BYSTOLIC Safely and Effectively
Total Page:16
File Type:pdf, Size:1020Kb
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). -
Pharmacology – Inhalant Anesthetics
Pharmacology- Inhalant Anesthetics Lyon Lee DVM PhD DACVA Introduction • Maintenance of general anesthesia is primarily carried out using inhalation anesthetics, although intravenous anesthetics may be used for short procedures. • Inhalation anesthetics provide quicker changes of anesthetic depth than injectable anesthetics, and reversal of central nervous depression is more readily achieved, explaining for its popularity in prolonged anesthesia (less risk of overdosing, less accumulation and quicker recovery) (see table 1) Table 1. Comparison of inhalant and injectable anesthetics Inhalant Technique Injectable Technique Expensive Equipment Cheap (needles, syringes) Patent Airway and high O2 Not necessarily Better control of anesthetic depth Once given, suffer the consequences Ease of elimination (ventilation) Only through metabolism & Excretion Pollution No • Commonly administered inhalant anesthetics include volatile liquids such as isoflurane, halothane, sevoflurane and desflurane, and inorganic gas, nitrous oxide (N2O). Except N2O, these volatile anesthetics are chemically ‘halogenated hydrocarbons’ and all are closely related. • Physical characteristics of volatile anesthetics govern their clinical effects and practicality associated with their use. Table 2. Physical characteristics of some volatile anesthetic agents. (MAC is for man) Name partition coefficient. boiling point MAC % blood /gas oil/gas (deg=C) Nitrous oxide 0.47 1.4 -89 105 Cyclopropane 0.55 11.5 -34 9.2 Halothane 2.4 220 50.2 0.75 Methoxyflurane 11.0 950 104.7 0.2 Enflurane 1.9 98 56.5 1.68 Isoflurane 1.4 97 48.5 1.15 Sevoflurane 0.6 53 58.5 2.5 Desflurane 0.42 18.7 25 5.72 Diethyl ether 12 65 34.6 1.92 Chloroform 8 400 61.2 0.77 Trichloroethylene 9 714 86.7 0.23 • The volatile anesthetics are administered as vapors after their evaporization in devices known as vaporizers. -
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) -
(12) United States Patent (10) Patent No.: US 8,603,526 B2 Tygesen Et Al
USOO8603526B2 (12) United States Patent (10) Patent No.: US 8,603,526 B2 Tygesen et al. (45) Date of Patent: Dec. 10, 2013 (54) PHARMACEUTICAL COMPOSITIONS 2008. O152595 A1 6/2008 Emigh et al. RESISTANT TO ABUSE 2008. O166407 A1 7/2008 Shalaby et al. 2008/0299.199 A1 12/2008 Bar-Shalom et al. 2008/0311205 A1 12/2008 Habib et al. (75) Inventors: Peter Holm Tygesen, Smoerum (DK); 2009/0022790 A1 1/2009 Flath et al. Jan Martin Oevergaard, Frederikssund 2010/0203129 A1 8/2010 Andersen et al. (DK); Karsten Lindhardt, Haslev (DK); 2010/0204259 A1 8/2010 Tygesen et al. Louise Inoka Lyhne-versen, Gentofte 2010/0239667 A1 9/2010 Hemmingsen et al. (DK); Martin Rex Olsen, Holbaek 2010, O291205 A1 11/2010 Downie et al. (DK); Anne-Mette Haahr, Birkeroed 2011 O159100 A1 6/2011 Andersen et al. (DK); Jacob Aas Hoellund-Jensen, FOREIGN PATENT DOCUMENTS Frederikssund (DK); Pemille Kristine Hoeyrup Hemmingsen, Bagsvaerd DE 20 2006 014131 1, 2007 (DK) EP O435,726 8, 1991 EP O493513 7, 1992 EP O406315 11, 1992 (73) Assignee: Egalet Ltd., London (GB) EP 1213014 6, 2002 WO WO 89,09066 10, 1989 (*) Notice: Subject to any disclaimer, the term of this WO WO91,040 15 4f1991 patent is extended or adjusted under 35 WO WO95/22962 8, 1995 U.S.C. 154(b) by 489 days. WO WO99,51208 10, 1999 WO WOOOf 41704 T 2000 WO WO 03/024426 3, 2003 (21) Appl. No.: 12/701,429 WO WOO3,O24429 3, 2003 WO WOO3,O24430 3, 2003 (22) Filed: Feb. -
1,1,1-Trichloroethane (CASRN 71-55-6) | IRIS
Integrated Risk Information System (IRIS) U.S. Environmental Protection Agency Chemical Assessment Summary National Center for Environmental Assessment 1,1,1-Trichloroethane; CASRN 71-55-6 Human health assessment information on a chemical substance is included in the IRIS database only after a comprehensive review of toxicity data, as outlined in the IRIS assessment development process. Sections I (Health Hazard Assessments for Noncarcinogenic Effects) and II (Carcinogenicity Assessment for Lifetime Exposure) present the conclusions that were reached during the assessment development process. Supporting information and explanations of the methods used to derive the values given in IRIS are provided in the guidance documents located on the IRIS website. STATUS OF DATA FOR 1,1,1-Trichloroethane File First On-Line 03/31/1987 Category (section) Assessment Available? Last Revised Oral RfD (I.A.) Acute Oral RfD (I.A.1.) qualitative discussion 09/28/2007 Short-term Oral RfD (I.A.2.) qualitative discussion 09/28/2007 Subchronic Oral RfD (I.A.3.) yes 09/28/2007 Chronic Oral RfD (I.A.4.) yes 09/28/2007 Inhalation RfC (I.B.) Acute Inhalation RfC (I.B.1.) yes 09/28/2007 Short-term Inhalation RfC (I.B.2.) yes 09/28/2007 Subchronic Inhalation RfC (I.B.3.) yes 09/28/2007 1 Integrated Risk Information System (IRIS) U.S. Environmental Protection Agency Chemical Assessment Summary National Center for Environmental Assessment Category (section) Assessment Available? Last Revised Chronic Inhalation RfC (I.B.4.) yes 09/28/2007 Carcinogenicity Assessment (II.) yes 09/28/2007 I. Health Hazard Assessments for Noncarcinogenic Effects I.A. -
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 -
Pharmacological Classification of the Abuse-Related Discriminative
Ashdin Publishing Journal of Drug and Alcohol Research ASHDIN Vol. 3 (2014), Article ID 235839, 10 pages publishing doi:10.4303/jdar/235839 Research Article Pharmacological Classification of the Abuse-Related Discriminative Stimulus Effects of Trichloroethylene Vapor Keith L. Shelton and Katherine L. Nicholson Department of Pharmacology and Toxicology, School of Medicine, Virginia Commonwealth University, P.O. Box 980613, Richmond, VA 23298, USA Address correspondence to Keith L. Shelton, [email protected] Received 10 December 2013; Revised 2 January 2014; Accepted 27 January 2014 Copyright © 2014 Keith L. Shelton and Katherine L. Nicholson. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Abstract Inhalants are distinguished as a class primarily based upon common means of administration suggests a homogeneity of a shared route of administration. Grouping inhalants according to mechanism and behavioral effects that may be scientifically their abuse-related in vivo pharmacological effects using the drug unwarranted. As an illustration of the inadequacy of this discrimination procedure has the potential to provide a more relevant classification scheme to the research and treatment community. simplistic taxonomic approach, consider the fact that if a Mice were trained to differentiate the introceptive effects of the similar system was applied to other common drugs of abuse, trichloroethylene vapor from air using an operant procedure. then tobacco, crack cocaine, and marijuana would be treated Trichloroethylene is a chlorinated hydrocarbon solvent once used as a single category. Instead, other classes of abused drugs as an anesthetic as well as in glues and other consumer products. -
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. -
Physiologically-Based Pharmacokinetic Modelling of Infant
AAS Open Research AAS Open Research 2018, 1:16 Last updated: 21 MAY 2018 RESEARCH ARTICLE Physiologically-based pharmacokinetic modelling of infant exposure to efavirenz through breastfeeding [version 1; referees: 1 approved with reservations] Adeniyi Olagunju 1,2, Rajith K. R. Rajoli 2, Shakir A. Atoyebi1, Saye Khoo2, Andrew Owen2, Marco Siccardi2 1Faculty of Pharmacy, Obafemi Awolowo University, Ile-Ife, Nigeria 2Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, L69 3GF, UK v1 First published: 14 May 2018, 1:16 (doi: 10.12688/aasopenres.12860.1) Open Peer Review Latest published: 14 May 2018, 1:16 (doi: 10.12688/aasopenres.12860.1) Referee Status: Abstract Background: Very little is known about the level of infant exposure to many drugs commonly used during breastfeeding. The aim of this study was to Invited Referees develop a physiologically-based pharmacokinetic (PBPK) model for predicting 1 infant exposure to maternal efavirenz through breastmilk. Methods: A breastfeeding PBPK model combining whole-body maternal and version 1 infant sub-models was constructed from drug-specific and system parameters published report affecting drug disposition using mathematical descriptions. The model was 14 May 2018 validated against published data on the pharmacokinetics of efavirenz in nursing mother-infant pairs. Further simulations were conducted to assess 1 Jeffrey W. Fisher, US Food and Drug exposure in the context of the 400 mg reduced dose of efavirenz as well as Administration, USA best- and worse-case scenarios. Results: The model adequately described efavirenz pharmacokinetics, with over 80% of observed data points (203 matched breast milk and plasma pairs) Discuss this article within the predictive interval. -
Federal Register/Vol. 71, No. 34/Tuesday, February 21, 2006
Federal Register / Vol. 71, No. 34 / Tuesday, February 21, 2006 / Notices 8859 DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND of the Public Health Service Act to HUMAN SERVICES HUMAN SERVICES conduct directly or by grants or contracts, research, experiments, and Office of the National Coordinator; Office of the National Coordinator; demonstrations relating to occupational American Health Information American Health Information safety and health and to mine health. Community Chronic Care Workgroup Community Consumer Empowerment The BSC shall provide guidance to the Meeting Workgroup Meeting Director, NIOSH on research and prevention programs. Specifically, the ACTION: Announcement of meeting. ACTION: Announcement of meeting. board shall provide guidance on the institute’s research activities related to SUMMARY: SUMMARY: This notice announces the This notice announces the developing and evaluating hypotheses, third meeting of the American Health third meeting of the American Health Information Community Consumer systematically documenting findings Information Community Chronic Care and disseminating results. The board Workgroup in accordance with the Empowerment Workgroup in accordance with the Federal Advisory shall evaluate the degree to which the Federal Advisory Committee Act (Pub. activities of NIOSH: (1) Conform to L. 92–463, 5 U.S.C., App.) Committee Act (Pub. L. 92–463, 5 U.S.C., App.) appropriate scientific standards, (2) DATES: March 22, 2006 from 1 p.m. to address current, relevant needs, and (3) DATES: March 20, 2006 from 1 p.m. to 5 p.m. produce intended results. 5 p.m. ADDRESSES: Hubert H. Humphrey Matters to be Discussed: Agenda items ADDRESSES: Hubert H. Humphrey Building (200 Independence Ave., SW., include a report from the Director, Building (200 Independence Ave., SW., Washington, DC 20201), Conference NIOSH; progress report by BSC working Washington, DC 20201), Conference Room 705A. -
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.