Apo-Celecoxib

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

Aktiva substanser:

Celecoxib 200mg

Tillgänglig från:

Apotex NZ Ltd

INN (International namn):

Celecoxib 200 mg

Dos:

200 mg

Läkemedelsform:

Capsule

Sammansättning:

Active: Celecoxib 200mg Excipient: Crospovidone Gelatin Magnesium stearate Povidone Purified water Sodium laurilsulfate Tekprint gold SB-3002 Titanium dioxide

Receptbelagda typ:

Prescription

Tillverkad av:

Cadila Pharmaceuticals Ltd

Terapeutiska indikationer:

Symptomatic treatment of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. For the management of acute pain and treatment of primary dysmenorrhoea in adults. The decision to prescribe a selective COX-2 inhibitor should only be made: · if non-pharmaceutical interventions and simple analgesic therapies have been tried and found to lack analgesic efficacy or to have unacceptable adverse effects in the individual patient, and · after assessment of the individual patient's overall risks. As the cardiovascular risks of the selective COX-2 inhibitors may increase with dose and duration of exposures, the shortest duration possible and the lowest effective daily dose should be used. Patients on long-term treatment should be reviewed regularly, such as every three months, with regards to efficacy, risk factors and ongoing need for treatment

Produktsammanfattning:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al - 30 capsules - 24 months from date of manufacture stored at or below 25°C

Tillstånd datum:

2014-03-28

Produktens egenskaper

NEW ZEALAND DATA SHEET
APO-CELECOXIB
CELECOXIB USP 100MG & 200MG CAPSULES
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 30
PRESENTATION
APO-CELECOXIB 100mg are hard gelatin capsules with white opaque body
and white
opaque cap. Imprinted “APO/C100” in blue ink. Filled with white to
off-white granular
powder.
APO-CELECOXIB 200mg are hard gelatin capsules with white opaque body
and white
opaque cap. Imprinted “APO/C200” in yellow ink. Filled with white
to off-white granular
powder.
INDICATIONS
Symptomatic treatment of pain and inflammation in osteoarthritis,
rheumatoid arthritis and
ankylosing spondylitis.
For the management of acute pain and treatment of primary
dysmenorrhoea in adults.
The decision to prescribe a selective COX-2 inhibitor should only be
made:

if non-pharmacological interventions and simple analgesic therapies
have been tried
and found to lack analgesic efficacy or to have unacceptable adverse
effects in the
individual patient, and

after assessment of the individual patient’s overall risks.
As the cardiovascular risks of the selective COX-2 inhibitors may
increase with dose and
duration of exposure, the shortest duration possible and the lowest
effective daily dose
should be used. Patients on long-term treatment should be reviewed
regularly, such as every
three months, with regards to efficacy, risk factors and on-going need
for treatment.
DOSAGE AND ADMINISTRATION
All patients taking celecoxib should commence therapy at the lowest
recommended dose,
and be titrated to the lowest dose compatible with effective control
of symptoms for the
shortest possible period.
ADULTS
The following doses can be given without regard to timing of meals.
OSTEOARTHRITIS
The recommended daily dose is 200mg taken once daily or in two divided
doses. A dose of
200mg twice daily may be used if needed.
RHEUMATOID ARTHRITIS
The recommended daily dose is 200-400mg taken in two divided doses.
ANKYLOSING SPONDYLITIS
The recommended daily dose is 200mg taken once