Arcoxia

Arcoxia

etoricoxib

Manufacturer:

Merck Sharp & Dohme

Distributor:

Zuellig Pharma

Marketer:

A. Menarini
Concise Prescribing Info
Contents
Etoricoxib
Indications/Uses
Acute & chronic treatment of signs & symptoms of OA & RA; ankylosing spondylitis (AS); acute gouty arthritis & pain including primary dysmenorrhoea & minor dental procedures.
Dosage/Direction for Use
OA 30 or 60 mg once daily. Not to exceed 60 mg daily. RA & AS 60 or 90 mg once daily. Not to exceed 90 mg daily. Acute pain Not to exceed 120 mg daily. Max duration of treatment: 8 days. Acute gouty arthritis & primary dysmenorrhoea Not to exceed 120 mg once daily. Minor dental procedures Not to exceed 90 mg once daily. Mild hepatic insufficiency (Child-Pugh score 5-6) Not to exceed 60 mg once daily. Moderate hepatic insufficiency (Child-Pugh score 7-9) Not to exceed 60 mg every other day.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. CHF (NYHA II-IV); established ischemic heart disease, peripheral arterial disease &/or cerebrovascular disease (including patients who recently undergone CABG surgery or angioplasty); inadequately controlled HTN. Pregnancy.
Special Precautions
Discontinue use at 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity; persistent abnormal liver function tests are detected. Not a substitute for aspirin in CV prophylaxis. Serious skin reactions eg, exfoliative dermatitis, Stevens-Johnson syndrome & toxic epidermal necrolysis. Increased risk of thrombotic events eg, MI, stroke; GI ulceration, bleeding & perforation. History of serious adverse events & other risk factors associated w/ PUD eg, alcoholism, smoking, corticosteroid therapy. Significant risk factors for CV events eg, HTN, hyperlipidaemia, DM; preexisting edema or heart failure; acute asthmatic attacks, urticaria or rhinitis; cardiac dysfunction. May mask fever. Long-term use. Ensure adequate hydration prior to therapy. Closely monitor BP during therapy. Monitor renal function in patients w/ preexisting significant renal impairment, uncompensated heart failure or cirrhosis. Not recommended in advanced renal disease. Hepatic or renal dysfunction. Not recommended in women of childbearing potential. Lactation. Ped. Elderly ≥65 yr, debilitated patients.
Adverse Reactions
Asthenia/fatigue, dizziness, lower extremity edema, HTN, dyspepsia, heartburn, nausea, headache, increased AST/ALT.
Drug Interactions
Increased prothrombin time INR w/ warfarin. Decreased plasma AUC w/ rifampin. Increased plasma conc & reduced renal clearance of methotrexate. Diminished antihypertensive effects of diuretics, ACE inhibitors & AIIAs. Increased plasma lithium levels. Increased rate of GI ulceration w/ low-dose aspirin. Increased steady-state AUC of ethinyl estradiol, unconjugated estrone, equilin, 17β-estradiol.
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
Arcoxia FC tab 120 mg
Packing/Price
30's
Form
Arcoxia FC tab 60 mg
Packing/Price
100's
Form
Arcoxia FC tab 90 mg
Packing/Price
100's;30's
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