ASPINAT CARDIO
Active material: Acetylsalicylic acid
When ATH: B01AC06
CCF: NSAIDs. Antiplatelet
ICD-10 codes (testimony): G45, I20.0, I21, i26, I61, I63, I74, I82
When CSF: 01.12.11.06.01
Manufacturer: VALENTA PHARMACEUTICALS OAO (Russia)
Pharmaceutical form, composition and packaging
◊ Pills, enteric coated white or white with a yellowish tint, round, lenticular, with a faint odor of acetic acid; in cross section showed two layers.
| 1 tab. | |
| acetylsalicylic acid | 100 mg |
Excipients: microcrystalline cellulose, starch 1500, colloidal silicon dioxide (aэrosyl), stearic acid.
The composition of the shell: acrylic-out (a copolymer of methacrylic acid with ethyl acrylate (1:1), Titanium dioxide, talc, triэtiltsitrat, silicon oxide, colloidal anhydrous, natriya carbonate, sodium lauryl), kopovydon, hydroksypropyltsellyuloza (Klucel).
10 PC. – packings Valium planimetric (1) – packs cardboard.
10 PC. – packings Valium planimetric (2) – packs cardboard.
10 PC. – packings Valium planimetric (3) – packs cardboard.
10 PC. – packings Valium planimetric (5) – packs cardboard.
10 PC. – packings Valium planimetric (10) – packs cardboard.
10 PC. – plastic jars (1) – packs cardboard.
20 PC. – plastic jars (1) – packs cardboard.
30 PC. – plastic jars (1) – packs cardboard.
50 PC. – plastic jars (1) – packs cardboard.
100 PC. – plastic jars (1) – packs cardboard.
Pharmacological action
NSAIDs. Antiplatelet. The mechanism of action of acetylsalicylic acid is based on irreversible inhibition of COX, as a result, the synthesis of thromboxane A is blocked2 and podavlyaetsya aggregation trombotsitov. Acetylsalicylic acid also has anti-inflammatory, analgesic and antipyretic effect.
Pharmacokinetics
Absorption
After oral administration, acetylsalicylic acid is absorbed from the upper small intestine. Cmax in blood plasma is achieved on average after 3 hours after oral administration.
Metabolism
Acetylsalicylic acid is partially metabolized in the liver with the formation of less active metabolites.
Deduction
Excreted by the kidneys in unchanged form, and in the form of metabolites.
T1/2 acetylsalicylic acid is about 15 m, for metabolites – about 3 no.
Testimony
- Prevention of acute myocardial infarction in the presence of risk factors (eg, diabetes, hyperlipidemia, arterial hypertension, obesity, smoking, advanced age);
- prevention of recurrent myocardial infarction;
- Prevention of stroke (incl. in patients with transient ischemic);
- prevention of transient cerebrovascular accident;
- Prevention of thromboembolism after surgery and invasive procedures on vessels (eg, coronary artery bypass grafting, carotid endarterectomy, arterio-venous shunting, Angioplasty sonnыh Arteries);
- Prevention of deep vein thrombosis and pulmonary embolism and its branches (eg, with prolonged immobilization as a result of extensive surgery).
Dosage regimen
The tablets should be taken orally, before meals, drinking plenty of fluids. The drug is intended for long-term use. Duration of therapy is determined by the attending physician.
At suspected acute myocardial infarction appointed 100-200 mg / day (The first tablet must be chewed for faster absorption).
To prevention of first-time acute myocardial infarction in the presence of risk factors – 50-100 mg / day.
To prevention of recurrent myocardial infarction, stroke and transient cerebrovascular accidents, prevention of thromboembolic complications after surgery or invasive examinations, unstable angina – 100 mg / day.
To prevention of deep vein thrombosis and thromboembolism of the pulmonary artery and its branches – 100-200 mg / day.
Side effect
From the digestive system: nausea, heartburn, vomiting, pain in the abdomen, erosive and ulcerative lesions of the mucous membrane of the stomach and duodenum (incl. perforation), gastrointestinal bleeding, increase in liver enzymes.
The respiratory system: bronchospasm.
From the hematopoietic system: increased bleeding; rarely – anemia.
CNS: dizziness, noise in ears.
Allergic reactions: hives, angioedema, anaphylactic reactions.
Contraindications
- Erosive and ulcerative lesions of the gastrointestinal tract;
- Gastro-intestinal bleeding;
- Gyemorragichyeskii diatyez;
- Bronchial asthma, induced intake of salicylates, and NSAIDs;
- “aspirinovaâ triad” (Triad Fernan-Vidal: a combination of asthma, recurrent nasal polyposis, and paranasal sinuses and intolerance of aspirin);
- The combined use with methotrexate 15 mg per week or more;
- renal and hepatic failure;
- I and III trimesters of pregnancy;
- Lactation (breast-feeding);
- Up to 18 years;
- Hypersensitivity to the drug;
-hypersensitivity to other NSAIDS.
FROM caution the drug should be used for gout, hyperuricemia; if there is a history of ulcerative lesions of the gastrointestinal tract or gastrointestinal bleeding, kidney and liver failure, asthma, chronic respiratory diseases, hay fever, nasal polyposis, allergic reactions to other drugs; in the II trimester of pregnancy, when combined with methotrexate at a dose of less than 15 mg per week, with deficiency of vitamin K and glucose-6-phosphate dehydrogenase.
Pregnancy and lactation
The drug is contraindicated for use during pregnancy in the 1st and 3rd trimesters.
The use of salicylates in high doses for the first time 3 months of pregnancy is associated with increased incidence of fetal malformations (cleft palate, congenital heart disease).
In the second trimester of pregnancy, salicylates can be prescribed only taking into account a strict assessment of the risk-benefit ratio.
In the III trimester salicylates high dose (more 300 mg / day) cause inhibition of labor, premature closure of the ductus arteriosus in the fetus, increased bleeding in the mother and fetus, and the appointment just before birth may cause intracranial hemorrhage, particularly premature infants.
Salicylates and their metabolites in small amounts are excreted in breast milk. Accidental intake of salicylates during lactation is not accompanied by the development of adverse reactions in the child and does not require stopping breastfeeding. However, if it is necessary to use the drug for a long time or prescribe it in a high dose, breastfeeding should be stopped immediately.
Cautions
The patient should use the drug after consulting a doctor.
It should be taken into account, that acetylsalicylic acid can provoke bronchospasm, and also cause attacks of bronchial asthma and other hypersensitivity reactions. Risk factors include the presence of a history of bronchial asthma, hay fever, nasal polyposis, chronic diseases of the respiratory system, and allergic reactions to other drugs (eg, skin reactions, itch, hives).
It should be taken into account, that when using acetylsalicylic acid during and after surgery, bleeding of varying severity may develop.
The combination of aspirin with anticoagulants, thrombolytic and antiplatelet agents associated with an increased risk of bleeding.
The use of acetylsalicylic acid in low doses may provoke the development of gout in predisposed patients (having reduced excretion of uric acid).
The combination of acetylsalicylic acid with methotrexate is accompanied by an increased incidence of side effects from the hematopoietic system.
When using acetylsalicylic acid in high doses, a hypoglycemic effect is observed, it must be borne in mind when assigning it to patients with diabetes, receiving hypoglycemic drugs.
When concomitantly prescribing corticosteroids and salicylates, one should take into account, that during treatment the level of salicylates in the blood decreases, and after the abolition of GCS possible overdose of salicylates.
Not recommended a combination of acetylsalicylic acid and ibuprofen, since the latter worsens the beneficial influence of Aspinath® Cardio for life.
With the combination of aspirin with alcohol increased the risk of damaging the gastrointestinal mucosa and prolonged bleeding.
Exceeding the dose of acetylsalicylic acid is associated with the risk of gastrointestinal bleeding.
Effects on ability to drive vehicles and management mechanisms
There was no effect of the drug on the ability to drive vehicles or operate machinery..
Overdose
Overdose symptoms of moderate severity: nausea, vomiting, noise in ears, amblyacousia, dizziness, confusion.
Treatment: reducing the dose of the drug.
Symptoms severe overdose: fever, hyperventilation, Ketoacidosis, respiratory alkalosis, coma, cardiovascular and respiratory failure, severe hypoglycemia.
Overdose of acetisalicylic acid is especially dangerous in elderly patients.
Treatment: immediate hospitalization in a specialized department for emergency treatment – gastric lavage, Determination of acid-base balance, alkaline and forced alkaline diuresis, hemodialysis, introduction of solutions, Activated carbon, simptomaticheskaya therapy. During the alkaline diuresis is necessary to achieve a pH between 7.5 and 8. Forced alkaline diuresis should be, when the concentration of salicylate in plasma is greater than 500 mg / l (3.6 mmol / l) adults and 300 mg / l (2.2 mmol / l) children.
Drug Interactions
When used simultaneously, acetylsalicylic acid enhances the effect of the following drugs:
- Methotrexate by reducing renal clearance and displacement of its association with proteins;
- Heparin and indirect anticoagulants due to dysfunction of platelets and displacing anticoagulants from binding with proteins;
- thrombolytic and antiplatelet drugs (ticlopidine);
- digoxin by reducing its renal excretion;
- hypoglycemic drugs (insulin and sulfonylureas) due hypoglycemic properties of the acetylsalicylic acid in high doses and displacement of sulfonylurea derivatives association with proteins;
- valproic acid due to its displacement from binding with proteins.
An additive effect is observed while taking acetylsalicylic acid with ethanol.
Acetylsalicylic acid weakens the effect of uricosuric drugs (ʙenzʙromarona) due to competitive elimination of uric acid tubular.
Enhancing the elimination of salicylates, systemic corticosteroids weaken their action.
Conditions of supply of pharmacies
The drug is resolved to application as an agent Valium holidays.
Conditions and terms
The drug should be stored out of reach of children, dry, dark place at a temperature no higher than 25 ° C. Shelf life – 2 year.
