Etoricoxib


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Osteoarthritis 30 mg once daily, may increase to 60 mg once daily as necessary. Ankylosing spondylitis; Rheumatoid arthritis 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. Acute gouty arthritis 120 mg once daily. Max duration: 8 days. Pain and inflammation associated with dental surgery 90 mg once daily. Max duration: 3 days.
Dosage Details
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.

Oral
Osteoarthritis
Adult: 30 mg once daily, may increase to 60 mg once daily as necessary.

Oral
Acute gouty arthritis
Adult: 120 mg once daily. Max duration: 8 days.

Oral
Pain and inflammation associated with dental surgery
Adult: 90 mg once daily. Max duration: 3 days.
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. Patient with active peptic ulceration or gastrointestinal bleeding, inflammatory bowel disease, congestive heart failure (NYHA II-IV), uncontrolled hypertension or with persistently high blood pressure (>140/90 mmHg), ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, history of bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or allergic-type reactions after taking aspirin, NSAIDs including COX-2 inhibitors. Children and adolescent <16 years. Renal (CrCl <30 mL/min) and severe hepatic (Child-Pugh ≥10) impairment. Pregnancy.
Special Precautions
Patient with history of gastrointestinal disease (e.g. ulceration, gastrointestinal bleeding), with risk factors for cardiovascular events (e.g. hyperlipidaemia, hypertension, diabetes mellitus, smoking), uncompensated heart failure, cirrhosis, history of cardiac failure, left ventricular dysfunction, pre-existing oedema, dehydration. Mild to moderate hepatic impairment. Elderly. Lactation.
Adverse Reactions
Significant: Fluid retention, oedema, hypertension, increased ALT or AST, hypersensitivity reactions including anaphylaxis and angioedema.
Cardiac disorders: Palpitations, arrhythmia.
Gastrointestinal disorders: Abdominal pain, constipation, flatulence, gastritis, heartburn, diarrhoea, dyspepsia, nausea, vomiting, oesophagitis, oral ulcer.
General disorders and admin site conditions: Asthenia, flu-like disease.
Infections and infestations: Alveolar osteitis.
Nervous system disorders: Headache.
Respiratory, thoracic and mediastinal disorders: Bronchospasm.
Potentially Fatal: Gastrointestinal perforations, ulcers or bleedings, exfoliative dermatitis, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN).
Patient Counseling Information
This drug may cause dizziness, vertigo or somnolence, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor blood pressure prior to and during therapy, and periodically thereafter.
Overdosage
Symptoms: Gastrointestinal events, cardiorenal events. Management: Supportive treatment e.g. removal of unabsorbed drug from the gastrointestinal tract and clinical monitoring.
Drug Interactions
Increased INR with anticoagulants (e.g. warfarin). May decrease effect of diuretics and antihypertensive agents. Concomitant use with ACE inhibitor or angiotensin II antagonist may further deteriorate renal function. May increase rate of gastrointestinal ulceration with concomitant low dose acetylsalicylic acid. 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: Etoricoxib, an NSAID, is a 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, food delays rate of absorption. Absolute bioavailability: Approx 100%. Time to peak plasma concentrations: Approx 1 hour (without food), 2 hours (with food).
Distribution: Volume of distribution: 120 L. Plasma protein binding: Approx 92%.
Metabolism: Extensively metabolised via CYP3A4 isoenzyme to form 6’-hydroxymethyl derivative of etoricoxib, then oxidised to 6’-carboxylic acid derivative (major metabolite).
Excretion: Mainly via urine (70%), 20% in faeces, <2% as unchanged drug. Elimination half-life: Approx 22 hours.
Chemical Structure

Chemical Structure Image
Etoricoxib

Source: National Center for Biotechnology Information. PubChem Database. Etoricoxib, CID=123619, https://pubchem.ncbi.nlm.nih.gov/compound/Etoricoxib (accessed on Jan. 23, 2020)

Storage
Store below 30°C.
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 10/04/2019.

Auxib 30 mg Film-Coated Tablets (Merck Sharp & Dohme Limited). MHRA. https://products.mhra.gov.uk/. Accessed 03/05/2019.

Buckingham R (ed). Etoricoxib. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.new.medicinescomplete.com. Accessed 14/05/2014.

Joint Formulary Committee. Etoricoxib. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 14/05/2014.

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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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