Thrombo ACC tablets p / o 50mg, No. 28

• 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 (repeated);

• stable and unstable angina pectoris;

• stroke prevention (including in patients with transient cerebrovascular accident);

• prevention of transient disorders of cerebral circulation;

• prevention of thromboembolism after surgery and invasive interventions on the vessels (for example, coronary artery bypass grafting, endarterectomy of the carotid arteries, 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).

Thrombotic ACCЃ should be taken before meals with plenty of liquid.

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 operations and invasive interventions on the vessels: 50-100 mg / day.

Prevention of deep vein thrombosis and thromboembolism of the pulmonary artery and its branches: 100-200 mg (2 tablets) / day.

Active substance:

acetylsalicylic acid - 50 mg

Excipients: lactose monohydrate - 65 mg, microcrystalline cellulose - 28.5 mg, colloidal silicon dioxide - 1.5 mg, potato starch - 5 mg.

Shell composition: talc - 2.53 mg, triacetin - 680 ?g, copolymer of methacrylic acid and ethyl acrylate (1: 1) (Eudragit L) - 6.79 mg.

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

• gastrointestinal bleeding;

• hemorrhagic diathesis;

• bronchial asthma induced by the intake of salicylates and other NSAIDs;

• a combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and ASA intolerance;

• simultaneous use with methotrexate at a dose of 15 mg per week or more;

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

• severe hepatic impairment (class B and higher on the Child-Pugh scale);

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

• pregnancy (I and III trimester);

• lactation period;

• age under 18;

• lactose intolerance, lactase deficiency and glucose-galactose malabsorption;

• hypersensitivity to ASA, excipients in the drug and other NSAIDs.

Carefully:with gout, hyperuricemia, gastric ulcer and duodenal ulcer or gastrointestinal bleeding (in history), renal failure (CC more than 30 ml / min), liver failure (below class B on the Child-Pugh scale), bronchial asthma, chronic diseases respiratory organs, hay fever, nasal polyposis, drug allergies, incl. for drugs of the NSAID group, analgesics, anti-inflammatory, antirheumatic drugs; pregnancy (II trimester), with the proposed surgical intervention (including minor, for example, tooth extraction); while taking with the following drugs (methotrexate at a dose of less than 15 mg per week, anticoagulants, thrombolytic or antiplatelet agents, NSAIDs and salicylic acid derivatives in large doses; digoxin;oral hypoglycemic agents (sulfonylurea derivatives) and insulin; valproic acid; ethanol (alcoholic beverages in particular); selective serotonin reuptake inhibitors; ibuprofen).

Clinical and pharmacological group: NSAIDs. Antiplatelet

Pharmaco-therapeutic group: Antiplatelet agent

pharmachologic effect

Acetylsalicylic acid (ASA) is an ester of salicylic acid, belongs to the group of NSAIDs. 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 the use of small doses of the drug and lasts for 7 days after a single dose. These properties of ASA are used in the prevention and treatment of myocardial infarction, coronary artery disease, complications of varicose veins.

ASA also has anti-inflammatory, antipyretic and analgesic effects.

Pharmacokinetics

Suction

When taken orally, ASA is absorbed from the gastrointestinal tract quickly and completely. The tablets are enteric coated, which reduces the direct irritant effect of ASA on the gastric mucosa. ASA is partially metabolized during absorption.

Distribution and metabolism

During and after absorption, ASA is converted into the main metabolite - salicylic acid, which is metabolized mainly in the liver under the influence of liver enzymes to form such metabolites as phenyl salicylate, glucuronide salicylate and salicyluric acid, found in many tissues and in urine. In women, the metabolic process is slower (less enzyme activity in the blood serum).

ASA and salicylic acid are highly bound to blood plasma proteins (from 66 to 98%, depending on the dose) and are rapidly distributed in the body. Salicylic acid crosses the placental barrier and is excreted in breast milk.

Withdrawal

T1 / 2 ASA from blood plasma is about 15-20 minutes. Unlike other salicylates, with repeated administration of the drug, non-hydrolyzed ASA does not accumulate in the blood serum. Only 1% of the ingested ASA is excreted by the kidneys in the form of non-hydrolyzed ASA, the rest is excreted in the form of salicylates and their metabolites. In patients with normal renal function, 80-100% of a single dose of the drug is excreted by the kidneys within 24-72 hours.

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 (repeated);

• stable and unstable angina pectoris;

• stroke prevention (including in patients with transient cerebrovascular accident);

• prevention of transient disorders of cerebral circulation;

• prevention of thromboembolism after surgery and invasive interventions on the vessels (for example, coronary artery bypass grafting, endarterectomy of the carotid arteries, 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).

Dosage regimen

Thrombotic ACCЃ should be taken before meals with plenty of liquid.

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 operations and invasive interventions on the vessels: 50-100 mg / day.

Prevention of deep vein thrombosis and thromboembolism of the pulmonary artery and its branches: 100-200 mg (2 tablets) / day.

Side effect

In general, Thrombotic ACCЃ is well tolerated by patients due to the low dosage.

Adverse reactions are rare.

From the digestive system: nausea, heartburn, vomiting, pain in the abdomen; rarely - stomach and duodenal ulcers, incl. perforated, gastrointestinal bleeding, transient liver dysfunction with increased activity of hepatic transaminases.

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

From the hematopoietic system: an increased frequency of perioperative (intra- and postoperative) bleeding, hematomas, nosebleeds, bleeding gums, bleeding from the urinary tract. There are reports of serious cases of bleeding, which include gastrointestinal bleeding and cerebral hemorrhage (especially in hypertensive patients who have not achieved blood pressure targets and / or received concomitant anticoagulant therapy, which in some cases can be life-threatening. Bleeding can lead to the development of acute or chronic posthemorrhagic / iron deficiency anemia (for example, due to latent bleeding) with corresponding clinical and laboratory symptoms (asthenia, pallor, hypoperfusion).

Allergic reactions: skin rash, itching, urticaria, Quincke's edema, rhinitis, edema of the nasal mucosa, bronchospasm, cardio-respiratory distress syndrome, as well as severe reactions, including anaphylactic shock.

Contraindications for use

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

• gastrointestinal bleeding;

• hemorrhagic diathesis;

• bronchial asthma induced by the intake of salicylates and other NSAIDs;

• a combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and ASA intolerance;

• simultaneous use with methotrexate at a dose of 15 mg per week or more;

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

• severe hepatic impairment (class B and higher on the Child-Pugh scale);

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

• pregnancy (I and III trimester);

• lactation period;

• age under 18;

• lactose intolerance, lactase deficiency and glucose-galactose malabsorption;

• hypersensitivity to ASA, excipients in the drug and other NSAIDs.

Carefully:with gout, hyperuricemia, gastric ulcer and duodenal ulcer or gastrointestinal bleeding (in history), renal failure (CC more than 30 ml / min), liver failure (below class B on the Child-Pugh scale), bronchial asthma, chronic diseases respiratory organs, hay fever, nasal polyposis, drug allergies, incl. for drugs of the NSAID group, analgesics, anti-inflammatory, antirheumatic drugs; pregnancy (II trimester), with the proposed surgical intervention (including minor, for example, tooth extraction); while taking with the following drugs (methotrexate at a dose of less than 15 mg per week, anticoagulants, thrombolytic or antiplatelet agents, NSAIDs and salicylic acid derivatives in large doses; digoxin;oral hypoglycemic agents (sulfonylurea derivatives) and insulin; valproic acid; ethanol (alcoholic beverages in particular); selective serotonin reuptake inhibitors; ibuprofen).

Application during pregnancy and lactation

The use of large doses of salicylates in the first 3 months of pregnancy is associated with an increased incidence of fetal defects (split upper palate, heart defects). The use of salicylates in the first trimester of pregnancy is contraindicated. In the last trimester of pregnancy, salicylates in a high dose (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 just before childbirth can cause intracranial hemorrhage, especially in premature babies. The use of salicylates in the last trimester of pregnancy is contraindicated. In the second trimester of pregnancy, salicylates can be used only with a strict assessment of the risk and benefit for the mother and the fetus, preferably in doses not exceeding 150 mg / day and for a short time.

Salicylates and their metabolites pass into breast milk in small amounts. Accidental intake of salicylates during lactation is not accompanied by the development of adverse reactions in the child and does not require termination of breastfeeding. However, with prolonged use of the drug or using it at a high dose, breastfeeding should be stopped immediately.

Application for violations of liver function

Contraindicated in severe hepatic impairment (class B and higher on the Child-Pugh scale).

The drug should be used with caution in liver failure (below class B on the Child-Pugh scale).

Application for impaired renal function

Contraindicated in severe renal failure (CC less than 30 ml / min).

The drug should be used with caution in renal failure (CC more than 30 ml / min).

Application in children

Contraindication: children and adolescents up to 18 years of age.

Use in elderly patients

Overdose is especially dangerous in elderly patients.

special instructions

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

ASA 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 (eg, skin reactions, itching, urticaria).

The inhibitory effect of ASA on platelet aggregation persists for several days after administration, in this regard, an increase in the risk of bleeding during surgery or in the postoperative period is possible. 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 ASA with anticoagulants, thrombolytics and antiplatelet drugs is accompanied by an increased risk of bleeding.

ASA in low doses can provoke the development of gout in susceptible individuals (with reduced excretion of uric acid).

The combination of ASA with methotrexate is accompanied by an increased incidence of side effects from the hematopoietic organs.

ASA in high doses has a hypoglycemic effect, which must be borne in mind when prescribing the drug to patients with diabetes mellitus receiving hypoglycemic agents for oral administration (sulfonylurea derivatives) and insulin.

With the combined appointment of GCS and salicylates, it should be remembered that during treatment, the level of salicylates in the blood is reduced, and after the abolition of GCS, an overdose of salicylates is possible.

The combination of ASA 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 ASA.

Exceeding the dose of ASA is associated with the risk of gastrointestinal bleeding.

Overdose is especially dangerous in elderly patients.

When ASA is combined with ethanol (drinks containing alcohol), the risk of damage to the gastrointestinal mucosa and lengthening of bleeding time is increased.

Influence on the ability to drive vehicles and use mechanisms

During the period of treatment, care must be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions, because the use of Thrombo ACCЃ may cause dizziness.

Overdose

ѕередозировка препарата может иметь т¤желые последстви¤, прежде всего, у пациентов пожилого возраста и у детей. —индром салицилизма развиваетс¤ при приеме ацетилсалициловой кислоты в дозе более 100 мг/кг/сут на прот¤жении более 2 сут вследствие употреблени¤ токсических доз препарата в рамках неправильного терапевтического применени¤ (хроническое отравление) или однократного случайного или намеренного приема токсической дозы препарата взрослым или ребенком (острое отравление).

ѕередозировка легкой и средней степени т¤жести (однократна¤ доза менее 150 мг/кг)

—имптомы: головокружение, шум в ушах, снижение слуха, повышенное потоотделение, тошнота и рвота, головна¤ боль, спутанность сознани¤, тахипноэ, гипервентил¤ци¤, респираторный алкалоз.

Ћечение: желудочный лаваж, многократный прием активированного угл¤, форсированный щелочной диурез, восстановление водно-электролитного баланса и кислотно-щелочного состо¤ни¤.

ѕередозировка средней и т¤желой степени т¤жести (однократна¤ доза 150-300 мг/кг - средн¤¤ степень т¤жести, более 300 мг/кг - т¤жела¤ степень отравлени¤)

—имптомы: со стороны дыхательной системы - респираторный алкалоз с компенсаторным метаболическим ацидозом, гиперпирекси¤, гипервентил¤ци¤, некардиогенный отек легких, угнетение дыхани¤, асфикси¤; со стороны сердечно-сосудистой системы - нарушени¤ ритма сердца, выраженное снижение ј?, угнетение сердечной де¤тельности; со стороны водно-электролитного баланса - дегидратаци¤, нарушение функции почек от олигурии вплоть до развити¤ почечной недостаточности, характеризующеес¤ гипокалиемией, гипернатриемией, гипонатриемией; нарушение метаболизма глюкозы - гипергликеми¤, гипогликеми¤ (особенно у детей), кетоацидоз; со стороны органа слуха - шум в ушах, глухота; со стороны пищеварительной системы - желудочно-кишечные кровотечени¤; гематологические нарушени¤ - от ингибировани¤ агрегации тромбоцитов до коагулопатии, удлинение протромбинового времени, гипопротромбинеми¤; неврологические нарушени¤ - токсическа¤ энцефалопати¤ и угнетение функции ?Ќ— (сонливость, спутанность сознани¤, кома, судороги).

Ћечение: немедленна¤ госпитализаци¤ в специализированные отделени¤ дл¤ проведени¤ экстренной терапии - желудочный лаваж, многократный прием активированного угл¤, форсированный щелочной диурез, гемодиализ, восстановление водно-электролитного баланса и кислотно-щелочного состо¤ни¤, симптоматическа¤ терапи¤.

Ћекарственное взаимодействие

ѕри одновременном применении ацетилсалицилова¤ кислота усиливает действие следующих лекарственных средств (при необходимости одновременного применени¤ препарата “ромбо ј——Ѓ с перечисленными средствами следует рассмотреть вопрос о необходимости уменьшени¤ их дозы):

ћетотрексата - за счет снижени¤ почечного клиренса и вытеснени¤ его из св¤зи с белками.

ѕри одновременном применении с антикоагул¤нтами, тромболитическими и антиагрегантными средствами (тиклопидин, клопидогрел) отмечаетс¤ увеличение риска кровотечений в результате синергизма основных терапевтических эффектов примен¤емых средств.

ѕри одновременном применении с препаратами, обладающими антикоагул¤нтным, тромболитическим или антиагрегантным действием отмечаетс¤ усиление повреждающего действи¤ на слизистую оболочку ? “.

—елективных ингибиторов обратного захвата серотонина - возможно повышение риска кровотечени¤ из верхних отделов ? “ (синергизм с ацетилсалициловой кислотой).

?игоксина - вследствие снижени¤ его почечной экскреции, что может привести к передозировке.

vипогликемических средств дл¤ приема внутрь (производных сульфонилмочевины) и инсулина - за счет гипогликемических свойств самой ацетилсалициловой кислоты в высоких дозах и вытеснени¤ производных сульфонилмочевины из св¤зи с белками плазмы крови.

ѕри одновременном применении с вальпроевой кислотой увеличиваетс¤ ее токсичность за счет вытеснени¤ ее св¤зи с белками плазмы крови.

Ќѕ¬— и производных салициловой кислоты в высоких дозах - повышение риска ульцерогенного эффекта и кровотечени¤ из ? “ в результате синергизма действи¤. ѕри одновременном применении с ибупрофеном отмечаетс¤ антагонизм в отношении необратимого угнетени¤ тромбоцитов, обусловленного действием, что приводит к снижению кардиопротекторных эффектов ацетилсалициловой кислоты.

Ётанола - повышен риск повреждени¤ слизистой оболочки ? “ и удлинение времени кровотечени¤ в результате взаимного усилени¤ эффектов ацетилсалициловой кислоты и этанола.

ќдновременное применение ацетилсалициловой кислоты в высоких дозах может уменьшать действие перечисленных ниже лекарственных средств (при необходимости одновременного назначени¤ препарата “ромбо ј——Ѓ с перечисленными средствами следует рассмотреть вопрос о необходимости коррекции их дозы):

Ћюбых диуретиков - при совместном применении с ацетилсалициловой кислотой в высоких дозах отмечаетс¤ снижение скорости клубочковой фильтрации (— ‘) в результате снижени¤ синтеза простагландинов в почках.

»нгибиторов јѕ‘ - отмечаетс¤ дозозависимое снижение — ‘ в результате ингибировани¤ простагландинов, обладающих сосудорасшир¤ющим действием, соответственно, ослабление гипотензивного действи¤.  линическое снижение — ‘ отмечаетс¤ при суточной дозе ацетилсалициловой кислоты более 160 мг.  роме того, отмечаетс¤ снижение положительного кардиопротекторного действи¤ ингибиторов јѕ‘, назначенных пациентам дл¤ терапии хронической сердечной недостаточности. Ётот эффект также про¤вл¤етс¤ при применении совместно с ацетилсалициловой кислотой в высоких дозах.

ѕрепаратов с урикозурическим действием (бензбромарон, пробенецид) - снижение урикозурического эффекта вследствие конкурентного подавлени¤ почечной канальцевой экскреции мочевой кислоты.

With simultaneous use with systemic corticosteroids (with the exception of hydrocortisone, used for substitution therapy for Addison's disease), there is an increase in the excretion of salicylates and, accordingly, a weakening of their action.

Storage conditions

The drug should be stored out of the reach of children, in a dry, dark place at a temperature not exceeding 25 ? C.

Shelf life

Shelf life is 3 years. Do not use after the expiration date.

Terms of sale

The drug is dispensed without a prescription.