Non-Preferred Drug List (NPDL)
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Oral Dosage Forms That Should Not Be Crushed Formulary-Specific List for VCMC and SPH
Oral Dosage Forms That Should Not be Crushed Formulary-Specific List for VCMC and SPH Generic Brand Dosage Form(s) Reasons/Comments amoxicillin-clavulanate Augmentin XR Tablet Slow-release (b,h) aspirin Aspirin EC Caplet; Tablet Slow-release; Enteric-coated aspirin and dipyridamole Aggrenox XR Capsule Slow-release atazanavir Reyataz Capsule Note: an oral powder is available, see prescribing information for administration instructions atomoxetine Strattera Capsule Note: capsule contents can cause ocular irritation - Do not open capsules as contents are an ocular irritant benzonatate Tessalon Perles Capsule Note: swallow whole; local anesthesia of the oral mucosa; choking could occur - Capsules are liquid-filled “perles” - Do not alter (break, cut, chew) integrity of dosage form; local mucosal irritant and anesthetic bisacodyl Dulcolax Capsule; Tablet Enteric-coated (c) bosentan Tracleer Tablet Note: women who are, or may become, pregnant, should not handle crushed or broken tablets brivaracetam Briviact Tablet Film-coated (b) budesonide Entocort EC Capsule Enteric-coated (a) - Capsules contain enteric-coated granules in extended-release matrix; can open capsules but do not crush contents - Products are formulated to release active drug at mid- to late small intestine buPROPion Wellbutrin XL Tablet Slow-release - Do not crush extended-release tablets - Immediate-release tablet products may be film-coated March 2019 carvedilol phosphate Coreg CR Capsule Slow-release (a) (Note: may add contents of capsule to chilled, not warm, applesauce -
Crofelemer Oral Delayed Release Tablet
Contains Nonbinding Recommendations Draft – Not for Implementation Draft Guidance on Crofelemer This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the Office of Generic Drugs. Active Ingredient: Crofelemer Dosage Form; Route: Tablet, delayed release; oral Strength: 125 mg Recommendations for the Assessment of Identity and Quality of Botanical Raw Material (BRM): Crofelemer is a botanical drug derived from BRM, the crude red latex of Croton lechleri Müll. Arg. [Fam. Euphorbiacae], which is also called dragon’s blood (sangre de drago). Generic drug applicants should use the same plant species and perform BRM assessment: 1. Crofelemer BRM should be collected from the crude red latex of Croton lechleri. The plant species should be correctly identified and authenticated based on techniques such as macroscopic/microscopic and/or analysis of genetic material. 2. Crude red latex as BRM should be collected from the mature tree with defined eco- geographic regions (EGRs). Implementing and enforcing established good agricultural and collection practice (GACP) procedures will minimize variations in BRM and ensure batch- to-batch consistency of crofelemer. 3. BRMs should be analyzed for their crofelemer content, total phenolics and taspine content, as well as heavy metals and pesticides. Recommendations for Demonstrating API Sameness: API sameness can be established by showing equivalence between Test API and API from the reference listed drug (RLD) product with the three criteria described in detail below. -
Medicaid Policy Change
MEDICAID POLICY CHANGE IMMINENT PERIL JUSTIFICATION September 25, 2019 ADVAIR: POLICY CHANGE: LDH is changing the preferred drug list to switch the diskus inhaled powder from preferred to non-preferred and adding the HFA inhaler to the preferred list instead. JUSTIFICATION: This product is used to control symptoms and prevent complications caused by asthma or chronic obstructive pulmonary disease. This change is necessary to make an easier delivery device available for recipients to aid with treatment. Without preferred status, recipients would be required to obtain prior authorization which could delay necessary treatment. This change is needed by 10/1/19 due to the coming seasonal change in weather, including influenza and allergy season, that can significantly exacerbate chronic lung diseases, and so this presents an imminent peril to public health. EFFECTIVE DATE: October 1, 2019 LA Medicaid Preferred Drug List (PDL)/Non-Preferred Drug List (NPDL) Effective Date: July 15October 1, 2019 AG – Authorized Generic DR – Concurrent Prescriptions Must Be Written by Same Prescriber PU – Prior Use of Other Medication is Required AL – Age Limits DS – Maximum Days’ Supply Allowed QL – Quantity Limits BH – Behavioral Health Clinical Authorization Required for Children Younger Than 6 DT – Duration of Therapy Limit RX – Specific Prescription Requirements Years Old BY – Diagnosis Codes Bypass Some Requirements DX – Diagnosis Code Requirements TD – Therapeutic Duplication UN – Drug Use Not Warranted (Needs Appropriate CL – More Detailed Clinical Information -
In Silico Methods for Drug Repositioning and Drug-Drug Interaction Prediction
In silico Methods for Drug Repositioning and Drug-Drug Interaction Prediction Pathima Nusrath Hameed ORCID: 0000-0002-8118-9823 Submitted in total fulfilment of the requirements for the degree of Doctor of Philosophy Department of Mechanical Engineering THE UNIVERSITY OF MELBOURNE May 2018 Copyright © 2018 Pathima Nusrath Hameed All rights reserved. No part of the publication may be reproduced in any form by print, photoprint, microfilm or any other means without written permission from the author. Abstract Drug repositioning and drug-drug interaction (DDI) prediction are two fundamental ap- plications having a large impact on drug development and clinical care. Drug reposi- tioning aims to identify new uses for existing drugs. Moreover, understanding harmful DDIs is essential to enhance the effects of clinical care. Exploring both therapeutic uses and adverse effects of drugs or a pair of drugs have significant benefits in pharmacology. The use of computational methods to support drug repositioning and DDI prediction en- able improvements in the speed of drug development compared to in vivo and in vitro methods. This thesis investigates the consequences of employing a representative training sam- ple in achieving better performance for DDI classification. The Positive-Unlabeled Learn- ing method introduced in this thesis aims to employ representative positives as well as reliable negatives to train the binary classifier for inferring potential DDIs. Moreover, it explores the importance of a finer-grained similarity metric to represent the pairwise drug similarities. Drug repositioning can be approached by new indication detection. In this study, Anatomical Therapeutic Chemical (ATC) classification is used as the primary source to determine the indications/therapeutic uses of drugs for drug repositioning. -
Download Book
Methods in Molecular Biology 2000 Volkmar Weissig Tamer Elbayoumi Editors Pharmaceutical Nanotechnology Basic Protocols M ETHODS IN M OLECULAR B IOLOGY Series Editor John M. Walker School of Life and Medical Sciences University of Hertfordshire Hatfield, Hertfordshire AL10 9AB, UK For further volumes: http://www.springer.com/series/7651 Pharmaceutical Nanotechnology Basic Protocols Edited by Volkmar Weissig and Tamer Elbayoumi Department of Pharmaceutical Sciences, College of Pharmacy, Midwestern University, Glendale, AZ, USA Nanomedicine Center of Excellence in Translational Cancer Research, Midwestern University, Glendale, AZ, USA Editors Volkmar Weissig Tamer Elbayoumi Department of Pharmaceutical Sciences Department of Pharmaceutical Sciences College of Pharmacy, Midwestern University College of Pharmacy, Midwestern University Glendale, AZ, USA Glendale, AZ, USA Nanomedicine Center of Excellence Nanomedicine Center of Excellence in Translational Cancer Research in Translational Cancer Research Midwestern University Midwestern University Glendale, AZ, USA Glendale, AZ, USA ISSN 1064-3745 ISSN 1940-6029 (electronic) Methods in Molecular Biology ISBN 978-1-4939-9515-8 ISBN 978-1-4939-9516-5 (eBook) https://doi.org/10.1007/978-1-4939-9516-5 © Springer Science+Business Media, LLC, part of Springer Nature 2019 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. -
DRUGS REQUIRING PRIOR AUTHORIZATION in the MEDICAL BENEFIT Page 1
Effective Date: 08/01/2021 DRUGS REQUIRING PRIOR AUTHORIZATION IN THE MEDICAL BENEFIT Page 1 Therapeutic Category Drug Class Trade Name Generic Name HCPCS Procedure Code HCPCS Procedure Code Description Anti-infectives Antiretrovirals, HIV CABENUVA cabotegravir-rilpivirine C9077 Injection, cabotegravir and rilpivirine, 2mg/3mg Antithrombotic Agents von Willebrand Factor-Directed Antibody CABLIVI caplacizumab-yhdp C9047 Injection, caplacizumab-yhdp, 1 mg Cardiology Antilipemic EVKEEZA evinacumab-dgnb C9079 Injection, evinacumab-dgnb, 5 mg Cardiology Hemostatic Agent BERINERT c1 esterase J0597 Injection, C1 esterase inhibitor (human), Berinert, 10 units Cardiology Hemostatic Agent CINRYZE c1 esterase J0598 Injection, C1 esterase inhibitor (human), Cinryze, 10 units Cardiology Hemostatic Agent FIRAZYR icatibant J1744 Injection, icatibant, 1 mg Cardiology Hemostatic Agent HAEGARDA c1 esterase J0599 Injection, C1 esterase inhibitor (human), (Haegarda), 10 units Cardiology Hemostatic Agent ICATIBANT (generic) icatibant J1744 Injection, icatibant, 1 mg Cardiology Hemostatic Agent KALBITOR ecallantide J1290 Injection, ecallantide, 1 mg Cardiology Hemostatic Agent RUCONEST c1 esterase J0596 Injection, C1 esterase inhibitor (recombinant), Ruconest, 10 units Injection, lanadelumab-flyo, 1 mg (code may be used for Medicare when drug administered under Cardiology Hemostatic Agent TAKHZYRO lanadelumab-flyo J0593 direct supervision of a physician, not for use when drug is self-administered) Cardiology Pulmonary Arterial Hypertension EPOPROSTENOL (generic) -
Therapeutic Class Overview Anticonvulsants
Therapeutic Class Overview Anticonvulsants INTRODUCTION Epilepsy is a disease of the brain defined by any of the following (Fisher et al 2014): ○ At least 2 unprovoked (or reflex) seizures occurring > 24 hours apart; ○ 1 unprovoked (or reflex) seizure and a probability of further seizures similar to the general recurrence risk (at least 60%) after 2 unprovoked seizures, occurring over the next 10 years; ○ Diagnosis of an epilepsy syndrome. Types of seizures include generalized seizures, focal (partial) seizures, and status epilepticus (Centers for Disease Control and Prevention [CDC] 2018, Epilepsy Foundation 2016). ○ Generalized seizures affect both sides of the brain and include: . Tonic-clonic (grand mal): begin with stiffening of the limbs, followed by jerking of the limbs and face . Myoclonic: characterized by rapid, brief contractions of body muscles, usually on both sides of the body at the same time . Atonic: characterized by abrupt loss of muscle tone; they are also called drop attacks or akinetic seizures and can result in injury due to falls . Absence (petit mal): characterized by brief lapses of awareness, sometimes with staring, that begin and end abruptly; they are more common in children than adults and may be accompanied by brief myoclonic jerking of the eyelids or facial muscles, a loss of muscle tone, or automatisms. ○ Focal seizures are located in just 1 area of the brain and include: . Simple: affect a small part of the brain; can affect movement, sensations, and emotion, without a loss of consciousness . Complex: affect a larger area of the brain than simple focal seizures and the patient loses awareness; episodes typically begin with a blank stare, followed by chewing movements, picking at or fumbling with clothing, mumbling, and performing repeated unorganized movements or wandering; they may also be called “temporal lobe epilepsy” or “psychomotor epilepsy” . -
Pharmacokinetics, Pharmacodynamics and Drug
pharmaceutics Review 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 Department of Clinical Pharmacy and Biopharmacy, Pozna´nUniversity of Medical Sciences, Sw.´ Marii Magdaleny 14 St., 61-861 Pozna´n,Poland; [email protected] Received: 28 October 2020; Accepted: 30 November 2020; Published: 3 December 2020 Abstract: In the last few years, there have been significant advances in migraine management and prevention. Lasmiditan, ubrogepant, rimegepant and monoclonal antibodies (erenumab, fremanezumab, galcanezumab, and eptinezumab) are new drugs that were launched on the US pharmaceutical market; some of them also in Europe. This publication reviews the available worldwide references on the safety of these anti-migraine drugs with a focus on the possible drug–drug (DDI) or drug–food interactions. As is known, bioavailability of a drug and, hence, its pharmacological efficacy depend on its pharmacokinetics and pharmacodynamics, which may be altered by drug interactions. This paper discusses the interactions of gepants and lasmiditan with, i.a., serotonergic drugs, CYP3A4 inhibitors, and inducers or breast cancer resistant protein (BCRP) and P-glycoprotein (P-gp) inhibitors. In the case of monoclonal antibodies, the issue of pharmacodynamic interactions related to the modulation of the immune system functions was addressed. It also focuses on the effect of monoclonal antibodies on expression of class Fc gamma receptors (FcγR). Keywords: migraine; lasmiditan; gepants; monoclonal antibodies; drug–drug interactions 1. Introduction Migraine is a chronic neurological disorder characterized by a repetitive, usually unilateral, pulsating headache with attacks typically lasting from 4 to 72 h. -
Reference List of Drugs with Potential Anticholinergic Effects 1, 2, 3, 4, 5
ANTICHOLINERGICS: Reference List of Drugs with Potential Anticholinergic Effects 1, 2, 3, 4, 5 J Bareham BSP © www.RxFiles.ca Aug 2021 WHENEVER POSSIBLE, AVOID DRUGS WITH MODERATE TO HIGH ANTICHOLINERGIC ACTIVITY IN OLDER ADULTS (>65 YEARS OF AGE) Low Anticholinergic Activity; Moderate/High Anticholinergic Activity -B in combo Beers Antibiotics Antiparkinsonian Cardiovascular Agents Immunosuppressants ampicillin *ALL AVAILABLE AS amantadine SYMMETREL atenolol TENORMIN azaTHIOprine IMURAN cefOXitin GENERIC benztropine mesylate COGENTIN captopril CAPOTEN cyclosporine NEORAL clindamycin bromocriptine PARLODEL chlorthalidone GENERIC ONLY hydrocortisone CORTEF gentamicin (Oint & Sol’n NIHB covered) carbidopa/levodopa SINEMET digoxin LANOXIN, TOLOXIN methylprednisolone MEDROL piperacillin entacapone COMTAN dilTIAZem CARDIZEM, TIAZAC prednisone WINPRED dipyridamole PERSANTINE, ethopropazine PARSITAN vancomycin phenelzine NARDIL AGGRENOX disopyramide RYTHMODAN Muscle Relaxants pramipexole MIRAPEX Antidepressants baclofen LIORESAL ( on intrathecal only) procyclidine KEMADRIN furosemide LASIX amitriptyline ELAVIL cyclobenzaprine FLEXERIL selegiline ELDEPRYL hydrALAZINE APRESOLINE clomiPRAMINE ANAFRANIL isosorbide ISORDIL methocarbamol ROBAXIN OTC trihexyphenidyl ARTANE desipramine NORPRAMIN metoprolol LOPRESOR orphenadrine NORFLEX OTC doxepin >6mg SINEQUAN Antipsychotics NIFEdipine ADALAT tiZANidine ZANAFLEX A imipramine TOFRANIL quiNIDine GENERIC ONLY C ARIPiprazole ABILIFY & MAINTENA -
Xifaxan® (Rifaximin)
Wednesday, October 14, 2015 4 p.m. Oklahoma Health Care Authority 4345 N. Lincoln Blvd. Oklahoma City, OK 73105 The University of Oklahoma Health Sciences Center COLLEGE OF PHARMACY PHARMACY MANAGEMENT CONSULTANTS MEMORANDUM TO: Drug Utilization Review Board Members FROM: Bethany Holderread, Pharm.D. SUBJECT: Packet Contents for Board Meeting – October 14, 2015 DATE: October 1, 2015 NOTE: The DUR Board will meet at 4:00 p.m. The meeting will be held at 4345 N Lincoln Blvd. Enclosed are the following items related to the October meeting. Material is arranged in order of the agenda. Call to Order Public Comment Forum Action Item – Approval of DUR Board Meeting Minutes – Appendix A Action Item – Vote on 2016 Meeting Dates – Appendix B Update on Medication Coverage Authorization Unit/Bowel Preparation Medication Post-Educational Mailing – Appendix C Action Item – Vote to Prior Authorize Tykerb® (Lapatinib), Halaven® (Eribulin), Ixempra® (Ixabepilone), Kadcyla® (Ado-Trastuzumab), Afinitor® (Everolimus), & Perjeta® (Pertuzumab) – Appendix D Action Item – Vote to Prior Authorize Orkambi™ (Lumacaftor/Ivacaftor) – Appendix E Action Item – Vote to Prior Authorize Savaysa® (Edoxaban) – Appendix F Action Item – Vote to Prior Authorize Epanova® (Omega-3-Carboxylic Acids), Praluent® (Alirocumab), & Repatha™ (Evolocumab) – Appendix G Annual Review of Constipation and Diarrhea Medications and 30-Day Notice to Prior Authorize Movantik™ (Naloxegol), Viberzi™ (Eluxadoline), & Xifaxan® (Rifaximin) – Appendix H 30-Day Notice to Prior Authorize Daraprim® (Pyrimethamine) – Appendix I Annual Review of Allergy Immunotherapies and 30-Day Notice to Prior Authorize Oralair® (Sweet Vernal, Orchard, Perennial Rye, Timothy, & Kentucky Blue Grass Mixed Pollens Allergen Extract) – Appendix J Annual Review of Non-Steroidal Anti-Inflammatory Drugs and 30-Day Notice to Prior Authorize Dyloject™ (Diclofenac Sodium) – Appendix K ORI-4403 • P.O. -
European Medicines Agency Accepts Marketing Authorization Application for Asfotase Alfa As a Treatment for Patients with Hypophosphatasia
July 24, 2014 European Medicines Agency Accepts Marketing Authorization Application for Asfotase Alfa as a Treatment for Patients with Hypophosphatasia -- Application designated for review under accelerated assessment process -- CHESHIRE, Conn.--(BUSINESS WIRE)-- Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that the Marketing Authorization Application (MAA) for asfotase alfa, an investigational, first-in-class targeted enzyme replacement therapy for the treatment of hypophosphatasia (HPP), has been validated and granted accelerated assessment by the European Medicines Agency (EMA). The acceptance of this MAA marks the beginning of the review process in the European Union (EU) for this potential new treatment. "HPP is a devastating disease for patients and their families due to progressive deterioration of bones and muscle weakness, which can result in impaired respiratory function, severe disability and death," said Leonard Bell, M.D., Chief Executive Officer of Alexion. "If approved, asfotase alfa would be the first therapy for patients with this life-threatening disorder." The EU filing includes positive data from 68 patients with pediatric-onset HPP (ranging from newborns to 66 years of age) enrolled in three pivotal prospective studies and their extensions, as well as a retrospective natural history study in infants. In April, Alexion initiated the rolling submission of a Biologics License Application (BLA) for asfotase alfa as a treatment for patients with HPP with the U.S. Food and Drug Administration (FDA). About -
Supplementary Information
Supplementary Information Network-based Drug Repurposing for Novel Coronavirus 2019-nCoV Yadi Zhou1,#, Yuan Hou1,#, Jiayu Shen1, Yin Huang1, William Martin1, Feixiong Cheng1-3,* 1Genomic Medicine Institute, Lerner Research Institute, Cleveland Clinic, Cleveland, OH 44195, USA 2Department of Molecular Medicine, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, OH 44195, USA 3Case Comprehensive Cancer Center, Case Western Reserve University School of Medicine, Cleveland, OH 44106, USA #Equal contribution *Correspondence to: Feixiong Cheng, PhD Lerner Research Institute Cleveland Clinic Tel: +1-216-444-7654; Fax: +1-216-636-0009 Email: [email protected] Supplementary Table S1. Genome information of 15 coronaviruses used for phylogenetic analyses. Supplementary Table S2. Protein sequence identities across 5 protein regions in 15 coronaviruses. Supplementary Table S3. HCoV-associated host proteins with references. Supplementary Table S4. Repurposable drugs predicted by network-based approaches. Supplementary Table S5. Network proximity results for 2,938 drugs against pan-human coronavirus (CoV) and individual CoVs. Supplementary Table S6. Network-predicted drug combinations for all the drug pairs from the top 16 high-confidence repurposable drugs. 1 Supplementary Table S1. Genome information of 15 coronaviruses used for phylogenetic analyses. GenBank ID Coronavirus Identity % Host Location discovered MN908947 2019-nCoV[Wuhan-Hu-1] 100 Human China MN938384 2019-nCoV[HKU-SZ-002a] 99.99 Human China MN975262