicylic acid-100 mgsupport substances: lactose monohydrate – 60 mg, microcrystalline cellulose-27 mg, colloidal silicon dioxide-3 mg, potato starch-10 mg. Shell composition: talc – 3.795 mg, triacetin-1.02 mg, copolymer of methacrylic acid and ethyl acrylate (1: 1) (Eudragit L) – 10.185 mg

Pharmacological action

of NSAIDs. Acetylsalicylic acid is an ester of salicylic acid. The mechanism of action is based on the irreversible inactivation of the COX-1 enzyme, which blocks the synthesis of prostaglandins, prostacyclines and thromboxane. Reduces platelet aggregation, adhesion and thrombosis by suppressing the synthesis of thromboxane A2 in platelets. Increases the fibrinolytic activity of blood plasma and reduces the concentration of vitamin K-dependent clotting factors (II, VII, IX, X). The antiplatelet effect is most pronounced in platelets, since they are unable to re-synthesize COX. The antiplatelet effect develops after using the drug in small doses and persists for 7 days after a single dose. These properties of acetylsalicylic acid are used in the prevention and treatment of myocardial infarction, coronary heart disease, and complications of varicose veins. Acetylsalicylic acid also has anti-inflammatory, antipyretic and analgesic effects.

Indications

Primary prevention of acute myocardial infarction in the presence of risk factors (such as diabetes mellitus, hyperlipidemia, arterial hypertension, obesity, smoking, old age);Secondary prevention of myocardial infarction; stable and unstable angina pectoris; prevention of stroke (including in patients with transient cerebrovascular accident);Prevention of transient cerebrovascular accident;Prevention of thromboembolism after surgery and invasive vascular interventions (for example carotid artery bypass grafting, carotid artery endarterectomy, angioplasty and coronary artery stenting);Prevention of deep vein thrombosis and thromboembolism of the pulmonary artery and its branches (for example, with prolonged immobilization as a result of extensive surgery).

Use during pregnancy and lactation

The use of high-dose salicylates in the first 3 months of pregnancy is associated with an increased frequency of fetal defects (split upper palate, heart defects). The use of salicylates in the first trimester of pregnancy is contraindicated. In the third trimester of pregnancy, salicylates in a high dose (more than 300 mg/day) cause inhibition of labor, premature closure of the arterial duct in the fetus, increased bleeding in the mother and fetus, and use immediately before delivery can cause intracranial hemorrhages, especially in premature babies. The use of salicylates in the third trimester of pregnancy is contraindicated. In the second trimester of pregnancy, salicylates can only be used with a strict assessment of the risk and benefit to the mother and fetus, preferably in doses not exceeding 150 mg/day and for a short time. Salicylates and their metabolites are excreted in small amounts in breast milk. Accidental intake of salicylates during lactation is not accompanied by the development of adverse reactions in the child and does not require discontinuation of breastfeeding. However, if the drug is used for a long time or at a high dose, breastfeeding should be stopped immediately.

Contraindications

Erosive and ulcerative lesions of the gastrointestinal tract in the acute phase; increased bleeding, blood clotting disorders, hemophilia;nephrolithiasis;”aspirin triad”; hypotrombinemia; glucose-6-phosphate dehydrogenase deficiency; lactation (breastfeeding); children and adolescents under 18 years of age;hypersensitivity to acetylsalicylic acid and its derivatives.

Side effects

In general, ACC thrombosis is well tolerated by patients due to its low dosage.  Adverse reactions are observed in rare cases. From the digestive system: nausea, heartburn, vomiting, abdominal pain; rarely-ulcers of the stomach and duodenum, including perforated, gastrointestinal bleeding, transient liver function disorders with increased activity of hepatic transaminases. From the central nervous system: dizziness, hearing loss, tinnitus, which may be a sign of an overdose of the drug. From the hematopoietic system: increased frequency of perioperative (intra – and postoperative) bleeding, hematomas, nosebleeds, bleeding gums, bleeding from the genitourinary tract. Serious cases of bleeding have been reported, which include gastrointestinal bleeding and brain hemorrhage (especially in patients with hypertension who have not reached the target blood pressure values and/or who have received 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 symptoms (asthenia, pallor, hypoperfusion). Allergic reactions: skin rash, pruritus, urticaria, angioedema, rhinitis, nasal mucosal edema, rhinitis, bronchospasm, cardio-respiratory distress syndrome, as well as severe reactions, including anaphylactic shock.

Interaction

When used concomitantly, acetylsalicylic acid enhances the effect of the following drugs (if it is necessary to simultaneously use the drug Trombo ACC with the listed drugs, the need to reduce their dose should be considered): Methotrexate – by reducing renal clearance and displacing it from binding to proteins. When used concomitantly with anticoagulants, thrombolytic and antiplatelet agents (ticlopidine, clopidogrel), there is an increased risk of bleeding as a result of the synergy of the main therapeutic effects of the drugs used. When used concomitantly with drugs that have anticoagulant, thrombolytic or antiplatelet effects, an increase in the damaging effect on the gastrointestinal mucosa is noted. Selective serotonin reuptake inhibitors may increase the risk of bleeding from the upper gastrointestinal tract (synergism with acetylsalicylic acid). Digoxin – due to a decrease in its renal excretion, which can lead to an overdose. Hypoglycemic agents for oral use (sulfonylurea derivatives) and insulin – due to the hypoglycemic properties of acetylsalicylic acid itself in high doses and the displacement of sulfonylurea derivatives from binding to plasma proteins. When used concomitantly with valproic acid, its toxicity increases due to the displacement of its binding to plasma proteins. NSAIDs and salicylic acid derivatives in high doses – increased risk of ulcerogenic effect and bleeding from the gastrointestinal tract as a result of synergism of action. When used concomitantly with ibuprofen, there is an antagonism against irreversible platelet suppression due to the action, which leads to a decrease in the cardioprotective effects of acetylsalicylic acid. Ethanol – increased risk of damage to the gastrointestinal mucosa and prolongation of bleeding time as a result of the mutual strengthening of the effects of acetylsalicylic acid and ethanol. Concomitant use of acetylsalicylic acid in high doses may reduce the effect of the following drugs (if it is necessary to simultaneously prescribe the drug Thrombo ASS with the listed drugs, the need for dose adjustment should be considered): Any diuretics – when combined with acetylsalicylic acid in high doses, a decrease in glomerular filtration rate (GFR) is noted as a result of a decrease in prostaglandin synthesis in the kidneys. ACE inhibitors – there is a dose-dependent decrease in GFR as a result of inhibition of prostaglandins that have a vasodilating effect, respectively, a weakening of the hypotensive effect. A clinical decrease in GFR is observed with a daily dose of acetylsalicylic acid of more than 160 mg. In addition, there is a decrease in the positive cardioprotective effect of ACE inhibitors prescribed to patients for the treatment of chronic heart failure. This effect is also evident when used together with acetylsalicylic acid in high doses. Drugs with uricosuric action (benzbromarone, probenecid) – a decrease in the uricosuric effect due to competitive suppression of renal tubular uric acid excretion. When used concomitantly with systemic corticosteroids (with the exception of hydrocortisone, used for the replacement therapy of Addison’s disease), there is an increase in the excretion of salicylates and, accordingly, a weakening of their action.

How to take it, course of use and dosage

It is advisable to take Trombo ACC before meals, with plenty of fluids. Do not take on an empty stomach. The drug is intended for long-term use. The duration of therapy is determined by the doctor. Primary prevention of acute myocardial infarction in the presence of risk factors: 50-100 mg / day. Secondary prevention of myocardial infarction, angina pectoris: 50-100 mg / day. Prevention of stroke and transient cerebrovascular accident: 50-100 mg/day. Prevention of thromboembolism after surgery and invasive vascular interventions: 50-100 mg / day. Prevention of deep vein thrombosis and pulmonary embolism and its branches: 100-200 mg (2 tablets)/day.

Overdose

Overdose of the drug Trombo ACC can have serious consequences, especially in elderly patients and in children. Salicylism syndrome develops when taking acetylsalicylic acid at a dose of more than 100 mg / kg / day for more than 2 days due to the use of toxic doses of the drug as part of improper therapeutic use (chronic poisoning) or a single accidental or intentional intake of a toxic dose of the drug by an adult or child (acute poisoning). Mild to moderate overdose (single dose less than 150 mg/kg) Symptoms: dizziness, tinnitus, hearing loss, increased sweating, nausea and vomiting, headache, confusion, tachypnea, hyperventilation, respiratory alkalosis. Treatment: gastric lavage, repeated use of activated charcoal, forced alkaline diuresis, restoration of water-electrolyte balance and acid-base state. Moderate and severe overdose (a single dose of 150-300 mg / kg – moderate severity, more than 300 mg / kg-severe poisoning) Symptoms: from the respiratory system – respiratory alkalosis with compensatory metabolic acidosis, hyperpyrexia, hyperventilation, non-cardiogenic pulmonary edema, respiratory depression, asphyxia; from the cardiovascular system – cardiac arrhythmias, a pronounced decrease in blood pressure, cardiac depression; from the water-electrolyte balance – dehydration, impaired renal function from oliguria to the development of renal failure, characterized by hypokalemia, hypernatremia, hyponatremia; glucose metabolism disorders – hyperglycemia, hypoglycemia (especially in children), ketoacidosis; from the hearing organ – tinnitus, deafness; from the digestive system – gastrointestinal bleeding; hematological disorders-from inhibition of platelet aggregation to coagulopathy, prolongation of prothrombin time, hypoprothrombinemia; neurological disorders – toxic encephalopathy, etc. depression 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, forced alkaline diuresis, hemodialysis, restoration of water-electrolyte balance and acid-base state, symptomatic therapy.

Special instructions

The drug should be used after the doctor’s appointment. 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). The inhibitory effect of acetylsalicylic acid on platelet aggregation persists for several days after use, and therefore there may be an increased risk of bleeding during surgery or in the postoperative period. If it is necessary to absolutely exclude bleeding during surgery, it is necessary, if possible, to completely abandon the use of acetylsalicylic acid in the preoperative period. 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 individuals (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. Acetylsalicylic acid in high doses has a hypoglycemic effect, which should be borne in mind when prescribing the drug to patients with diabetes mellitus receiving hypoglycemic agents for oral use (sulfonylureas) and insulin. With the combined appointment of corticosteroids and salicylates, it should be remembered that during treatment, the level of salicylates in the blood is reduced, and after the withdrawal of corticosteroids, 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, since the latter reduces the positive effect of acetylsalicylic acid on life expectancy, i. e. reduces the cardioprotective effect of acetylsalicylic acid. Exceeding the dose of acetylsalicylic acid is associated with the risk of gastrointestinal bleeding. Overdose is especially dangerous in elderly patients. When acetylsalicylic acid is combined with ethanol (drinks containing alcohol), the risk of damage to the gastrointestinal mucosa and prolonging the bleeding time is increased. Influence on the ability to drive motor vehicles and control mechanisms During treatment, care should be taken when driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions, because the use of the drug Trombo ACC can cause dizziness.

Form of production

Tablets coated with an enteric film coating of white color, round, biconvex; with a shiny, smooth or slightly rough surface.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Acetylsalicylic acid

Dosage form

Tablets

Purpose

For adults who are only pregnant in the second trimester as prescribed by a doctor

Indications

Prevention of thrombosis, Angina pectoris, Prevention of heart attacks and strokes