Thrombopol tablets p / o 75mg, No. 30

• Prevention of acute myocardial infarction in the presence of risk factors (for example, diabetes mellitus, hyperlipidemia, arterial hypertension, obesity, smoking, old age) and repeated myocardial infarction;

• unstable angina;

• 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, carotid endarterectomy, arteriovenous bypass grafting, carotid angioplasty);

• prevention of deep vein thrombosis and thromboembolism of the pulmonary artery and its branches (including, with prolonged immobilization as a result of extensive surgical intervention).

The tablets should be taken with or without food, without chewing, with a small amount of water.

The drug is intended for long-term use. The duration of therapy is determined by the doctor.

Prophylaxis for suspected acute myocardial infarction:
75 mg or 150 mg per day.

Prevention of new-onset acute myocardial infarction in the presence of risk factors:
75 mg or 150 mg per day.

Prevention of recurrent myocardial infarction. Unstable angina. Prevention of stroke and transient cerebrovascular accident. Prevention of thromboembolic complications after surgery or invasive studies:
75 mg or 150 mg per day.

Prevention of deep vein thrombosis and thromboembolism of the pulmonary artery and its branches:
75 mg or 150 mg per day.

1 enteric coated tablet contains:
Active substance: acetylsalicylic acid 75 mg
Excipients: corn starch, microcrystalline cellulose, sodium carboxymethyl starch. Coating
: hypromellose, Acryl-Eyes (mixture for coating tablets): methacrylic acid copolymer type C, talc, titanium dioxide, triethyl citrate, crimson dye [Ponso 4R], colloidal silicon dioxide, sodium bicarbonate, sodium lauryl sulfate.

• Hypersensitivity to acetylsalicylic acid, drug excipients and other NSAIDs;

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

• combined use with metatrexate at a dose of 15 mg per week or more;

• pregnancy (I and III trimester) and lactation period;

• age up to 18 years.

With caution : with gout, hyperuricemia, gastric ulcer and 12 duodenal ulcer or gastrointestinal bleeding (in history), renal / hepatic failure, bronchial asthma, chronic respiratory diseases, hay fever, nasal polyposis, drug allergies, concomitant use methotrexate at a dose of less than 15 mg / week, concomitant anticoagulant therapy, pregnancy (II trimester).

Trade name of the drug:

THROMBOPOLЃ

International non-proprietary or group name:

acetylsalicylic acid

Dosage form:

enteric-coated tablets

Composition:

1 enteric-coated tablet contains:
Active ingredient: acetylsalicylic acid 75 mg or 150 mg.
Excipients: corn starch, microcrystalline cellulose, sodium carboxymethyl starch. Coating
: hypromellose, Acryl-Eyes (mixture for coating tablets): methacrylic acid copolymer type C, talc, titanium dioxide, triethyl citrate, crimson dye [Ponso 4R], colloidal silicon dioxide, sodium bicarbonate, sodium lauryl sulfate.

Description:

Enteric-coated tablets, pink, round, biconvex.

Pharmacotherapeutic group:

non-steroidal anti-inflammatory drug (NSAID)

ATX code : N02BA01

Pharmacological properties

Pharmacodynamics

The mechanism of the antiplatelet action of acetylsalicylic acid is based on the irreversible inhibition of cyclooxygenase (COX-1), as a result of which the synthesis of thromboxane A 2 is blocked and platelet aggregation is suppressed. The antiplatelet effect develops even after the use of small doses of the drug and lasts 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, complications of varicose veins.

Acetylsalicylic acid (ASA) also has anti-inflammatory, antipyretic and analgesic effects.

TROMBOPOLЃ tablets have an enteric coating, due to which they dissolve and release the active substance in the more alkaline environment of the duodenum, reducing the irritating effect of acetylsalicylic acid on the gastric mucosa.

Pharmacokinetic

The absorption of acetylsalicylic acid from enteric-coated tablets begins 3-4 hours after taking the drug, confirming that the shell effectively blocks the dissolution of the drug in the stomach.
The maximum plasma concentration is observed after about 2-3 hours and averages 12.7 ?g / ml for 150 mg tablets and 6.72 ?g / ml for 75 mg tablets.
The presence of food in the gastrointestinal tract slows down the absorption of the drug.
The systemic absorption rate (AUC) is 56.42 ?g x hour / ml for 75 mg tablets and 108.08 ?g x hour / ml for 150 mg tablets.

Distribution
Acetylsalicylic acid quickly and largely penetrates into most tissues and body fluids.
The relative distribution is about 0.15-0.2 l / kg and increases simultaneously with an increase in the concentration of the drug in the blood serum. The degree of connection of the drug with blood plasma proteins depends on the concentration; in healthy individuals, it decreases simultaneously with a decrease in this concentration.
In renal failure, during pregnancy and in newborns, salicylates can displace bilirubin from the association with albumin and contribute to the development of bilirubin encephalopathy.

Metabolism
Acetylsalicylic acid is partially metabolized during absorption. This process occurs under the influence of enzymes, mainly in the liver, with the formation of metabolites such as phenyl salicylate, glucuronide salicylate and salicyluric acid, found in many tissues and urine.
In women, the metabolic process is slower (less enzyme activity in the blood serum).

Withdrawal
The half-life (T1 / 2) of acetylsalicylic acid from blood plasma is about 15-20 minutes.
Unlike other salicylates, with repeated administration of the drug, non-hydrolyzed acetylsalicylic acid does not accumulate in the blood serum. Only 1% of the ingested dose of acetylsalicylic acid is excreted by the kidneys in the form of non-hydrolyzed acetylsalicylic acid, 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 for use

• Prevention of acute myocardial infarction in the presence of risk factors (for example, diabetes mellitus, hyperlipidemia, arterial hypertension, obesity, smoking, old age) and repeated myocardial infarction;

• unstable angina;

• 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, carotid endarterectomy, arteriovenous bypass grafting, carotid angioplasty);

• prevention of deep vein thrombosis and thromboembolism of the pulmonary artery and its branches (including, with prolonged immobilization as a result of extensive surgical intervention).

Contraindications

• Hypersensitivity to acetylsalicylic acid, drug excipients and other NSAIDs;

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

• combined use with metatrexate at a dose of 15 mg per week or more;

• pregnancy (I and III trimester) and lactation period;

• age up to 18 years.

With caution : with gout, hyperuricemia, gastric ulcer and 12 duodenal ulcer or gastrointestinal bleeding (in history), renal / hepatic failure, bronchial asthma, chronic respiratory diseases, hay fever, nasal polyposis, drug allergies, concomitant use methotrexate at a dose of less than 15 mg / week, concomitant anticoagulant therapy, pregnancy (II trimester).

Pregnancy use

The use of salicylates in the first trimester of pregnancy leads to the development of cleavage of the upper palate, heart defects; in the third trimester, it causes inhibition of labor, premature closure of the ductus arteriosus in the fetus, increased bleeding in the mother and fetus, and administration immediately before childbirth can cause intracranial hemorrhage, especially in premature babies - the use of salicylates in these trimesters is contraindicated.
In the second trimester of pregnancy, salicylates can be prescribed only with a rigorous assessment of the risks and benefits.

Application during breastfeeding

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 prescribing it in a high dose, breastfeeding should be stopped immediately.

Method of administration and dosage

The tablets should be taken with or without food, without chewing, with a small amount of water.

The drug is intended for long-term use. The duration of therapy is determined by the doctor.

Prophylaxis for suspected acute myocardial infarction:
75 mg or 150 mg per day.

Prevention of new-onset acute myocardial infarction in the presence of risk factors:
75 mg or 150 mg per day.

Prevention of recurrent myocardial infarction. Unstable angina. Prevention of stroke and transient cerebrovascular accident. Prevention of thromboembolic complications after surgery or invasive studies:
75 mg or 150 mg per day.

Prevention of deep vein thrombosis and thromboembolism of the pulmonary artery and its branches:
75 mg or 150 mg per day.

Side effect

Gastrointestinal tract: nausea, heartburn, vomiting, pain in the abdomen, diarrhea, ulcers of the mucous membrane of the stomach and duodenum, including perforated, gastrointestinal bleeding, increased activity of 'liver' enzymes.
Respiratory system: bronchospasm.
Central nervous system: dizziness, tinnitus.
Hematopoietic system: increased bleeding, anemia (rare).
Allergic reactions: urticaria, Quincke's edema.

Overdose

The first symptoms of an acetylsalicylic acid overdose are: nausea, vomiting, tinnitus, and rapid breathing.
Symptoms such as hearing loss, visual impairment, headaches, motor agitation, drowsiness, convulsions, hyperthermia can also be observed. With severe intoxication, a violation of the acid-base and water-electrolyte balance (metabolic acidosis and dehydration) may develop.
Symptoms of mild to moderate intoxication develop after the use of acetylsalicylic acid at a dose of 150-300 mg / kg. Symptoms of severe overdose develop at a dose of 300-500 mg / kg. The potentially lethal dose of ASA is more than 500 mg / kg.

Treatment : there is no specific antidote.
In case of an overdose of acetylsalicylic acid, you must:

• induce vomiting and gastric lavage (in order to reduce the absorption of the drug). Such actions give an effect within 3-4 hours after taking the drug, and in the case of taking a very large dose - up to 10 hours;

• to reduce the absorption of ASA, it is necessary to take activated carbon in the form of an aqueous suspension (dose for adults - 50-100 g, for children - 30-60 g);

• it is necessary to carefully monitor the violation of the water-electrolyte balance and replenish it;

• in order to accelerate the excretion of ASA through the kidneys and in the treatment of acidosis, sodium bicarbonate must be administered intravenously. It is necessary to maintain the pH in the range of 7.0 - 7.5;

• with very severe intoxication, it is necessary to carry out hemodialysis or peritoneal dialysis;

• due to the possibility of developing respiratory acidosis, it is forbidden to take drugs that depress the central nervous system, for example, barbiturates;

• Patients with respiratory impairment need to ensure airway patency and oxygen access. If necessary, perform intratracheal intubation and provide mechanical ventilation.

Interaction with other medicinal products

With the simultaneous use of ASA enhances the effect of the following drugs:

• methotrexate, by reducing renal clearance and displacing it from the connection with proteins;

• heparin and indirect anticoagulants, due to dysfunction of platelets and displacement of indirect anticoagulants from the connection with proteins;

• thrombolytic drugs and platelet aggregation inhibitors (ticlopidine);

• digoxin, due to a decrease in its renal excretion;

• hypoglycemic agents (insulin and sulfonylurea derivatives), due to the hypoglycemic properties of ASA itself in high doses and displacement of sulfonylurea derivatives from the connection with proteins;

• valproic acid, by displacing its association with proteins;

• NSAIDs;

• sulfonylmides (including co-trimoxazole);

• barbiturates;

• lithium compounds.

An additive effect is observed with the simultaneous administration of ASA with alcohol.

ASK weakens the action:

• anti-gout drugs that increase the excretion of uric acid (probenecid, sulfinpyrazone, benzbromarone), due to the competitive tubular elimination of uric acid;

• antihypertensive agents including angiotensin converting enzyme inhibitors;

• aldosterone antagonists (eg spironolactone);

• Loop diuretics (eg furosemide);

”силива¤ элиминацию салицилатов, системные глюкокортикостероиды ослабл¤ют их действие.

ќсобые указани¤

ј—  может провоцировать бронхоспазм, а также вызывать приступы бронхиальной астмы и другие реакции повышенной чувствительности. ‘акторами риска ¤вл¤ютс¤ наличие бронхиальной астмы в анамнезе, сенной лихорадки, полипоза носа, хронических заболеваний дыхательной системы, а также аллергических реакций на другие препараты (например, кожные реакции, зуд, крапивница).

ј—  может вызывать кровотечени¤ различной степени выраженности во врем¤ и после хирургических вмешательств. ѕрием препарата необходимо прекратить за 5-7 дней до предполагаемой операции.

—очетание ј—  с антикоагул¤нтами, тромболитическими препаратами и ингибиторами агрегации тромбоцитов сопровождаетс¤ повышенным риском развити¤ кровотечений. ј—  в низких дозах может спровоцировать развитие подагры у предрасположенных лиц (имеющих сниженную экскрецию мочевой кислоты).

—очетание ј—  с метотрексатом сопровождаетс¤ повышенной частотой развити¤ побочных эффектов со стороны органов кроветворени¤.

¬ысокие дозы ј—  оказывают гипогликемический эффект, что необходимо иметь в виду при назначении ее пациентам с сахарным диабетом, получающим гипогликемические средства.

ѕри сочетанном назначении глюкокортикостероидов (v —) и салицилатов следует помнить, что во врем¤ лечени¤ уровень салицилатов в крови снижен, а после отмены v — возможна передозировка салицилатов.

Ќе рекомендуетс¤ сочетание ј—  с ибупрофеном, поскольку он снижает эффективность препарата “–ќћЅќѕќЋЃ и, вследствие этого, может снижать продолжительность жизни.

ѕревышение дозы ј—  сопр¤жено с риском желудочно-кишечного кровотечени¤.

ѕри сочетании ј—  с этанолом повышен риск повреждени¤ слизистой оболочки желудочно-кишечного тракта и удлинени¤ времени кровотечени¤.

ѕередозировка особенно опасна у пожилых людей. ѕациенты старше 65 лет из-за пониженной работоспособности почек и более частого возникновени¤ побочных реакций со стороны желудочно-кишечного тракта должны принимать ј—  в меньших дозах.

¬ли¤ние на способности к концентрации внимани¤ и скорость психомоторных реакций

?анных об отрицательном воздействии на способности к управлению автомобилем или работу с механизмами нет.

‘орма выпуска

“аблетки, покрытые кишечнорастворимой оболочкой, 75 мг или 150 мг.

“аблетки 75 мг: по 10 или 25 таблеток в блистеры из ѕ¬’/јL-фольги. ѕо 2 блистера (25 таблеток) или 3,5,6 блистеров (10 таблеток) с инструкцией по медицинскому применению в картонную пачку.

“аблетки 150 мг: по 10 таблеток в блистер из ѕ¬’/јL-фольги. ѕо 3, 5 или 6 блистеров с инструкцией по медицинскому применению в картонную пачку.

”слови¤ хранени¤

¬ сухом, защищенном от света месте, при температуре не выше 25?—.
’ранить в недоступном дл¤ детей месте.

—рок годности

2 года.
Ќе использовать после истечени¤ срока годности, указанного на упаковке.

”слови¤ отпуска из аптек

Ѕез рецепта

ѕроизводитель

Pharmaceutical plant 'POLFARMA' JSC
st. Pelplinska 19.83-200
Starogard Gdansk, Poland

Organization accepting customer claims

JSC 'Chemical and pharmaceutical plant' AKRIKHIN
142450, Moscow region, Noginsky district, Old Kupavna, st. Kirov, 29