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Ethezib-60/Ethezib-90/Ethezib-120

Ethezib-60/Ethezib-90/Ethezib-120

etoricoxib

Manufacturer:

Hetero Labs

Distributor:

Mega Lifesciences
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 of moderate pain associated w/ dental surgery in adults & adolescents ≥16 yr.
Dosage/Direction for Use
OA 30 mg once daily, may be increased to 60 mg once daily. RA 90 mg once daily. Ankylosing spondylitis 90 mg once daily. Acute gouty arthritis 120 mg once daily, max of 8 days. Post-op dental surgery pain 90 mg once daily, max of 3 days. Patient w/ mild hepatic dysfunction Max of 60 mg once daily. Patient w/ moderate hepatic dysfunction Max of 30 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active peptic ulceration or active GI bleeding. Patients who, after taking ASA or NSAIDs including COX-2 inhibitors, experience bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions. Severe hepatic dysfunction (serum albumin <25 mg/L or Child-Pugh score ≥10). Estimated renal CrCl <30 mL/min. Inflammatory bowel disease. CHF (NYHA II-IV). Patients w/ HTN whose BP is persistently elevated above 140/90 mmHg & has not been adequately controlled. Established ischemic heart disease, peripheral arterial disease, &/or cerebrovascular disease. Childn & adolescents <16 yr. Pregnancy & lactation.
Special Precautions
Discontinue treatment at 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Risk of upper GI complications (perforations, ulcers, bleedings); thrombotic events (especially MI & stroke); fluid retention, oedema, HTN; new onset or recurrent CHF. Not a substitute for ASA for prophylaxis of CV thromboembolic diseases. Under conditions of compromised renal perfusion, etoricoxib may cause reduction in prostaglandin formation &, secondarily, in renal blood flow, & thereby impair renal function. Control HTN before treatment initiation & monitor BP during treatment. Monitor any patients w/ symptoms &/or signs suggesting liver dysfunction, or in whom an abnormal LFT has occurred. Discontinue treatment in case of hepatic insufficiency or persistent abnormal LFTs. Caution when initiating treatment in patients w/ dehydration; rehydrate patients prior to starting therapy. May mask fever & other signs of inflammation. Caution when co-administering w/ warfarin or other oral anticoagulants. Patients who experience dizziness, vertigo or somnolence while on treatment should refrain from driving or operating machinery. Patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Ensure appropriate medical supervision in elderly & in patients w/ renal, hepatic, or cardiac dysfunction. Not recommended in 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, diarrhea, dyspepsia/epigastric discomfort, nausea, vomiting, oesophagitis, oral ulcer; increased ALT/AST; ecchymosis; asthenia/fatigue, flu-like disease.
Drug Interactions
Increased INR w/ warfarin; closely monitor prothrombin time, INR in the 1st few days of treatment initiation or dose change when taken w/ oral anticoagulants. May reduce effects of diuretics & other antihypertensive drugs. Risk of further renal deterioration w/ ACE inhibitor or AIIA in patients w/ compromised renal function. Increased rate of GI ulceration or other complications w/ low-dose ASA; not recommended w/ doses of ASA above those for CV prophylaxis or w/ other NSAIDs. May increase nephrotoxic effect of ciclosporin or tacrolimus. Increased lithium plasma levels. May increase MTX plasma conc & reduce its renal clearance. Increased exposure of ethinyl estradiol/estrogens, which can increase incidence of adverse events associated w/ OCs & HRT. Increased Cmax of digoxin. Exercise care when co-administering w/ drugs primarily metabolised by human sulfotransferases (eg, oral salbutamol & minoxidil). Decreased plasma conc w/ rifampicin (potent CYP inducer); co-administration w/ rifampicin is not recommended.
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
Ethezib-120 FC tab 120 mg
Packing/Price
30's
Form
Ethezib-60 FC tab 60 mg
Packing/Price
30's
Form
Ethezib-90 FC tab 90 mg
Packing/Price
30's
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