Acetylsalicylic acid, tablets 500 mg 20 pcs

Pharmgroup:

NSAIDs.

Pharmic action:

PNP; has anti-inflammatory, analgesic and antipyretic effects associated with indiscriminate inhibition of COX activity, and COX2, regulating the synthesis of PG. As a result, GHs are not formed, providing formation of edema and hyperalgesia. Decrease of GH content (mainly E1) in the thermoregulation center leads to decrease of body temperature due to dilation of skin vessels and increase of sweating.

The analgesic effect is due to both central and peripheral action.

Decreases aggregation, platelet adhesion and thrombosis by inhibiting the synthesis of thromboxane A2 in platelets. Antiplatelet effect lasts for 7 days after a single dose (more pronounced in men than in women).
Reduces mortality and risk of myocardial infarction in unstable angina.

Effective in primary prevention of cardiovascular diseases, especially myocardial infarction in men over 40 years, and in secondary prevention of myocardial infarction. At a daily dose of 6 g or more inhibits prothrombin synthesis in the liver and increases prothrombin time.

Increases plasma fibrinolytic activity and decreases the concentration of vitamin K-dependent clotting factors (II, VII, IX, X).
It increases the frequency of hemorrhagic complications during surgical interventions, increases the risk of bleeding during anticoagulant therapy.

Stimulates uric acid excretion (disrupts its reabsorption in the renal tubules), but in high doses. Blockade of COX, in the gastric mucosa leads to inhibition of gastroprotective Pg, which may cause mucosal ulceration and subsequent bleeding.

Less irritating effect on the mucous membrane of the gastrointestinal tract are the drug forms containing buffer substances, enteric coating, and special “effervescent” forms of pills.

Indications

Arthritis and arthritis, Myalgia (muscle pain), Migraine, Pain, Toothache, Headache, Menstrual pain (algodysmenorrhea), Muscle pain (myalgia), Back pain, Joint pain (arthralgia), Throat pain

Symptomatic treatment of pain syndrome: Headache (including withdrawal syndrome), toothache, sore throat, back and muscle pain, joint pain, menstrual pain.

Elevated body temperature in colds and other infectious and inflammatory diseases (in adults and children over 15 years).

Active ingredient

Acetylsalicylic acid

Composition

1 tablet contains:

the active ingredient:

• acetylsalicylic acid 500 mg.

excipients:

• potato starch,

• stearic acid,<

• citric acid,

• talc.

.

How to take, the dosage

Ingestion, adults and children over 12 years of age: a single dose is 0.25-0.5 g, maximum single dose is 1.0 g (2 0.5 g tablets), maximum daily dose is 3.0 g (6 0.5 g tablets) a single dose can be taken 3-4 times a day with an interval of at least 4 hours if necessary.

In children, except for acute respiratory diseases caused by viral infections due to the risk of Reye’s syndrome (encephalopathy and acute fatty liver dystrophy with acute development of liver failure): a single dose for children aged 3 years and more is 0.125 g (1/2 tablet 250 mg), starting from 6 years old 0.25 g tablets can be prescribed.

The drug should be taken after a meal with water, milk or alkaline mineral water.
Frequency and time of administration: if necessary a single dose may be taken 3-4 times a day with an interval of at least 4 hours. Regular adherence to the regimen of taking the drug allows to 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 analgesic and more than 3 days as an antipyretic.

Interaction

Co-administration:

• with methotrexate at a dose of 15 mg per week or more: increased hemolytic cytotoxicity of methotrexate (decreased renal clearance of methotrexate and methotrexate is replaced by salicylates in binding to plasma proteins);

• with anticoagulants such as heparin: increased risk of bleeding due to inhibition of platelet function, gastrointestinal mucosal damage, displacement of anticoagulants (oral) from binding to plasma proteins;

• with other nonsteroidal anti-inflammatory drugs: synergistic interaction, increases risk of gastric ulceration and bleeding;

• with uricosuric drugs, such as benzbromaron: decreases the uricosuric effect;

• with digoxin: Digoxin concentrations are increased due to decreased renal excretion;

• with hypoglycemic drugs such as insulin: hypoglycemic effects of hypoglycemic drugs are increased due to the hypoglycemic effects of acetylsalicylic acid;

• with drugs in the thrombolytic group: risk of bleeding increases;

• with systemic glucocorticosteroids, excluding hydrocortisone used as replacement therapy for Addison’s disease: glucocorticosteroids decrease blood levels of salicylates by increasing excretion of the latter;

• with angiotensin-converting enzyme inhibitors: decreases glomerular filtration by inhibiting prostaglandins and, consequently, decreases the antihypertensive effect;

• with valproic acid: increased toxicity of valproic acid;

• with ethanol (alcoholic beverages): Increases the risk of damaging effects on gastrointestinal mucosa and increases the risk of GI bleeding;

• Increases the effects of narcotic analgesics, thrombolytics and platelet aggregation inhibitors, sulfonamides (including co-trimoxazole);

• increases plasma concentrations of barbiturates, lithium salts;

• antacids containing magnesium and/or aluminum slow down and impair absorption of acetylsalicylic acid;

• myelotoxic drugs increase the hematotoxicity of the drug.

.

Special Instructions

Acetylsalicylic acid may cause bronchospasm, an attack of bronchial asthma or other hypersensitivity reactions. Risk factors include the presence of bronchial asthma, nasal polyps, fever, chronic bronchopulmonary disease, 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 considered when surgical interventions are necessary, including minor interventions such as tooth extraction.

Before a surgical procedure, in order to reduce bleeding during surgery and in the postoperative period, the drug administration should be stopped 5-7 days in advance and the physician should be informed.

In children, medications containing acetylsalicylic acid should not be prescribed because the risk of Reye’s syndrome increases if there is a viral infection. Symptoms of Reye’s syndrome include prolonged vomiting, acute encephalopathy, and enlarged liver.

Breastfeeding should be discontinued if the drug has to be used during lactation.

In the treatment of vascular disease, the daily dose of acetylsalicylic acid is 75 to 300 mg.

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

There is no effect of taking the drug on driving and other mechanisms.

Contraindications

• High sensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs or other drug components;
• Errotic ulcers of the gastrointestinal tract (acute phase), gastrointestinal bleeding;
• bronchial asthma induced by taking salicylates and nonsteroidal anti-inflammatory drugs;
hemorrhagic diathesis;

– concomitant use of methotrexate at a dose of 15 mg or more per week;

– Pregnancy, breastfeeding;

• combination of bronchial asthma, recurrent polyposis of the nose and sinuses, and intolerance to acetylsalicylic acid;
• children under 12 years (for this dosage form)

.

The drug is not indicated in children under 15 years of age with acute respiratory illnesses caused by viral infections due to the risk of Reye’s syndrome (encephalopathy and acute fatty liver dystrophy with acute development of liver failure).

With caution

. In concomitant therapy with anticoagulants, gout, gastric and/or duodenal ulcer (history), including chronic or recurrent peptic ulcer disease, or episodes of gastrointestinal bleeding; renal and/or hepatic insufficiency, glucose-6-phosphate dehydrogenase deficiency; hyperuricemia, bronchial asthma, chronic obstructive pulmonary disease, hay fever, nasal polyposis, drug allergy, concomitant administration of methotrexate at a dose less than 15 mg/week, pregnancy.

Side effects

• Gastrointestinal tract: abdominal pain, heartburn, nausea, vomiting, overt (vomiting with blood, tarry stools) or latent signs of gastrointestinal bleeding, which may lead to iron deficiency anemia, gastrointestinal erosive and ulcerative lesions (including with perforation), single cases – liver function disorders (increased liver transaminases).

• Central nervous system: dizziness, tinnitus (usually a sign of overdose).

• Hematopoietic system: increased risk of bleeding due to the effect of acetylsalicylic acid on platelet aggregation.

• Allergic reactions: skin rash, anaphylactic reactions, bronchospasm, Quincke’s edema.

If these symptoms occur, it is recommended that you stop taking the drug and see your physician immediately.

Overdose

Symptoms: Moderate overdose: nausea, vomiting, tinnitus, hearing loss, headache, dizziness and confusion. These symptoms go away when the dose of the drug is reduced.

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

Treatment: Hospitalization, gastric lavage, administration of activated charcoal, monitoring of acid-base balance, alkaline diuresis to obtain urine pH between 7.5-8 (forced alkaline diuresis is considered achieved if plasma salicylate concentration 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.

Similarities

Trombo ACC, Aspirin Cardio, Acetylsalicylic Acid, Upsarin Upsa, CardiASC, Trombopol, Aspirin Express