Nosmen

Nosmen

etoricoxib

Manufacturer:

Biolab

Distributor:

Biopharm

Marketer:

Biopharm
Concise Prescribing Info
Contents
Etoricoxib
Indications/Uses
Symptomatic treatment of acute & chronic 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 eg, chronic low back pain; acute pain eg, dental surgery.
Dosage/Direction for Use
OA, chronic musculoskeletal pain including low back pain 60 mg once daily. RA, ankylosing spondylitis 60 or 90 mg once daily. Acute gouty arthritis 120 mg once daily. Post-op dental pain 90 mg once daily for a max of 3 days. Primary dysmenorrhea 120 mg once daily for a max of 8 days. Post-op abdominal gynecological pain 90 mg or 120 mg once daily. Acute pain Max duration: 8 days. Mild hepatic impairment (Child-Pugh score 5-6) Max: 60 mg daily, moderate hepatic impairment (Child-Pugh score 7-9) Max: 60 mg on alternate days or 30 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. CHF (NYHA II-IV); ischemic heart disease, peripheral arterial &/or cerebrovascular disease (including patients who have recently undergone CABG surgery or angioplasty), HTN w/ inadequately controlled BP, active peptic ulceration or GI bleeding; inflammatory bowel disease. Patients who developed signs of asthma, acute rhinitis, nasal polyps, angioneurotic oedema or urticaria following administration of aspirin or other NSAIDs. Renal impairment (CrCl <30 mL/min). Severe hepatic impairment (Child-Pugh score ≥10). Pregnancy & lactation. Childn <16 yr.
Special Precautions
Discontinue if worsening heart failure, edema or uncontrolled/severe HTN occurs; at 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity; signs or symptoms of hepatic disease develop, systemic manifestations occur, or w/ persistent or worsening abnormal hepatic function test. Not to be used in patients w/ active GI ulceration or bleeding; bronchospasm, asthma, rhinitis or urticaria w/ NSAID or aspirin therapy. Not to be given to patient w/ BP persistently >140/90 mmHg & inadequately controlled. Increased risk of MI & stroke due to long-term use or pre-existing cardiac risk factors eg, HTN, hyperlipidemia, DM, smoking. New onset or worsening edema & heart failure. Pre-existing edema, left ventricular dysfunction or NYHA class I heart failure. Carefully evaluate individual CV profiles prior to prescribing & periodically re-evaluate need for symptomatic relief & response to therapy. History of GI bleeding or ulcer. Renal papillary necrosis during long-term use. May mask signs & symptoms of infection. Control high BP prior to treatment & monitor for 2 wk afterwards then regularly thereafter. Closely monitor hepatic function in patients w/ previous abnormal hepatic function test or signs/symptoms of hepatic dysfunction. Monitor renal function. Concurrent therapy w/ aspirin or other NSAIDs, anticoagulants &/or corticosteroids, smoking, alcohol. Concomitant use w/ diuretics, ACE inhibitors, angiotensin II receptor blockers. Renal impairment. Avoid in eGFR <30 mL/min/1.73 m2. Avoid during pregnancy. Not to breastfeed during treatment. Elderly or debilitated patients.
Adverse Reactions
Thrombocytopenia; gastroenteritis, upper resp infection, UTI; hypersensitivity reactions eg, angioedema, anaphylactic/anaphylactoid reactions including shock; increased or decreased appetite, wt gain; anxiety, depression, decreased mental acuity, confusion, hallucinations, restlessness; dysgeusia, insomnia, paresthaesia/hypaesthesia, somnolence, asthenia/fatigue, dizziness, headache; blurred vision; tinnitus; CHF, non-specific ECG changes, MI, palpitations, angina, arrhythmia, atrial fibrillation; flushing, CVA, hypertensive crisis, HTN, edema; cough, dyspnea, epistaxis, bronchospasm; abdominal distention & pain, acid reflux, changes in bowel movement pattern, constipation, dry mouth, gastroduodenal & oral ulcers, irritable bowel syndrome, oesophagitis, peptic ulcers including perforation & bleeding (elderly), vomiting gastritis, flatulence, diarrhea, dyspepsia, heartburn, epigastric discomfort, nausea; hepatitis, jaundice, hepatic failure, increased ALT & AST; ecchymosis, facial oedema, pruritus, erythema, rash, SJS, TEN, urticaria, fixed drug eruption, oedema/fluid retention, lower extremity edema; 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, hyperkalaemia; flu-like disease, post-dental extraction alveolitis (dry socket). Nephrotoxicity including interstitial nephritis & nephrotic syndrome; hepatotoxicity including hepatic failure.
Drug Interactions
Decreased antihypertensive effect & increased nephrotoxicity of ACE inhibitors &/or AIIAs. Increased plasma conc w/ fluconazole, ketoconazole. Increased GI bleeding w/ oral prednisone. Increased risk of bleeding w/ clopidogrel, prasugrel. Increased risk of anticoagulant-induced bleeding w/ warfarin. Impaired antihypertensive effect of β-blockers. Increased nephrotoxicity w/ cyclosporin & tacrolimus. Decreased diuretic effects & increased risk of acute renal failure w/ thiazides, K-sparing & loop diuretics. Increased plasma lithium levels. Increased MTX toxicity. Reduced blood conc w/ rifampin. Increased steady-state AUC of ethinyl estradiol/norethindrone & estrogenic components. Increased digoxin plasma conc.
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
Nosmen film-coated tab 120 mg
Packing/Price
1 × 5's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in