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 Symptomatic treatment of OA & low back pain 200 mg once daily or 100 mg bd. Symptomatic treatment of RA 100 or 200 mg bd. Ankylosing spondylitis 200 mg as single dose or 100 mg bd. Total daily dose: 400 mg. Primary dysmenorrhea & management of acute pain Initially 400 mg, followed by 200 mg if needed on 1st day. Subsequently, 200 mg bd as needed.
May be taken with or without 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 acetylsalicylic acid 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, Stevens-Johnson syndrome & toxic epidermal necrolysis. 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
HTN; diarrhoea. Bronchitis, sinusitis, upper resp tract infection, UTI; insomnia; dizziness; HTN (eg, aggravated HTN); cough; vomiting, abdominal pain, diarrhoea, dyspepsia, flatulence; pruritus (eg, generalized pruritus), rash; oedema, peripheral oedema; ear & fungal infection; MI, angina pectoris; dyspnoea; vomiting, dysphagia, irritable bowel syndrome, GERD, nausea, diverticulum; increased hepatic enzyme; muscle spasms; nephrolithiasis; vag haemorrhage, prostatitis, benign prostatic hyperplasia; increased blood creatinine, prostatic specific antigen & 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.
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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