LIPITOR

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

ATORVASTATIN CALCIUM TRIHYDRATE

Tersedia dari:

PFIZER INDONESIA - Indonesia

INN (Nama Internasional):

ATORVASTATIN CALCIUM TRIHYDRATE

Dosis:

40 MG

Bentuk farmasi:

TABLET SALUT SELAPUT

Unit dalam paket:

DUS, 10 BLISTER @ 10 TABLET SALUT SELAPUT (BULK)

Diproduksi oleh:

PFIZER MANUFACTURING DEUTSCHLAND Gmbh - Germany

Tanggal Otorisasi:

2017-11-24

Karakteristik produk

Generic Name: Atorvastatin
Trade Name: Lipitor
CDS Effective Date: December 15, 2020
Supersedes: January 24, 2020
Approved by BPOM:
2020-0064300
Page 1 of 22
PT. PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
GENERIC NAME: ATORVASTATIN
TRADE NAME: LIPITOR
CDS EFFECTIVE DATE: DECEMBER 15, 2020
SUPERSEDES: JANUARY 24, 2020
DESCRIPTION
Atorvastatin tablets for oral administration contain 10 mg, 20 mg, 40
mg and 80 mg
atorvastatin and the following inactive ingredients: calcium
carbonate, microcrystalline
cellulose, lactose monohydrate, croscarmellose sodium, polysorbate 80,
hydroxypropyl
cellulose,
magnesium
stearate,
Opadry
White
YS-1-7040,
Antifoam
AF
Emulsion
Medical.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
Atorvastatin
calcium
is
a
synthetic
lipid-lowering
agent,
which
is
an
inhibitor
of
3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme
catalyzes
the conversion of HMG-CoA to mevalonate, an early and rate-limiting
step in cholesterol
biosynthesis.
The
empirical
formula
of
atorvastatin
calcium
is
(C
33
H
34
FN
2
O
5
)
2
Ca
•
3H
2
O
and
its
molecular weight is 1209.42. Its structural formula is:
Atorvastatin calcium is a white to off-white crystalline powder,
practically insoluble in
aqueous solutions of pH 4 and below. It is very slightly soluble in
distilled water, pH 7.4
phosphate buffer, and acetonitrile, slightly soluble in ethanol and
freely soluble in
methanol.
DISETUJUI OLEH BPOM : 28/01/2022
ID REG : EREG10024112100282; EREG10024112100283;
EREG10024112100284; EREG10024112100285;
EREG10024112100286; EREG10024112100287;
EREG10024112100288; EREG10024112100289.
Generic Name: Atorvastatin
Trade Name: Lipitor
CDS Effective Date: December 15, 2020
Supersedes: January 24, 2020
Approved by BPOM:
2020-0064300
Page 2 of 22
MECHANISM OF ACTION - Atorvastatin is a selective, competitive
inhibitor of HMG-CoA
reductase, the rate-limiting enzyme that converts HMG-CoA to
mevalonate, a precursor
of sterols, including cholesterol. In patients with homozygous and
heterozygous familial
hypercholes