acetylsalicylic acid - 75.00 mg;
magnesium hydroxide - 15.20 mg.
microcrystalline cellulose - 83.90 mg,
croscarmellose sodium - 8.00 mg,
povidone-K25 - 6.00 mg,
magnesium stearate - 1.90 mg.
hypromellose - 2.40 mg,
macrogol-4000 - 0.60 mg,
titanium dioxide - 1.00 mg.
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 drug Phazostabil, has an antacid effect and protects the mucous membrane of the gastrointestinal tract from the effects of ASA.
- 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 recurrent 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.
- Hypersensitivity to ASA, excipients of the drug and other non-steroidal anti-inflammatory drugs (NSAIDs);
- Cerebral hemorrhage;
- Bleeding tendency (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 cyclooxygenase-2 (COX-2) inhibitors (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 the 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 the age of 18.
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:
infrequently - urticaria, angioedema (angioedema), skin rash, itching, rhinitis, edema of the nasal mucosa;
very rarely - anaphylactic shock, cardio-respiratory distress syndrome.
From the gastrointestinal tract:
very often - heartburn;
often - nausea, vomiting;
infrequently - pain in the abdomen, ulcers of the mucous membrane of the stomach and duodenum, including perforated (rarely), gastrointestinal bleeding;
very rarely - stomatitis, esophagitis, erosive lesions of the upper gastrointestinal tract (including with strictures), colitis, irritable bowel syndrome.
From the respiratory system, chest and mediastinal organs:
often - bronchospasm.
On the part of the blood and lymphatic system:
very often - increased bleeding;
rarely - anemia; very rarely - aplastic anemia, hypoprothrombinemia, thrombocytopenia, neutropenia, leukopenia, eosinophilia, agranulocytosis.
There are reports of cases of hemolysis and hemolytic anemia in patients with severe glucose-6-phosphate dehydrogenase deficiency.
From the nervous system:
often - headache, insomnia;
infrequently - dizziness, drowsiness; rarely - tinnitus, intracerebral hemorrhage.
From the side of the kidneys and urinary tract:
very rarely - impaired renal function.
Influence on the results of laboratory and instrumental studies:
rarely - increased activity of "liver" enzymes.
- With the simultaneous use of ASA, it enhances the effect and increases the risk of toxicity:
- valproic acid (due to displacement from the connection with blood plasma proteins);
- ASA enhances the effect and increases the risk of adverse reactions:
- hypoglycemic agents for oral administration (sulfonylurea derivatives) and insulin due to the hypoglycemic properties of ASA itself in high doses (more than 2 g per day) and displacement of sulfonylurea derivatives from the connection with proteins blood plasma
- thrombolytic agents, heparin, indirect anticoagulants (ticlopidine, warfarin), antiplatelet agents (including clopidogrel, dipyridamole) - due to the synergism of the main therapeutic effects and displacement from the connection with blood plasma proteins;
- sulfonamides, including co-trimoxazole - due to displacement from the bond with blood plasma proteins and an increase in plasma concentration;
- carbonic anhydrase inhibitors (acetazolamide). Simultaneous use with ASA can lead to the development of severe acidosis and increased toxicity to the central nervous system;
- digoxin and lithium - by reducing the renal excretion of digoxin and lithium with an increase in their concentration in the blood plasma;
- selective serotonin reuptake inhibitors (including sertraline, paroxetine), which can lead to an increased risk of bleeding from the upper gastrointestinal tract (synergism with ASA);
- an additive effect is observed with the simultaneous administration of ASA with ethanol (alcohol): the damage to the mucous membrane of the gastrointestinal tract increases and the bleeding time is lengthened (due to the additive action of ethanol and ASA).
- Reduce the antiplatelet effect of ASA:
- systemic glucocorticosteroids (with the exception of hydrocortisone, which is used for substitution therapy for Addison's disease) (increase the elimination of salicylates);
- antacids containing aluminum and / or magnesium hydroxide, cholestyramine (reduce the absorption of ASA in the gastrointestinal tract);
- ASA in low doses weakens the effect of uricosuric agents (benzbromarone, probenecid, sulfinpyrazone) due to the competitive tubular elimination of uric acid.
- ASA in high doses, like other NSAIDs, can reduce the antihypertensive effect of diuretics (due to a decrease in the glomerular filtration rate due to suppression of the synthesis of renal prostaglandins) and antihypertensive drugs. In particular, due to the competitive blockade of prostacyclin synthesis, the effectiveness of angiotensin-converting enzyme (ACE) inhibitors may decrease.
How to take, course of administration and dosage
The drug Fazostabil is intended for long-term treatment.
The duration of treatment is determined by the doctor.
- 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 Phazostabil containing ASA at a dose of 150 mg for the first day, then 1 tablet containing ASA at a dose of 75 mg 1 time per day.
- Prevention of re-myocardial infarction and blood vessel thrombosis
1 tablet of Fazostabil containing ASA at a dose of 75-150 mg once a day.
- 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.
- Unstable angina pectoris
1 tablet of Fazostabil containing ASA in a dose of 75-150 mg once a day.
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, do 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.
Overdose is especially dangerous in elderly patients.
Overdose symptoms in mild to moderate severity (single dose less than 150 mg / kg):
Dizziness, tinnitus, hearing loss, increased sweating, nausea and vomiting, headache, confusion, tachypnea, hyperventilation, respiratory alkalosis.
Treatment: gastric lavage, repeated intake of activated carbon, forced alkaline diuresis, restoration of water-electrolyte balance and acid-base state.
Overdose symptoms in moderate and severe severity (single dose 150 mg / kg - 300 mg / kg - moderate severity, more than 300 mg / kg - severe poisoning):
Respiratory alkalosis with compensatory metabolic acidosis, hyperpyrexia, hyperventilation, noncardiogenic pulmonary edema , respiratory depression, asphyxia;
on the part of the cardiovascular system:
- violation of the heart rhythm, a pronounced decrease in blood pressure,
- inhibition of cardiac activity;
on the part of the water-electrolyte balance:
- impaired renal function from oliguria up to the development of renal failure, characterized by hypokalemia, hypernatremia, hyponatremia;
- violation of glucose metabolism: hyperglycemia, hypoglycemia (especially in children), ketoacidosis;
- tinnitus, deafness;
- gastrointestinal bleeding;
- hematological disorders: from inhibition of platelet aggregation to coagulopathy, prolongation of prothrombin time, hypoprothrombinemia;
- neurological disorders: toxic encephalopathy and depression of the central nervous system (drowsiness, confusion, coma, convulsions).
Treatment: immediate hospitalization in specialized departments for emergency therapy - gastric lavage, repeated intake of activated charcoal, restoration of water-electrolyte balance and acid-base state, forced alkaline diuresis, symptomatic therapy.
The drug should be used as directed by a doctor.
ASA can provoke bronchospasm, as well as cause attacks of bronchial asthma and other hypersensitivity reactions. Risk factors include a history of bronchial asthma, hay fever, nasal polyposis, chronic respiratory diseases, and allergic reactions to other drugs (eg, skin reactions, itching, urticaria).
ASA can cause bleeding of varying degrees of severity during and after surgery.
A few days before the planned surgery, the risk of bleeding should be assessed in comparison with the risk of ischemic complications in patients taking low doses of ASA. If the risk of bleeding is significant, ASA should be temporarily discontinued.
The simultaneous use of ASA with anticoagulants, thrombolytics and antiplatelet drugs is accompanied by an increased risk of bleeding.
In case of impaired renal function (CC more than 30 ml / min), as well as in case of circulatory disorders arising from atherosclerosis of the renal arteries, chronic heart failure, extensive surgery, sepsis, cases of massive bleeding, caution should be exercised, since in all these cases, ASA can increase the risk of developing acute renal failure / deterioration of renal function.
It is known that the risk of developing acute renal failure increases with the combined use of other NSAIDs with ACE inhibitors or diuretics.
In patients with mild to moderate hepatic impairment, liver function should be monitored regularly.
ASA in low doses can provoke the development of gout in predisposed patients (with reduced excretion of uric acid).
The combination of ASA with methotrexate is accompanied by an increased incidence of side effects from the hematopoietic organs; combined use with valproic acid increases the risk of its toxicity. During the first weeks of the simultaneous use of the drug Phazostabil and methotrexate at a dose of less than 15 mg per week, a blood test should be performed weekly. Careful monitoring must be carried out in the presence of even minor renal dysfunctions, as well as in elderly patients.
The simultaneous use of ASA with anticoagulants, thrombolytic and antiplatelet drugs is associated with an increased risk of bleeding and damaging effects on the mucous membrane of the gastrointestinal tract.
The simultaneous use of the drug Fazostabil with ibuprofen is not recommended in patients with an increased risk of developing cardiovascular diseases, since a decrease in the antiplatelet effect of ASA in doses up to 300 mg leads to a decrease in cardioprotective effects. Patients taking ibuprofen for pain relief should inform their doctor about this.
It is recommended to monitor the concentration of digoxin and lithium in blood plasma at the beginning or at the end of the simultaneous use of the drug Fazostabil; dose adjustment may be required.
When combined with diuretics and antihypertensive drugs (for example, ACE inhibitors), a possible decrease in their effectiveness should be considered.
High doses of ASA have a hypoglycemic effect, which must be borne in mind when prescribing it to patients with diabetes mellitus receiving oral hypoglycemic agents and insulin.
With the simultaneous use of systemic glucocorticosteroids and salicylates, it should be remembered that during treatment, the concentration of salicylates in the blood is reduced, and after the cancellation of systemic glucocorticosteroids, an overdose of salicylates is possible. With prolonged use of low doses of ASA as an antiplatelet therapy, caution should be exercised in elderly patients due to the risk of gastrointestinal bleeding.
With long-term use of the drug Fazostabil, you should periodically monitor a complete blood count and fecal occult blood test, as well as the functional state of the liver.
With the simultaneous administration of ASA with alcohol, the risk of damage to the mucous membrane of the gastrointestinal tract and lengthening of bleeding time is increased.
In severe forms of glucose-6 phosphate dehydrogenase deficiency, ASA can cause hemolysis and hemolytic anemia. Factors that increase the risk of hemolysis and hemolytic anemia are fever, acute infections, and high doses of ASA.
Influence on the ability to drive vehicles and work with mechanisms
During the period of treatment with Fazostabil, care must be taken when driving vehicles and engaging in potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions.
Keep out of the reach of children.
Do not use the drug after the expiration date.