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Acetylsalicylic acid

Registration number: P N003627/01

Trade name: Acetylsalicylic acid.

MNI or group name: Acetylsalicylic acid.

Dosage form: Tablets.

Composition per tablet: Active substance:

Acetylsalicylic acid – 500 mg

Excipients:

Potato starch - 91 mg
Talc - 9 mg

Description: Tablets are white, slightly marbled, flat-cylindrical in shape with a chamfer and a score.

Pharmacotherapeutic group: Non-steroidal anti-inflammatory drug (NSAID).

ATX code: N02BA01

Pharmacological properties: The drug has an analgesic, antipyretic, and anti-inflammatory effect, which is due to the inhibition of cyclooxygenases involved in the synthesis of prostaglandins. Acetylsalicylic acid inhibits platelet aggregation by blocking the synthesis of thromboxane A2.

Pharmacokinetics: When taken orally, absorption is complete. During absorption, it undergoes presystemic elimination in the intestinal wall and in the liver (deacetylated). The absorbed part is quickly hydrolyzed by nonspecific plasma cholinesterases and albuminesterase, so the half-life is no more than 15-20 minutes. It circulates in the body (75 - 90% due to albumin) and is distributed in tissues in the form of salicylic acid anion. Time to reach maximum concentration is 2 hours. Serum concentration of salicylates is highly variable. Salicylates easily penetrate many tissues and body fluids, incl. into the cerebrospinal, peritoneal and synovial fluids. Penetration into the joint cavity accelerates in the presence of hyperemia and edema and slows down in the proliferative phase of inflammation. Salicylates are found in small quantities in nervous tissue, traces in bile, sweat, and feces. When acidosis occurs, most of the salicylic acid is converted into non-ionized acid, which penetrates well into tissues, incl. into the brain. It quickly passes through the placenta and is excreted in small quantities in breast milk. Metabolized primarily in the liver. Metabolites of acetylsalicylic and salicylic acids are the glycine conjugant of salicylic acid, gentisic acid and its glycine conjugant. It is excreted primarily by active secretion in the renal tubules in the form of salicylic acid (60%) and in the form of metabolites. The excretion of salicylic acid depends on the pH of the urine (with alkalinization of the urine, the ionization of salicylates increases, their reabsorption worsens and excretion increases significantly). The rate of elimination depends on the dose: when taking small doses, the half-life is 2-3 hours, with increasing doses it can increase to 15-30 hours.

Indications for use: Treatment of moderate or mild pain: headache (including withdrawal symptoms), toothache, sore throat, back and muscle pain, joint pain, menstrual pain. Increased body temperature during colds and other infectious and inflammatory diseases (in adults and children over 15 years of age).

Contraindications:

Hypersensitivity to acetylsalicylic acid and other NSAIDs or other components of the drug;
Erosive and ulcerative lesions of the gastrointestinal tract (GIT) (in the acute phase);
Gastrointestinal bleeding;
Hemorrhagic diathesis;
Concomitant use of methotrexate at a dose of 15 mg per week or more;
Complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid;
Bronchial asthma induced by taking salicylates and other NSAIDs;
Pregnancy (I and III trimester), breastfeeding period;
Children's age (up to 15 years - when used as an antipyretic). The drug is not prescribed to children under 15 years of age with acute respiratory diseases caused by viral infections due to the risk of developing Reye's syndrome (encephalopathy and acute fatty liver with acute development of liver failure).

With caution: With concomitant therapy with anticoagulants, gout, gastric ulcer and/or duodenal ulcer (history), including chronic or recurrent peptic ulcer, or episodes of gastrointestinal bleeding; with renal and/or liver failure, glucose-6-phosphate dehydrogenase deficiency; hyperuricemia, bronchial asthma, chronic obstructive pulmonary disease, hay fever, nasal polyposis, drug allergies, concomitant use of methotrexate at a dose of less than 15 mg/week, pregnancy (II trimester).

Use during pregnancy and lactation: During pregnancy, the use of the drug is contraindicated. If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Method of administration and dosage: Orally, adults and children over 12 years of age: single dose is 250-500 mg, maximum single dose is 1.0 g (2 tablets of 500 mg), maximum daily dose is 3.0 g (6 tablets of 500 mg). mg), a single dose, if necessary, can be taken 3-4 times a day with an interval of at least 4 hours. Children (as an analgesic) aged 6 to 12 years, with the exception of acute respiratory diseases caused by viral infections, due to the risk of developing Reye's syndrome (encephalopathy and acute fatty liver with acute development of liver failure), a single dose is 250 mg per dose, take up to 3 times a day.

Directions for use: The drug should be taken after meals 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 regimen allows you to avoid a sharp increase in temperature and reduce the intensity of pain. The duration of treatment (without consulting a doctor) should not exceed 7 days when prescribed as an analgesic and more than 3 days when prescribed as an antipyretic.

Side effects: From the gastrointestinal tract: Decreased appetite, abdominal pain, heartburn, nausea, vomiting, obvious (vomiting with blood, tarry stools) or hidden signs of gastrointestinal bleeding, which can lead to iron deficiency anemia, erosive - ulcerative lesions (including perforation) of the gastrointestinal tract, isolated cases of liver dysfunction (increased liver transaminases), diarrhea. From the central nervous system: Dizziness, tinnitus (usually signs of overdose); with long-term use - headache, blurred vision, decreased hearing acuity, aseptic meningitis. From the cardiovascular system: With long-term use - increased symptoms of chronic heart failure. From the hematopoietic system: Increased risk of bleeding, which is a consequence of the effect of acetylsalicylic acid on platelet aggregation, thrombocytopenia, anemia, leukopenia. From the excretory system: Impaired renal function; with long-term use - interstitial nephritis, prerenal azotemia with increased creatinine levels in the blood and hypercalcemia, papillary necrosis, acute renal failure, nephrotic syndrome, edema. Allergic reactions: Skin rash, anaphylactic reactions, bronchospasm, Quincke's edema. Reye's syndrome (encephalopathy and acute fatty liver with rapid development of liver failure). If such symptoms appear, it is recommended to stop taking the drug and immediately consult your doctor.

Overdose: Symptoms: Moderate overdose: Nausea, vomiting, tinnitus, hearing loss, headache, dizziness and confusion. These symptoms disappear when the dose is reduced or the drug is discontinued. Severe overdose: Fever, hyperventilation, ketoacidosis, respiratory alkalosis, metabolic acidosis, coma, cardiogenic shock, respiratory failure, severe hypoglycemia. In chronic overdose, the concentration determined in plasma does not correlate well with the severity of intoxication. The greatest risk of developing chronic intoxication is observed in elderly people when taking more than 100 mg/kg/day for several days. 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 concentration above 70 mg% indicates moderate or severe poisoning; above 100 mg% - extremely severe, prognostically unfavorable. For moderate to severe poisoning, hospitalization is required.

Treatment: Hospitalization, gastric lavage, activated charcoal, monitoring of acid-base balance, alkalinization of urine in order to obtain a urine pH between 7.5 - 8 (forced alkaline diuresis is considered achieved if the concentration of salicylate in the blood plasma is no more than 500 mg /l (3.6 mmol/l) in adults or 300 mg/l (2.2 mmol/l) in children), hemodialysis, replacement of fluid loss, symptomatic therapy. Caution should be exercised in elderly patients in whom intensive fluid infusion may lead to pulmonary edema. The use of acetazolamide for alkalinization of urine is not recommended (it may cause acidosis and enhance the toxic effect of salicylates). Hemodialysis is indicated when the concentration of salicylates is more than 100 - 130 mg%, in patients with chronic poisoning - 40 mg% and lower if indicated (refractory acidosis, progressive deterioration, severe damage to the central nervous system, pulmonary edema and renal failure). For pulmonary edema, artificial ventilation of the lungs with an oxygen-enriched mixture.

Interaction with other drugs: Concomitant use:

With methotrexate at a dose of 15 mg per week or more is a contraindication: the hemolytic cytotoxicity of methotrexate increases (renal clearance of methotrexate decreases and methotrexate is replaced by salicylates in connection with blood plasma proteins);
With anticoagulants, for example, heparin: the risk of bleeding increases due to impaired platelet function, damage to the mucous membrane of the gastrointestinal tract, displacement of anticoagulants (indirect) from connection with blood plasma proteins;
With other non-steroidal anti-inflammatory drugs: as a result of synergistic interaction, the risk of ulcers and bleeding from the stomach and duodenum increases;
With uricosuric drugs, for example, benzbromarone: reduces the uricosuric effect;
With digoxin: diogoxin concentration increases due to decreased renal excretion;
With hypoglycemic drugs: the hypoglycemic effect of hypoglycemic drugs increases due to the hypoglycemic effect of acetylsalicylic acid;
With drugs of the thrombolytic group: the fibrinolytic effect of the latter is enhanced and the risk of bleeding increases;
With glucocorticosteroids, excluding hydrocortisone, used as replacement therapy for Addison's disease: when using glucocorticosteroids, the concentration of salicelates in the blood decreases due to increased excretion of the latter;
With angiotensin-converting enzyme inhibitors: glomerular filtration is reduced due to inhibition of prostaglandin synthesis and, as a result, the antihypertensive effect is reduced;
With valproic acid: the toxicity of valproic acid increases;
With glucocorticosteroids, ethanol (alcoholic beverages) and ethanol-containing drugs: the risk of damaging the mucous membrane of the gastrointestinal tract increases, the risk of developing gastrointestinal bleeding increases;
Enhances the effects of narcotic analgesics, indirect anticoagulants and antiplatelet agents, sulfonamides (including co-trimoxazole - increases their activity and toxicity), triiodothyronine (increases the activity and increases the risk of side effects of the latter);
Reduces the effect of antihypertensive drugs, diuretics (spironolactone, furosemide);
Increases the concentration of barbiturates and lithium salts in plasma;
Antacids containing magnesium and/or aluminum slow down and impair the absorption of acetylsalicylic acid;
Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

Special instructions: Acetylsalicylic acid may cause bronchospasm, an attack of bronchial asthma or other hypersensitivity reactions. Risk factors are the presence of bronchial asthma, nasal polyps, fever, chronic bronchopulmonary diseases, and a history of allergies (allergic rhinitis, skin rashes). Acetylsalicylic acid may increase the tendency to bleeding, which is associated with its inhibitory effect on platelet aggregation. This should be taken into account when surgical interventions are necessary, including minor interventions such as tooth extraction. Before surgery, to reduce bleeding during surgery and in the postoperative period, you should stop taking the drug 5-7 days in advance and notify the doctor. Children should not be prescribed medications containing acetylsalicylic acid, since in the case of a viral infection the risk of Reye's syndrome increases. Symptoms of Reye's syndrome are prolonged vomiting, acute encephalopathy, and liver enlargement. Acetylsalicylic acid reduces the excretion of uric acid from the body, which can cause an acute attack of gout in predisposed patients. There was no effect of taking the drug on driving a vehicle and other mechanisms, which may affect the ability to drive vehicles, etc. Acetylsalicylic acid has a teratogenic effect; when used in the first trimester, it leads to the development of cleft 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. It is excreted in breast milk, which increases the risk of bleeding in the baby due to impaired platelet function. During the treatment period, you should refrain from taking ethanol.

Release form: Tablets 500 mg. 10 tablets per blister-free or blister pack. One or two blister packs along with instructions for use are placed in a box made of cardboard. Contour cellless packages, together with an equal number of instructions for use, are placed in a group package.

Storage conditions: Store in a dry place, protected from light, at a temperature not exceeding 25 °C. Keep out of the reach of children.

Shelf life: 4 years. Do not use the drug after the expiration date.

Conditions for dispensing from pharmacies: Without a prescription.