Thrombo ACS, 100 mg 28 pcs

NSAIDS. Acetylsalicylic acid is a ester of salicylic acid.

The mechanism of action is based on the irreversible inactivation of COX-1 enzyme, resulting in blocking the synthesis of prostaglandins, prostacyclins and thromboxane. Reduces aggregation, platelet adhesion and thrombosis by inhibiting the synthesis of thromboxane A2 in platelets. Increases fibrinolytic activity of blood plasma and reduces the concentration of vitamin K-dependent clotting factors (II, VII, IX, X). Antiplatelet effect is more expressed in platelets as they are not able to re-synthesize COX.

Antiplatelet effect is developed after low doses of the drug and is maintained for 7 days after single use. These properties of acetylsalicylic acid are used in the prevention and treatment of myocardial infarction, CHD, 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; 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, coronary artery bypass grafting, carotid endarterectomy, angioplasty and stenting of the coronary arteries);

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).

Pharmacological effect

NSAIDs. Acetylsalicylic acid is an ester of salicylic acid.

The mechanism of action is based on the irreversible inactivation of the COX-1 enzyme, as a result of which the synthesis of prostaglandins, prostacyclins and thromboxane is blocked. Reduces platelet aggregation, adhesion and thrombus formation by suppressing the synthesis of thromboxane A2 in platelets. Increases the fibrinolytic activity of blood plasma and reduces the concentration of vitamin K-dependent coagulation factors (II, VII, IX, X). The antiplatelet effect is most pronounced in platelets, because 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, ischemic heart disease, and complications of varicose veins.
Acetylsalicylic acid also has anti-inflammatory, antipyretic and analgesic effects.

Special instructions

The drug should be used after a doctor’s prescription.

Acetylsalicylic acid can provoke bronchospasm, as well as cause attacks of bronchial asthma and other hypersensitivity reactions. Risk factors include a history of bronchial asthma, hay fever, nasal polyposis, chronic respiratory diseases, and allergic reactions to other drugs (for example, skin reactions, itching, urticaria). The inhibitory effect of acetylsalicylic acid on platelet aggregation persists for several days after administration, and therefore the risk of bleeding may increase during surgery or in the postoperative period.

If it is necessary to absolutely eliminate 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 accompanied by an increased risk of bleeding.

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

Acetylsalicylic acid in high doses has a hypoglycemic effect, which must be kept in mind when prescribing the drug to patients with diabetes mellitus receiving oral hypoglycemic agents (sulfonylurea derivatives) and insulin. When concomitantly prescribing GCS and salicylates, it should be remembered that during treatment the level of salicylates in the blood is reduced, and after discontinuation of GCS, 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 combining acetylsalicylic acid with ethanol (drinks containing alcohol), there is an increased risk of damage to the gastrointestinal mucosa and prolongation of bleeding time.

Impact on the ability to drive vehicles and operate machinery
During the treatment period, care must be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions, since the use of the drug Thrombo ACC can cause dizziness.

Active ingredient

Acetylsalicylic acid

Composition

Active substance:

Acetylsalicylic acid – 100 mg

Excipients:
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.

Pregnancy

The use of salicylates in high doses in the first 3 months of pregnancy is associated with an increased incidence of fetal defects (cleft palate, heart defects).

The use of salicylates in the first trimester of pregnancy is contraindicated. In the third trimester of pregnancy, salicylates in high doses (more than 300 mg/day) cause inhibition of labor, premature closure of the ductus arteriosus in the fetus, increased bleeding in the mother and fetus, and administration immediately before birth can cause intracranial hemorrhages, especially in premature infants.

The use of salicylates in the third trimester of pregnancy is contraindicated. In the second trimester of pregnancy, salicylates can be used only taking into account a strict assessment of the risks and benefits for the mother and fetus, preferably in doses not exceeding 150 mg/day and for a short period of time. Salicylates and their metabolites are excreted in small quantities into breast milk.

Accidental intake of salicylates during lactation is not accompanied by the development of adverse reactions in the child and does not require cessation of breastfeeding. However, with long-term use of the drug or use of it in a high dose, breastfeeding should be stopped immediately.

Contraindications

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

Side Effects

In general, Thrombo ACC is well tolerated by patients due to its low dosage.

Adverse reactions are observed in rare cases.

From the digestive system: nausea, heartburn, vomiting, pain in the abdominal area; rarely – gastric and duodenal ulcers, incl. perforation, gastrointestinal bleeding, transient liver dysfunction with increased activity of liver transaminases.

From the central nervous system: dizziness, hearing loss, tinnitus, which may be a sign of a drug overdose.

From the hematopoietic system: increased frequency of perioperative (intra- and postoperative) bleeding, hematomas, nosebleeds, bleeding gums, bleeding from the genitourinary tract.

There have been reports of serious cases of bleeding, which include gastrointestinal bleeding and cerebral hemorrhage (especially in patients with arterial hypertension who have not achieved blood pressure targets and/or receiving concomitant therapy with anticoagulant agents, which in some cases can be life-threatening in nature. Bleeding can lead to the development of acute or chronic post-hemorrhagic/iron deficiency anemia (for example, due to occult bleeding) with associated clinical and laboratory symptoms (asthenia, pallor, hypoperfusion).

Allergic reactions: skin rash, itching, urticaria, Quincke’s edema, rhinitis, swelling of the nasal mucosa, rhinitis, bronchospasm, cardiorespiratory distress syndrome, as well as severe reactions, including anaphylactic shock.

Interaction

With simultaneous use, acetylsalicylic acid enhances the effect of the following drugs (if it is necessary to simultaneously use the drug Thrombo ACC with the listed drugs, the need to reduce their dose should be considered): Methotrexate – by reducing renal clearance and displacing it from protein binding.

When used simultaneously with anticoagulants, thrombolytic and antiplatelet agents (ticlopidine, clopidogrel), there is an increase in the risk of bleeding as a result of the synergism of the main therapeutic effects of the drugs used. When used simultaneously with drugs that have anticoagulant, thrombolytic or antiplatelet effects, an increased damaging effect on the gastrointestinal mucosa is observed. 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 administration (sulfonylurea derivatives) and insulin – due to the hypoglycemic properties of acetylsalicylic acid itself in high doses and the displacement of sulfonylurea derivatives from communication with blood plasma proteins.

When used simultaneously with valproic acid, its toxicity increases due to the displacement of its connection with blood 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 synergistic action. When used concomitantly with ibuprofen, antagonism is observed in relation to the irreversible inhibition of platelets caused by 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 enhancement of the effects of acetylsalicylic acid and ethanol.

The simultaneous use of acetylsalicylic acid in high doses may reduce the effect of the drugs listed below (if it is necessary to simultaneously prescribe the drug Thrombo ACC with the listed drugs, the need to adjust their dose should be considered): Any diuretics – when used together with acetylsalicylic acid in high doses, a decrease in glomerular filtration rate (GFR) is observed as a result of a decrease in the synthesis of prostaglandins in the kidneys.

ACE inhibitors – there is a dose-dependent decrease in GFR as a result of inhibition of prostaglandins that have a vasodilatory 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 also occurs when used in combination 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 excretion of uric acid.
When used simultaneously with systemic corticosteroids (with the exception of hydrocortisone used for replacement therapy of Addison’s disease), there is an increase in the excretion of salicylates and, accordingly, a weakening of their effect.

Overdose

An overdose of Thrombo ACC can have serious consequences, especially in elderly patients and children.

Salicylic 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 intake of activated carbon, forced alkaline diuresis, restoration of water-electrolyte balance and acid-base state.

Overdose of moderate and severe severity (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, marked decrease in blood pressure, depression of cardiac activity; from the side of water and electrolyte balance – dehydration, impaired renal function from oliguria up to the development of renal failure, characterized by hypokalemia, hypernatremia, hyponatremia; impaired glucose metabolism – hyperglycemia, hypoglycemia (especially in children), ketoacidosis; from the organ of hearing – 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 and depression of central nervous system function (drowsiness, confusion, coma, convulsions).

Treatment: immediate hospitalization in specialized departments for emergency treatment – gastric lavage, repeated intake of activated charcoal, forced alkaline diuresis, hemodialysis, restoration of water-electrolyte balance and acid-base state, symptomatic therapy.

Storage conditions

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

Shelf life

3 years

Manufacturer

G.L.Pharma GmbH, Austria