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Exib

Exib

etoricoxib

Manufacturer:

Millimed

Distributor:

Mediline

Marketer:

Mediline
Concise Prescribing Info
Contents
Etoricoxib
Indications/Uses
Symptomatic relief of OA, RA, ankylosing spondylitis, pain & signs of inflammation associated w/ acute gouty arthritis. Short-term treatment for moderate pain associated w/ dental surgery.
Dosage/Direction for Use
Adult & adolescent ≥16 yr OA 30 mg or 60 mg once daily. Max: 60 mg once daily. RA 60 mg or 90 mg once daily. Max: 90 mg once daily. Ankylosing spondylitis 60 mg or 90 mg once daily. Max: 90 mg once 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. Patients w/ severe heart failure. Treatment of peri-operative pain in CABG surgery setting. 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. CHF (NYHA II-IV). Patients w/ HTN whose BP is persistently elevated >140/90 mmHg & has not been adequately controlled. Established ischaemic heart disease, peripheral arterial disease, &/or cerebrovascular disease. Severe hepatic impairment (serum albumin <25 g/L or Child-Pugh score ≥10). Estimated renal CrCl <30 mL/min. Pregnancy & lactation. 3rd trimester of pregnancy. Childn & adolescents <16 yr.
Special Precautions
Use only for acute symptomatic period in acute pain conditions. Use at the lowest effective dose for the shortest possible time. Increased risk of serious CV thrombotic events, MI, & stroke; serious GI adverse events including bleeding, ulceration, & perforation of the stomach or intestines. Risk of renal papillary necrosis & other renal injury w/ long-term administration. Risk of renal toxicity in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. Not recommended in patients w/ advanced renal disease. Associated w/ serious liver injury in rare cases. Risks of premature closure of the ductus arteriosus & potential to prolong parturition during the 3rd trimester of pregnancy. Caution during the 1st & 2nd trimesters of pregnancy, particularly from middle to end of 2nd trimester (onset at approx 20 wk) due to possible fetal renal dysfunction leading to oligohydramnios &, in some cases, neonatal renal impairment or failure. Not recommended in women attempting to conceive.
Adverse Reactions
Alveolar osteitis; edema/fluid retention; dizziness, headache; palpitations, arrhythmia; HTN; bronchospasm; abdominal pain, 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
Closely monitor prothrombin time/INR in patients receiving oral anticoagulants, particularly in the 1st few days when etoricoxib is initiated. Reduced effect of diuretics & other antihypertensive drugs (ACE inhibitors or AIIAs). Concomitant administration w/ ASA doses above those for CV prophylaxis or w/ other NSAIDs is not recommended. Increased nephrotoxic effect of cyclosporine or tacrolimus. Decreased renal excretion & increased plasma levels of lithium. Monitor for MTX-related toxicity when etoricoxib & MTX are administered concomitantly. Increased incidence of adverse events associated w/ OCs. Increased risk of adverse events associated w/ HRT. Monitor patients at high risk of digoxin toxicity when etoricoxib & digoxin are administered concomitantly.
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
Exib FC tab 120 mg
Packing/Price
3 × 10's;50 × 10's
Form
Exib FC tab 90 mg
Packing/Price
3 × 10's;50 × 10's
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