Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Celecoxib 200mg
Apotex NZ Ltd
Celecoxib 200 mg
200 mg
Capsule
Active: Celecoxib 200mg Excipient: Crospovidone Gelatin Magnesium stearate Povidone Purified water Sodium laurilsulfate Tekprint gold SB-3002 Titanium dioxide
Prescription
Cadila Pharmaceuticals Ltd
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
Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al - 30 capsules - 24 months from date of manufacture stored at or below 25°C
2014-03-28
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 Read the complete document