DOCSLIB.ORG

Reference ID: 3940505 FULL PRESCRIBING INFORMATION

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
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. (1) excessive reductions in heart rate, blood pressure, and cardiac ----------------------DOSAGE AND ADMINISTRATION----------------------­ contractility. (7) • As initial therapy and in patients not adequately controlled on valsartan 80 • Potassium sparing diuretics, potassium supplements or salt substitutes mg or nebivolol up to and including 10 mg, the recommended dose is 5 may lead to increases in serum potassium. (7) mg/ 80 mg taken orally once daily. (2) • NSAID use may lead to increased risk of renal impairment and loss of • Maximum antihypertensive effects are attained within 2 to 4 weeks. (2) antihypertensive effect. (7) • BYVALSON may be substituted for its components in patients already • Dual inhibition of the renin-angiotensin system: Increased risk of renal receiving 5 mg nebivolol and 80 mg valsartan. (2) impairment, hypotension, and hyperkalemia. (7) • Lithium: Increases in serum lithium concentrations and lithium toxicity ---------------------DOSAGE FORMS AND STRENGTHS---------------------­ (7) • Tablets: 5 mg/ 80 mg (3) -----------------------USE IN SPECIFIC POPULATIONS-----------------------­ -------------------------------CONTRAINDICATIONS-----------------------------­ • Lactation: Advise not to breastfeed. (8.2) • Severe bradycardia (4) • Heart block greater than first degree (4) • Patients with cardiogenic shock (4) See 17 for PATIENT COUNSELING INFORMATION and FDA- • Decompensated cardiac failure (4) approved patient labeling • Sick sinus syndrome (unless a permanent pacemaker is in place) (4) • Patients with severe hepatic impairment (Child-Pugh >B) (4) Revised 06/2016 • Hypersensitivity to any component of this product (4) ______________________________________________________________________________________________________________________________________ FULL PRESCRIBING INFORMATION: CONTENTS* 6.1 Clinical Trials Experience WARNING: FETAL TOXICITY 6.2 Postmarketing Experience 1 INDICATIONS AND USAGE 7 DRUG INTERACTIONS 2 DOSAGE AND ADMINISTRATION 8 USE IN SPECIFIC POPULATIONS 3 DOSAGE FORMS AND STRENGTHS 8.1 Pregnancy 4 CONTRAINDICATIONS 8.2 Lactation 5 WARNINGS AND PRECAUTIONS 8.4 Pediatric Use 5.1 Fetal Toxicity 8.5 Geriatric Use 5.2 Hypotension 8.6 Renal Impairment 5.3 Abrupt Cessation of Therapy 8.7 Hepatic Impairment 5.4 Cardiac Failure 10 OVERDOSAGE 5.5 Bronchospastic Diseases 11 DESCRIPTION 5.6 Anesthesia and Major Surgery 12 CLINICAL PHARMACOLOGY 5.7 Diabetes and Hypoglycemia 12.1 Mechanism of Action 5.8 Thyrotoxicosis 12.2 Pharmacodynamics 5.9 Peripheral Vascular Disease 12.3 Pharmacokinetics 5.10 Non-dihydropyridine Calcium Channel Blockers 13 NONCLINICAL TOXICOLOGY 5.11 Impaired Renal Function 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.12 Risk of Anaphylactic Reactions 14 CLINICAL STUDIES 5.13 Pheochromocytoma 16 HOW SUPPLIED/STORAGE AND HANDLING 5.14 Hyperkalemia 17 PATIENT COUNSELING INFORMATION 6 ADVERSE REACTIONS *Sections or subsections omitted from the full prescribing information are not listed ______________________________________________________________________________________________________________________________________ 1 Reference ID: 3940505 FULL PRESCRIBING INFORMATION WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue BYVALSON as soon as possible (5.1, 8.1). • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1, 8.1). 1 INDICATIONS AND USAGE BYVALSON is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the β-blocker class to which nebivolol principally belongs and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with BYVALSON. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. BYVALSON may be used alone or in combination with other antihypertensive agents. 2 DOSAGE AND ADMINISTRATION As initial therapy and in patients not adequately controlled on valsartan 80 mg or nebivolol up to and including 10 mg, the recommended dose of BYVALSON is one tablet, 5 mg/ 80 mg 2 Reference ID: 3940505 (nebivolol/valsartan) taken orally once daily. Maximum antihypertensive effects are attained within 2 to 4 weeks. Increasing the dose of BYVALSON does not result in any meaningful further blood pressure reduction [see Clinical Studies (14)]. BYVALSON may be substituted for its components in patients already receiving 5 mg nebivolol and 80 mg valsartan. 3 DOSAGE FORMS AND STRENGTHS BYVALSON is available as a purple, capsule shaped, film-coated tablet with FL1 debossed on one side containing 5 mg of nebivolol and 80 mg of valsartan. 4 CONTRAINDICATIONS BYVALSON is contraindicated in the following conditions: • Severe bradycardia • Heart block greater than first degree • Patients with cardiogenic shock • Decompensated cardiac failure • Sick sinus syndrome (unless a permanent pacemaker is in place) • Patients with severe hepatic impairment (Child-Pugh >B) • Patients who are hypersensitive to any component of this product. • Do not co-administer aliskiren with BYVALSON in patients with diabetes [see Drug Interactions (7)]. 5 WARNINGS AND PRECAUTIONS 5.1 Fetal Toxicity Valsartan Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases
Load more

Recommended publications
  • 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).
    [Show full text]
  • 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)
    [Show full text]
  • 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
    [Show full text]
  • 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.
    [Show full text]
  • 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.
    [Show full text]
  • 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,
    [Show full text]
  • 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.
    [Show full text]
  • Review of Existing Classification Efforts
    Project No. TREN-05-FP6TR-S07.61320-518404-DRUID DRUID Driving under the Influence of Drugs, Alcohol and Medicines Integrated Project 1.6. Sustainable Development, Global Change and Ecosystem 1.6.2: Sustainable Surface Transport 6th Framework Programme Deliverable 4.1.1 Review of existing classification efforts Due date of deliverable: (15.01.2008) Actual submission date: (07.02.2008) Start date of project: 15.10.2006 Duration: 48 months Organisation name of lead contractor for this deliverable: UGent Revision 1.0 Project co-funded by the European Commission within the Sixth Framework Programme (2002-2006) Dissemination Level PU Public X PP Restricted to other programme participants (including the Commission Services) RE Restricted to a group specified by the consortium (including the Commission Services) CO Confidential, only for members of the consortium (including the Commission Services) Task 4.1 : Review of existing classification efforts Authors: Kristof Pil, Elke Raes, Thomas Van den Neste, An-Sofie Goessaert, Jolien Veramme, Alain Verstraete (Ghent University, Belgium) Partners: - F. Javier Alvarez (work package leader), M. Trinidad Gómez-Talegón, Inmaculada Fierro (University of Valladolid, Spain) - Monica Colas, Juan Carlos Gonzalez-Luque (DGT, Spain) - Han de Gier, Sylvia Hummel, Sholeh Mobaser (University of Groningen, the Netherlands) - Martina Albrecht, Michael Heiβing (Bundesanstalt für Straßenwesen, Germany) - Michel Mallaret, Charles Mercier-Guyon (University of Grenoble, Centre Regional de Pharmacovigilance, France) - Vassilis Papakostopoulos, Villy Portouli, Andriani Mousadakou (Centre for Research and Technology Hellas, Greece) DRUID 6th Framework Programme Deliverable D.4.1.1. Revision 1.0 Review of Existing Classification Efforts Page 2 of 127 Introduction DRUID work package 4 focusses on the classification and labeling of medicinal drugs according to their influence on driving performance.
    [Show full text]
  • The Safety of Cardio-Selective Beta1-Blockers in Asthma: Literature Review and Search of Global Pharmacovigilance Safety Reports
    Early View Review The safety of cardio-selective beta1-blockers in asthma: literature review and search of global pharmacovigilance safety reports Miriam Bennett, Catherina L Chang, Michael Tatley, Ruth Savage, Robert J Hancox Please cite this article as: Bennett M, Chang CL, Tatley M, et al. The safety of cardio-selective beta1-blockers in asthma: literature review and search of global pharmacovigilance safety reports. ERJ Open Res 2021; in press (https://doi.org/10.1183/23120541.00801-2020). This manuscript has recently been accepted for publication in the ERJ Open Research. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJOR online. ©The authors 2021. This version is distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0. For commercial reproduction rights and permissions contact [email protected] The safety of cardio-selective beta1-blockers in asthma: literature review and search of global pharmacovigilance safety reports Miriam Bennett1, Catherina L Chang1, Michael Tatley3, Ruth Savage3,4,5, Robert J Hancox1,2 1 Respiratory Research Unit, Department of Respiratory Medicine, Waikato Hospital, Hamilton, New Zealand, 2 Department of Preventive and Social Medicine & 3 New Zealand Pharmacovigilance Centre, Division of Health Sciences, University of Otago, Dunedin, New Zealand 4 Department of General Practice, University of Otago, Christchurch, New Zealand, 5 Uppsala Monitoring Centre, Uppsala, Sweden Take home message for social media (max 256 characters with spaces) We found no published reports of asthma deaths associated with cardio-selective beta1- blocker use and only one possible death in WHO VigiBase reports.
    [Show full text]
  • A Dose-Response Trial of Nebivolol in Essential Hypertension
    Journal of Human Hypertension (1997) 11, 139–144 1997 Stockton Press. All rights reserved 0950-9240/97 $12.00 A dose-response trial of nebivolol in essential hypertension L Van Nueten, AG Dupont, C Vertommen, H Goyvaerts and JIS Robertson International Clinical R&D, Janssen Research Foundation, Beerse, Belgium A double-blind placebo-controlled dose-response trial clear inferiority of efficacy in black patients. A single of nebivolol, a cardioselective beta-blocking drug which daily dose of 5 mg was appropriate, with no evident also induces endothelium-dependent dilatation via nitric advantage at 10 mg. The drug was well tolerated, even oxide, has been performed. Nebivolol reduced blood at 10 mg daily. BP control was achieved largely in the pressure (BP) in a dose dependent way, and was shown absence of typical side effects of beta-blockade. The to be effective given once daily, without appreciable dif- combination of properties of nebivolol renders it an ferences between peak and trough drug levels. There attractive addition to the antihypertensive repertoire. was no postural component to the BP fall. There was no Keywords: hypertension therapeutic trials; b-blockers; vasodilation; nitric oxide; black patients; side effects Introduction All were required to have a fifth phase diastolic pressure of at least 95 mm Hg at the end of a 1 month Nebivolol is a highly cardioselective beta-adrenergic placebo ‘run-in’ period. Patients previously either blocking agent, devoid of intrinsic sympathomi- treated or untreated could be recruited. Exclusion 1,2 metic activity. It has been shown to control blood criteria are listed in Table 1.
    [Show full text]
  • Effectiveness of Β-Blockers in Physically Active Patients with Hypertension: Protocol of a Systematic Review
    Open Access Protocol BMJ Open: first published as 10.1136/bmjopen-2015-010534 on 15 June 2016. Downloaded from Effectiveness of β-blockers in physically active patients with hypertension: protocol of a systematic review Dagmar Tučková,1,2 Miloslav Klugar,1,2 Eliška Sovová,3 Markéta Sovová,4 Lenka Štégnerová3 To cite: Tucková̌ D, ABSTRACT cardiovascular diseases.1 In 2013, the et al Klugar M, Sovová E, . Introduction: Based on more than 5 decades of European Society of Cardiology and the Effectiveness of β-blockers in epidemiological studies, it is now widely accepted that European Society of Hypertension set out physically active patients with higher physical activity patterns and levels of hypertension: protocol of a new guidelines for the management of arter- cardiorespiratory fitness are associated with better systematic review. BMJ Open ial hypertension. health outcomes. Therefore, it is necessary to consider 2016;6:e010534. Appropriate lifestyle changes are the how treatment methods affect these two components. doi:10.1136/bmjopen-2015- cornerstone for the prevention and cure of 010534 Clinically, one very important question concerns the influence of aerobic performance on patients being hypertension. The recommended lifestyle treated for hypertension. The administration of β- measures that have been shown to be effective ▸ Prepublication history and — in reducing BP are salt restriction, moder- additional material is blockers can significantly reduce maximal and — available. To view please visit especially submaximal aerobic exercise capacity. The ation of alcohol consumption, change of diet, the journal (http://dx.doi.org/ objective of this review is to determine, by comparison weight reduction and regular physical activity 10.1136/bmjopen-2015- of existing mono and combination therapy, which β- such as moderate aerobic exercise 5–7 days – 010534).
    [Show full text]
  • Managing Blood Pressure in the PAD Patient: Selecting Drug and Target
    Managing Blood Pressure in the PAD Patient: Selecting Drug and Target Ehrin J. Armstrong MD MSc Associate Professor of Medicine University of Colorado Director, Interventional Cardiology Director, Vascular Laboratory Denver VA Medical Center What Are the Guidelines in Peripheral Artery Disease? X Copy Here X Abbott Vascular, Boston Scientific, Cardiovascular Systems, Medtronic, Philips Gerhard-Herman et al, 2016 ACC/AHA PAD Guidelines Whelton et al, 2017 Hypertension Clinical Practice Guideline 2017 Multisocietal Guidelines for Hypertension What About Beta Blockers? • Longstanding concern that beta-adrenergic receptor antagonists could worsen symptoms of claudication. • Unopposed alpha-receptor mediated vasconstriction. • Initial study of 20 patients with PAD assigned to propanolol, atenolol, labetalol, or captopril demonstrated worsened claudication symptoms with beta blockers, and decreased calf blood flow. • However, other studies of metoprolol and propanolol did not demonstrate reductions in calf blood flow. Roberts et al, Lancet 1987;2:650-653; Hiatt et al, Circulation 1985;1226-1231 • 128 patients with claudication and hypertension. • Randomized to nebivolol 5 mg daily or metoprolol 95 mg daily. • 48 week treatment period. • Baseline SBP 148 mm Hg in both groups • Similar absolute changes in SBP: -3.9 mm Hg vs. -5.2 mm Hg Espinola-Klein C et al, Hypertension 2011;58:148-154 Espinola-Klein C et al, Hypertension 2011;58:148-154 Initial and Absolute Claudication Distances • 177 patients with PAD and HTN • Randomized to nebivolol 5 mg daily vs. HCTZ 25 mg daily • Primary endpoint was initial claudication distance at 24 months Diehm et al, J Hypertens 2011;29:1448-1456 Diehm et al, J Hypertens 2011;29:1448-1456 Reduced 30 Day Mortality With Beta Blockers (Unmatched) • 1,873 consecutive patients with CLI.
    [Show full text]