Страна: Індонезія
мова: індонезійська
Джерело: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ATORVASTATIN CALCIUM TRIHYDRATE; EZETIMIBE
MERCK SHARP & DOHME PHARMA - Indonesia
ATORVASTATIN CALCIUM TRIHYDRATE; EZETIMIBE
10/10 MG/MG
TABLET SALUT SELAPUT
DUS, 3 BLISTER @ 10 TABLET SALUT SELAPUT
MERCK SHARP & DOHME - Netherlands
2019-05-21
ATOZET ® (EZETIMIBE/ATORVASTATIN TABLET) 1. INDICATIONS AND USAGE PRIMARY HYPERCHOLESTEROLEMIA ATOZET is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with primary (heterozygous familial and non-familial) hypercholesterolemia or mixed hyperlipidemia. HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HOFH) ATOZET is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis). 2. DOSAGE AND ADMINISTRATION 2.1 GENERAL The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with ATOZET. The dosage should be individualized according to the baseline LDL-C level, the recommended goal of therapy, and the patient’s response. ATOZET can be administered as a single dose at any time of the day, with or without food. 2.2 ADULTS PRIMARY HYPERCHOLESTEROLEMIA The dosage range of ATOZET is 10/10 to 10/40 mg once daily. The recommended starting dose of ATOZET is 10/10 or 10/20 mg once daily. Patients who require a larger reduction in LDL-C (more than 55%) may be started at 10/40 mg once daily. After initiation and/or upon titration of ATOZET, lipid levels should be analyzed within 2 or more weeks and dosage adjusted accordingly. DISETUJUI OLEH BPOM: 09/06/2021 EREG100373VR12100070 EREG100373VR12100071 EREG100373VR12100072 DOSAGE IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA The dosage of ATOZET in patients with homozygous familial hypercholesterolemia is 10/40 or 10/80 mg daily. ATOZET should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable. The 10/80 mg dose of ATOZET is not locally available. 2.3 PEDIATRIC PATIENTS Treatment with ATOZET is not recommended. 2.4 GERIATRIC PATIENTS Прочитайте повний документ