Adult: 60 mg once daily, may increase to 90 mg once daily as necessary. Once patient is clinically stable, may reduce dose to 60 mg once daily. Use the lowest effective dose and follow the shortest possible duration of treatment. Child: ≥16 years Same as adult dose.
Adult: 30 mg once daily, may increase to 60 mg once daily as necessary. Use the lowest effective dose and follow the shortest possible duration of treatment. Child: ≥16 years Same as adult dose.
Oral Acute gouty arthritis
Adult: 120 mg once daily. Max treatment duration: 8 days. Child: ≥16 years Same as adult dose.
Oral Acute pain
Adult: For the treatment of postoperative dental surgery pain: 90 mg once daily. Max treatment duration: 3 days. Doses should only be given during the acute symptomatic period. Dosage recommendations may vary among countries or individual products (refer to specific product guidelines). Child: ≥16 years Same as adult dose.
Oral Primary dysmenorrhoea
Adult: For the treatment of acute pain: 120 mg once daily. Max treatment duration: 8 days. Doses should only be given during the acute symptomatic period. Dosage recommendations may vary among countries or individual products (refer to specific product guidelines). Child: ≥16 years Same as adult dose.
Mild (Child-Pugh score 5-6): Max: 60 mg once daily. Moderate (Child-Pugh score 7-9): Max: 30 mg once daily. Severe (Child-Pugh score ≥10): Contraindicated.
May be taken with or without food.
Hypersensitivity; history of allergic type reactions (e.g. bronchospasm, acute rhinitis, nasal polysps, angioneurotic oedema, or urticaria) after taking aspirin, NSAIDs, or other cyclooxygenase-2 (COX-2) inhibitors; active peptic ulceration or gastrointestinal haermorhage, inflammatory bowel disease; New York Heart Association (NYHA) class II-IV congestive heart failure, uncontrolled hypertension or with persistently high blood pressure (>140/90 mmHg), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease (including patients who have recently undergone coronary artery bypass graft surgery or angioplasty. Children and adolescent <16 years. Renal (CrCl <30 mL/min) and severe hepatic (Child-Pugh ≥10) impairment. Pregnancy and lactation.
Patient with a history of gastrointestinal disease (e.g. ulceration, gastrointestinal bleeding), with a predispostion for CV events (e.g. hyperlipidaemia, hypertension, diabetes mellitus, smoking), uncompensated heart failure, cirrhosis, history of cardiac failure, left ventricular dysfunction, pre-existing oedema, dehydration. Use may mask the signs and symptoms of infection. Mild to moderate hepatic impairment. Elderly.
Significant: Fluid retention; new-onset or exacerbation of oedema, hypertension, new-onset or recurrent CHF; increased ALT or AST, hypersensitivity reactions (e.g. anaphylaxis, angioedema). Cardiac disorders: Palpitations, arrhythmia. Gastrointestinal disorders: Abdominal pain, constipation, flatulence, gastritis, acid reflux, diarrhoea, dyspepsia, epigastric discomfort, nausea, vomiting, oesophagitis, oral ulcer. General disorders and administration site conditions: Asthenia, fatigue, flu-like disease. Infections and infestations: Alveolar osteitis. Nervous system disorders: Headache, dizziness. Respiratory, thoracic and mediastinal disorders: Bronchospasm. Skin and subcutaneous tissue disorders: Ecchymosis. Potentially Fatal: Gastrointestinal perforations, ulcers, or haemorrhage, CV thrombotic events (e.g. MI, stroke). Rarely, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis.
PO: Z (NSAIDs caused foetal ductus arteriosus premature closure, foetal renal impairment and persistent pulmonary hypertension. Avoid near term, else use lowest dose for shortest time.)
Patient Counseling Information
This drug may cause dizziness, vertigo, or somnolence; if affected, do not drive or operate machinery.
Monitor blood pressure during treatment, within 2 weeks after initiation of treatment, and periodically thereafter; renal function, hepatic function, basic metabolic panel. Asses for weight gain, oedema, and signs and symptoms of haemorrhage.
Symptoms: Gastrointestinal or cardiorenal events. Management: Supportive treatment. Remove unabsorbed drug from the gastrointestinal tract. Perform clinical monitoring.
Increased INR with anticoagulants (e.g. warfarin). May diminish the therapeutic effect of diuretics and antihypertensive agents. May increase the risk of gastrointestinal ulceration with aspirin (even at low doses). Increased plasma concentrations of ethinylestradiol, lithium, methotrexate, and other drugs metabolised by human sulfotransferases (e.g. oral salbutamol, minoxidil). Decreased plasma concentrations with rifampicin.
Description: Etoricoxib, an NSAID, is an orally active, highly selective cyclo-oxygenase-2 (COX-2) inhibitor. Its anti-inflammatory and analgesic action is exhibited by inhibition of prostaglandin synthesis via inhibition of COX-2. Pharmacokinetics: Absorption: Well absorbed from the gastrointestinal tract. Absolute bioavailability: Approx 100%. Time to peak plasma concentrations: Approx 1 hour (without food). Distribution: Plasma protein binding: Approx 92%. Metabolism: Extensively metabolised by the CYP3A4 isoenzyme to form the 6'-hydroxymethyl derivative of etoricoxib, which undergoes further oxidation to form the major metabolite 6'-carboxylic acid derivative. Excretion: Mainly via urine (70% as metabolites; <2% as unchanged drug); faeces (20% as metabolites; <62% as unchanged drug). Elimination half-life: Approx 22 hours.
Store below 30°C. Protect from light and moisture.