Preventative Medication List

Total Page:16

File Type:pdf, Size:1020Kb

Preventative Medication List MedImpact Safe Harbor Preventative Drug List This list includes medications identified as those most likely to qualify as “preventive” based on the U.S. Department of Treasury Department/ IRS guidance. This list may not include all medications considered preventive or every health condition for which a preventive drug may be prescribed. At this time, neither MedImpact nor your health plan can guarantee which medications will satisfy U.S. Treasury Department definition for preventative safe harbor medications. Please also note: --- Utilization management (ie. prior authorization, step therapy, and quantity limits) may apply to listed medications based on benefit design --- Use of generics may be required depending on plan design --- Some strengths or dosage forms may not be included --- Certain products or therapeutic categories may not be covered --- Brand and generic status may not be current due to the changes and drug availability in the market --- This list is subject to change without prior notice --- Regardless of their appearance in this document, please contact member services at the number on your prescription benefits card should you have any questions regarding coverage THERAPEUTIC AREA DRUG CLASS GENERIC NAME BRAND NAME ANAPHYLAXIS ANAPHYLAXIS THERAPY EPINEPHRINE AUVI-Q*, EPINEPHRINE, EPIPEN, THERAPY AGENTS EPIPEN 2-PAK, EPIPEN JR, EPIPEN JR 2-PAK, SYMJEPI* ANTICOAGULANTS / ANTICOAGULANTS,COU WARFARIN SODIUM JANTOVEN, WARFARIN SODIUM ANTIPLATELET MARIN TYPE DIRECT FACTOR XA APIXABAN ELIQUIS* INHIBITORS RIVAROXABAN XARELTO* EDOXABAN TOSYLATE SAVAYSA* HEPARIN AND RELATED DALTEPARIN FRAGMIN* PREPARATIONS SODIUM,PORCINE ENOXAPARIN SODIUM ENOXAPARIN SODIUM, LOVENOX FONDAPARINUX SODIUM ARIXTRA, FONDAPARINUX SODIUM PLATELET ASPIRIN/ DIPYRIDAMOLE ASPIRIN-DIPYRIDAMOLE ER AGGREGATION INHIBITORS CILOSTAZOL CILOSTAZOL CLOPIDOGREL BISULFATE CLOPIDOGREL, PLAVIX DIPYRIDAMOLE DIPYRIDAMOLE PRASUGREL HCL EFFIENT, PRASUGREL HCL TICAGRELOR BRILINTA* VORAPAXAR SULFATE ZONTIVITY* SICKLE CELL ANEMIA HYDROXYUREA DROXIA*, SIKLOS* AGENTS GLUTAMINE ENDARI* Effective July 1, 2021 *Available as Brand Only 1 of 14 THERAPEUTIC AREA DRUG CLASS GENERIC NAME BRAND NAME THROMBIN DABIGATRAN ETEXILATE PRADAXA* INHIBITORS,SELECTIVE,D MESYLATE IRECT, & REVERSIBLE ASTHMA AND COPD ANTICHOLINERGICS, TIOTROPIUM BROMIDE SPIRIVA RESPIMAT*, SPIRIVA* ORALLY INHALED LONG ACTING UMECLIDINIUM BROMIDE INCRUSE ELLIPTA* GLYCOPYRROLATE SEEBRI NEOHALER* ACLIDINIUM BROMIDE TUDORZA PRESSAIR* REVEFENACIN YUPELRI* GLYCOPYRROL/ LONHALA MAGNAIR STARTER* NEBULIZER/ ACCESSOR GLYCOPYRROLATE/ LONHALA MAGNAIR REFILL* NEB.ACCESSORIES BETA-ADRENERGIC ALBUTEROL SULFATE ALBUTEROL SULFATE, ALBUTEROL AGENTS, INHALED, SULFATE HFA, PROAIR DIGIHALER*, SHORT ACTING PROAIR HFA, PROAIR RESPICLICK*, PROVENTIL HFA, VENTOLIN HFA LEVALBUTEROL HCL LEVALBUTEROL CONCENTRATE, LEVALBUTEROL HCL, XOPENEX, XOPENEX CONCENTRATE LEVALBUTEROL TARTRATE LEVALBUTEROL TARTRATE HFA, XOPENEX HFA BETA-ADRENERGIC FORMOTEROL FUMARATE PERFOROMIST* AGENTS, ORALLY INHALED,LONG ACTING SALMETEROL XINAFOATE SEREVENT DISKUS* ARFORMOTEROL ARFORMOTEROL TARTRATE, TARTRATE BROVANA BETA-ADRENERGIC AND BUDESONIDE/ BUDESONIDE-FORMOTEROL GLUCOCORTICOID FORMOTEROL FUMARATE FUMARATE, SYMBICORT* COMBINATIONS FLUTICASONE PROPION/ ADVAIR DISKUS, ADVAIR HFA*, SALMETEROL AIRDUO DIGIHALER*, AIRDUO RESPICLICK, FLUTICASONE- SALMETEROL, WIXELA INHUB FLUTICASONE/ BREO ELLIPTA* VILANTEROL MOMETASONE/ DULERA* FORMOTEROL Effective July 1, 2021 *Available as Brand Only 2 of 14 THERAPEUTIC AREA DRUG CLASS GENERIC NAME BRAND NAME GLUCOCORTICOIDS, BECLOMETHASONE QVAR REDIHALER* ORALLY INHALED DIPROPIONATE BUDESONIDE BUDESONIDE, PULMICORT, PULMICORT FLEXHALER* FLUTICASONE FUROATE ARNUITY ELLIPTA* FLUTICASONE ARMONAIR DIGIHALER*, FLOVENT PROPIONATE DISKUS*, FLOVENT HFA* CICLESONIDE ALVESCO* MOMETASONE FUROATE ASMANEX HFA*, ASMANEX* LEUKOTRIENE RECEPTOR MONTELUKAST SODIUM MONTELUKAST SODIUM, ANTAGONISTS SINGULAIR ZAFIRLUKAST ACCOLATE, ZAFIRLUKAST MAST CELL STABILIZERS, CROMOLYN SODIUM CROMOLYN SODIUM, ORALLY INHALED GASTROCROM, CROMOLYN SODIUM ANTICHOLINERGIC, IPRATROPIUM BROMIDE ATROVENT HFA*, IPRATROPIUM ORALLY INHALED SHORT BROMIDE ACTING BETA-ADRENERGIC INDACATEROL MALEATE ARCAPTA NEOHALER* AGENTS, INHALED, ULTRA-LONG ACTING OLODATEROL HCL STRIVERDI RESPIMAT* BETA-ADRENERGIC AND ACLIDINIUM BROM/ DUAKLIR PRESSAIR* ANTICHOLINERGIC FORMOTEROL FUM COMBINATIONS GLYCOPYRROLATE/ BEVESPI AEROSPHERE* FORMOTEROL FUM INDACATEROL/ UTIBRON NEOHALER* GLYCOPYRROLATE IPRATROPIUM/ COMBIVENT RESPIMAT*, ALBUTEROL SULFATE IPRATROPIUM-ALBUTEROL TIOTROPIUM BR/ STIOLTO RESPIMAT* OLODATEROL HCL UMECLIDINIUM BRM/ ANORO ELLIPTA* VILANTEROL TR BETA-ADRENERGIC- FLUTICASONE/ TRELEGY ELLIPTA* ANTICHOLINERGIC- UMECLIDIN/ VILANTER GLUCOCORT, INHALED BUDESONIDE/ GLYCOPYR/ BREZTRI AEROSPHERE* FORMOTEROL Effective July 1, 2021 *Available as Brand Only 3 of 14 THERAPEUTIC AREA DRUG CLASS GENERIC NAME BRAND NAME PHOSPHODIESTERASE-4 ROFLUMILAST DALIRESP* (PDE4) INHIBITORS GLUCOCORTICOIDS PREDNISONE PREDNISONE, PREDNISONE INTENSOL*, RAYOS* BEHAVIORAL HEALTH SELECTIVE SEROTONIN CITALOPRAM CELEXA, CITALOPRAM HBR - ANTIDEPRESSANTS REUPTAKE INHIBITOR HYDROBROMIDE (SSRIS) ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE, LEXAPRO FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE ER PAROXETINE HCL PAROXETINE CR, PAROXETINE ER, PAROXETINE HCL, PAXIL, PAXIL CR, PAXIL* SERTRALINE HCL SERTRALINE HCL, ZOLOFT FLUOXETINE HCL FLUOXETINE DR, FLUOXETINE HCL, PROZAC PAROXETINE MESYLATE PEXEVA* SSRI & 5HT1A PARTIAL VILAZODONE HCL VIIBRYD* AGONIST ANTIDEPRESSANT SSRI & SEROTONIN VORTIOXETINE TRINTELLIX* RECEPTOR MODULATOR HYDROBROMIDE ANTIDEPRESSANT CANCER PREVENTION SELECTIVE ESTROGEN TAMOXIFEN CITRATE TAMOXIFEN CITRATE RECEPTOR MODULATORS (SERM) ANTINEOPLASTIC ANASTROZOLE ANASTROZOLE, ARIMIDEX AROMATASE INHIBITORS EXEMESTANE AROMASIN, EXEMESTANE BONE RESORPTION RALOXIFENE HCL EVISTA, RALOXIFENE HCL INHIBITORS CARDIOVASCULAR ACE AMLODIPINE BESYLATE/ AMLODIPINE BESYLATE- INHIBITOR/CALCIUM BENAZEPRIL BENAZEPRIL, LOTREL CHANNEL BLOCKER COMBINATION TRANDOLAPRIL/ TARKA, TRANDOLAPRIL-VERAPAMIL VERAPAMIL HCL ER PERINDOPRIL ARG/ PRESTALIA* AMLODIPINE BES Effective July 1, 2021 *Available as Brand Only 4 of 14 THERAPEUTIC AREA DRUG CLASS GENERIC NAME BRAND NAME ACE INHIBITOR/THIAZIDE BENAZEPRIL/ BENAZEPRIL- & THIAZIDE-LIKE HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE, LOTENSIN DIURETIC HCT CAPTOPRIL/ CAPTOPRIL- HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE ENALAPRIL/ ENALAPRIL- HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE, VASERETIC FOSINOPRIL/ FOSINOPRIL- HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE LISINOPRIL/ LISINOPRIL- HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE, ZESTORETIC QUINAPRIL/ ACCURETIC, QUINAPRIL- HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE ALPHA/BETA- CARVEDILOL CARVEDILOL, COREG ADRENERGIC BLOCKING AGENTS CARVEDILOL PHOSPHATE CARVEDILOL ER, COREG CR LABETALOL HCL LABETALOL HCL ANGIOTEN.RECEPTR AMLODIPINE/ AMLODIPINE-VALSARTAN-HCTZ, ANTAG./CAL.CHANL VALSARTAN/ HCTHIAZID EXFORGE HCT BLKR/THIAZIDE CB OLMESARTAN/ OLMESARTAN-AMLODIPINE-HCTZ, AMLODIPIN/ HCTHIAZID TRIBENZOR ANGIOTENSIN RECEPTOR AZILSARTAN MED/ EDARBYCLOR* ANTAG./THIAZIDE CHLORTHALIDONE DIURETIC COMB CANDESARTAN/ ATACAND HCT, CANDESARTAN- HYDROCHLOROTHIAZID HYDROCHLOROTHIAZID IRBESARTAN/ AVALIDE, IRBESARTAN- HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE LOSARTAN/ HYZAAR, LOSARTAN- HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE OLMESARTAN/ BENICAR HCT, OLMESARTAN- HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TELMISARTAN/ MICARDIS HCT, TELMISARTAN- HYDROCHLOROTHIAZID HYDROCHLOROTHIAZID VALSARTAN/ DIOVAN HCT, VALSARTAN- HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE Effective July 1, 2021 *Available as Brand Only 5 of 14 THERAPEUTIC AREA DRUG CLASS GENERIC NAME BRAND NAME ANGIOTENSIN RECEPTOR AMLODIPINE BES/ AMLODIPINE-OLMESARTAN, AZOR ANTGNST & OLMESARTAN MED CALC.CHANNEL BLOCKR AMLODIPINE BESYLATE/ AMLODIPINE-VALSARTAN, VALSARTAN EXFORGE TELMISARTAN/ TELMISARTAN-AMLODIPINE, AMLODIPINE TWYNSTA ANTIHYPERTENSIVES, BENAZEPRIL HCL BENAZEPRIL HCL, LOTENSIN ACE INHIBITORS CAPTOPRIL CAPTOPRIL ENALAPRIL MALEATE ENALAPRIL MALEATE, EPANED*, VASOTEC FOSINOPRIL SODIUM FOSINOPRIL SODIUM LISINOPRIL LISINOPRIL, PRINIVIL, QBRELIS*, ZESTRIL MOEXIPRIL HCL MOEXIPRIL HCL PERINDOPRIL ERBUMINE PERINDOPRIL ERBUMINE QUINAPRIL HCL ACCUPRIL, QUINAPRIL HCL RAMIPRIL ALTACE, RAMIPRIL TRANDOLAPRIL TRANDOLAPRIL ANTIHYPERTENSIVES, AZILSARTAN MEDOXOMIL EDARBI* ANGIOTENSIN RECEPTOR ANTAGONIST CANDESARTAN CILEXETIL ATACAND, CANDESARTAN CILEXETIL EPROSARTAN MESYLATE EPROSARTAN MESYLATE IRBESARTAN AVAPRO, IRBESARTAN LOSARTAN POTASSIUM COZAAR, LOSARTAN POTASSIUM OLMESARTAN BENICAR, OLMESARTAN MEDOXOMIL MEDOXOMIL TELMISARTAN MICARDIS, TELMISARTAN VALSARTAN DIOVAN, VALSARTAN BETA-ADRENERGIC ACEBUTOLOL HCL ACEBUTOLOL HCL BLOCKING AGENTS ATENOLOL ATENOLOL, TENORMIN BETAXOLOL HCL BETAXOLOL HCL BISOPROLOL FUMARATE BISOPROLOL FUMARATE METOPROLOL SUCCINATE KAPSPARGO SPRINKLE*, METOPROLOL SUCCINATE, TOPROL XL METOPROLOL TARTRATE LOPRESSOR, METOPROLOL TARTRATE Effective July 1, 2021 *Available as Brand Only 6 of 14 THERAPEUTIC AREA DRUG CLASS GENERIC NAME BRAND NAME NADOLOL CORGARD, NADOLOL NEBIVOLOL HCL BYSTOLIC* PINDOLOL PINDOLOL PROPRANOLOL HCL HEMANGEOL*, INDERAL LA, INDERAL XL*, INNOPRAN XL*, PROPRANOLOL HCL, PROPRANOLOL HCL ER SOTALOL HCL BETAPACE, BETAPACE AF, SORINE, SOTALOL, SOTALOL AF, SOTYLIZE* TIMOLOL MALEATE TIMOLOL MALEATE PENBUTOLOL SULFATE LEVATOL* BETA-ADRENERGIC ATENOLOL/ ATENOLOL-CHLORTHALIDONE, BLOCKING CHLORTHALIDONE TENORETIC 100, TENORETIC 50 AGENTS/THIAZIDE & RELATED BISOPROLOL/ BISOPROLOL- HYDROCHLOROTHIAZIDE
Recommended publications
  • FDA Approves ZONTIVITY™ (Vorapaxar), First-In-Class PAR-1
    NEWS RELEASE FDA Approves ZONTIVITY™ (vorapaxar), First-in-Class PAR-1 Antagonist, for the Reduction of Thrombotic Cardiovascular Events in Patients with a History of Heart Attack or with Peripheral Arterial Disease 5/12/2014 ZONTIVITY Added to Standard of Care Demonstrated Long-Term Benet Through Three Years Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved ZONTIVITY™ (vorapaxar) for the reduction of thrombotic cardiovascular events in patients with a history of heart attack (myocardial infarction) or in patients with narrowing of leg arteries, called peripheral arterial disease (PAD). For patients with a history of heart attack or with PAD who had no history of stroke or transient ischemic attack (TIA), ZONTIVITY added to standard of care produced a signicant 17 percent relative risk reduction over the three years of the study for the combined events of cardiovascular (CV) death, myocardial infarction (MI), stroke, and urgent coronary revascularization (UCR) [event rate 10.1 percent vs. 11.8 percent for placebo]. For the key secondary composite ecacy endpoint of CV death, MI and stroke alone, ZONTIVITY produced a signicant 20 percent relative risk reduction in these patients [7.9 percent vs. 9.5 percent for placebo]. These results were driven by an 18 percent relative risk reduction in MI [5.4 percent vs. 6.4 percent for placebo] and a 33 percent relative risk reduction in rst stroke [1.2 percent vs. 1.6 percent for placebo]. The prescribing information for ZONTIVITY includes a boxed warning regarding bleeding risk.
    [Show full text]
  • Zontivity (Vorapaxar)
    HIGHLIGHTS OF PRESCRIBING INFORMATION antiplatelet drugs or with ZONTIVITY as the only antiplatelet These highlights do not include all the information needed to use agent. (2.2) ZONTIVITY safely and effectively. See full prescribing information for ZONTIVITY. --------------------- DOSAGE FORMS AND STRENGTHS --------------------- Tablets: 2.08 mg vorapaxar. (3) ZONTIVITY™ (vorapaxar) Tablets 2.08 mg*, for oral use *Equivalent to 2.5 mg vorapaxar sulfate ------------------------------- CONTRAINDICATIONS ------------------------------- Initial U.S. Approval: 2014 History of stroke, TIA, or ICH. (4.1) Active pathologic bleeding. (4.2) WARNING: BLEEDING RISK See full prescribing information for complete boxed warning. ----------------------- WARNINGS AND PRECAUTIONS ----------------------- • Do not use ZONTIVITY in patients with a history of stroke, Like other antiplatelet agents, ZONTIVITY increases the risk of transient ischemic attack (TIA), or intracranial hemorrhage (ICH); bleeding. (5.1) or active pathological bleeding. (4.1, 4.2) Avoid use with strong CYP3A inhibitors or inducers. (5.2) • Antiplatelet agents, including ZONTIVITY, increase the risk of bleeding, including ICH and fatal bleeding. (5.1) ------------------------------ ADVERSE REACTIONS ------------------------------ Bleeding, including life-threatening and fatal bleeding, is the most ----------------------------INDICATIONS AND USAGE ---------------------------- commonly reported adverse reaction. (6.1) ZONTIVITY is a protease-activated receptor-1 (PAR-1) antagonist indicated for the reduction of thrombotic cardiovascular events in To report SUSPECTED ADVERSE REACTIONS, contact Merck patients with a history of myocardial infarction (MI) or with peripheral Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877­ arterial disease (PAD). ZONTIVITY has been shown to reduce the rate 888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization.
    [Show full text]
  • 2018 Annual Results Presentation
    2018 Annual Results Presentation Sihuan Pharmaceutical Holdings Group Ltd. 四环医药控股集团有限公司 0 Disclaimer The sole purpose of this Presentation (the “Presentation”) is to assist the recipient in deciding whether it wishes to proceed with a further investigation of Sihuan Pharmaceutical Holdings Group Ltd. (the “Company”) and it is not intended to form the basis of any decision to purchase securities, interests or assets in or of the Company. This Presentation does not constitute or contain an offer or invitation or recommendation or solicitation for the sale or purchase of securities, interests or assets in or of the Company and neither this document nor anything contained herein shall form the basis of, or be relied upon in connection with, any contract or commitment whatsoever. Any decision to purchase or subscribe for securities in any offering must be made solely on the basis of the information contained in the prospectus or offering circular issued by the company in connection with such offerings. All the information in this Presentation has been provided by the Company and has not been independently verified. No representation or warranty, express or implied, is or will be made in or in relation to, and no responsibility or liability is or will be accepted by the Company or any of its subsidiaries as to the appropriateness, accuracy, completeness or reliability of, this Presentation or any other written or oral information made available to any interested party or its advisers and any liability therefore is hereby expressly disclaimed. And no reliance should be placed on the accuracy, fairness, completeness or correctness of the information contained in this Presentation.
    [Show full text]
  • 2019 Chinese Guideline for the Management of Hypertension in the Elderly
    Journal of Geriatric Cardiology (2019) 16: 6799 ©2019 JGC All rights reserved; www.jgc301.com Guidelines Open Access 2019 Chinese guideline for the management of hypertension in the elderly Hypertension Branch of Chinese Geriatrics Society National Clinical Research Center of the Geriatric Diseases-Chinese Alliance of Geriatric Cardiovascular Disease Guideline Writing And Review Committee Co-Chairs: Qi HUA*, Li FAN* Vice Chairs: Jun CAI, Lu-Yuan CHEN, Wei-Wei CHEN, Ping-Jin GAO, Yi-Fang GUO, Qing HE, Jing LI, Nan-Fang LI, Wei-Min LI, Yue LI, Mei-Lin LIU, Ning-Ling SUN, Wen WANG, Liang-Di XIE, Jin-Gang YANG, Hong YUAN Guideline Writing Committee Members Jing LI, Qi HUA, Li FAN, Jun CAI, Lu-Yuan CHEN, Wei-Wei CHEN, Xiao-Ping CHEN, Yi-Fang GUO, Qing HE, Yi-Xin HU, Yi-Nong JIANG, Nan-Fang LI, Wei-Min LI, Yan LI, Yue LI, Yong LI, Qing-Feng MA, Lin PI, Hai-Qing SONG, Xi-Peng SUN, Qing WANG, Zeng-Wu WANG, Hai-Ying WU, Hai-Yun WU, Liang-Di XIE, Jin-Gang YANG, Wei YANG Guideline Review Committee Members (Listed in alphabetic order by last name in Chinese Pinyin) Jun CAI, Jian CAO, Bu-Xing CHEN, Hong CHEN, Lu-Yuan CHEN, Wei-Wei CHEN, Xiao-Ping CHEN, Yuan-Yuan CHEN, Hong-Liang CONG, Ai-Min DANG, Li FAN, Zhen-Xing FAN, Ning-Yuan FANG, Ying-Qing FENG, Yan FU, Hai-Qing GAO, Ping-Jin GAO, Cai-Xia GUO, Jin-Cheng GUO, Jun GUO, Yi-Fang GUO, Qing-Hua HAN, Qing HE, Da-Yi HU, Shao-Dong HU, Yi-Xin HU, Qi HUA, Yi-Nong JIANG, Bo-Yu LI, Dong-Bao LI, Hong-Wei LI, Jing LI, Nan-Fang LI, Wei-Min LI, Yan-Fang LI, Yan LI, Yue LI, Yong LI, Li LIN, Zhan-Yi LIN, De-Ping
    [Show full text]
  • Annexes to the Annual Report of the European Medicines Agency 2014
    Annexes to the annual report of the European Medicines Agency 2014 Table of contents Annex 1 – Members of the Management Board ............................................................................. 2 Annex 2 – Members of the Committee for Medicinal Products for Human Use ................................... 4 Annex 3 – Members of the Pharmacovigilance Risk Assessment Committee ...................................... 6 Annex 4 – Members of the Committee for Medicinal Products for Veterinary Use ............................... 8 Annex 5 – Members of the Committee on Orphan Medicinal Products ............................................ 10 Annex 6 – Members of the Committee on Herbal Medicinal Products .............................................. 12 Annex 07 – Committee for Advanced Therapies .......................................................................... 14 Annex 8 – Members of the Paediatric Committee ........................................................................ 16 Annex 9 – Working parties and working groups .......................................................................... 18 Annex 10 – CHMP opinions in 2014 on medicinal products for human use ...................................... 22 Annex 11 – CVMP opinions in 2014 on medicinal products for veterinary use .................................. 36 Annex 12 – COMP opinions in 2014 on designation of orphan medicinal products ............................ 41 Annex 13 – HMPC European Union herbal monographs in 2014....................................................
    [Show full text]
  • Antithrombotic Therapy in Patients with Coronary Artery Disease and Prior Stroke
    Journal of Clinical Medicine Review Antithrombotic Therapy in Patients with Coronary Artery Disease and Prior Stroke Elisa Bellettini and Leonardo De Luca * Department of Cardiosciences, U.O.C. of Cardiology, Azienda Ospedaliera San Camillo-Forlanini, 00152 Roma, Italy; [email protected] * Correspondence: [email protected] or [email protected]; Tel.: +39-06-58704419; Fax: +39-06-5870-4361 Abstract: Patients with coronary artery disease (CAD) and prior cerebrovascular events (CVE) are frequently faced in clinical practice and present a high rate of both ischemic and bleeding events. For these reasons, the antithrombotic management is particularly challenging in this subgroup of patients. Recent trials suggest that, although a potent antiplatelet strategy is safe in the acute phases of myocardial ischemia for these patients, the risk of major bleeding complications, including intracranial hemorrhage, is extremely high when the antithrombotic therapy is prolonged for a long period of time. Therefore, especially in patients with chronic CAD and history of CVE, the antithrombotic management should be carefully balanced between ischemic and bleeding risks. The present review is aimed at critically evaluating the available evidence to help make these crucial clinical decisions regarding the better antithrombotic therapy to use in this high-risk subgroup Citation: Bellettini, E.; De Luca, L. of patients. Antithrombotic Therapy in Patients with Coronary Artery Disease and Prior Stroke. J. Clin. Med. 2021, 10, Keywords: antithrombotic therapy; clopidogrel; ticagrelor; prasugrel; aspirin; rivaroxaban; acute 1923. https://doi.org/10.3390/ coronary syndromes; prior stroke jcm10091923 Academic Editors: Wolfgang Dichtl and Andrzej Surdacki 1. Introduction Patients with ischemic stroke present a 4-fold increased risk for coronary artery disease Received: 28 February 2021 (CAD) compared to patients without cerebrovascular diseases (CVD) [1].
    [Show full text]
  • Patent Application Publication ( 10 ) Pub . No . : US 2019 / 0192440 A1
    US 20190192440A1 (19 ) United States (12 ) Patent Application Publication ( 10) Pub . No. : US 2019 /0192440 A1 LI (43 ) Pub . Date : Jun . 27 , 2019 ( 54 ) ORAL DRUG DOSAGE FORM COMPRISING Publication Classification DRUG IN THE FORM OF NANOPARTICLES (51 ) Int . CI. A61K 9 / 20 (2006 .01 ) ( 71 ) Applicant: Triastek , Inc. , Nanjing ( CN ) A61K 9 /00 ( 2006 . 01) A61K 31/ 192 ( 2006 .01 ) (72 ) Inventor : Xiaoling LI , Dublin , CA (US ) A61K 9 / 24 ( 2006 .01 ) ( 52 ) U . S . CI. ( 21 ) Appl. No. : 16 /289 ,499 CPC . .. .. A61K 9 /2031 (2013 . 01 ) ; A61K 9 /0065 ( 22 ) Filed : Feb . 28 , 2019 (2013 .01 ) ; A61K 9 / 209 ( 2013 .01 ) ; A61K 9 /2027 ( 2013 .01 ) ; A61K 31/ 192 ( 2013. 01 ) ; Related U . S . Application Data A61K 9 /2072 ( 2013 .01 ) (63 ) Continuation of application No. 16 /028 ,305 , filed on Jul. 5 , 2018 , now Pat . No . 10 , 258 ,575 , which is a (57 ) ABSTRACT continuation of application No . 15 / 173 ,596 , filed on The present disclosure provides a stable solid pharmaceuti Jun . 3 , 2016 . cal dosage form for oral administration . The dosage form (60 ) Provisional application No . 62 /313 ,092 , filed on Mar. includes a substrate that forms at least one compartment and 24 , 2016 , provisional application No . 62 / 296 , 087 , a drug content loaded into the compartment. The dosage filed on Feb . 17 , 2016 , provisional application No . form is so designed that the active pharmaceutical ingredient 62 / 170, 645 , filed on Jun . 3 , 2015 . of the drug content is released in a controlled manner. Patent Application Publication Jun . 27 , 2019 Sheet 1 of 20 US 2019 /0192440 A1 FIG .
    [Show full text]
  • Cholesterol-Rich Microdomains Contribute to PAR1 Signaling in Platelets Despite a Weak Localization of the Receptor in These Microdomains
    International Journal of Molecular Sciences Article Cholesterol-Rich Microdomains Contribute to PAR1 Signaling in Platelets Despite a Weak Localization of the Receptor in These Microdomains Vahideh Rabani 1, Jennifer Lagoutte-Renosi 1,2 , Jennifer Series 3, Benoit Valot 4, Jean-Marie Xuereb 3 and Siamak Davani 1,2,* 1 EA 3920 Université Bourgogne Franche-Comté, F-25000 Besancon, France; [email protected] (V.R.); [email protected] (J.L.-R.) 2 Laboratoire de Pharmacologie Clinique et Toxicologie-CHU de Besançon, F-25000 Besancon, France 3 Inserm UMR1048, Institut des Maladies Métaboliques et Cardiovasculaires (I2MC), F-31100 Toulouse, France; [email protected] (J.S.); [email protected] (J.-M.X.) 4 UMR CNRS 6249 Chrono-Environnement, Université Bourgogne Franche-Comté, F-25000 Besancon, France; [email protected] * Correspondence: [email protected]; Tel.: +33-3-81-66-80-55 Received: 28 September 2020; Accepted: 27 October 2020; Published: 29 October 2020 Abstract: Platelet protease-activated receptor 1 (PAR1) is a cell surface G-protein-coupled receptor (GPCR) that acts as a thrombin receptor promoting platelet aggregation. Targeting the PAR1 pathway by vorapaxar, a PAR1 antagonist, leads to a reduction in ischemic events in cardiovascular patients with a history of myocardial infarction or with peripheral arterial disease. In platelets, specialized microdomains highly enriched in cholesterol act as modulators of the activity of several GPCRs and play a pivotal role in the signaling pathway. However, their involvement in platelet PAR1 function remains incompletely characterized. In this context, we aimed to investigate whether activation of PAR1 in human platelets requires its localization in the membrane cholesterol-rich microdomains.
    [Show full text]
  • Short‑ and Long‑Term Treatment with Angiotensin‑Converting Enzyme
    EXPERIMENTAL AND THERAPEUTIC MEDICINE 21: 14, 2021 Short‑ and long‑term treatment with angiotensin‑converting enzyme inhibitors or calcium channel blockers for the prevention of diabetic nephropathy progression: A meta‑analysis JIALANG LIANG1*, JIARONG LAN2*, QIZHI TANG1, WENJING LING3 and MIN LI4 1Endocrinology Department, Integrated Traditional Chinese and Western Medicine Hospital of Guangdong Province, Foshan, Guangdong 528200; 2Nephrology Department, Huzhou Hospital of Traditional Chinese Medicine Affiliated Zhejiang University of Traditional Chinese Medicine, Huzhou, Zhejiang 313000;3 Emergency Department, Integrated Traditional Chinese and Western Medicine Hospital of Guangdong Province, Foshan, Guangdong 528200; 4Endocrinology Department, Huzhou Hospital of Traditional Chinese Medicine Affiliated Zhejiang University of Traditional Chinese Medicine, Huzhou, Zhejiang 313000, P.R. China Received May 21, 2020; Accepted October 14, 2020 DOI: 10.3892/etm.2020.9446 Abstract. Treatments with angiotensin‑converting enzyme better outcomes with ACE inhibitors [odds ratio (OR), 0.70; (ACE) inhibitors or calcium channel blockers (CCBs) may 95% CI, 0.49‑1.00; P=0.05]. There was no statistically signifi‑ delay the development of albuminuria in patients with early cant difference between ACE inhibitors and CCBs regarding diabetic nephropathy. However, evidence in the literature the progression from microalbuminuria to macroalbuminuria has not been consistent. The present meta‑analysis aimed to (OR, 1.78; 95% CI, 0.82‑3.87; P=0.15). In conclusion, the compare the short‑ and long‑term therapeutic effects of ACE present study indicated that the antiproteinuric efficacy of inhibitors and CCBs (when used separately) for preventing the CCBs may be less than that of ACE inhibitors after short‑term progression of nephropathy in patients with diabetes mellitus.
    [Show full text]
  • Levamlodipine)Tablets, for Oral Use
    HIGHLIGHTS OF PRESCRIBING INFORMATION ------------------------WARNINGS AND PRECAUTIONS----------------------­ These highlights do not include all the information needed to use • Symptomatic hypotension is possible, particularly in patients with CONJUPRI safely and effectively. See full prescribing information severe aortic stenosis. However, acute hypotension is unlikely. for CONJUPRI. (5.1) • Worsening angina and acute myocardial infarction can develop CONJUPRI®(levamlodipine)tablets, for oral use. after starting or increasing the dose of amlodipine, particularly in Initial U.S. Approval: 1992 patients with severe obstructive coronary artery disease. (5.2) • Titrate slowly in patients with severe hepatic impairment. (5.3) -----------------------------INDICATIONS AND USAGE-------------------------­ CONJUPRI is calcium channel blocker and may be used alone or in -------------------------------ADVERSE REACTIONS-----------------------------­ combination with other antihypertensive agents for the treatment of Most common adverse reactions to amlodipine is edema which hypertension, to lower blood pressure. Lowering blood pressure occurred in a dose related manner. Other adverse experiences not reduces the risk of fatal and nonfatal cardiovascular events, primarily dose related but reported with an incidence >1.0% are fatigue, nausea, strokes and myocardial infarctions. abdominal pain and somnolence. (6) ----------------------DOSAGE AND ADMINISTRATION----------------------­ To report SUSPECTED ADVERSE REACTIONS, call CSPC Ouyi • Adult recommended starting dose: 2.5 mg orally once daily with Pharmaceutical Co., Ltd at 1-877-436-7220 or FDA at 1-800-FDA­ maximum dose 5 mg once daily. (2.1) 1088 or www.fda.gov/medwatch. o Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 1.25 mg once daily. (2.1) ------------------------------DRUG INTERACTIONS------------------------------­ • Pediatric starting dose: 1.25 mg to 2.5 mg once daily.
    [Show full text]
  • 204886Orig1s000
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 204886Orig1s000 MEDICAL REVIEW(S) DIVISION OF CARDIOVASCULAR & RENAL PRODUCTS Divisional Memo NDA: 204886 Zontivity; vorapaxar for reduction of atherothrombotic events in patients with a history of myocardial infarction. Sponsor: Merck Review date: 25 April 2014 Reviewer: N. Stockbridge, M.D., Ph.D., HFD-110 Distribution: NDA 204886 This memo conveys the Division’s recommendation to approve this application. This application has been the subject of reviews of CMC (Wong; 9 January 2014), biopharmaceutics (Eradiri; 9 January 2014), pharmacology/toxicology (Harlow; 17 December 2013, 19 February 2014), clinical pharmacology (Hariharan, Bilal, and Li; 16 December 2013), clinical (Rose and Levine; 16 December 2013, 18 April 2014) and statistics (Chen; 13 December 2013). There is a comprehensive CDTL memo (Marciniak; 18 April 2014) with which I am in general agreement. I highlight a few matters here. Vorapaxar is a low molecular weight blocker of PAR-1. On platelets, PAR-1 mediates platelet activation by thrombin, the hexapeptide TRAP, and possibly other short peptides. PAR-1 receptors exist in many other places, although vorapaxar’s effects seem only to be important at the platelet. Although inhibition of PAR-1 is reversible, the half-life of the drug in circulation is longer even than the life of platelets. There are no pending CMC issues. Vorapaxar has 7 chiral centers (b) (4) a single isomer that apparently does not undergo racemization. Crystalline vorapaxar tends to assume an amorphous form upon storage, but these forms are both highly soluble. Manufacturing site inspections are complete. Release specifications have been negotiated.
    [Show full text]
  • Pharmacokinetics, Pharmacodynamics
    Supplementary Pharmacokinetics, Pharmacodynamics and Drug-Drug Interactions of New Anti-Migraine Drugs–Lasmiditan, Gepants, and Calcitonin-Gene-Related Peptide (CGRP) Receptor Monoclonal Antibodies Danuta Szkutnik-Fiedler Table S1. Possible drug-drug interactions of lasmiditan [14,28,31,35–38,40,42,45–47]. The risk or severity of Serum concentration of the Serum concentration of Lasmiditan may serotonin syndrome can following drugs (P-gp lasmiditan (P-gp substrate) increase the be potentially increased and/or BCRP substrates) may potentially increase bradycardic when lasmiditan is may potentially increase when it is combined with effects of the combined with the when combined with the following drugs3,. following drugs. following drugs1,. lasmiditan2,. 5-hydroxytryptophan* afatinib acebutolol alfentanil* alpelisib amlodipine almotriptan* ambrisentan atenolol amitriptiline* apixaban betaxolol amoxapine* belinostat carteolol buspirone* bisoprolol carvedilol citalopram* brentuximab vedotin diltiazem clomipramine* cabazitaxel esmolol cyclobenzaprine* ceritinib felodipine desipramine* cladribine isradipine desvenlavaxine* cobimetinib clobazam ivabradine dexfenfluramine* colchicine* daclatasvir labetalol dextromethorphan* cyclosporine erythromycin levobetaxolol dihydroergotamine* daunorubicin fexofenadine levobunolol dolasetron* delafloxacin lapatinib methyldopa doxepin* digitoxin ritonavir metipranolol doxepin topical* digoxin metoprolol duloxetine* donepezil nadolol eletriptan* doxorubicin nebivolol ergotamine* edoxaban* nicardipine escitalopram*
    [Show full text]