Zuellig Pharma
Concise Prescribing Info
Symptomatic treatment of OA, RA & ankylosing spondylitis. Management of acute pain & low back pain. Primary dysmenorrhea.
Dosage/Direction for Use
OA 200 mg as single dose; may be increased to 200 mg bid. RA 200 mg bid. Ankylosing spondylitis 200 mg as single dose up to total daily dose of 400 mg. Acute pain & primary dysmenorrhea Initially 400 mg followed by an additional 200 mg on the 1st day, if needed; subsequently 200 mg bid or 400 mg daily, as needed. Low back pain 200 mg or 400 mg daily as a single 200 mg dose or as 100 or 200 mg bid up to total daily dose of 400 mg throughout the course.
May be taken with or without food.
Hypersensitivity to celecoxib or sulfonamide. History of asthma, urticaria or allergic-type reaction after taking aspirin or NSAIDs. Treatment of peri-op pain in CABG surgery. Childn <18 yr.
Special Precautions
Increased risk of serious CV thrombotic events, MI & stroke. May lead to the onset of new HTN or worsening of the preexisting HTN. Closely monitor BP during initiation & throughout the course of therapy in patients w/ HTN; preexisting CHF, edema, compromised cardiac function, or other conditions predisposing to or worsened by fluid retention including those taking diuretics or otherwise at risk of hypovolemia. Risk of developing GI complications in patients w/ CV disease, concomitant use w/ aspirin, glucocorticoids or other NSAIDs, alcohol; history of, or active GI disease eg, ulceration, GI bleeding or inflammatory conditions. Renal toxicity. Dehydrated patients; rehydrate patients prior to start of therapy. Closely monitor renal function in patients w/ advanced renal disease. Anaphylactoid reactions. Discontinue at 1st appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. Moderate to severe hepatic impairment. Concomitant use w/ warfarin/coumarin-type & novel anticoagulants (eg, apixaban, dabigatran, rivaroxaban). Avoid concomitant use w/ non-aspirin NSAIDs. Pregnancy & lactation. Elderly <50 kg.
Adverse Reactions
Bronchitis, sinusitis, upper resp tract infection, UTI; insomnia; dizziness; HTN (including aggravated HTN); cough; vomiting; abdominal pain, diarrhoea, dyspepsia, flatulence; pruritus (including generalized pruritus), rash; peripheral oedema. Ear infection, fungal infection; MI, angina pectoris; dyspnoea; dysphagia, irritable bowel syndrome, GERD, nausea, diverticulum; increased hepatic enzyme; muscle spasms; nephrolithiasis; vag haemorrhage, prostatitis, benign prostatic hyperplasia; increased blood creatinine, increased prostatic specific antigen, increased wt.
Drug Interactions
Increased plasma conc w/ CYP2C9 inhibitors & fluconazole. Decreased plasma conc w/ CYP2C9 inducers eg, rifampicin, carbamazepine & barbiturates. Increased risk of bleeding w/ oral anticoagulants. Increase plasma levels of lithium, dextromethorphan & metoprolol. Diminished effect of antihypertensives eg, ACE inhibitors &/or angiotensin-receptor blockers, diuretics & β-blockers. Increased risk of renal impairment w/ ACE inhibitors, angiotensin II antagonists or diuretics. Increased risk of nephrotoxicity w/ cyclosporine. Reduce natriuretic effect of furosemide & thiazides.
ATC Classification
M01AH01 - celecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Celebrex cap 200 mg
Celebrex cap 400 mg
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