CELEBREX CAPSULES 200 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CELECOXIB

Available from:

VIATRIS PRIVATE LIMITED

ATC code:

M01AH01

Dosage:

200 mg

Pharmaceutical form:

CAPSULE

Composition:

CELECOXIB 200 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Viatris Pharmaceuticals, LLC

Authorization status:

ACTIVE

Authorization date:

1999-12-13

Patient Information leaflet

 
Page 1 of 26 
_CELEBREX_
_TM_
_ _

1.  
NAME OF THE MEDICINAL PRODUCT 

CELEBREX™. 

2.  
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each 100 mg capsule contains 100 mg celecoxib. 
Each 200 mg capsule contains 200 mg celecoxib. 
Each 400 mg capsule contains 400 mg celecoxib. 

3.  
PHARMACEUTICAL FORM 

Hard capsules for oral use. 
100 mg Capsules: Opaque, white capsules with blue
bands marked 7767 
and 100. 
200 mg Capsules: Opaque, white capsules with
gold bands marked 7767 
and 200. 
400 mg Capsules: Opaque, white capsules with green
bands marked 7767 
and 400. 

4.  
CLINICAL PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

• Symptomatic treatment of osteoarthritis
and rheumatoid arthritis. 
• Management of acute pain in adults. 
• Treatment of primary dysmenorrhoea. 
• Relief of signs and symptoms of ankylosing spondylitis. 
• Management of chronic low back pain. 

The decision to prescribe a selective COX-2
inhibitor should be based on an 
assessment of the individual patient’s overall risks (see
Sections 4.3 
Contraindications, 4.4 Special warnings and precautions for use),
taking into 
consideration other available therapeutic options. 

4.2   POSOLOGY AND METHOD OF ADMINISTRATION 

Celecoxib capsules, at doses up to 200 mg twice per day can be
taken with or 
without food. 

Page 2 of 26 
As the cardiovascular risks of celecoxib may increase with dose and
duration of 
exposure, the shortest duration possible and the lowest effective
daily dose 
should be used.  

_Symptomatic Treatment of Osteoarthritis_: The recommended dose
is 200 mg 
administered as a single dose or as 100 mg twice per day.  

_Symptomatic Relief in the Treatment of Rheumatoid Arthritis_:
The recommended 
daily dose is 100 mg or 200 mg twice per day.  

_Ankylosing Spondylitis (AS): _The r

Summary of Product characteristics

CELEBREX
®
1.
NAME OF THE MEDICINAL PRODUCT
CELEBREX
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 mg capsule contains 100 mg celecoxib.
Each 200 mg capsule contains 200 mg celecoxib.
Each 400 mg capsule contains 400 mg celecoxib.
3.
PHARMACEUTICAL FORM
Hard capsules for oral use.
100 mg capsules: Opaque, white capsules with blue bands marked 7767
and 100.
200 mg capsules: Opaque, white capsules with gold bands marked 7767
and 200.
400 mg capsules: Opaque, white capsules with green bands marked 7767
and 400.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Symptomatic treatment of osteoarthritis (OA) and rheumatoid arthritis
(RA).
•
Management of acute pain in adults.
•
Treatment of primary dysmenorrhea.
•
Relief of signs and symptoms of ankylosing spondylitis (AS).
•
Management of chronic low back pain.
The decision to prescribe a selective COX-2 inhibitor should be based
on an assessment of
the individual patient’s overall risks (see Sections
4.3 CONTRAINDICATIONS
and 4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE
), taking into consideration other available therapeutic
options.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Celecoxib capsules, at doses up to 200 mg twice per day, can be taken
with or without food.
As the cardiovascular (CV) risks of celecoxib may increase with dose
and duration of
exposure, the shortest duration possible and the lowest effective
daily dose should be used.
_SYMPTOMATIC TREATMENT OF OSTEOARTHRITIS (OA)_:
The recommended dose of celecoxib is
200 mg administered as a single dose or as 100 mg twice per day.
_SYMPTOMATIC RELIEF IN THE TREATMENT OF RHEUMATOID ARTHRITIS (RA)_:
The recommended
daily dose of celecoxib is 100 mg or 200 mg twice per day.
_ANKYLOSING SPONDYLITIS (AS): _
The recommended dose of celecoxib is 200 mg administered as
a single dose or as 100 mg twice per day.
The maximum recommended daily dose is 400 mg for above indications.
_MANAGEMENT OF ACUTE PAIN IN ADULTS_:
The recommended dose of celecoxib is 400 mg,
initially, followed by an addition