ETORICOXIB

Product overview:
TRADE NAME GENERIC NAME COMPANY NAME : ACROXIA :ETORICOXIB :sun pharma.intr labs etc

ROUTES OF ADMINISTRATION:
Adult: 60 mg once daily. Hepatic impairment: Mild impairment (Child-Pugh score of 5 or 6): 60 mg once daily; moderate impairment (Child-Pugh 7-9): 60 mg every other day. Avoid in severe hepatic impairment (ChildPugh 10). Oral Rheumatoid arthritis Adult: 90 mg once daily. Hepatic impairment: Mild impairment (Child-Pugh score of 5 or 6): 60 mg once daily; moderate impairment (Child-Pugh 7-9): 60 mg every other day. Avoid in severe hepatic impairment (ChildPugh 10). Oral Acute gout Adult: 120 mg once daily. Max duration: 8 days. Hepatic impairment: Mild impairment (Child-Pugh score of 5 or 6): 60 mg once daily; moderate impairment (Child-Pugh 7-9): 60 mg every other day. Avoid in severe hepatic impairment (ChildPugh 10). Food(before/after) May be taken with or without food. The CPMP, during its meeting held from 23 to 25 July 2002 decided to start a referral procedure under Article 31 of Directive 2001/83/EC as amended, for medicinal products containing celecoxib, etoricoxib, parecoxib, rofecoxib and valdecoxib. The questions identified related to gastrointestinal and cardiovascular safety. In October 2002, the CPMP asked additional questions relating to serious hypersensitivity reactions (anaphylaxis and angioedema) and serious skin reactions including Stevens- Johnson syndrome, toxic epidermal necrolysis, erythema multiforme and exfoliative dermatitis in patients treated with COX-2 inhibitors.

The Marketing Authorisation Holders provided written explanations by 31 October 2002, and supplementary information by 30 April 2003 and by 15 August 2003. An oral explanation was given by the Marketing Authorisation Holders on 24 September 2003. Upon consideration of all available data, the CPMP adopted an opinion on 20 November 2003, which was revised on 26 February 2004. This opinion recommended the maintenance of the Marketing Authorisations for celecoxib containing medicinal in the indications stated in the Summary of Product Characteristics as set out in Annex III. The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended Summary of Product Characteristics in Annex III. On the basis of the CPMP Opinion, the European Commission issued a Decision on 29 April 2004.

ALIAS NAMES:
ALGIX,ACROXIA,MK-663,NUCOXIA,TAXUIB,ETORICOXIB.

DESCRIPTION
PRODUCT DESCRIPTION:
Etoricoxib is a COX-2 selective inhibitor (approx. 106.0 times more selective for COX-2 inhibition over COX-1) from Merck & Co. Doses are 60, 90 mg/day for chronic pain and 120 mg/day for acute pain. Currently it is approved in more than 60 countries worldwide but not in the US, where the Food and Drug Administration (FDA) requires additional safety and efficacy data for etoricoxib before it will issue approval. Current therapeutic indications are: treatment of rheumatoid arthritis, psoriatic arthritis, osteoarthritis, ankylosing spondylitis, chronic low back pain, acute pain and gout. Note that approved indications differ by country. Like any other COX-2 selective inhibitor, Etoricoxib selectively inhibits iso-form 2 of cyclooxygenase enzyme (COX-2). This reduces the generation of prostaglandins (PGs) from arachidonic acid. Among the different functions exerted by PGs, their role in the inflammation cascade should be highlighted. COX-2 selective inhibitor (aka "COXIB") showed less marked activity on type 1 cycloxigenase compared to traditional non-steroidal anti-inflammatory drugs (NSAID). This reduced activity is the cause of reduced gastrointestinal toxicity, as demonstrated in several large clinical trials performed with different COXIB. Pharmacodynamics GI disorders; ischemic cardiac events; hypersensitivity reactions, headache, dizziness, nervousness, depression, drowsiness, insomnia, vertigo, tinnitus, photosensitivity; blood disorders, fluid retention, hypertension; dry mouth, taste disturbance, mouth ulcers; appetite and wt changes; chest pain, fatigue, paraesthesia, influenza-like syndrome, myalgia. Renal toxicityDosage

MECHANISM OF ACTION:
Etoricoxib is the inhibitor of COX2 enzymes especially iso form of COX2 enzymes. this makes the decreased synthesis of arachidonic acid which is the starting material of (PGS)prostaglandins synthesis. As well prostaglandins mediate inflammatory reactions which is get suppressed by the use of etoricoxib.

THERAPEUTIC CLASS:
It belongs to (NSAIDS)NON STEROIDAL ANTI-INFLAMMATORY DRUGS.

OTHER KEY WORDS:

Adverse Reactions GI disorders; ischemic cardiac events; hypersensitivity reactions, headache, dizziness, nervousness, depression, drowsiness, insomnia, vertigo, tinnitus, photosensitivity; blood disorders, fluid retention, hypertension; dry mouth, taste disturbance, mouth ulcers; appetite and wt changes; chest pain, fatigue, par aesthesia, influenza-like syndrome, malign. Renal toxicity. Precautions Information Not Available Special Precautions Allergic disorders, coagulation defects; history of cardiac failure, left ventricular dysfunction, hypertension, or in patients with edema due to other reasons; elderly, renal, cardiac or hepatic impairment. Withdraw treatment if GI lesions develop; caution when admin to dehydrated patients. Regular BP monitoring is advisable. May mask fever and other signs of infection, Pregnancy. Other Drug Interactions CYP3A4 inhibitors or inducers; rifampicin, ethinyloestradiol; oral salbutamol and minoxidil. Antidepressant SSRIs and venlafaxine may increase risk of bleeding. Risk of side effects increased with concomitant use of aspirin, ciclosporin, ketorolac or other NSAIDs. Lithium and methotrexate, coumarins, phenindione, phenytoin and sulphonylureas.

MARKETING DETAILS:
Coxet from Anthus [Etoricoxib]
Strength Coxet: 60mg Coxet: 90mg Volume Presentation Price* 10 10 Coxet: TAB 49.75 Coxet: TAB 69.75

Ebov from Glenmark (Integrace) [Etoricoxib]

Strength Ebov: 60mg Ebov: 90mg Ebov: 120mg Volume Presentation Price* 10 10 10 Ebov: TAB Ebov: TAB Ebov: TAB 37.70 52.80 75.50

Read more on Coxet from Anthus

Read more on Ebov from Glenmark (Integrace)

Erofica from Micro HC [Etoricoxib]

Strength Volume Presentation Price*

Eteron from CFL [Etoricoxib]

Strength Volume Presentation Price*

Erofica: 60mg Erofica: 90mg Erofica:120mg

10 10 10

Erofica: TAB Erofica: TAB 71.00 Erofica: TAB 87.00

Eteron: 60mg Eteron: 90mg Eteron: 120mg

10 10 10

Eteron: TAB 79.00 Eteron: TAB 109.00 Eteron: TAB 139.00

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Etody from Piramal HC [Etoricoxib]

Strength Etody: 60mg Etody: 90mg Etody: 120mg Volume Presentation Price* 10 10 10 Etody: TAB 37.00 Etody: TAB 52.00 Etody: TAB 75.00

Etom from Intra Labs [Etoricoxib]

Strength Etom: 90mg Etom: 120mg Volume Presentation Price* 10 10 Etom: TAB Etom: TAB 99.00 109.00

Read more on Etom from Intra Labs Read more on Etody from Piramal HC

Etorica from Micro Eros [Etoricoxib]

Strength Etorica: 60mg Etorica: 90mg Etorica:120mg Volume Presentation Price* 10 10 10 Etorica: TAB 42.50 Etorica: TAB 55.00 Etorica: TAB 68.00

Etoshine from Sun [Etoricoxib]

Strength Etoshine: 60mg Etoshine: 90mg Etoshine: 120mg Volume Presentation 10 10 10 Price*

Etoshine: TAB 79.00 Etoshine: TAB 89.00 Etoshine: TAB 99.00

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APPLICATION NUMBER:
DEUTERIUM ENRICHED PARTICLES:20090076087 DATE:2009\03\19

EXPIRY DATE:
Depends on the date of manufacture.

REGULATORY DETAILS
BRANDNAMES: COXET,EBOV,ERFICA,EYERON,ETODT,ETEROM,ETORICA,ETOSHINE,ETOXIB,ETOZOX,ETROBAX,HIC OX,HIRETO,NUCOXIA,NUCOXIA-P,TORCOXIA.

THERPEUTIC EQUIVALENCE CODE:

DESCRIPTION: list of therapeutic equivalence code. NUMBER OF CARDS:15 SAVE COUNT:1

CREATED:2007\07\31 TAGS:Equvivalent therapeutic

CLINICAL TRIALS
Abstract OBJECTIVE: To evaluate the efficacy and safety of etoricoxib and indomethacin in the treatment of patients with acute gout METHODS: A randomized, double-blind, active-comparator study was conducted at 42 sites. A total of 189 men and women (> or =18 years of age) who were experiencing an acute attack (< or =48 hours) of clinically diagnosed gout were treated for 8 days with etoricoxib, 120 mg/day (n = 103), or indomethacin, 50 mg 3 times a day (n = 86). The primary efficacy end point was the patient's assessment of pain in the study joint (0-4-point Likert scale) over days 2-5. Safety was assessed by adverse experiences (AEs) occurring during the trial. RESULTS: Etoricoxib demonstrated clinical efficacy comparable to that of indomethacin in terms of the patient's assessment of pain in the study joint. The difference in the mean change from baseline over days 2-5 was -0.08 (95% confidence interval -0.29, 0.13) (P = 0.46), which fell within the pre-specified comparability bounds of -0.5 to 0.5. Secondary end points over the 8-day study, including the onset of efficacy, reduction in signs of inflammation, and patient's and investigators global assessments of response to therapy, confirmed the comparable efficacy of the two treatments. The etoricoxib-treated patients had a numerically lower incidence of AEs (43.7%) than did the indomethacin-treated patients (57.0%) and a significantly lower incidence of drug-related AEs (16.5% versus 37.2%; P < 0.05). CONCLUSION: Etoricoxib at a dosage of 120 mg once daily was confirmed to be an effective treatment for acute gout. Etoricoxib was comparable in efficacy to indomethacin at a dosage of 50 mg 3 times daily, and it was generally safe and well tolerated. Drug Category: Cyclooxygenase Inhibitors Drug Type: Small Molecule; Approved Other Brand Names containing Etoricoxib: Arcoxia; Nucoxia; Tauxib; Algix; Absorption: Bioavailability is 100% following oral administration. Toxicity (Overdose): This reduced activity is the cause of reduced gastrointestinal toxicity, as demonstrated in several large clinical trials performed with different COXIB (see below links on NEJM and The Lancet). Some clinical trials and meta-analysis showed that treatment with COXIB lead to increased incidence of cardiovascular adverse events compared to placebo Protein Binding: 92% Biotransformation: Hepatic, primarily via CYP3A4. Half Life: 22 hours Dosage Forms of Algix: Not Available

Chemical IUPAC Name: 5-chloro-2-(6-methylpyridin-3-yl)-3-(4-methylsulfonylphenyl)pyridine Chemical Formula: C18H15ClN2O2S Etoricoxib on Wikipedia: http://en.wikipedia.org/wiki/Etoricoxib Organisms Affected: Humans and other mammals

CHEMICAL DETAILS
ACTIVE INGREDIENTS: Ingredients Active ingredient: ARCOXIA 30 mg tablet contains 30 mg etoricoxib ARCOXIA 60 mg tablet contains 60 mg etoricoxib ARCOXIA 120 mg tablet contains 120 mg etoricoxib Inactive ingredients: calcium hydrogen phosphate (anhydrous) microcrystalline cellulose lactose croscarmellose sodium hypromellose magnesium stearate carnauba wax titanium dioxide glycerol triacetate iron oxide yellow CI77492 (60 mg and 120 mg tablets) indigo carmine CI73015 (60 mg and 120 mg tablets) ARCOXIA does not contain gluten, sucrose, tartrazine or any other azo dyes. Manufacturer/Supplier ARCOXIA is made/supplied in Australia by: Merck Sharp & Domes (Australia) Pty Limited A.C.N. 000 173 508 54-68 Ferndell Street SOUTH GRANVILLE NSW 2142 This leaflet was prepared in June 2010. Australian Register Numbers: 30 mg tablet - AUST R 131797 60 mg tablet - AUST R 81456 120 mg tablet - AUST R 81458 = Trademark Copyright 2010. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, N.J., U.S.A.

WPC-ACX-T-052010

CAS NUMBER:202409-33-4
CHEMICAL FORMULA: C18H15CIN2O2S. MOL.MASS:358.8g|mole