Etoricoxib Sandoz

Etoricoxib Sandoz

etoricoxib

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Etoricoxib
Indications/Uses
Symptomatic relief of OA, RA, ankylosing spondylitis, & the pain & signs of inflammation associated w/ acute gouty arthritis; 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 up to 60 mg once daily. RA & ankylosing spondylitis 90 mg once daily. Acute gouty arthritis 120 mg once daily. Max duration: 8 days. Postoperative dental surgery pain 90 mg once daily for a max of 3 days. Moderate hepatic dysfunction (Child-Pugh score 7-9) 60 mg every other day.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Severe hepatic dysfunction (serum albumin <25 g/L or Child-Pugh score ≥10). Estimated renal CrCl <30 mL/min. Active peptic ulcer or active GI bleeding. Patients who, after taking acetylsalicylic acid or NSAIDs including cyclooxygenase-2 (COX-2) inhibitors, experience bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions. Inflammatory bowel disease. CHF (NYHA II-IV). Patients w/ HTN (persistent elevated BP >140/90 mmHg). Established ischaemic heart disease, peripheral arterial disease, &/or cerebrovascular disease. Pregnancy & lactation. Childn & adolescents <16 yr.
Special Precautions
Increased risk of GI effects in elderly, patients w/ history of GI disease eg, ulceration & GI bleeding, concomitant use w/ other NSAID or acetylsalicylic acid. Risk of thrombotic events, eg, MI or stroke. Periodically re-evaluate need for symptomatic relief & response to therapy. Should consider carefully before treatment patients w/ significant risk factors for CV events (eg, HTN, hyperlipidaemia, DM, smoking). Preexisting impaired renal function, uncompensated heart failure or cirrhosis. Monitor renal & liver function. History of cardiac failure, left ventricular dysfunction, HTN & those w/ preexisting oedema. Control HTN prior to treatment; monitor BP w/in 2 wk after initiation of treatment & periodically thereafter. Discontinue if signs of hepatic insufficiency or if persistently abnormal liver function tests (>3 x ULN); deterioration of any organ system functions; skin rash, mucosal lesions or any other sign of hypersensitivity occurs. Patients w/ dehydration; rehydrate patients prior to starting treatment. May mask fever & other signs of inflammation. Concomitant use w/ warfarin or other oral anticoagulants. May affect ability to drive or operate machinery. 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, diarrhoea, dyspepsia/epigastric discomfort, nausea, vomiting, oesophagitis, oral ulcer; increased ALT & AST; ecchymosis; asthenia/fatigue, flu-like disease.
Drug Interactions
Oral anticoagulants. Reduced effect of diuretics & other antihypertensive drug. May cause renal deterioration w/ concomitant use w/ ACE inhibitors & AIIA in some patients w/ compromised renal function. Increased rate of GI ulceration w/ acetylsalicylic acid. Increase nephrotoxic effect of ciclosporin & tacrolimus. Increase lithium plasma levels. Increased plasma conc w/ methotrexate. May increase steady state AUC0-24hr of OCs. Increased estrogenic conc w/ hormone replacement therapy (HRT). Increased serum conc of drugs metabolized by sulfotransferases (eg, oral salbutamol & minoxidil). Plasma conc may be decreased by 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
Etoricoxib Sandoz FC tab 120 mg
Packing/Price
3 × 10's
Form
Etoricoxib Sandoz FC tab 60 mg
Packing/Price
3 × 10's
Form
Etoricoxib Sandoz FC tab 90 mg
Packing/Price
3 × 10's
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