XOLSTAT TABLETS 10 mg

Land: Malaysia

Sprog: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv bestanddel:

ROSUVASTATIN CALCIUM

Tilgængelig fra:

RANBAXY (MALAYSIA) SDN. BHD.

INN (International Name):

ROSUVASTATIN CALCIUM

Enheder i pakken:

3x10tablet Tablets; 4x7tablet Tablets; 10x10tablet Tablets; 10x10tablet Tablets

Fremstillet af:

RANBAXY (MALAYSIA) SDN. BHD.

Produktets egenskaber

1
_For the Use Only of a Registered Medical Practitioner _
PRESCRIBING INFORMATION
XOLSTAT TABLETS
(Rosuvastatin Calcium Tablets 5 mg / 10 mg / 20 mg)
COMPOSITION
XOLSTAT 5 MG
Each film coated tablet contains
Rosuvastatin Calcium equivalent to
Rosuvastatin ………………. 5 mg
XOLSTAT 10 MG
Each film coated tablet contains
Rosuvastatin Calcium equivalent to
Rosuvastatin ………………. 10 mg
XOLSTAT 20 MG
Each film coated tablet contains
Rosuvastatin Calcium equivalent to
Rosuvastatin ………………. 20 mg
EXCIPIENTS:
XOLSTAT 5 MG tablets also contain: Lactose monohydrate, crospovidone,
microcrystalline cellulose, sodium
citrate, magnesium stearate, opadry yellow (hypromellose, titanium
dioxide, polyethylene glycol / macrogol, yellow
iron oxide).
XOLSTAT 10 MG & 20 MG tablets also contain: Lactose monohydrate,
crospovidone, microcrystalline cellulose,
sodium citrate, magnesium stearate, opadry pink (hypromellose,
titanium dioxide, polyethylene glycol / macrogol,
red iron oxide).
PRODUCT DESCRIPTION
XOLSTAT 5 MG: Light yellow to yellow colored round film coated tablets
with 'RT1' on one side and plain on the
other side.
XOLSTAT 10 MG: Light pink to pink colored round film coated tablets
with 'RT2' on one side and plain on the
other side.
2
XOLSTAT 20 MG: Light pink to pink colored round film coated tablets
with 'RT3' on one side and plain on the
other side.
DESCRIPTION
XOLSTAT tablets contain rosuvastatin calcium, which is a synthetic
lipid-lowering agent for oral administration.
The empirical formula for rosuvastatin calcium is (C
22
H
27
FN
3
O
6
S)
2
Ca and the molecular weight is 1001.14.
The
chemical
name
for
rosuvastatin
calcium
is
bis[(_E_)-7-[4-(4-fluorophenyl)-6-isopropyl-
2-[methyl(methylsulfonyl)amino]
pyrimidin-5-yl](3_R_,5_S_)-3,5-dihydroxyhept-6-enoic
acid]
calcium
salt
with
the
following structural formula:
_ _
ROSUVASTATIN CALCIUM
INDICATIONS
Rosuvastatin is indicated as an adjunct to diet, at least equivalent
to the Adult Treatment Panel III (ATP III TLC
diet), for the reduction of ele