Estacoxib

Celecoxib

Symptomatic treatment of OA & RA. Acute pain management in adults. Primary dysmenorrhoea. Symptomatic relief of ankylosing spondylitis (AS). Chronic low back pain management.

200 mg bd. Symptomatic treatment of OA Recommended dose: 200 mg single dose or 100 mg bd. Max daily dose: 400 mg. Symptomatic relief of RA Recommended daily dose: 100 mg or 200 mg bd. Max daily dose: 400 mg. AS Recommended dose: 200 mg single dose or 100 mg bd. Max daily dose: 400 mg. Acute pain management Adult Recommended dose: Initially 400 mg followed by additional 200 mg if needed on the 1st day. Administer 200 mg bd as needed on subsequent days. Chronic low back pain management Adult Recommended dose: 200 mg or 400 mg daily. Administer 200 mg single dose or 100 mg or 200 mg bd. Primary dysmenorrhea Recommended dose: Initially 400 mg followed by additional 200 mg if needed on the 1st day. Administer 200 mg bd as needed on subsequent days. Moderate hepatic impairment & patient receiving fluconazole Initiate ½ of recommended dose. Elderly weighing <50 kg Initiate therapy at lowest recommended dose.

May be taken with or without food: Dose for OA/RA may be given w/ or w/o meals.

Hypersensitivity to celecoxib or sulfonamide. Patients w/ active peptic ulceration or GI bleeding; who have experienced asthma, urticaria or allergic-type reactions after taking ASA or other NSAIDs including other COX-2 specific inhibitors. Peri-operative pain treatment in CABG surgery. CHF (NYHA II-IV). Established ischaemic heart, peripheral arterial &/or cerebrovascular disease.

Anaphylactoid reactions. Possible serious skin reactions including exfoliative dermatitis, SJS & TEN. Discontinue use at first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. May increase risk of serious CV thrombotic events, MI & stroke. Not a substitute for ASA in CV thromboembolic diseases prophylaxis. Closely monitor BP during therapy initiation & throughout course of therapy; patients w/ pre-existing CHF or HTN. Patients w/ compromised cardiac function, pre-existing edema or other conditions predisposing to or worsened by fluid retention including those taking diuretics or otherwise at risk of hypovolemia. Possible upper & lower GI perforations, ulcers or bleeds. Concomitant use w/ oral anticoagulants. Monitor anticoagulation/INR in patients taking warfarin/coumarin-type anticoagulant after treatment initiation or changing dose. Possible renal toxicity. Patients w/ dehydration; advise to rehydrate patients first & then start therapy. Closely monitor in patients w/ advanced renal disease. Carefully monitor development of more severe hepatic reaction while on therapy in patient w/ symptoms &/or signs of liver dysfunction or in whom abnormal LFT has occurred. Contains lactose. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption. Avoid concomitant use w/ non-aspirin NSAID. Co-administration w/ other CYP2C9 inhibitors. Patients who are known or suspected to be CYP2C9 poor metabolizers. Not recommended in severe hepatic (Child-Pugh class C) & renal impairment. Avoid use during 3rd trimester of pregnancy; closely monitor for amniotic fluid vol in pregnant women (2nd or 3rd trimester). Lactation. Childn <18 yr.

Bronchitis, sinusitis, URTI, UTI; insomnia; dizziness; HTN (including aggravated HTN); cough; vomiting, abdominal pain, diarrhea, dyspepsia, flatulence; pruritus (including generalized pruritus), rash; peripheral oedema.

Increased plasma conc w/ CYP2C9 inhibitors; fluconazole. May decrease plasma conc w/ CYP2C9 inducers (eg, rifampicin, carbamazepine & barbiturates). May diminish effect of anti-hypertensives including ACE inhibitors &/or ARBs, diuretics & β-blockers. Co-administration of NSAIDs including selective COX-2 inhibitors w/ ACE inhibitors, AIIA or diuretics may result in renal function deterioration including possible acute renal failure. May cause unresponsiveness to lisinopril. May increase risk of nephrotoxicity w/ cyclosporine. Increased plasma conc of dextromethorphan & metoprolol. May reduce natriuretic effect of furosemide & thiazides. Increased plasma levels of lithium.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

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

POM