Celetor-200

Celecoxib

Symptomatic relief in the treatment of OA, RA & ankylosing spondylitis in adults. Management of acute pain & treatment of primary dysmenorrhea.

OA 200 mg once daily in 2 divided doses. May increase to 200 mg bid if patient has 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 increase to 400 mg daily or in 2 divided doses if patient has insufficient relief from symptoms. Max: 400 mg daily. Acute pain Initially 400 mg, followed by an additional 200 mg if needed on the 1st day. On subsequent days, 200 mg bid or 400 mg once daily as needed. Primary dysmenorrhea Initially 400 mg, followed by an additional 200 mg if needed on the 1st day. On subsequent days, 200 mg bid as needed. Elderly (>65 yr) Initially 200 mg/day. May be increased to 200 mg bid if needed. Moderate liver impairment (serum albumin 25-35 g/L) Initiate at ½ the recommended dose.

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

Hypersensitivity to celecoxib & sulphonamides. Patients w/ history of stroke (CVA), heart attack (MI), CBAG, uncontrolled HTN, CHF (NYHA II-IV). Patients who experienced asthma, acute rhinitis, nasal polyps, angioneurotic edema, urticaria or other allergic-type reactions after taking acetylsalicylic acid (aspirin) or other NSAID including COX-2 inhibitors. Treatment of peri-op pain in the setting of CABG surgery. Pregnancy.

Not to be given to patients w/ allergy to NSAIDs & those w/ asthma. Patients w/ ischemic heart disease & those w/ risk factors for heart disease, HTN, hyperlipidemia, diabetes, smoking, & w/ peripheral arterial disease. Not a substitute for acetylsalicylic acid for prophylaxis of CV thromboembolic diseases. Risk of developing upper & lower GI complications (perforations, ulcers or bleedings) in elderly; concomitant use of other NSAIDs or acetylsalicylic acid; glucocorticoids; alcohol use; prior history of GI disease eg, ulceration & GI bleeding. Fluid retention & edema in patients w/ history of cardiac failure, left ventricular dysfunction or HTN, preexisting edema; those taking diuretics or at risk of hypovolemia. Onset of new HTN or worsening of preexisting HTN; closely monitor BP during initiation & throughout the course of therapy. Dehydrated patients; rehydrate patients prior to start of therapy. Discontinue at the 1st appearance of skin rash, mucosal lesions, or any other signs of hypersensitivity. May mask fever & other signs of inflammation. Closely monitor patients receiving warfarin/coumarin-type oral anticoagulants & novel oral anticoagulant (eg, apixaban, dabigatran & rivaroxaban). Patients known to be poor CYP2C9 metabolizers. Avoid concomitant use w/ non-aspirin NSAID. Risk of renal toxicity. May affect ability to drive or operate machinery. Lactation. Not indicated for use in childn. Elderly.

HTN (including aggravated HTN). Sinusitis, upper resp tract infection, pharyngitis, UTI; hypersensitivity; insomnia; dizziness, hypertonia, headache; MI; rhinitis, cough, dyspnea; nausea, abdominal pain, diarrhea, flatulence, vomiting, dysphagia; rash, pruritus (including generalized pruritus); arthralgia; flu-like illness, peripheral edema/fluid retention; injury (accidental injury).

Increased risk of bleeding complications w/ warfarin or other anticoagulants. May reduce effect of anti-hypertensives eg, including ACE-inhibitors, AIIA, diuretics & β-blockers. May increase nephrotoxic effect of ciclosporin or tacrolimus. Increased risk of GI ulceration or other GI complications w/ low-dose acetylsalicylic acid. Increased plasma conc of CYP2D6 substrates eg, anti-depressants (TCAs & SSRIs), neuroleptics, antiarrhythmics; dextromethorphan & metoprolol. Inhibited metabolism of CYP2C19 (eg, diazepam, citalopram & imipramine). Increased plasma levels of lithium. Increased exposure, C_max & AUC, & plasma conc w/ fluconazole. May reduce 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