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Gastrointestinal (GI) Motility, Chronic Therapeutic Class Review
Gastrointestinal (GI) Motility, Chronic Therapeutic Class Review (TCR) March 7, 2019 No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage or retrieval system without the express written consent of Magellan Rx Management. All requests for permission should be mailed to: Magellan Rx Management Attention: Legal Department 6950 Columbia Gateway Drive Columbia, Maryland 21046 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Send comments and suggestions to [email protected]. March 2019 Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004–2019 Magellan Rx Management. All Rights Reserved. FDA-APPROVED INDICATIONS Drug Manufacturer Indication(s) alosetron (Lotronex®)1 generic, . -
Patriotic Lollipops
Patriotic Lollipops Perfect for your July 4th celebrations! To make the centerpiece pictured, see instructions below recipe. Ingredients Hard Candy Recipe (3 batches-one for each color) 1 teaspoon LorAnn Super Strength Flavoring of choice (for each batch) (we used blueberry, raspberry and pina colada) 1/4 teaspoon White Liquid Food Coloring 1/8 teaspoon Sky Blue Gel Food Coloring 1/8 teaspoon Ruby Red Gel Food Coloring 2 Bright Star Lollipop sheet molds 2 Stars Lollipop sheet molds 1 Stars Pieces sheet mold Directions White Lollipops 1. Spray Bright Star and Stars Lollipop molds lightly with cooking spray and insert sucker sticks. 2. Follow directions for making hard candy, adding 1/4 teaspoon of white liquid food coloring when syrup mixture reaches 260°F. Do not stir; boiling action will incorporate color. Continue cooking as directed. 3. When boiling action ceases, stir in flavoring. Allow mixture to rest a few seconds until large bubbles are no longer visible. Pour candy syrup into prepared star molds first, then pour excess into the star pieces mold. 4. Allow candy to harden on the counter for 10 to 15 minutes. Remove from molds. For optimal storage, cover lollipops with sucker bags and secure with twist ties. Store piece candy in an airtight container. Do not refrigerate. Blue Lollipops Follow directions for making the white lollipops, substituting 1/8 teaspoon of the Sky Blue Gel food coloring for the White Liquid color. Share your creations with us on social media! #lorannoils @lorannoils Red Lollipops Follow directions for making the white lollipops, substituting 1/8 teaspoon of the Ruby Red Gel food coloring for the White Liquid color. -
NEISS Coding Manual January 2019
NEISS Coding Manual January 2019 NEISS – National Electronic Injury Surveillance System January 2019 Table of Contents Introduction .............................................................................................................................. 1 General Instructions ................................................................................................................ 1 General NEISS Reporting Rule................................................................................................ 2 Do Report ............................................................................................................................... 2 Definitions ........................................................................................................................... 2 Do Not Report ........................................................................................................................ 3 Specific Coding Instructions ................................................................................................... 4 Treatment Date ...................................................................................................................... 4 Case Number ......................................................................................................................... 5 Comments/Narrative ............................................................................................................... 5 Abbreviations ..................................................................................................................... -
204760Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 204760Orig1s000 OTHER REVIEW(S) MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH DATE: September 16, 2014 FROM: Julie Beitz, MD SUBJECT: Approval Action TO: NDA 204760 Movantik (naloxegol) tablets AstraZeneca Pharmaceuticals LP Summary Naloxegol is an antagonist of opioid binding at the muͲopioid receptor. When administered at the recommended dose levels, naloxegol functions as a peripherallyͲacting opioid receptor antagonist in tissues such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids. Naloxegol is a PEGylated derivative of naloxone and a new molecular entity. Pegylation confers the following properties: naloxegol has reduced passive permeability across membranes compared to naloxone; naloxegol is a PͲglycoprotein (PͲgp) efflux transporter substrate; and naloxegol is orally bioavailable. The reduced passive permeability and PͲgp efflux transporter properties limit CNS entry of naloxegol compared to naloxone. This memo documents my concurrence with the Division of Gastroenterology and Inborn Errors Product’s recommendation for approval of NDA 204760 for Movantik (naloxegol) tablets for the treatment of opioidͲinduced constipation (OIC) in adult patients with chronic nonͲcancer pain. Discussions regarding product labeling, and postmarketing study requirements and commitments have been satisfactorily completed. There are no inspectional issues that preclude approval. Dosing The recommended dose of Movantik (naloxegol) tablets is 25 mg taken once daily in the morning on an empty stomach. Patients who do not tolerate this dose, may reduce the dose to 12.5 mg once daily. Maintenance laxatives should be discontinued prior to initiation of therapy with Movantik. -
Design and Synthesis of Cyclic Analogs of the Kappa Opioid Receptor Antagonist Arodyn
Design and synthesis of cyclic analogs of the kappa opioid receptor antagonist arodyn By © 2018 Solomon Aguta Gisemba Submitted to the graduate degree program in Medicinal Chemistry and the Graduate Faculty of the University of Kansas in partial fulfillment of the requirements for the degree of Doctor of Philosophy. Chair: Dr. Blake Peterson Co-Chair: Dr. Jane Aldrich Dr. Michael Rafferty Dr. Teruna Siahaan Dr. Thomas Tolbert Date Defended: 18 April 2018 The dissertation committee for Solomon Aguta Gisemba certifies that this is the approved version of the following dissertation: Design and synthesis of cyclic analogs of the kappa opioid receptor antagonist arodyn Chair: Dr. Blake Peterson Co-Chair: Dr. Jane Aldrich Date Approved: 10 June 2018 ii Abstract Opioid receptors are important therapeutic targets for mood disorders and pain. Kappa opioid receptor (KOR) antagonists have recently shown potential for treating drug addiction and 1,2,3 4 8 depression. Arodyn (Ac[Phe ,Arg ,D-Ala ]Dyn A(1-11)-NH2), an acetylated dynorphin A (Dyn A) analog, has demonstrated potent and selective KOR antagonism, but can be rapidly metabolized by proteases. Cyclization of arodyn could enhance metabolic stability and potentially stabilize the bioactive conformation to give potent and selective analogs. Accordingly, novel cyclization strategies utilizing ring closing metathesis (RCM) were pursued. However, side reactions involving olefin isomerization of O-allyl groups limited the scope of the RCM reactions, and their use to explore structure-activity relationships of aromatic residues. Here we developed synthetic methodology in a model dipeptide study to facilitate RCM involving Tyr(All) residues. Optimized conditions that included microwave heating and the use of isomerization suppressants were applied to the synthesis of cyclic arodyn analogs. -
Flamingo Ingredients Chocolate Cupcakes Topped with Frosting
VIRTUAL CHOCOLATE-COVERED WEEKEND Flamingo Ingredients Chocolate cupcakes topped with frosting. ● Chocolate cupcakes (1 box/batch) ● Vanilla frosting (1 container) ● Pink food coloring ● Mini marshmallows (1 10.5 oz bag) ● Chocolate chips or black cake writing gel ● Lollipop sticks or straws Preparation 1. Make a batch of your favorite cupcakes. Once cool, arrange them on a platter in the shape of a flamin- go. 2. Mix the pink food coloring with the frosting in a bowl using a hand mixer. 3. Scoop the pink frosting into a piping bag or ziplock Inspired by our mosaiculture flamingo: with a corner cut off. Gently squeeze the frosting onto the cupcakes using a swirling motion. 4. Place marshmallows, chocolate chips and black cake gel on the “head” to make a face (see photo). Place straws for legs. 5. Eat and enjoy! Tips You could make flamingo faces on each cupcake in- stead by adding chocolate chips and other decorations in a face shape. Or decorate your cupcake to look like a creature of your own imagining. Our favorite food coloring McCormick’s “Nature’s Inspi- Ready in 1 hour ration” because it is made from plants instead of syn- Serves 20 people thetic dyes and has a vibrant pink color called “berry”. 10 of Hearts Ingredients Brownies topped with frosting and candy. ● Brownie mix (1 box/batch) ● Vanilla frosting (1 container) ● Black or red cake writing gel ● Candy hearts ● Lollipop sticks Preparation 1. Make a batch of your favorite brownies in a square or rectangular pan. 2. Once cool, cut the brownies into rectangles and slide 2 lollipop sticks halfway into a short end. -
Opioids in Palliative Care: Evidence Update May 2014
Opioids in palliative care Evidence Update May 2014 A summary of selected new evidence relevant to NICE clinical guideline 140 ‘Opioids in palliative care: safe and effective prescribing of strong opioids for pain in palliative care of adults’ (2012) Evidence Update 58 Contents Introduction ................................................................................................................................ 3 Key points .................................................................................................................................. 4 1 Commentary on new evidence .......................................................................................... 5 1.1 Communication .......................................................................................................... 5 1.2 Starting strong opioids – titrating the dose ................................................................ 5 1.3 First-line maintenance treatment ............................................................................... 6 1.4 First-line treatment if oral opioids are not suitable – transdermal patches ................ 6 1.5 First-line treatment if oral opioids are not suitable – subcutaneous delivery ............. 7 1.6 First-line treatment for breakthrough pain in patients who can take oral opioids ...... 7 1.7 Management of constipation ..................................................................................... 8 1.8 Management of nausea .......................................................................................... -
THE HARD TRUTH ABOUT PROKINETIC MEDICATION USE in PETS Introduction Pathophysiology/Etiology to That Observed in Dogs
VETTALK Volume 15, Number 04 American College of Veterinary Pharmacists THE HARD TRUTH ABOUT PROKINETIC MEDICATION USE IN PETS Introduction Pathophysiology/Etiology to that observed in dogs. It can be The moving topic of this Vet Talk As with most diseases in the veteri- due to a trichobezoar, dehydration, newsletter will be prokinetic medica- nary world, the etiology and patho- obesity, old age, diabetes, immobility, tions. The availability of information physiology of constipation are varied pain from trauma to the low back, on the many prokinetic agents is var- depending on the species being dis- bladder infection, or an anal sac infec- ied at best so an overall consensus of cussed, where in their gastrointestinal tion. In cases that are more chronic, prokinetic medications will be as- tract the problem is occurring, and underlying disease such as colitis or sessed in this article, hopefully giving any accompanying comorbid condi- Irritable Bowel Syndrome (IBS) may better insight to practitioners about tions. be the culprit. On the other hand, the which agents to use in their patients. cause may be idiopathic which is Canines: In man’s best friend, consti- frustrating for both veterinarian and Prevalence pation has many origins. A dog’s patient since this form is most diffi- Chronic constipation and gastroin- digestive tract itself is complex but cult to treat. testinal stasis are highly debilitating ultimately the mass movements and conditions that not only affect human haustral contractions from the large Equines: Despite their large size, patients but our four legged patients intestine (colon), propel feces into the horses have incredibly delicate diges- as well! Though this condition is rectum stimulating the internal anal tive systems. -
Keeping up with FDA Drug Approvals: 60 New Drugs in 60 Minutes Elizabeth A
Keeping Up with FDA Drug Approvals: 60 New Drugs in 60 Minutes Elizabeth A. Shlom, PharmD, BCPS Senior Vice President & Director Clinical Pharmacy Program | Acurity, Inc. Privileged and Confidential April 10, 2019 Privileged and Confidential Program Objectives By the end of the presentation, the pharmacist or pharmacy technician participant will be able to: ▪ Identify orphan drugs and first-in-class medications approved by the FDA in 2018. ▪ List five new drugs and their indications. ▪ Identify the place in therapy for three novel monoclonal antibodies. ▪ Discuss at least two new medications that address public health concerns. Dr. Shlom does not have any conflicts of interest in regard to this presentation. Both trade names and generic names will be discussed throughout the presentation Privileged and Confidential 2018 NDA Approvals (NMEs/BLAs) ▪ Lutathera (lutetium Lu 177 dotatate) ▪ Braftovi (encorafenib) ▪ Vizimpro (dacomitinib) ▪ Biktarvy (bictegravir, emtricitabine, ▪ TPOXX (tecovirimat) ▪ Libtayo (cemiplimab-rwic) tenofovir, ▪ Tibsovo (ivosidenib) ▪ Seysara (sarecycline) alafenamide) ▪ Krintafel (tafenoquine) ▪ Nuzyra (omadacycline) ▪ Symdeko (tezacaftor, ivacaftor) ▪ Orilissa (elagolix sodium) ▪ Revcovi (elapegademase-lvir) ▪ Erleada (apalutamide) ▪ Omegaven (fish oil triglycerides) ▪ Tegsedi (inotersen) ▪ Trogarzo (ibalizumab-uiyk) ▪ Mulpleta (lusutrombopag) ▪ Talzenna (talazoparib) ▪ Ilumya (tildrakizumab-asmn) ▪ Poteligeo (mogamulizumab-kpkc) ▪ Xofluza (baloxavir marboxil) ▪ Tavalisse (fostamatinib disodium) ▪ Onpattro (patisiran) -
Recommended Methods for the Identification and Analysis of Fentanyl and Its Analogues in Biological Specimens
Recommended methods for the Identification and Analysis of Fentanyl and its Analogues in Biological Specimens MANUAL FOR USE BY NATIONAL DRUG ANALYSIS LABORATORIES Laboratory and Scientific Section UNITED NATIONS OFFICE ON DRUGS AND CRIME Vienna Recommended Methods for the Identification and Analysis of Fentanyl and its Analogues in Biological Specimens MANUAL FOR USE BY NATIONAL DRUG ANALYSIS LABORATORIES UNITED NATIONS Vienna, 2017 Note Operating and experimental conditions are reproduced from the original reference materials, including unpublished methods, validated and used in selected national laboratories as per the list of references. A number of alternative conditions and substitution of named commercial products may provide comparable results in many cases. However, any modification has to be validated before it is integrated into laboratory routines. ST/NAR/53 Original language: English © United Nations, November 2017. All rights reserved. The designations employed and the presentation of material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariat of the United Nations concerning the legal status of any country, territory, city or area, or of its authorities, or concerning the delimitation of its frontiers or boundaries. Mention of names of firms and commercial products does not imply the endorse- ment of the United Nations. This publication has not been formally edited. Publishing production: English, Publishing and Library Section, United Nations Office at Vienna. Acknowledgements The Laboratory and Scientific Section of the UNODC (LSS, headed by Dr. Justice Tettey) wishes to express its appreciation and thanks to Dr. Barry Logan, Center for Forensic Science Research and Education, at the Fredric Rieders Family Founda- tion and NMS Labs, United States; Amanda L.A. -
The Pharmacology of Prokinetic Agents and Their Role in the Treatment of Gastrointestinal Disorders
The Pharmacology of ProkineticAgents IJGE Issue 4 Vol 1 2003 Review Article The Pharmacology of Prokinetic Agents and Their Role in the Treatment of Gastrointestinal Disorders George Y. Wu, M.D, Ph.D. INTRODUCTION Metoclopramide Normal peristalsis of the gut requires complex, coordinated neural and motor activity. Pharmacologic Category : Gastrointestinal Abnormalities can occur at a number of different Agent. Prokinetic levels, and can be caused by numerous etiologies. This review summarizes current as well as new Symptomatic treatment of diabetic gastric agents that show promise in the treatment of stasis gastrointestinal motility disorders. For these Gastroesophageal reflux e conditions, the most common medications used in s Facilitation of intubation of the small the US are erythromycin, metoclopramide, and U intestine neostigmine (in acute intestinal pseudo- Prevention and/or treatment of nausea and obstruction). A new prokinetic agent, tegaserod, vomiting associated with chemotherapy, has been recently approved, while other serotonin radiation therapy, or post-surgery (1) agonist agents (prucalopride, YM-31636, SK-951, n ML 10302) are currently undergoing clinical o Blocks dopamine receptors in chemoreceptor i t studies. Other prokinetics, such as domperidone, c trigger zone of the CNS (2) A are not yet approved in the US, although are used in f Enhances the response to acetylcholine of o other countries. tissue in the upper GI tract, causing enhanced m s i n motility and accelerated gastric emptying a DELAYED GASTRIC EMPTYING OR h without stimulating gastric, biliary, or c G A S T R O E S O P H A G E A L R E F L U X e pancreatic secretions. -
VHA/Dod CLINICAL PRACTICE GUIDELINE for the MANAGEMENT of POSTOPERATIVE PAIN
VHA/DoD CLINICAL PRACTICE GUIDELINE FOR THE MANAGEMENT OF POSTOPERATIVE PAIN Veterans Health Administration Department of Defense Prepared by: THE MANAGEMENT OF POSTOPERATIVE PAIN Working Group with support from: The Office of Performance and Quality, VHA, Washington, DC & Quality Management Directorate, United States Army MEDCOM VERSION 1.2 JULY 2001/ UPDATE MAY 2002 VHA/DOD CLINICAL PRACTICE GUIDELINE FOR THE MANAGEMENT OF POSTOPERATIVE PAIN TABLE OF CONTENTS Version 1.2 Version 1.2 VHA/DoD Clinical Practice Guideline for the Management of Postoperative Pain TABLE OF CONTENTS INTRODUCTION A. ALGORITHM & ANNOTATIONS • Preoperative Pain Management.....................................................................................................1 • Postoperative Pain Management ...................................................................................................2 B. PAIN ASSESSMENT C. SITE-SPECIFIC PAIN MANAGEMENT • Summary Table: Site-Specific Pain Management Interventions ................................................1 • Head and Neck Surgery..................................................................................................................3 - Ophthalmic Surgery - Craniotomies Surgery - Radical Neck Surgery - Oral-maxillofacial • Thorax (Non-cardiac) Surgery.......................................................................................................9 - Thoracotomy - Mastectomy - Thoracoscopy • Thorax (Cardiac) Surgery............................................................................................................16