Facoxia

Facoxia

etoricoxib

Manufacturer:

Favorex

Distributor:

DKSH
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 in adults & adolescents ≥16 yr.
Dosage/Direction for Use
OA 30 mg once daily; increase to 60 mg once daily in patients w/ insufficient relief from symptoms. Max: 60 mg daily. RA & ankylosing spondylitis 60 mg once daily; increase to 90 mg once daily in patients w/ insufficient relief from symptoms. Down-titrate to 60 mg once daily when patient is clinically stabilised. Max: 90 mg daily. Acute gouty arthritis 120 mg once daily, limited to max of 8 days. Post-op dental surgery pain 90 mg once daily, limited to max of 3 days. Patient w/ mild hepatic impairment (Child-Pugh score 5-6) Max: 60 mg once daily. Patient w/ moderate hepatic impairment (Child-Pugh score 7-9) Max: 30 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active peptic ulceration or 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. CHF (NYHA II-IV). Hypertensive patients w/ BP persistently elevated >140/90 mmHg & inadequately controlled. Established ischaemic heart disease, peripheral arterial disease, &/or cerebrovascular disease. Patients w/ severe heart failure. Treatment of peri-operative pain in CABG surgery setting. Severe hepatic impairment (serum albumin <25 g/L or Child-Pugh score ≥10). Estimated renal CrCl <30 mL/min. Pregnancy & lactation. Childn & adolescents <16 yr.
Special Precautions
Use only during acute symptomatic period in acute pain conditions. Discontinue at the 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Risk of upper GI complications (perforations, ulcers or bleedings). Caution in the elderly, patients concomitantly using any other NSAID or ASA, or patients w/ prior history of GI disease. Associated w/ risk of thrombotic events (especially MI & stroke). Only treat patients w/ significant risk factors for CV events (eg, HTN, hyperlipidaemia, DM, smoking) after careful consideration. Not a substitute for ASA for prophylaxis of CV thrombo-embolic diseases. May cause a reduction in prostaglandin & renal blood flow in patients w/ compromised renal perfusion; monitor renal function. Risk of renal papillary necrosis & other renal injury during long-term administration. Not recommended in patients w/ advanced renal disease. Risk of fluid retention, oedema & HTN. Associated w/ new onset or recurrent CHF. Caution in patients w/ history of cardiac failure, left ventricular dysfunction, or HTN & in patients w/ pre-existing oedema from any other reason. Control HTN before treatment. Monitor BP w/in 2 wk after treatment initiation & periodically thereafter. Associated, in rare cases, w/ serious liver injury. Reports of ALT &/or AST elevations. Discontinue if signs of hepatic insufficiency occur or if persistently abnormal liver function tests are detected. Caution when initiating in patients w/ dehydration. Rehydrate prior to starting therapy. May mask fever & other signs of inflammation. Caution when co-administering w/ warfarin or other oral anticoagulants. May impair ability to drive or operate machinery. Patients w/ moderate hepatic impairment. Not recommended in women attempting to conceive.
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
Increase in prothrombin time INR w/ oral anticoagulants. Reduced effect of diuretics & other antihypertensives. Co-administration w/ ACE inhibitors or AIIA in patients w/ compromised renal function may result in further renal function deterioration. Increased risk of GI ulceration or other complications w/ low-dose ASA. Not recommended w/ doses of ASA above those for CV prophylaxis or w/ other NSAIDs. Increased nephrotoxic effect of cyclosporine or tacrolimus. Decreased renal excretion of lithium. Monitor for methotrexate-related toxicity. Increased exposure of ethinyl estradiol which may increase the incidence of adverse events associated w/ OCs. Increased exposure of estrogen which may increase the risk of adverse events associated w/ HRT. Monitor patients at high risk of digoxin toxicity. Decreased plasma conc w/ rifampicin. Caution when co-administered w/ drugs primarily metabolised by human sulfotransferases (eg, oral salbutamol & minoxidil).
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
Facoxia FC tab 120 mg
Packing/Price
30's
Form
Facoxia FC tab 60 mg
Packing/Price
30's
Form
Facoxia FC tab 90 mg
Packing/Price
30's
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