Etoricoxib T.O.

Etoricoxib T.O.

etoricoxib

Manufacturer:

T. O. Chemicals

Distributor:

T. O. Chemicals

Marketer:

T. O. Chemicals
Concise Prescribing Info
Contents
Etoricoxib
Indications/Uses
Ankylosing spondylitis (AS), acute gouty arthritis, primary dysmenorrhea, moderate to severe acute post-op pain associated w/ abdominal gynecological surgery; symptomatic treatment of acute & chronic OA & RA; relief of chronic musculo-skeletal pain including low back pain & acute pain associated w/ dental surgery in adult & adolescent ≥16 yr.
Dosage/Direction for Use
OA Initially 30 mg once daily, may increase to max of 60 mg once daily. AS, RA 90 mg once daily. Acute gouty arthritis 120 mg once daily for ≤8 days. Acute pain conditions 90-120 mg daily for ≤8 days. Max: 120 mg once daily. Post-op dental surgery pain 90 mg once daily for ≤3 days. Primary dysmenorrheal pain 120 mg once daily for ≤8 days. Patient w/ mild hepatic impairment (Child-Pugh score 5-6) Max: 60 mg once daily, moderate hepatic impairment (Child-Pugh score 7-9) Max: 60 mg every other day or 30 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. History of allergic-type reaction (eg, bronchospasm, acute rhinitis, nasal polyps, angioedema, urticaria) to aspirin or other NSAID. Patients w/ acute PUD or GI bleeding, inflammatory bowel disease, CHF [New York Heart Association (NYHA) II-IV], persistent uncontrolled HTN (>140/90 mmHg), established ischemic heart disease, peripheral arterial disease &/or cerebrovascular disease (including patients who have recently undergone CABG surgery or angioplasty);CV disease; MI; history of ischemic heart disease or paralysis from cerebrovascular disease. Severe hepatic dysfunction (serum albumin <25 g/L or Child-Pugh class C). Severe renal impairment (CrCl <30 mL/min). Pregnancy & breastfeeding. Childn <16 yr.
Special Precautions
Not to be used in patients w/ bronchospasm, asthma, rhinitis, or urticaria w/ NSAIDs or aspirin therapy. Discontinue use at 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity; if worsening heart failure, edema, or uncontrolled severe HTN occurs & consider alternate therapies for high-risk patients; if signs or symptoms of hepatic disease develop, if systemic manifestations, or persistent or worsening abnormal hepatic function tests & abnormal renal function tests occur. History of GI disease (bleeding or ulcers). Concurrent therapy w/ aspirin or other NSAIDs, anticoagulants &/or corticosteroids, alcohol. Use gastroprotective therapy (eg, PPIs, misoprostol) in concomitant use w/ aspirin even at low doses. Increased risk of serious adverse CV thrombotic events including MI & stroke w/ long-term use or pre-existing cardiac risk factors (eg, HTN, hyperlipidemia, diabetes, smoking); risk for renal toxicity in patients w/ impaired renal function, dehydration, heart failure, liver dysfunction, those taking diuretucs, ACE inhibitors, angiotensin II receptor blockers, elderly. Carefully evaluate individual CV profiles prior to prescribing & periodically re-evaluate the need for symptomatic relief & response to therapy. Not recommended for the treatment of pre-op pain in the setting of coronary artery bypass graft. New-onset or worsening HTN, edema & heart failure; renal papillary necrosis in long term use may occur. Maintain BP <140/90 mmHg prior to initiation & monitor carefully throughout therapy. Pre-existing edema (any cause), left ventricular dysfunction, or NYHA class I heart failure. Mild to moderate hepatic impairment. Closely monitor hepatic function in patients w/ previous abnormal hepatic function tests or signs/symptoms of hepatic dysfunction; renal function. Adequately hydrate patients prior to initiation of therapy. Not recommended in women who want to become pregnant. Pregnancy & lactation. Childn <16 yr. Elderly & debilitated patients.
Adverse Reactions
Abdominal pain. Arrhythmia, palpitations; ecchymosis; diarrhea, dyspepsia, flatulence, heartburn, nausea, vomiting, constipation, gastritis, oesophagitis, oral ulcer; increased ALT & AST; alveolar osteitis; flu-like syndrome; oedema/fluid retention; dizziness, headache; asthenia/fatigue; bronchospasm; HTN.
Drug Interactions
Increased levels/effects of 5-aminosalicylic acids derivatives, aliskiren, aminoglycosides, anticoagulants, bisphosphonate derivatives, systemic cyclosporin; deferasirox, desmopressin, digoxin, drospirenone, eplerenone, estrogen derivatives, haloperidol, lithium, mecamylamine, methotrexate, NSAID (COX-2 inhibitor), omacetaxine, profimer, K-sparing diuretics, pralatrexate, quinolone antibiotics, systemic tacrolimus, tenofovir products, triflusal, vancomycin, verteporfin, vit K antagonists. Increased level/effects w/ ACE inhibitors, ethyl alcohol, angiotensin II receptor blockers, tricyclic & tertiary amine antidepressants, aspirin, systemic corticosteroids & systemic cyclosporin, dexketoprofen, floctafenine, herb (anticoagulant/antiplatelet properties), nasal & systemic ketorolac, loop diuretics, morniflumate; NSAIDs, osimertinib, probenecid, SSRIs, Na phosphates, talniflumate, thiazide & thiazide-like diuretics, treprostinil, triflusal. Decreased levels/effects of ACE inhibitors, aliskiren, angiotensin II receptor blockers, β-blockers, eplerenone, hydralazine, loop diuretics, K-sparing diuretics, ophth prostaglandins, SSRIs, thiazide & thiazide-like diuretics. Decreased levels/effects w/ bile acid sequestrants, bosentan, moderate & strong CYP3A4 inducers, dabrafenib, defasirox, enzalutamide, mitotane, osimertinib, situximab, St. John's Wort, tocilizumab. Increased prothrombin time, INR w/ warfarin. Reduced effect of diuretics & antihypertensive drugs. Increased rate of GI ulceration w/ low-dose acetylsalicylic acid. Increased nephrotoxic effects of cyclosporin & tacrolimus. Decreased renal excretion of lithium. Reduced renal clearance of methotrexate. Increased steady state AUC0-24hr of ethinyl estradiol, unconjugated estrone, equilin & 17-β-estradiol. Increased digoxin Cmax. Coadministration w/ cyclosporin & tacrolimus. Slightly increased exposure w/ oral voriconazole, topical miconazole (strong CYP3A4 inhibitors). Decreased plasma conc w/ rifampicin. 120 mg: Increased plasma conc & reduce renal clearance of methotrexate.
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 T.O. FC tab 120 mg
Packing/Price
3 × 10's
Form
Etoricoxib T.O. FC tab 90 mg
Packing/Price
3 × 10's
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