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Nexlizet

Nexlizet Dosage/Direction for Use

Manufacturer:

Daiichi Sankyo Europe GmbH

Distributor:

Zuellig Pharma

Marketer:

Daiichi Sankyo Thailand
Full Prescribing Info
Dosage/Direction for Use
Posology: The recommended dose of Nexlizet is one film-coated tablet of 180 mg/10 mg taken once daily.
Coadministration with bile acid sequestrants: Dosing of Nexlizet should occur either at least 2 hours before or at least 4 hours after administration of a bile acid sequestrant.
Concomitant simvastatin therapy: When Nexlizet is coadministered with simvastatin, simvastatin dose should be limited to 20 mg daily (or 40 mg daily for patients with severe hypercholesterolaemia and high risk for cardiovascular complications, who have not achieved their treatment goals on lower doses and when the benefits are expected to outweigh the potential risks) (see Precautions and Interactions).
Special populations: Elderly patients: No dose adjustment is necessary in elderly patients (see Pharmacology: Pharmacokinetics under Actions).
Patients with renal impairment: No dose adjustment is necessary in patients with mild or moderate renal impairment. There are limited data available in patients with severe renal impairment (defined as estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2), and patients with end-stage renal disease (ESRD) on dialysis have not been studied with bempedoic acid. Additional monitoring for adverse reactions may be warranted in these patients when Nexlizet is administered (see Precautions).
Patients with hepatic impairment: No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh A). Treatment with Nexlizet is not recommended in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment due to the unknown effects of the increased exposure to ezetimibe (see Precautions).
Paediatric population: The safety and efficacy of Nexlizet in children aged less than 18 years have not been established. No data are available.
Method of administration: Each film-coated tablet should be taken orally with or without food. Tablet should be swallowed whole.
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