Uni Drug
Concise Prescribing Info
Symptomatic relief of OA, RA, ankylosing spondylitis & pain & signs of inflammation associated w/ acute gouty arthritis. Acute pain including that related to primary dysmenorrhea & minor dental procedures.
Dosage/Direction for Use
Adult & adolescent ≥16 yr OA 30 mg once daily. May be increased to 60 mg once daily Max: 60 mg daily. RA & ankylosing spondylitis 60 mg once daily. May be increased to 90 mg once daily. Once clinically stabilized, reduction to 60 mg once daily may be appropriate. Max: 90 mg daily. Acute pain 90 or 120 mg once daily. Max dose: 120 mg daily. Max duration of treatment: 8 days. Acute gouty arthritis 120 mg once daily. Max dose: 120 mg daily. Max duration of treatment: 8 days. Primary dysmenorrhea 120 mg once daily. Max: 120 mg daily. Post-procedure dental pain 90 mg once daily. Max dose: 90 mg daily. Max duration of treatment: 3 days. Mild hepatic impairment (Child-Pugh score 5-6) Max: 60 mg once daily. Moderate hepatic impairment (Child-Pugh score 7-9) Max: 60 mg every other day. 30 mg once daily may also be considered.
May be taken with or without food.
Hypersensitivity. Patients who, after taking acetylsalicylic or NSAIDs including COX-2 inhibitors, experience asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions. Active peptic ulceration or GI bleeding. Inflammatory bowel disease. CHF (NYHA II-IV). Patients w/ HTN whose BP is persistently elevated >140/90 mmHg & has not been adequately controlled; established ischemic heart disease, peripheral arterial disease &/or cerebrovascular disease (including patients who have recently undergone CABG surgery or angioplasty). Severe hepatic dysfunction (serum albumin <25 g/L or Child-Pugh score ≥10). Estimated renal CrCl <30 mL/min. Pregnancy & lactation. Childn & adolescents <16 yr.
Special Precautions
Discontinue at 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Possible serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, & toxic epidermal necrolysis. Potentially fatal, upper GI complications (perforations, ulcers or bleedings) on patients most as risk (the elderly, those concomitantly using other NSAID or acetylsalicylic acid or w/ history of GI disease). Patients w/ significant risk factors for CV events (eg, HTN, hyperlipidaemia, DM, smoking). Not a substitute for acetylsalicylic acid for prophylaxis of CV thromboembolic diseases. Discontinue if condition of patients w/ history of cardiac failure, left ventricular dysfunction, or HTN & preexisting oedema deteriorates. Control HTN prior to treatment & monitor BP during treatment, w/in 2 wk after initiation of treatment & periodically thereafter. Dehydrated patients. May mask fever & other signs of inflammation. Concomitant use w/ warfarin or other oral anticoagulants. May affect ability to drive & use machines. Renal papillary necrosis & other renal injury in long-term administration. Monitor renal function in patients w/ preexisting significantly impaired renal function, uncompensated heart failure, or cirrhosis. Discontinue if signs of hepatic insufficiency occur or abnormal liver function tests (3 times the upper limit of normal) are persistently detected. Not recommended in women attempting to conceive. Elderly.
Adverse Reactions
Oedema/fluid retention; dizziness, headache; HTN; GI disorders (eg, abdominal pain, flatulence, heartburn), diarrhoea, dyspepsia, epigastric discomfort, nausea; asthenia/fatigue, flu-like disease; increased ALT & AST.
Drug Interactions
Increased prothrombin time INR w/ warfarin. May reduce effect of diuretics & other antihypertensives. May further deteriorate renal function including possible acute renal failure w/ ACE inhibitor or AIIA in some patients w/ compromised renal function. May increase GI ulceration rate or other complications w/ low-dose acetylsalicylic acid. May increase nephrotoxic effect of ciclosporin or tacrolimus. Decreased renal excretion & increased plasma levels of lithium. Increased plasma conc & reduced renal clearance of methotrexate. Increased steady state AUC0-24 hr & serum conc of ethinyl estradiol. Increased mean steady state AUC0-24 hr of unconjugated estrone, equilin, & 17-β-estradiol. Increased Cmax of digoxin. Slightly increased exposure w/ oral voriconazole or topical miconazole. Decreased plasma conc w/ rifampicin.
ATC Classification
M01AH05 - etoricoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
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