Phazostabil tab. p / o captivity. 150mg + 30.39mg No. 50

Dosage form

Film-coated tablets of white or almost white color.

Slight marbling of the surface is allowed.

On the fracture of the tablets, an almost white core and a film shell are visible.

Dosage 150 mg + 30.39 mg - round, biconvex, with a line on one side.

Structure

Active ingredients: acetylsalicylic acid - 150.00 mg

magnesium hydroxide - 30.39 mg.

Excipients (core): microcrystalline cellulose - 167.81 mg, croscarmellose sodium - 16.00 mg, povidone-K25 - 12.00 mg, magnesium stearate - 3.80 mg.

Excipients (shell): hypromellose - 4.80 mg, macrogol-4000 - 1.20 mg, titanium dioxide - 2.00 mg.

pharmachologic effect

The mechanism of action of acetylsalicylic acid (ASA) is based on irreversible inhibition of cyclooxygenase (COX-1), as a result of which the synthesis of thromboxane A2 is blocked and platelet aggregation is suppressed.

It is believed that ASA has other mechanisms for suppressing platelet aggregation, which expands the scope of its application in various vascular diseases.

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

The anti-inflammatory effect is associated with a decrease in blood flow due to inhibition of prostaglandin E2 synthesis.

Magnesium hydroxide, which is part of the preparation Phazostabil, has an antacid effect and protects the mucous membrane of the gastrointestinal tract from the effects of ASA.

Pharmacokinetics

Suction

After oral administration, ASA is rapidly and almost completely absorbed from the gastrointestinal tract.

Simultaneous food intake slows down absorption.

Partially metabolized during absorption.

Distribution and metabolism

During and after absorption, ASA is converted into the main metabolite - salicylic acid, which is metabolized under the influence of enzymes, mainly in the liver with the formation of metabolites (phenyl salicylate, glucuronide salicylate and salicyluric acid) found in many tissues and body fluids.

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

The maximum concentration of ASA in blood plasma is achieved within 10-20 minutes after ingestion, salicylic acid - after 0.3-2 hours.

ASA and salicylic acid are highly bound to blood plasma proteins and are rapidly distributed in the body.

The degree of binding of salicylic acid to blood plasma proteins depends on the concentration, not linear.

At low concentrations (less than 100 μg / ml), up to 90% of salicylic acid binds to blood plasma proteins, at high concentrations (more than 400 μg / ml) - up to 75%.

Bioavailability of ASA is 50-68%, salicylic acid - 80-100%.

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

In renal failure, during pregnancy and in newborns, salicylates can displace bilirubin from the association with albumin and contribute to the development of bilirubin encephalopathy.

Withdrawal

ASA and its metabolites are excreted mainly by the kidneys.

The half-life of ASA is 15-20 minutes, salicylic acid - 2-3 hours when taking ASA in low doses and significantly increases when taking ASA in high doses as a result of saturation of enzyme systems.

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

In patients with normal renal function, 80-100% of a single dose of ASA is excreted by the kidneys within 24-72 hours.

Magnesium hydroxide in the doses used does not affect the bioavailability of ASA.

Side effects

The frequency of adverse reactions listed below, in accordance with the classification of the World Health Organization, was determined according to the following: very often (? 1/10)

often (? 1/100, < 1/10)

infrequently (? 1/1000, < 1/100)

rarely (? 1/10000, < 1/1000)

very rare (< 1/10000), including isolated messages.

From the immune system: nothing

Name ENG

FAZOSTABIL

ATX code

Combinations of antiplatelet agents

Dosage

150mg + 30.39mg

Structure

Active ingredients: acetylsalicylic acid - 150.00 mg

magnesium hydroxide - 30.39 mg.

Excipients (core): microcrystalline cellulose - 167.81 mg, croscarmellose sodium - 16.00 mg, povidone-K25 - 12.00 mg, magnesium stearate - 3.80 mg.

Excipients (shell): hypromellose - 4.80 mg, macrogol-4000 - 1.20 mg, titanium dioxide - 2.00 mg.

Indications

Primary prevention of cardiovascular diseases such as thrombosis and acute heart failure in the presence of risk factors (for example, diabetes mellitus, hyperlipidemia, arterial hypertension, obesity, smoking, old age)

- prevention of repeated myocardial infarction and blood vessel thrombosis

- prevention of thromboembolism after surgical interventions on the vessels (coronary artery bypass grafting, percutaneous transluminal coronary angioplasty)

- unstable angina pectoris.

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 2 years

Contraindications

Hypersensitivity to ASA, excipients of the drug and other non-steroidal anti-inflammatory drugs (NSAIDs) - hemorrhage in the brain - a tendency to bleeding (vitamin K deficiency, thrombocytopenia, hemorrhagic diathesis) - chronic heart failure of functional class III-IV according to NYHA classification - bronchial asthma induced by the intake of salicylates and NSAIDs - complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses, and intolerance to ASA or other NSAIDs, including inhibitors of cyclooxygenase-2 (COX-2) (including a history) - erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase) - gastrointestinal bleeding - severe renal failure (creatinine clearance (CC) less than 30 ml / min.) - liver failure (class B and C according to Child-Pugh classification) - pregnancy (I and III trimesters), breastfeeding period - deficiency of glucose-6-phosphate dehydrogenase - simultaneous reception with methotrexate (more than 15 mg per week) - children under 18 years of age. With caution: With gout, hyperuricemia, a history of ulcerative lesions of the gastrointestinal tract or gastrointestinal bleeding, renal failure of mild to moderate severity (CC more than 30 ml / min), liver failure (class A according to Child-Pugh classification) , bronchial asthma, hay fever, nasal polyposis, allergic conditions, in the II trimester of pregnancy, with diabetes mellitus, old age with simultaneous use with the following drugs: methotrexate (less than 15 mg per week), anticoagulants,thrombolytic and antiplatelet agents, NSAIDs and salicylates in high doses, narcotic analgesics, sulfonamides (including co-trimoxazole), carbonic anhydrase inhibitors (acetazolamide), digoxin, lithium, hypoglycemic agents for oral administration (sulfonyl urea derivatives, b), insuripuric acid selective serotonin reuptake inhibitors, ibuprofen, systemic glucocorticosteroids, ethanol (alcohol-containing drugs, drinks) (see the section Interaction with other medicinal products").selective serotonin reuptake inhibitors, ibuprofen, systemic glucocorticosteroids, ethanol (alcohol-containing drugs, drinks) (see the section "Interaction with other drugs").selective serotonin reuptake inhibitors, ibuprofen, systemic glucocorticosteroids, ethanol (alcohol-containing drugs, drinks) (see the section "Interaction with other medicinal products").

INN / Active ingredient

Magnesium hydroxide + acetylsalicylic acid

Specifications

Category

Anticoagulants

Scope of the drug

Heart, vessels, blood

Release form

Tablet

Manufacturer country

Russia

Package quantity, pcs

fifty

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Ozone OOO

The amount of the dosage form in the primary package

50 pcs.

Primary packaging type

Bottle

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Antiplatelet agent

Anatomical and therapeutic characteristics

B01AC30 Platelet aggregation inhibitors in combination

Dosage form

Film-coated tablets

Expiration date in days

730

Package weight, g

85

Mode of application

:

Inside, film-coated tablets of the drug Phazostabil are swallowed whole with water. The drug Fazostabil is intended for long-term treatment. The duration of treatment is determined by the doctor. < br> - Primary prevention of cardiovascular diseases such as thrombosis and acute heart failure in the presence of risk factors (for example, diabetes mellitus, hyperlipidemia, arterial hypertension, obesity, smoking, old age) 1 tablet of the drug Phazostabil containing ASA in dose of 150 mg on the first day, then 1 tablet containing ASA at a dose of 75 mg 1 time per day. < br> - Prevention of recurrent myocardial infarction and blood vessel thrombosis 1 tablet of the drug Fazostabil, containing ASA at a dose of 75-150 mg 1 time per day. < br> - Prevention of thromboembolism after surgical interventions on the vessels (coronary artery bypass grafting, percutaneous transluminal coronary angioplasty) 1 tablet of Phazostabil containing ASA at a dose of 75 - 150 mg once a day. < br> - Unstable angina pectoris 1 tablet of the drug Fazostabil containing ASA at a dose of 75 -150 mg 1 time per day. < br> If you skip the next dose of Fazostabil, you must take the missed dose of the drug as soon as the patient remembers it. To avoid doubling the dose, you should not take the missed pill if the time for taking the next dose is approaching. No peculiarities of action were observed at the first administration or withdrawal of the drug.containing ASA in a dose of 75 - 150 mg 1 time per day. < br> - Unstable angina 1 tablet of the drug Fazostabil containing ASA in a dose of 75 -150 mg once a day. < br> If you miss the next dose of Fazostabil, you must take the missed dose of the drug as soon as the patient remembers it. To avoid doubling the dose, you should not take the missed pill if the time for taking the next dose is approaching. No specific features of the action at the first administration or withdrawal of the drug were observed.containing ASA in a dose of 75 - 150 mg 1 time per day. < br> - Unstable angina 1 tablet of the drug Fazostabil containing ASA in a dose of 75 -150 mg once a day. < br> If you skip the next dose of Fazostabil, you must take the missed dose of the drug as soon as the patient remembers it. To avoid doubling the dose, you should not take the missed pill if the time for taking the next dose is approaching. No specific features of the action at the first administration or withdrawal of the drug were observed.To avoid doubling the dose, you should not take the missed pill if the time for taking the next dose is approaching. No peculiarities of action were observed at the first administration or withdrawal of the drug.To avoid doubling the dose, you should not take the missed pill if the time for taking the next dose is approaching. No peculiarities of action were observed at the first administration or withdrawal of the drug.

Dosage (volume) of the substance in the preparation

:

acetylsalicylic acid - 150.00 mg

magnesium hydroxide - 30.39 mg

Information on technical characteristics, delivery set, country of manufacture "