Thrombotic ass tab n / 100mg kish.rastv.plenochnoy about 100 pieces

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Thrombotic ass tab n / 100mg kish.rastv.plenochnoy about 100 pieces

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Description

Composition
Active substance:
1 tablet contains: 50 mg of acetylsalicylic acid and 100 mg ,.
Excipients:
Lactose monohydrate 65.0 / 60.0 mg Microcrystalline cellulose 28.5 / 27.0 mg silica colloidal 1.5 / 3.0 mg potato starch 5.0 / 10.0 mg; sheath: talcum 2.53 / 3.795 mg Triacetin 0.68 / 1,020 mg, methacrylic acid-ethyl acrylate copolymer (1: 1) (Eudragit L) 6,79 / 10,185 mg.
Description:
Round, biconvex, white, film-coated. Tablet surface smooth or slightly rough, shiny.
Product form:
The tablets coated with enteric film coating of 50 mg and 100 mg. By 14 to 20 tablets or tablets in PVC / Al blister. 2 blisters (for 14 tablets) or 5 blisters (for 20 tablets), together with instructions for use in a cardboard box.
Contraindications
Hypersensitivity to ASA, auxiliary substances in the composition of the drug and other NSAIDs; erosive and ulcerative lesions of the gastrointestinal tract (exacerbation); gastrointestinal bleeding; hemorrhagic diathesis; bronchial asthma induced by intake of salicylates and other NSAIDs; combination of asthma, recurrent nasal polyposis and paranasal sinuses and neperenosimostiASK; combined use with methotrexate at a dose of 15 mg per week or more; pregnancy (I and III trimester) and lactation; age of 18 years; severe renal failure (creatinine clearance (CC) of less than 30 ml / min); severe hepatic insufficiency (class B or higher on the scale of Child-Pugh); chronic heart failure III-IV NYHA functional class classification. lactose intolerance, lactase deficiency and glucose-galactose malabsorption.
Precautions: gout, hyperuricemia, gastric ulcer and duodenum 12 or gastrointestinal bleeding (history), renal failure (creatinine clearance of more than 30 ml / min), hepatic failure (below class B Child-Pugh) asthma, chronic respiratory diseases, hay fever, nasal polyposis, drug allergies, including to drugs NSAIDs group, analgesics, anti-inflammatory and anti-rheumatic agents; pregnancy (II trimester), assuming a surgical procedure (including minor, e.g., tooth extraction); while receiving with the following drugs (. see interaction with other drugs) methotrexate at a dose less than 15 mg per week; anticoagulants, thrombolytic or antiplatelet agents; NSAIDs and salicylic acid derivatives in high doses; with digoxin; with hypoglycemic agents for oral use (sulfonylurea derivatives) and insulin; valproic acid; with alcohol (alcohol in particular); a selective serotonin reuptake inhibitor; ibuprofen.
Dosage
100 mg
Indications
Primary prevention of acute myocardial infarction in the presence of risk factors (e.g., diabetes, hyperlipidemia, hypertension, obesity, smoking, advanced age); secondary prevention of myocardial infarction (repeat); stable and unstable angina; prevention of stroke (including patients with transient ischemic attack); prevention of transient cerebral circulation; prevention of thromboembolism following surgery and invasive interventions on vessels (e.g., coronary artery bypass grafting, carotid endarterectomy, angioplasty and stenting of the coronary arteries); prevention of deep vein thrombosis and pulmonary embolism and its branches (including in long-term immobilization due to extensive surgery).
Interaction with other drugs
With simultaneous use of ASA enhances the effect of the following medicines; if necessary, the simultaneous use of ASA with the above means should consider the need to reduce the dose of these agents: methotrexate, by reducing renal clearance and displace it from its association with proteins; while the use of anticoagulants, thrombolytic and antiplatelet agents (ticlopidine, clopidogrel) indicates increased risk of bleeding as a result of major therapeutic synergistic effects of the means; while the use of drugs having anticoagulant, thrombolytic and antiplatelet effects, there is a growing damaging effect on the gastrointestinal mucosa; selective serotonin reuptake inhibitors, which may lead to increased risk of bleeding from the upper GI tract (synergism with ASA); digoxin, due to the reduction of its renal excretion, which may lead to overdose; hypoglycemic agents for oral use (sulfonylurea derivatives) and insulin hypoglycemic properties due to the very high doses of ASA and displacement of sulfonylurea derivatives connection with plasma proteins; while the use of valproic acid increases its toxicity due to replacement of its connection with plasma proteins;
NSAID derivatives and salicylic acid in high doses (increased risk ulcerogenic effects and bleeding from the gastrointestinal tract as a result of synergism of action); while the use of ibuprofen marked antagonism of irreversible platelet inhibition caused by the action of ASA, which leads to a reduction cardioprotective effects of ASA; ethanol (increased risk of damage to the gastrointestinal mucosa and prolonged bleeding resulting from mutually reinforcing effects of ASA and ethanol).
The simultaneous use of high doses of ASA may weaken the action of the following medicines; if necessary simultaneously with the above purpose ACK resources should consider the need for dose adjustment means listed: any diuretics (when used in conjunction with high doses of ASA in a decline in glomerular filtration rate (GFR) due to a decrease of prostaglandin synthesis in kidney); angiotensin converting enzyme (ACE) inhibitors (marked dose-dependent decrease in glomerular filtration rate by inhibiting prostaglandins possessing vasodilating action, respectively, the attenuation of the hypotensive action. Clinical GFR decline is observed at a daily dose of ASA 160 mg. In addition, there is a decrease of positive cardioprotective effects of ACE inhibitors, designated therapy for patients with chronic heart failure. This effect is also apparent when used in conjunction with ASA in large ozah). uricosuric drugs with action – benzbromarone, probenecid (urikozuricheskogo reduction effect due to competitive suppressing renal tubular excretion of uric acid); while the use of systemic corticosteroids (except hydrocortisone used for replacement therapy Addison’s disease) has increased, and accordingly removal salicylates weakening their action.
Overdose
It can have serious consequences, especially in the elderly and in children. salitsilizma syndrome develops when receiving ACK in a dose of 100 mg / kg / day for more than 2 days due to use of toxic doses of the drug under improper therapeutic uses (chronic poisoning) or single accidental or intentional receiving a toxic dose adult or child (acute poisoning).
Overdose symptoms: -with mild and moderate severity (single dose of less than 150 mg / kg): vertigo, tinnitus, hearing loss, increased sweating, nausea and vomiting, headache, confusion, tachypnea, hyperventilation, respiratory alkalosis. Treatment: gastric lavage, repeated administration of activated charcoal, forced alkaline diuresis, restoring the balance of water and electrolyte and acid-base status.
-with moderate and severe severity (single dose of 150 mg / kg-300 mg / kg, – the average severity of more than 300 mg / kg – severe degree of poisoning): respiratory alkalosis with compensatory metabolic acidosis, hyperpyrexia, hyperventilation, non-cardiogenic pulmonary edema, respiratory depression, apnea; on the part of the cardiovascular system: cardiac arrhythmias, marked reduction in blood pressure, depression of cardiac activity; with the water-electrolyte balance: dehydration, renal failure by oliguria until the development of renal failure characterized by hypokalemia, hypernatremia, hyponatremia; impaired glucose metabolism: hyperglycemia, hypoglycemia (especially in children), ketoacidosis; tinnitus, deafness; gastrointestinal bleeding; haematological disorders: inhibition of platelet aggregation to coagulopathy, prolonged prothrombin time, hypoprothrombinemia; neurological disorders: toxic encephalopathy and depression of the central nervous system (drowsiness, confusion, coma, convulsions). Treatment: immediate hospitalization in a specialized department for Emergency therapy – gastric lavage, repeated administration of activated charcoal, forced alkaline diuresis, hemodialysis, restoring fluid and electrolyte balance and acid-base status, symptomatic therapy.
pharmachologic effect
Pharmacological group:
Antiplatelet agent.
Pharmacodynamics:
Acetylsalicylic acid (ASA) is an ester of salicylic acid, belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs). The mechanism of action is based on the irreversible inactivation of the enzyme cyclooxygenase (COX-1), resulting in blocked synthesis of prostaglandins, prostacyclin and thromboxane. Decreases aggregation, platelet adhesion and thrombus formation by inhibiting thromboxane A2 synthesis in platelets.
It enhances fibrinolytic activity of blood plasma and reduces the concentration of vitamin K-dependent coagulation factors (II, VII, IX, X). Antiplatelet effect is most pronounced in platelets, because they are unable to re-synthesize cyclooxygenase. Antiplatelet effect develops after administration of low doses of drug and continued for seven days after a single dose. These properties of ASA used in the prevention and treatment of myocardial infarction, coronary heart disease, complications of varicose veins.
ASA also has anti-inflammatory, antipyretic and analgesic action.
Pharmacokinetics:
If ingestion of ASA is absorbed rapidly and completely from the gastrointestinal tract. Thrombotic ACC tablets enteric-coated, which reduces direct irritant effect of ASA on the gastric mucosa. ASA is partially metabolized in the absorption time. During and after absorption ASA converted to the major metabolite – salicylic acid, which is metabolized primarily in the liver under the influence of liver enzymes to form metabolites such as phenyl salicylate, and salicylate glucuronide salitsilurovaya acid, found in many tissues and urine. In women, the process of metabolism is slower (lower activity in serum enzymes).
ASA and salicylic acid is highly bound to plasma proteins (66 to 98%, depending on the dose) and rapidly distributed in the organism. Salicylic acid crosses the placenta and is excreted in breast milk.
The half-life ACK from plasma is about 15-20 minutes. Unlike other salicylates, when multiple dose preparation negidrolizirovannaya ACK does not accumulate in the serum. Only 1% of an oral ASA excreted by the kidneys in the form negidrolizirovannoy ACK, the remainder is output as salicylates and their metabolites. In patients with normal renal function 80-100% of a single dose of the drug is excreted by the kidneys within 24-72 hours.
Pregnancy and breast-feeding
Pregnancy
The use of high doses of salicylates in the first 3 months of pregnancy is associated with an increased rate of fetal defects (cleft upper palate, heart defects). The use of salicylates in the I trimester of pregnancy is contraindicated.
In the last trimester of pregnancy salicylates in high dose (300 mg / day) cause inhibition of labor, premature closure of the ductus arteriosus in the fetus, increased bleeding in the mother and the fetus, and the destination just before birth can cause intracranial hemorrhage, especially in premature infants. The use of salicylates in the last trimester of pregnancy is contraindicated.
During II trimester salicylates can be used only with the strong risk assessment and benefits to the mother and fetus, preferably in doses not exceeding 150 mg / day, and short-lived.
Use in lactation
Salicylates and their metabolites in small amounts into breast milk. Accidental intake of salicylates during lactation is not accompanied by the development of adverse reactions in children and does not require stopping breastfeeding. However, long-term use of the drug or applying it at a high dose lactation should be stopped immediately.
Conditions of supply of pharmacies
Without recipe.
side effects
In general Thrombotic ASS® due to the low dosage is well tolerated by patients, however, the following undesirable effects may occur in rare cases:
On the part of the digestive tract: nausea, heartburn, vomiting, pain in the abdomen; rarely – gastric ulcer and duodenal ulcer, including perforated, gastrointestinal hemorrhage, transient liver function abnormalities with increased activity of “liver” transaminases.
The central nervous system: dizziness, hearing loss, tinnitus, which may be a sign of overdosing (see overdose.).
From the hematopoietic system: increased perioperative (intraoperative and postoperative) bleeding, bruising, nose bleeds, bleeding gums, urinary tract bleeding. There are reports of serious cases of bleeding, which include gastrointestinal bleeding and bleeding in the brain (especially in hypertensive patients who have not reached the target blood pressure (BP) and / or receiving concomitant therapy with anticoagulant drugs), which in some cases may wear life-threatening. Bleeding can lead to acute or chronic posthemorrhagic / iron deficiency anemia (e.g., flush due to bleeding) with relevant clinical laboratory symptoms (fatigue, pallor, hypoperfusion).
Allergic reactions: skin rash, pruritus, urticaria, angioedema, rhinitis, swelling of the nasal mucosa, rhinitis, bronchospasm, cardio-respiratory distress syndrome, and severe reactions, including anaphylactic shock.
special instructions
The drug should be used when prescribing physician.
ASA may provoke bronchospasm and also cause bronchial asthma and other hypersensitivity reactions. Risk factors are the availability of a history of asthma, hay fever, nasal polyposis, chronic diseases of the respiratory system as well as of allergic reactions to other drugs (e.g., skin reactions, pruritus, urticaria).
The inhibitory effect of ASA on platelet aggregation persists for several days after administration, and therefore, may increase the risk of bleeding during surgery or postoperatively. If necessary, the absolute exclusion of bleeding during surgery is necessary, if possible, to completely abandon the use of ASA in the preoperative period.
The combination of ASA with an anticoagulant, thrombolytic and antiplatelet drugs is accompanied by an increased risk of bleeding.
ASA in low doses can trigger the development of gout in predisposed individuals (with a reduced excretion of uric acid).
The combination of ASA with MTX accompanied by increased incidence of side effects of hematopoiesis.
High doses of ASA have a hypoglycemic effect, it is necessary to bear in mind when assigning it to patients with diabetes receiving hypoglycemic agents for oral use (sulfonylurea derivatives) and insulin.
When combined appointment of glucocorticosteroids (GCS) and salicylates should be remembered that during treatment the level of salicylates in the blood is reduced, and after discontinuation of corticosteroids possible overdose of salicylates.
We do not recommend the combination of ASA with ibuprofen in patients with an increased risk of cardiovascular disease, as the latter reduces the positive effect of ASA on longevity (reduced cardioprotective effects of ASA).
Exceeding the dose ASA carries a risk of gastrointestinal bleeding.
Overdose is especially dangerous in elderly patients.
When combining ASA with ethanol (alcohol) increased risk of gastrointestinal mucosal damage and bleeding time prolongation.
Effects on ability to drive vehicles / moving machinery
During the period of treatment must be careful when driving vehicles and classes of potentially hazardous activities that require high concentration and psychomotor speed reactions, since the use of the drug Thrombotic ASS® may cause dizziness.
Storage conditions
Stored in a dry place protected from light at a temperature not higher than 25 ° C.
Keep out of the reach of children.
Dosing and Administration
Thrombotic ASS® tablet formulation desirably taken before meals, with plenty of fluids.
The preparation is intended for long term use. The duration of therapy is determined by the doctor.
Primary prevention of acute myocardial infarction in the presence of risk factors: 50-100 mg per day.
Prophylaxis of recurrent myocardial infarction, angina pectoris: 50-100 mg per day.
Prevention of stroke and transient ischemic attack: 50-100 mg per day.
Prevention of thromboembolism following surgery and interventional vascular procedures: 50-100 mg per day.
Prevention of deep vein thrombosis and pulmonary artery and its branches: 100-200 mg (2 tablets) per day.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

VALEANT

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