Meicoxia

Meicoxia

etoricoxib

Manufacturer:

Meiji

Distributor:

Zuellig Pharma

Marketer:

Meiji
Concise Prescribing Info
Contents
Etoricoxib
Indications/Uses
Acute & chronic treatment of signs & symptoms of OA & RA. Ankylosing spondylitis; acute gouty arthritis; primary dysmenorrhea; moderate to severe acute post-op pain associated w/ abdominal gynecological surgery. Relief of chronic musculoskeletal pain including chronic low back pain; acute pain including dental surgery.
Dosage/Direction for Use
OA 30 mg or 60 mg once daily. Max: 60 mg daily. RA & ankylosing spondylitis 60 mg or 90 mg once daily. Min effective dose: 60 mg once daily. Max: 90 mg daily. Acute gouty arthritis & primary dysmenorrhea Recommended & max dose: 120 mg once daily. Post-op gynecological pain Administer initial dose shortly before surgery. Recommended dose: 90 mg once daily. May be increased to max 120 mg daily. Chronic musculoskeletal pain including chronic low back pain 60 mg once daily. Acute pain 90 mg or 120 mg once daily. Use only for acute symptomatic period (max of 8 days). Max: 120 mg daily. Post-op dental pain Recommended & max dose: 90 mg once daily. Mild hepatic insufficiency (Child-Pugh score 5-6) Max: 60 mg once daily. Moderate hepatic insufficiency (Child-Pugh score 7-9) 30 mg once daily or max of 60 mg every other day.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active peptic ulceration or GI bleeding; estimated CrCl <30 mL/min; inflammatory bowel disease; MI or CHF (NYHA II-IV); inadequately controlled HTN; history of & established ischemic heart disease, peripheral arterial &/or cerebrovascular disease (including patients who have recently undergone CABG surgery or angioplasty; w/ history of paralysis). Patients who develop signs of asthma, acute rhinitis, nasal polyps, angioneurotic oedema or urticaria following administration of aspirin or other NSAIDs. Severe hepatic dysfunction (Child-Pugh score >9). Pregnancy & lactation. Childn <16 yr.
Special Precautions
Discontinue treatment at 1st signs of hypersensitivity including anaphylaxis & angioedema; if persistently abnormal liver enzyme values occur. Not to be used in patients w/ ischemic heart disease, peripheral arterial &/or cerebrovascular disease; HTN w/ uncontrolled BP. More frequent & severe HTN at high doses compared w/ other NSAIDs & selective COX-2 inhibitors. Patients w/ significant risk factors for CV disease eg, HTN, hyperlipidemia, DM & smokers; liver or renal disease; at risk of developing GI complication; prior history of GI disease eg, ulceration & GI bleeding. Dehydrated patients. Monitor BP during treatment. Periodically re-evaluate patient's need for symptomatic relief & response to therapy. Hydrate patient before administration. Not recommended in advance renal disease (CrCl <30 mL/min). Avoid use in severe hepatic impairment (Child-Pugh score ≥10). Severe hepatic insufficiency (Child-Pugh score >9). Not recommended in women attempting to conceive. Discontinue therapy if woman becomes pregnant during treatment. Not to be given to ped patients. Higher incidence of adverse reactions in elderly & those using any other NSAID or ASA concomitantly.
Adverse Reactions
Thrombocytopenia; gastroenteritis, upper resp infection, UTI; hypersensitivity reactions including angioedema, anaphylactic/anaphylactoid reactions including shock; increased/decreased appetite, wt gain, hyperkalemia; anxiety, depression, decreased mental acuity, confusion, hallucinations, restlessness; dysgeusia, insomnia, paresthesia/hypaesthesia, somnolence; blurred vision; tinnitus; CHF, non-specific ECG changes, MI, palpitations, angina, arrhythmia; flushing, CVA, hypertensive crisis; cough, dyspnea, epistaxis, bronchospasm; abdominal distension, acid reflux, bowel movement pattern change, constipation, dry mouth, gastroduodenal ulcer, irritable bowel syndrome, oesophagitis, oral ulcers, peptic ulcers including perforation & bleeding (mainly in elderly), vomiting, gastritis; hepatitis, jaundice, hepatic failure; ecchymosis, facial oedema, pruritus, erythema, rash, SJS, TEN, urticaria, fixed drug eruption; muscular cramp/spasm, musculoskeletal pain/stiffness; proteinuria, renal insufficiency including renal failure; chest pain; increased BUN, creatine phosphokinase, serum creatinine & uric acid, decreased haematocrit, Hb, leukocytes & platelets; nephrotoxicity including interstitial nephritis & nephrotic syndrome; hepatotoxicity.
Drug Interactions
Concomitant use w/ warfarin; MTX; digoxin; drugs primarily metabolized by human sulfotransferases (eg, oral salbutamol & minoxidil). Decreased plasma AUC w/ rifampin. May diminish antihypertensive effect of diuretics, ACE inhibitors & AIIAs. Increased plasma lithium levels. Increased GI ulceration rate or other complication w/ low dose aspirin. May increase nephrotoxic effect of cyclosporine or tacrolimus. Increased incidence of venous thromboembolic events in woman at risk & steady state AUC0-24hr of ethinyl estradiol. Increased mean steady state AUC0-24hr of unconjugated estrone, equilin & 17β-estradiol of HRT.
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
Meicoxia FC tab 120 mg
Packing/Price
5 × 5's
Form
Meicoxia FC tab 60 mg
Packing/Price
5 × 5's
Form
Meicoxia FC tab 90 mg
Packing/Price
5 × 5's
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