Zuellig Pharma
Concise Prescribing Info
Management of acute pain in adults & treatment of primary dysmenorrhea. Relief of acute & chronic pain & inflammation of RA & OA. Relief of signs & symptoms of ankylosing spondylitis. Management of low back pain (200 mg only).
Dosage/Direction for Use
Adult Acute pain & primary dysmenorrhea Initially 400 mg, followed by 200 mg if needed on 1st day. Subsequently, 200 mg bd as needed. Ankylosing spondylitis 200-400 mg daily. OA 200 mg once daily. RA 200 mg bd. Low back pain 200 mg once daily or 100 mg bd.
Should be taken with food.
Hypersensitivity to celecoxib or sulfonamides. Patients who have experienced asthma, urticaria or allergic-type reactions after taking aspirin or NSAIDs, including other COX-2 inhibitors. Peri-op pain treatment in CABG, established CV disease (ischemic heart disease & stroke).
Special Precautions
Discontinue use at 1st appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. Not a substitute for ASA for prophylaxis of CV thromboembolic disease. Increased risk of serious CV thrombotic events, MI & stroke. Patients w/ prior history of or active GI disease eg, ulceration, bleeding or inflammation or other risk factors associated w/ PUD eg, alcoholism, smoking or corticosteroid therapy. Heart disease, HTN, hyperlipidaemia, DM, peripheral arterial disease; CHF; compromised cardiac function, preexisting edema or other conditions predisposed to or worsened by fluid retention or at risk of hypovolemia. Serious skin infections eg, exfoliative dermatitis, SJS & TEN. Patients who are known or suspected to be CYP2C9 poor metabolizers. Ensure adequate hydration. Avoid concomitant use w/ non-aspirin NSAIDs. Concomitant use w/ oral anticoagulants. Not recommended w/ severe hepatic impairment. Moderate hepatic impairment (Child-Pugh class B). Advanced renal disease; severe renal impairment. Avoid use during 2nd or 3rd trimester of pregnancy. Lactation. Not to be used in childn. Elderly or debilitated patients.
Adverse Reactions
Bronchitis, sinusitis, upper resp tract infection, UTI, ear & fungal infection, insomnia, dizziness, HTN (eg, aggravated HTN), cough, vomiting, abdominal pain, diarrhoea, dysphagia, irritable bowel syndrome, GERD, nausea, diverticulum, dyspepsia, flatulence, pruritus (eg, generalized pruritus), rash, oedema peripheral edema, MI, angina pectoris, dyspnoea, increased hepatic enzyme, muscle spasms, nephrolithiasis, vag haemorrhage, prostatitis, benign prostatic hyperplasia, increased blood creatinine, PSA & wt.
Drug Interactions
Increased plasma conc by CYP2C9 inhibitors. Decreased plasma conc w/ CYP2C9 inducers eg, rifampicin, carbamazepine & barbiturates. Increased lithium plasma levels. Diminished effect of antihypertensives eg, ACE inhibitors &/or ARBs, diuretics & β-blockers. Increased risk of nephrotoxicity w/ cyclosporine. Increased plasma conc of dextromethorphan & metoprolol. Reduced natriuretic effect of furosemide & thiazides.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
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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