Kardyseu 75 mg pills number 30

Author Ольга Кияница

2017-05-11

Amount in a package 30
Product form Pills
Manufacturer Farmak OJSC (Ukraine, Kiev)
Registration certificate UA/14585/01/02
The main medicament -
morion code 327234

Cardisay (Acetylsalicylic Acid) Instructions for use

Composition:

active ingredient : acetylsalicylic acid; 1 tablet contains acetylsalicylic acid, based on 100% dry substance 75 mg;
auxiliary substances: magnesium hydroxide, pregelatinised starch, microcrystalline cellulose (200), silicon colloidal anhydrous dioxide, magnesium stearate; Film coat: Opadry II 85G18490 white (alcohol polyvinyl, polyethylene glycol, talc, titanium dioxide (E 171), lecithin).

Dosage form

Tablets coated with a film coat.

Basic physical and chemical properties

Tablets of round shape with a biconvex surface coated with a film coat, white or almost white.

Pharmacotherapeutic group

Antithrombotic agents. Code АТХ В01А С06.

Pharmacological properties

Pharmacodynamics.

Acetylsalicylic acid is analgesic, anti-inflammatory, antipyretic and anti-aggregate.

The main pharmacological effect is the inhibition of the formation of prostaglandins and thromboxanes.

The analgesic effect is an additional effect that is induced by the inhibition of the cyclooxygenase enzyme. The anti-inflammatory effect is associated with reduced blood flow caused by inhibition of PGE2 synthesis.

Acetylsalicylic acid irreversibly inhibits the synthesis of prostaglandins G / H, its effect on prostaglandins lasts longer than acetylsalicylic acid is present in the body. The effect of acetylsalicylic acid on thromboxane biosynthesis in platelets and on bleeding time persists for a long time after discontinuation of treatment. The action is stopped only after the appearance of new platelets in plasma.

Magnesium hydroxide has an antacid effect and protects the mucous membrane of the digestive tract from the irritating effect of acetylsalicylic acid.

Pharmacokinetics.

Absorption. After ingestion, acetylsalicylic acid is rapidly absorbed from the digestive tract. The rate of absorption is reduced with food intake and in patients with migraine attacks, and increases - in patients with aclorohydrium or in patients who take polysorbates or antacids. The maximum concentration in the serum is reached in 0.5-2 hours.

When administered orally, magnesium in small quantities is slowly absorbed from the small intestine.

Distribution. The binding of acetylsalicylic acid to plasma proteins is 80-90%. The volume of distribution in adults is 170 ml / kg of body weight. Salicylates strongly bind to plasma proteins and rapidly spread throughout the body. Salicylates penetrate breast milk and can penetrate the placental barrier. Magnesium is distributed with bound proteins (about 25-30%). A small amount is excreted in breast milk. Magnesium can penetrate the placental barrier.

Metabolism. Acetylsalicylic acid hydrolyzes to the active metabolite - salicylate - in the wall of the stomach. After absorption, acetylsalicylic acid rapidly converts to salicylic acid, but within the first 20 minutes after ingestion it is dominant in the plasma.

Removing Salicylate is excreted mainly due to hepatic metabolism. The half-life is 2-3 hours. At a high dose of acetylsalicylic acid, the half-life is increased to 15-30 hours. Salicylate is also excreted unchanged in urine. The volume withdrawn depends on the dose level and urine pH. About 30% of the dose is excreted in the urine, if the urine reaction is alkaline, and only 2% - if acidic. A small amount of magnesium is excreted in urine, but most of it is reabsorbed and excreted with feces.

Indications

  • Acute (unstable angina, acute myocardial infarction) and chronic ischemic heart disease.
  • Prevention of recurrent thrombosis.
  • Primary prophylaxis of thrombosis, cardiovascular diseases such as acute coronary syndrome in patients over 50 years of age with cardiovascular disease developmentalities: arterial hypertension, hypercholesterolemia, diabetes mellitus, obesity (body mass index> 30), hereditary history ( myocardial infarction at least one parent or brother or sister under the age of 55).

Contraindications

Hypersensitivity to the components of the drug, other salicylates; stomach ulcer in exacerbation phase; tendency to bleeding (vitamin K deficiency, thrombocytopenia, hemophilia); severe hepatic failure, severe renal impairment (glomerular filtration rate <10 ml / min); pronounced heart failure; asthma, Queinc's edema, caused by the use of salicylates or nonsteroidal anti-inflammatory drugs (NSAIDs), in history.

Interaction with other drugs and other types of interactions

Contraindications for simultaneous use.

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

ACE inhibitors. Angiotensin converting enzymes (ACE) inhibitors, in combination with high doses of acetylsalicylic acid, reduce the filtration in the glomeruli by inhibiting the vasodilator effect of prostaglandins and reducing the antihypertensive effect.

Acetazolamide A possible increase in the concentration of acetazolamide may lead to the penetration of salicylates from the blood plasma into the tissue and cause acetazolamide toxicity (fatigue, lethargy, drowsiness, confusion, hyperchloremic metabolic acidosis), and toxicity of salicylates (vomiting, tachycardia, hyperpnea, confusion).

Probenecid, sulfinpyrazone. When using probenecid and high doses of salicylates (≦ 500 mg), the metabolism of both drugs is inhibited, and excretion of uric acid may decrease.

Combinations that need to be used with caution.

Methotrexate. With the use of acetylsalicylic acid and methotrexate at doses less than 15 mg / week, hematological toxicity of methotrexate increases (decreasing renal clearance of methotrexate by anti-inflammatory agents and displacement of methotrexate salicylates from binding to plasma proteins).

Clopidogrel, ticlopidine. Combined use of clopidogrel and acetylsalicylic acid has a synergistic effect. This combined use is carried out with caution as it increases the risk of bleeding.

Anticoagulants (warfarin, fenprocumone). It is possible to reduce the production of thrombin, which results in an indirect effect on the reduction of platelet activity (antagonist of vitamin K) and increases the risk of bleeding.

Abciximab, tirofiban, eptifibatide. Inhibition of glycoprotein IIB / IIIa receptors on platelets is possible, which leads to an increased risk of bleeding.

Heparin It is possible to reduce the production of thrombin, which results in an indirect effect on the reduction of platelet activity, which leads to an increased risk of bleeding.

If two or more of the above substances are used together with acetylsalicylic acid, this can lead to a synergistic effect of enhancing the inhibition of platelet activity and, as a result, an increase in hemorrhagic diathesis.

NSAIDs and COX-2 inhibitors (celecoxib). Joint application increases the risk of gastrointestinal disturbances, which can lead to gastrointestinal bleeding.

Ibuprofen Simultaneous administration of ibuprofen inhibits irreversible platelet aggregation, due to the action of acetylsalicylic acid. Treatment with ibuprofen in patients at increased risk of cardiovascular effects may limit the cardioprotective effect of acetylsalicylic acid. Patients who take acetylsalicylic acid once daily for the purpose of preventing cardiovascular disease and taking ibuprofen from time to time should take acetylsalicylic acid at least 2 hours before taking ibuprofen.

Furosemide Inhibition of proximal tubular elimination of furosemide is possible, which leads to a decrease in the diuretic effect of furosemide.

Quinidine Possibly additive effect on platelets, which leads to an increase in the duration of bleeding.

Spironolactone. A modified renin effect is possible, which leads to a reduction in the efficacy of spirolonolactone.

Selective serotonin reuptake inhibitors. Joint application increases the risk of gastrointestinal disturbances, which can lead to gastrointestinal bleeding.

Valproat When co-administered with valproate, acetylsalicylic acid displaces it from the plasma proteins, increasing its toxicity (central nervous system depression, gastrointestinal disturbances).

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

Anti-diabetic drugs. Simultaneous use of acetylsalicylic acid and anti-diabetic drugs increases the risk of hypoglycaemia.

Antacids It is possible to increase renal clearance and decrease renal absorption (due to an increase in urine pH), which leads to a decrease in the effect of acetylsalicylic acid.

Vaccine against chickenpox. Joint application increases the risk of developing Ray's syndrome.

Ginkgo biloba Joint application with ginkgo biloba prevents platelet aggregation, which results in an increased risk of bleeding.

Digoxin When co-administered with digoxin, the concentration of the latter in plasma is increased due to a decrease in renal excretion.

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

Application features

Cardisay should be used with caution in the following cases:

  • hypersensitivity to analgesic, anti-inflammatory, antirheumatic drugs, as well as allergies to other substances;
  • ulcers of the gastrointestinal tract, including chronic and recurrent ulcerative diseases or gastrointestinal bleeding in the history;
  • simultaneous application of anticoagulants;
  • Patients with impaired renal function or with cardiovascular disorders (eg kidney vascular pathology, congestive heart failure, hypovolaemia, extensive surgery, sepsis or severe bleeding), since acetylsalicylic acid also increases the risk of renal dysfunction and acute renal failure;
  • Patients with severe glucose-6-phosphate dehydrogenase deficiency, since acetylsalicylic acid can cause them hemolysis or hemolytic anemia, especially in the presence of risk factors (eg high doses of the drug, fever or acute infectious process);
  • abnormal liver function

Ibuprofen may reduce the inhibitory effect of acetylsalicylic acid relative to platelet aggregation. In the case of using Cardyseub before taking ibuprofen as an analgesic, the patient should consult a physician.

Acetylsalicylic acid can cause the development of bronchospasm or an attack of bronchial asthma or other reactions of increased sensitivity. Risk factors include asthma in history, hay fever, nasal polyposis or chronic respiratory disease, allergic reactions (eg, skin reactions, itching, urticaria) to other substances in the history.

Due to the inhibitory effect of acetylsalicylic acid on platelet aggregation, which persists for several days after administration, the use of acetylsalicylic acid formulations increases the risk of bleeding in surgical operations (including minor surgical procedures such as tooth extraction).

With the use of small doses of acetylsalicylic acid, uric acid excretion may decrease. This can lead to an outbreak of gout in patients who are prone to it.

Do not use drugs that contain acetylsalicylic acid, children and adolescents with acute respiratory viral infection (ARVI), which is accompanied or not accompanied by an increase in body temperature without consulting a physician. In some viral diseases, especially with influenza A, influenza B and chickenpox, there is a risk of developing Ray's syndrome, a very rare but life-threatening illness that requires urgent medical intervention. The risk may be elevated if acetylsalicylic acid is used as a concomitant drug, but the cause-effect relationship is not proven in this case. If these conditions are accompanied by constant vomiting, this can be a manifestation of Ray's syndrome.

Use during pregnancy or breastfeeding

The decision to use Cardisay in the I-II trimester of pregnancy and during breastfeeding should be taken after careful evaluation of the benefit / risk ratio. The drug in such cases is used in the most low doses (up to 100 mg per day) and under careful observation. The term of application is as short as possible.

The drug is contraindicated in the third trimester of pregnancy.

Ability to influence the speed of reaction when driving motor vehicles or other mechanisms

Does not affect.

Method of administration and dose

Acute and chronic ischemic heart disease.

Recommended initial dose - 150 mg per day. Supportive dose - 75 mg per day.

Acute myocardial infarction. Unstable angina

Recommended dose - 150-450 mg, used as soon as possible after the onset of symptoms.

Prevention of recurrent thrombosis.

Recommended initial dose - 150 mg per day. Supportive dose - 75 mg per day.

Primary prophylaxis of thrombosis, cardiovascular diseases such as acute coronary syndrome in patients with cardiovascular disease.

The recommended prophylactic dose is 75 mg per day.

The tablets are swallowed whole, if necessary, washed with water. If desired, the tablet can be broken in half, flashed or pre-rinsed.

The course of treatment is determined by the doctor individually, depending on the indications and severity of the disease.

Where are you

The drug should not be used by children.

Overdose

Dangerous dose for adults - 150 mg / kg of body weight.

Symptoms of chronic secondary poisoning (the result of long-term use of high doses of the drug): dizziness, ringing in the ears, deafness, vasodilation, increased sweating, nausea, vomiting, headache, blurred consciousness.

Symptoms of severe and acute poisoning (due to overdose): hyperventilation of the lungs, fever, anxiety, ketosis, respiratory alkalosis and metabolic acidosis.

In the case of severe poisoning, oppression of the central nervous system can lead to coma, cardiovascular collapse and respiratory arrest.

Acute poisoning with acetylsalicylic acid (> 300 mg / kg) often causes acute hepatic failure, and a dose of more than 500 mg / kg can be fatal.
Treatment In case of acute overdose, it is necessary to wash the stomach and take activated charcoal.

It is necessary to restore the balance of fluid and electrolytes to avoid acidosis, hyperpyrexia, hypercalemia and dehydration. Effective methods for removing salicylate from the plasma are alkaline diuresis, hemodialysis or hemoperfusion.

Adverse reactions

The undesirable effects in frequency of occurrence are classified according to the following categories: very common (> 1/10); often (> 1/100, <1/10); Uncommon (> 1/1000, <1/100), rarely (> 1/10000, <1/1000), very rarely (<1 / 10,000, including isolated cases).

Blood and lymphatic system disorders.

Very common: increased bleeding, inhibition of platelet aggregation.
Uncommon: Concealed bleeding.

Rarely: Anemia in the case of long-term therapy.

Very rarely: hypoprotrombinemia (high doses), thrombocytopenia, neutropenia, aplastic anemia, eosinophilia, agranulocytosis.

Immune system disorders.

Uncommon: anaphylactic reactions, allergic rhinitis.

Disorders of the endocrine system.

Rarely: hypoglycemia.

Disturbances from the nervous system.

Often: headache, insomnia.

Uncommon: dizziness (vertigo), drowsiness.

Rarely: intracerebral hemorrhage.

Violations from the sensory organs.

Uncommon: ringing in the ears.

Rarely: dose-dependent reversible loss of hearing and deafness.

Disorders of the respiratory system.

Often: bronchospasm (in patients with asthma).

Disorders of the digestive tract.

Very common: heartburn, reflux.

Often: erosive lesions of the upper department of the digestive tract, nausea, dyspepsia, vomiting, diarrhea.

Uncommon: ulcers of the upper department of the digestive tract, including vomiting with blood and a stomach-type stool.

Rarely: gastrointestinal bleeding, perforation.

Very rarely, stomatitis, esophagitis, toksycheskoe defeat with yazvamy nyzhneho Division of pyschevarytelnoho tract, strictures, colitis, exacerbations syndrome razdrazhennoy colon.
Violations co storony liver.

Rarely: Increase urovnja transaminases and alkaline phosphatase sera.

Very rarely, dose-dependent Acute hepatitis oboratymыy an average degree.

Violations co storony skin.

Common: krapyvnytsa, sыp razlychnoho nature, anhyoэdema, purple, gemorragichesky vaskulit, multyformnaya эrytema, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Shelf life

2 years Do not apply after the expiry date stated on the packaging.

Storage conditions

Store in original packaging at a temperature not exceeding 25 ºС. Keep out of the reach of children.

Packaging

10 tablets in blister. At 3 or 5 blysterov in packs.

Vacation category

Without prescription - 30 pills.
Prescription - 50 pills.


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