| Revision as of 11:28, 11 October 2011 editEdgar181 (talk | contribs)Extended confirmed users196,325 editsm Disambiguate Merck to Merck & Co. using popups← Previous edit |
Latest revision as of 19:51, 20 December 2023 edit undoJJMC89 bot III (talk | contribs)Bots, Administrators3,685,221 editsm Moving Category:Merck & Co. brands to Category:Drugs developed by Merck & Co. per Misplaced Pages:Categories for discussion/Log/2023 December 9#Category:AstraZeneca brands |
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{{short description|Combination drug}} |
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{{Drugbox |
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{{Drugbox |
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| type = combo |
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| verifiedrevid = 455022189 |
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| component1 = Simvastatin |
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| image = Simvastatin and sitagliptin.svg |
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| class1 = ] ] |
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| component2 = Sitagliptin |
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<!--Combo data--> |
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| class2 = ] ] |
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| type = combo |
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| component1 = Sitagliptin |
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| class1 = ] ] |
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| component2 = Simvastatin |
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| class2 = ] ] |
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<!--Clinical data--> |
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<!--Clinical data--> |
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| tradename = Juvisync |
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| tradename = Juvisync |
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| Drugs.com = |
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| Drugs.com = {{drugs.com|CDI|juvisync}} |
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| MedlinePlus = |
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| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> |
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| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> |
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| pregnancy_US = <!-- A / B / C / D / X --> |
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| pregnancy_category= |
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| pregnancy_category= |
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| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled--> |
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| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled--> |
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| legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII --> |
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| legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII --> |
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| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM --> |
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| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM --> |
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| legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V --> |
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| legal_US = Rx-only |
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| ATC_prefix = None |
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<!--Identifiers--> |
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<!--Identifiers--> |
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| CAS_number = |
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| CAS_number = 1448892-92-9 |
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| ATCvet = |
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| ATCvet = |
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| ATC_prefix = <!-- 'none' if uncategorised --> |
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| DrugBank_Ref = {{drugbankcite|correct|drugbank}} |
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| KEGG_Ref = {{keggcite|changed|kegg}} |
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| KEGG = D10258 |
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'''Sitagliptin/simvastatin''', sold under the brand name '''Juvisync''', is a ] ] used to treat ] and ]. It contains ] and ]. Sitagliptin is a ] and simvastatin is an ].<ref>{{cite web | url = https://www.forbes.com/sites/larryhusten/2011/10/07/fda-approves-juvisync-combination-of-sitagliptin-and-simvastatin/ | title = FDA Approves Juvisync, Combination of Sitagliptin and Simvastatin | work = Forbes | date = October 7, 2011}}</ref> These two disorders commonly occur in people at the same time, and have been typically treated with administration of these medications separately. The combination was approved in 2011, and sold under the brand name Juvisync by ]. Juvisync was later removed from the market in 2013, due to business reasons.<ref>{{cite web | url = https://www.fda.gov/drugs/drugsafety/drugshortages/ucm050794.htm | archive-url = https://web.archive.org/web/20090603081808/http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050794.htm | url-status = dead | archive-date = June 3, 2009 | title = Drugs to be Discontinued | accessdate = 2013-12-11 | author = U.S. Food and Drug Administration| website = ] }}</ref> |
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==History== |
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'''Simvastatin/sitagliptin''' is a fixed-dose combination drug consisting of ] and ]. Sitagliptin is used to treat for ] and simvastatin is used to treat ].<ref>{{cite web | url = http://www.forbes.com/sites/larryhusten/2011/10/07/fda-approves-juvisync-combination-of-sitagliptin-and-simvastatin/ | title = FDA Approves Juvisync, Combination of Sitagliptin and Simvastatin | publisher = Forbes | date = October 7, 2011}}</ref> These two disorders commonly occur in patients at the same time, and have been typically treated with administration of these two drugs in separate tablets. The combination was approved in 2011 and is marketed as Juvisync by ]. |
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In 1991, Merck & Co's ] was approved as an HMG-COA inhibitor to lower the levels of LDL cholesterol.{{citation needed|date=April 2014}} In 2006, Merck & Co's ] was approved by the FDA for treatment of diabetes mellitus type 2.<ref>{{cite news | vauthors = Alvey L | title = FDA Approves New Treatment for Diabetes: First in a New Class of Diabetes Drugs | date = 2006-10-17 | url = https://www.fda.gov/newsevents/newsroom/pressannouncements/2006/ucm108770.htm | work = FDA News Release | accessdate = 2013-12-11}}</ref> |
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==Regulation== |
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Juvisync was the first product to combine a cholesterol lowering drug with a type 2 diabetes drug in the same tablet.<ref>{{cite news | first = Morgan | last = Liscinsky | title = FDA Approves Combination Therapy Juvisync | date = 2011-10-07 | url = https://www.fda.gov/newsevents/newsroom/pressannouncements/2011/ucm274748.htm | archive-url = https://web.archive.org/web/20111014194443/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2011/ucm274748.htm | url-status = dead | archive-date = October 14, 2011 | work = FDA News Release | accessdate = 2013-12-11}}</ref> |
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==Nonclinical toxicology== |
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Sitagliptin: Using male and female rats, a two-year ] study was carried out with doses of 50, 150, and 500 mg/kg/day. The 500 mg/kg dose has exposure limits of 60 times what would be seen in the highest dose in humans. At this dose, liver ]/] was seen. Tumors were not seen from the smaller doses. No] or ] effects were seen from tests using several assays (CHO, rat, etc.). Fertility studies in rats showed no ] effects.<ref>{{cite web | url = http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s001s002s004lbl.pdf | title = Highlights of Prescribing Information | accessdate = 2013-12-11 | author = Food and Drug Administration}}</ref> |
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Simvastatin: No tumorigenic effect was seen in a 72-week carcinogenicity study using mice at the low dose levels. However, at the higher dose levels (eight and 16 times the human dose equivalent), liver carcinomas and adenomas, lung adenomas, and adenomas of the ] occurred. No mutagenic effects were seen in assays. Testicular atrophy was noted in dogs and rats at four and eight times the human exposure, respectively.<ref>{{cite web | url = http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s001s002s004lbl.pdf | title = Highlights of Prescribing Information | accessdate = 2013-12-11 | author = Food and Drug Administration}}</ref> |
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==Limitations of use== |
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It should not be used in patients with ], ], ], Fredrickson types I and V ], and severe renal impairment.<ref>{{cite web | url = http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s001s002s004lbl.pdf | title = Highlights of Prescribing Information | accessdate = 2013-12-11 | author = Food and Drug Administration}}</ref> |
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==Drug interactions== |
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Juvisync should not be used with: strong ] inhibitors, ], ], ], and other ].<ref>{{cite web | url = http://www.rxlist.com/juvisync-drug/indications-dosage.htm | title = Juvisync Indications & Dosage | accessdate = 2013-12-11 | author = RxList: The Internet drug Index}}</ref> Caution should be used and the patient should be monitored if they are taking the following: ], ], ], ], ], ], ] anticoagulants, and ].<ref>{{cite web | url = http://www.rxlist.com/juvisync-drug/indications-dosage.htm | title = Juvisync Side Effects & Drug Interactions | accessdate = 2013-12-11 | author = RxList: The Internet drug Index}}</ref> |
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==References== |
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==References== |
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{{reflist}} |
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{{reflist}} |
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== External links == |
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* {{cite web | url = https://druginfo.nlm.nih.gov/drugportal/name/simvastatin%20%252Fsitagliptin | publisher = U.S. National Library of Medicine | work = Drug Information Portal | title = Juvisync }} |
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{{Oral hypoglycemics and insulin analogs}} |
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{{pharma-stub}} |
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{{Portal bar | Medicine}} |
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{{DEFAULTSORT:Sitagliptin Simvastatin}} |
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