Trombopol pills 75 mg 30 pcs
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Active ingredients
Acetylsalicylic acid
Release form
Pills
Composition
1 tab. acetylsalicylic acid 75 mg. Excipients: corn starch, microcrystalline cellulose, sodium carboxymethyl starch.
Pharmacological effect
NSAID antiagregant. The basis of the mechanism of action of acetylsalicylic acid is irreversible inhibition of COX-1, as a result of which blockade of the synthesis of thromboxane A2 occurs and the suppression of platelet aggregation. Antiplatelet effect develops even after the use of the drug in small doses and persists for 7 days after a single dose. Due to these properties, acetylsalicylic acid is used for the prevention and treatment of myocardial infarction, coronary artery disease, complications of varicose veins. Acetylsalicylic acid also has anti-inflammatory, analgesic, antipyretic effects. Trombopol pills have an enteric coating, due to which the active substance dissolves and secrete in a more alkaline environment of the duodenum, reducing the irritant effect of acetylsalicylic acid on the gastric mucosa.
Pharmacokinetics
Absorption: The absorption of acetylsalicylic acid from enteric-coated pills begins after 3-4 hours from the moment of taking the drug, confirming that the shell effectively blocks the dissolution of the drug in the stomach. Cmax in plasma is reached in about 2-3 hours and averages 12.7 mcg / ml for pills 150 mg and 6.72 mcg / ml for pills 75 mg. The presence of food in the gastrointestinal tract slows down the absorption of the drug. The AUC is 56.42 mcg × h / ml for 75 mg pills and 108.08 mcg × h / ml for 150 mg pills. Distribution: Acetylsalicylic acid quickly and largely penetrates into most tissues and body fluids. The degree of drug binding to plasma proteins depends on the concentration; in healthy individuals decreases simultaneously with a decrease in this concentration. The relative distribution is about 0.15-0.2 l / kg and increases simultaneously with an increase in the concentration of the drug in blood serum. Unlike other salicylates, with repeated use of the drug, non-hydrolyzed acetylsalicylic acid does not accumulate in the blood serum.Metabolism: Acetylsalicylic acid is partially metabolized during absorption. This process occurs under the influence of enzymes, mainly in the liver, with the formation of such metabolites as phenyl salicylate, glucuronide salicylate and salicyuric acid, found in many tissues and urine. Withdrawal: T1 / 2 of acetylsalicylic acid from blood plasma is about 15-20 minutes. Only 1% of the ingested dose of acetylsalicylic acid is excreted by the kidneys as non-hydrolyzed acetylsalicylic acid, the rest is excreted as salicylates and their metabolites. In patients with normal kidney function, 80-100% of a single dose of the drug is excreted by the kidneys within 24-72 hours. Pharmacokinetics in special clinical situations: In renal failure, in pregnancy and in newborns, salicylates can displace bilirubin from albumin and promote the development of bilirubin encephalopathy . In women, the metabolic process is slower (lower serum enzyme activity).
Indications
- prevention of acute myocardial infarction in the presence of risk factors (for example, diabetes, hyperlipidemia, arterial hypertension, obesity, smoking, old age) and recurrent myocardial infarction - unstable stenocardia - prevention of stroke (including in patients with transient cerebral circulation) ) - prevention of transient cerebral circulatory disorders - prevention of thromboembolism after operations and invasive interventions on the vessels (for example, coronary artery bypass surgery, carotid endarterectomy and Theurillat, arteriovenous bypass grafting, angioplasty, carotid arteries) - prevention of deep vein thrombosis and pulmonary artery and its branches (including at prolonged immobilization resulting from extensive surgery).
Contraindications
- erosive and ulcerative lesions of the gastrointestinal tract in the acute phase - gastrointestinal bleeding - hemorrhagic diathesis - bronchial asthma induced by salicylate intake and NSAIDs - a combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance of the acetylalicus, anomalous arteries. a week or more - I and III trimesters of pregnancy - lactation period (breastfeeding) - age up to 18 years old - hypersensitivity to the components of the drug - hypersensitivity ity of the other NSAIDs.The drug should be used with caution in gout, hyperuricemia, gastric ulcer and duodenal ulcer or gastrointestinal bleeding (history), renal / hepatic failure, bronchial asthma, chronic respiratory diseases, hay fever, nasal polyposis, drug allergies, while taking methotrexate in a dose of less than 15 mg / week., concomitant therapy with anticoagulants, in the second trimester of pregnancy.
Use during pregnancy and lactation
The use of the drug Trombopol in the I and III trimesters of pregnancy and during lactation is contraindicated. The use of salicylates in the first trimester of pregnancy leads to the development of splitting of the upper palate, heart disease; in trimester III, it causes inhibition of labor, premature closure of the ductus arteriosus in the fetus, increased bleeding in the mother and fetus, and the administration immediately before birth can cause intracranial hemorrhages, especially in premature babies. In the second trimester of pregnancy, salicylates can be prescribed only after a rigorous assessment of the expected benefits of therapy for the mother and the potential risk to the fetus. Salicylates and their metabolites in small quantities are excreted 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, with prolonged use of the drug or the appointment of a high dose of breastfeeding should be stopped immediately.
Dosage and administration
The drug is intended for long-term use. The duration of therapy is determined by the doctor. Tablets are taken orally, regardless of the meal, not chewed, squeezed with a small amount of water. For the purpose of prevention in cases of suspected acute myocardial infarction, 75 mg / day or 150 mg / day is prescribed. For the purpose of prophylaxis for the first-time acute myocardial infarction in the presence of risk factors, 75 mg / day or 150 mg / day is prescribed. In order to prevent recurrent myocardial infarction, with unstable angina, to prevent stroke and transient cerebral circulation, prevent thromboembolic complications after surgery or invasive studies, 75 mg / day or 150 mg / day is prescribed.In order to prevent deep vein thrombosis and pulmonary thromboembolism, 75 mg / day or 150 mg / day is prescribed.
Side effects
On the part of the digestive system: nausea, heartburn, vomiting, pain in the abdomen, diarrhea, ulcers of the mucous membrane of the stomach and duodenum, incl. perforated, gastrointestinal bleeding, increased liver enzymes. On the part of the respiratory system: bronchospasm. From the side of the central nervous system: dizziness, tinnitus. On the part of the blood system: increased bleeding; rarely - anemia. Allergic reactions: urticaria, angioedema.
Overdose
Symptoms: The first symptoms are nausea, vomiting, tinnitus, and rapid breathing. Hearing loss, visual disturbances, headaches, motor agitation, drowsiness, convulsions, hyperthermia are also possible. When severe intoxication may develop disorders of acid-base and water-electrolyte balance (metabolic acidosis and dehydration). Mild to moderate intoxication symptoms develop after the use of acetylsalicylic acid in 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 acetylsalicylic acid is more than 500 mg / kg. Treatment: induce vomiting and flush the stomach (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 in an excessive dose - up to 10 hours. To reduce the absorption of acetylsalicylic acid, it is necessary to take activated carbon as an aqueous suspension (the dose for adults is 50-100 g children - 30-60 g); it is necessary to carefully observe the violation of water and electrolyte balance and to fill it. In order to accelerate the excretion of acetylsalicylic acid by the kidneys and in the treatment of acidosis, sodium bicarbonate must be in / in. It is necessary to maintain a pH in the range of 7.0-7.5. For very severe intoxication, hemodialysis or peritoneal dialysis is necessary. In connection with the possibility of developing respiratory acidosis, it is prohibited to take drugs that depress the central nervous system, for example, barbiturates. Patients with impaired breathing need to ensure airway and oxygen. If necessary, perform intratracheal intubation and provide for mechanical ventilation. The specific antidote is absent.
Interaction with other drugs
With simultaneous use of acetylsalicylic acid enhances the action of methotrexate by reducing renal clearance and pushing it out of communication with proteins; heparin and indirect anticoagulants due to dysfunction of platelets and the displacement of indirect anticoagulants from binding to 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 acetylsalicylic acid itself in high doses and forcing out sulfonylurea derivatives from their association with proteins; valproic acid due to the displacement of its connection with proteins; NSAIDs; sulfonamides (including co-trimoxazole); barbiturates; lithium salts. An additive effect is observed while taking acetylsalicylic acid with alcohol. Acetylsalicylic acid reduces the action of anti-arthritic drugs that increase the excretion of uric acid (probenecid, sulfinpyrazone, benzbromarone), due to competitive tubular elimination of uric acid; antihypertensive drugs, including ACE inhibitors; aldosterone antagonists (eg, spironolactone); "loop" diuretics (for example, furosemide). Enhancing the elimination of salicylates, GCS for systemic use weakens their action.
special instructions
Acetylsalicylic acid can provoke bronchospasm, as well as cause attacks of asthma and other hypersensitivity reactions. Risk factors are a history of bronchial asthma, hay fever, nasal polyposis, chronic diseases of the respiratory system, as well as allergic reactions to other drugs (eg, skin reactions, itching, urticaria). Acetylsalicylic acid can cause bleeding of varying severity during and after surgery. The drug should be stopped 5-7 days before the intended operation. The combination of acetylsalicylic acid with anticoagulants, thrombolytic drugs and platelet aggregation inhibitors is associated with an increased risk of bleeding. Acetylsalicylic acid in low doses can trigger the development of gout in predisposed individuals (with reduced excretion of uric acid). The combination of acetylsalicylic acid with methotrexate is accompanied by an increased incidence of side effects from the blood-forming organs.Acetylsalicylic acid in high doses has a hypoglycemic effect, which must be borne in mind when prescribing it to patients with diabetes mellitus receiving hypoglycemic agents. It should be borne in mind that the combined appointment of GCS and salicylates decreases the concentration of salicylates in the blood, and after the removal of the GCS overdose of salicylates is possible. The combination of Trombopol with ibuprofen is not recommended, since the latter reduces the effectiveness of acetylsalicylic acid. Excess doses of acetylsalicylic acid are associated with the risk of gastrointestinal bleeding. The combination of acetylsalicylic acid and ethanol increases the risk of damage to the gastrointestinal mucosa and lengthening the bleeding time. Overdose is especially dangerous in older people. Patients over the age of 65 due to the deterioration of renal function and the more frequent occurrence of adverse reactions from the digestive system should be prescribed in smaller doses. Impact on the ability to drive vehicles and control mechanisms Data on the negative effects of the drug Trombopol on the ability to drive vehicles or to work with mechanisms is not available.