XELODA TABLETS 150 mg

Country: Singapura

Bahasa: Inggeris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

CAPECITABINE

Boleh didapati daripada:

DKSH SINGAPORE PTE. LTD.

Kod ATC:

L01BC06

Dos:

150 mg

Borang farmaseutikal:

TABLET, FILM COATED

Komposisi:

CAPECITABINE 150 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

Prescription Only

Dikeluarkan oleh:

F HOFFMANN-LA ROCHE LTD (Primary and Secondary Packager)

Status kebenaran:

ACTIVE

Tarikh kebenaran:

1999-01-20

Risalah maklumat

1
XELODA
®

Capecitabine

1. DESCRIPTION 
1.1 
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG 
Cytostatic agent 
1.2 
TYPE OF DOSAGE FORM 
Tablets 150 mg and 500 mg. 
1.3 ROUTE 
OF 
ADMINISTRATION 
Oral  
1.4 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Active ingredient: capecitabine  

2. CLINICAL

PARTICULARS 
2.1 THERAPEUTIC 
INDICATION(S) 
_Breast Cancer: _
Xeloda in combination with
docetaxel is indicated for the treatment of patients with
locally advanced or metastatic breast cancer after failure 
of cytotoxic chemotherapy. Previous
therapy should have included an anthracycline. Xeloda
is also indicated as monotherapy for the 
treatment of patients with locally advanced or metastatic breast
cancer after failure of a taxane and an
anthracycline-containing 
chemotherapy regimen or for whom further anthracycline
therapy is not indicated. 
_Colorectal cancer: _
Xeloda
is indicated for the adjuvant treatment of patients following surgery of stage
III (Dukes' stage C) colon cancer. 
Xeloda is indicated for the treatment of metastatic colorectal
carcinoma. 
_Gastric Cancer _
Xeloda is indicated for first-line treatment of advanced gastric
cancer in combination with a platinum-based regimen. 

2.2 DOSAGE 
AND 
ADMINISTRATION 
STANDARD DOSAGE 
Xeloda should only be prescribed by a qualified physician experienced in the
utilisation of anti-neoplastic agents. Xeloda tablets should be 
swallowed with water within 30 minutes after a meal. Treatment
should be discontinued if progressive disease or intolerable
toxicity is 
observed. Standard and reduced dose
calculations according to body surface area for starting doses
of Xeloda of 1250 mg/m
2
 and 
1000 mg/m
2
 are provided in tables 1 and 2, respectively. 
_Monotherapy: _
_Colon, colorectal and breast

Ciri produk

TAB-XEL-2023 05
XELODA
®
Capecitabine
1.
DESCRIPTION
1.1.
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Cytostatic agent
ATC code: L01BC06
1.2.
TYPE OF DOSAGE FORM
Tablets 150 mg and 500 mg.
Tablets 150 mg: Light peach, biconvex and oblong-shaped film-coated
tablets containing 150 mg capecitabine. The tablets are engraved
"XELODA" on one side and "150" on the other side.
Tablets 500 mg: Peach, biconvex, and oblong-shaped film-coated tablets
containing 500 mg capecitabine. The tablets are engraved “XELODA”
on
one side and “500” on the other
1.3.
ROUTE OF ADMINISTRATION
Oral
1.4.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: capecitabine
One 150 mg tablet contains 150 mg capecitabine.
One 500 mg tablet contains 500 mg capecitabine
2.
CLINICAL PARTICULARS
2.1.
THERAPEUTIC INDICATION(S)
_Breast Cancer:_
Xeloda in combination with docetaxel is indicated for the treatment of
patients with locally advanced or metastatic breast cancer after
failure of
cytotoxic chemotherapy. Previous therapy should have included an
anthracycline. Xeloda is also indicated as monotherapy for the
treatment of
patients with locally advanced or metastatic breast cancer after
failure of
a taxane and an anthracycline-containing chemotherapy regimen or for
whom further anthracycline therapy is not indicated.
_Colorectal cancer:_
Xeloda is indicated for the adjuvant treatment of patients following
surgery
of stage III (Dukes' stage C) colon cancer. Xeloda is indicated for
the
treatment of metastatic colorectal carcinoma.
_Gastric Cancer_
Xeloda is indicated for first-line treatment of advanced gastric
cancer in
combination with a platinum-based regimen.
2.2.
DOSAGE AND ADMINISTRATION
STANDARD DOSAGE
Xeloda should only be prescribed by a qualified physician experienced
in
the utilisation of anti-neoplastic agents. Xeloda tablets should be
swallowed
whole with water within 30 minutes after a meal. Xeloda tablets should
not
be crushed or cut. If patients cannot swallow Xeloda tablets whole and
tablets must be crushed or cut, this