Cardisave 150 mg tablet number 30

Author Ольга Кияница

2017-05-11

Amount in a package 30
Product form Pills
Manufacturer Farmak OJSC (Ukraine, Kiev)
Registration certificate UA/14585/01/01
The main medicament -
morion code 327232

Acetylsalicylic Acid instructions for use

Composition:

active ingredient: acetylsalicylic acid; 1 tablet contains acetylsalicylic acid in terms of 100% dry substance 150 mg;
auxiliary substances: magnesium hydroxide, pregelatinized starch, microcrystalline cellulose (200), silicon dioxide colloidal anhydrous, magnesium stearate; film shell: Opadry II 85G18490 white (polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E 171), lecithin).

Dosage form

Film-coated tablets.

Basic physical and chemical properties

Round tablets with biconvex surface, with a risk, covered with a film coat, white or almost white.

Pharmacotherapeutic group

Antithrombotic agents. Code ATX B01A C06.

Pharmacological properties

Pharmacodynamics.

Acetylsalicylic acid is an analgesic, anti-inflammatory, antipyretic and antiplatelet agent.

The main pharmacological effect is the inhibition of the formation of prostaglandins and thromboxanes. The analgesic effect is an additional effect, which is caused 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 in the body. The effect of acetylsalicylic acid on the biosynthesis of thromboxane in platelets and at the time of bleeding continues for a long time after discontinuation of treatment. The action stops only after the appearance of new platelets in the plasma.

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

Pharmacokinetics.

Absorption. After ingestion, acetylsalicylic acid is rapidly absorbed from the digestive tract. Absorption rate decreases with food intake and in patients with migraine attacks, increases in patients with achlorhydria or in patients who take polysorbates or antacids. The maximum concentration in the blood serum is achieved after 0.5-2 hours.

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

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 the breast milk and can penetrate the placental barrier. Magnesium is distributed with proteins in a bound form (approximately 25-30%). A small amount is excreted in breast milk. Magnesium can penetrate the placental barrier.

Metabolism. Acetylsalicylic acid is hydrolyzed to the active metabolite - salicylate - in the wall of the stomach. After absorption, acetylsalicylic acid quickly turns into salicylic acid, but within the first 20 minutes after ingestion it is the dominant one in the plasma.

Excretion. Salicylate is excreted mainly due to hepatic metabolism. Half-life is 2-3 hours. At a high dose of acetylsalicylic acid, the elimination half-life increases to 15-30 hours. Salicylate is also excreted unchanged in urine. The withdrawn volume depends on the level of the dose and the pH of the urine. Approximately 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 the urine, but most are reabsorbed and excreted with feces.

Indications

Acute and chronic ischemic heart disease.

Contraindications

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

Interaction with other drugs and other interactions

When combined, Cardisave increases the effect of hypoglycemic agents, anticoagulants (eg, warfarin, fenprokumone, clopidogrel, heparin), acetazolamide, methotrexate. Inhibits the action of furosemide, spironolactone, ACE inhibitors. Not recommended for joint use with NSAIDs. Antacids can reduce the absorption of the drug. The clinical significance of the interaction of acetylsalicylic acid and magnesium is minimal due to the small amount of magnesium that is part of the preparation. Use with probenecid weakens the effect of both drugs.

Application features

It is necessary to avoid prolonged joint use of Cardisave with non-steroidal anti-inflammatory drugs, as the risk of side effects increases. In elderly patients with prolonged use of the drug increases the risk of gastrointestinal bleeding.

In the case of a planned surgery, it is recommended to stop taking the drug for a few days.

It should be used with caution in patients with asthma and allergic reactions, dyspepsia, lesions of the gastric mucosa, impaired liver or kidney function. With the use of small doses of acetylsalicylic acid, the excretion of uric acid may decrease.

Use during pregnancy or lactation.

The decision to use Cardidesave in the I-II trimester of pregnancy and during lactation should be taken after a thorough assessment of the benefit / risk ratio. The drug in such cases used in the lowest possible doses (up to 100 mg per day) and under close supervision. The period of application is as short as possible.

The drug is contraindicated in the third trimester of pregnancy.

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

Does not affect.

Dosing and Administration

The recommended initial dose is 150 mg per day. The maintenance dose is 75 mg per day.
Tablets should be swallowed whole, if necessary, washed down with water. If desired, the tablet can be broken in half, chewed or pre-grated.

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

Children

The drug should not be used in children.

Overdose

A dangerous dose for adults is 150 mg / kg body weight.

Symptoms of chronic moderate poisoning (the result of prolonged 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 an overdose): hyperventilation of the lungs, fever, anxiety, ketosis, respiratory alkalosis and metabolic acidosis.

In case of severe poisoning, the depression 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 impairment, and a dose of more than 500 mg / kg can be fatal.
Treatment. In case of acute overdosage, gastric lavage and activated charcoal should be taken.

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

Adverse Reactions

Undesirable effects on the incidence rate are classified into these categories: very often (> 1/10); often (> 1/100, <1/10);infrequently (> 1/1000, <1/100), rarely (> 1/10000, <1/1000), very rarely (<1/10000, including isolated cases).

Violations of the blood and lymphatic system.

Very often: increased bleeding, inhibition of platelet aggregation.
Infrequently: latent bleeding.

Rarely: anemia in case of prolonged therapy.

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

Impaired immune system.

Infrequently: anaphylactic reactions, allergic rhinitis.

Disorders from the endocrine system.

Rarely: hypoglycemia.

Violations from the nervous system.

Often: headache, insomnia.

Infrequently: dizziness (vertigo), drowsiness.

Rarely: intracerebral hemorrhage.

Disorders from the senses.

Infrequent: ringing in the ears.

Rarely: dose-dependent reversible hearing loss and deafness.

Disturbances from the respiratory system.

Often: bronchospasm (in patients with asthma).

Disorders from the digestive tract.

Very often: heartburn, reflux.

Often: erosive lesions of the upper part of the digestive tract, nausea, indigestion, vomiting, diarrhea.

Infrequently: ulcers of the upper part of the digestive tract, including vomiting with blood and tarry stools.

Rarely: gastrointestinal bleeding, perforation.

Very rarely: stomatitis, esophagitis, toxic damage with ulcers of the lower part of the digestive tract, stricture, colitis, exacerbation of irritable bowel syndrome.
Violations of the liver.

Rarely: increased levels of transaminases and serum alkaline phosphatase.

Very rarely: a dose-dependent reversible acute hepatitis of medium degree.

Disturbances from the skin.

Often: hives, various rashes, angioedema, purpura, hemorrhagic vasculitis, erythema multiforme, Stevens-Johnson syndrome, Lyell syndrome.

Shelf life

2 years. Do not use the product after the expiration date printed on the package.

Storage conditions

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

Packaging

10 tablets in a blister pack. For 3 or 5 blisters in a pack.

Category of leave

Without a prescription - 30 tablets.
Prescription - 50 tablets.


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