Icox

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

Adult OA 200 mg once daily or in 2 divided doses, may be increased up to 200 mg bid in some patients w/ insufficient relief from symptoms. RA Initially 200 mg daily in 2 divided doses, may be increased to 200 mg bid, if needed. Ankylosing spondylitis 200 mg once daily or in 2 divided doses, may be increased to 400 mg once daily or in 2 divided doses in patients w/ insufficient relief from symptoms. All indications Max recommended daily dose: 400 mg. Elderly >65 yr Initially 200 mg daily, may be increased to 200 mg bid, if needed. Patient w/ established moderate liver impairment (serum albumin 25-35 g/L) Initiate at ½ the recommended dose.

May be taken with or without food.

Hypersensitivity to celecoxib or sulfonamides. Active peptic ulceration or GI bleeding; inflammatory bowel disease; CHF (NYHA II-IV); established ischaemic heart disease, peripheral arterial disease &/or cerebrovascular disease. Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking ASA or other NSAIDs including COX-2 inhibitors. Severe hepatic dysfunction (serum albumin <25 g/L or Child-Pugh score=10). Patients w/ estimated CrCl <30 mL/min. Breast-feeding.

Not a substitute for ASA for prophylaxis of CV thromboembolic diseases. Consider treatment discontinuation if patients deteriorate in any of organ system functions during treatment. Discontinue treatment at the 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Patients w/ significant risk factors for CV events (eg, HTN, hyperlipidaemia, DM, smoking); history of cardiac failure, left ventricular dysfunction or HTN, & pre-existing oedema; patients taking diuretic treatment or otherwise at risk of hypovolaemia; CYP2C9 poor metabolisers. Risk of upper & lower GI complications (perforations, ulcers or bleedings); CV effects; fluid retention & oedema; onset of new HTN or worsening of pre-existing HTN; renal toxicity. Reports of severe hepatic reactions; serious skin reactions including exfoliative dermatitis, SJS, & TEN. May mask fever & other signs of inflammation. Closely monitor BP during initiation & throughout the course of therapy. Avoid concomitant use w/ non-aspirin NSAID. Concomitant use w/ dose-titrated drugs that are metabolised by CYP2D6; warfarin or other oral anticoagulants, including novel anticoagulants (eg, apixaban, dabigatran & rivaroxaban). Patients w/ hepatic impairment or mild or moderate renal impairment. Contraindicated in pregnancy & in women who can become pregnant. Discontinue if woman becomes pregnant during treatment. Do not breastfeed during treatment. Not indicated for use in childn. Elderly.

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

Increased risk of bleeding complications w/ anticoagulants. May reduce effect of antihypertensives including ACE inhibitors, AIIA, diuretics & β-blockers. May increase risk of acute renal insufficiency w/ ACE inhibitors, AIIA &/or diuretics in some patients w/ compromised renal function. May increase nephrotoxic effect of ciclosporin or tacrolimus. May increase plasma conc of drugs that are substrates of CYP2D6 [eg, antidepressants (TCAs & SSRIs), neuroleptics, anti-arrhythmic drugs]. Increased plasma conc of dextromethorphan & metoprolol. Potential to inhibit CYP2C19 catalysed metabolism. Consider adequate monitoring for MTX-related toxicity when combining w/ MTX. Closely monitor patients when celecoxib is introduced or withdrawn in patients on lithium treatment. Increased exposure w/ CYP2C9 inhibitors eg, fluconazole. Reduced plasma conc w/ CYP2C9 inducers eg, rifampicin, carbamazepine & barbiturates.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

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

Rx