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Medication Guide
1 Medication Guide REYVOW® (RAY-vow) (lasmiditan) tablets, for oral use, CV What is the most important information I should know about REYVOW? • Do not drive or operate machinery for at least 8 hours after you take REYVOW, even if you feel well enough. • You should not take REYVOW if you cannot wait at least 8 hours between taking REYVOW and driving or operating machinery. What is REYVOW? REYVOW is a prescription medicine used for the acute treatment of migraine attacks with or without aura in adults. • REYVOW is not used as a preventive treatment of migraine. • It is not known if REYVOW is safe and effective in children. • REYVOW is a federally controlled substance (CV) because it contains lasmiditan that can be abused. Keep REYVOW in a safe place to protect it from theft. Never give your REYVOW to anyone else, because it may harm them. Selling or giving away REYVOW is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs. Before you take REYVOW, tell your healthcare provider about all of your medical conditions, including if you: • have liver problems • have high blood pressure • have a low heart rate • are allergic to lasmiditan • are pregnant or plan to become pregnant. It is not known if REYVOW will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if REYVOW passes into your breastmilk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. -
Ayahuasca: Spiritual Pharmacology & Drug Interactions
Ayahuasca: Spiritual Pharmacology & Drug Interactions BENJAMIN MALCOLM, PHARMD, MPH [email protected] MARCH 28 TH 2017 AWARE PROJECT Can Science be Spiritual? “Science is not only compatible with spirituality; it is a profound source of spirituality. When we recognize our place in an immensity of light years and in the passage of ages, when we grasp the intricacy, beauty and subtlety of life, then that soaring feeling, that sense of elation and humility combined, is surely spiritual. The notion that science and spirituality are somehow mutually exclusive does a disservice to both.” – Carl Sagan Disclosures & Disclaimers No conflicts of interest to disclose – I don’t get paid by pharma and have no potential to profit directly from ayahuasca This presentation is for information purposes only, none of the information presented should be used in replacement of medical advice or be considered medical advice This presentation is not an endorsement of illicit activity Presentation Outline & Objectives Describe what is known regarding ayahuasca’s pharmacology Outline adverse food and drug combinations with ayahuasca as well as strategies for risk management Provide an overview of spiritual pharmacology and current clinical data supporting potential of ayahuasca for treatment of mental illness Pharmacology Terms Drug ◦ Term used synonymously with substance or medicine in this presentation and in pharmacology ◦ No offense intended if I call your medicine or madre a drug! Bioavailability ◦ The amount of a drug that enters the body and is able to have an active effect ◦ Route specific: bioavailability is different between oral, intranasal, inhalation (smoked), and injected routes of administration (IV, IM, SC) Half-life (T ½) ◦ The amount of time it takes the body to metabolize/eliminate 50% of a drug ◦ E.g. -
The Migraine Attack As a Homeostatic, Neuroprotective Response to Brain Oxidative Stress: Preliminary Evidence for a Theory
ISSN 0017-8748 Headache doi: 10.1111/head.13214 VC 2017 American Headache Society Published by Wiley Periodicals, Inc. Views and Perspectives The Migraine Attack as a Homeostatic, Neuroprotective Response to Brain Oxidative Stress: Preliminary Evidence for a Theory Jonathan M. Borkum, PhD Background.—Previous research has suggested that migraineurs show higher levels of oxidative stress (lipid peroxides) between migraine attacks and that migraine triggers may further increase brain oxidative stress. Oxidative stress is trans- duced into a neural signal by the TRPA1 ion channel on meningeal pain receptors, eliciting neurogenic inflammation, a key event in migraine. Thus, migraines may be a response to brain oxidative stress. Results.—In this article, a number of migraine components are considered: cortical spreading depression, platelet acti- vation, plasma protein extravasation, endothelial nitric oxide synthesis, and the release of serotonin, substance P, calcitonin gene-related peptide, and brain-derived neurotrophic factor. Evidence is presented from in vitro research and animal and human studies of ischemia suggesting that each component has neuroprotective functions, decreasing oxidant production, upregulating antioxidant enzymes, stimulating neurogenesis, preventing apoptosis, facilitating mitochondrial biogenesis, and/or releasing growth factors in the brain. Feedback loops between these components are described. Limitations and challenges to the model are discussed. Conclusions.—The theory is presented that migraines are an integrated -
What Are the Acute Treatments for Migraine and How Are They Used?
2. Acute Treatment CQ II-2-1 What are the acute treatments for migraine and how are they used? Recommendation The mainstay of acute treatment for migraine is pharmacotherapy. The drugs used include (1) acetaminophen, (2) non-steroidal anti-inflammatory drugs (NSAIDs), (3) ergotamines, (4) triptans and (5) antiemetics. Stratified treatment according to the severity of migraine is recommended: use NSAIDs such as aspirin and naproxen for mild to moderate headache, and use triptans for moderate to severe headache, or even mild to moderate headache when NSAIDs were ineffective in the past. It is necessary to give guidance and cautions to patients having acute attacks, and explain the methods of using medications (timing, dose, frequency of use) and medication use during pregnancy and breast-feeding. Grade A Background and Objective The objective of acute treatment is to resolve the migraine attack completely and rapidly and restore the patient’s normal functions. An ideal treatment should have the following characteristics: (1) resolves pain and associated symptoms rapidly; (2) is consistently effective; (3) no recurrence; (4) no need for additional use of medication; (5) no adverse effects; (6) can be administered by the patients themselves; and (7) low cost. Literature was searched to identify acute treatments that satisfy the above conditions. Comments and Evidence The acute treatment drugs for migraine generally include (1) acetaminophens, (2) non-steroidal anti-inflammatory drugs (NSAIDs), (3) ergotamines, (4) triptans, and (5) antiemetics. For severe migraines including status migrainosus and migraine attacks refractory to treatment, (6) anesthetics, and (7) corticosteroids (dexamethasone) are used (Tables 1 and 2).1)-9) There are two approaches to the selection and sequencing of these medications: “step care” and “stratified care”. -
PMA-Sio2: Heteropolyacid Catalysis for Michael Addition-Convenient Route to Substituted-3-Indoles
Available online at www.derpharmachemica.com ISSN 0975-413X Der Pharma Chemica, 2017, 9(13):112-117 CODEN (USA): PCHHAX (http://www.derpharmachemica.com/archive.html) PMA-SiO2: Heteropolyacid Catalysis for Michael Addition-Convenient Route to Substituted-3-Indoles Vijay Kumar Pasala* Deapartment of Chemistry, Osmania University, Hyderabad-500007, Telangana, India ABSTRACT Synthesis of 3-substituted indoles in a hassel-free, ecofriendly manner by treating indoles with α, β-unsaturated carbonyl or nitro compounds under acidic conditions to give good to excellent yields with shorter reaction durations are described. The catalyst is recyclable for three to four times without great loss in the activity. Keywords: Phosphomolybdic Acid (PMA), Substituted indoles, α, β-unsaturated carbonyl compounds, α, β-unsaturated nitro compounds, Michael addition INTRODUCTION Heterocyclic chemistry is one of the quintessential branches of organic synthesis beaconing towards new scaffolds with medicinal values, new methodologies to the existing active principles etc. One among such skeletons is indole. It is perhaps the most common heterocycles in chemistry and its derivatives are obtained from coal pitch, variety of plants or by the bacterial decay of tryptophan in the intestine [1]. Indole derivatives serve as signaling chemicals in plants and animals, as nucleus building blocks (serotonin [2] (A) a crucial neurotransmitter in the central nervous system [3]), as antibacterial [4], antiviral [5], protein kinase inhibitors [6], anticancer agents [7], entheogens (psilocybin (B) causes perceptional changes), hormones (melatonin (C) regulates sleep and wakefulness), antidepressants (roxindole (D), bufotenin (E)), sumatriptan (F) for the treatment of migraine and ondansetron (G) for the suppression of nausea and vastly found in natural products such as alkaloids (Corynanthe, Iboga, and Aspidosperma alkaloids) [8-10], indigoids etc., which originate, either fully or partly, from bio-oxidation of indoles [11]. -
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. -
Menstrually Related and Nonmenstrual Migraines in A
MENSTRUALLY RELATED AND NONMENSTRUAL MIGRAINES IN A FREQUENT MIGRAINE POPULATION: FEATURES, CORRELATES, AND ACUTE TREATMENT DIFFERENCES A dissertation presented to the faculty of the College of Arts and Sciences of Ohio University In partial fulfillment of the requirements for the degree Doctor of Philosophy Brenda F. Pinkerman March 2006 This dissertation entitled MENSTRUALLY RELATED AND NONMENSTRUAL MIGRAINES IN A FREQUENT MIGRAINE POPULATION: FEATURES, CORRELATES, AND ACUTE TREATMENT DIFFERENCES by BRENDA F. PINKERMAN has been approved for the Department of Psychology and the College of Arts and Sciences by Kenneth A. Holroyd Distinguished Professor of Psychology Benjamin M. Ogles Interim Dean, College of Arts and Sciences PINKERMAN, BRENDA F. Ph.D. March 2006. Clinical Psychology Menstrually Related and Nonmenstrual Migraines in a Frequent Migraine Population: Features, Correlates, and Acute Treatment Differences (307 pp.) Director of Dissertation: Kenneth A. Holroyd This research describes and compares menstrually related migraines as defined by recent proposed guidelines of the International Headache Society (IHS, 2004) to nonmenstrual migraines in a population of female migraineurs with frequent, disabling migraines. Migraines are compared by frequency per day of the menstrual cycle, headache features, use of abortive and rescue medications, and acute migraine treatment outcomes. In addition, this study explores predictors of acute treatment response and headache recurrence within 24 hours following acute migraine treatment for menstrually related migraines. Participants are 107 menstruating female migaineurs who met IHS (2004) proposed criteria for menstrually related migraines and completed headache diaries using hand-held computers. Diary data are analyzed using repeated measures logistic regression. The frequency of migraines is significantly increased during the perimenstrual period, and menstrually related migraines are of longer duration and greater frequency with longer lasting disability than nonmenstrual migraines. -
The Serotonergic System in Migraine Andrea Rigamonti Domenico D’Amico Licia Grazzi Susanna Usai Gennaro Bussone
J Headache Pain (2001) 2:S43–S46 © Springer-Verlag 2001 MIGRAINE AND PATHOPHYSIOLOGY Massimo Leone The serotonergic system in migraine Andrea Rigamonti Domenico D’Amico Licia Grazzi Susanna Usai Gennaro Bussone Abstract Serotonin (5-HT) and induce migraine attacks. Moreover serotonin receptors play an impor- different pharmacological preventive tant role in migraine pathophysiolo- therapies (pizotifen, cyproheptadine gy. Changes in platelet 5-HT content and methysergide) are antagonist of are not casually related, but they the same receptor class. On the other may reflect similar changes at a neu- side the activation of 5-HT1B-1D ronal level. Seven different classes receptors (triptans and ergotamines) of serotoninergic receptors are induce a vasocostriction, a block of known, nevertheless only 5-HT2B-2C neurogenic inflammation and pain M. Leone • A. Rigamonti • D. D’Amico and 5HT1B-1D are related to migraine transmission. L. Grazzi • S. Usai • G. Bussone (౧) syndrome. Pharmacological evi- C. Besta National Neurological Institute, Via Celoria 11, I-20133 Milan, Italy dences suggest that migraine is due Key words Serotonin • Migraine • e-mail: [email protected] to an hypersensitivity of 5-HT2B-2C Triptans • m-Chlorophenylpiperazine • Tel.: +39-02-2394264 receptors. m-Chlorophenylpiperazine Pathogenesis Fax: +39-02-70638067 (mCPP), a 5-HT2B-2C agonist, may The 5-HT receptor family is distinguished from all other 5- Introduction 1 HT receptors by the absence of introns in the genes; in addi- tion all are inhibitors of adenylate cyclase [1]. Serotonin (5-HT) and serotonin receptors play an important The 5-HT1A receptor has a high selective affinity for 8- role in migraine pathophysiology. -
Use of Analgesics in Exotic Felids Edward C. Ramsay, DVM Professor, Department of Small Animal Clinical Sciences, University Of
Use of Analgesics in Exotic Felids Formatted: Centered Edward C. Ramsay, DVM Professor, Department of Small Animal Clinical Sciences, University of Tennessee, and Consulting Veterinarian, Knoxville Zoological Gardens, Knoxville, Tennessee. Corresponding address: Ed Ramsay Dept. of Sm Animal Clin Sci C247, Veterinary Teaching Hospital University of Tennessee Knoxville, TN 37996-4544 Phone: 865-755-8219 FAX: 865-974-5554 Email: [email protected] 2 Treatment of pain in domestic and non-domestic cats has been a challenge for the clinician. Many cat species are stoic and show few or very subtle external signs of pain. Additionally, the adverse effects of nonsteroidal antiinflammatory drugs (NSAIDs) in domestic cats are well documented and have discouraged many practitioners from trying novel NSAID’s in exotic felids. As in other animals, each cat’s response to pain and analgesics will vary, necessitating an individualized treatment plan. As a rule, always treat painful felids to effect, and not by rote reliance on published dosages. It is frequently necessary to try different agents and combinations to find which produces the optimal analgesic effect in exotic felids. In order to minimize adverse effects, it is desirable to work toward treatment with the lowest effective dose when treating chronic pain. Non-steroidal Antiinflammatory Drugs NSAIDs are antiinflammatory drugs which act both centrally and peripherally. The primary effects are believed to be caused by their ability to inhibit cyclooxygenase (COX) enzymes in the arachidonic acid metabolism cascade. The COX-1 isoform is regarded as constitutive (continuously expressed) and is responsible for many homeostatic processes, such as maintenance of gastric mucosal integrity, platelet function, and renal autoregulation. -
Lasmiditan Is an Effective Acute Treatment for Migraine: a Phase 3 Randomized Study Bernice Kuca, Stephen D
ARTICLE OPEN ACCESS CLASS OF EVIDENCE Lasmiditan is an effective acute treatment for migraine A phase 3 randomized study Bernice Kuca, BA, MS, Stephen D. Silberstein, MD, Linda Wietecha, BSN, MS, Paul H. Berg, MS, Correspondence Gregory Dozier, MPH, and Richard B. Lipton, MD, on behalf of the COL MIG-301 Study Group Ms. Wietecha [email protected] Neurology® 2018;91:e2222-e2232. doi:10.1212/WNL.0000000000006641 Abstract RELATED ARTICLE Objective Article To assess the efficacy and safety of lasmiditan in the acute treatment of migraine. Galcanezumab in chronic migraine: The randomized, Methods double-blind, placebo- Adult patients with migraine were randomized (1:1:1) to a double-blind dose of oral lasmiditan controlled REGAIN study 200 mg, lasmiditan 100 mg, or placebo and were asked to treat their next migraine attack within Page 1082 4 hours of onset. Over 48 hours after dosing, patients used an electronic diary to record headache pain and the presence of nausea, phonophobia, and photophobia, one of which was MORE ONLINE designated their most bothersome symptom (MBS). Class of Evidence Criteria for rating Results ≥ therapeutic and diagnostic Of the 1,856 patients who treated an attack, 77.9% had 1 cardiovascular risk factors in addition studies to migraine. Compared with placebo, more patients dosed with lasmiditan 200 mg were free of NPub.org/coe headache pain at 2 hours after dosing (32.2% vs 15.3%; odds ratio [OR] 2.6, 95% confidence interval [CI] 2.0–3.6, p< 0.001), similar to those dosed with lasmiditan 100 mg (28.2%; OR 2.2, 95% CI 1.6–3.0, p< 0.001). -
APPENDIX a Scoping Letter, NOP, and NOP Comments
APPENDIX A Scoping Letter, NOP, and NOP Comments THE CITY OF SAN DIEGO PLANNING DEPARTMENT Date of Notice: November 24, 2014 PUBLIC NOTICE OF THE PREPARATION OF A PROGRAM ENVIRONMENTAL IMPACT REPORT AND A SCOPING MEETING INTERNAL ORDER No. 21003411 PUBLIC NOTICE: The City of San Diego as the Lead Agency has determined that the project described below will require the preparation of a Program Environmental Impact Report (PEIR) in compliance with the California Environmental Quality Act (CEQA). This Notice of Preparation of a PEIR and Scoping Meeting was publicly noticed and distributed on November 24, 2014. This notice was published in the SAN DIEGO DAILY TRANSCRIPT and placed on the City of San Diego website at: http://www.sandiego.gov/city-clerk/officialdocs/notices/index.shtml SCOPING MEETING: Two public scoping meetings will be held by the City of San Diego's Planning Department one on Tuesday, December 9, 2014 from 5:30 p.m. to 7:30 PM at the South Bay Recreation Center located at 1885 Coronado Avenue, San Diego CA 92154, and one on Thursday, December 11, 2014 from 6:00 PM to 8:00 PM at the Public Utilities Department Metropolitan Operations Complex located at 9192 Topaz Way, San Diego CA 92123. Please note that depending on the number of attendees, the meeting could end earlier than the end times noted above. Verbal and written comments regarding the scope and alternatives of the proposed EIR will be accepted at the meeting. Please send in written/mail-in comments may also be sent to the following address: Myra Herrmann, Environmental Planner, City of San Diego Development Services Center, 1222 First Avenue, MS 501, San Diego, CA 92101 or e-mail your comments to [email protected] with the Project Name and Number in the subject line Number in the subject line within 30 days of the receipt of this notice/date of the Public Notice above. -
Triptans Step Therapy/Quantity Limit Criteria
Triptans Step Therapy/Quantity Limit Criteria Program may be implemented with the following options 1) step therapy 2) quantity limits or 3) step therapy with quantity limits For Blue Cross and Blue Shield of Illinois Option 1 (step therapy only) will apply. Brand Generic Dosage Form Amerge® naratriptan tablets Axert® almotriptan tablets Frova® frovatriptan tablets Imitrex® sumatriptan injection*, nasal spray, tablets* Maxalt® rizatriptan tablets Maxalt-MLT® rizatriptan tablets Relpax® eletriptan tablets Treximet™ sumatriptan and naproxen tablets Zomig® zolmitriptan tablets, nasal spray Zomig-ZMT® zolmitriptan tablets * generic available and included as target agent in quantity limit edit FDA APPROVED INDICATIONS1-7 The following information is taken from individual drug prescribing information and is provided here as background information only. Not all FDA-approved indications may be considered medically necessary. All criteria are found in the section “Prior Authorization Criteria for Approval.” Amerge® Tablets1, Axert® Tablets2, Frova® Tablets3,Imitrex® injection4, Imitrex Nasal Spray5, Imitrex Tablets6, Maxalt® Tablets7, Maxalt-MLT® Tablets7, Relpax® Tablets8, Treximet™ Tablets9, Zomig® Tablets10, Zomig-ZMT® Tablets10, and Zomig® Nasal Spray11 Amerge (naratriptan), Axert (almotriptan), Frova (frovatriptan), Imitrex (sumatriptan), Maxalt (rizatriptan), Maxalt-MLT (rizatriptan orally disintegrating), Relpax (eletriptan), Treximet (sumatriptan/naproxen), Zomig (zolmitriptan), and Zomig-ZMT (zolmitriptan orally disintegrating) tablets, and Imitrex (sumatriptan) and Zomig (zolmitriptan) nasal spray are all indicated for the acute treatment of migraine attacks with or without aura in adults. They are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. Safety and effectiveness of all of these products have not been established for cluster headache, which is present in an older, predominantly male population.