Celebrex

Symptomatic treatment of OA & RA. Relief of signs & symptoms of ankylosing spondylitis. Management of acute pain & low back pain. Primary dysmenorrhea.

OA 200 mg as single dose. May increase to 200 mg bid. RA 200 mg bid. Ankylosing spondylitis 200 mg as single dose up to total daily dose of 400 mg. Acute pain & primary dysmenorrhea Initially 400 mg followed by an additional 200 mg on the 1st day, if needed. Subsequently 200 mg bid or 400 mg daily, as needed. Low back pain 200 or 400 mg daily as single 200 mg dose or as 100 or 200 mg bid up to total daily dose of 400 mg. Elderly Initially 200 mg daily, may be increased to 200 mg bid. Patients w/ established moderate liver impairment w/ serum albumin 25-35 g/L Initiate at ½ of recommended dose.

May be taken with or without food: May open cap & mix w/ soft foods. Take immediately w/ water.

Hypersensitivity to celecoxib or sulfonamides. Active peptic ulceration or GI bleeding; inflammatory bowel disease; CHF (NYHA II-IV); established ischemic heart disease, peripheral arterial disease &/or cerebrovascular disease. Patients who have coronary artery surgery in immediately post-op period. History of asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking ASA (aspirin) or other NSAIDs including COX-2 inhibitors; MI; CHD (stenosed or occluded) or paresis, paralysis due to CVA. Patients w/ estimated CrCl <30 mL/min. Severe hepatic dysfunction (serum albumin <25 g/L or Child-Pugh score ≥10). Women of childbearing potential not using effective method of contraception. Pregnancy & lactation.

Discontinue treatment at first appearance of skin rash, mucosal lesions or any sign of hypersensitivity; if there is erythema multiforme or flu-like symptom. Consider discontinuation of therapy if patients deteriorate in any organ system functions during treatment. Serious skin reactions including exfoliative dermatitis, SJS, TEN; hypersensitivity reactions (eg, anaphylaxis, angioedema & DRESS or hypersensitivity syndrome). Increased CV events mainly MI; risk of CV & thrombotic adverse events w/ long term treatment. Onset of new or worsening of pre-existing HTN. Upper & lower GI complications; fluid retention & oedema; renal toxicity; severe hepatic reactions, including fulminant hepatitis, liver necrosis & hepatic failure. History of sulfonamide or any drug allergy; GI disease eg, ulceration & bleeding; cardiac failure, left ventricular dysfunction or HTN. Patients w/ significant risk factors for CV events (eg, HTN, hyperlipidemia, DM, smoking); pre-existing oedema or at risk of hypovolemia. CYP2C9 poor metabolizers. Not a substitute for ASA for prophylaxis of CV thromboembolic diseases. May mask fever & other signs of inflammation. Carefully monitor patients w/ impaired renal function, heart failure, liver dysfunction & those taking diuretics, ACE inhibitors, AIIA. Re-evaluate patient's need for symptomatic relief & response periodically especially in patients w/ OA. Closely monitor BP during initiation & throughout treatment. Avoid concomitant use w/ non-aspirin NSAID. Increased risk of GI adverse effects w/ ASA (even at low doses); prothrombin time & risk of bleeding w/ warfarin or other oral anticoagulants (eg, apixaban, dabigatran & rivaroxaban). Concomitant use w/ other NSAIDs; alcohol; products metabolized by CYP2D6. Not to be given to patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. May have minor influence on ability to drive & use machines. Cirrhotic patients. Mild or moderate renal impairment. May cause reversibility of infertility in some women. Discontinue treatment during pregnancy. Do not breastfeed during treatment. Childn <18 yr. Elderly weighing <50 kg.

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 (including generalised pruritus); arthralgia; flu-like illness, oedema, peripheral/fluid retention; injury (accidental injury). SJS, TEN, DRESS.

Increased risk of bleeding w/ warfarin or other anticoagulants; GI ulceration or other GI complications w/ low-dose ASA. May reduce anti-hypertensive effects of ACE inhibitors, AIIA, diuretics & β-blockers. Increased nephrotoxic effect of ciclosporin or tacrolimus. Increased plasma conc of medicinal products metabolized by CYP2D6 eg, antidepressants (tricyclics & SSRIs), neuroleptics, anti-arrhythmics; CYP2D6 substrates dextromethorphan & metoprolol. Concomitant use w/ medicinal products metabolized by CYP2C19 eg, diazepam, citalopram & imipramine; MTX. Increased C_max & AUC of lithium. 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.

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