Axcel Etoricoxib

Axcel Etoricoxib

etoricoxib

Manufacturer:

Kotra Pharma

Distributor:

Kotra Pharma
Concise Prescribing Info
Contents
Etoricoxib
Indications/Uses
Acute & chronic symptomatic treatment 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 mg once daily, may be increased to max: 90 mg daily. Acute pain & gouty arthritis, primary dysmenorrhoea Not to exceed 120 mg once daily for 8 days. Minor dental procedures Not to exceed 90 mg once daily for 8 days. Mild hepatic insufficiency (Child-Pugh 5-6) Not to exceed 60 mg once daily. Moderate hepatic insufficiency (Child-Pugh 7-9) Not to exceed 60 mg every other day.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. CHF (NYHA II-IV); increased risk of CV disease eg, ischemic heart disease & stroke; peripheral arterial disease &/or cerebrovascular disease including patients who recently undergone CABG surgery or angioplasty; inadequately controlled HTN; active peptic ulceration or GI bleeding; inflammatory bowel disease. Severe hepatic dysfunction (Child-Pugh ≥10 or serum albumin <25 g/L); estimated renal CrCl <30 mL/min. Pregnancy. Childn & adolescents <16 yr.
Special Precautions
Discontinue use at 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity; persistent abnormal LFTs are detected. Not a substitute for aspirin in CV prophylaxis. Serious skin reactions eg, exfoliative dermatitis, SJS & TEN. Increased risk of thrombotic events eg, MI, stroke; GI ulceration, bleeding & perforation. Conditions predisposing to GI events eg, history of peptic ulcer, upper GI disease, ulcerative colitis, smoking, advancing age, concurrent aspirin or corticosteroids, alcohol abuse, stress. Significant risk factors for CV disease 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. Not to be used during lactation.
Adverse Reactions
Thrombocytopenia; hypersensitivity reactions; anxiety, insomnia, confusion, hallucinations; dysgeusia, somnolence; blurred vision; CHF, palpitations, angina; hypertensive crisis; bronchospasm; GI disorders; hepatitis, jaundice; angioedema, pruritus, rash, SJS, TEN, urticaria; renal insufficiency.
Drug Interactions
Monitor prothrombin time INR w/ warfarin; MTX-related toxicity. Decreased plasma conc w/ rifampicin. Reduced effects of diuretics, ACE inhibitors & AIIAs. Increased plasma lithium levels. Increased rate of GI ulceration w/ low-dose ASA.
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
Axcel Etoricoxib tab 120 mg
Packing/Price
3 × 10's
Form
Axcel Etoricoxib tab 60 mg
Packing/Price
3 × 10's
Form
Axcel Etoricoxib tab 90 mg
Packing/Price
3 × 10's
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