ATOZET

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

ATORVASTATIN CALCIUM TRIHYDRATE, EZETIMIBE

Tersedia dari:

ORGANON PHARMA INDONESIA TBK - Indonesia

INN (Nama Internasional):

ATORVASTATIN CALCIUM TRIHYDRATE, EZETIMIBE

Dosis:

10.9 MG /10 MG

Bentuk farmasi:

TABLET SALUT SELAPUT

Unit dalam paket:

DUS, 3 BLISTER @ 10 TABLET SALUT SELAPUT

Diproduksi oleh:

MSD INTERNATIONAL GMBH (PUERTO RICO BRANCH) L.L.C - Puerto Rico

Tanggal Otorisasi:

2021-06-23

Karakteristik produk

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