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Препарат АСК. СООО "Лекфарм" Республика Беларусь


Producer: SOOO "Lekfarm" Republic of Belarus

Code of automatic telephone exchange: B01AC06

Release form: Firm dosage forms. Tablets.

Indications to use: Acute myocardial infarction. Stroke. Stenocardia. Embolism. Arterial hypertension. Lipidemia. Obesity. Diabetes mellitus.


General characteristics. Structure:

Active ingredient: 75 mg or 150 mg of acetylsalicylic acid.

Vveshchestva: starch corn, кросповидон (полипласдон XL-10), talc, cellulose microcrystallic.

Structure of a cover: Advantiya Prefered® (gidroksipropilmetiltsellyuloza, коповидон, polydextrose, propylene glycol, triglycerides of an average chain, titanium dioxide, iron oxide yellow), Advantiya Perfomans® (copolymer of methacrylic acid and ethyl acrylate, talc, titanium dioxide, triethyl citrate, silicon dioxide, orange yellow E 110, red charming E 129).

It is used for decrease in risk of thrombosis, including coronary and brain arteries that considerably reduces risk of development of heart attacks, ischemic strokes and other cardiovascular troubles.




Pharmacological properties:

Pharmacodynamics. Acetylsalicylic acid inhibits aggregation of thrombocytes, and also has the febrifugal, anesthetizing and antiinflammatory effect. Aggregation is inhibited even after use of drug in low doses, the effect remains for several days after reception of a single dose. The tablets covered with a kishechnorastvorimy cover are a pharmaceutical form which does not break up in a stomach, and thus the risk of direct contact of acetylsalicylic acid with a mucous membrane of a stomach and its damage decreases. Disintegration of a tablet and release of active ingredient happens only in the environment of a duodenum.


Indications to use:

For decrease in risk:

- death at patients with suspicion of an acute myocardial infarction;

- death at the patients who had a myocardial infarction;

- the tranzitorny ischemic attacks (TIA) and a stroke at patients with TIA;

- incidences and death at stable and unstable stenocardia.

For prevention:

- thromboses and an embolism after operations on vessels (transdermal translyuminarny catheter angioplasty (RTSA), endarterectomy of a carotid artery, aortocoronary shunting (CABG), arteriovenous shunting);

- a deep vein thrombosis and an embolism of lungs after a long immobilization (postsurgeries);

- a myocardial infarction at patients with high - risk of development of cardiovascular complications (a diabetes mellitus, controlled arterial hypertension) and to persons with multifactorial risk of cardiovascular diseases (a lipidemia, obesity, smoking, advanced age, etc.)


Route of administration and doses:

The adult usually appoint on 1-2 tablets 75 mg or 1 tablet of 150 mg a day in time or after food. Tablets should be swallowed entirely, washing down with a small amount of water.

At recently postponed myocardial infarction or for patients with suspicion of a myocardial infarction: the initial sating dose makes 225-300 mg of acetylsalicylic acid of 1 times a day for the purpose of achievement of bystry suppression of aggregation of thrombocytes. The dosage of 300 mg a day can quickly be applied according to therapeutic indications.

Tablets can be chewed for more bystry absorption.


Features of use:

Drug is used with care at:
- hypersensitivity to analgetic, anti-inflammatory, antirheumatic drugs, and also in the presence of an allergy to other substances;
- GIT ulcers, including chronic and recurrent or gastroкишечниые bleedings in the anamnesis;
- simultaneous use of anticoagulants;
- renal failures and/or liver.

In case of prolonged use of drug before reception of an ibuprofen the patient has to consult with the doctor.

At patients with allergic complications, including with bronchial asthma, allergic rhinitis, a small tortoiseshell, a skin itch, hypostasis of a mucous membrane and polipotozy a nose, and also at their combination to persistent infections of respiratory tracts and at patients with hypersensitivity to NPVP against the background of treatment with acetylsalicylic acid development of a bronchospasm or attack of bronchial asthma is possible. At surgeries (including dental) use of the drugs containing acetilsalicylic acid can increase probability of emergence/strengthening of bleeding. At use of small doses of acetylsalicylic acid removal of uric acid can decrease. It can lead to developing of gout at patients with the lowered removal of uric acid.

During treatment by acetylsalicylic acid it is not necessary to take alcohol, considering the increased risk of approach of injury of a mucous membrane of a GIT.

Drug can be used during pregnancy only in that case when other medicines are inefficient.

Use of salicylates in the I trimester of pregnancy in case of some retrospective epidemiological researches was associated with the increased risk of development of inborn defects (палатосхиз "a wolf mouth", heart diseases). However at prolonged use of drug in the therapeutic doses exceeding 150 mg/days, this risk was low: as a result of the research conducted on 32 000 couples "mother - the child", communication between use of acetylsalicylic acid and increase in amount of inborn defects is not revealed.

Salicylates can be applied in I and II trimesters of pregnancy only after ratio assessment risk advantage. According to preliminary estimates, at prolonged use of drug it is desirable not to accept acetylsalicylic acid in the dose exceeding 150 mg/days.

In the III trimester of pregnancy reception of salicylates in high doses (more than 300 mg/days) can cause perenashivany pregnancies and weakening of pains at the time of delivery, and also can result in cardiopulmonary toxicity (to premature closing of ductus arteriosus at children).

Use of acetylsalicylic acid in high doses shortly before childbirth can lead to intracranial bleedings, especially at premature children. Thus, except extremely special cases stipulated by cardiological or obstetric medical indications on the basis of special monitoring, use of acetylsalicylic acid during the last trimester of pregnancy is contraindicated.

Acetylsalicylic acid and its metabolites in small amounts are emitted with breast milk of the feeding women. So far at short-term use of salicylates by mothers approach of undesirable effects at the children who are on GV is not established and in the feeding termination by a breast, as a rule, there is no need. However in case of prolonged use of high doses of acetylsalicylic acid feeding by a breast should be stopped.

It is not necessary to use the drugs containing acetylsalicylic acid, to children with a SARS which is followed or is not followed by fervescence. At some viral diseases, especially at flu A, flu B and chicken pox, there is a risk of development of a syndrome of Ray which is very rare, but life-threatening disease and demands urgent medical intervention. The risk can be raised if acetylsalicylic acid is applied as the accompanying medicine, however relationship of cause and effect in this case is not proved. If the specified states are followed by long vomiting, it can be a sign of a syndrome of Ray. Considering the above-mentioned reasons, use of drug without existence of special instructions (a disease of Kawasaki) is contraindicated to children up to 16 years.

Drug of acetylsalicylic acid does not influence ability to driving of motor transport and control of mechanisms.


Side effects:

From a GIT dyspepsia, pain in epigastric area and abdominal pain, in some cases – a digestive tract inflammation, clinical manifestations of erosive cankers of a GIT which can in rare instances is observed, cause gastrointestinal hemorrhages and perforation with the corresponding laboratory indicators.

Owing to antiagregantny action on thrombocytes acetylsalicylic acid can increase risk of development of bleedings. Such bleedings as intraoperative hemorrhages, hematomas, bleedings from bodies of urinogenital system, nasal bleedings, odontorrhagias were observed, it is rare or very rare – serious bleedings, such as GIT hemorrhages, brain hemorrhages (especially at patients from uncontrollable AG and/or at simultaneous use of anti-haemo static means), in rare instances could threaten life potentially. Hemorrhages can lead to acute and chronic posthemorrhagic anemia / an iron deficiency anemia (owing to the so-called latent microbleeding) with the corresponding laboratory manifestations and clinical symptoms, such as an adynamy, pallor of an integument, hypoperfusion.

At patients with individual hypersensitivity to salicylates development of allergic reactions of skin, including such symptoms as rash, urticaria, hypostasis, an itch is possible. At patients with bronchial asthma increase in frequency of emergence of a bronchospasm is possible; allergic reactions from insignificant to moderate degree potentially affect skin, a respiratory path, a GIT and cardiovascular system. Very seldom observed heavy reactions, including an acute anaphylaxis. Seldom – a tranzitorny liver failure with increase in level of transaminases of a liver.

Dizziness and ring in ears were observed that can demonstrate overdose.


Interaction with other medicines:

Use of acetylsalicylic acid along with a methotrexate in doses of 15 mg/week and more, owing to increase in hematologic toxicity of a methotrexate is contraindicated (decrease in renal clearance of a methotrexate by antiinflammatory agents and replacement by methotrexate salicylates from communication with proteins of plasma).

Combinations which should be applied with care:
- use with a methotrexate in doses less than 15 mg/week increases гематологическю toxicity of a methotrexate (decrease in renal clearance of a methotrexate by antiinflammatory agents and replacement by methotrexate salicylates from communication with proteins of plasma).
- simultaneous use of an ibuprofen interferes with irreversible suppression of thrombocytes atsetisalitsilovy acid. Treatment by an ibuprofen of the patients having risk of cardiovascular diseases can limit cardiotyre-tread effect of acetylsalicylic acid.
- at simultaneous use of drug and anticoagulants the risk of development of bleeding increases. At simultaneous use of high doses of salicylates with NPVP (thanks to mutually exclusive effect) the risk of developing of ulcers and gastrointestinal bleedings increases.
- simultaneous use with uricosuric means, such as бензобромарон, пробенецид, reduces effect of removal of uric acid (thanks to the competition for removal of uric acid renal tubules).
- at simultaneous use with digoxin concentration of the last in a blood plasma increases, owing to decrease in renal excretion.
- at simultaneous use of high doses of acetylsalicylic acid and peroral antidiabetic drugs from group of derivatives of sulphonylurea or insulin the hypoglycemic effect of the last due to hypoglycemic effect of acetylsalicylic acid and replacement of the sulphonylurea connected with proteins of plasma amplifies.
- diuretics in combination with high doses of acetylsalicylic acid reduce filtering by a klubochka thanks to decrease in synthesis of prostaglandins in kidneys.
- the system glucocorticosteroids (except for a hydrocortisone) applied to replacement therapy at Addison's disease during treatment by corticosteroids reduce the level of salicylates in blood and increase risk of overdose after the end of treatment. At use of GKS the risk of development of gastrointestinal bleedings increases.
- selective serotonin reuptake inhibitors: the risk of bleeding from upper parts of a GIT because of a possibility of synergy effect increases. IAPF (APF) in a combination with high doses of acetylsalicylic acid cause decrease in filtering in balls owing to inhibition of vazodilatatorny prostaglandins and decrease in anti-hypertensive effect.
- at simultaneous use with valproic acid acetylsalicylic acid forces out it from communication with proteins of plasma, increasing toxicity of the last.

Alcohol promotes injury of a mucous membrane of a GIT and prolongs a bleeding time owing to a synergism of acetylsalicylic acid and alcohol.


Contraindications:

- hypersensitivity to acetylsalicylic acid, other salicylates or any component of drug;
- the chronic asthma caused by reception of salicylates or NPVP in the anamnesis;
- acute round ulcers;
- hemorrhagic diathesis;
- the expressed renal failure;
- the expressed liver failure;
- the expressed heart failure;
- the combination with a methotrexate in a dose of 15 mg/week or is more.


Overdose:

The overdose of salicylates is possible owing to the chronic intoxication which arose because of long therapy and also owing to acute intoxication which poses threat for life (overdose) and which reasons can be, for example, an accidental use by children or unexpected overdose.

The first symptoms of intoxication acetylsalicylic acid are dizzinesses, nausea, vomiting, a sonitus and increase of breath, balance disturbance. Also other symptoms were observed: a hearing loss, a vision disorder, a headache, the strengthened sweating, motor arousing, drowsiness and a coma, spasms, a hyperthermia, confusion of consciousness. Chronic poisoning with salicylates can have the hidden character as signs and its symptoms are not specific.

In case of reception of a bigger drug dose, than recommended, it is necessary to see urgently a doctor, and in case of acute poisoning it is necessary to address to hospital immediately.

The overdose by drug at elderly patients and at small children (reception big, than the recommended doses or accidental poisoning) requires special attention as in these groups of patients it can lead to death.

At heavy intoxication there come disturbances of acid-base equilibrium and water and electrolytic balance (a metabolic acidosis and dehydration). The Spetsificheky antidote is absent.


Storage conditions:

In the place protected from moisture at a temperature not above 25 °C. List B. To store in the place, unavailable to children. Period of validity 2 years.


Issue conditions:

Without recipe


Packaging:

On 10 or 15 tablets in a blister strip packaging. On three, five or six blister strip packagings on 10 tablets in a pack. On six blister strip packagings on 15 tablets in a cardboard pack.



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