Index of drugs

In combination with Acetylsalicylic acid to prevent cardiovascular events in patients with acute coronary syndromes (eg unstable angina, ST-elevation myocardial infarction or ST segment elevation myocardial infarction undergoing primary or delayed percutaneous coronary intervention.

1 tabl powl. contains 5 mg or 10 mg of prasugrel in the form of a hydrochloride. The drug contains lactose.

Platelet aggregation inhibitor. Inhibits the activation and aggregation of platelets through stable binding of the active metabolite to the P2Y class₁₂ ADP receptors on blood platelets, thus reducing the incidence of cardiovascular events, i.e. death, myocardial infarction or stroke. It absorbs quickly. Within the intestine, it undergoes rapid hydrolysis to thiolactone, which is converted by cytochrome P-450 to the active metabolite. C_max the active metabolite occurs after approx. 30 min. It binds 98% of plasma proteins. It is excreted in 68% of the urine in the form of inactive metabolites and in 27% in the faeces. T_0,5 is 7.4 hours.

Hypersensitivity to prasugrel or other components of the preparation. Active pathological bleeding. Stroke or transient ischemic attack. Severe hepatic failure.

It is not recommended for use in children and adolescents under 18 years of age (no data on safety and efficacy). In patients with an increased risk of bleeding (persons ≥ 75 years of age, with a tendency to bleed eg due to recent trauma, surgery, recent or recurrent gastrointestinal bleeding or active peptic ulcer disease, weighing <60 kg, receiving concurrent medicines that may increase the risk of bleeding: oral anticoagulants, Clopidogrel, NSAIDs and fibrinolytics), the preparation should be considered if the benefits of preventing ischemic events are considered to outweigh the risks of severe bleeding. In patients with active bleeding, in whom it is necessary to reverse the pharmacological action of the preparation, platelet transfusion may be helpful. The use is not recommended in patients ≥ 75 years of age; treatment can only be started after a thorough benefit and risk analysis. If treatment is started, a lower maintenance dose of 5 mg should be used. A maintenance dose of 5 mg should also be used for people <60 kg. Caution should be exercised in patients with impaired renal function (including end-stage renal disease) and moderate hepatic impairment. Stopping bleeding while using the preparation may take longer than usual. In patients with unstable angina / non-ST segment elevation myocardial infarction (UA / NSTEMI), where coronary angiography is performed within 48 hours after admission to the hospital, the loading dose should only be given during percutaneous coronary intervention (PCI ) to reduce the risk of bleeding. The preparation should be discontinued at least 7 days before the operation. Within 7 days after discontinuation of prasugrel, the incidence and severity of bleeding in patients undergoing coronary artery bypass surgery may be 3-fold higher. The benefits and risks of prasugrel should be carefully considered in patients whose coronary artery anatomy is unknown and urgent coronary artery bypass surgery may be required. The occurrence of hypersensitivity symptoms in patients allergic to thienopyridine derivatives should be monitored. The drug contains lactose - do not use in patients with rare inherited disorders associated with galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.

The preparation should be used during pregnancy only if the expected benefits to the mother outweigh the potential risk to the fetus. It is not recommended to use the product during breastfeeding.

Common: anemia; hematoma; epistaxis; hemorrhage in the stomach and intestines; rash, bruise; hematuria; hematoma at the site of the blood vessel; hemorrhage at the puncture site; contusion. Uncommon: hypersensitivity, including angioneurotic edema; eye bleeding; hemoptysis; retroperitoneal haemorrhage, rectal haemorrhage, presence of fresh blood in the stool, bleeding of the gums; hemorrhage after surgery. Rare: thrombocytopenia; subcutaneous hematoma. In addition: thrombotic thrombocytopenic purpura; ischemic attack, stroke. There was fatal bleeding.

Orally. Adults: start with a single 60 mg loading dose and continue on a once daily dose of 10 mg; patients should also take acetylsalicylic acid 75-325 mg daily. In patients with acute coronary syndrome undergoing coronary angioplasty, it is recommended to continue treatment for up to 12 months; Early interruption of treatment increases the risk of thrombosis, myocardial infarction or death. Patients aged ≥75 years: not recommended; treatment can only be started after a careful benefit / risk analysis from a single 60 mg loading dose and continued with a 5 mg maintenance dose once a day. Patients <60 kg: start with a single 60 mg loading dose and continue with 5 mg once a day. No dosage adjustment is necessary for patients with renal impairment and mild or moderate hepatic impairment.
The preparation can be taken regardless of meals. Fasting 60 mg loading dose on an empty stomach may result in faster onset of action.