Thrombotic ACC tab. p / o captivity. ksh / sol. 50 mg # 100

Release form, composition and packaging

Enteric film coated tablets of white color, round, biconvex

with a shiny, smooth or slightly rough surface.

1 tab.

acetylsalicylic acid 50 mg

Excipients: lactose monohydrate - 65 mg, microcrystalline cellulose - 28.5 mg, colloidal silicon dioxide - 1.5 mg, potato starch - 5 mg.

Shell composition: talc - 2.53 mg, triacetin - 680 μg, copolymer of methacrylic acid and ethyl acrylate (1: 1) (Eudragit L) - 6.79 mg.

Clinical and pharmacological group: NSAIDs.

Antiplatelet agent

Pharmaco-therapeutic group: Antiplatelet agent

pharmachologic effect

Acetylsalicylic acid (ASA) is an ester of salicylic acid, belongs to the group of NSAIDs.

The mechanism of action is based on the irreversible inactivation of the COX-1 enzyme, as a result of which the synthesis of prostaglandins, prostacyclins and thromboxane is blocked.

Reduces aggregation, platelet adhesion and thrombus formation by inhibiting the synthesis of thromboxane A2 in platelets.

Increases the fibrinolytic activity of blood plasma and reduces the concentration of vitamin K-dependent coagulation factors (II, VII, IX, X).

The antiplatelet effect is most pronounced in platelets, because

they are unable to re-synthesize COX.

The antiplatelet effect develops after the use of small doses of the drug and lasts for 7 days after a single dose.

These properties of ASA are used in the prevention and treatment of myocardial infarction, coronary artery disease, complications of varicose veins.

ASA also has anti-inflammatory, antipyretic and analgesic effects.

Pharmacokinetics

Suction

When taken orally, ASA is absorbed from the gastrointestinal tract quickly and completely.

The tablets are enteric coated, which reduces the direct irritant effect of ASA on the gastric mucosa.

ASA is partially metabolized during absorption.

Distribution and metabolism

During and after absorption, ASA is converted into the main metabolite, salicylic acid, which is metabolized mainly in the liver under the influence of liver enzymes to form such metabolites as phenyl salicylate, glucuronide salicylate and salicyluric acid, found in many tissues and in urine.

In women, the metabolic process is slower (less enzyme activity in the blood serum).

ASA and salicylic acid are highly bound to blood plasma proteins (from 66 to 98%, depending on the dose) and are rapidly distributed in the body.

Salicylic acid crosses the placental barrier and is excreted in breast milk.

Withdrawal

T1 / 2 ASA from blood plasma is about 15-20 minutes.

Unlike other salicylates, with repeated administration of the drug, non-hydrolyzed ASA does not accumulate in the blood serum.

Only 1% of ingested ASA is excreted by the kidneys in the form of non-hydrolyzed ASA, the rest is excreted in the form of 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.

Indications

- primary prevention of acute myocardial infarction in the presence of risk factors (such as diabetes mellitus, hyperlipidemia, arterial hypertension, obesity, smoking, old age)

- secondary prevention of myocardial infarction (repeated)

- stable and unstable angina pectoris

- stroke prevention (including in patients with transient cerebrovascular accident)

- prevention of transient disorders of cerebral circulation

- prevention of thromboembolism after surgery and invasive interventions on the vessels (for example, coronary artery bypass grafting, endarterectomy of the carotid arteries, angioplasty and stenting of the coronary arteries)

- prevention of deep vein thrombosis and thromboembolism of the pulmonary artery and its branches (for example, with prolonged immobilization as a result of extensive

Name ENG

THROMBO ASS

Clinical and pharmacological group

NSAIDs.

Antiplatelet agent

ATX code

Acetylsalicylic acid

Dosage

50mg

Structure

1 tablet contains - acetylsalicylic acid 50 mg.

Excipients: lactose, microcrystalline cellulose, colloidal silicon dioxide, potato starch, talc, triacetin, silicone antifoam SE2, eudragit L30D (methacrylic acid and ethacrylate copolymer).

Indications

primary prevention of acute myocardial infarction in the presence of risk factors (such as diabetes mellitus, hyperlipidemia, arterial hypertension, obesity, smoking, old age)

secondary prevention of myocardial infarction (repeated)

stable and unstable angina

stroke prevention (including in patients with transient cerebrovascular accident)

prevention of transient disorders of cerebral circulation

prevention of thromboembolism after surgery and invasive interventions on the vessels (for example, coronary artery bypass grafting, carotid endarterectomy, angioplasty and coronary artery stenting)

prevention of deep vein thrombosis and thromboembolism of the pulmonary artery and its branches (for example, with prolonged immobilization as a result of extensive surgery).

Contraindications

erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase)

gastrointestinal bleeding

hemorrhagic diathesis

bronchial asthma induced by the intake of salicylates and other NSAIDs

a combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and ASA intolerance

simultaneous use with methotrexate at a dose of 15 mg per week or more

severe renal failure (CC less than 30 ml / min)

severe hepatic impairment (class B and higher on the Child-Pugh scale)

chronic heart failure III-IV functional class according to NYHA classification

pregnancy (I and III trimester)

lactation period

age up to 18 years

lactose intolerance, lactase deficiency and glucose-galactose malabsorption

hypersensitivity to ASA, excipients in the drug and other NSAIDs.

With caution: in case of gout, hyperuricemia, gastric ulcer and duodenal ulcer or gastrointestinal bleeding (in history), renal failure (CC more than 30 ml / min), liver failure (below class B on the Child-Pugh scale), bronchial asthma , chronic respiratory diseases, hay fever, nasal polyposis, drug allergies, incl. for drugs of the NSAID group, analgesics, anti-inflammatory, antirheumatic drugs pregnancy (II trimester), with a proposed surgical intervention (including minor, for example, tooth extraction) when taken simultaneously with the following drugs (methotrexate at a dose of less than 15 mg per week, anticoagulants, thrombolytic or antiplatelet agents, NSAIDs and salicylic acid derivatives in high doses digoxin oral hypoglycemic agents (sulfonylurea derivatives) and insulin valproic acid ethanol (alcoholic beverages in particular) selective serotonin reuptake inhibitors ibuprofen).

INN / Active ingredient

Acetylsalicylic acid

Storage conditions and periods

In a dry, dark place at a temperature not exceeding 25 degrees.

Expiration date: 3 years

Specifications

Category

Anticoagulants

Scope of the medicinal product

Heart, vessels, blood

Release form

Tablet

Manufacturer country

Austria

Package quantity, pcs

one hundred

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Lannacher

The amount of the dosage form in the primary package

20 pcs.

Primary packaging type

Blister

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Antiplatelet agent

Anatomical and therapeutic characteristics

B01AC06 Acetylsalicylic acid

Dosage form

Enteric film coated tablets

Dosage (volume) of the substance in the preparation

50 mg

Expiration date in days

1095

Package weight, g

ten

Mode of application

:

Thrombo ACC tablets should be taken orally, without chewing, before meals, with a small amount of liquid. < br> Assign orally at 50-100 mg 1 time / day. < br> Thrombo ACC is intended for long-term use.

The duration of therapy is determined individually.

Information on technical characteristics, delivery set, country of manufacture