Ritemed Celecoxib

Celecoxib

Symptomatic relief of OA, RA & ankylosing spondylitis in adults.

OA 200 mg once daily or in 2 divided doses, may be increased to 200 mg bid. RA Initially 200 mg in 2 divided doses, may be increased to 200 mg bid. Ankylosing spondylitis 200 mg once daily or in 2 divided doses, may be increased to 400 mg once daily or in 2 divided doses. All indications Max daily dose: 400 mg. Elderly >65 yr Initially 200 mg daily, may be increased to 200 mg bid. Moderate hepatic impairment (serum albumin 25-35 g/L) Initially ½ the recommended dose. CYP2C9 poor metabolisers Consider reducing dose to ½ of lowest recommended dose.

May be taken with or without food: For patients w/ difficulty swallowing, entire cap contents may be carefully emptied onto a level tsp of cool or room temp applesauce, rice gruel, yogurt or mashed banana & should be ingested immediately w/ glass of water.

Hypersensitivity to celecoxib or sulphonamides. Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic reactions after taking ASA (aspirin) or other NSAIDs including COX-2 inhibitors. Active peptic ulceration or GI bleeding. Inflammatory bowel disease. CHF (NYHA II-IV). Established ischaemic heart, peripheral arterial &/or cerebrovascular disease. Severe hepatic dysfunction (serum albumin <25 g/L or Child-Pugh score ≥10). Patients w/ CrCl <30 mL/min. Women of childbearing potential not using effective contraception. Pregnancy & lactation.

Discontinue use at 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Not a substitute for ASA for prophylaxis of CV thromboembolic diseases. Upper & lower GI complications (perforations, ulcers or bleedings). Increased number of CV events, mainly MI. Fluid retention & oedema. Onset of new HTN or worsening of preexisting HTN. May cause renal toxicity. Severe hepatic reactions including fulminant hepatitis, liver necrosis & hepatic failure. May mask fever & other signs of inflammation. Patients w/ prior history of GI disease; risk factors for CV events eg, HTN, hyperlipidaemia, DM, smoking; cardiac failure, left ventricular dysfunction or HTN, or w/ preexisting oedema from any other reason, or at risk of hypovolemia. CYP2C9 poor metabolisers. Closely monitor prothrombin time (INR) in patients receiving warfarin/coumarin-type oral anticoagulants. Avoid concomitant use w/ non-aspirin NSAID. Dose reduction may be necessary for individually dose-titrated medicinal products metabolized by CYP2D6. Concomitant use w/ any other NSAID, ASA or glucocorticoids, alcohol; diuretics; ACE inhibitors & AIIAs; warfarin or other oral anticoagulants including novel anticoagulants eg, apixaban, dabigatran & rivaroxaban. Mild or moderate renal impairment. Patients experiencing dizziness, vertigo or somnolence during treatment should refrain from driving or operating machinery. May delay or prevent rupture of ovarian follicles which is associated w/ reversible infertility in some women. Not to be used during lactation. Not indicated for childn. Elderly <50 kg.

HTN (including aggravated HTN). Sinusitis, URTI, UTI; hypersensitivity; insomnia; dizziness, hypertonia, headache; MI; rhinitis, cough, dyspnoea; nausea, abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting, dysphagia; rash, pruritus (including generalised pruritus); arthralgia; flu-like illness, peripheral oedema/fluid retention; injury (accidental injury).

Increased risk of bleeding complications w/ warfarin or other anticoagulants. May reduce effect of antihypertensives eg, ACE inhibitors, AIIAs, diuretics & β-blockers. May increase risk of acute renal insufficiency w/ ACE inhibitors, AIIAs &/or diuretics in some patients w/ compromised renal function. May increase nephrotoxic effect of ciclosporin & tacrolimus. Increased risk of GI ulceration or other GI complications w/ low-dose ASA. May increase plasma conc of CYP2D6 substrates eg, antidepressants (tricyclics & SSRIs), neuroleptics, antiarrhythmics. Increased plasma conc of dextromethorphan & metoprolol. Inhibit CYP2C19 catalysed metabolism. Increased C_max & AUC of lithium. Increased C_max & AUC w/ fluconazole. Plasma conc may be reduced w/ CYP2C9 inhibitors eg, rifampicin, carbamazepine & barbiturates.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AH01 - celecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.

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