Dynastat parecoxib as sodium 20 mg and 40 mg powder for injection with diluent. Etoricoxib united states pharmacopeia usp reference. Dynastat, innparecoxib european medicines agency europa eu. Parecoxib is awhite to offwhite, crystalline solid.
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. A very few analytical literature are available on parecoxib sodium injection. A list of us medications equivalent to parecoxib sodium is available on the website. 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. This is the ninth edition of the international pharmacopoeia, published in 2019 the international pharmacopoeia 1 ph. The international pharmacopoeia world health organization. Medicines compendium mc, a freely available, onlineonly compendium of public standards for. Dynastat 40mg powder for solution for injection summary. Celecoxib inn is a nonsteroidal antiinflammatory drug nsaid used in the treatment of osteoarthritis, rheumatoid arthritis, acute pain, painful menstruation and menstrual symptoms, and to reduce numbers of colon and rectum polyps.
Efficacy and safety of postoperative intravenous parecoxib. Parecoxib drug information indications, dosage, side. The active ingredient in dynastat is parecoxib as parecoxib sodium. The occurrence of shivering, visual analogue score vas, ramsy sedation scale rss, postoperative nausea and vomiting were recorded an hour after extubation.
Seventy elderly patients were included, who were 6582 years of age, 4875 kg of weight, and asa grade iii. Role of parecoxib sodium for postoperative pain management in open hepatectomy. Learn how to pronounce the drugs name, its indications, dosage, how to take, when to take, when not to. Parecoxib sodium 198470858 reference standards for pharmacological research. To investigate the effect of preemptive parecoxib sodium, given in addition to routine analgesic treatment, on postoperative cognitive function in elderly patients. Dynastat also contains dibasic sodium phosphate, phosphoric acid and sodium hydroxide. Renal function should be monitored when parecoxib sodium and any of these medicinal products are coadministered. Parecoxib sodium is indicated in the shortterm treatment of postoperative pain. Healthcare professionals smpc patients pil legal categories. Analgesia begins within 15 minutes of an intravenous or. 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.
Coadministration of nsaids and cyclosporin or tacrolimus has been suggested to increase the nephrotoxic effect of cyclosporin and tacrolimus. Parecoxib is an amide prodrug of the cyclooxygenase ii cox2 selective, nonsteroidal antiinflammatory drug nsaid valdecoxib, with antiinflammatory, analgesic, and antipyretic activities. The bp 2016 includes almost 4,000 monographs which are legally enforced by the human medicines regulations 2012, and becomes legally effective. Parecoxib sodium is a medicine available in a number of countries worldwide. Intravenous parecoxib sodium as an analgesic alternative to morphine in acute trauma pain in the emergency department. The study of different approaches of parecoxib sodium. 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. The incidence of any pain was significantly less with parecoxib 40 mg 26%, p a nsaid for 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.
Original article the effects of parecoxib sodium and. Parecoxib is a potent and selective cox2 inhibitor. We offer as per requirements of rnd development quantities or commercials, buy high quality source with supportive technical package. Reconstitute the vial with 2 ml of sodium chloride 0. Each 2 ml of reconstituted powder contains 40 mg of parecoxib. Parecoxib, sold under the brand name dynastat among others, is a watersoluble and injectable prodrug of valdecoxib. You must not be given dynastat if you have an allergy to.
Valdecoxib and parecoxib valdecoxib is a derivative of isoxazole and binds noncovalently to cox2 to form a tight and relatively stable enzymeinhibitor complex. Find out more about cookies or view our cookie policy. National pharmacopoeia s no regional pharmacopoeia s no international pharmacopoeia s no note. The injection site was monitored for 24 hours for adverse events. Patients received parecoxib sodium for at least 3 days and then were transitioned to valdecoxib for a total treatment duration of 1014 days.
How to use dynastat before you are given dynastat when it must not be used. Jp17th edition pdfopen a new window linked to mhlw website march 7, 2016, the mhlw ministerial notification. For further information and support please go to the website of the issuing pharmacopoeia. Parecoxib, also known as sc69124a and dynastat, is a cyclooxygenase2 inhibitor used for the shortterm treatment of postoperative pain in adults. It is the prodrug of valdecoxib which reduces the production of inflammatory mediators by inhibiting the enzyme cyclooxygenase 2. Validated stabilityindicating rphplc method for the determination of parecoxib sodium and degradation impurities in bulk drug volume. The united states pharmacopeia and national formulary are updated annually, plus two supplements are published each year. Updates to the online and pdf versions of the nzf are published on the 1st working day of each calendar month. Analysis note these products are for test and assay use only. Specific batches of candidate material are selected. The parecoxib injection formulation is a sterile, preservativefree, clear, and colorless isotonic solution. The aim of the current study was to develop and validate a precise, accurate, and specific hplc method systematically which could accomplish the stability indicating of pcx bulk drug and qualitation and quantization. Calcium, sodium, potassium, magnesium, iron, chloride, phosphate. Food and drug administration fda, advising the company that the new drug application nda for parecoxib had not been approved.
Cardiovascular risks in coronary artery bypass graft cabg surgery and serious adverse skin reactions. Efficacy and safety of postoperative intravenous parecoxib sodium followed by oral celecoxib pipforce posttotal knee arthroplasty in patients with osteoarthritis. Public statement on parecoxib sodium dynastatrayzon. Role of parecoxib sodium for postoperative pain management. In male kunming mice with acetic acidinduced writhing, the ed50 of choline and parecoxib sodium administered via the tail vein at 2 h and 30 min before modeling, respectively and their combined use were determined. All information provided in support of this product, including sds and any product information leaflets have been developed and issued under the authority of the issuing pharmacopoeia. Listing a study does not mean it has been evaluated by the u. Shutdown of european pharmacopoeia 9th edition edqm.
F, parecoxib sodium 40 mg group p or normal saline group s 40 minutes before the end of surgery. Japanese pharmacopoeia 17th edition pharmaceuticals and. Qiuyang yu, qiuli yu, lei wu, jing sun, panqin ma, xiaojie liu, wenxiang dong and peng zhang affiliation. Parecoxib is a cox2 selective inhibitor in the same category as celecoxib celebrex and rofecoxib vioxx. Parecoxib sodium is a watersoluble prodrug of valdecoxib which is a poorly watersoluble cox2. Parecoxib parecoxib sodium is an injectable prodrug of valdecoxib, which is a potent and selective inhibitor of cyclooxygenase2. The following structural formula of parecoxib sodium is shown below. The edqm supplies chemical reference substances crs, herbal reference standards hrs and biological reference preparations brp as well as reference spectra for the tests and assays to be carried out in accordance with the official methods prescribed in the european pharmacopoeia establishment. Dailymed parecoxib sodium injection, powder, for solution. In russia, it is commonly sold under the analgin russian. For the salts of bases, the british approved name of the base is followed by the conventional anion name, eg acebutolol giving acebutolol hydrochloride. In support of the second approach, usp has created the. Search results for parecoxib sodium 2 results found save this search. This medicinal product contains less than 1 mmol sodium 23 mg per dose.
Patients receiving parecoxib sodium 20 mg bd and 40 mg bd consumed 15. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Simultaenous quantification of parecoxib and its potential. It is a potent inhibitor of pge 2 production in humans. Parecoxib sodium is indicated in the shortterm treatment of. All patients received standard of care analgesia during treatment and. Metamizole is generic, and in countries where it is marketed, it is available under many brand names. Out of scope information includes radiopharmaceuticals, contrast media, herbals, homeopathics, and food. The plasma halflife of parecoxib is only 22 minutes because of its rapid conversion to valdecoxib. British pharmacopoeia 2016 pdf free download full edition. No authors listed 1 parecoxib is the second nonsteroidal antiinflammatory drug, after ketoprofen, to be marketed in france for the treatment of postoperative pain.
After reconstitution, the concentration of parecoxib is 20 mgml. Jigs chemical is global manufacturer, supplier of parecoxib sodium cas no. Zhuang q, bian y, wang w, jiang j, feng b, sun t, lin j, zhang m, yan s, shen b, pei f, weng x. Parecoxib medicinal forms bnf content published by nice. Api eu written confirmation parecoxib sodium nuray. List of active pharmaceutical ingredients apis for which written confirmations have been obtained by nuray chemicals private limited. Unless otherwise specified in the individual monograph, sodium chloride or other suitable substances, may be added to an aqueous solution for injection in. Fewliteratures are available on the pharmacodynamics, pharmacokinetics, and plasma studies 59. This metaanalysis was performed to evaluate the efficacy and safety of parecoxib sodium for acute postoperative pain. By continuing to browse this website you are agreeing to our use of cookies. View eu written confirmations wc issued to nuray chemicals private limited for written confirmations number. To investigate the synergistic analgesic effect of choline and parecoxib sodium and study its mechanism. A randomized study of the efficacy and safety of parecoxib. The indian pharmacopoeia is the legally recognized book of standards for the quality of.
Validated stabilityindicating rphplc method for the. Parecoxib is an injectable cyclooxygenase2 inhibitor with proven. The first cabg surgery study evaluated patients treated with iv parecoxib sodium dynastat 40 mg twice daily for a minimum of 3 days, followed by treatment with valdecoxib 40 mg twice daily parecoxib sodiumvaldecoxib group n311 or placeboplacebo n151 in a 14day, doubleblind placebocontrolled study. 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. A thorough literature studies shows no pharmacopoeia methods on either parecoxib sodium or its injection formulation. Parecoxib sodium injection, powder, for solution out of scope out of scope for rxnorm and will not receive rxnorm normal forms. Department of pharmaceutical analysis, school of pharmacy, shenyang pharmaceutical university, wenhua.
Parecoxib is a watersoluble and injectable prodrug of valdecoxib. European pharmacopoeia reference standards purpose and. It was patented in 1996 and approved for medical use in 2002. Parecoxib sodium is a nonnarcotic injectable cox2 selective analgesic for the treatment of acute pain. Upon administration, parecoxib is hydrolyzed by hepatic carboxyesterases to its active form, valdecoxib.
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