Table 1 provides a summary of the indications, contraindications, dosage, administration, warnings, precautions, and other relevant information for the drug Prasugrel.
| Table 1. | Summary |
|---|---|
| Indications | Prasugrel, in combination with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndromes undergoing percutaneous coronary intervention (PCI). |
| Contraindications | – Contraindicated for those with hypersensitivity to the active substance or any excipient. – Active bleeding. – Previous stroke or transient ischemic attack. – Severe liver impairment (Child Pugh class C). |
| Dosage | – Initiate with a single 60 mg loading dose, followed by a 10 mg daily dose. – For UA/NSTEMI patients undergoing coronary angiography within 48 hours, the dose should be given at the time of PCI. – Patients taking Prasugrel should also receive ASA (75 mg to 325 mg daily). |
| Administration | Prasugrel is for oral use and can be taken regardless of meals. The tablets should not be crushed or split. |
| Warnings and Precautions | – There’s an increased risk of bleeding, especially in patients aged ≥75 years, those with a bleeding tendency, those weighing less than 60 kg, and those taking medications that increase bleeding risk. – Discontinue Prasugrel at least 7 days before elective surgery. |
| Interactions | – Prasugrel can be administered with ASA, heparin, digoxin, and drugs that raise stomach pH. – ASA: Prasugrel Mylan is intended to be administered with ASA. – Heparin: A single intravenous bolus dose of unfractionated heparin did not significantly change the prasugrel-mediated inhibition of platelet aggregation. – Statins: Atorvastatin did not change the pharmacokinetics of prasugrel. – Drugs that raise stomach pH: Concurrent daily administration of certain drugs did not change the AUC or Tmax of prasugrel’s active metabolite but reduced Cmax. – CYP3A Inhibitors: Ketoconazole did not affect prasugrel-mediated inhibition of platelet aggregation. – CYP3A Inducers: Rifampicin did not change prasugrel’s pharmacokinetics. – Morphine: Delayed and reduced exposure to oral P2Y12 inhibitors, including prasugrel, has been observed in patients treated with morphine. |
| Prasugrel effects on other drugs | – Digoxin: Prasugrel has no clinically significant effect on digoxin’s pharmacokinetics. – Drugs metabolized with CYP2C9: Prasugrel does not inhibit CYP2C9. – Drugs metabolized with CYP2B6: Prasugrel is a weak inhibitor of CYP2B6. |
| Pregnancy | No clinical studies have been conducted on pregnant or breastfeeding women. Animal studies do not indicate direct harmful effects during pregnancy. Prasugrel should only be used during pregnancy if the potential benefit to the mother is deemed to outweigh the potential risk to the fetus. |
| It is unknown if prasugrel is excreted in human breast milk. Animal studies have shown the excretion of prasugrel in breast milk. Use of prasugrel during breastfeeding is not recommended. | It is unknown if prasugrel is excreted in human breast milk. Animal studies have shown excretion of prasugrel in breast milk. Use of prasugrel during breastfeeding is not recommended. |
| Fertility | Prasugrel had no effect on fertility in male and female rats at oral doses. |
| Traffic | Prasugrel has no or negligible effect on driving. |
