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ACETYL SALICYLIC ACID
Release form
Tablets
For children
From 15 years
For pregnant women
With caution
For nursing mothers
With caution
For drivers
Does not affect
Storage temperature
to 25 °C
INSTRUCTION
storage
active substance: acetylsalicylic acid; 1 tablet contains acetylsalicylic acid 500 mg (0.5 g); excipients: citric acid, monohydrate; stearic acid; potato starch.
Medicinal form
Tablets. Main physicochemical properties: white tablets with a flat surface, beveled edges and a line.
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. The mechanism of its action consists in the irreversible inactivation of cyclooxygenase enzymes, which play an important role in the synthesis of prostaglandins. When taken orally in doses of 0.3 g to 1 g, acetylsalicylic acid is used to relieve pain and conditions that are accompanied by fever, such as the common cold, to reduce fever and relieve joint and muscle pain. Acetylsalicylic acid inhibits the aggregation of platelets by blocking the synthesis of thromboxane A2. Pharmacokinetics. After oral administration, acetylsalicylic acid is quickly and completely absorbed from the gastrointestinal tract. During and after absorption, it turns into the main active metabolite - salicylic acid. The maximum concentration of acetylsalicylic acid in blood plasma is reached after 10-20 minutes, salicylates - 20-120 minutes. Acetylsalicylic and salicylic acids are completely bound to blood plasma proteins and are quickly distributed in the body. Salicylic acid penetrates through the placenta and is excreted in breast milk. Salicylic acid is metabolized in the liver. The metabolites of salicylic acid are salicyluric acid, salicylphenol glucuronide, salicylacyl glucuronide, gentisic acid and gentisuric acid. The kinetics of elimination of salicylic acid depends on the dose, since the 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 mainly by the kidneys.
Indication
Treatment of mild and moderately severe, acute pain syndrome (headache, toothache, joint and ligament pain, back pain). Symptomatic treatment of fever and/or pain syndrome in colds.
Contraindication
Hypersensitivity to acetylsalicylic acid, other salicylates or any component of the drug. 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. Combination with methotrexate at a dosage of 15 mg/week or more (see section "Interaction with other medicinal products and other types of interactions"). Special security measures. Acetylsalicylic acid should be used with caution in case of: - hypersensitivity to analgesic, anti-inflammatory, anti-rheumatic agents, as well as in the presence of allergies to other substances; - gastrointestinal ulcers in the anamnesis, including chronic or recurrent ulcer disease or gastrointestinal bleeding in the anamnesis; - simultaneous use of anticoagulants; - impaired kidney function or circulatory disorders (such as renal vascular disease, congestive heart failure, dehydration, massive surgery, sepsis or significant blood loss), as acetylsalicylic acid may further increase the risk of kidney damage and cause acute renal failure; - liver function disorders. In patients with allergic complications, including bronchial asthma, allergic rhinitis, urticaria, skin itching, edema of the mucous membrane and nasal polyps, as well as in their combination with chronic respiratory tract infections and in patients with hypersensitivity to NSAIDs and on the background treatment with acetylsalicylic acid may develop bronchospasm, an attack of bronchial asthma or other hypersensitivity reactions. Due to its effect of inhibiting platelet aggregation, which lasts up to several days after use, acetylsalicylic acid can increase the tendency to bleed during and after surgical operations (including minor operations, such as tooth extraction). When using small doses of acetylsalicylic acid, the excretion of uric acid may decrease. This can lead to a gout attack in patients with reduced 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. Long-term use of analgesics can lead to headaches. Frequent use of painkillers can cause temporary kidney failure with the risk of developing kidney failure (analgesic nephropathy). The risk is particularly high when several different analgesics are used at the same time.
Interaction with other medicinal products and other forms of interaction
Contraindicated combinations. The use of acetylsalicylic acid with methotrexate in doses of 15 mg/week and more increases the hematological toxicity of methotrexate (reduction of renal clearance of methotrexate by anti-inflammatory agents and displacement of methotrexate from the connection with blood plasma proteins by salicylates). Combinations to be used with caution. When using acetylsalicylic acid with 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 from the connection with blood plasma proteins by salicylates). Simultaneous use of ibuprofen interferes with the irreversible inhibition of platelets by acetylsalicylic acid. Ibuprofen treatment of patients at risk of cardiovascular disease may limit the cardioprotective effect of acetylsalicylic acid. Simultaneous use of acetylsalicylic acid with metamizole can reduce the clinically significant level of platelet aggregation. With the simultaneous use of high doses of salicylates with NSAIDs (due to the mutually reinforcing effect), the risk of ulcers and gastrointestinal bleeding increases. With the simultaneous use of acetylsalicylic acid and anticoagulants, the risk of bleeding increases. Simultaneous use with uricosuric agents, such as benzobromarone, probenecid, reduces the effect of uric acid removal (due to competition with the removal of uric acid by the renal tubules). With simultaneous use 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 of the group of sulfonylurea derivatives or insulin, the hypoglycemic effect of the latter increases due to the hypoglycemic effect of acetylsalicylic acid and the displacement of sulfonylurea bound to blood plasma proteins. Diuretics in combination with high doses of acetylsalicylic acid reduce glomerular filtration due to a reduction in the synthesis of prostaglandins in the kidneys. Systemic glucocorticosteroids (with the exception of hydrocortisone, which is used for replacement therapy in Addison's disease). When using acetylsalicylic acid simultaneously with corticosteroids, the level of salicylates in the blood decreases and the risk of overdose increases after the end of treatment, as well as 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 vasodilator prostaglandins and a decrease in the hypotensive effect. Selective serotonin reuptake inhibitors. The risk of bleeding from the upper parts of the gastrointestinal tract increases due to the possibility of a synergistic effect. When used simultaneously with valproic acid, acetylsalicylic acid displaces it from binding to blood plasma proteins, increasing the toxicity of the latter. Ethyl alcohol promotes damage to the mucous membrane of the gastrointestinal tract and prolongs the bleeding time due to the synergism of acetylsalicylic acid and alcohol.
Features of use
Pregnancy. Acetylsalicylic acid can be used during pregnancy only if other drugs are not effective and only after assessing the risk/benefit ratio. Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonic/intrauterine development. Available data from epidemiological studies indicate a risk of miscarriage and fetal malformations after the use of prostaglandin synthesis inhibitors in early pregnancy. The risk increases with increasing dose and duration of therapy. According to the available data, the connection between taking acetylsalicylic acid and an increased risk of miscarriage has not been confirmed. The available epidemiological data on the occurrence of malformations are not consistent, but an increased risk of gastroschisis cannot be excluded with the use of acetylsalicylic acid. The results of a prospective study of exposure in early pregnancy (1-4th month) involving approximately 14,800 woman-child pairs do not indicate any association with an increased risk of malformations. Animal studies indicate reproductive toxicity. During the I and II trimesters of pregnancy, preparations containing acetylsalicylic acid should not be prescribed without a clear clinical need. In women who are likely to be pregnant, or during the I and II trimesters of pregnancy, the dose of drugs containing acetylsalicylic acid should be as low as possible, and the duration of treatment should be as short as possible. During the III trimester of pregnancy, all inhibitors of prostaglandin synthesis can affect the fetus in the following ways: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - impaired kidney function with possible further development of renal failure with oligohydramnios. Inhibitors of prostaglandin synthesis can affect the woman and the fetus in the following ways: - possibility of lengthening the bleeding time, antiplatelet effect, which can occur even after very low doses; - inhibition of uterine contractions, which can lead to a delay or prolongation of childbirth. Considering this, acetylsalicylic acid is contraindicated during the third trimester of pregnancy. Fertility There is some evidence that drugs that inhibit prostaglandin synthesis may impair reproductive function in women through effects on ovulation. This phenomenon is reversible and disappears after treatment is discontinued. Breast-feeding. Salicylates and their metabolites enter breast milk in small amounts. Since adverse reactions have not been observed in infants whose mothers have taken acetylsalicylic acid, it is generally not necessary to interrupt breastfeeding. With long-term use of the drug or the use of acetylsalicylic acid in high doses, the issue of stopping breastfeeding should be resolved. The ability to influence the speed of reaction when driving vehicles or other mechanisms.
Methods of application
Acetylsalicylic acid should be taken orally after meals, drinking a sufficient amount of liquid. Acetylsalicylic acid cannot be used for longer than 3-5 days without consulting a doctor. Adults and children over 15 years old. 1-2 tablets as a single dose. Repeated reception is possible after 4-8 hours. The maximum daily dose should not exceed 4 g (8 tablets). 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 can be used by children aged 15 and over. Medicines containing acetylsalicylic acid should not be used in children with acute respiratory viral infections (ARVI) with or without fever without consulting a doctor. Certain viral diseases, especially influenza A, influenza B, and chicken pox, carry the risk of developing Reye's syndrome, which is a very rare but life-threatening condition that requires immediate medical attention. The risk may be increased if acetylsalicylic acid is used as a concomitant medication, but a causal relationship in this case has not been proven. If these conditions are accompanied by prolonged vomiting, this may be a sign of Reye's syndrome
Overdose
Salicylate toxicity (the use of more than 100 mg/kg/day for more than 2 days can cause toxicity) is possible due to chronic intoxication resulting from long-term therapy, as well as due to acute intoxication (overdose), which is potentially life-threatening and the causes of which can be, for example, accidental use by children or overdose. Chronic intoxication with salicylates can have a hidden nature, as its symptoms are non-specific. Moderate chronic intoxication caused by salicylates or salicylism usually occurs only after repeated use of large doses. Symptoms Dizziness, ringing in the ears, deafness, sweating, nausea and vomiting, headache, confusion. These symptoms can be controlled by reducing the dose. Ringing in the ears is possible when the concentration of salicylates in the blood plasma exceeds 150-300 μg/ml. More serious side reactions are observed when the concentration of salicylates in the blood plasma is more than 300 μg/ml. Acute intoxication is indicated by a pronounced change in the acid-base balance, which depends on the age of the patient and the severity of intoxication. In children, the most characteristic manifestation is metabolic acidosis. The severity of the condition cannot be estimated only on the basis of the concentration of salicylates in the blood plasma. Absorption of acetylsalicylic acid can be slowed down due to delayed gastric release, formation of concretions in the stomach or in the case of taking the drug in the form of enteric-coated tablets. Due to complex pathophysiological effects, signs and symptoms of salicylate poisoning can be: Intoxication from mild to moderate - tachypnea, hyperpnea, respiratory alkalosis. Sweating, nausea and vomiting. Intoxication from moderate to severe – respiratory alkalosis accompanied by compensatory metabolic acidosis, hyperpyrexia. From the respiratory system: from hyperpnea, non-cardiogenic pulmonary edema to respiratory arrest and asphyxia. From the side of the cardiovascular system: from arrhythmia, hypotension to cardiac arrest. Dehydration, oliguria up to kidney failure is also observed; glucose metabolism disorders, ketosis; gastrointestinal bleeding; hematological changes - from suppression of platelets to coagulopathy. From the side of the nervous system: toxic encephalopathy and depression of the central nervous system, which manifests itself in the form of drowsiness, depression of consciousness to the development of coma and convulsions. Changes in laboratory and other indicators: alkalemia, alkaluria, acidemia, aciduria, changes in blood pressure, changes in ECG, hypokalemia, hypernatremia, hyponatremia, changes in renal function, hyperglycemia, hypoglycemia (especially in children). Increased level of ketone bodies, hypoprothrombinemia. Treatment. Treatment of intoxication caused by an overdose of acetylsalicylic acid is determined by the degree of severity, clinical symptoms and is provided by standard methods used in poisoning (gastric lavage, use of activated carbon, forced diuresis). All applied measures should be aimed at accelerating the removal of the drug and restoring the electrolyte and acid-base balance. Depending on the state of acid-alkaline balance and electrolyte balance, electrolyte solutions should be administered by infusion. In severe poisoning, hemodialysis is indicated.
Side effects
From the gastrointestinal tract. Dyspepsia, vomiting, nausea, diarrhea, epigastric pain and abdominal pain, heartburn; in some cases – inflammation of the gastrointestinal tract, erosive-ulcerative lesions of the gastrointestinal tract, which can in isolated cases cause gastrointestinal bleeding and perforations with corresponding laboratory and clinical manifestations. Rarely - transient liver failure with an increase in the level of liver transaminases. From the blood and lymphatic system. As a result of its antiplatelet effect on platelets, acetylsalicylic acid can increase the risk of bleeding. Such bleedings as perioperative bleedings, hematomas, urogenital bleedings, nosebleeds, bleeding from the gums were observed; rarely or very rarely - serious bleeding, such as gastrointestinal bleeding and cerebral hemorrhage (especially in patients with uncontrolled arterial hypertension and/or with the simultaneous use of antihemostatic agents), which in isolated cases can be life-threatening. Bleeding can lead to acute and chronic posthemorrhagic anemia/iron deficiency anemia (due to so-called hidden microbleeding) with corresponding laboratory manifestations and clinical symptoms, such as asthenia, pallor of the skin, hypoperfusion. Hemolysis and the development of hemolytic anemia have been reported in patients with severe glucose-6-phosphate dehydrogenase deficiency. From the side of the immune system. In patients with individual hypersensitivity to salicylates, the development of allergic reactions is possible, including such symptoms as toxicoderma, rash, urticaria, swelling, itching, eczema, rhinitis, nasal congestion, lowering of blood pressure. Severe hypersensitivity reactions including anaphylactic shock, angioedema and non-cardiogenic pulmonary edema have been observed very rarely. In patients with bronchial asthma, an increase in the frequency of bronchospasm is possible; mild to moderate allergic reactions that potentially affect the skin, respiratory system, gastrointestinal tract, and cardiovascular system. From the side of the nervous system. Headache, dizziness, hearing impairment; ringing in the ears and confusion may be signs of an overdose. From the urinary system. Impairment of kidney function and development of acute renal failure have been reported.
Expiration date
4 years.
Storage conditions
In the original packaging at a temperature not higher than 25 ºС. Keep out of the reach of children.
Packaging
10 tablets in a strip; 1 strip in a paper envelope; 10 tablets in a strip; 2 or 10 strips in a cardboard pack; 10 tablets in a blister; 1, or 2, or 10 blisters in a cardboard pack; 10 tablets in blisters or in strips.
Leave category
Without a prescription.
Producer
Monfarm PJSC.
Address
Ukraine, 19161, Cherkasy region, Uman district, village Avramivka, str. Zavodska, 8.