Effient

Effient Dosage/Direction for Use

prasugrel

Manufacturer:

Daiichi Sankyo

Distributor:

Zuellig Pharma

Marketer:

Daiichi Sankyo
Full Prescribing Info
Dosage/Direction for Use
Posology: Adults: Effient should be initiated with a single 60 mg loading dose and then continued at 10 mg once daily.
In UA/NSTEMI patients, where coronary angiography is performed within 48 hours after admission, the loading dose should only be given at the time of PCI (see Precautions, Adverse Reactions and Pharmacology: Pharmacodynamics under Actions). Patients taking Effient should also take ASA daily (75 mg to 325 mg).
In patients with acute coronary syndrome (ACS) who are managed with PCI, premature discontinuation of any antiplatelet agent, including Effient, could result in an increased risk of thrombosis, myocardial infarction or death due to the patient's underlying disease. A treatment of up to 12 months is recommended unless the discontinuation of Effient is clinically indicated (see Precautions and Pharmacology: Pharmacodynamics under Actions).
Patients ≥75 years old: Because of the risk of bleeding (including fatal bleeding) and uncertain effectiveness in patients ≥75 years of age, use of Effient is generally not recommended in these patients, except in high-risk situations (patients with diabetes or history of myocardial infarction) where its effect appears to be greater and its use may be considered. If, after a careful individual benefit/risk evaluation by the prescribing physician (see Precautions), treatment is deemed necessary in the patients age group ≥75 years, then following a 60 mg loading dose a reduced maintenance dose of 5 mg should be prescribed. Patients ≥75 years of age have greater sensitivity to bleeding and higher exposure to the active metabolite of prasugrel (see Precautions, Adverse Reactions and Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
Patients Weighing <60 kg: Effient should be given as a single 60 mg loading dose and then continued at a 5 mg once daily dose.
The 10 mg maintenance dose is not recommended. This is due to an increase in exposure to the active metabolite of prasugrel, and an increased risk of bleeding in patients with body weight <60 kg when given a 10 mg once daily dose compared with patients ≥60 kg (see Precautions, Adverse Reactions and Pharmacology: Pharmacokinetics under Actions).
Renal Impairment: No dose adjustment is necessary for patients with renal impairment, including patients with end-stage renal disease (ESRD) (see Pharmacology: Pharmacokinetics under Actions). There is limited therapeutic experience in patients with renal impairment (see Precautions).
Hepatic Impairment: No dose adjustment is necessary in subjects with mild to moderate hepatic impairment (Child-Pugh class A and B) (see Pharmacology: Pharmacokinetics under Actions). There is limited therapeutic experience in patients with mild and moderate hepatic dysfunction (see Precautions). Effient is contraindicated in patients with severe hepatic impairment (Child-Pugh class C).
Paediatric population: The safety and efficacy of Effient in children below age 18 has not been established. Limited data are available in children with sickle cell anaemia (see Pharmacology: Pharmacodynamics under Actions).
Method of administration: For oral use. Effient may be administered with or without food. Administration of the 60 mg prasugrel loading dose in the fasted state may provide most rapid onset of action (see Pharmacology: Pharmacokinetics under Actions). Do not crush or break the tablet.
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