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Etoroxx

Etoroxx

etoricoxib

Manufacturer:

Ajanta Pharma

Distributor:

Ajanta Pharma Phil
Concise Prescribing Info
Contents
Etoricoxib
Indications/Uses
Symptomatic relief of OA, RA, ankylosing spondylitis, & the 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. May be increased to 60 mg once daily in patient w/ insufficient relief from symptoms. Do not exceed a dose of 60 mg daily. RA & ankylosing spondylitis 60 mg once daily. May be increased to 90 mg once daily in patient w/ insufficient relief from symptoms. Down-titration to 60 mg once daily once patient is clinically stabilized. Do not exceed a dose of 90 mg daily. Acute pain conditions Use only for acute symptomatic period. Acute gouty arthritis 120 mg once daily. May be given for 8 days, as in clinical trials. Do not exceed a dose of 120 mg daily, limited to max of 8 days treatment. Post-op dental surgery pain 90 mg once daily, limited to max of 3 days. Do not exceed a dose of 90 mg daily, limited to max of 3 days. Mild hepatic dysfunction (Child-Pugh score 5-6) Do not exceed a dose of 60 mg once daily. Moderate hepatic dysfunction (Child-Pugh score 7-9) Do not exceed a dose of 30 mg once daily.
Administration
May be taken with or without food: May be administered w/o food for faster onset of effect when rapid symptomatic relief is needed.
Contraindications
Hypersensitivity. Active peptic ulceration or GI bleeding. Patients who experience bronchospasm, acute rhinitis, nasal polyps, angioneurotic edema, urticaria, or allergic-type reactions after taking ASA or NSAIDs, including COX-2 inhibitors. Severe hepatic dysfunction (serum albumin <25 g/L or Child-Pugh score ≥10). Estimated renal CrCl <30 mL/min. 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. Pregnancy & lactation. Childn & adolescents <16 yr.
Special Precautions
Serious hypersensitivity reactions (eg, anaphylaxis & angioedema). May mask fever & other signs of inflammation. Caution when initiating treatment in patients w/ dehydration; rehydrate patients prior to starting therapy. Caution in treatment of patients most at risk of developing GI complication w/ NSAIDs; elderly, patients using any other NSAID or ASA concomitantly or patients w/ prior history of GI disease eg, ulceration & GI bleeding. Use the shortest duration possible & the lowest effective daily dose as CV risks may increase w/ dose & duration of exposure. Re-evaluate patient's need for symptomatic relief & response to therapy periodically, especially in patients w/ OA. Treat patients w/ significant risk factors for CV events (eg, HTN, hyperlipidemia, DM, & smoking) only after careful consideration. Not a substitute for ASA for prophylaxis of CV thromboembolic diseases because of lack of antiplatelet effect; do not discontinue antiplatelet therapies. Contains lactose; not to be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May cause reduction in prostaglandin formation &, secondarily, in renal blood flow, & thereby impair renal function under conditions of compromised renal perfusion. Monitor renal function in patients w/ pre-existing significantly impaired renal function, uncompensated heart failure, or cirrhosis. Fluid retention, edema & HTN. Caution in patients w/ history of cardiac failure, left ventricular dysfunction, or HTN & in patients w/ pre-existing edema from any other reason; co-administration w/ warfarin or other oral anticoagulants. Control HTN before treatment & pay special attention to BP monitoring during treatment. Monitor BP w/in 2 wk after initiation of treatment & periodically thereafter. Consider alternative treatment if BP rises significantly. Caution in patients w/ moderate hepatic dysfunction. Monitor patients w/ symptoms &/or signs suggesting liver dysfunction, or in whom abnormal LFT has occurred. Discontinue if signs of hepatic insufficiency occur, or if persistently abnormal LFTs (3 times ULN) are detected; at the 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Refrain patients who experience dizziness, vertigo or somnolence while taking etoricoxib from driving or operating machinery. Not recommended in women attempting to conceive. Discontinue use if a woman becomes pregnant during treatment. Women who use etoricoxib must not breastfeed. Elderly.
Adverse Reactions
Abdominal pain. Alveolar osteitis; edema/fluid retention; dizziness, headache; palpitations, arrhythmia; HTN; bronchospasm; constipation, flatulence, gastritis, heartburn/acid reflux, diarrhea, dyspepsia/epigastric discomfort, nausea, vomiting, esophagitis, oral ulcer; increased ALT & AST; ecchymosis; asthenia/fatigue, flu-like disease.
Drug Interactions
Increased prothrombin time INR in subjects stabilized on chronic warfarin therapy or patients receiving oral anticoagulants. Reduced effect of diuretics & other antihypertensive drugs. Increased rate of GI ulceration or other complications w/ concomitant administration of low-dose ASA. May increase nephrotoxic effect of cyclosporin or tacrolimus. Decreased lithium renal excretion & increased lithium plasma levels. Increased MTX plasma conc & reduced renal clearance of MTX. Increase in ethinyl estradiol exposure can increase incidence of adverse events associated w/ OCs (eg, venous thromboembolic events in women at risk). Increased mean steady state AUC0-24hr of unconjugated estrone, equilin, & 17-β-estradiol w/ HRT consisting of conjugated estrogens might increase risk of adverse events associated w/ HRT. There was an increase in digoxin Cmax; monitor patients at high risk of digoxin toxicity. Exercise care when administering w/ drugs primarily metabolized by human sulfotransferases (eg, oral salbutamol & minoxidil). 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
Etoroxx FC tab 120 mg
Packing/Price
30's (P24.5/film-coated tab)
Form
Etoroxx FC tab 90 mg
Packing/Price
30's (P19.5/film-coated tab)
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