Dynastat also contains dibasic sodium phosphate, phosphoric acid and sodium hydroxide. Valdecoxib and parecoxib valdecoxib is a derivative of isoxazole and binds noncovalently to cox2 to form a tight and relatively stable enzymeinhibitor complex. The indian pharmacopoeia is the legally recognized book of standards for the quality of. These cookies are necessary for the website to function and. Reference standards of european pharmacopoeia edqm. Parecoxib is a watersoluble and injectable prodrug of valdecoxib. Parecoxib, sold under the brand name dynastat among others, is a watersoluble and injectable prodrug of valdecoxib. Parecoxib sodium information, side effects, warnings and. The study of different approaches of parecoxib sodium.
Welcome to contact us for further details including current dmf status for the product. Parecoxib is awhite to offwhite, crystalline solid. Pharmacokinetic profile of parecoxib sodium, an injectable prodrug of the cox2selective inhibitor, valdecoxib. By deep intramuscular injection, or by intravenous injection. Sc69124, sodium 45methyl3phenylisoxazol4ylphenylsulfonylpropionylamide empirical formula hill notation. Parecoxib is a potent and selective cox2 inhibitor. A thorough literature studies shows no pharmacopoeia methods on either parecoxib sodium or its injection formulation. Simultaenous quantification of parecoxib and its potential. Reconstitute the vial with 2 ml of sodium chloride 0. International pharmacopoeia for albendazole chewable tablets was revised. We offer as per requirements of rnd development quantities or commercials, buy high quality source with supportive technical package. Zhuang q, bian y, wang w, jiang j, feng b, sun t, lin j, zhang m, yan s, shen b, pei f, weng x. Dynastat parecoxib as sodium 20 mg and 40 mg powder for injection with diluent. Who pharmacopoeia library world health organization.
Efficacy and safety of postoperative intravenous parecoxib. Each 2 ml of reconstituted powder contains 40 mg of parecoxib. Parecoxib medicinal forms bnf content published by nice. However, the efficacy and safety of parecoxib in children remain unclear. Pubmed, cochrane central register of controlled trials, ebsco, springer, ovid and chinese national knowledge infrastructure cnki databases were searched from january 1999 to january 20 to comprehensively collect randomized controlled trials rcts of parecoxib sodium for. Ivim management of acute pain initially 40 mg followed by 20 or 40 mg every 612 hr as required. Patients receiving parecoxib sodium 20 mg bd and 40 mg bd consumed 15. The international pharmacopoeia world health organization. Dynastat 40mg powder for solution for injection summary of. Unlike ketorolac, parecoxib has no effect on platelet function and.
Perioperative parecoxib administration reduces postoperative pain, opioid consumption, and adverse events in adult patients. After a single dose, the duration of analgesia was dose and clinical pain model dependent and ranged from 6 to greater than 24 hours. The active ingredient in dynastat is parecoxib as parecoxib sodium. This metaanalysis was performed to evaluate the efficacy and safety of parecoxib sodium for acute postoperative pain. Yes in case where starting and raw materials, active substances or excipients are described neither in the european pharmacopoeia nor in the pharmacopoeia of a member state, compliance with the monograph of a third country pharmacopoeia can be accepted. Parecoxib, also known as sc69124a and dynastat, is a cyclooxygenase2 inhibitor used for the shortterm treatment of postoperative pain in adults. Useful for the shortterm treatment of postoperative pain in adults. This metaanalysis included related published studies to address this concern.
The cox2 specific inhibitor parecoxib sodium is effective in treating postoperative pain in total hip arthroplasty patients. This medicinal product contains less than 1 mmol sodium 23 mg per dose. Preclinical data reveal no special hazards for human based on conventional studies of safety pharmacology or repeated dose toxicity at 2fold the maximum human exposure to parecoxib dynastat. Efficacy and safety of postoperative intravenous parecoxib sodium followed by oral celecoxib pipforce posttotal knee arthroplasty in patients with osteoarthritis. Dynastat 40mg powder for solution for injection summary.
This is the ninth edition of the international pharmacopoeia, published in 2019. Our objective is to analyze and observe the different administration routes of parecoxib sodium pretreatment on the behavioral improvement of rats with neuropathic pain to provide the preclinical data of parecoxib sodium on neuropathic pain treatment. Apr 11, 2016 parecoxib sodium injection 40 mg store at 25c 77f. Qualitative and quantitative composition 20 mg vial. Initially 40 mg, then 2040 mg every 612 hours as required for up to 3 days. Nov 12, 2012 parecoxib parecoxib sodium is an injectable prodrug of valdecoxib, which is a potent and selective inhibitor of cyclooxygenase2. Physicochemical properties and quantitative determination. The prodrug parecoxib as well as its active metabolite val have a specific affinity to the cannabinoid cb receptor measured in cb1expressing hek 293 cells and rat brain tissue 1. Intravenous parecoxib sodium as an analgesic alternative to morphine in acute trauma pain in the emergency department article pdf available in international journal of emergency medicine 71. This medicine is used for the prevention and treatment of pain. Original article the effects of parecoxib sodium and.
Food and drug administration fda, advising the company that the new drug application nda for parecoxib had not been approved. Dynastat 40mg powder and solvent for solution for injection vials pfizer ltd active ingredients. Parecoxib sodium pcx, the selective cyclooxygenase cox2 inhibitor, has aroused great interests among researchers mainly because of its central role in analgesic and antiinflammatory effects in a wide range of perioperative or postoperative procedures. Elderly parecoxib, sold under the brand name dynastat among others, is a watersoluble and injectable prodrug of valdecoxib. A randomized study of the efficacy and safety of parecoxib for the treatment of pain following total knee arthroplasty in korean patients margaret noyes essex,1 heeyoun choi,2 pritha bhadra brown,1 raymond cheung1 1pfizer inc.
Dailymed parecoxib sodium injection, powder, for solution. The bp 2016 includes almost 4,000 monographs which are legally enforced by the human medicines regulations 2012, and becomes legally effective. By continuing to browse the site you are agreeing to our policy on the use of cookies. The occurrence of shivering, visual analogue score vas, ramsy sedation scale rss, postoperative nausea and vomiting were recorded an hour after extubation. Adult male spraguedawley rats were administered parecoxib 10 or 30 mg kg1, ip or isotonic saline twice a day. After reconstitution, the final concentration of parecoxib is 20 mgml. Parecoxibdynastat generic is a nonsteroidal antiinflammatory drug nsaid, prescribed for postoperative pain in adults. After reconstitution, the concentration of parecoxib is 20 mgml.
Ceo and chair, council of experts international meeting of world pharmacopoeias 29 february to 2 march 2012. Department of pharmaceutical analysis, school of pharmacy, shenyang pharmaceutical university, wenhua road, shenyang 110016. Parecoxib parecoxib sodium is an injectable prodrug of valdecoxib, which is a potent and selective inhibitor of cyclooxygenase2. It can be used to relieve pain and reduce inflammation swelling and soreness which may occur after surgery. Sep 20, 2005 parecoxib sodium is a nonnarcotic injectable cox2 selective analgesic for the treatment of acute pain. Valdecoxib is the active metabolite of parecoxib sodium. A randomized study of the efficacy and safety of parecoxib. Healthcare professionals smpc patients pil legal categories. Usp reference standards are specified for use in conducting official usp nf tests and assays. The parecoxib injection formulation is a sterile, preservativefree, clear, and colorless isotonic solution. Prevention or reduction of postop pain 40 mg 3045 min prior to surgical incision, may be continued postop as needed for adequate effect.
Validated stabilityindicating rphplc method for the determination of parecoxib sodium and degradation impurities in bulk drug volume. Determination of nitrogen by sulphuric acid digestion semimicro method place a quantity of the subst ance to be examined m g containing about 2 mg of nitrogen in a combustion flask, add 4 g of a powdered mixture of 100 g of dipotassium. Parecoxib is a selective inhibitor of cyclooxygenase2. Efficacy and safety of perioperative parecoxib for acute. Parecoxib is an injectable cyclooxygenase2 inhibitor with proven postoperative. A very few analytical literature are available on parecoxib sodium injection.
Check your settings below and select the cookies youre happy with. A list of us medications equivalent to parecoxib sodium is available on the website. F, parecoxib sodium 40 mg group p or normal saline group s 40 minutes before the end of surgery. Delivers crucial information for european markets earlier than any other pharmacopoeia. Parecoxib sodium is indicated in the shortterm treatment of. The isobolograms of parecoxib sodium and choline showed that the measured ed50 of the two drugs combined was below the theoretical ed50 value p0. Within the eu1 it is marketed as an intravenous or intramuscular injection in austria, denmark, finland, germany, ireland, netherlands, portugal, sweden, united kingdom and also in norway. A novel stability indicating reverse phase ultra performance. Parecoxib sodium is a nonnarcotic injectable cox2 selective analgesic for the treatment of acute pain. Within the eu1 it is marketed as an intravenous or intramuscular. Upon administration, parecoxib is hydrolyzed by hepatic carboxyesterases to its active form, valdecoxib. Parecoxib sodium information, side effects, warnings and recalls. Cox2specific inhibitors coxibs celecoxib was the first cox2specific inhibitor coxib approved by the fda in december 1998, followed by rofecoxib in may 1999, and then valdecoxib in november 2001.
Jigs chemical is global manufacturer, supplier of parecoxib sodium cas no. Parecoxib is a cox2 selective inhibitor in the same category as celecoxib celebrex and rofecoxib vioxx. As it is injectable, it can be used perioperatively when patients are unable to. Parecoxib sodium is indicated in the shortterm treatment of postoperative pain. A pharmacopoeia, pharmacopeia, or pharmacopoea in its modern technical sense, is a book containing directions for the identification of compound medicines. Parecoxib is an amide prodrug of the cyclooxygenase ii cox2 selective, nonsteroidal antiinflammatory drug nsaid valdecoxib, with antiinflammatory, analgesic, and antipyretic activities. Public statement on parecoxib sodium dynastatrayzon. Public statement on parecoxib sodium dynastatrayzonzapit. A pharmacopoeia also covers pharma ceutical starting. British pharmacopoeia 2016 pdf free download full edition. Jul 24, 2014 zhuang q, bian y, wang w, jiang j, feng b, sun t, lin j, zhang m, yan s, shen b, pei f, weng x. Powder and solvent for solution for injection all products.
Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may 2020, wolters kluwer updated. Parecoxib sodium is a medicine available in a number of countries worldwide. Usage, warnings, side effects, and community information for the prescription drug parecoxib sodium. Pharmacopoeial standards world health organization. It is a potent inhibitor of pge 2 production in humans. It was patented in 1996 and approved for medical use in 2002. Search results for parecoxib sodium 2 results found save this search. Objective to preliminarily study the physicochemical properties and to develop a method to determine the content of parecoxib sodium. Patients received parecoxib sodium for at least 3 days and then were transitioned to valdecoxib for a total treatment duration of 1014 days. The aim of the current study was to develop and validate a precise.
Parecoxib sodium is an injectable prodrug of valdecoxib, that acts as a potent and selective inhibitor of cyclooxygenase2 cox2. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Fewliteratures are available on the pharmacodynamics, pharmacokinetics, and plasma studies 59. It is therefore possible that such reactions may also occur with use of parecoxib sodium. Who provides the international pharmacopoeia free of charge for who. All patients received standard of care analgesia during treatment and. Calcium, sodium, potassium, magnesium, iron, chloride, phosphate. The following structural formula of parecoxib sodium is shown below. Qiuyang yu, qiuli yu, lei wu, jing sun, panqin ma, xiaojie liu, wenxiang dong and peng zhang affiliation. After iv or im dosing of parecoxib sodium dynastat, the elimination halflife t 12 of valdecoxib is about 8 hours. The 10th edition initial release plus supplements 10. They are expecting approval in the fourth quarter of 2001. It is approved through much of europe for short term perioperative pain control. Parecoxib parecoxib sodium is an injectable pro drug of valdecoxib, which is a potent and selective inhibitor of cyclooxygenase2.
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