Pfizer Corporation Hong Kong Limited 美國輝瑞科研製藥

Indication¹

Celebrex® is indicated for the relief of signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) in adults and ankylosing spondylitis (AS); the management of acute pain (AP) in adults and treatment of primary dysmenorrheal (PD); the treatment of signs and symptoms of low back pain (LBP).

Clinical Evidence

Fast onset and long lasting efficacy in oral surgery²
As effective as diclofenac in relieving pain and inflammation in RA³ and OA⁴ patients
- RA, rheumatoid arthritis; BID, twice a day

Superior gastrointestinal safety profile over ns-NSAIDs plus a PPI^5,6

Safety Profile¹

ADVERSE REACTIONS: Abdominal pain, diarrhea, dyspepsia, flatulence, nausea; back pain; peripheral edema, accidental injury; dizziness, headache, insomnia; pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, rash.

INTERACTIONS: ACE inhibitors, aspirin, fluconazole, furosemide, lithium; anticoagulant activity should be monitored in patients taking warfarin or similar agents, particularly in the first few days after initiating or changing the dose of celecoxib

Dosages¹

Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Except for treatment in LBP, doses can be given with or without meals
OA: 200 mg daily as a single dose or divided (bid) doses
RA: 100–200 mg bid
AS: 200 mg daily as a single dose or divided (bid) doses
AP and PD: Initially 400 mg, followed by 200 mg if needed on the first day; subsequently, 200 mg bid as needed
LBP: 100mg bid, morning and evening after meal

Strengths¹

100 mg, 200 mg, 400 mg

Packing¹

Capsule: 100 mg x 30's (trade sector only), 100's; 200 mg x 30's (trade sector only), 100's; 400 mg x 10's

Important Safety Information¹

CONTRAINDICATIONS: Celebrex® is contraindicated in patients with allergic-type reactions to sulphonamides; previous experience of asthma; urticaria, allergic-type reactions after taking aspirin or other NSAIDs; treatment of perioperative pain in the coronary artery bypass graft (CABG) surgery setting.

SPECIAL PRECAUTIONS: Serious cardiovascular thrombotic events, hypertension, fluid retention, heart failure; prior history of ulcer disease or GI bleeding; patients with impaired renal function, heart failure, liver dysfunction, those taking diuretics and angiotensin-converting enzyme (ACE) inhibitors, elderly; advanced renal disease, anaphylactoid and skin reactions; anemia, pre-existing asthma; pregnancy.

ADVERSE REACTIONS: Abdominal pain, diarrhea, dyspepsia, flatulence, nausea; back pain; peripheral edema, accidental injury; dizziness, headache, insomnia; pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, rash.

PREGNANCY and LACTATION: Pregnancy Category C – Celebrex® should only be used in pregnancy if the potential benefit justifies the potential risk to the fetus. Exercise caution with administration of Celebrex® in nursing women.

Please refer to the full prescribing information for more safety information

References

1. Celebrex® (celecoxib) Prescribing Information. Pfizer Corporation Hong Kong Limited: March 2011.

2. Cheung R, Krishnaswami S, Kowalski K. Analgesic efficacy of celecoxib in postoperative oral surgery pain: A single-dose, two-center, randomized, double-blind, active- and placebo-controlled study. Clin Ther. 2007;29 Suppl:2498-2510.

3. Emery P, Zeidler H, Kvien T, Guslandi M, Naudin R, Stead H, Verburg K, Isakson P, Hubbard R, Geis GS. Celecoxib versus diclofenac in long-term management of rheumatoid arthritis: randomised double-blind comparison. Lancet. 1999; 354: 2106-11

4. McKenna F BD, Wendt H, Wallemark C, Lefkowith JB, Geis GS. Celecoxib versus diclofenac in the management of osteoarthritis of the knee: A placebo-controlled, randomised, double-blind comparison. Scand J Rheumatol. 2001;30(1):11-18.

5. Moore RA, Derry S, Makinson GT, McQuay HJ. Tolerability and adverse events in clinical trials of celecoxib in osteoarthritis and rheumatoid arthritis: Systematic review and meta-analysis of information from company clinical trial reports. Arthritis Res Ther. 2005;7(3):R644-665.

6. Chan FKL, Lanas A, Scheiman J, Berger MF, Nguyen H, Goldstein JL. Celecoxib versus omeprazole and diclofenac in patients with osteoarthritis and rheumatoid arthritis (CONDOR): A randomised trial. Lancet. 2010;376(9736):173-179.

Please review the full product information or package insert before prescribing.

CEL11013P