Concise Prescribing Info
Acute & chronic symptomatic treatment of OA & RA. Ankylosing spondylitis (AS); acute gouty arthritis & pain eg, primary dysmenorrhea, minor dental procedures.
Dosage/Direction for Use
OA 30 or 60 mg once daily. Not to exceed 60 mg daily. RA & AS 60 mg once daily, may be increased to max: 90 mg daily. Acute pain & gouty arthritis, primary dysmenorrhea Not to exceed 120 mg once daily for 8 days. Minor dental procedures Not to exceed 90 mg once daily for 8 days. Mild hepatic insufficiency (Child-Pugh 5-6) Not to exceed 60 mg once daily. Moderate hepatic insufficiency (Child-Pugh 7-9) Not to exceed 60 mg every other day.
May be taken with or without food.
Hypersensitivity. Active peptic ulceration or GI bleeding; inflammatory bowel disease; CHF (NYHA II-IV); increased risk of CV disease eg, ischaemic heart disease & stroke; peripheral arterial disease &/or cerebrovascular disease; uncontrolled HTN. Experienced allergic-type reaction w/ ASA or NSAIDs eg, COX-2 inhibitors. Severe hepatic dysfunction (serum albumin <25 g/L or Child-Pugh ≥10); estimated renal CrCl <30 mL/min. Pregnancy & lactation. Childn & adolescents <16 yr.
Special Precautions
Discontinue use at 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity; persistent abnormal LFTs are detected. Not a substitute for aspirin in CV prophylaxis. Increased risk of GI ulceration, bleeding & perforation. History of serious GI events & other risk factors associated w/ PUD eg, alcoholism, smoking, corticosteroid therapy; cardiac failure, left ventricular dysfunction. Significant risk factors for CV events eg, HTN, hyperlipidaemia, DM; preexisting oedema; peripheral arterial disease. May mask fever. Ensure adequate hydration prior to therapy. Monitor BP 2 wk after initiation & periodically thereafter. Monitor renal function in patients w/ preexisting significant renal impairment, uncompensated heart failure or cirrhosis. Concomitant use w/ NSAIDs, other NSAIDs or ASA even at low doses; warfarin or other oral anticoagulants. Not recommended in advanced renal disease (CrCl <30 mL/min). Not recommended in women of childbearing potential. Not to be used during pregnancy & lactation. Elderly ≥65 yr, debilitated patients.
Adverse Reactions
Abdominal pain. Alveolar osteitis; oedema/fluid retention; dizziness, headache; palpitations, arrhythmia; HTN; bronchospasm; constipation, flatulence, gastritis, heartburn/acid reflux, diarrhea, dyspepsia/epigastric discomfort, nausea, vomiting, oesophagitis, oral ulcer; increased ALT & AST; ecchymosis; asthenia/fatigue, flu-like disease.
Drug Interactions
Increased risk of anticoagulant-induced bleeding w/ oral anticoagulants. Reduced effects of diuretics, ACE inhibitors, AIIAs. Increased rate of GI ulceration w/ low-dose ASA. Increased nephrotoxic effect of cyclosporin or tacrolimus. Increased lithium plasma levels. Increased risk of MTX-related toxicity. Increased ethinyl estradiol plasma conc. Increased conjugated estrogen exposure. Increased risk of GI ulcer or bleeding w/ corticosteroids. Increased serum conc & prolonged t½ of digoxin. Reduced blood conc w/ rifampicin. Drugs metabolised by sulfotransferases eg, salbutamol PO, minoxidil.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AH05 - etoricoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Biocoxib FC tab 120 mg
3 × 10's
Biocoxib FC tab 90 mg
3 × 10's;5 × 5's
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