Ecoxib

Ecoxib

etoricoxib

Manufacturer:

Atlantic Lab

Distributor:

Atlantic Pharma

Marketer:

Atlantic Pharma
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 musculo-skeletal pain including chronic low back pain; acute pain including dental surgery.
Dosage/Direction for Use
Adult & adolescent ≥16 yr OA 30 mg or 60 mg once daily. Max: 60 mg daily. RA & ankylosing spondylitis Recommended & max dose: 90 mg once daily. Acute gouty arthritis & primary dysmenorrhea Recommended & max dose: 120 mg once daily. Chronic musculo-skeletal pain including chronic low back pain Recommended & max dose: 60 mg once daily. Acute pain Max: 120 mg daily. Use only for acute symptomatic period (max of 8 days). Post-op dental pain Recommended & max dose: 90 mg once daily. Post-op gynecological pain 90 mg once daily. Administer initial dose shortly before surgery. May be increased to max 120 mg once daily. Adolescent weighing <60 kg Consider dose reduction. Mild hepatic impairment (Child-Pugh class A) Max: 60 mg once daily. Moderate hepatic impairment (Child-Pugh class B) Max: 30 mg once daily or 60 mg every other day.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients w/ active peptic ulceration or GI bleeding; estimated renal CrCl <30 mL/min; inflammatory bowel disease; CHF (NYHA II-IV); inadequately controlled HTN; ischemic heart disease, peripheral &/or cerebrovascular disease (including patients who have recently undergone CABG surgery or angioplasty). Patients who develop signs of asthma, acute rhinitis, nasal polyps, angioneurotic oedema or urticaria following administration of aspirin or other non-NSAID(s). Severe hepatic dysfunction (Child-Pugh score >9). Pregnancy & lactation. Childn <16 yr.
Special Precautions
Discontinue use if worsening heart failure, edema, or uncontrolled/severe HTN occur; at 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity; if signs/symptoms of hepatic disease develop, systemic manifestations occur or w/ persistent or worsening abnormal hepatic & renal function tests. Not to be used in patients w/ bronchospasm, asthma, rhinitis, or urticaria w/ NSAID or aspirin therapy; CV disease or stroke; history of ischemic heart disease or paralysis caused by stroke. Serious hypersensitivity reactions eg, anaphylaxis, angioedema, SJS, TEN. Increased risk of serious adverse CV thrombotic events including MI & stroke; long-term use or pre-existing cardiac risk factors (eg, HTN, hyperlipidemia, diabetes, smoking); CABG surgery. Not recommended for perioperative pain in CABG setting. New onset or worsening HTN; edema & heart failure. Elevated transaminases (>3x ULN); hepatitis, jaundice, liver failure. Renal decompensation; papillary necrosis in long-term use. Patients w/ history of GI disease (bleeding or ulcers), concurrent therapy w/ aspirin or other NSAIDs, anticoagulants, corticosteroids, alcohol; preexisting edema, left ventricular dysfunction, or NYHA class I heart failure; dehydration, those taking diuretics, ACE inhibitors, ARBs; hypercholesterolemia. Smoking. Carefully evaluate individual CV profiles of patients prior to treatment. Maintain BP <140/90 mmHg prior to initiation & monitor carefully throughout therapy. Closely monitor hepatic function in patients w/ previous abnormal hepatic function tests or signs/symptoms of hepatic dysfunction; renal function. Adequately hydrate prior treatment. Mild & moderate hepatic impairment. Contraindicated in severe renal impairment (CrCl <30 mL/min). May cause uterine inertia, premature closure of ductus arteriosus & adverse fetal events, & affect fertility. Not recommended in women who wish to become pregnant. Elderly or debilitated patients.
Adverse Reactions
Edema, HTN, palpitations; dizziness, fatigue, headache; bruising; abdominal pain, diarrhea, dyspepsia, flatulence, heartburn, nausea; increased ALT & AST; weakness; alveolar osteitis, flu-like syndrome. SJS, TEN.
Drug Interactions
Avoid concomitant use w/ dexketoprofen, floctafenine, nasal & systemic ketorolac, morniflumate, NSAID (COX-2 inhibitor), omacetaxine, pelubiprofen, phenylbutazone, talniflumate, tenoxicam, zaltoprofen. Increased levels/effects of 5-ASA, bisphosphonate & estrogen derivatives, aliskiren, aminoglycosides, aminolevulinic acid, anticoagulants, systemic cyclosporine & tacrolimus, deferasirox, desmopressin, digoxin, drospirenone, eplerenone, haloperidol, lithium, MTX, NSAID (COX-2 inhibitor), omacetaxine, porfimer, K-sparing diuretics, pralatrexate, quinolone antibiotics, tenofovir products, tolperisone, triflusal, vancomycin, verteporfin, vit K antagonists. Increased levels/effects w/ ACE inhibitors, ethyl alcohol, ARBs, antidepressants (tricyclic, tertiary amine), aspirin, systemic corticosteroids & cyclosporine, dexketoprofen, felbinac, floctafenine, herbs w/ anticoagulant/antiplatelet properties, nasal & systemic ketorolac, loop, thiazide & thiazide-like diuretics, morniflumate, naftazone, NSAIDs, pelubiprofen, phenylbutazone, probenecid, SSRIs, Na phosphates, talniflumate, tenoxicam, tolperisone, triflusal, zaltoprofen. Decreased levels/effects of ACE inhibitors, aliskiren, ARBs, β-blockers, eplerenone, hydralazine, loop, K-sparing, thiazide & thiazide-like diuretics, ophth prostaglandins, SSRIs. Decreased levels/effects w/ bile acid sequestrants, bosentan, strong & moderate CYP3A4 inducers, dabrafenib, deferasirox, enzalutamide, mitotane, siltuximab, St. John's Wort, tocilizumab.
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
Ecoxib FC tab 120 mg
Packing/Price
5 × 5's
Form
Ecoxib FC tab 60 mg
Packing/Price
5 × 5's
Form
Ecoxib FC tab 90 mg
Packing/Price
5 × 5's
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