Acecor Cardio 100 mg tablet number 100

Author Ольга Кияница

2017-05-11

Amount in a package 100
Product form Pills
Manufacturer Microhim Ltd. (Ukraine, Rubezhnoye)
Registration certificate UA/9628/01/01
The main medicament Acecor
morion code 352933

ACECOR CARDIO instructions for use

Composition

active substance: acetylsalicylic acid, 1 tablet contains acetylsalicylic acid 100 mg;
auxiliary substances: potato starch; talc cellulose microcrystallic acid citric monohydrate, triethyl citrate; methacrylate copolymer (type A).

Dosage form

The pills are intestinal.

Basic physical and chemical properties:

Tablets of white color with biconvex smooth surface, covered with a film membrane.

Pharmacological group

Antithrombotic agents. Code ATX B01A C06.

Pharmacological properties

Pharmacodynamics.

Acetylsalicylic acid suppresses platelet aggregation by blocking the synthesis of thromboxane A2. The mechanism of its action is the irreversible inactivation of the enzyme cyclooxygenase (COX-1). This inhibitory effect is particularly pronounced for platelets, since they are not capable of resynthesis of the said enzyme. It is also recognized that acetylsalicylic acid also exhibits other inhibitory effects on platelets. Thanks to these effects, it can be used for many vascular diseases.

Acetylsalicylic acid belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs) with analgesic, antipyretic and anti-inflammatory properties. Orally at higher doses, acetylsalicylic acid can be used to relieve pain and in light febrile conditions such as the common cold and the flu, to reduce temperature and relieve joint and muscle pain, with acute and chronic inflammatory diseases such as rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.

Pharmacokinetics.

After ingestion, acetylsalicylic acid is rapidly and completely absorbed from the gastrointestinal tract. During and after absorption, it turns into the main active metabolite - acid salicylic. The maximum concentration of acetylsalicylic acid in the blood plasma is reached after 10-20 minutes, salicylic acid - after 20-120 minutes, respectively. Due to the enteric coating of the tablets Acecor Cardio 100 mg, the release of the active substance occurs not in the stomach, but in the alkaline environment of the intestine. Therefore, the absorption of acetylsalicylic acid is slowed down to 3-6 hours after the application of the tablet coated with an enteric-coated membrane, compared to a conventional tablet of acetylsalicylic acid.

Acetylsalicylic and salicylic acids completely bind to blood plasma proteins and are quickly distributed in the body.Salicylic acid penetrates the placenta, as well as into breast milk.

Salicylic acid is metabolized primarily in the liver. Metabolites of salicylic acid are salicylurea, salicylphenol glucuronide, salicylacyl glucuronide, gentisic acid and gentisine-sulfuric 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 period depends on the dose and increases from 2-3 hours when low doses are used up to 15 hours - when high doses are used. Salicylic acid and its metabolites are excreted mainly by the kidneys.

Indications

To reduce the risk:

  • death in patients with suspected acute myocardial infarction;
  • morbidity and mortality in patients who underwent myocardial infarction
  • transient ischemic attacks (TIA) and stroke in patients with TIA;
  • morbidity and mortality in stable and unstable angina;
  • myocardial infarction in patients with a high risk of developing cardiovascular complications (diabetes mellitus, controlled arterial hypertension) and people with a multifactorial risk of cardiovascular disease (hyperlipidemia, obesity, smoking, old age).

For prevention:

  • thrombosis and embolism after vascular surgery (percutaneous transluminal catheter angioplasty (PTCA), carotid endarterectomy, coronary artery bypass grafting (CABG), arteriovenous shunting);
  • thrombosis of deep veins and embolism of the legendary artery after prolonged immobilization (after surgical operations).

For secondary prevention of stroke.

Contraindications

Hypersensitivity to acetylsalicylic acid, other salicylates or to any component of the drug.
Asthma caused by the intake of salicylates or substances with a similar effect, especially NSAIDs in the history.
Acute peptic ulcers.
Hemorrhagic diathesis.
Renal failure is severe.
Hepatic insufficiency is severe.
Heart failure is severe.
Combination with methotrexate in a dosage of 15 mg / week or more (see Section "Interaction with Other Drugs and Other Interactions").

Interaction with other drugs and other interactions

Contraindications for simultaneous use.

The use of acetylsalicylic acid and methotrexate at doses of 15 mg / week and more raises the hematological toxicity of methotrexate (decreased renal clearance of methotrexate by anti-inflammatory agents and the displacement of methotrexate from salicylates from plasma proteins).

Combinations that should be used with caution.

With the use of acetylsalicylic acid and methotrexate in doses less than 15 mg / week, hematological toxicity of methotrexate (reduction of renal clearance of methotrexate by anti-inflammatory agents and displacement of methotrexate from salicylates from plasma proteins) is increasing.

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

With the simultaneous use of Acecorro Cardio and anticoagulants, thrombolytics / other inhibitors of hemostasis platelet aggregation, the risk of bleeding increases.

With the simultaneous use of high doses of salicylates with NSAIDs (through mutually complementary effect), the risk of ulcers and gastrointestinal bleeding increases.

When used with selective serotonin reuptake inhibitors, the risk of developing gastrointestinal bleeding increases because of the possible synergistic effect.

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 antidiabetic drugs from the sulfonylurea group, the hypoglycemic effect of the latter is enhanced by the displacement of the sulfonylurea associated with plasma proteins with acetylsalicylic acid.

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

Systemic glucocorticosteroids (excluding hydrocortisone, which is used for replacement therapy in Addison's disease) reduce the level of salicylates in the blood and increase the risk of overdose after the end of treatment.

ACE (ACE) in combination with high doses of acetylsalicylic acid causes a decrease in glomerular filtration due to inhibition of the vasodilator effect of prostaglandins and a reduction in the antihypertensive effect.

With simultaneous application with valproic acid, acetylsalicylic acid displaces it from the bond with plasma proteins, increasing the toxicity of the latter.

Alcohol contributes to damage to the mucous membrane of the gastrointestinal tract and prolongs the time of bleeding due to synergism of acetylsalicylic acid and alcohol.

Simultaneous use with uricosuric agents, such as benzobromarone, probenecid, reduces the effect of excretion of uric acid (due to competition excretion of uric acid by renal tubules).

Application features

Use Acercor Cardio with caution when:

  • hypersensitivity to analgesic, anti-inflammatory, antirheumatic drugs, as well as allergy to other substances;
  • ulcers of the gastrointestinal tract, including chronic and recurrent ulcerative diseases or gastrointestinal hemorrhage in an anamnesis
  • simultaneous use of anticoagulants;
  • violations of the kidney and / or liver.
  • disorders of the cardiovascular circulation (eg, kidney vascular pathology, congestive heart failure, hypovolemia, extensive surgery, sepsis, or severe bleeding), as acetylsalicylic acid can also increase the risk of impaired kidney function and acute renal failure
  • severe insufficiency of glucose-6-phosphate dehydrogenase, acetylsalicylic acid can cause hemolysis or hemolytic anemia. Especially in the presence of factors that may increase the risk of hemolysis, such as high doses of the drug, fever, or an acute infectious process.

Ibuprofen may reduce the inhibitory effect of acetylsalicylic acid on platelet aggregation. In case of long-term use of Acecoru Cardio before starting ibuprofen, the patient should consult a physician.

In patients with allergic complications, including bronchial asthma, allergic rhinitis, urticaria, pruritus, mucosal edema and polyposis of the nose, as well as when combined with chronic infections of the respiratory tract and in patients with hypersensitivity to NSAIDs in the context of treatment with Acecorom Cardio possibly the development of bronchospasm or an attack of bronchial asthma.

Through the inhibitory effect of acetylsalicylic acid on platelet aggregation, which persists for several days after ingestion, the use of drugs containing acetylsalicylic acid may increase the likelihood of the appearance / increase of bleeding in surgical operations (including minor surgical interventions, such as tooth extraction).

With the use of small doses of acetylsalicylic acid, the excretion of uric acid may decrease. This can lead to the appearance of gout in patients with decreased excretion of uric acid.

Do not use drugs containing acetylsalicylic acid, children with acute respiratory viral infection (ARVI), which is accompanied or not accompanied by a rise in body temperature, without consulting a doctor. With some viral diseases, especially with influenza A, influenza B and chickenpox, there is a risk of developing Ray's syndrome, which is a very rare but life-threatening disease, requires urgent medical intervention. The risk may increase if acetylsalicylic acid is used as a concomitant medication, but the cause-and-effect relationship is not proven in this case. If these conditions are accompanied by prolonged vomiting, this may be a sign of Ray's syndrome.

Use during pregnancy and lactation

The inhibition of prostaglandin synthesis may adversely affect pregnancy and / or fetal / intrauterine development. The available data from epidemiological studies indicate the risk of miscarriage and fetal malformations after the use of inhibitors of prostaglandin synthesis in early pregnancy. The risk rises depending on the increase in dose and duration of therapy. According to the available data, the connection between the intake of acetylsalicylic acid and the increased risk of miscarriage is not confirmed.

The available epidemiological data on the occurrence of malformations is not consistent, but an increased risk of gastroschisis can not be ruled out with the use of acetylsalicylic acid. The results of a prospective study of the effect in the early stages of pregnancy (1-4 months) involving approximately 14,800 female-child pairs do not indicate any association with an increased risk of developing malformations.

Animal studies indicate reproductive toxicity.

In the I and II trimesters of pregnancy, preparations containing acetylsalicylic acid should not be prescribed without a clear clinical need. For women who are likely to be pregnant or women in I and II trimesters of pregnancy, the dose of drugs containing acetylsalicylic acid should be as low as possible and the duration of treatment as short as possible.

In the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can affect the fetus as follows:

  • cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension)
  • renal dysfunction with possible subsequent development of renal insufficiency with oligohydroamniosis;

on a woman and a child at the end of pregnancy, the inhibitors of prostaglandin synthesis can be influenced as follows:

  • the possibility of prolonging the time of bleeding, an antiaggregant effect that can occur even after very low doses;
  • inhibition of contractions of the uterus, which can lead to a delay or an increase in the duration of labor.

Despite this, acetylsalicylic acid is contraindicated in the third trimester of pregnancy.

Salicylates and their metabolites penetrate into breast milk in small amounts.

Since there was no adverse effect of the drug on the baby after admission to women during lactation, it is usually not necessary to interrupt breastfeeding. However, in cases of regular use or with the use of high doses of breast-feeding, it is necessary to stop at early stages.

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

There was no impact on the ability to drive and other mechanisms.

Dosing and Administration

The drug is taken orally 30-60 minutes before meals, without chewing, squeezed with enough liquid.

To reduce the risk of death in patients with suspected acute myocardial infarction, use the drug at a dose of 100-300 mg per day. Within 30 days after a heart attack, continue taking a maintenance dose of 100-300 mg per day. After 30 days, further prevention of recurrence of myocardial infarction should be considered.

To achieve rapid absorption when used for this indication, the first tablet must be chewed.

To reduce the risk of morbidity and death in patients who underwent myocardial infarction, apply 100-300 mg per day.

For secondary prevention of stroke, use the drug at a dose of 100-300 mg per day.

To reduce the risk of transient ischemic attack (TIA) and stroke in patients with TIA, use 100-300 mg per day.

To reduce the risk of developing the disease and death in patients with stable and unstable angina: 100-300 mg per day.

To prevent thromboembolism after vascular surgery (percutaneous transluminal catheter angioplasty (PTCA), carotid endarterectomy, coronary artery bypass grafting (CABG), arteriovenous shunting), use the drug at a dose of 100-200 mg per day daily or 300 mg per day every other day.

For prevention of deep vein thrombosis and pulmonary embolism after a prolonged state of immobilization (after surgery) - 100-200 mg per day or 300 mg per day every other day.

For the prevention of myocardial infarction in patients with a high risk of developing cardiovascular complications (diabetes mellitus, controlled arterial hypertension) and people with a multifactorial risk of cardiovascular diseases (hyperlipidemia, obesity, smoking, old age, etc.) Apply 100 mg per day or 300 mg per day every other day.

Children

According to the indications (see the section "Indication"), the drug Acecor Cardio should not be used in children.

The use of acetylsalicylic acid in children under the age of 16 can cause severe side effects (including Reye's syndrome, one of the symptoms of which is constant vomiting). Please see the information in the "Special Security Measures" section.

Overdose

The toxic effect of salicylates is possible due to chronic intoxication caused by prolonged therapy (the use of more than 100 mg / kg / day for more than 2 days can cause toxic effects), as a result of acute intoxication, which carries a life threat (overdose), and which can be caused, for example , accidental use by children or an unexpected overdose.

Chronic poisoning with salicylates can be of a hidden nature, since its signs and symptoms are nonspecific. Moderate chronic intoxication caused by salicylates, or salicylism occurs, usually only after repeated use of large doses.

Symptoms. Dizziness, ringing in the ears, deafness, increased sweating, nausea and vomiting, headache, confusion.These symptoms can be controlled by lowering the dose. Ringing in the ears can occur when the concentration of salicylates in the blood plasma is above 150-300 μg / ml. Serious adverse reactions occur when the concentration of salicylates in the blood plasma is higher than 300 μg / ml.

Acute intoxication is indicated by a marked change in the acid-base balance, which may differ depending on the age and severity of intoxication. Most often, its manifestation in children is metabolic acidosis.Severity of the condition can not be estimated only on the basis of salicylates plasma concentration. The absorption of acetylsalicylic acid can slow down due to delayed gastric release, the formation of concretions in the stomach or in the case of taking the drug in tablet form coated with an enteric coating.

Treatment.

Treatment of acute intoxication caused by an overdose of acetylsalicylic acid, determined by the severity, clinical symptoms, and is provided by conventional methods which are used in cases of poisoning. All applied measures should aim to accelerate the removal of the drug and restore electrolyte and acid-base balance.

Through complex pathophysiologic effects of salicylate poisoning signs and symptoms / test results may include:

Signs and symptoms Test results therapeutic measures
Intoxication mild or moderate   Gastric lavage, reintroduction of the activated carbon, forced alkaline diuresis
Tachypnea, hyperventilation, respiratory alkalosis Alkalemiya, alkaluriya Restoration of electrolyte and acid-base balance
Hyperhidrosis (excessive sweating)   Hyperhidrosis (excessive sweating)
Nausea, vomiting    
Intoxication moderate or severe   Gastric lavage, reintroduction of the activated carbon, alkaline forced diuresis, dialysis in severe cases,
Respiratory alkalosis with compensatory metabolic acidosis Acidemia, aciduria Restoration of electrolyte and acid-base balance
hyperpyrexia   Restoration of electrolyte and acid-base balance
Respiratory: hyperventilation, non-cardiogenic pulmonary edema, respiratory failure, asphyxia    
Cardiovascular: dizaritmii, hypotension, cardiovascular failure For example, changes in blood pressure, ECG  
The loss of fluids and electrolytes, dehydration, oliguria, renal failure For example, hypokalemia, hypernatremia, hyponatremia, renal changes Restoration of electrolyte and acid-base balance
Impaired glucose metabolism, ketoacidosis Hyperglycemia, hypoglycemia (especially in children)  
Tinnitus, deafness    
Gastrointestinal: Bleeding in the digestive tract    
Hematologic: inhibition of platelet coagulopathy For example, the prolongation of PT, gipoprotrombinemii  
Neurologic: Toxic encephalopathy and CNS depression with manifestations such as the lethargy, confusion, coma and convulsions    

Adverse Reactions

On the part of the gastrointestinal tract: dyspepsia, epigastric pain and abdominal pain, inflammation of the gastrointestinal tract, erosive and ulcerative lesions of the gastrointestinal tract, which can in rare cases cause gastro-intestinal hemorrhage and perforation with the relevant laboratory parameters and clinical manifestations .

From the blood, and the blood: intraoperative hemorrhage, hematoma, bleeding of the organs of the urogenital system, nosebleeds, bleeding from the gums, hemorrhages of the gastrointestinal tract, brain hemorrhage (especially in patients with uncontrolled hypertension, and / or while the application antigemostatichnih funds). Hemorrhage may lead to acute and chronic posthemorrhagic anemia / iron deficiency anemia (due to the so-called hidden mikrokrovotecheniya) with corresponding laboratory manifestations and clinical symptoms such as fatigue, pallor of skin, hypoperfusion.

In patients with severe deficiency of glucose-6-phosphate dehydrogenase were observed hemolysis and hemolytic anemia.

Cardio-vascular system: pallor, hypoperfusion.

Immune system: allergic reactions, including rash, hives, swelling, itching, anaphylactic shock.

The respiratory system: bronchospasm, cardiovascular disease, respiratory failure, rhinitis, nasal congestion.

From the side of Hearing: tinnitus.

Others: asthenia, dizziness, transient hepatic failure with an increase in liver transaminase levels.

It reported renal dysfunction and acute renal failure.

Hypersensitivity reactions with appropriate laboratory and clinical manifestations include asthmatic condition, skin reactions mild or moderate, and also the part of the respiratory tract, gastrointestinal tract, and cardiovascular system.

Shelf life

3 goda.Ne use after the expiration date printed on the package.

Storage conditions

Store at a temperature not higher than 30 ° C in original upakovke.Hranit the reach of children.

Packaging

Of 50 or 100 tablets bank polymer in the pack of cardboard.
50 tablets (10 × 5) or 100 tablets (25 × 4) in the blister pack from the carton.

Category of leave

Without recipe.

 


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