Selexa

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

OA 200 mg as single dose. May increase dose to 200 mg bid in patients w/ insufficient symptomatic relief. RA 200 mg bid. Ankylosing spondylitis 200 mg as single dose. Total daily dose: 400 mg. Acute pain & primary dysmenorrhea Initially 400 mg followed by additional 200 mg on 1st day, if needed. Subsequently 200 mg bid or 400 mg once daily as needed. Low back pain 200 mg or 400 mg daily as single 200 mg dose or as 100 or 200 mg bid. Total daily dose: 400 mg. Elderly 200 mg daily. May increase dose to 200 mg bid. Moderate liver impairment (serum albumin 25-35 g/L), cirrhotic patients Initiate at ½ of recommended dose.

May be taken with or without food: May open cap & dissolve contents in soft foods. Take immediately.

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 w/ asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs including COX-2 inhibitors. Treatment of perioperative pain in CABG surgery setting. Severe hepatic dysfunction (serum albumin <25 g/L or Child-Pugh score ≥10). Patients w/ estimated CrCl <30 mL/min. Women of childbearing potential not using effective contraception method. Pregnancy & lactation.

Serious hypersensitivity reactions eg, anaphylaxis, angioedema, DRESS, or hypersensitivity syndrome. Discontinue treatment at 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity; if patient deteriorates in any organ system functions during treatment. Not to be used as substitute to ASA for CV prophylaxis. Upper & lower GI complications eg, perforations, ulcers or bleeding. May mask fever & other signs of inflammation; lead to onset of new HTN or worsening of pre-existing HTN. Increased risk of serious CV events eg, MI; CV & thrombotic adverse events w/ long-term use. Fluid retention & oedema. Severe hepatic reactions eg, fulminant hepatitis, liver necrosis & hepatic failure. Patients at risk of developing GI complication w/ NSAIDs; known to be CYP2C9 poor metabolizers; w/ risk factors for CV events eg, HTN, hyperlipidemia, DM, smoking; w/ pre-existing edema; w/ impaired renal function heart failure, liver dysfunction. History of sulfonamide or any drug allergy; GI disease eg, ulceration & GI bleeding; cardiac failure, left ventricular dysfunction or HTN. Alcohol use. Closely monitor BP during initiation & throughout treatment; patients receiving warfarin/coumarin-type anticoagulants. Avoid concomitant use w/ non-aspirin NSAID. Serious bleeding events w/ warfarin. Concomitant use of NSAIDs or antiplatelet drugs (ASA), glucocorticoids; diuretics; ACE inhibitors; AIIAs; medicinal products metabolized by CYP2D6; anticoagulants eg, apixaban, dabigatran & rivaroxaban. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Minor influence on ability to drive & use machines. Mild or moderate renal impairment. May cause reversible infertility in some women. Discontinue treatment if patient becomes pregnant. Not to breastfeed while receiving treatment. Childn <18 yr. Elderly <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, peripheral oedema/fluid retention; accidental injury. SJS, TEN, DRESS.

Increased risk of bleeding complications w/ warfarin or other anticoagulants. Reduced effect of antihypertensives & increased risk of acute renal insufficiency w/ ACE inhibitors, AIIAs, diuretics, β-blockers. Increased nephrotoxic effect of ciclosporin & tacrolimus. Increased risk of GI ulceration or other GI complications w/ low-dose ASA. Increased plasma conc of CYP2D6 substrates eg, antidepressants (tricyclics & SSRIs), neuroleptics, antiarrhythmics, dextromethorphan, metoprolol. Increased C_max & AUC of lithium. Increased exposure, mean C_max & AUC w/ CYP2C9 inhibitors eg, fluconazole. Reduced plasma conc w/ rifampicin, carbamazepine & barbiturates. Concomitant use w/ medicinal products metabolized by CYP2C19 eg, diazepam, citalopram & imipramine; MTX.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

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

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