Effient 5 mg Tablet (Prasugrel Hydrochloride)

Adult dose

This medicine is for adults weighing 60 kilograms or more and aged under 75 years (body weight ≥ 60 kg, age < 75 years) only. Administer a single oral loading dose of 60 milligrams of prasugrel, followed by a maintenance dose of 10 milligrams once daily. However, for patients at increased risk of bleeding, administer a maintenance dose of 5 milligrams once daily. (See the bleeding risk factors under 1. Warnings and 3. Use with caution in the following patients in Precautions for Use.) For patients with unstable angina/non-ST-segment elevation myocardial infarction, if coronary angiography is performed within 48 hours of admission, the loading dose must be administered at the time of percutaneous coronary intervention (PCI). This medicine may be taken with or without food and must be administered concomitantly with aspirin (75~325 milligrams daily). Patients with renal impairment No dosage adjustment is required for patients with renal impairment; however, since experience with this medicine is limited, it should be administered with caution. Patients with hepatic impairment No dosage adjustment is required for patients with mild to moderate hepatic impairment (Child-Pugh Class A and B); however, since experience with this medicine is limited, it should be administered with caution.

Child dose

Safety and efficacy have not been established in pediatric and adolescent patients 18 years of age or younger.

This medication is an antiplatelet drug that prevents blood clotting. However, taking this medication may increase the risk of bleeding, so it should not be administered, especially to patients with existing bleeding or those at high risk of bleeding. Elderly patients over 75 years old or those weighing less than 60 kg are at greater risk of bleeding, so its use is not recommended. Patients undergoing surgery should discontinue this medication at least 7 days before the surgery, and caution is necessary as bleeding may occur during or after the surgery. This medication may further increase the risk of bleeding when taken with other drugs that elevate bleeding risk, such as warfarin, heparin, and non-steroidal anti-inflammatory drugs. If sudden bleeding symptoms appear, the physician should be notified immediately, and in cases of severe bleeding, treatments such as platelet transfusion may be necessary. Pregnant or breastfeeding women should consult with a physician regarding the use of this medication, and safety and efficacy have not been established in children and adolescents. Additionally, during the use of this medication, special care is required during trauma or surgery due to the risk of bleeding, and it may take longer to stop the bleeding. This medication inhibits platelet function and interferes with blood clotting, so if blood tests or symptoms related to bleeding abnormalities occur, medical personnel should be consulted immediately. Lastly, patients taking this medication should inform healthcare providers of all other medications they are taking, paying special attention to interactions with drugs that pose a bleeding risk.

• Hemorrhage
• intracranial hemorrhage
• gastrointestinal hemorrhage
• puncture site bleeding
• nosebleed
• hemoptysis
• subcutaneous hematoma
• post-procedural bleeding
• retroperitoneal hemorrhage
• retinal hemorrhage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is best kept at room temperature, specifically between 1°C and 30°C.

Appearance

Yellow hexagonal film-coated tablet

Package unit

30 tablets (6 tablets/PTPX5)/carton