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Myox

Myox

etoricoxib

Manufacturer:

KRKA

Distributor:

UNILAB, Inc

Marketer:

Westmont
Concise Prescribing Info
Contents
Etoricoxib
Indications/Uses
Acute & chronic treatment of OA & RA; ankylosing spondylitis; acute gouty arthritis; moderate to severe acute post-op pain associated w/ dental surgery; primary dysmenorrhea; moderate to severe acute post-op pain associated w/ abdominal gynecological surgery.
Dosage/Direction for Use
OA 30 mg once daily, may increase to 60 mg once daily. Max daily dose: 60 mg. RA 60 mg once daily, may increase to 90 mg once daily. Max daily dose: 90 mg. Ankylosing spondylitis 60 mg once daily, may increase to 90 mg once daily. Max daily dose: 90 mg. Acute pain 90 mg or 120 mg once daily for 8 days. Max: 120 mg daily. Acute gouty arthritis 120 mg once daily for 8 days. Max daily dose: 120 mg. Post-op dental surgery pain 90 mg once daily for 3 days. Max daily dose: 90 mg. Primary dysmenorrhea 120 mg once daily. Max daily dose: 120 mg. Post-op gynecological pain 90 mg once daily. Max daily dose: 120 mg. Patient w/ mild hepatic dysfunction (Child-Pugh scores 5-6) Max: 60 mg once daily, moderate hepatic dysfunction (Child-Pugh scores 7-9) Max: 30 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to etoricoxib & other NSAIDs. History of stroke, heart attack, CABG, uncontrolled HTN, CHF NYHA II-IV. Patients w/ asthma, acute rhinitis, nasal polyps, angioneurotic edema, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs including other COX-2 specific inhibitors; anaphylactoid reactions to NSAIDs. Previous or active gastric, duodenal or peptic ulceration, active GI bleeding or inflammatory bowel disease. Severe renal impairment (CrCl <30 mL/min) or deteriorating renal disease. Hepatic dysfunction (serum albumin <25 g/L or Child-Pugh score ≥10). Unstable or significant established ischemic heart disease, peripheral arterial disease &/or cerebrovascular disease. Patients who have undergone angioplasty. Use in peri-op period in patients undergoing cardiac or major vascular surgery. Pregnancy & lactation. Childn & adolescent <16 yr.
Special Precautions
Risk of serious CV & GI events including bleeding, ulceration, & perforation of the stomach or intestines. Discontinue treatment if organ system functions deteriorate during treatment. Increased risk of serious CV thrombotic events (MI & stroke); patients w/ known CV disease, history of atherosclerotic disease, or significant risk factors for CV events (eg, HTN, hyperlipidemia, DM, ischemic heart disease, cardiac failure, smoking). Not a substitute for aspirin for CV prophylaxis. Fluid retention & edema; patients w/ history of cardiac failure, left ventricular dysfunction or HTN & patients w/ pre-existing edema. Monitor BP for 2 wk after initiation of treatment & periodically thereafter. May cause upper GI complications (eg, perforation, bleeding). Serious GI toxicity in elderly & patients w/ concomitant NSAID or aspirin therapy. SJS & TEN. Increased risk of bleeding events. May mask fever & other usual signs & symptoms of infection. May affect ability to drive & use machines. Renal papillary necrosis & other renal injury; patients w/ considerable dehydration. Not recommended in patients w/ advanced renal disease (CrCl <39 mL/min). Jaundice; hepatotoxicity. Not recommended in women attempting to conceive. Pregnancy & lactation. Elderly.
Adverse Reactions
Abdominal pain, HTN, dizziness, headache, ecchymosis, alveolar osteitis, edema, fluid retention, palpitations, arrhythmia, bronchospasm, constipation, flatulence, gastritis, dyspepsia, GERD, diarrhea, epigastric discomfort, nausea, vomiting, esophagitis, pharyngitis, oral ulcer, asthenia, fatigue, flu-like illness, increased ALT &/or AST.
Drug Interactions
Increased rate of GI ulceration or other complications w/ aspirin. Increase risk of ciclosporin or tacrolimus-induced nephrotoxicity. Decreased plasma AUC w/ CYO inducers (eg, rifampicin). Increased AUC w/ CYP inhibitors (eg, ketoconazole). Increase Cmax of digoxin. May diminish effects of diuretics & other antihypertensive drugs. Increased serum conc w/ ethinyl estradiol, oral salbutamol, minoxidil. Increased estrogenic conc w/ hormonal replacement therapy. Decreased renal clearance & increased plasma conc of lithium. Increased MTX plasma levels. Increased prothrombin time INR w/ warfarin. Increased steady state area AUC of ethinyl 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
Myox FC tab 120 mg
Packing/Price
30's
Form
Myox FC tab 60 mg
Packing/Price
30's
Form
Myox FC tab 90 mg
Packing/Price
30's
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