ARCOXIA TABLET 60 mg

Negara: Singapura

Bahasa: Inggris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

ETORICOXIB

Tersedia dari:

ORGANON SINGAPORE PTE. LTD.

Kode ATC:

M01AH05

Dosis:

60 mg

Bentuk farmasi:

TABLET, FILM COATED

Komposisi:

ETORICOXIB 60 mg

Rute administrasi :

ORAL

Jenis Resep:

Prescription Only

Diproduksi oleh:

Rovi Pharma Industrial Services S.A.

Status otorisasi:

ACTIVE

Tanggal Otorisasi:

2002-10-18

Selebaran informasi

SG-SPC-MK0663-T-082011 

Trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Whitehouse
Station, NJ,, 
USA 
Copyright © 2011 Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, 
NJ, USA 

All rights reserved Page 1 

1. 
NAME OF THE MEDICINAL PRODUCT 

ARCOXIA
®
 30 mg Film-coated Tablets  
ARCOXIA
®
 60 mg Film-coated Tablets  
ARCOXIA
®
 90 mg Film-coated Tablets  
ARCOXIA
®
 120 mg Film-coated Tablets  

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each film-coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.  For excipients, see 
6.1. 

3. 
PHARMACEUTICAL FORM 

Film-coated tablet. 

30mg Tablets: Blue-green, apple-shaped, biconvex tablets debossed '101' on one side and 
'ACX 30' on the other side. 

60 mg  Tablets:    Dark  green,  apple-shaped,  biconvex  tablets  debossed  ‘200’  on  one  side 
and ‘ARCOXIA 60’ on the other side. 

90 mg  Tablets:    White,  apple-shaped,  biconvex  tablets  debossed  ‘202’  on  one  side  and 
‘ARCOXIA 90’ on the other side. 

120 mg Tablets:  Pale-green, apple-shaped, biconvex tablets debossed ‘204’ on one side 
and ‘ARCOXIA 120’ on the other side. 

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

ARCOXIA tablets are indicated for: 
- Symptomatic relief of osteoarthritis (OA),  
- Rheumatoid arthritis (RA), 
- Symptomatic relief of ankylosing spondylitis (AS), 
- Pain and signs of inflammation associated with
acute gouty arthritis, 
-  Treatment  of  acute  pain,  including  that  related  to  primary  dysmenorrhea  and  minor 
dental procedures. 
The decision to prescribe a selective COX-2 inhibitor should be based on an assessment 
of  the  individual  patient’s  overall  risks,  taking

Karakteristik produk

SG-SPC-OG0663-T-012023
1.
NAME OF THE MEDICINAL PRODUCT
ARCOXIAⓇ 30 mg Film-coated Tablets
ARCOXIAⓇ 60 mg Film-coated Tablets
ARCOXIAⓇ 90 mg Film-coated Tablets
ARCOXIAⓇ 120 mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.
For excipients, see
6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
30 mg Tablets: Blue-green, apple-shaped, biconvex tablets debossed
‘101’ on one side
and ‘ACX 30’ on the other side.
60 mg Tablets: Dark green, apple-shaped, biconvex tablets debossed
‘200’ on one side
and ‘ARCOXIA 60’ on the other side.
90 mg Tablets: White, apple-shaped, biconvex tablets debossed
‘202’ on one side and
‘ARCOXIA 90’ on the other side.
120 mg Tablets: Pale-green, apple-shaped, biconvex tablets debossed
‘204’ on one side
and ‘ARCOXIA 120’ on the other side.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
ARCOXIA tablets are indicated for:
−
Symptomatic relief of osteoarthritis (OA),
−
Rheumatoid arthritis (RA),
−
Symptomatic relief of ankylosing spondylitis (AS),
−
Pain and signs of inflammation associated with acute gouty arthritis,
−
Treatment of acute pain, including that related to primary
dysmenorrhea and minor
dental procedures.
The decision to prescribe a selective COX-2 inhibitor should be based
on an assessment
of
the
individual
patient’s
overall
risks,
taking
into
consideration
other
available
therapeutic
options
(see
4.3 ‘Contra-indications’
and
4.4 ‘Special
warnings
and
precautions for use’).
4.2
Posology and method of administration
ARCOXIA is administered orally and may be taken with or without food.
The onset of
drug effect may be faster when ARCOXIA is administered without food.
This should be
considered when rapid symptomatic relief is needed. ARCOXIA should be
administered
for the shortest duration possible and the lowest effective daily dose
should be used.
Osteoarthritis
The recommended dose is 30 mg once daily. In some patients with
insufficien