Etoricoxib


Generic Medicine Info
Indications and Dosage
Oral
Ankylosing spondylitis, Rheumatoid arthritis
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.

Oral
Osteoarthritis
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.
Renal Impairment
CrCl (mL/min) Dosage
<30 Contraindicated.
Hepatic Impairment
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.
Administration
May be taken with or without food.
Contraindications
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.
Special Precautions
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.
Adverse Reactions
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.
Monitoring Parameters
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.
Overdosage
Symptoms: Gastrointestinal or cardiorenal events. Management: Supportive treatment. Remove unabsorbed drug from the gastrointestinal tract. Perform clinical monitoring.
Drug Interactions
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.
Action
Description:
Mechanism of Action: 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.
Chemical Structure

Chemical Structure Image
Etoricoxib

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 123619, Etoricoxib. https://pubchem.ncbi.nlm.nih.gov/compound/Etoricoxib. Accessed June 28, 2022.

Storage
Store below 30°C. Protect from light and moisture.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AH05 - etoricoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
References
Anon. Etoricoxib. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/02/2022.

Arcoxia (Organon Malaysia Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 14/06/2022.

Buckingham R (ed). Etoricoxib. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/02/2022.

Etoricoxib 120 mg Film-coated Tablets (Teva UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 14/06/2022.

Etoricoxib 30 mg Film-coated Tablets (Teva UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 02/02/2022.

Etoricoxib 60 mg Film-coated Tablets (Zentiva Pharma UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 14/06/2022.

Etoricoxib 90 mg Film-coated Tablets (Zentiva Pharma UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 14/06/2022.

Joint Formulary Committee. Etoricoxib. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/02/2022.

Organon (New Zealand) Limited. Arcoxia Film Coated Tablets data sheet 24 May 2021. Medsafe. http://www.medsafe.govt.nz. Accessed 02/02/2022.

Disclaimer: This information is independently developed by MIMS based on Etoricoxib from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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