Etoricoxib Alvogen

Etoricoxib Alvogen





Zuellig Pharma
Concise Prescribing Info
Symptomatic relief of OA, RA, ankylosing spondylitis, & pain & signs of inflammation associated w/ acute gouty arthritis in adults & adolescents ≥16 yr. Short-term treatment of moderate pain associated w/ dental surgery.
Dosage/Direction for Use
OA 30 mg once daily, may be increased to 60 mg once daily. Max: Not to exceed 60 mg daily. RA, ankylosing spondylitis 60 mg once daily, may be increased to 90 mg once daily. Down-titrate dose to 60 mg once daily when clinically stabilised. Max: Not to exceed 90 mg daily. Acute gouty arthritis 120 mg once daily for 8 days. Max: Not to exceed 120 mg daily. Post-op dental surgery pain 90 mg once daily to max of 3 days. Moderate hepatic impairment (Child Pugh 7-9) Not to exceed 30 mg once daily; mild hepatic impairment (Child-Pugh score 5-6) Not to exceed 60 mg once daily.
May be taken with or without food.
Hypersensitivity. Active peptic ulceration or GI bleeding; inflammatory bowel disease. Patients w/ HTN whose BP is persistently elevated >140/90 mmHg & not adequately controlled. CHF (NYHA II-IV). Established ischemic heart disease, peripheral arterial disease &/or cerebrovascular disease. Patients who experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or allergic-type reactions w/ acetylsalicylic acid or NSAIDs eg, cyclooxygenase-2 (COX-2) inhibitors. 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
Serious skin reactions eg, exfoliative dermatitis, SJS & TEN. Discontinue at 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Increased risk of GI ulceration or other complications. New onset or recurrent CHF. Fluid retention, oedema & HTN. Preexisting significantly impaired renal function, uncompensated heart failure, or cirrhosis. Patients w/ significant risk factors for CV events eg, HTN, hyperlipidaemia, DM, smoking; history of cardiac failure, left ventricular dysfunction, preexisting oedema; dehydration. Monitor BP w/in 2 wk after initiation of treatment & periodically thereafter; renal function. May mask fever & other signs of inflammation. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Co-administration w/ warfarin or other oral anticoagulants; medicinal products known to inhibit cyclooxygenase/prostaglandin. May affect ability to drive & use machines. Discontinue if signs of hepatic insufficiency or persistently abnormal liver function tests (3x ULN) occurs. Not recommended in women attempting to conceive. Pregnancy & lactation. Childn & adolescents <16 yr. Elderly.
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 prothrombin time w/ oral anticoagulants. Reduced effect of diuretics & other antihypertensives. Further deterioration of renal function w/ ACE inhibitor or angiotensin II antagonist & agents inhibiting COX. Increased rate of GI ulceration or other complications w/ low-dose acetylsalicylic acid. Increased nephrotoxic effect of cyclosporin or tacrolimus. Increased lithium plasma levels. Increased MTX plasma conc. Increased AUC of ethinylestradiol & oestrogen. Increased digoxin Cmax. Increased serum conc of ethinylestradiol. Decreased plasma conc w/ rifampicin.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AH05 - etoricoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Etoricoxib Alvogen FC tab 120 mg
Etoricoxib Alvogen FC tab 30 mg
Etoricoxib Alvogen FC tab 60 mg
Etoricoxib Alvogen FC tab 90 mg
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