Module 1 (Part I)
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Angiotensin-Converting Enzyme Inhibitors Or Angiotensin II Receptor Blockers and the Risk of Developing Rheumatoid Arthritis in Antihypertensive Drug Users
Jong, H.J.I. de, Vandebriel, R.J., Saldi, S.R.F., Dijk, L. van, Loveren, H. van, Cohen Tervaert, J.W., Klungel, O.H. Angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers and the risk of developing rheumatoid arthritis in antihypertensive drug users. Pharmacoepidemiology and Drug Safety: 2012, 21(8), 835-843 Postprint Version 1.0 Journal website http://dx.doi.org/10.1002/pds.3291 Pubmed link http://www.ncbi.nlm.nih.gov/pubmed/22674737 DOI 10.1002/pds.3291 This is a NIVEL certified Post Print, more info at http://www.nivel.eu Angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers and the risk of developing rheumatoid arthritis in antihypertensive drug users†‡ HILDA J. I. DE JONG1,2,3, ROB J. VANDEBRIEL1, SITI R. F. SALDI3, LISET VAN DIJK4, HENK VAN LOVEREN1,2, JAN WILLEM COHEN TERVAERT5, OLAF H. KLUNGEL3,* ABSTRACT Purpose: Angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) are effective in the treatment of cardiovascular disease. Next to effects on hypertension and cardiac function, these drugs have anti-inflammatory and immunomodulating properties which may either facilitate or protect against the development of autoimmunity, potentially resulting in autoimmune diseases. Therefore, we determined in the current study the association between ACE inhibitor and ARB use and incident rheumatoid arthritis (RA). Methods: A matched case–control study was conducted among patients treated with antihypertensive drugs using the Netherlands Information Network of General Practice (LINH) database in 2001–2006. Cases were patients with a first-time diagnosis of RA. Each case was matched to five controls for age, sex, and index date, which was selected 1 year before the first diagnosis of RA. -
M2021: Pharmacogenetic Testing
Pharmacogenetic Testing Policy Number: AHS – M2021 – Pharmacogenetic Prior Policy Name and Number, as applicable: Testing • M2021 – Cytochrome P450 Initial Presentation Date: 06/16/2021 Revision Date: N/A I. Policy Description Pharmacogenetics is defined as the study of variability in drug response due to heredity (Nebert, 1999). Cytochrome (CYP) P450 enzymes are a class of enzymes essential in the synthesis and breakdown metabolism of various molecules and chemicals. Found primarily in the liver, these enzymes are also essential for the metabolism of many medications. CYP P450 are essential to produce many biochemical building blocks, such as cholesterol, fatty acids, and bile acids. Additional cytochrome P450 are involved in the metabolism of drugs, carcinogens, and internal substances, such as toxins formed within cells. Mutations in CYP P450 genes can result in the inability to properly metabolize medications and other substances, leading to increased levels of toxic substances in the body. Approximately 58 CYP genes are in humans (Bains, 2013; Tantisira & Weiss, 2019). Thiopurine methyltransferase (TPMT) is an enzyme that methylates azathioprine, mercaptopurine and thioguanine into active thioguanine nucleotide metabolites. Azathioprine and mercaptopurine are used for treatment of nonmalignant immunologic disorders; mercaptopurine is used for treatment of lymphoid malignancies; and thioguanine is used for treatment of myeloid leukemias (Relling et al., 2011). Dihydropyrimidine dehydrogenase (DPD), encoded by the gene DPYD, is a rate-limiting enzyme responsible for fluoropyrimidine catabolism. The fluoropyrimidines (5-fluorouracil and capecitabine) are drugs used in the treatment of solid tumors, such as colorectal, breast, and aerodigestive tract tumors (Amstutz et al., 2018). A variety of cell surface proteins, such as antigen-presenting molecules and other proteins, are encoded by the human leukocyte antigen genes (HLAs). -
Supporting Information a Analysed Substances
Electronic Supplementary Material (ESI) for Analyst. This journal is © The Royal Society of Chemistry 2020 List of contents: Tab. A1 Detailed list and classification of analysed substances. Tab. A2 List of selected MS/MS parameters for the analytes. Tab. A1 Detailed list and classification of analysed substances. drug of therapeutic doping agent analytical standard substance abuse drug (WADA class)* supplier (+\-)-amphetamine ✓ ✓ S6 stimulants LGC (+\-)-methamphetamine ✓ S6 stimulants LGC (+\-)-3,4-methylenedioxymethamphetamine (MDMA) ✓ S6 stimulants LGC methylhexanamine (4-methylhexan-2-amine, DMAA) S6 stimulants Sigma cocaine ✓ ✓ S6 stimulants LGC methylphenidate ✓ ✓ S6 stimulants LGC nikethamide (N,N-diethylnicotinamide) ✓ S6 stimulants Aldrich strychnine S6 stimulants Sigma (-)-Δ9-tetrahydrocannabinol (THC) ✓ ✓ S8 cannabinoids LGC (-)-11-nor-9-carboxy-Δ9-tetrahydrocannabinol (THC-COOH) S8 cannabinoids LGC morphine ✓ ✓ S7 narcotics LGC heroin (diacetylmorphine) ✓ ✓ S7 narcotics LGC hydrocodone ✓ ✓ Cerillant® oxycodone ✓ ✓ S7 narcotics LGC (+\-)-methadone ✓ ✓ S7 narcotics Cerillant® buprenorphine ✓ ✓ S7 narcotics Cerillant® fentanyl ✓ ✓ S7 narcotics LGC ketamine ✓ ✓ LGC phencyclidine (PCP) ✓ S0 non-approved substances LGC lysergic acid diethylamide (LSD) ✓ S0 non-approved substances LGC psilocybin ✓ S0 non-approved substances Cerillant® alprazolam ✓ ✓ LGC clonazepam ✓ ✓ Cerillant® flunitrazepam ✓ ✓ LGC zolpidem ✓ ✓ LGC VETRANAL™ boldenone (Δ1-testosterone / 1-dehydrotestosterone) ✓ S1 anabolic agents (Sigma-Aldrich) -
Evaluating Onco-Geriatric Scores and Medication Risks to Improve Cancer Care for Older Patients
Evaluating onco-geriatric scores and medication risks to improve cancer care for older patients Dissertation zur Erlangung des Doktorgrades (Dr. rer. nat.) der Mathematisch-Naturwissenschaftlichen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn vorgelegt von IMKE ORTLAND aus Quakenbrück Bonn 2019 Angefertigt mit Genehmigung der Mathematisch-Naturwissenschaftlichen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn. Diese Dissertation ist auf dem Hochschulschriftenserver der ULB Bonn elektronisch publiziert. https://nbn-resolving.org/urn:nbn:de:hbz:5-58042 Erstgutachter: Prof. Dr. Ulrich Jaehde Zweitgutachter: Prof. Dr. Andreas Jacobs Tag der Promotion: 28. Februar 2020 Erscheinungsjahr: 2020 Danksagung Auf dem Weg zur Promotion haben mich viele Menschen begleitet und in ganz unterschiedlicher Weise unterstützt. All diesen Menschen möchte ich an dieser Stelle ganz herzlich danken. Mein aufrichtiger Dank gilt meinem Doktorvater Prof. Dr. Ulrich Jaehde für das in mich gesetzte Vertrauen, sowie für die Überlassung dieses spannenden Dissertationsthemas. Die uneingeschränkte Unterstützung, wertvollen Diskussionen und die mitreißende Begeisterung für die Wissenschaft haben mich während aller Phasen der Dissertation stets motiviert, unterstützt und sehr viel Wertvolles gelehrt. Prof. Dr. Andreas Jacobs danke ich herzlich für die Initiierung dieses interessanten Projekts, für die stetige Begeisterung und Unterstützung, sowie für das mir entgegengebrachte Vertrauen. Die ausgezeichnete Zusammenarbeit mit dem Johanniter Krankenhaus Bonn hat ganz maßgeblich zum Gelingen dieser Arbeit beigetragen. Auch danke ich Prof. Dr. Andreas Jacobs herzlich für die Bereitschaft, das Koreferat dieser Arbeit zu übernehmen. Ebenfalls danke ich herzlich Prof. Dr. Yon-Dschun Ko für seine fortwährende Motivation und seinen Einsatz, sowie für das mir geschenkte Vertrauen, dieses Projekt am Johanniter Krankenhaus zu realisieren. Ebenfalls danke ich Prof. -
Medication Risks in Older Patients with Cancer
Medication risks in older patients with cancer 1 Medication risks in older patients (70+) with cancer and their association with therapy-related toxicity Imke Ortland1, Monique Mendel Ott1, Michael Kowar2, Christoph Sippel3, Yon-Dschun Ko3#, Andreas H. Jacobs2#, Ulrich Jaehde1# 1 Institute of Pharmacy, Department of Clinical Pharmacy, University of Bonn, An der Immenburg 4, 53121 Bonn, Germany 2 Department of Geriatrics and Neurology, Johanniter Hospital Bonn, Johanniterstr. 1-3, 53113 Bonn, Germany 3 Department of Oncology and Hematology, Johanniter Hospital Bonn, Johanniterstr. 1-3, 53113 Bonn, Germany # equal contribution Corresponding author Ulrich Jaehde Institute of Pharmacy University of Bonn An der Immenburg 4 53121 Bonn, Germany Phone: +49 228-73-5252 Fax: +49-228-73-9757 [email protected] Medication risks in older patients with cancer 2 Abstract Objectives To evaluate medication-related risks in older patients with cancer and their association with severe toxicity during antineoplastic therapy. Methods This is a secondary analysis of two prospective, single-center observational studies which included patients ≥ 70 years with cancer. The patients’ medication was investigated regarding possible risks: polymedication (defined as the use of ≥ 5 drugs), potentially inadequate medication (PIM; defined by the EU(7)-PIM list), and relevant potential drug- drug interactions (rPDDI; analyzed by the ABDA interaction database). The risks were analyzed at two different time points: before and after start of cancer therapy. Severe toxicity during antineoplastic therapy was captured from medical records according to the Common Terminology Criteria for Adverse Events (CTCAE). The association between Grade ≥ 3 toxicity and medication risks was evaluated by univariate regression. -
Drugs-Biologicals FORMULARY for INTERNET PAGE 12 26 18
AVG ITEM Average Patient Item Charge Code Description BIL AWP /pkg COST Price 25000041 SODIUM and POTASSIUM BICARBONATE TBEF UD $3.61 $0.12 $1.00 25000054 GLIMEPIRIDE TAB 1 MG UD $8.25 $0.11 $1.30 25000086 amLODIPine TAB 5 MG UD $8.65 $0.06 $1.00 25000087 AMMONIA AROMATIC SOLN 15 % (W/V) UD $3.53 $0.17 $1.00 25000090 AMOXICILLIN CAP 500 MG UD $20.12 $0.19 $1.00 25000102 ABACAVIR TAB 300 MG UD $507.10 $8.45 $16.90 25000103 ACAMPROSATE TBEC 333 MG UD $182.38 $0.80 $1.76 25000104 ACARBOSE TAB 25 MG UD $16.70 $0.27 $1.00 25000106 ACETAMINOPHEN SUPP 120 MG UD $5.09 $0.42 $1.00 25000108 ACETAMINOPHEN SUPP 325 MG UD $4.91 $0.44 $1.00 25000109 ACETAMINOPHEN TAB 325 MG UD $12.39 $0.02 $1.00 25000111 ACETAMINOPHEN TAB 500 MG UD $2.34 $0.02 $1.00 25000112 ACETAMINOPHEN SUPP 650 MG UD $3.83 $0.17 $1.00 25000113 ACETAMINOPHEN SOLN 650 MG/20.3 ML UD $75.74 $0.48 $1.22 25000117 ACETAMINOPHEN-CODEINE TAB 300-30 MG UD $12.41 $0.09 $1.00 25000121 ACETYLCYSTEINE SOLN 200 MG/ML (20 %) UD $18.18 $7.66 $15.32 25000140 ALBUTEROL SULFATE NEBU 2.5MG/3ML (0.083 %) UD $8.58 $0.29 $1.00 25000147 ALLOPURINOL TAB 100 MG UD $18.45 $0.12 $1.00 25000150 ALPRAZolam TAB 0.25 MG UD $8.87 $0.09 $1.00 25000151 ALPRAZolam TAB 0.5 MG UD $4.16 $0.04 $1.00 25000182 AMIODARONE TAB 200 MG UD $15.70 $0.20 $1.00 25000184 AMITRIPTYLINE TAB 10 MG UD $8.73 $0.06 $1.00 25000186 AMITRIPTYLINE TAB 25 MG UD $17.46 $0.08 $1.00 25000188 AMITRIPTYLINE TAB 50 MG UD $34.90 $0.16 $1.00 25000205 HYDROCORTISONE ACETATE SUPP 25 MG UD $127.30 $5.75 $11.50 25000206 HEMORRHOIDAL SUPPOSITORY SUPP 0.25 -
Reference ID: 3940505 FULL PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION • Do not co-administer aliskiren with BYVALSON in patients with These highlights do not include all the information needed to use diabetes. (4) BYVALSON safely and effectively. See full prescribing information for -----------------------WARNINGS AND PRECAUTIONS----------------------- BYVALSON. • Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue. (5.3) BYVALSON (nebivolol and valsartan) tablets, for oral use • Diabetes: Monitor glucose as β-blockers may mask symptoms of Initial U.S. Approval: 2016 hypoglycemia. (5.7) • Monitor renal function and potassium in susceptible patients. (5.11) WARNING: FETAL TOXICITY ------------------------------ADVERSE REACTIONS------------------------------ See full prescribing information for complete boxed warning. No adverse reactions were observed more frequently on BYVALSON than on • When pregnancy is detected, discontinue BYVALSON as soon as placebo. (6.1) possible (5.1, 8.1) • Drugs, including BYVALSON, that act directly on the renin To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1 angiotensin system can cause injury and death to the developing 800-272-5525or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. fetus. (5.1, 8.1) ------------------------------DRUG INTERACTIONS------------------------------ • CYP2D6 enzyme inhibitors increase nebivolol levels. (7) ----------------------------INDICATIONS AND USAGE-------------------------- • Reserpine or clonidine may produce excessive reduction of sympathetic BYVALSON is a beta adrenergic blocker and an angiotensin II receptor activity. (7) blocker (ARB) indicated for the treatment of hypertension, to lower blood • Digitalis glycosides increase the risk of bradycardia. (7) pressure. Lowering blood pressure reduces the risk of fatal and nonfatal • Verapamil- or diltiazem-type calcium channel blockers may cause cardiovascular events, primarily strokes and myocardial infarctions. -
Comparative Effects of Nebivolol and Atenolol on Blood Pressure and Insulin Sensitivity in Hypertensive Subjects with Type II Diabetes
Journal of Human Hypertension (1997) 11, 753–757 1997 Stockton Press. All rights reserved 0950-9240/97 $12.00 ORIGINAL ARTICLE Comparative effects of nebivolol and atenolol on blood pressure and insulin sensitivity in hypertensive subjects with type II diabetes R Fogari1, A Zoppi1, P Lazzari1, A Mugellini1, P Lusardi1, P Preti1, L Van Nueten2 and C Vertommen2 1Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy; 2Janssen Research Foundation, Beerse, Belgium The aim of this double-blind, parallel group study was to rate during the last 60 min of clamp and total glucose compare the effects of nebivolol and atenolol on blood requirements were evaluated. Nebivolol 5 mg once daily pressure (BP) and insulin sensitivity in hypertensive was of an equivalent efficacy as atenolol 50 mg once patients with type II, non-insulin dependent diabetes daily at reducing supine and standing systolic and dias- mellitus (NIDDM). After a 4-week run-in period on pla- tolic BP values. Neither b-blocker adversely affected cebo, 30 patients (14 males and 16 females) aged 43 to carbohydrate metabolism in terms of insulin sensitivity, 69 years, with stable NIDDM and mild to moderate whole body glucose utilization, HbA1c and 24-h urinary hypertension (DBP >95 and ,116 mm Hg) were random- C-peptide excretion. No significant changes in choles- ised to receive either nebivolol 5 mg or atenolol 50 mg, terol (total, high density and low density lipoprotein) both administered once daily for 6 months. At the end and triglycerides plasma levels were observed with both of the placebo and the active treatment periods, supine b-blockers. -
Compositions Comprising Nebivolol
(19) TZZ ZZ__T (11) EP 2 808 015 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.: 03.12.2014 Bulletin 2014/49 A61K 31/34 (2006.01) A61K 31/502 (2006.01) A61K 31/353 (2006.01) A61P 9/00 (2006.01) (21) Application number: 14002458.9 (22) Date of filing: 16.11.2005 (84) Designated Contracting States: • O’Donnell, John AT BE BG CH CY CZ DE DK EE ES FI FR GB GR Morgantown, WV 26505 (US) HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI • Bottini, Peter Bruce SK TR Morgantown, WV 26505 (US) • Mason, Preston (30) Priority: 31.05.2005 US 141235 Morgantown, WV 26504 (US) 10.11.2005 US 272562 • Shaw, Andrew Preston 15.11.2005 US 273992 Morgantown, WV 26504 (US) (62) Document number(s) of the earlier application(s) in (74) Representative: Samson & Partner accordance with Art. 76 EPC: Widenmayerstraße 5 09015249.7 / 2 174 658 80538 München (DE) 05848185.4 / 1 890 691 Remarks: (71) Applicant: MYLAN LABORATORIES, INC This application was filed on 16-07-2014 as a Morgantown, NV 26504 (US) divisional application to the application mentioned under INID code 62. (72) Inventors: • Davis, Eric Morgantown, WV 26508 (US) (54) Compositions comprising nebivolol (57) The active ingredients of the pharmaceutical composition described consist of nebivolol, one or more ACE inhibitors and one or more ARB. EP 2 808 015 A1 Printed by Jouve, 75001 PARIS (FR) EP 2 808 015 A1 Description [0001] This application is a continuation-in-part of application Ser. -
Compendial Deferrals for USP41-NF36 1S
Compendial Deferrals for USP41-NF36 1S Category Monograph Title Monograph Section Scientific Liaison {Emollient} Sodium Lauroyl Sarcosinate, {Emulsifying Agent} Sodium Lauroyl Revision USP AND NF EXCIPIENTS, LISTED BY CATEGORY PF 42(2) Pg. ONLINE Sarcosinate, {Chaotropic Agent} Hong Wang Introduction, 1. INTRODUCTION, 2. GENERAL QUALITY TESTS FOR INHALATION DRUG <5> INHALATION AND NASAL DRUG PRODUCTS GENERAL INFORMATION AND PRODUCTS, 3. GENERAL QUALITY TESTS FOR NASAL DRUG PRODUCTS, 4. Revision PRODUCT QUALITY TESTS PF 43(1) Pg. ONLINE DESCRIPTION OF PRODUCT QUALITY TESTS Kahkashan Zaidi Bendamustine Hydrochloride, Ropivacaine, Bortezomib, Sodium Lauroyl Sarcosinate, Epinastine Hydrochloride, Imipramine Hydrochloride, Carglumic Acid, Iloperidone, Benzphetamine Hydrochloride, Deferasirox, Eletriptan Hydrobromide, Milnacipran New DESCRIPTION AND SOLUBILITY PF 43(1) Pg. ONLINE Hydrochloride, Nebivolol Hydrochloride Feiwen Mao Title, INTRODUCTION/Introduction, PROCEDURE/Identification, PROCEDURE/Enumeration, PERFORMANCE TESTS/, CONTAMINANTS/Introduction, CONTAMINANTS/Listeria, ADDITIONAL REQUIREMENTS/Storage, ADDITIONAL New <64> PROBIOTIC TESTS - GENERAL PF 43(2) Pg. ONLINE REQUIREMENTS/Labeling, ??UNKNOWN??/Introduction Seong Jae Yoo Title, Introduction, INTRODUCTION, CHARACTERISTICS, IDENTIFICATION, TEST PROCEDURES, BIOLOGICAL TESTS, PHYSICOCHEMICAL TESTS, FUNCTIONALITY New <381> ELASTOMERIC CLOSURES FOR INJECTIONS PF 43(3) Pg. ONLINE TESTS, 1. INTRODUCTION, 2. SCOPE, 3. SPECIFICATIONS, 4. TEST METHODS Desmond Hunt Title, 1. INTRODUCTION, -
BYSTOLIC Safely and Effectively
HIGHLIGHTS OF PRESCRIBING INFORMATION • Patients with severe hepatic impairment (Child-Pugh >B) These highlights do not include all the information needed to (4) use BYSTOLIC safely and effectively. See full prescribing • Hypersensitive to any component of this product (4) information for BYSTOLIC. -------------WARNINGS AND PRECAUTIONS---------- BYSTOLIC® (nebivolol) tablets, for oral use • Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue. (5.1) Initial U.S. Approval: 2007 • Diabetes: Monitor glucose as β-blockers may mask symptoms of hypoglycemia. (5.5) ------------RECENT MAJOR CHANGES------------------ Indications and Usage (1.1) 12/2011 -----------------ADVERSE REACTIONS----------------- Most common adverse reactions (6.1): --------------INDICATIONS AND USAGE--------------- • Headache, fatigue BYSTOLIC is a beta-adrenergic blocking agent indicated for To report SUSPECTED ADVERSE REACTIONS, Contact the treatment of hypertension, to lower blood pressure. Forest Laboratories, Inc. at 1-800-678-1605 or FDA at Lowering blood pressure reduces the risk of fatal and nonfatal 1-800-FDA-1088 or www.fda.gov/medwatch. cardiovascular events, primarily strokes and myocardial infarctions. (1.1) ----------------DRUG INTERACTIONS------------------ • CYP2D6 enzyme inhibitors may increase nebivolol levels. ------------DOSAGE AND ADMINISTRATION---------- (7.1) Can be taken with and without food. Individualize to the • Reserpine or clonidine may produce excessive reduction needs of the patient and monitor during up-titration. (2) of sympathetic activity. (7.2) • Hypertension: Most patients start at 5 mg once daily. • Both digitalis glycosides and β-blockers slow Dose can be increased at 2-week intervals up to 40 mg. atrioventricular conduction and decrease heart rate. (2.1) Concomitant use can increase the risk of bradycardia. -
Summary of Product Characteristics
Health Products Regulatory Authority Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Carvedilol Krka 3.125 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 3.125 mg carvedilol. Excipients: Each tablet contains 75.375 mg lactose monohydrate and 5 mg sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets. Appearance: Round, slightly biconvex, white bevel edged tablet. 4 CLINICAL PARTICULARS 4.1 Therapeutic Indications Adjunctive therapy for the treatment of symptomatic congestive heart failure to reduce morbidity and increase patient well-being. Treatment of hypertension. 4.2 Posology and method of administration Posology Symptomatic congestive heart failure The dosage must be titrated to individual requirements and patients' clinical status should be monitored for 2 - 3 hours after initiation and any dose increase during up-titration. For those patients receiving diuretics and/or digoxin and/or ACE inhibitors, dosing of these other drugs should be stabilised prior to initiation of Carvedilol Krka treatment. Adults The recommended dose for the initiation of therapy is 3.125 mg twice a day for two weeks. If this dose is tolerated, the dosage should be increased subsequently, at intervals of not less than two weeks, to 6.25 mg twice daily, followed by 12.5 mg twice daily and thereafter 25 mg twice daily. Dosing should be increased to the highest level tolerated by the patient. The recommended maximum daily dose is 25 mg given twice daily in patients weighing less than 85 kg (187 lbs) and 50 mg twice daily in patients weighing more than 85 kg.