Description
packaging 20 pcs
Pharmacological action of
NSAIDs. It has anti-inflammatory, analgesic and antipyretic effects, and also inhibits platelet aggregation. The mechanism of action is associated with the inhibition of COX activity – the main enzyme of the metabolism of arachidonic acid, which is a precursor of prostaglandins, which play a major role in the pathogenesis of inflammation, pain and fever. A decrease in the content of prostaglandins (mainly E1) in the center of thermoregulation leads to a decrease in body temperature due to the expansion of blood vessels of the skin and increased sweating. The analgesic effect is due to both central and peripheral action. Reduces aggregation, platelet adhesion and thrombosis by inhibiting the synthesis of thromboxane A2 in platelets.
Reduces mortality and the risk of developing myocardial infarction with unstable angina pectoris. It is effective in the primary prevention of diseases of the cardiovascular system and in the secondary prevention of myocardial infarction. In a daily dose of 6 g or more, it inhibits the synthesis of prothrombin in the liver and increases prothrombin time. Increases plasma fibrinolytic activity and reduces the concentration of vitamin K-dependent coagulation factors (II, VII, IX, X). Increases hemorrhagic complications during surgical interventions, increases the risk of bleeding during therapy with anticoagulants. It stimulates the excretion of uric acid (disrupts its reabsorption in the renal tubules), but in high doses. Blockade of COX-1 in the gastric mucosa leads to inhibition of gastroprotective prostaglandins, which can lead to ulceration of the mucous membrane and subsequent bleeding.
Indications
Rheumatism, rheumatoid arthritis, infectious and allergic myocarditis fever in infectious and inflammatory diseases of mild and moderate intensity pain of various origins (including neuralgia, myalgia, headache) prevention of thrombosis and secondary myocardial embolism prevention of cerebrovascular accidents according to the ischemic type.
In clinical immunology and allergology: in gradually increasing doses for prolonged aspirin desensitization and the formation of persistent tolerance to NSAIDs in patients with aspirin asthma and the aspirin triad.
Contraindications
Gastrointestinal erosive and ulcerative lesions in the acute phase, gastrointestinal bleeding, aspirin triad, history of hives, rhinitis caused by acetylsalicylic acid and other NSAIDs, hemophilia arrhythmias, diarrheaemia, hemorrhagia, hemorrhagia, hemorrhagia, hemorrhagia, hemorrhagia, hemorrhagia, hemorrhagia, hemorrhagia, hemorrhagia, hemorrhagia, hemorrhagia, hemorrhagia, hemorrhagia, hemorrhagia, hemorrhagia, hemorrhagia, hemorrhagia, hemorrhagia, hemorrhagia, hemorrhagia, hemorrhagia, hemorrhages, and hemorrhagia hypertension, vitamin K deficiency, liver and / or renal failure, glucose-6-phosphate dehydrogenase deficiency, Reye syndrome, childhood (up to 15 years – the risk of Reye syndrome in children with hyp dermis against viral diseases), I and III trimesters of pregnancy, lactation, hypersensitivity to acetylsalicylic acid and other salicylates.
Use during pregnancy and lactation
Acetylsalicylic acid is contraindicated for use in the first and third trimesters of pregnancy. In the II trimester of pregnancy, a single admission is possible according to strict indications.
It has a teratogenic effect: when used in the first trimester, it leads to the development of cleavage of the upper palate, in the third trimester it causes inhibition of labor (inhibition of prostaglandin synthesis), premature closure of the ductus arteriosus in the fetus, pulmonary vascular hyperplasia and hypertension in the pulmonary circulation.
Acetylsalicylic acid is excreted in breast milk, which increases the risk of bleeding in a child due to impaired platelet function, therefore, mother should not use acetylsalicylic acid during lactation.
Composition
1 tablet contains: active ingredient: acetylsalicylic acid 500 mg.
excipients: potato starch, stearic acid, citric acid, talc.
Dosage and administration
Inside, adults and children over 12 years of age: a single dose is 0.25-0.5 g, the maximum single dose is 1.0 g (2 tablets of 0.5 g), the maximum daily intake is 3 , 0 g (6 tablets of 0.5 g) a single dose, if necessary, can be taken 3-4 times a day with an interval of at least 4 hours. Children, with the exception of acute respiratory infections caused by viral infections, due to the risk of Reye syndrome (encephalopathy and acute fatty liver disease with acute development of liver failure): single dose for children over 3 years old – 0.125 g (1/2 tablet 250 mg), starting from the age of 6, it can be prescribed in tablets of 0.25 g per reception.
The drug should be taken after a meal, washed down with water, milk or alkaline mineral water.
Frequency and time of administration: a single dose, if necessary, can be taken 3-4 times a day with an interval of at least 4 hours. Regular adherence to the drug can avoid a sharp increase in temperature and reduce the intensity of the pain syndrome.
The duration of treatment (without consulting a doctor) should not exceed 7 days when prescribed as an anesthetic and more than 3 days as an antipyretic.
Side effects of the digestive system: nausea, vomiting, anorexia, epigastric pain, diarrhea rarely – the occurrence of erosive and ulcerative lesions, bleeding from the gastrointestinal tract, impaired liver function.
From the side of the central nervous system: with prolonged use, dizziness, headache, reversible visual impairment, tinnitus, aseptic meningitis are possible.
From the hemopoietic system: rarely – thrombocytopenia, anemia.
From the blood coagulation system: rarely – hemorrhagic syndrome, prolonged bleeding time.
From the urinary system: rarely – impaired renal function with prolonged use – acute renal failure, nephrotic syndrome.
Allergic reactions: rarely – skin rash, Quincke’s edema, bronchospasm, aspirin triad (a combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid and pyrazolone drugs).
Other: in some cases – Reye’s syndrome with prolonged use – increased symptoms of chronic heart failure.
Drug Interaction
With the use of antacids, containing magnesium and / or aluminum hydroxide, slow down and reduce the absorption of acetylsalicylic acid.
The simultaneous use of calcium channel blockers, agents that limit calcium intake or increase the excretion of calcium from the body, increases the risk of bleeding.
When used with acetylsalicylic acid, the effect of heparin and indirect anticoagulants, hypoglycemic agents, sulfonylureas, insulins, methotrexate, phenytoin, valproic acid is enhanced.
When used with ACS, the risk of ulcerogenic action and gastrointestinal bleeding is increased.
When used simultaneously, the effectiveness of diuretics (spironolactone, furosemide) is reduced.
When used with other NSAIDs, the risk of side effects is increased. Acetylsalicylic acid can reduce the plasma concentrations of indomethacin, piroxicam.
Acetylsalicylic acid may induce liver damage when used with gold preparations.
When used simultaneously, the effectiveness of uricosuric agents (including probenecid, sulfinpyrazone, benzbromarone) is reduced.
Severe oesophagitis may develop with acetylsalicylic acid and sodium alendronate.
Acetylsalicylic acid absorption may be impaired with the use of griseofulvin.
A case of spontaneous hemorrhage into the iris of a ginkgo biloba extract has been described on the background of prolonged use of acetylsalicylic acid at a dose of 325 mg / day. It is believed that this may be due to an additive inhibitory effect on platelet aggregation.
Increased plasma salicylate Cmax and AUC may occur with concomitant administration of dipyridamole.
Concentrations of digoxin, barbiturates and lithium salts in blood plasma are increased when co-administered with acetylsalicylic acid.
Toxicity with salicylates is possible with the use of salicylates at high doses with carbonic anhydrase inhibitors.
Acetylsalicylic acid at doses of less than 300 mg / day has little effect on the efficacy of captopril and enalapril. The use of acetylsalicylic acid in high doses may reduce the effectiveness of captopril and enalapril.
When used concurrently, caffeine increases the rate of absorption, plasma concentration and bioavailability of acetylsalicylic acid.
When used concomitantly with metoprolol, it can increase Salma Cmax in blood plasma.
With the use of pentazocine on the background of long-term administration of acetylsalicylic acid in high doses, there is a risk of severe adverse reactions from the kidneys.
When co-administered with phenylbutazone, it reduces the uricosuria caused by acetylsalicylic acid.
Ethanol may increase the effect of acetylsalicylic acid on the gastrointestinal tract when used simultaneously.
Overdose
Symptoms (single dose less than 150 mg / kg – acute poisoning is considered mild, 150-300 mg / kg – moderate, more than 300 mg / kg – severe): salicylic syndrome (nausea, vomiting, tinnitus, visual impairment) , dizziness, severe headache, general malaise, fever – poor prognostic sign in adults). Severe poisoning – hyperventilation of the lungs of central genesis, respiratory alkalosis, metabolic acidosis, confused consciousness, drowsiness, collapse, convulsions, anuria, bleeding. Initially, central hyperventilation of the lungs leads to respiratory alkalosis – shortness of breath, asphyxiation, cyanosis, cold sticky sweat with increased intoxication increases respiratory paralysis and the separation of oxidative phosphorylation causing respiratory acidosis.
In chronic overdose, plasma concentrations are poorly correlated with the severity of intoxication. The greatest risk of developing chronic intoxication is observed in elderly persons with intake for several days more than 100 mg / kg / day. In children and elderly patients, the initial signs of salicylicism are not always noticeable, so it is advisable to periodically determine the concentration of salicylates in the blood: a level above 70 mg% indicates moderate or severe poisoning above 100 mg% – extremely severe, prognostically unfavorable. At moderate poisoning, hospitalization for 24 hours is required. Treatment: provocation of vomiting, appointment of activated charcoal and laxatives, constant monitoring of CBS and electrolyte balance depending on the state of metabolism – introduction of sodium bicarbonate, sodium citrate or sodium lactate solution. Increasing the reserve alkalinity increases the elimination of ASA by alkaline urination. Urine alkalinity is indicated at salicylate levels above 40 mg% and is provided by / in infusion of sodium bicarbonate (88 mEq in 1 l of 5% dextrose solution, at a rate of 10-15 ml / h / kg). Recovery of BCC and induction of diuresis are achieved by introducing sodium bicarbonate into the same doses and dilution, which is repeated 2-3 times. Caution should be exercised in elderly patients whose intense fluid infusion may lead to pulmonary edema. Acetazolamide is not recommended for alkaline urination (may cause acidemia and enhance the toxic effect of salicylates). Hemodialysis is indicated with salicylate levels greater than 100-130 mg%, in patients with chronic poisoning – 40 mg% and below in the presence of indications (refractive acidosis, progressive deterioration, severe CNS lesion, pulmonary edema, and renal failure). In the case of pulmonary edema, IVL is a mixture enriched with oxygen.
Storage conditions
Store in a dry place, at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Expiration
4 years.
Deystvuyuschee substances
Atsetylsalytsylovaya Acid
Pharmacy outlets
over the counter
Dosage form
Dosage form
tablets
Pharmstandard-Leksredstva, Russia
