Storage:
active substance: acetylsalicylic acid;
1 tablet contains acetylsalicylic acid 500 mg;
excipients: citric acid monohydrate, potato starch.
Medicinal form. Tablets.
The main physical and chemical properties: tablets are white in color, round in shape, with a biconvex surface, with a chamfer.
Pharmacotherapeutic group. Analgesics and antipyretics.
Acetylsalicylic acid. ATX code N02B A01.
Pharmacological properties.
Pharmacodynamics.
Acetylsalicylic acid is a nonsteroidal anti-inflammatory drug (NSAID), a derivative of salicylate. The main mechanism of action of acetylsalicylic acid is the inactivation of the enzyme COX (cyclooxygenase), as a result of which the production of inflammatory mediators: prostaglandins, prostacyclins and thromboxane decreases. A decrease in the synthesis of prostaglandins leads to a decrease in their effect on the centers of thermoregulation, which leads to a decrease in the temperature raised due to inflammation. Reduces the sensitizing effect of prostaglandins on pain-sensitive nerve endings, which reduces their sensitivity to pain mediators. Irreversible inhibition of the synthesis of thromboxane A2 in platelets causes the antiplatelet effect of acetylsalicylic acid.
The pharmacodynamics of acetylsalicylic acid depends on the daily dose:
small doses – 30−325 mg – cause inhibition of platelet aggregation;
medium doses – 1.5-2 g – have an analgesic and antipyretic effect;
large doses – 4 g – have an anti-inflammatory effect.
In a dose of less than 4 g, acetylsalicylic acid delays the excretion of uric acid.
Pharmacokinetics.
When taken internally, it is almost completely absorbed from the gastrointestinal tract (GI). The time to reach the maximum concentration in blood plasma (Tmax) is 10-20 minutes. Tmax of total salicylate formed as a result of metabolism is 0.3-2 hours. The degree of binding to blood plasma proteins is 49-70%. 50% is metabolized during the first passage through the liver. Glycyl conjugate of salicylic acid is formed. It is excreted from the body by the kidneys in the form of metabolites. The elimination half-life (T1/2) is 20 minutes. T1/2 for salicylic acid is about 2 hours. Penetrates into breast milk, synovial fluid, cerebrospinal fluid.
Clinical characteristics.
Indication.
· Treatment of mild and moderately pronounced, acute pain syndrome (headache, toothache, joint and ligament pain, back pain).
· Symptomatic treatment of fever and/or pain syndrome in cold diseases.
Contraindication.
Hypersensitivity to acetylsalicylic acid, other salicylates or any auxiliary component of the medicinal product.
· Bronchial asthma caused by the use of salicylates or other NSAIDs in the anamnesis.
· Acute gastrointestinal ulcers.
· Hemorrhagic diathesis.
· Pronounced renal failure.
· Pronounced liver failure.
· Pronounced heart failure.
· Combined use with methotrexate in a dosage of 15 mg per week or more (see the section “Interaction with other medicinal products and other types of interactions”).
Method of application and dosage.
The medicine should be taken orally after a meal, drinking a sufficient amount of liquid. Do not use for longer than 3-5 days without consulting a doctor.
Adults and children over 15 years old.
500-1000 mg as a single dose. Re-application is possible after 4-8 hours. The maximum daily dose should not exceed 4 g.
Warning.
For patients with concomitant disorders of liver or kidney function, it is necessary to reduce the dose of the drug or increase the interval between applications.
Children.
The drug should be used by children over 15 years of age.
Expiry date. 4 years.
Storage conditions.
Store in the original packaging at a temperature not higher than 25 °C.
Keep out of the reach of children.
Packaging.
10 tablets each in a contoured blister pack; 1 to 2 or 5 contour envelopes in a pack; 10 tablets each in contour blister packs.
Leave category.
Without a prescription – packs No. 10, No. 20.
According to the recipe – pack No. 50.
Manufacturer. PJSC “Pharmaceutical firm “Darnytsia”.
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