Acetylsalicylic acid "York" - instructions for use, dose, side effects, contraindications

Round, biconvex tablets of white color, odorless or with a weak characteristic odor, with a solid edge or small roughness along the edge, with engraving "Aspirin ITA" on one side; the reverse side is smooth.

A slight coating on the inner walls of the vial is possible, which is formed as a result of rubbing of the tablets.

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

ATX: & nbsp

N.02.B.A Salicylic acid and its derivatives

Pharmacodynamics:Has anti-inflammatory, analgesic and antipyretic effects associated with the suppression of cyclooxygenases 1 and 2, regulating the synthesis of prostaglandins.Reduces aggregation, platelet adhesiveness and thrombus formation by suppressing the synthesis of thromboxane A₂ in thrombocytes. Antiaggregant effect persists for 7 days after a single dose (more pronounced in men than in women).

Pharmacokinetics:

At intake the absorption is complete. During absorption, it undergoes presystemic elimination in the intestinal wall and in the liver (deacetylated). The absorbed part is rapidly hydrolyzed by esterases, therefore T1 / 2 - no more than 15-20 minutes.

In the body it circulates (75-90% in association with albumin) and is distributed in tissues as an anion of salicylic acid.

TSmah -2 h. The serum salicylate level is very variable. Salicylates easily penetrate into many tissues and body fluids, including. into the cerebrospinal fluid (CSF). peritoneal and synovial fluid. Penetration into the joint cavity is accelerated in the presence of hyperemia and edema and slows down in the proliferative phase of inflammation. In small amounts, salicylates are found in the brain tissues, traces in bile, sweat, feces. When acidosis occurs, most of the acetylsalicylic acid is converted to non-ionized acid, good penetrating into tissues, incl. in the brain.Rapidly passes through the placenta, in small quantities is excreted in breast milk.

Metabolized acetylsalicylic acid mainly in the liver with the formation of 4 metabolites, found in many tissues and urine.

It is excreted mainly by active secretion in the renal tubules in unchanged form (60%) and in the form of metabolites. Excretion of unchanged salicylic acid depends on the pH of the urine (urine alkalinization increases the ionization of salicylates, their reabsorption deteriorates and the excretion increases significantly). The rate of excretion depends on the dose: when taking small doses of T1 / 2 2-3 hours, with an increase in the dose may increase to 15-30 hours.

Indications:

- Moderately or weakly expressed pain syndrome of various origin (headache, toothache, migraine, neuralgia, arthralgia, muscle pain, pain during menstruation).

- Elevated body temperature for colds and other infectious and inflammatory diseases.

Contraindications:

- Hypersensitivity to acetylsalicylic acid and other NSAIDs or other components of the drug;

- Erosive-ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation);

- Pronounced violations of the liver and kidneys;

- Hemorrhagic diathesis (hemophilia, von Willebrand's disease, telangiectasia, hypoprothrombinemia, thrombocytopenia, thrombocytopenic purpura);

- Combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid;

- Simultaneous reception of methotrexate in a dose of 15 mg per week or more;

- Pregnancy (I and III trimester), the period of breastfeeding;

- Children under 12 years (for this dosage form).

The drug is not prescribed as an antipyretic agent for children under 15 with acute respiratory infections caused by viral infections, because of the risk of developing Reye syndrome (encephalopathy and acute fatty liver disease with acute development of liver failure).

Carefully:

Gout, hyperuricemia, gastric ulcer and duodenal ulcer or gastrointestinal hemorrhage (history), renal / hepatic insufficiency, bronchial asthma, chronic obstructive pulmonary disease, hay fever, nasal polyposis, drug allergy, concomitant use of methotrexate in a dose less than 15 mg / week, pregnancy (II trimester).

Dosing and Administration:

Inside, adults and children over 12 years of age: a single dose of 0.325 g (1 tablet), the maximum single dose - 0.975 g (3 tablets), the maximum daily dose should not exceed 2,925 g (9 tablets). Intervals between doses of the drug should be at least 4 hours. To reduce the irritant effect on the gastrointestinal tract, the drug should be taken after meals, washed down with water, milk, alkaline mineral water.

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:

Allergic reactions: skin rash, bronchospasm, angioedema;

Formation on the basis of the hapten mechanism of the "aspirin triad" (a combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses, and intolerance to acetylsalicylic acid and pyrazolone preparations);

From the gastrointestinal tract: nausea, vomiting, epigastric pain, diarrhea;

From the side hematopoiesis systems: thrombocytopenia, anemia, leukopenia, hemorrhagic syndrome (epistaxis, bleeding gums), prolongation of clotting time;

With prolonged use in large doses, there may be erosive and ulcerative lesions of the gastrointestinal tract, bleeding, black "tarry" stool, general weakness, interstitial nephritis, prerenal azotemia with increased creatinine content in the blood and hyperkalemia, bronchospasm, papillary necrosis, acute renal failure , nephrotic syndrome, increased activity of "liver" transaminases, aseptic meningitis, increased symptoms of chronic heart failure, edema.

When such symptoms appear, it is recommended to stop taking the drug and immediately consult a doctor.

Overdose:

Overdose of moderate severity: nausea, vomiting, tinnitus, hearing impairment, headache, dizziness and confusion. These symptoms occur after the drug is discontinued.

Severe overdose: fever, hyperventilation, ketoacidosis, respiratory alkalosis, metabolic acidosis, coma, cardiogenic shock, respiratory failure, severe hypoglycemia.

Treatment: hospitalization, gastric lavage, reception of activated carbon, monitoring of acid-base balance,alkalinization of urine in order to obtain a urine pH of 7.5-8 (forced alkalinization of urine is considered achieved if the concentration of salicylic acid in the blood plasma is more than 500 mg / l (3.6 mmol / l) in adults or 300 mg / l ( 2.2 mmol / l) in children), hemodialysis, fluid loss compensation, symptomatic therapy.

Interaction:

Joint application:

- with methotrexate at a dose of 15 mg per week or more: the hemolytic cytotoxicity of methotrexate is increased (the renal clearance of methotrexate and methotrexate is replaced by salicylates in connection with blood plasma proteins), so the use of such doses of methotrexate together with acetylsalicylic acid is contraindicated;

- with indirect anticoagulants and heparin: increased risk of bleeding due to impaired platelet function, damage to the mucosa of the gastrointestinal tract, displacement of anticoagulants (indirect) from the 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 from the duodenum increases;

- with uricosuric medicines, for example, benzbromarone: reduces the uricosuric effect

- with digoxin: the concentration of digoxin is increased due to decreased renal excretion;

- enhances the effects of oral hypoglycemic drugs;

- with preparations of thrombolytics group: the risk of bleeding increases;

- with systemic glucocorticosteroids, excluding hydrocortisone, used as a substitute therapy for Addison's disease: when applying glucocorticosteroids reduces the concentration of salicylates in the blood by increasing the excretion of the latter;

- with inhibitors of angiotensin-converting enzyme: glomerular filtration is reduced by inhibiting the synthesis of prostaglandins and, as a consequence, the antihypertensive effect decreases;

- with valproic acid: increases the toxicity of valproic acid;

- strengthens the main clinical effects of narcotic analgesics, thrombolytic and antiaggregants, sulfonamides (including co-trimoxazole);

- increases the concentration of barbiturates, lithium salts in plasma;

- antacids containing magnesium and / or aluminum slow down and worsen the absorption of acetylsalicylic acid;

- myelotoxic drugs increase the manifestation of hematotoxicity of the drug;

- strengthens the main clinical effects of triiodothyronine; reduces the effect of antihypertensive drugs, diuretics (spironolactone, furosemide).

Glucocorticoid means, ethanol and ethanol-containing drugs increase the damaging effect of acetylsalicylic acid on the mucous membrane of the gastrointestinal tract, increase the risk of developing gastrointestinal bleeding.

Special instructions:

Acetylsalicylic acid can cause bronchospasm, an attack of bronchial asthma or other hypersensitivity reactions. Risk factors are the presence of bronchial asthma, polyps of the nose, fever, chronic bronchopulmonary diseases, cases of allergy in the anamnesis (allergic rhinitis, rashes on the skin). Acetylsalicylic acid can increase the tendency to bleeding, which is due to its inhibitory effect on platelet aggregation, this should be considered when surgical interventions are required, including such minor interventions as tooth extraction.Before surgery, to reduce bleeding during surgery and in the postoperative period, you should cancel taking the drug for 5-7 days and inform the doctor.

Children under 15 years as an antipyretic agent with acute respiratory infections caused by viral infections should not be prescribed drugs containing acetylsalicylic acid, because in the case of a viral infection, the risk of developing Reye syndrome increases. Symptoms of Reye's syndrome include prolonged vomiting, acute encephalopathy, and enlargement of the liver.

If you need to use the drug during lactation, breastfeeding should be discontinued.

Acetylsalicylic acid reduces the excretion of uric acid from the body, which can cause an acute attack of gout in predisposed patients.

During treatment should refrain from taking ethanol.

Effect on the ability to drive transp. cf. and fur:

There was no evidence of the effect of drug administration on vehicle management and other mechanisms.

Form release / dosage:Tablets 325 mg.

Packaging:At 20, 30, 50, 100, 120, 130 and 150 tablets in a plastic bottle with a neck tightened with a protective film of aluminum foil, sealed with a plastic lid with a safety valve. 1 bottle with instructions for use in a cardboard box. The instructions for use can be in the form of a separate sheet or in the form of a folding sheet placed under the movable part of the label, while a part of the label is attached to the bottle with a special adhesive tape that allows lifting the label.

Storage conditions:

In a dry place at a temperature of no higher than 30 ° C.

In a place inaccessible to children.

Shelf life:

3 years. The drug should not be used after the period indicated on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N015564 / 01

Date of registration:03.03.2009 / 03.12.2013

Expiration Date:Unlimited

The owner of the registration certificate:International Trade Association of America Inc.International Trade Association of America Inc. USA

Manufacturer: & nbsp

GEMINI PHARMACEUTICALS, Inc. USA

Representation: & nbspMEDEX-Consult Ltd.MEDEX-Consult Ltd.Russia

Information update date: & nbsp02.10.2017

Illustrated instructions

Instructions

Acetylsalicylic acid "York" (Acetylsalicylic acid "York")