Capecitabine Sandoz capecitabine 150mg film coated tablet bottle

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

Capecitabine

Tillgänglig från:

Sandoz Pty Ltd

INN (International namn):

Capecitabine

Produktens egenskaper

_Product Information _
_ Page _
_Capecitabine Sandoz 150mg & 500mg Tablet _
_08/2016 _
_Sandoz Pty Ltd _
_ _
_Version 04 _
_1 _
PRODUCT INFORMATION
CAPECITABINE SANDOZ
® 150MG & 500MG TABLET
NAME OF THE MEDICINE
_ _
Capecitabine Sandoz 150mg tablet
Capecitabine Sandoz 500mg tablet
CAPECITABINE
Chemical name: 5’-deoxy-5-fluoro-N-[(pentyloxy)carbonyl]-cytidine
Chemical structure:
CAS 154361-50-9
Empirical formula: C
15
H
22
FN
3
O
6
MW: 359.35
DESCRIPTION
_ _
CAPECITABINE SANDOZ tablet (capecitabine) is an oral, antineoplastic
agent
belonging to the fluoropyrimidine carbamate class. It was rationally
designed as an
orally
administered
precursor
of
5'-deoxy-5-fluorouridine
(5'-DFUR),
which
is
selectively activated to the cytotoxic moiety, fluorouracil, in
tumours. Capecitabine is
a white to off-white crystalline powder and is freely soluble in
methanol, soluble in
acetronitrile and ethanol and sparingly soluble in water.
CAPECITABINE SANDOZ tablet is supplied as modified oval film-coated
tablets for
oral administration. Each pink coloured tablet contains 150 mg
capecitabine and 500
mg capecitabine. The inactive ingredients in CAPECITABINE SANDOZ
tablet are
lactose monohydrate, hypromellose, microcrystalline cellulose,
croscarmellose sodium
and magnesium stearate. The pink film coating contains hypromellose,
talc, titanium
dioxide and iron oxide red C177491.
_ _
_Product Information _
_ Page _
_Capecitabine Sandoz 150mg & 500mg Tablet _
_08/2016 _
_Sandoz Pty Ltd _
_ _
_Version 04 _
_2 _
PHARMACOLOGY
Capecitabine itself is non-cytotoxic; however, it is selectively
activated to the cytotoxic
moiety, fluorouracil (5-FU), by thymidine phosphorylase in tumours.
PHARMACODYNAMICS
Bioactivation
Capecitabine is a fluoropyrimidine carbamate derivative that was
designed as an orally
administered, tumour-activated and tumour-selective cytotoxic agent.
Capecitabine is
non-cytotoxic
_in vitro. _
Capecitabine
is
absorbed
unchanged
from
the
gastrointestinal
tract,
metabolised
primarily in the liver by the 60 kDa carboxylesterase