Cardiomagnyl pills p/o 75mg №100

Name:
Cardiomagnyl tabl p / film.ob. 75mg/15.2mg per vial. No. 100
Description:
Tablets, film-coated white in the form of a stylized “heart”. The main active ingredient is Acetylsalicylic acid. Release form Tablets. Dosage 75 mg. section “Interaction with other drugs and other forms of interaction”). Cardiomagnyl should not be used in children under 2 years of age without a doctor’s instructions. Elderly patients should not use Cardiomagnyl for a long time as an analgesic, anti-inflammatory, antipyretic, and for the treatment of rheumatic diseases due to the risk of gastrointestinal bleeding. The use of low doses of acetylsalicylic acid in elderly patients for the treatment of acute or chronic coronary heart disease, stroke, stroke prevention or coronary heart disease should be carried out with caution due to the risk of gastrointestinal bleeding. Preparations containing acetylsalicylic acid should not be used to treat viral infections in children under 15 years of age without a doctor’s prescription. In the case of viral diseases such as influenza A, influenza B and chickenpox, there is a risk of developing Reye’s syndrome, which is a very rare but potentially life-threatening disease and requires immediate medical attention. The risk of developing this syndrome may increase with the concomitant use of acetylsalicylic acid, but there is no evidence of a causal relationship. The appearance of persistent vomiting against the background of these viral diseases may be a sign of the development of Reye’s syndrome. It should be assessed whether it is necessary to temporarily stop taking low doses of the drug Cardiomagnyl a few days before the date of planned surgical interventions, if the risk of bleeding outweighs the risk of ischemia. Acetylsalicylic acid can provoke bronchospasm, as well as cause asthma attacks and other hypersensitivity reactions. Risk factors include a history of asthma, pollinosis, nasal polyps or chronic respiratory disease, and allergic reactions to other drugs (eg, skin reactions, itching, or urticaria). Therefore, the drug Cardiomagnyl should be used with caution in patients with hypersensitivity to other analgesics, anti-inflammatory and antirheumatic drugs and a history of allergies. The drug should be prescribed with caution in: diseases of the gastrointestinal tract, a tendency to dyspepsia; concomitant treatment with anticoagulants (vitamin K antagonists and heparin (see section “Interaction with other drugs and other forms of interaction”)); renal failure; liver failure. Fertility The use of acetylsalicylic acid may impair fertility and should not be used by women who are planning a pregnancy. Women who have difficulty conceiving or are undergoing fertility testing should consider discontinuing acetylsalicylic acid (see Pregnancy and lactation section). Pharmacological properties Acetylsalicylic acid is an analgesic, anti-inflammatory, antipyretic substance, which also prevents the process of platelet aggregation. This increases the clotting time. The main pharmacological action of acetylsalicylic acid is the inhibition of the formation of prostaglandins and thromboxanes. Analgesic action is peripheral, associated with inhibition of the enzyme cyclooxygenase. The anti-inflammatory effect is associated with a decrease in blood flow due to inhibition of PGE2 synthesis. Acetylsalicylic acid acetylates and irreversibly inhibits prostaglandin G / H synthase, and this effect in platelets lasts longer than the time of presence of acetylsalicylic acid in the body. The effect of acetylsalicylic acid on the biosynthesis of thromboxane in platelets and on the bleeding time is maintained for several days after stopping treatment. This effect decreases as new platelets appear in the plasma. Salicylate (active metabolite), in addition to its anti-inflammatory action, has an effect on respiration, acid-base balance and stomach. Salicylates mainly stimulate respiration by direct action on the medulla oblongata. Salicylates have a direct irritant effect on the gastric mucosa, which forms a predisposition to ulceration by inhibiting vasodilating and cytoprotective prostaglandins. Pharmacokinetic properties Absorption Acetylsalicylic acid is rapidly absorbed from the gastrointestinal tract. After oral administration of the drug in the stomach and intestines, absorption of non-ionized acetylsalicylic acid occurs. Food reduces the rate of absorption; the same is the case in patients who suffer from migraine. The rate of absorption is increased in patients suffering from achlorhydria or in patients taking polysorbents or antacids. The peak concentration of acetylsalicylic acid in serum is reached within half an hour, salicylic acid – within 1-2 hours. Distribution Acetylsalicylic acid is 80-90% bound to plasma proteins. The volume of distribution in adult patients is 170 ml/kg body weight. With an increase in the concentration of the active substance in plasma, the binding sites of proteins are saturated with acetylsalicylic acid, which contributes to an increase in the volume of distribution. Salicylates bind well to plasma protein and are rapidly distributed in the body. Salicylic acid passes into breast milk and can pass through the placenta. Biotransformation Acetylsalicylic acid is partially hydrolyzed to the active metabolite salicylate in the intestinal wall. After absorption, acetylsalicylic acid quickly turns into salicylic acid, however, in the first 20 minutes after oral administration, acetylsalicylic acid predominates in plasma. Withdrawal Salicylic acid is excreted from the body mainly by hepatic metabolism. Equilibrium concentrations of salicylate in plasma increase disproportionately to the dose. A dose of 325 mg of acetylsalicylic acid corresponds to the kinetics of the first order, the half-life is 2-3 hours. High doses of acetylsalicylic acid increase the time of its excretion up to 15-30 hours. Salicylate is also excreted unchanged in the urine. The excreted amount depends on the dose of the drug and the pH level of the urine. Approximately 30% of the drug dose will be excreted in the urine if the urine is alkaline, and only 2% of the drug dose will be excreted in the urine if the urine is acidic. Excretion through the kidneys includes the process of glomerular filtration, active tubular secretion and passive tubular reabsorption. Preclinical Safety Data Formal toxicity studies with acetylsalicylic acid have been limited. The oral LD50 in rats is 1.75 g/kg. In rats that received acetylsalicylic acid, a longer gestational period and the period of childbirth was revealed, and the mortality of rats during childbirth also increased. Indications for use Unstable angina – as part of standard therapy. Acute myocardial infarction – as part of standard therapy. Prevention of recurrent myocardial infarction. Prevention of recurrent transient ischemic attack (TIA) and recurrent cerebral infarction. coronary artery bypass grafting (CABG) or primary percutaneous coronary intervention (PCI)). Prevention of cardiovascular diseases in high-risk patients is possible only on prescription if the benefit of therapy outweighs the risk of adverse events, in particular bleeding, and there is the possibility of diagnosing hidden bleeding. Note: acetylsalicylic acid in a single dose of 75-150 mg is not intended for the treatment of pain. The tablet is recommended to be chewed and washed down with plenty of water. Acetylsalicylic acid 75 mg is intended for long-term use. The duration of therapy is determined by the doctor. Children under 2 years of age Do not use in children unless directed by a doctor. Hepatic insufficiency Should not be prescribed to patients with severe hepatic insufficiency (see section “Contraindications”). In the treatment of patients with hepatic insufficiency, dose adjustment may be required (see section “Special Instructions and Precautions”). Renal insufficiency Do not administer to patients with severe renal insufficiency (glomerular filtration rate (GFR) <0.2 ml / s (10 ml / min)) (see section "Contraindications"). In the treatment of patients with renal insufficiency, dose adjustment may be required (see section "Special Instructions and Precautions"). Use in pregnancy and lactation Pregnancy Low doses (up to 100 mg/day) Clinical studies show that doses up to 100 mg/day are safe for certain obstetric conditions, but require specialized patient monitoring. Doses 100-500 mg/day There is insufficient clinical experience with doses of 100-500 mg/day. Thus, it is recommended to follow the instructions below for taking the drug at doses of 500 mg / day. Doses of 500 mg/day and above Third trimester: Prostaglandin synthesis inhibitors are contraindicated during the third trimester of pregnancy as their use may result in: cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which can progress to renal failure and, therefore, lead to a decrease in the volume of amniotic fluid. At the end of pregnancy, prostaglandin synthesis inhibitors can provoke in the mother and newborn: a possible increase in bleeding time due to the antiplatelet effect, which can occur even when taking the drug at very low doses; suppression of uterine contractions, which will delay the birth period. First and second trimester: During the first and second trimester of pregnancy, prostaglandin synthesis inhibitors should not be taken unless clearly necessary, while the dose should be minimal, and the duration of treatment as short as possible. Fertility: Acetylsalicylic acid should not be used in women who are planning a pregnancy, as prostaglandin synthesis inhibitors are thought to reduce fertility. If it is necessary to undergo treatment with acetylsalicylic acid, then the treatment should be as short as possible, and the doses should be minimal. The effect of the drug on fertility is reversible. Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonic/fetal development. Data from epidemiological studies indicate an increased risk of spontaneous abortion, the occurrence of congenital heart defects and gastroschisis after the use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of congenital heart disease increases from less than 1% to approximately 1.5%. It is believed that the risk increases with an increase in the dose of the drug and the duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to lead to increased pre- and post-implantation embryonic loss and fetal fetal mortality. In addition, the number of cases of various malformations, including those of the cardiovascular system, increased, which was recorded in animals treated with prostaglandin synthesis inhibitors during the period of organogenesis. Therefore, acetylsalicylic acid at doses of 100 mg/day and above is contraindicated during the third trimester of pregnancy. Lactation Data are insufficient. Before using acetylsalicylic acid, all the benefits of treatment should be evaluated taking into account the potential risk to the child. Interaction with other drugs Combinations with the following drugs should be avoided Methotrexate Possible mechanism: decreased clearance of methotrexate. Consequence: methotrexate toxicity (leukopenia, thrombocytopenia, anemia, nephrotoxicity, mucosal ulcers). Angiotensin-converting enzyme (ACE) inhibitors Possible mechanism: inhibition of prostaglandin synthesis. Consequence: reduced effect of ACE inhibitors. Acetazolamide Possible mechanism: Elevated concentrations of acetazolamide may lead to diffusion of salicylate from plasma into tissues. Consequence: toxicity of acetazolamide (fatigue, lethargy, drowsiness, confusion, hyperchloremic metabolic acidosis). Salicylate toxicity (vomiting, tachycardia, hyperpnea, confusion). Probenecid, sulfinpyrazone Possible mechanism: Probenecid and high doses of salicylate (>500 mg) mutually block each other’s action on uric acid excretion. Consequence: decreased excretion of uric acid. Caution should be exercised when combined with the following drugs Clopidogrel, ticlopidine The combination of clopidogrel and acetylsalicylic acid has a synergistic effect. This is associated with an increased risk of bleeding, which requires caution when prescribing this combination. Anticoagulants: warfarin, phenprocoumon Possible mechanism: reduces the formation of thrombin, which indirectly leads to a decrease in platelet activity (vitamin K antagonist). Consequence: increased risk of bleeding. Abciximab, tirofiban, eptifibatide Possible mechanism: inhibits the action of glycoprotein IIb/IIIa receptors in platelets. Consequence: increased risk of bleeding. Heparin Possible mechanism: Reduces the rate of thrombin formation, which indirectly reduces platelet activity. Consequence: increased risk of bleeding. If two or more of the above substances are taken simultaneously with acetylsalicylic acid, this may lead to a synergistic effect with increased inhibition of platelet activity and an increased risk of bleeding. NSAIDs and COX-2 inhibitors (celecoxib) Possible mechanism: additional irritation of the gastrointestinal tract. Consequence: increased risk of gastrointestinal bleeding. Ibuprofen The simultaneous use of ibuprofen inhibits platelet aggregation induced by the intake of acetylsalicylic acid. The cardioprotective effect of acetylsalicylic acid may be reduced in patients with an increased risk of cardiovascular disease who take ibuprofen. Patients who take acetylsalicylic acid once a day for the treatment or prevention of cardiovascular diseases, if necessary, the use of ibuprofen should take acetylsalicylic acid at least 2 hours before taking ibuprofen. Furosemide Possible mechanism: inhibition of furosemide secretion in the proximal tubules of the kidneys. Consequence: a decrease in the diuretic effect of furosemide. Quinidine Possible mechanism: additional effect on platelets. Consequence: increased bleeding time. Spironolactone Possible mechanism: modification of the renin effect. Consequence: reduced action of spironolactone. Selective serotonin reuptake inhibitor Possible mechanism: additional irritation of the gastrointestinal tract. Consequence: increased risk of gastrointestinal bleeding. Valproate Possible mechanism: acetylsalicylic acid alters the binding and metabolism of valproate. Consequence: toxicity of valproate (CNS depression, gastrointestinal disorders). In the case of combining drugs, it may be necessary to adjust the dose of valproate. Corticosteroids Possible mechanism: additional irritation of the gastrointestinal tract, as well as an increase in renal clearance or metabolism of salicylates. Consequence: increased risk of gastrointestinal ulcers and sub-therapeutic salicylic acid plasma concentrations. Antidiabetic drugs Possible mechanism: additional hypoglycemic effect. Outcome: hypoglycemia. Antacids Possible mechanism: increased renal clearance and reduced renal absorption (due to increased urinary pH). Consequence: reduced action of acetylsalicylic acid. Varicella vaccination Possible mechanism: unknown. Consequence: increased risk of developing Reye’s syndrome. Ginkgo Biloba Possible Mechanism: Ginkgo Biloba inhibits platelet aggregation. Consequence: increased risk of bleeding. Contraindications Cardiomagnyl is contraindicated in patients with the following conditions/diseases: hypersensitivity to salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs) and/or any of the excipients; hemorrhagic diathesis (vitamin K deficiency, thrombocytopenia, hemophilia); acute peptic ulcer; severe renal failure (GFR < 0.2 ml / s (10 ml / min)); severe liver failure; severe heart failure; doses > 100 mg / day during the third trimester of pregnancy; children under 15 years of age with fever (risk of Reye’s syndrome, see. section “Special instructions and precautions”) Composition Each tablet contains 75 mg of acetylsalicylic acid. For a complete list of excipients, see the “List of excipients” section. Overdose Toxicity Toxic dose Adults: 300 mg/kg. Children: Single dose of 150 mg/kg or more than 100 mg/kg/day for more than 2 days. Symptoms Chronic intoxication with salicylates in a mild form, as a rule, occurs only after prolonged use of high doses of the drug. Symptoms include fever, tachypnea, tinnitus, respiratory alkalosis, metabolic acidosis, lethargy, mild dehydration, nausea, and vomiting. Symptoms of severe or acute salicylate intoxication include hypoglycemia (especially in children), encephalopathy, coma, hypotension, pulmonary edema, convulsions, coagulopathy, cerebral edema, and arrhythmias. Acute intoxication with salicylates (>300 mg/kg) is often debilitating, and doses in excess of 500 mg/kg can be fatal. The severity of intoxication is usually more pronounced with chronic overdose or abuse of the drug, as well as when taken by the elderly or children. Treatment In case of acute overdose of salicylate, gastric lavage should be performed. Repeated doses of activated charcoal may be given if the patient is expected to have taken more than 120 mg/kg of the drug. It is necessary to measure the level of salicylate in the blood serum, at least every two hours after administration, until the level of salicylate decreases and the acid-base balance improves. Prothrombin time and/or INR should be monitored, especially if bleeding is suspected. Fluid and electrolyte balance should be restored. Alkaline diuresis and hemodialysis are effective methods for removing salicylate from plasma. The need for hemodialysis in cases of severe intoxication should be considered, as it quickly removes salicylate and restores acid-base and water-salt balance. Side effects The most common adverse reactions are reactions from the gastrointestinal tract. The development of adverse reactions, as a rule, depends on the dose of the drug and the duration of the course of treatment. Storage conditions In a dry, dark place at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Cardiomagnyl tablets p / o 75 mg No. 100 about 75mg #100