Information for the User Ezetimibe/Simvastatin Clonmel 10 Mg/10 Mg Tablets Ezetimibe/Simvastatin Clonmel 10 Mg
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Ezetimibe: a Novel Selective Cholesterol Absorption Inhibitor by Michele Koder, Pharm.D
OREGON DUR BOARD NEWSLETTER A N E VIDENCE B ASED D RUG T HERAPY R ESOURCE COPYRIGHT 2003 OREGON STATE UNIVERSITY. ALL RIGHTS RESERVED Volume 5, Issue 2 Also available on the web and via e-mail list-serve at February 2003 http://pharmacy.orst.edu/drug_policy/newsletter_email.html Ezetimibe: A novel selective cholesterol absorption inhibitor By Michele Koder, Pharm.D. , OSU College of Pharmacy Ezetimibe (Zetia) is a novel selective cholesterol absorption inhibitor that was approved by the FDA in October 2002. Unlike statins (HMG-CoA reductase inhibitors) and bile acid sequestrants, ezetimibe does not inhibit hepatic cholesterol synthesis or increase bile acid secretion. In contrast, ezetimibe selectively inhibits the uptake of dietary cholesterol from enterocytes in the brush border of the intestinal lumen resulting in a decrease in the delivery of dietary cholesterol to the liver and a subsequent decrease in hepatic cholesterol stores and increased cholesterol clearance from the blood.1 Ezetimibe’s unique action has generated interest in its use in combination with other cholesterol-lowering agents. It is indicated for the treatment of primary hypercholesterolemia as monotherapy and in combination with a statin. Ezetimibe is also approved for homozygous familial hypercholesterolemia and homozygous sitosterolemia. TABLE 1: EZETIMIBE CLINICAL TRIAL SUMMARY Study / Design Population Treatment % Change LDL % Change HDL % Change TG Bays et al3 N=432 EZ 5 mg -15.7 +2.9 MC, R, DB, PC LDL 130-250mg/dl EZ 10 mg -18.5 +3.5 NS 12 wk; Phase II TG -
Fenofibrate Ezetimibe Studies
FenofibrateFenofibrate EzetimibeEzetimibe SurrogateSurrogate TrialsTrials ThomasThomas Dayspring,Dayspring, MD,MD, FACPFACP Clinical Assistant Professor of Medicine University of Medicine and Dentistry of New Jersey Attending in Medicine: St Joseph’s Hospital, Paterson, NJ Certified Menopause Practitioner: North American Menopause Society North Jersey Institute of Menopausal Lipidology PharmacokineticPharmacokinetic DataData FenofibrateFenofibrate –– EzetimibeEzetimibe PharmacodynamicPharmacodynamic andand PharmacokineticPharmacokinetic InteractionInteraction StudyStudy Placebo (n = 8) Ezetimibe 10 mg (n = 8) Patients have no physical 30 activity and are on a high Fenofibrate 200 mg (n = 8) carbohydrate low fat diet which lowers HDL-C 20 Fenofibrate 200mg + 10 Ezetimibe 10 mg (n = 8) 0 -10 -20 -30 Change from Baseline (%) -40 -50 TC LDL-C HDL-C TG Mean (SE) percentage change from baseline in serum lipids on day 14 following oral administration of fenofibrate monotherapy, ezetimibe monotherapy, fenofibrate-ezetimibe co- administration therapy or placebo once daily to 14 healthy subjects with hypercholesterolemia Kosoglou T et al. Curr Med Res & Opin 2004;20:1185-1195 FenofibrateFenofibrate –– EzetimibeEzetimibe PharmacodynamicPharmacodynamic andand PharmacokineticPharmacokinetic InteractionInteraction StudyStudy Placebo (n = 8) 30 Ezetimibe 10 mg (n = 8) Fenofibrate 200 mg (n = 8) Combination therapy 20 produced significantly Fenofibrate 200mg + 10 Ezetimibe 10 mg (n = 8) greater reductions in 0 LDL-C and in small LDL-III -10 Levels of -
SUMMARY of the PRODUCT CHARACTERISTICS 1. NAME of the MEDICINAL PRODUCT <Invented Name> 10 Mg/10 Mg Film-Coated Tablets
SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT <Invented name> 10 mg/10 mg film-coated tablets <Invented name> 20 mg/10 mg film-coated tablets <Invented name> 40 mg/10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION <Invented name> 10 mg/10 mg: Each film-coated tablet contains 10 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe. <Invented name> 20 mg/10 mg: Each film-coated tablet contains 20 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe. <Invented name> 40 mg/10 mg: Each film-coated tablet contains 40 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe. Excipient with known effect: <Invented name> 10 mg/10 mg: Each film-coated tablet contains 111.2 mg of lactose (as lactose monohydrate). <Invented name> 20 mg/10 mg: Each film-coated tablet contains 168.6 mg of lactose (as lactose monohydrate). <Invented name> 40 mg/10 mg: Each film-coated tablet contains 286.0 mg of lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) <Invented name> 10 mg/10 mg: white to off-white oblong film-coated tablets. <Invented name> 20 mg/10 mg: yellow to light yellow oblong film-coated tablets. <Invented name> 40 mg/10 mg: pink oblong film-coated tablets. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Primary Hypercholesterolaemia/Homozygous Familial Hypercholesterolaemia (HoFH) <Invented name> is indicated for substitution therapy in adult patients who are adequately controlled with rosuvastatin and ezetimibe given concurrently at the same dose level as in the fixed combination, but as separate products, as adjunct to diet for treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or homozygous familial hypercholesterolaemia. -
Zetia® (Ezetimibe) Tablets
29480958T REV 14 ZETIA® (EZETIMIBE) TABLETS DESCRIPTION ZETIA (ezetimibe) is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe is 1-(4-fluorophenyl)- 3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is: OH OH S SR N F F O Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. ZETIA is available as a tablet for oral administration containing 10 mg of ezetimibe and the following inactive ingredients: croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF, microcrystalline cellulose NF, povidone USP, and sodium lauryl sulfate NF. CLINICAL PHARMACOLOGY Background Clinical studies have demonstrated that elevated levels of total cholesterol (total-C), low density lipoprotein cholesterol (LDL-C) and apolipoprotein B (Apo B), the major protein constituent of LDL, promote human atherosclerosis. In addition, decreased levels of high density lipoprotein cholesterol (HDL-C) are associated with the development of atherosclerosis. Epidemiologic studies have established that cardiovascular morbidity and mortality vary directly with the level of total-C and LDL-C and inversely with the level of HDL-C. Like LDL, cholesterol-enriched triglyceride-rich lipoproteins, including very-low- density lipoproteins (VLDL), intermediate-density lipoproteins (IDL), and remnants, can also promote atherosclerosis. The independent effect of raising HDL-C or lowering triglycerides (TG) on the risk of coronary and cardiovascular morbidity and mortality has not been determined. -
Package Leaflet: Information for the Patient Nustendi 180 Mg/10 Mg Film-Coated Tablet Bempedoic Acid/Ezetimibe This Medicine Is
Package leaflet: Information for the patient Nustendi 180 mg/10 mg film-coated tablet bempedoic acid/ezetimibe This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Nustendi is and what it is used for 2. What you need to know before you take Nustendi 3. How to take Nustendi 4. Possible side effects 5. How to store Nustendi 6. Contents of the pack and other information 1. What Nustendi is and what it is used for What Nustendi is and how it works Nustendi is a medicine that lowers levels of ‘bad’ cholesterol (also called “LDL-cholesterol”), a type of fat, in the blood. Nustendi contains two active substances, which reduce your cholesterol in two ways: • bempedoic acid decreases the production of cholesterol in the liver and increases the removal of LDL-cholesterol from the blood; • ezetimibe works in your bowel by reducing the amount of cholesterol absorbed from food. -
Quasi-Experimental Health Policy Research: Evaluation of Universal Health Insurance and Methods for Comparative Effectiveness Research
Quasi-Experimental Health Policy Research: Evaluation of Universal Health Insurance and Methods for Comparative Effectiveness Research The Harvard community has made this article openly available. Please share how this access benefits you. Your story matters Citation Garabedian, Laura Faden. 2013. Quasi-Experimental Health Policy Research: Evaluation of Universal Health Insurance and Methods for Comparative Effectiveness Research. Doctoral dissertation, Harvard University. Citable link http://nrs.harvard.edu/urn-3:HUL.InstRepos:11156786 Terms of Use This article was downloaded from Harvard University’s DASH repository, and is made available under the terms and conditions applicable to Other Posted Material, as set forth at http:// nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of- use#LAA Quasi-Experimental Health Policy Research: Evaluation of Universal Health Insurance and Methods for Comparative Effectiveness Research A dissertation presented by Laura Faden Garabedian to The Committee on Higher Degrees in Health Policy in partial fulfillment of the requirements for the degree of Doctor of Philosophy in the subject of Health Policy Harvard University Cambridge, Massachusetts March 2013 © 2013 – Laura Faden Garabedian All rights reserved. Professor Stephen Soumerai Laura Faden Garabedian Quasi-Experimental Health Policy Research: Evaluation of Universal Health Insurance and Methods for Comparative Effectiveness Research Abstract This dissertation consists of two empirical papers and one methods paper. The first two papers use quasi-experimental methods to evaluate the impact of universal health insurance reform in Massachusetts (MA) and Thailand and the third paper evaluates the validity of a quasi- experimental method used in comparative effectiveness research (CER). My first paper uses interrupted time series with data from IMS Health to evaluate the impact of Thailand’s universal health insurance and physician payment reform on utilization of medicines for three non-communicable diseases: cancer, cardiovascular disease and diabetes. -
Ehealth DSI [Ehdsi V2.2.2-OR] Ehealth DSI – Master Value Set
MTC eHealth DSI [eHDSI v2.2.2-OR] eHealth DSI – Master Value Set Catalogue Responsible : eHDSI Solution Provider PublishDate : Wed Nov 08 16:16:10 CET 2017 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 1 of 490 MTC Table of Contents epSOSActiveIngredient 4 epSOSAdministrativeGender 148 epSOSAdverseEventType 149 epSOSAllergenNoDrugs 150 epSOSBloodGroup 155 epSOSBloodPressure 156 epSOSCodeNoMedication 157 epSOSCodeProb 158 epSOSConfidentiality 159 epSOSCountry 160 epSOSDisplayLabel 167 epSOSDocumentCode 170 epSOSDoseForm 171 epSOSHealthcareProfessionalRoles 184 epSOSIllnessesandDisorders 186 epSOSLanguage 448 epSOSMedicalDevices 458 epSOSNullFavor 461 epSOSPackage 462 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 2 of 490 MTC epSOSPersonalRelationship 464 epSOSPregnancyInformation 466 epSOSProcedures 467 epSOSReactionAllergy 470 epSOSResolutionOutcome 472 epSOSRoleClass 473 epSOSRouteofAdministration 474 epSOSSections 477 epSOSSeverity 478 epSOSSocialHistory 479 epSOSStatusCode 480 epSOSSubstitutionCode 481 epSOSTelecomAddress 482 epSOSTimingEvent 483 epSOSUnits 484 epSOSUnknownInformation 487 epSOSVaccine 488 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 3 of 490 MTC epSOSActiveIngredient epSOSActiveIngredient Value Set ID 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 TRANSLATIONS Code System ID Code System Version Concept Code Description (FSN) 2.16.840.1.113883.6.73 2017-01 A ALIMENTARY TRACT AND METABOLISM 2.16.840.1.113883.6.73 2017-01 -
Regulation of Pharmaceutical Prices: Evidence from a Reference Price Reform in Denmark
A Service of Leibniz-Informationszentrum econstor Wirtschaft Leibniz Information Centre Make Your Publications Visible. zbw for Economics Kaiser, Ulrich; Mendez, Susan J.; Rønde, Thomas Working Paper Regulation of pharmaceutical prices: Evidence from a reference price reform in Denmark ZEW Discussion Papers, No. 10-062 Provided in Cooperation with: ZEW - Leibniz Centre for European Economic Research Suggested Citation: Kaiser, Ulrich; Mendez, Susan J.; Rønde, Thomas (2010) : Regulation of pharmaceutical prices: Evidence from a reference price reform in Denmark, ZEW Discussion Papers, No. 10-062, Zentrum für Europäische Wirtschaftsforschung (ZEW), Mannheim This Version is available at: http://hdl.handle.net/10419/41440 Standard-Nutzungsbedingungen: Terms of use: Die Dokumente auf EconStor dürfen zu eigenen wissenschaftlichen Documents in EconStor may be saved and copied for your Zwecken und zum Privatgebrauch gespeichert und kopiert werden. personal and scholarly purposes. Sie dürfen die Dokumente nicht für öffentliche oder kommerzielle You are not to copy documents for public or commercial Zwecke vervielfältigen, öffentlich ausstellen, öffentlich zugänglich purposes, to exhibit the documents publicly, to make them machen, vertreiben oder anderweitig nutzen. publicly available on the internet, or to distribute or otherwise use the documents in public. Sofern die Verfasser die Dokumente unter Open-Content-Lizenzen (insbesondere CC-Lizenzen) zur Verfügung gestellt haben sollten, If the documents have been made available under an Open gelten abweichend von diesen Nutzungsbedingungen die in der dort Content Licence (especially Creative Commons Licences), you genannten Lizenz gewährten Nutzungsrechte. may exercise further usage rights as specified in the indicated licence. www.econstor.eu Dis cus si on Paper No. 10-062 Regulation of Pharmaceutical Prices: Evidence from a Reference Price Reform in Denmark Ulrich Kaiser, Susan J. -
Efficacy of Combination Therapy of Rosuvastatin and Ezetimibe Vs
Original Article DOI: 10.7860/JCDR/2017/30458.11004 Efficacy of Combination Therapy Internal Medicine Section of Rosuvastatin and Ezetimibe vs Rosuvastatin Monotherapy on Lipid Profile of Patients with Coronary Artery Disease SANDEEP JOSHI1, RUBY SHARMA2, HARBIR KAUR RAO3, UDIT NARANG4, NITIN GUPTA5 ABSTRACT baseline investigations and lifestyle modifications, Group I Introduction: Dyslipidaemia is one of the most important was started on rosuvastatin 10 mg once daily, while Group modifiable risk factor for the development of Coronary II was started on rosuvastatin 10 mg+ezetimibe 10 mg daily. Artery Disease (CAD). Although, statins are established as The fasting serum lipid profile was repeated initially after first line lipid-lowering therapy, they may not be able to 12 weeks and then after 24 weeks. The two groups were achieve treatment goals in significant number of patients. observed for side effects which were noted. Combination therapy of statin with a non-statin drug like Results: The combination therapy of rosuvastatin and Ezetimibe is a therapeutic option. ezetimibe resulted in significantly higher change in all Aim: To compare the efficacy and safety of Rosuvastatin/ lipid parameters (LDL-C, TC, TG, HDL-C) as compared to Ezetimibe combination therapy vs Rosuvastatin alone on the treatment with rosuvastatin alone. There was no difference in lipid profile of patients with CAD in Northern India. the adverse effects seen after treatment in the two groups. Materials and Methods: This randomized prospective Conclusion: Our study showed that combination therapy study was conducted on 80 patients of CAD presenting of ezetimibe with rosuvastatin can be used as an effective to Department of Medicine, Government Medical College, and safe therapy in high risk patients of CAD, especially in Patiala, Punjab, India. -
Supplemental Material BMJ Open Doi: 10.1136/Bmjopen-2020-039104 :E039104. 10 2020; BMJ Open , Et Al. Randall SM
BMJ Publishing Group Limited (BMJ) disclaims all liability and responsibility arising from any reliance Supplemental material placed on this supplemental material which has been supplied by the author(s) BMJ Open Supplementary Table 1 – Injury categories Injury Category ICD Codes Fractures S02, S12, S22, S32, S42, S52, S62, S72, S82, S92, T02.1-5, T02.8-9, T08, T10, T12, T14.2, T90.2, T91.1-2 T92.1-2, T93.1-2 Open Wounds S01, S05.2, S05.3, S05.4, S05.5, S05.6, S05.7, S08.0, S09.2, S11, S21, S31.0-5, S31.7-8, S41, S51, S61, S71.0-8, S81, S91, T01.2-3, T01.9, T09.1, T11.1, T13.1, T14.1, T90.1, T92.0, T93.0, Contusions and superficial S00, S05.0-1, S10, S20, S30.0-2, S30.7-9, S40, S50, S60, S70, S80, S90, T00.2-3, T00.8- injuries 9, T09.0, T11.0, T13.0, T14.0, T90.0 Dislocations S03.0-3, S13.0-3, S23.0-3, S33.0-4, S43.0-3, S53.0-1, S63.0-2, S66, S73.0, S83, S86, S93.0-1, S93.3 Internal organ injuries S06, S14.0-2, S24.0-1, S26.0, S27.0-6, S27.8-9, S34.0-1, S34.3, S36, S37, S39.6-7, T06.5, T09.3, T90.5, T91.3-5 Foreign bodies T15-9 Amputations S08.1-9, S18, S28.1, S38.2-3, S48, S58, S68, S78, S88, S98, T05.0, T05.2-3, T05.5, T05.8-9, T09.6, T11.6, T13.6 Burns T20-T32 Randall SM, et al. -
CP.PMN.237 Bempedoic Acid (Nexletol)
Clinical Policy: Bempedoic Acid (Nexletol), Bempedoic Acid/Ezetimibe (Nexlizet) Reference Number: CP.PMN.237 Effective Date: 09.01.20 Last Review Date: 02.21 Revision Log Line of Business: Commercial, HIM, Medicaid See Important Reminder at the end of this policy for important regulatory and legal information. Description The following are adenosine triphosphate-citrate lyase (ACL) inhibitors requiring prior authorization: bempedoic acid (Nexletol™) and bempedoic acid/ezetimibe (Nexlizet™). Nexlizet contains ezetimibe, which is a cholesterol absorption inhibitor. FDA Approved Indication(s) Nexletol and Nexlizet are indicated for use as adjuncts to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Limitation(s) of use: The effect of Nexletol and Nexlizet on cardiovascular morbidity and mortality has not been determined. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. It is the policy of health plans affiliated with Centene Corporation® that Nexletol and Nexlizet are medically necessary when the following criteria are met: I. Initial Approval Criteria A. Heterozygous Familial Hypercholesterolemia and Atherosclerotic Cardiovascular Disease (must meet all): 1. Diagnosis of one of the following (a or b): a. ASCVD as evidenced by a history of any one of the following conditions (i-vii): i. Acute coronary syndromes; ii. Clinically significant coronary heart disease (CHD) diagnosed by invasive or noninvasive testing (such as coronary angiography, stress test using treadmill, stress echocardiography, or nuclear imaging); iii. -
Information for the Patient Questran Light™ 4 G/Sachet Powder for Oral Suspension Colestyramine
Package leaflet: Information for the patient Questran Light™ 4 g/sachet Powder for Oral Suspension Colestyramine Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What QUESTRAN LIGHT is and what it is used for 2. What you need to know before you take QUESTRAN LIGHT 3. How to take QUESTRAN LIGHT 4. Possible side effects 5. How to store QUESTRAN LIGHT 6. Contents of the pack and other information 1. What QUESTRAN LIGHT is and what it is used for Questran Light contains the active substance colestyramine. Each sachet of Questran Light contains 4 g of colestyramine. Colestyramine belongs to a group of medicines called bile acid binding resins. Questran Light is used to lower your body’s level of cholesterol (a type of fat) which can cause heart disease. This medicine works in the digestive system and absorbs the cholesterol-containing bile acids, which then pass out through the body in the faeces. Questran Light may also be used to help stop some types of diarrhoea or itching.