HIGHLIGHT
Ebicox

Ebicox

etoricoxib

Manufacturer:

ACME

Distributor:

Cathay Drug
Concise Prescribing Info
Contents
Etoricoxib
Indications/Uses
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 if relief of symptoms is insufficient. Max: 60 mg daily. RA & ankylosing spondylitis 60 mg once daily. May be increased to 90 mg once daily if relief of symptoms is insufficient. Down-titration to 60 mg once daily if patient is clinically stabilized. Max: 90 mg daily. Acute gouty arthritis 120 mg once daily for 8 days. Post-op dental surgery pain 90 mg once daily, limited to max of 3 days. Mild hepatic dysfunction (Child-Pugh score 5-6) Max: 60 mg once daily. Moderate hepatic dysfunction (Child-Pugh score 7-9) Max: 30 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients w/ history of stroke (CVA), heart attack (MI), CABG, uncontrolled HTN, CHF (NYHA II-IV). Active peptic ulceration or active GI bleeding. Patients who experience bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking ASA or NSAIDs including COX-2 inhibitors. Inflammatory bowel disease. Established ischaemic heart disease, peripheral arterial disease, &/or cerebrovascular disease. 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
Hypersensitivity reactions eg, anaphylaxis & angioedema. Patients at risk of developing GI complication eg, those using any other NSAID or ASA concomitantly or those w/ prior history of GI disease eg, ulceration & GI bleeding. Patients w/ significant risk factors for CV events (eg, HTN, hyperlipidemia, DM, smoking). Not a substitute for ASA for prophylaxis of CV thromboembolic diseases. Preexisting significantly impaired renal function, uncompensated heart failure, or cirrhosis; history of cardiac failure, left ventricular dysfunction, pre-existing oedema. Fluid retention, oedema & HTN. Monitor patients w/ symptoms &/or signs suggesting liver dysfunction, or in whom an abnormal LFT has occurred. Dismiss use if signs of hepatic insufficiency occur, or if persistently abnormal LFTs (3 x ULN) are detected. Discontinue therapy when any of the organ system functions deteriorate; at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Patients w/ dehydration. Serious skin reactions including exfoliative dermatitis, SJS, TEN. May mask fever & other signs of inflammation. Co-administration w/ warfarin or other oral anticoagulants. Refrain from driving or operating of machinery if experiencing dizziness, vertigo or somnolence. Not recommended in women attempting to conceive. 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
Closely monitor prothrombin time INR when concomitantly used w/ oral anticoagulants. May reduce effect of diuretics, ACE inhibitors, AIIA & other antihypertensive drugs. Further deterioration of renal function, including possible acute renal failure w/ ACE inhibitors or AIIA in some patients w/ compromised renal function. Increased rate of GI ulceration or other complications w/ low-dose ASA. May increase the nephrotoxic effect of cyclosporin or tacrolimus. Decreased renal excretion & increased plasma levels of lithium. Adequate monitoring for toxicity when concomitantly administered w/ MTX; digoxin. Increased conc & exposure of OCs (ethinyl estradiol) or HRT (estrogen). May increase serum conc of drugs metabolized by human sulfotransferases (eg, oral salbutamol & minoxidil). Increased AUC w/ ketoconazole. Slight increase in exposure w/ oral voriconazole or topical miconazole oral gel, strong CYP3A4 inhibitors. 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.
Presentation/Packing
Form
Ebicox FC tab 120 mg
Packing/Price
30's
Form
Ebicox FC tab 90 mg
Packing/Price
30's
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