Trombolik-kardio of the tab. of p/o of 100 mg No. 20

Trombolik-kardio tab.100 of mg No. 20

Group: Means influencing the system of blood and a hematopoiesis

Acting with the Eastern Military District: acetylsalicylic acid

General characteristic

Composition of medicine:

active ingredient: acetylsalicylic acid;

1 tablet contains acetylsalicylic acid 100 mg;

excipients: cellulose powdery, starch corn, methacrylate copolymer dispersion, talc, triethyl citrate, polysorbate 80, sodium lauryl sulfate.

Dosage form. Tablets covered with a kishechnorastvorimy cover.

Tablet of round shape, coated, white or almost white color, with a biconvex surface. On a break under a magnifying glass the kernel surrounded with one continuous layer is visible.

Name and location of the producer. CIAO "Technologist", Ukraine, 20300,

Cherkassk Region, Uman, Manuilsky St., 8.

Pharmacotherapeutic group.

Antitrombotichesky means. Acetylsalicylic acid. Code of automatic telephone exchange B01A C06.

Pharmacodynamics. Acetylsalicylic acid oppresses aggregation of thrombocytes by blocking of synthesis of thromboxane A ₂ . The mechanism of its action consists in an irreversible inactivation of enzyme of cyclooxygenase (TsOG-1). The designated inhibiting effect is especially significant for thrombocytes as they are not capable to resynthesis of the specified enzyme. Acetylsalicylic acid reveals as well other inhibiting effects on thrombocytes. Thanks to the specified effects, it is applied in many vascular and vascular diseases.

Acetylsalicylic acid belongs to

to group of non-steroidal anti-inflammatory medicaments (NPVS) with analgetic, febrifugal and anti-inflammatory properties. Orally in doses of 0.3 g and 1 g medicament is used for pain relief and at states which are followed by heat of easy degree, such as cold and flu, for decrease in temperature and easing of a joint pain and muscles.

acetylsalicylic acid is quickly and completely soaked up by

After intake from digestive tract. And after absorption it turns into time for the main active metabolite – salicylic acid. The maximum concentration of acetylsalicylic acid in blood plasma is reached in 10-20 min., salicylates – in 20 - 120 min. according to. Thanks to a kishechnorastvorimy cover of the tablets Trombolik-Kardio the release of active agent is carried out not in a stomach, and in the alkaline environment of intestines. Therefore absorption of acetylsalicylic acid slows down till 3-6 o'clock after use of the tablet covered with a kishechnorastvorimy cover in comparison with a usual tablet. Acetilsalicylic and salicylic acids completely contact proteins of blood plasma and are quickly distributed in an organism. Salicylic acid gets through a placenta and also gets to breast milk. Salicylic acid is exposed to metabolism in a liver. Salitsilmochevy acid, salitsilfenol a glucuronide is metabolites of salicylic acid, the glucuronide, gentisic acid and gentizinmochevy acid salitsilatsit. The kinetics of removal of salicylic acid depends on a dose as metabolism is limited to activity of enzymes of a liver. Elimination half-life depends on a dose and increases of 2-3 o'clock at use of low doses till 15 o'clock at use of high doses. Salicylic acid and its metabolites are removed from an organism mainly by kidneys.

Indications.

For risk reduction:

• death at patients with suspicion of an acute myocardial infarction;
• death at the patients who had a myocardial infarction;
• the tranzitorny ishemichny attacks (TIA) and a stroke at patients with TIA;
• diseases and death in stable and unstable stenocardia.

For prevention:

• thromboses and embolisms after operations on vessels (transdermal translyuminarny catheter angioplasty (RTSA), endarterectomy of a carotid, aortocoronary shunting (CABG), arteriovenous shunting);
• a deep vein thrombosis and embolisms of lungs after a long immobilization (after surgeries);
• a myocardial infarction at patients with high risk of development of cardiovascular complications (diabetes, the controlled arterial hypertension) and to persons with multiple-factor risk of cardiovascular diseases (a lipidemia, obesity, smoking, advanced age, etc.);
• stroke (secondary prevention).

Contraindication.

• Hypersensitivity to acetylsalicylic acid, other salicylates or any component drug.
• The chronic asthma caused by use of salicylates or NPVS in the anamnesis.
• Acute round ulcers.
• Hemorrhagic diathesis.
• Profound renal failure.
• Profound liver failure.
• Profound heart failure.
• A combination with a methotrexate in a dosage of 15 mg/week or more (see. "Interaction with other medicines and other types of interactions").
• The III trimester of pregnancy.
• Children's age up to 16 years.

Special cautions .

Trombolik-Kardio's

is applied with care at: hypersensitivity to analgetic, anti-inflammatory, antirheumatic medicaments and also in the presence of an allergy to other substances; digestive tract ulcers, including chronic and recurrent peptic ulcers or gastrointestinal bleedings in the anamnesis; simultaneous use of anticoagulants; disturbances of functions of kidneys and/or liver.

In cases of prolonged use of the medicament Trombolik-Kardio 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 itching, hypostasis of a mucous membrane and polipozy a nose and also at their combination to persistent infections of airways and in patients with hypersensitivity to NPVS against the background of the Trombolik-Kardio medicament treatment the development of a bronchospasm or attack of bronchial asthma is possible

.

At surgeries (including dental) use of the medicaments containing acetylsalicylic acid can increase the probability of emergence/strengthening of bleeding.

At use of small doses of acetylsalicylic acid the removal of uric acid can decrease. It can lead to developing of gout at patients in whom removal of uric acid is reduced.

should not use the medicaments containing acetylsalicylic acid, to children with the acute respiratory viral infection (ARVI) which is followed or is not followed by fervescence, without consultation with the doctor. In some viral diseases, especially 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 demanding urgent medical intervention. The risk can be increased if acetylsalicylic acid is applied as the accompanying medicine, but relationship of cause and effect in this case is not proved. If the specified states are followed by long vomiting, it can be sign of a syndrome of Ray.

Use during pregnancy or feeding by a breast.

Trombolik-Kardio's

can be applied during pregnancy only if other medicines are inefficient.

Use of salicylates in І a pregnancy trimester in some retrospective epidemiological tests was associated with the increased risk of development of congenital defects (palatoskhizis ("a wolf mouth"), heart diseases). But at prolonged use of medicament in the therapeutic doses exceeding 150 mg/days, this risk is low: as a result of the research conducted on 32,000 couples "mother - the child", communication between use of the medicament Trombolik-Kardio and increase in amount of congenital defects is not revealed.

Salicylates can be applied in І and ІІ pregnancy trimesters only after ratio assessment risk/advantage. It agrees with the previous estimates, at prolonged use of the medicament Trombolik-Kardio it is undesirable to accept acetylsalicylic acid in the dose exceeding 150 mg/days.

intake of salicylates at high doses (more than 300 mg/days) can lead

In the III trimester of pregnancy to a perenashivaniye of pregnancy and weakening of pains during childbirth and also to cardiopulmonary toxicity (premature closing of ductus arteriosus) in children.

Use of acetylsalicylic acid in high doses before childbirth can lead

to intracranial bleedings, especially in premature children. Thus, except extremely special cases caused by cardiological or obstetric medical indications with use of special monitoring, use of acetylsalicylic acid during the last trimester of pregnancy is contraindicated.

Salitsilati's

and their metabolites get into breast milk in a small amount.

As side reactions at babies after accidental use of the medicament Trombolik-Kardio were not observed by

, it is not required to interrupt feeding with a breast, as a rule. At prolonged use of medicament or use of acetylsalicylic acid at high doses it is necessary to resolve an issue of the feeding termination by a breast.

Ability to influence speed of response at control of motor transport or work with other mechanisms.

does not influence.

Children

Considering the above-stated reasons, aged up to 16 years the use of medicament without availability of special indications (disease of Kawasaki) is contraindicated to children.

Route of administration and doses.

Trombolik-Kardio's

is appointed to adults and children 16 years are more senior. The medicament is taken inside to food, without chewing, wash down with enough liquid.

For reduction of risk of death in patients with suspicion of an acute myocardial infarction use medicament in a dose of 100 mg a day. Dosing of 300 mg a day can quickly be applied according to therapeutic indications. To reach fast absorption, the first tablet needs to be chewed.

To reduction of risk of death in the patients who had a myocardial infarction are applied by 100 mg a day. Dosing of 300 mg a day can quickly will be applied according to therapeutic indications.

apply To secondary prevention of a stroke in a dose 100 mg a day. Dosing of 300 mg a day can quickly be applied according to therapeutic indications.

To reduction of risk of TIA and a stroke in patients with TIA are applied by 100-200 mg a day. Dosing of 300 mg a day can quickly be applied according to therapeutic indications.

For reduction of risk of development of a disease and death at patients with stable and unstable stenocardia: from 100 mg a day. Dosing of 300 mg a day can quickly be applied according to therapeutic indications.

To prevention of thromboses and embolisms after operations on vessels (chrezkozhny translyuminarny catheter angioplasty (RTSA), endarterectomy of a carotid, aortocoronary shunting (CABG), arteriovenous shunting) is applied from 100 mg to 300 mg a day.

For prevention of a deep vein thrombosis and embolisms of lungs after a long condition of an immobilization (after surgeries) – 100-200 mg a day or 300 mg a day every other day.

To prevention of a myocardial infarction in patients with high risk of development of cardiovascular complications (diabetes, the controlled arterial hypertension) and to persons with multiple-factor risk of cardiovascular diseases (lipidemia, obesity, smoking, advanced age) are applied by 100 mg a day. Dosing of 300 mg a day can quickly be applied according to therapeutic indications.

Prevention:

to Children needs to appoint medicament by

taking into account information stated in the section of the Instruction "Special Cautions".

Overdose.

Overdose of salicylates is possible

owing to the chronic intoxication which resulted from long therapy (use more than 100 mg/kg/days can cause more than 2 days toxic effects) and also owing to the acute intoxication posing threat of life (overdose) and the reasons which accidental use by children or unexpected overdose can be, for example.

Chronic poisoning with salicylates can have the hidden character as signs and symptoms its not specific. The moderate chronic intoxication caused by salicylates or a salitsilizm meets, as a rule, only after repeated receptions of high doses.

Symptoms. Dizziness, vertigo, a ring in ears, deafness, sweating strengthening, nausea and vomiting, a headache, confusion of consciousness. The specified symptoms can be controlled a dose decline. The ring in ears can meet at concentration of salicylates in blood plasma higher than 150-300 mkg/ml. More serious side reactions meet at concentration of salicylates in blood plasma higher than 300 mkg/ml.

significant change of acid-base balance which can differ depending on age and weight of intoxication testifies To acute intoxication. The metabolic acidosis is the most general indicator for children. Weight of a state cannot be estimated only on the basis of concentration of salicylates in plasma. Absorption of acetylsalicylic acid can slow down in connection with a delay of gastric release, forming of concrements in a stomach or in case of administration of medicament in the form of the tablets covered with a kishechnorastvorimy cover.

Treatment. Treatment of intoxication caused by overdose by acetylsalicylic acid is defined by severity, clinical symptoms and is provided with standard methods, applied in poisoning. All taken measures have to be directed to acceleration of removal of medicament and recovery of electrolytic and acid-base balance. Apply activated carbon, the forced alkaline diuresis. Depending on a condition of acid-base equilibrium and electrolytic balance carry out infusional administration of solutions of electrolytes. In serious poisonings the hemodialysis is shown.

Side effects.

• Digestive tract : dyspepsia, pain in epigastric area and abdominal pain; in some cases – inflammation of digestive tract, digestive tract erosive cankers which can cause in isolated cases gastrointestinal hemorrhages and perforation with the corresponding laboratory indicators and clinical manifestations.
• Central nervous system : dizzinesses and a ring in ears were observed that can demonstrate overdose.
• Haematogenic system : owing to antiagregantny action on thrombocytes acetylsalicylic acid can increase risk of developing bleedings. Such bleedings as intraoperative hemorrhages, hematomas, bleedings from bodies of an urinogenital system, nasal bleedings, odontorrhagias were observed; seldom or very seldom – serious bleedings, such as digestive tract hemorrhages, brain hemorrhages (especially at patients with not controlled arterial hypertension and/or at simultaneous use of anti-hemostatics) which in isolated cases 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 asthenia, pallor of an integument, hypoperfusion.
• Liver: it is rare – a tranzitorny liver failure with increase in level of transaminases of a liver.
• Allergic reactions : at patients with individual hypersensitivity to salicylates the development of allergic reactions of skin, including such symptoms as rash, urticaria, hypostasis, an itching is possible. At patients with bronchial asthma the increase in frequency of emergence of a bronchospasm is possible; allergic reactions from insignificant to moderate degree, potentially striking skins, a respiratory path, digestive tract and a cardiovascular system. Very seldom observed heavy reactions, including an acute anaphylaxis.

Interaction with other medicines and other types of interaction.

Contraindication for interaction.

Use of a methotrexate in doses of 15 mg/week and more increases hematologic toxicity of a methotrexate (decrease in renal clearance of a methotrexate by anti-inflammatory agents and replacement by methotrexate salicylates from communication with plasma proteins).

Combination which need to be applied with care.

When using a methotrexate in doses less than 15 mg/week increase hematologic toxicity of a methotrexate (decrease in renal clearance of a methotrexate by anti-inflammatory agents and replacement by methotrexate salicylates from communication with plasma proteins).

Simultaneous use of an ibuprofen interferes with irreversible inhibition of thrombocytes acetylsalicylic acid. Treatment by an ibuprofen of the patients having risk of cardiovascular diseases can limit kardioprootektorny effect of acetylsalicylic acid.

At simultaneous use of the medicament Trombolik-Kardio and anticoagulants the risk of developing bleedings increases.

At simultaneous use of high doses of salicylates from NPVS (thanks to the mutually strengthening effect) the risk of developing of ulcers and gastrointestinal bleedings increases.

Simultaneous use with urikozurichny means, such as benzobromaron, probenetsid, reduces effect of removal of uric acid (thanks to the competition of removal of uric acid renal tubules).

At simultaneous use with digoxin the concentration of the last in plasma increases owing to decrease in renal excretion.

At simultaneous use of high doses of acetylsalicylic acid and oral anti-diabetic medicaments 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 plasma proteins amplifies.

Diuretic means in a combination with high doses of acetylsalicylic acid reduce filtration of balls thanks to decrease in synthesis of prostaglandins in kidneys.

System glucocorticosteroids (excepting a hydrocortisone) which are applied to the substituted therapy in 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 with corticosteroids the risk of developing gastrointestinal bleeding increases.

Angiotenzinpreobrazuyushchy enzymes (APF) in a combination with high doses of acetylsalicylic acid cause decrease in filtration in balls owing to inhibition of vazodilatatorny prostaglandins and decrease in antihypertensive effect.

At simultaneous use with valproic acid acetylsalicylic acid forces out it from communication with plasma proteins, increasing toxicity of the last.

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

Expiration date.

3 years.

Storage conditions.

to Store

at a temperature not over 25 ⁰ S.

to Store out of children's reach.

Packing.

On 10 tablets dosing of 100 mg in blisters.

On 2 blisters in a pack from cardboard.

Category of release.

Without prescription.