Celeflam

Symptomatic relief of RA, OA & ankylosing spondylitis. Adjunctive treatment of adenomatous colorectal polyps. Management of acute pain & dysmenorrhea.

OA 200 mg daily as single dose or 100 mg bid. RA 100-200 mg bid. Juvenile RA Ped patient ≥2 yr weighing >25 kg 100 mg bid, ≥10 kg-≤25 kg 50 mg bid. Ankylosing spondylitis 200 mg daily in single or 2 divided doses, may be increased to 400 mg after 6 wk if no effect is observed. Management of acute pain & treatment of primary dysmenorrhea Initially 400 mg followed by an additional dose of 200 mg, if necessary on the 1st day; thereafter, 200 mg bid as needed. Familial adenomatous polyposis 400 mg bid. Moderate hepatic impairment Reduce dose by 50%.

May be taken with or without food.

Hypersensitivity to celecoxib, aspirin, or other NSAIDs. Patients w/ allergic-type reactions to sulfonamides; asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Peri-operative pain in the setting of CABG surgery.

Do not administer to patients w/ history of stroke, CVA, heart attack, MI, CABG, uncontrolled HTN, CHF (NYHA II-IV), GI bleeding, ulceration, perforation. May cause serious skin adverse events eg, exfoliative dermatitis, SJS, & TEN. May cause increased risk of serious CV thrombotic events, MI & stroke; serious GI adverse events including bleeding, ulceration, & perforation of the stomach or intestines. Patients w/ fluid retention or heart failure; prior history of ulcer disease or GI bleeding; anemia; pre-existing asthma. May cause onset of new HTN or worsening of preexisting HTN; risk of disseminated intravascular coagulation in ped patients. Fluid retention & edema may occur. Monitored carefully for evidence of the development of a more severe hepatic reaction. Renal papillary necrosis & other renal injury may occur in long term therapy. Not a substitute for corticosteroids or to treat corticosteroid insufficiency. Monitor for signs or symptoms of GI bleeding; periodically monitor CBC & chemistry profile in patients receiving long-term treatment. May mask diagnostic signs in detecting infectious complications of presumed noninfectious, painful conditions. Concomitant use w/ any dose of non-aspirin NSAID. Patients who are known or suspected to be poor CYP2C9 metabolizers based on previous history/experience w/ other CYP2C9 substrates (eg, warfarin, phenytoin). Not recommended in severe hepatic impairment. Pregnancy.

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 mean steady-state lithium plasma levels. Increase in plasma conc w/ fluconazole.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

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

Rx