Concise Prescribing Info
Acute pain & low back pain management. Primary dysmenorrhoea. Relief of acute & chronic pain, RA & OA inflammation. Symptomatic relief of ankylosing spondylitis.
Dosage/Direction for Use
Adult Symptomatic treatment of OA 200 mg as single dose 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 dose: 400 mg daily. Acute pain management, primary dysmenorrhea Initially 400 mg, followed by additional 200 mg on 1st day, then 200 mg bd on subsequent days. Low back pain 100 mg bd or 200 mg once daily.
May be taken with or without food: Dose for OA/RA may be given w/ or w/o meals.
Hypersensitivity to celecoxib or sulfonamides. Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 inhibitors; increased risk of CV disease (ischaemic heart disease & stroke). Active peptic ulceration or GI bleeding; CHF (NYHA II-IV); established ischaemic heart disease, peripheral arterial disease &/or cerebrovascular disease. Severe hepatic dysfunction; CrCl <30 mL/min. Women of childbearing potential. Pregnancy & lactation.
Special Precautions
Discontinue use at 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Serious skin infections eg, exfoliative dermatitis, Stevens-Johnson syndrome & toxic epidermal necrolysis. Not a substitute for acetylsalicylic acid in prophylaxis of CV thromboembolic diseases. Risk of GI complication w/ NSAIDs; history of GI disease eg, ulceration, GI bleeding; CV events eg, HTN, hyperlipidemia, DM, smoking; history of cardiac failure, left ventricular dysfunction, pre-existing oedema; hypovolaemia; peripheral arterial disease. May mask fever & other signs of inflammation. Patients who are known or suspected to be CYP2C9 poor metabolizers. Ensure adequate hydration. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Closely monitor BP during therapy. Avoid use w/ non-aspirin NSAID. Concomitant use w/ other NSAID or acetylsalicylic acid; diuretics; ACE inhibitors, AIIA; warfarin, other anticoagulants. Moderate to severe hepatic & severe renal impairment. Not to be used during pregnancy & lactation. Not to be used in childn. Elderly.
Adverse Reactions
HTN. Sinusitis, upper resp tract infection, UTI; aggravated allergy; insomnia; dizziness, hypertonia; MI; pharyngitis, rhinitis, cough, dyspnoea; abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting, dysphagia; rash, pruritus; flu-like symptoms, peripheral oedema/fluid retention; angina pectoris; irritable bowel syndrome; nephrolithiasis; increased blood creatinine & wt; benign prostatic hyperplasia.
Drug Interactions
Monitor prothrombin time w/ warfarin or other anticoagulants. Reduced effect of diuretics & antihypertensives. Increased risk of acute renal insufficiency w/ ACE inhibitors or AIIA. Unresponsive to lisinopril in patients w/ HTN. Increased nephrotoxic effect of ciclosporin, tacrolimus. Increased risk of GI ulceration or other GI complications w/ low-dose acetylsalicylic acid. Increased plasma conc w/ CYP2D6-metabolized drugs eg, tricyclics & SSRIs antidepressants, neuroleptics, anti-arrhythmics. Inhibited metabolism of diazepam, citalopram, imipramine. Monitor methotrexate-related toxicity. Increased Cmax & AUC of lithium. Increased Cmax & AUC by fluconazole. Reduced plasma conc w/ rifampicin, carbamazepine, barbiturates.
ATC Classification
M01AH01 - celecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Zobrex cap 200 mg
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