Etoricoxib Stada

Etoricoxib Stada

etoricoxib

Manufacturer:

Stada

Distributor:

HK Medical Supplies
Concise Prescribing Info
Contents
Etoricoxib
Indications/Uses
Symptomatic relief of OA, RA, ankylosing spondylitis (Bekhterev's disease), & the pain & signs of inflammation associated w/ acute gouty arthritis. Short-term treatment of moderate pain associated w/ dental surgery.
Dosage/Direction for Use
Adult & adolescent ≥16 yr OA 30 mg once daily, can be increased to max 60 mg once daily if insufficient symptom relief. RA 60 mg once daily, can be increased to max 90 mg once daily if insufficient symptom relief. Ankylosing spondylitis (Bekhterev's disease) 60 mg once daily, can be increased to max 90 mg once daily if insufficient symptom relief. Acute gouty arthritis 120 mg once daily for 8 days. Post-op dental surgery pain 90 mg once daily, limited to a max of 3 days. Patients w/ mild hepatic dysfunction (Child-Pugh score 5-6) Max: 60 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Severe heart failure. Treatment of peri-operative pain in CABG surgery. Active peptic ulceration or GI bleeding. Patients who experience bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors. Inflammatory bowel disease. CHF (NYHA II-IV). HTN w/ inadequately controlled & persistently elevated BP >140/90 mmHg. Established ischaemic heart disease, peripheral arterial disease &/or cerebrovascular disease. Severe hepatic dysfunction (serum albumin <25 g/L or Child-Pugh score ≥10). Estimated renal CrCl <30 mL/min. Pregnancy & lactation. Childn & adolescents <16 yr.
Special Precautions
Use lowest effective daily dose for shortest duration possible. Increased risk of serious GI adverse events eg, bleeding, ulceration, & stomach/intestine perforation; serious CV thrombotic events, MI, & stroke. Renal papillary necrosis & other renal injury on long-term use; renal toxicity if renal prostaglandins have a compensatory role in renal perfusion maintenance. Fluid retention, oedema & HTN. Elevations of ALT &/or AST. Not recommended in patients w/ advanced renal disease. Discontinue at the 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. May mask fever & other signs of inflammation. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ warfarin or other oral anticoagulants. Patients w/ renal, hepatic, or cardiac dysfunction. Patients w/ dehydration; rehydrate patients prior to starting therapy. May impair ability to drive or operate machinery. Not recommended in women attempting to conceive. Elderly.
Adverse Reactions
Abdominal pain. Alveolar osteitis; oedema/fluid retention; dizziness, headache; palpitations, arrhythmia; HTN; bronchospasm; constipation, flatulence, gastritis, heartburn/acid reflux, diarrhea, dyspepsia/epigastric discomfort, nausea, vomiting, oesophagitis, oral ulcer; increased ALT & AST; ecchymosis; asthenia/fatigue, flu-like disease. Nephrotoxicity including interstitial nephritis & nephrotic syndrome.
Drug Interactions
Increased prothrombin time/INR w/ oral anticoagulants eg, chronic warfarin therapy. Reduced effect of diuretics, ACE inhibitors & angiotensin II antagonists. Increased rate of GI ulceration w/ low-dose acetylsalicylic acid. Increased nephrotoxic effect of cyclosporin or tacrolimus. Increased plasma levels of lithium; methotrexate; ethinyl estradiol; conjugated oestrogens (in hormone replacement therapy); digoxin; medicinal products primarily metabolised by sulfotransferases eg, oral salbutamol, minoxidil. Decreased plasma conc w/ rifampicin (potent CYP enzyme inducer).
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 Stada FC tab 60 mg
Packing/Price
20's
Form
Etoricoxib Stada FC tab 90 mg
Packing/Price
20's
Form
Etoricoxib Stada FC tab 120 mg
Packing/Price
20's
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