Tromba ASS

Active material: Acetylsalicylic acid
When ATH: B01AC06
CCF: NSAIDs. Antiplatelet
ICD-10 codes (testimony): G45, I20.0, I21, i26, I63, I74, I82
When CSF: 01.12.11.06.01
Manufacturer: LANNACHER HEILMITTEL Ges.m.b.H. (Austria)

Pharmaceutical form, composition and packaging

Pills, film-coated enteric-coated white, round, lenticular; with a brilliant, smooth or slightly rough surface.

1 tab.
acetylsalicylic acid50 mg
-“-100 mg

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

10 PC. – blisters (3) – packs cardboard.

 

Pharmacological action

NSAIDs. The mechanism of action of aspirin (ASK) It is irreversible inhibition of cyclooxygenase, whereby blocked synthesis of thromboxane A2 and podavlyaetsya aggregation trombotsitov. It is believed, that there are other mechanisms of inhibition of platelet aggregation, that expands the scope of its application in various vascular diseases.

Also has anti-inflammatory, analgesic and antipyretic effect.

 

Pharmacokinetics

Absorption

After oral administration, acetylsalicylic acid is absorbed from the upper small intestine. Cmax plasma observed after an average of 3 h after dosing.

Metabolism

Acetylsalicylic acid is partially metabolized in the liver with the formation of less active metabolites.

Deduction

Excreted by the kidneys in unchanged form, as well as metabolites. T1/2 ASA is about to 15 m, for metabolites – about 3 no.

 

Testimony

- Prevention of acute myocardial infarction in the presence of risk factors (such as diabetes mellitus, hyperlipidemia, arterial hypertension, obesity, smoking, advanced age);

- Secondary prevention of myocardial infarction;

- Unstable angina;

- Prevention of stroke (incl. in patients with transient ischemic);

- Prevention of transient ischemic attacks;

- Prevention of thromboembolism after surgery and invasive procedures on vessels (takix You shall aorto-koronarnoe şuntirovanie, carotid endarterectomy, arterio-venous shunting, Angioplasty sonnыh Arteries);

- Prevention of deep vein thrombosis and pulmonary embolism and its branches (eg, during prolonged immobilization due to major surgery).

 

Dosage regimen

The tablets should be taken orally, without chewing, before eating, drinking a small amount of liquid.

Assign inside of 50 -100 mg 1 time / day.

Thrombo ASS® designed for prolonged use. The duration of therapy is determined individually.

 

Side effect

Allergic reactions: hives, angioedema, anaphylactic reactions.

From the digestive system: nausea, heartburn, vomiting, abdominal pain, ulcers of gastric mucosa and intestine dvenadtsatiprestnoy (incl. ruptured), increase in liver enzymes.

The respiratory system: bronchospasm.

From the hematopoietic system: anemia (rarely), increased bleeding.

CNS: dizziness, noise in ears.

Overall Thrombotic ASS® well tolerated (due to the low content of acetylsalicylic acid in a preparation). Adverse effects were noted in some cases.

 

Contraindications

- Erosive and ulcerative lesions of the gastrointestinal tract, gastrointestinal bleeding;

- “Aspirin” asthma (bronchial asthma, induced by the intake of salicylates, and NSAIDs);

- “aspirinovaâ triad” (a combination of asthma, recurrent nasal polyposis, and paranasal sinuses and intolerance of aspirin);

- Gyemorragichyeskii diatyez;

- The combined use with methotrexate 15 mg or more per week;

- Pregnancy (I and III trimester);

- Lactation (breast-feeding);

- Childhood and adolescence up 18 years;

- Hypersensitivity to acetylsalicylic acid, excipients to the drug and other NSAIDs.

FROM caution prescribed for gout, hyperuricemia, ulcerative lesions of the gastrointestinal tract, or bleeding from the gastrointestinal tract in history, in renal and liver failure, asthma, Chronic respiratory diseases, with hay fever, nasal polyposis, allergic reactions to medications in history, while the use of methotrexate 15 mg or less per week.

 

Pregnancy and lactation

Application of large doses of salicylates in the first 3 months of pregnancy is associated with increased incidence of fetal malformations (cleft palate, heart disease). During II trimester salicylates may be administered only on the basis of strict risk assessment and benefit. Appointment ASA is contraindicated in the last trimester.

Salicylates and their metabolites in small doses into breast milk. Long-term use of salicylates is the reason for the cessation of breastfeeding. Accidental intake of salicylates during lactation is not accompanied by the development of adverse reactions in the child and does not require stopping breastfeeding.

 

Cautions

ASA may provoke bronchospasm, and also cause asthma attacks and other hypersensitivity reactions. Risk factors include the presence of a history of bronchial asthma, hay fever, nasal polyposis, chronic respiratory diseases, and allergic reactions to other drugs (itch, hives).

ASA can cause varying degrees of severity of bleeding during and after surgery.

ASA combination with anticoagulants, thrombolytics, antiplatelet agents associated with an increased risk of bleeding.

ASA in low doses can trigger the development of gout in susceptible individuals, having reduced excretion of uric acid.

ASA combination with methotrexate is accompanied by an increased incidence of side effects from the hematopoietic system.

High doses of ASA have hypoglycemic effect, it is necessary to consider the appointment of her patients with diabetes, receiving hypoglycemic drugs.

When combined with the appointment of the SCS should be remembered, that during the treatment the level in the blood decreased salicylates, and after the abolition of GCS possible overdose of salicylates.

We do not recommend the combination of ASA with ibuprofen, since the latter degrades the beneficial effect of ASA on life expectancy.

When combined with alcohol ASK increased risk of damage to the gastrointestinal mucosa and prolonged bleeding.

 

Overdose

Overdose is unlikely due to the low content of ASA in preparation. Excess doses of ASA runs the risk of gastrointestinal bleeding. Overdose is especially dangerous in the elderly.

Symptoms: nausea, vomiting, noise in ears, dizziness, confusion, general malaise.

Treatment: artificial vomiting, appointment of activated carbon, laxatives; If necessary, a correction of the acid-base balance.

 

Drug Interactions

In an application Thrombotic ASS® enhances the effect of the following medicines:

- 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 agents (ticlopidine);

- Digoxin due to the decrease in its renal excretion;

- Hypoglycemic agents (insulin and sulfonylureas) hypoglycemic properties by itself in high doses of ASA and sulfonylurea derivatives displacement connection with protein;

- Valproic acid due to displacement from its association with proteins.

An additive effect is observed while receiving ASA and ethanol.

ASA reduces the effect of uricosuric agents (ʙenzʙromarona) due to competitive elimination of uric acid tubular.

With simultaneous use of corticosteroids increases the excretion of salicylates and 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 in a dry, protected from light, inaccessible to children at temperature not exceeding 25 ° C. Shelf life – 3 year.

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