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INSTRUCTIONS

for medical use of the drug
ACETYLSALICYLIC
ACID
Composition:

active substance:

acetylsalicylic acid;

1 tablet contains acetylsalicylic acid 500 mg;

Excipients:

powdered cellulose, corn starch.

Dosage form.

Pills.

Basic physical and chemical properties:

single-layer tablets of round shape, with convex upper and lower surfaces, white or almost white. A relatively homogeneous structure can be seen on the fracture under a magnifying glass.

Pharmacotherapeutic group.

Analgesics and antipyretics. Acetylsalicylic acid. ATX code N02B A01.

Pharmacological properties.

Pharmacodynamics.

Acetylsalicylic acid belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs) with analgesic, antipyretic and anti-inflammatory properties. Its mechanism of action is the irreversible inactivation of cyclooxygenase enzymes, which play an important role in the synthesis of prostaglandins.

When taken orally in a dose of 0.3 g to 1 g, the drug is used to relieve pain and conditions accompanied by mild fever, such as colds and flu, to reduce fever and relieve pain in joints and muscles.

Acetylsalicylic acid is also used for acute and chronic inflammatory diseases such as rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.

Acetylsalicylic acid suppresses platelet aggregation by blocking the synthesis of thromboxane A2 and is used for many vascular diseases in doses of 75-300 mg per day.

Pharmacokinetics.

After oral administration, acetylsalicylic acid is quickly and completely absorbed from the gastrointestinal tract. During and after absorption, it is converted into the main active metabolite - salicylic acid. The maximum concentration of acetylsalicylic acid in the blood plasma is achieved after 10-20 minutes, salicylates - after 20-120 minutes, respectively.

Acetylsalicylic and salicylic acids are completely bound to blood plasma proteins and are quickly distributed in the body. Salicylic acid crosses the placenta and passes into breast milk.

Salicylic acid is metabolized in the liver. Metabolites of salicylic acid are salicylic acid, salicylphenol glucuronide, salicylacyl glucuronide, gentisic acid and gentisin uric acid.

The kinetics of salicylic acid elimination is dose dependent, since metabolism is limited by the activity of liver enzymes. The half-life depends on the dose and increases from 2-3 hours when using low doses to 15 hours when using high doses. Salicylic acid and its metabolites are excreted from the body primarily by the kidneys.

Clinical characteristics.

Indications.

For the symptomatic treatment of headache, toothache; sore throat caused by a cold; algodismenorrhea; pain in muscles and joints; back pain; moderate pain due to arthritis.

For colds or acute respiratory illnesses for symptomatic relief of pain and fever.

Contraindications.

Hypersensitivity to acetylsalicylic acid, other salicylates or any component of the drug.

Bronchial asthma caused by a history of taking salicylates or other NSAIDs.

Acute gastrointestinal ulcers.

Hemorrhagic diathesis.

Severe renal failure.

Severe liver failure.

Severe heart failure.

Combination with methotrexate at a dosage of 15 mg/week or more (see section “Interaction with other drugs and other types of interactions”).

III trimester of pregnancy.

Interaction with other drugs and other types of interactions.

Contraindications for interaction

The use of methotrexate in doses of 15 mg/week or more increases the hematological toxicity of methotrexate (reduction of renal clearance of methotrexate by anti-inflammatory agents and displacement of methotrexate by salicylates from binding to plasma proteins).

Combinations that should be used with caution.

When using methotrexate in doses less than 15 mg/week, the hematological toxicity of methotrexate increases (reduction of renal clearance of methotrexate by anti-inflammatory agents and displacement of methotrexate by salicylates from plasma proteins).

The simultaneous use of ibuprofen prevents the irreversible inhibition of platelets by acetylsalicylic acid. Treatment of patients at risk of cardiovascular disease with ibuprofen may limit the cardioprotective effect of acetylsalicylic acid.

With simultaneous use of the drug and anticoagulants, the risk of bleeding increases. With the simultaneous use of high doses of salicylates with NSAIDs (due to their mutually complementary effect), the risk of ulcers and gastrointestinal bleeding increases. Simultaneous use with uricosuric drugs, such as benzobromarone, probenecid, reduces the effect of uric acid excretion (due to competition with the excretion of uric acid by the renal tubules).

When used simultaneously with digoxin, the concentration of the latter in the blood plasma increases due to a decrease in renal excretion.

With the simultaneous use of high doses of acetylsalicylic acid and oral antidiabetic drugs from the group of sulfonylurea derivatives or insulin, the hypoglycemic effect of the latter is enhanced due to the hypoglycemic effect of acetylsalicylic acid and the displacement of sulfonylurea associated with blood plasma proteins.

Diuretics in combination with high doses of acetylsalicylic acid reduce glomerular filtration by reducing the synthesis of prostaglandins in the kidneys.

Systemic glucocorticosteroids (excluding hydrocortisone), which are used for replacement therapy for Addison's disease, reduce the level of salicylates in the blood during corticosteroid treatment and increase the risk of overdose after treatment. When used with corticosteroids, the risk of gastrointestinal bleeding increases. ACE inhibitors in combination with high doses of acetylsalicylic acid cause a decrease in glomerular filtration due to inhibition of vasodilatory prostaglandins and a decrease in the hypotensive effect.

Selective serotonin reuptake inhibitors: Increased risk of upper gastrointestinal bleeding due to the possibility of a synergistic effect.

When used simultaneously with valproic acid, acetylsalicylic acid displaces it from its connection with blood plasma proteins, increasing the toxicity of the latter.

Ethyl alcohol causes damage to the mucous membrane of the gastrointestinal tract and prolongs bleeding time due to the synergy of acetylsalicylic acid and alcohol.

Features of application.

Use the drug with caution when:

- hypersensitivity to analgesic, anti-inflammatory, antirheumatic drugs, as well as in the presence of allergies to other substances;

- a history of gastrointestinal ulcers, including chronic or recurrent peptic ulcer disease or a history of gastrointestinal bleeding;

- simultaneous use of anticoagulants;

- impaired renal function or circulatory disorders (for example, renal vascular disease, congestive heart failure, decreased circulating blood volume, major surgery, sepsis or significant blood loss), since acetylsalicylic acid may further increase the risk of kidney damage and cause acute renal failure;

- liver dysfunction.

In patients with allergic complications, including bronchial asthma, allergic rhinitis, urticaria, itching, swelling of the mucous membrane and nasal polyposis, as well as in their combination with chronic respiratory tract infections and in patients with hypersensitivity to NSAIDs during treatment with the drug, it is possible development of bronchospasm or attack of bronchial asthma.

During surgical interventions (including dental), the use of drugs containing acetylsalicylic acid may increase the likelihood of the appearance/intensification of bleeding due to inhibition of platelet aggregation for some time after the use of acetylsalicylic acid.

When using small doses of acetylsalicylic acid, the excretion of uric acid may be reduced. This may lead to a gout attack in patients who have decreased uric acid excretion.

In patients with glucose-6-phosphate dehydrogenase deficiency, acetylsalicylic acid can cause hemolysis or hemolytic anemia. Factors that increase the risk of hemolysis are, for example, the use of high doses, fever or acute infections.

Use during pregnancy or breastfeeding.

The drug can be used during pregnancy only if other drugs are ineffective. Salicylates can be used during pregnancy only after assessing the risk/benefit ratio.

During the first and second trimesters of pregnancy, drugs containing acetylsalicylic acid should not be prescribed unless absolutely necessary. If drugs containing acetylsalicylic acid are used by women who are planning a pregnancy, as well as during the first and second trimesters of pregnancy, their doses should be as low and the course of treatment as short as possible. The use of salicylates in the first trimester of pregnancy in some retrospective epidemiological studies was associated with an increased risk of developing birth defects (palatoschisis (“cleft palate”), heart defects, gastroschisis). However, with long-term use of the drug in therapeutic doses exceeding 150 mg / day, this risk turned out to be low: as a result of a study conducted in 32,000 mother-child pairs, no connection was found between taking the drug and an increased risk of birth defects.

According to preliminary estimates, with long-term use of the drug it is not recommended to take acetylsalicylic acid in a dose exceeding 150 mg/day.

In the third trimester of pregnancy, taking salicylates in high doses (more than 300 mg/day) can cause post-term pregnancy and weakening of contractions during childbirth, as well as lead to cardiopulmonary toxicity (premature closure of the ductus arteriosus and the development of pulmonary hypertension) or impaired renal function in the fetus, which can progress to kidney failure with a decrease in the amount of amniotic fluid.

Prostaglandin synthesis inhibitors used late in pregnancy may cause increased maternal and fetal bleeding time and an antiplatelet effect that may occur even at very low doses.

The use of acetylsalicylic acid in large doses shortly before birth can lead to intracranial bleeding, especially in premature infants.

Thus, except in extremely special cases due to cardiac or obstetric medical indications using special monitoring, the use of acetylsalicylic acid during the third trimester of pregnancy is contraindicated.

Salicylates and their metabolites pass into breast milk in small quantities.

Since no adverse reactions have been observed in infants after accidental use of the drug, it is usually not necessary to interrupt breastfeeding. With long-term use of the drug or use of acetylsalicylic acid in high doses, the issue of stopping breastfeeding should be decided.

The ability to influence the reaction rate when driving vehicles or other mechanisms.

There was no effect on the ability to drive a car or use other machinery.

Method of administration and dose.

Take the drug orally after meals with a sufficient amount of liquid.

The drug should not be used for longer than 3-5 days without consulting a doctor.

Adults
and children over 15 years old
.

500-1000 mg once. Repeated use is possible after 4-8 hours. The maximum daily dose should not exceed 4 g.

Warning.

For patients with concomitant impairment 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 in children over 15 years of age. Do not use drugs containing acetylsalicylic acid in children with acute respiratory viral infection (ARVI), which is accompanied or not accompanied by an increase in body temperature. Some viral illnesses, especially influenza A, influenza B and chickenpox, are at risk of developing Reye's syndrome, which is a very rare but life-threatening illness that requires urgent medical attention. The risk may be increased if acetylsalicylic acid is used as a concomitant drug, but a cause-and-effect relationship has not been proven in this case. If these conditions are accompanied by prolonged vomiting, this may be a sign of Reye's syndrome.

Overdose.

An overdose of salicylates is possible due to chronic intoxication resulting from long-term therapy (use of more than 100 mg/kg/day for more than 2 days can cause toxic effects), as well as due to acute intoxication, which is life-threatening (overdose), and the causes of which may be , such as accidental use by children or accidental overdose.

Chronic poisoning with salicylates can be hidden, since its symptoms are nonspecific. Moderate chronic intoxication caused by salicylates, or salicylicism, occurs, as a rule, only after repeated doses of large doses.

Symptoms

. Impaired balance, dizziness, ringing in the ears, deafness, increased sweating, nausea and vomiting, headache, confusion. These symptoms can be controlled by reducing the dose. Tinnitus can occur when the concentration of salicylates in the blood plasma is more than 150-300 mcg/ml. More serious adverse reactions occur when plasma concentrations of salicylates exceed 300 mcg/ml. An increase in respiratory rate, hyperventilation, and respiratory alkalosis may also be observed. In case of moderate to severe intoxication, the development of respiratory alkalosis with compensatory metabolic acidosis, hyperpyrexia, non-cardiogenic pulmonary edema to respiratory arrest, asphyxia is possible; arrhythmia, arterial hypotension until cardiac arrest;

dehydration, oliguria to renal failure, glucose metabolism disorders, ketosis; gastrointestinal bleeding; hematological changes - from platelet inhibition to coagulopathies; from the nervous system - toxic encephalopathy and depression of the central nervous system, manifested in the form of drowsiness, depression of consciousness up to the development of coma and convulsions.

Acute intoxication is indicated by a pronounced change in the acid-base balance, which may differ depending on the age and severity of intoxication. The most common indicator for children is metabolic acidosis. The severity of the condition cannot be determined solely on the basis of the concentration of salicylates in the blood plasma. Absorption of acetylsalicylic acid may be slowed due to delayed gastric emptying, the formation of gastric stones, or when the drug is taken in the form of enteric-coated tablets.

Treatment.

Treatment of intoxication caused by an overdose of acetylsalicylic acid is determined by the severity, clinical symptoms and is provided by standard methods that are used for poisoning. All measures taken should be aimed at accelerating the removal of the drug and restoring the electrolyte and acid-base balance. Activated carbon and forced alkaline diuresis are used. Depending on the state of acid-base balance and electrolyte balance, infusion of electrolyte solutions is carried out. In case of serious poisoning, hemodialysis is indicated.

Adverse reactions.

Gastrointestinal disorders

. Dyspepsia, epigastric pain and abdominal pain; in some cases - inflammation of the gastrointestinal tract, erosive and ulcerative lesions of the gastrointestinal tract, which can rarely cause gastrointestinal bleeding and perforation with corresponding laboratory and clinical manifestations. Rarely - transient liver failure with increased levels of liver transaminases.

Blood system.

Due to its antiplatelet effect on platelets, acetylsalicylic acid may increase the risk of bleeding. Bleedings such as intraoperative hemorrhages, hematomas, bleeding from the genitourinary system, nosebleeds, and bleeding from the gums were observed; rarely or very rarely - serious bleeding, such as gastrointestinal bleeding and cerebral hemorrhage (especially in patients with uncontrolled hypertension and/or concomitant use of antihemostatic agents), which in isolated cases could potentially be life-threatening.

Bleeding can lead to acute and chronic posthemorrhagic anemia/iron deficiency anemia (due to the so-called hidden microbleeding) with corresponding laboratory manifestations and clinical symptoms such as asthenia, pale skin, hypoperfusion.

Hemolysis and the development of hemolytic anemia have been reported in patients with severe glucose-6-phosphate dehydrogenase deficiency.

Allergic reactions.

Patients with individual hypersensitivity to salicylates may develop allergic reactions, including symptoms such as rash, urticaria, swelling, itching, rhinitis, nasal congestion.

In patients with bronchial asthma, the incidence of bronchospasm may increase; mild to moderate allergic reactions that potentially affect the skin, respiratory system, gastrointestinal tract and cardiovascular system. Severe reactions, including anaphylactic shock and non-cardiogenic pulmonary edema, have been observed very rarely.

Nervous system.

Dizziness and ringing in the ears have been observed, which may indicate an overdose.

Genitourinary system

. Kidney damage and acute renal failure have been reported.

Best before date.

3 years.

Storage conditions.

Store in original packaging at a temperature not exceeding 30 °C. Keep out of the reach of children.

Package.

10 tablets in blisters;

10 tablets in a blister; 1 blister in a pack.

Vacation category.

Over the counter.

Manufacturer.

PJSC "Technologist"

The location of the manufacturer and its address of place of business.

Ukraine, 20300, Cherkasy region, Uman city, Staraya Proriznaya street, building 8

Date of last revision.

General information about the drug

Absolutely all medications, including acetylsalicylic acid in the prescription, are in Latin. This language is the main one in medicine. By the Latin name, a medical specialist immediately determines what kind of substance it is. Acidum acetylsalicylicum is a salicylic ester, a derivative of acetic acid.

The substance is obtained in the form of a light crystalline powder, having a slightly acidic taste and odorless. Easily soluble in hot water, alcohol and alkali solutions. It is used as an analgesic, anti-inflammatory and antipyretic agent.

Side effects

Acetylsalicylic acid (in Latin, Acidum acetylsalicylicum) is not prescribed to patients with intolerance to the substance. The drug may cause unwanted effects.

Cardiovascular system and blood: thrombocytopenia, anemia.
Digestive system: nausea and vomiting, intestinal dispersion, heartburn, loss of appetite.
Allergic manifestations: laryngeal edema, eosinophilic rhinitis, sinusitis, bronchospasm, “aspirin” triad.

There is also a risk of developing dysfunction of the liver and kidneys.

With prolonged use, the following symptoms may occur:

Headache.
Decreased visual and hearing acuity.
Capillary necrosis.
Generalized edema.
Symptoms of heart failure.
Increased concentration of creatine and aminotransferases in the blood.

Application of the substance

Previously, pharmacies issued acetylsalicylic acid with a prescription in Latin. It was believed that if prescribed independently (not by a doctor), the patient could harm himself. Today the drug is sold freely and is used in the following cases:

Myocardial ischemia without pain.
Reducing the likelihood of recurrent myocardial infarction.
Therapy and prevention of thromboembolism.
Reducing the risk of relapse of diseases characterized by narrowing of tubular vessels and anatomical openings of organs.
Coronary artery dissection.
Arthritis, arthralgia.
Increased temperature in inflammatory diseases of infectious etiology.
Mild headache, toothache, as well as myalgia, neuralgia, algodismenorrhea.

A little history

Acetylsalicylic acid in Latin is Acidum acetylsalicylicum. Many people are interested in why this particular language is used in medicine? Because it is considered the international language of science. All the first scientific works, including medical ones, take their roots from Ancient Rome or Greece. But Rome was an empire and conqueror of most European countries, including Greece, which contributed to the popularization of the Latin language.

The first mentions of the substance appear on clay tablets of Ancient Mesopotamia and the ancient Egyptian medical treatise, the Ebers papyrus. Hippocrates noted that tea made from plants rich in salicylate helps reduce fevers. Most often, decoctions were made from willow bark, which is translated from Latin as salix, hence the name.

Salicylic acid was isolated in a stable form much later. In 1838, Italian-born chemist Rafael Piria isolated a substance suitable for purification from white willow bark. The acid was synthesized in 1859 by the French scientist Charles Frederic Gerre.

The German pharmaceutical company Bayer AG first produced acetylsalicylic acid in a form suitable for medical use in 1897. To obtain a pure, stable form, F. Hoffman, a member of the company's laboratory, used the method of introducing an acyl into the compound (acylation). He also discovered the medicinal properties of the substance while trying to find a cure for rheumatism.