Uni Drug
Concise Prescribing Info
Symptomatic relief of OA, RA & ankylosing spondylitis in adults.
Dosage/Direction for Use
Adult OA 200 mg once daily, may increase to 200 mg bd. Max: 400 mg daily. RA Initially 200 mg once daily, may increase to 200 mg bd if needed. Max: 400 mg daily. Ankylosing spondylitis 200 mg once daily, may increase to 400 mg once daily or in 2 divided doses. Max: 400 mg daily. Moderate liver impairment ½ the recommended dose.
May be taken with or without food.
Hypersensitivity to celecoxib or suphonamides. Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or NSAIDs including cyclooxygenase-2 inhibitors. Active peptic ulceration or GI bleeding. Inflammatory bowel disease. CHF (NYHA II-IV). Established ischaemic heart disease, peripheral arterial disease &/or cerebrovascular disease. Treatment of peri-op pain in CABG surgery. Severe hepatic dysfunction (serum albumin <25 g/L or Child-Pugh score ≥10). Patients w/ estimated CrCl <30 mL/min. Women of childbearing potential (unless using an effective contraceptive method). Pregnancy & lactation.
Special Precautions
Patients most at risk of developing GI complication w/ NSAIDs; those w/ CV disease; concomitantly using glucocorticoids, antiplatelets (eg, aspirin) or other NSAIDs; those w/ prior history of GI disease (eg, ulceration, GI bleeding or inflammatory conditions). Avoid concomitant use w/ non-aspirin NSAID. May increase risk of serious CV thrombotic events, MI & stroke; inform patients about signs & symptoms of serious CV toxicity. Carefully consider patients w/ significant risk factors for CV events (eg, HTN, hyperlipidaemia, DM, smoking). Not a substitute for acetylsalicylic acid for CV thromboembolic disease prophylaxis. May result in renal function deterioration & fluid retention in patients w/ history of cardiac failure, left ventricular dysfunction or HTN, preexisting oedema; patients taking diuretics or at risk of hypovolaemia. Closely monitor BP during initiation & throughout the course of therapy. Maintain medically appropriate supervision for possible compromised renal or hepatic function & especially cardiac dysfunction (more likely in the elderly). May cause renal toxicity; carefully monitor those w/ renal impairment, heart failure, liver dysfunction, those taking diuretics, ACE inhibitors, AIIA. Possible severe hepatic reactions including fulminant hepatitis, liver necrosis & hepatic failure. Consider discontinuation of therapy & take appropriate measures in any deterioration of organ system functions during treatment. Dehydrated patients. May reduce dose for individually dose-titrated drugs metabolised by CYP2D6. Possible serious skin reactions including exfoliative dermatitis, Stevens-Johnson syndrome & toxic epidermal necrolysis; discontinue use at the 1st appearance of skin rash, mucosal lesions, or any other signs of hypersensitivity. May mask fever & other signs of inflammation. Concurrent therapy w/ warfarin & other oral anticoagulants. Contains lactose; not to be taken by patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Increased risk of dose-dependent AR in patients who are known, or suspected to be CYP2C9 poor metabolizers or previous history w/ other CYP2C9 substrates. Patients who experience dizziness, vertigo or somnolence should refrain from driving or operating machinery. Not indicated for childn <18 yr. Elderly (particularly w/ body wt <50 kg).
Adverse Reactions
Bronchitis, sinusitis, upper resp tract infection, UTI; insomnia; dizziness; HTN (including aggravated HTN); cough; vomiting, abdominal pain, diarrhea, dyspepsia, flatulence; pruritus (including generalized pruritus), rash; peripheral oedema.
Drug Interactions
Increased risk of bleeding complications w/ warfarin or other anticoagulants. May reduce effects of diuretics & antihypertensives. Possible increased nephrotoxic effect of ciclosporin & tacrolimus. Potential increased risk of GI ulceration or other GI complications in concomitant use w/ low-dose acetylsalicylic acid. Increased plasma conc of CYP2D6 substrate metabolised drug ie, dextromethorphan; may increase plasma conc of other CYP2D6 substrate metabolised drugs [eg, antidepressants (eg, TCAs & SSRIs), neuroleptics, anti-arrhythmics]. Potential inhibition of drugs metabolised by CYP2C19 (eg, diazepam, citalopram & imipramine). Consider monitoring for methotrexate-related toxicity when used in combination w/ methotrexate, in patients w/ RA. Increased Cmax & AUC of lithium. Possible further increased systemic exposure in patients who are CYP2C9 poor metabolisers & demonstrate increased systemic exposure to celecoxib. Increased Cmax & AUC by potent CYP2C9 inhibitor (eg, fluconazole). Plasma conc may be reduced by CYP2C9 inducers (eg, rifampicin, carbamazepine & barbiturates).
ATC Classification
M01AH01 - celecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Aclexa hard cap 200 mg
30 × 1's
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Sign up for free
Already a member? Sign in