Thrombo ACC (Acetylsalicylic acid) tablets

The composition and form of issue 

Tablets, covered enteric coated film-coated:

1 tablet contains: acetylsalicylic acid 50 mg and 100 mg,

excipients: lactose, cellulose microcrystalline, silica colloidal anhydrous, potato starch, talc, glycerol triacetate + poly(ethylacrylate, methyl acrylate) (Eudragit L30D).

blistere in 10 PCs., in box 3 blister.

Registration number

P # 013722/01-2002 27.02.02

Pharmacological action

The operation. Reduces blood clotting by reducing platelet aggregation by suppressing synthesis of thromboxane A2 in them.

The use of Thrombotic ACC, starting with doses of 50 mg, leads to prolonged reduction of 90-95% of serum thromboxane A2 and its metabolites.

Tablets covered with a film of the drug is enteric-coated, resistant to the action of gastric juice, thereby decreasing the risk of side effects from the stomach.

Pharmacokinetics

Suction

Enteric coating prevents the absorption of acetylsalicylic acid in the stomach. The average Cmax observed after 3 h after administration of the drug inside.

Distribution

The plasma protein binding 80-85%, the degree of binding is reduced to 50% with increasing doses of acetylsalicylic acid.

Metabolism

Acetylsalicylic acid undergoes partial metabolism in a liver with formation of active metabolites (salicylic acid, salicylic glucuronide).

Excretion

Excreted by the kidneys both in unchanged form and as metabolites. The rate and extent of excretion of unchanged active substance and metabolites depends on the pH of urine (free of salicylic acid may be from 85% of the total excretion in alkaline urine to 10% with an acid reaction).

Testimony

– primary prevention of myocardial infarction (risk reduction of myocardial infarction in patients with coronary artery disease),

– secondary prevention of myocardial infarction,

– prevention of violations of cerebral circulation by ischemic type

– prevention of thrombosis and embolism including patients with increased risk of their occurrence (after operations on the heart and blood vessels, coronary artery bypass grafting).

Contraindications

– erosivno-azwenne shock syndrome in acute phase,

– increased bleeding, blood clotting disorders, hemophilia,

– nephrolithiasis,

– “aspirin triad”,

– hypothrombinemia,

– the deficit glukozo-6-fosfatdegidrogenaza,

– lactation (breastfeeding),

– child and adolescence to 18 years,

– hypersensitivity to acetylsalicylic acid and its derivatives.

Method of application and doses

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

Tablets should be taken with liquid, squeezed small amount of liquid.

Side effects

Allergic reactions: bronchospasm, skin rash. In predisposed patients – provocation of asthma attacks.

From the digestive system: nausea, vomiting, diarrhea.

On the part of the hemopoietic system: thrombocytopenia, iron deficiency anemia (due to hidden bleeding from the digestive tract).

From the reproductive system: the elongation of menstruation.

Long-term use of the drug in high doses, possible renal dysfunction, dizziness, tinnitus, ulcerative lesions of the gastrointestinal tract, bleeding.

In General, Thrombotic acc well tolerated by patients (due to low content of acetylsalicylic acid in preparation). Side effects are in some cases.

Pregnancy and lactation

Do not recommend the use of Thrombotic acc in the third trimester of pregnancy, and the use of the drug as part of combination therapy in I and II trimesters of pregnancy.

Thrombotic acc is contraindicated in lactation (breastfeeding).

Special instructions

Use caution when prescribing the drug to patients with the history of hypersensitivity reactions when using NSAIDs, with erosive-ulcerative and inflammatory diseases of the gastrointestinal tract beyond the phase of exacerbation, disorders of the liver and/or kidneys.

In applying the drug development of habituation were not observed.

Overdose

Overdose is unlikely due to low content of acetylsalicylic acid in the product.

Symptoms: nausea, vomiting, tinnitus, General malaise.

Treatment: artificial vomiting, the appointment of activated charcoal, laxatives, if necessary, a correction of the AAR.

Drug interactions

While the use of Thrombotic ACC enhances the action of anticoagulants, NSAIDs, hypoglycemic agents, methotrexate.

In a joint application, Thrombotic acc with glucocorticoids and ethanol increases the probability of ulcerogenic action of the drug, increases the risk of gastrointestinal bleeding.

While the use of Thrombotic ACC reduces the effect of diuretics (spironolactone, furosemide) and uricosuric drugs (if necessary, combined use Thrombotic acc and the above drugs, the interval must be at least 1-3 h).

Concurrent administration of antacids has no significant effect on the bioavailability of acetylsalicylic acid.

Storage conditions

The drug should be stored in a dry, dark, inaccessible to children place at temperature not exceeding 25°C.

Shelf life:3 years.

Conditions of supply of pharmacies

The drug is approved for use as non-prescription medicines..

* – Price “Thrombotic acc pills 100 mg, 30 PCs.” is extremely reduced. “Thrombotic acc pills 100 mg, 30 pieces” is in the list of vital and essential drugs (EDL), approved by the Government of the Russian Federation for state regulation of prices for medicinal products.