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Role of Citicoline in the Management of Traumatic Brain Injury
pharmaceuticals Review Role of Citicoline in the Management of Traumatic Brain Injury Julio J. Secades Medical Department, Ferrer, 08029 Barcelona, Spain; [email protected] Abstract: Head injury is among the most devastating types of injury, specifically called Traumatic Brain Injury (TBI). There is a need to diminish the morbidity related with TBI and to improve the outcome of patients suffering TBI. Among the improvements in the treatment of TBI, neuroprotection is one of the upcoming improvements. Citicoline has been used in the management of brain ischemia related disorders, such as TBI. Citicoline has biochemical, pharmacological, and pharmacokinetic characteristics that make it a potentially useful neuroprotective drug for the management of TBI. A short review of these characteristics is included in this paper. Moreover, a narrative review of almost all the published or communicated studies performed with this drug in the management of patients with head injury is included. Based on the results obtained in these clinical studies, it is possible to conclude that citicoline is able to accelerate the recovery of consciousness and to improve the outcome of this kind of patient, with an excellent safety profile. Thus, citicoline could have a potential role in the management of TBI. Keywords: CDP-choline; citicoline; pharmacological neuroprotection; brain ischemia; traumatic brain injury; head injury Citation: Secades, J.J. Role of 1. Introduction Citicoline in the Management of Traumatic brain injury (TBI) is among the most devastating types of injury and can Traumatic Brain Injury. result in a different profile of neurological and cognitive deficits, and even death in the most Pharmaceuticals 2021, 14, 410. -
Neurontin (Gabapentin)
Texas Prior Authorization Program Clinical Criteria Drug/Drug Class Gabapentin Clinical Criteria Information Included in this Document Neurontin (gabapentin) • Drugs requiring prior authorization: the list of drugs requiring prior authorization for this clinical criteria • Prior authorization criteria logic: a description of how the prior authorization request will be evaluated against the clinical criteria rules • Logic diagram: a visual depiction of the clinical criteria logic • Supporting tables: a collection of information associated with the steps within the criteria (diagnosis codes, procedure codes, and therapy codes); provided when applicable • References: clinical publications and sources relevant to this clinical criteria Note: Click the hyperlink to navigate directly to that section. Gralise (gabapentin Extended Release) • Drugs requiring prior authorization: the list of drugs requiring prior authorization for this clinical criteria • Prior authorization criteria logic: a description of how the prior authorization request will be evaluated against the clinical criteria rules • Logic diagram: a visual depiction of the clinical criteria logic • Supporting tables: a collection of information associated with the steps within the criteria (diagnosis codes, procedure codes, and therapy codes); provided when applicable • References: clinical publications and sources relevant to this clinical criteria Note: Click the hyperlink to navigate directly to that section. March 29, 2019 Copyright © 2019 Health Information Designs, LLC 1 Horizant -
Preventive Report Appendix
Title Authors Published Journal Volume Issue Pages DOI Final Status Exclusion Reason Nasal sumatriptan is effective in treatment of migraine attacks in children: A Ahonen K.; Hamalainen ML.; Rantala H.; 2004 Neurology 62 6 883-7 10.1212/01.wnl.0000115105.05966.a7 Deemed irrelevant in initial screening Seasonal variation in migraine. Alstadhaug KB.; Salvesen R.; Bekkelund SI. Cephalalgia : an 2005 international journal 25 10 811-6 10.1111/j.1468-2982.2005.01018.x Deemed irrelevant in initial screening Flunarizine, a calcium channel blocker: a new prophylactic drug in migraine. Amery WK. 1983 Headache 23 2 70-4 10.1111/j.1526-4610.1983.hed2302070 Deemed irrelevant in initial screening Monoamine oxidase inhibitors in the control of migraine. Anthony M.; Lance JW. Proceedings of the 1970 Australian 7 45-7 Deemed irrelevant in initial screening Prostaglandins and prostaglandin receptor antagonism in migraine. Antonova M. 2013 Danish medical 60 5 B4635 Deemed irrelevant in initial screening Divalproex extended-release in adolescent migraine prophylaxis: results of a Apostol G.; Cady RK.; Laforet GA.; Robieson randomized, double-blind, placebo-controlled study. WZ.; Olson E.; Abi-Saab WM.; Saltarelli M. 2008 Headache 48 7 1012-25 10.1111/j.1526-4610.2008.01081.x Deemed irrelevant in initial screening Divalproex sodium extended-release for the prophylaxis of migraine headache in Apostol G.; Lewis DW.; Laforet GA.; adolescents: results of a stand-alone, long-term open-label safety study. Robieson WZ.; Fugate JM.; Abi-Saab WM.; 2009 Headache 49 1 45-53 10.1111/j.1526-4610.2008.01279.x Deemed irrelevant in initial screening Safety and tolerability of divalproex sodium extended-release in the prophylaxis of Apostol G.; Pakalnis A.; Laforet GA.; migraine headaches: results of an open-label extension trial in adolescents. -
Eletriptan Smpc
For the use only of a neurologist/ specialist or a Hospital or a Laboratory Generic Name Citicoline Trade Name Ceham 1. NAME OF THE MEDICINAL PRODUCT: Citicoline 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Each film coated tablet contains: Citicoline sodium equivalent to Citicoline……………………………500mg 3. PHARMACEUTICAL FORM: Film coated tablet 4. CLINICAL PARTICULARS 4.1 Therapeutic Indications: For the treatment of disturbance of consciousness as resulting from head injuries, brain operation and acute stage of cerebral infarction in adult only. For the treatment of patients with serious cerebral injuries of vascular traumatic nature with or without loss of consciousness & for treatment of degenerative damages & chronic cerebral vascular injuries in senile dementia. 4.2 Posology and Method of Administration The usually recommended dose of Citicoline is 500mg to 1000mg daily and can increase up to 2000mg. Elderly: No dosage adjustment is required in this patient population and the usually recommended adult dose can be administered. 4.3 Contraindications Hypersensitivity to citicoline or any other component of the formulation 4.4 Special Warnings and Special Precautions for Use: Citicoline may cause hypotension and in case necessary the hypotensive effect can be treated with corticosteroids or sympathomimetics. 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction: Citicoline must not be used with medicines containing meclophenoxates (or centrophenoxine). Citicoline increases the effects of L-dopa. 4.6 Fertility, Pregnancy and Lactation There are no adequate and well controlled studies of citicoline during pregnancy and lactation. Citicoline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. -
Conjugation of Tryptamine to Biologically Active Carboxylic Acids in Order to Create Prodrugs
ISSN 2380-5064 | The Arsenal is published by the Augusta University Libraries | http://guides.augusta.edu/arsenal Volume 4, Issue 1 (2021) Special Edition Issue CONJUGATION OF TRYPTAMINE TO BIOLOGICALLY ACTIVE CARBOXYLIC ACIDS IN ORDER TO CREATE PRODRUGS Colin Miller, Jr. and Iryna O. Lebedyeva Citation Miller, C., Jr., & Lebedyeva, I. O. (2021). Conjugation of tryptamine to biologically active carboxylic acids in order to create prodrugs. The Arsenal: The Undergraduate Research Journal of Augusta University, 4(1), 26. http://doi.org/10.21633/issn.2380.5064/s.2021.04.01.26 © Miller, Jr. and Lebedyeva 2021. This open access article is distributed under a Creative Commons Attribution NonCommercial-NoDerivs 2.0 Generic License (https://creativecommons.org/licenses/by-nc-nd/2.0/). Conjugation of Tryptamine to Biologically Active Carboxylic Acids in Order to Create Prodrugs Presenter(s): Colin Miller, Jr. Author(s): Colin Miller Jr. and Iryna O. Lebedyeva Faculty Sponsor(s): Iryna O. Lebedyeva, PhD Affiliation(s): Department of Chemistry and Physics (Augusta Univ.) ABSTRACT A number of blood and brain barrier penetrating neurotransmitters contain polar functional groups. Gamma-aminobutyric acid (GABA) is an amino acid, which is one of the primary inhibitory neurotransmitter in the brain and a major inhibitory neurotransmitter in the spinal cord. Antiepileptic medications such as Gabapentin, Phenibut, and Pregabalin have been developed to structurally represent GABA. These drugs are usually prescribed for the treatment of neuropathic pain. Since these drugs contain a polar carboxylic acid group, it affects their ability to penetrate the blood and brain barrier. To address the low bioavailability and tendency for intramolecular cyclization of Gabapentin, its less polar prodrug Gabapentin Enacarbil has been approved in 2011. -
(12) United States Patent (10) Patent No.: US 8,283,487 B2 Ben Moha-Lerman Et Al
USOO8283487B2 (12) United States Patent (10) Patent No.: US 8,283,487 B2 Ben Moha-Lerman et al. (45) Date of Patent: Oct. 9, 2012 (54) PROCESSES FOR THE PREPARATION AND 2003/0176398 A1 9/2003 Gallop et al. PURIFICATION OF GABAPENTIN 2004/0077553 A1* 4/2004 Gallop et al. ................... 514, 19 2005/O154057 A1 7/2005 Estrada et al. ENACARBL 2007/0049627 A1 3, 2007 Tran (75) Inventors: Elena Ben Moha-Lerman, Kiryat Ono FOREIGN PATENT DOCUMENTS (IL); Tamar Nidam, Yehud (IL); Meital WO WO O2/10O347 12/2002 Cohen, Petach-Tikva (IL); Sharon WO WO 2005/0377.84 4/2005 Avhar-Maydan, Givataym (IL); Anna Balanov, Rehovot (IL) OTHER PUBLICATIONS X. Yuan et al. “In Situ Preparation of Zinc Salts of Unsaturated (73) Assignee: Teva Pharmaceutical Industries Ltd., Carboxylic Acids to Reinforce NBR' J. Applied Polymer Science, Petach-Tikva (IL) vol. 77, p. 2740-2748 (2000). - r J. Alexander et al. “(Acyloxy)alkyl Carbamates as Novel Biorevers (*) Notice: Subject to any disclaimer, the term of this ible Prodrugs for Amines: Increased Permeation through Biological patent is extended or adjusted under 35 Membranes”.J. Med. Chem. 1988, 31, pp. 318-322. U.S.C. 154(b) by 249 days. S.M. Rahmathullah et al. “Prodrugs for Amidines: Synthesis and Anti-Pneumocystis carinii Activity of Carbamates of 2.5-Bis(4- (21) Appl. No.: 12/626,682 amidinophenyl)furan” J. Med. Chem. 1999, 42, pp. 3994-4000. (22) Filed: Nov. 26, 2009 * cited by examiner (65) Prior Publication Data Primary Examiner — Joseph K. McKane US 2010/O160665 A1 Jun. 24, 2010 Assistant Examiner — Alicia L Otton (74) Attorney, Agent, or Firm — Arent Fox LLP Related U.S. -
Effect of Combined Therapy with Thrombolysis and Citicoline in a Rat
Journal of the Neurological Sciences 247 (2006) 121–129 www.elsevier.com/locate/jns Effect of combined therapy with thrombolysis and citicoline in a rat model of embolic stroke ⁎ María Alonso de Leciñana a,e, , María Gutiérrez a,d, Jose María Roda a,c, Fernando Carceller a,c, Exuperio Díez-Tejedor a,b a Cerebrovascular Research Unit, La Paz University Hospital, Universidad Autónoma de Madrid, Madrid, Spain b Department of Neurology, La Paz University Hospital, Madrid, Spain c Department of Neurosurgery, La Paz University Hospital, Madrid, Spain d Cerebrovascular Experimental Lab, La Paz University Hospital, Madrid, Spain e Department of Neurology, Ramón y Cajal University Hospital, Madrid, Spain Received 28 April 2005; received in revised form 3 January 2006; accepted 3 March 2006 Available online 22 June 2006 Abstract An approach combining reperfusion mediated by thrombolytics with pharmacological neuroprotection aimed at inhibiting the physiopathological disorders responsible for ischemia-reperfusion damage, could provide an optimal treatment of ischemic stroke. We investigate, in a rat embolic stroke model, the combination of rtPA with citicoline as compared to either alone as monotherapy, and whether the neuroprotector should be provided before or after thrombolysis to achieve a greater reduction of ischemic brain damage. One hundred and nine rats have been studied: four were sham-operated and the rest embolized in the right internal carotid artery with an autologous clot and divided among 5 groups: 1) control; 2) iv rtPA 5 mg/kg 30 min post-embolization 3) citicoline 250 mg/kg ip ×3 doses, 10 min, 24 h and 48 h post-embolization; 4) citicoline combined with rtPA following the same pattern; 5) rtPA combined with citicoline, with a first dose 10 min after thrombolysis. -
A Comparative Effectiveness Meta-Analysis of Drugs for the Prophylaxis of Migraine Headache
University of South Florida Masthead Logo Scholar Commons School of Information Faculty Publications School of Information 7-2015 A Comparative Effectiveness Meta-Analysis of Drugs for the Prophylaxis of Migraine Headache Authors: Jeffrey L. Jackson, Elizabeth Cogbill, Rafael Santana-Davila, Christina Eldredge, William Collier, Andrew Gradall, Neha Sehgal, and Jessica Kuester OBJECTIVE: To compare the effectiveness and side effects of migraine prophylactic medications. DESIGN: We performed a network meta-analysis. Data were extracted independently in duplicate and quality was assessed using both the JADAD and Cochrane Risk of Bias instruments. Data were pooled and network meta-analysis performed using random effects models. DATA SOURCES: PUBMED, EMBASE, Cochrane Trial Registry, bibliography of retrieved articles through 18 May 2014. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: We included randomized controlled trials of adults with migraine headaches of at least 4 weeks in duration. RESULTS: Placebo controlled trials included alpha blockers (n = 9), angiotensin converting enzyme inhibitors (n = 3), angiotensin receptor blockers (n = 3), anticonvulsants (n = 32), beta-blockers (n = 39), calcium channel blockers (n = 12), flunarizine (n = 7), serotonin reuptake inhibitors (n = 6), serotonin norepinephrine reuptake inhibitors (n = 1) serotonin agonists (n = 9) and tricyclic antidepressants (n = 11). In addition there were 53 trials comparing different drugs. Drugs with at least 3 trials that were more effective than placebo for episodic migraines -
Anticraving Therapy for Alcohol Use Disorder: a Clinical Review
Received: 10 April 2018 | Revised: 11 June 2018 | Accepted: 11 June 2018 DOI: 10.1002/npr2.12028 INVITED REVIEW Anticraving therapy for alcohol use disorder: A clinical review Winston W. Shen1,2 1Department of Psychiatry, Wan Fang Medical Center, Taipei Medical University, Abstract Taipei, Taiwan Aim: In this review, the author focused on anticraving therapy for alcohol use disor- 2Department of Psychiatry, College of der (AUD) defined by DMS‐5. A comprehensive review was carried out on the avail- Medicine, Taipei Medical University, Taipei, Taiwan able published papers on anticraving drugs for treating AUD patients. Methods: The author described all drugs with anticraving benefits for treating Correspondence Winston W. Shen, Department of AUD patients approved by the Food and Drug Administration of the United States Psychiatry, Wan Fang Medical Center, No. (US FDA) and European Medicines Agency of the European Union. Then, the com- 111, Section 3, Hsing Long Road, Taipei 116, Taiwan. monly prescribed anticraving drugs and those under development were also Email: [email protected] described. Results: The US FDA‐approved anticraving drugs included acamprosate and naltrex- one, and those approved by European Medicines Agency were gamma‐hydroxybuty- rate and nalmefene. The author also highlighted topiramate, gabapentin, ondansetron, LY196044, ifenprodil, varenicline, ABT‐436, mifepristone, citicoline, and baclofen. The putative mechanisms of action of and the use in clinical practice of those anticraving drugs were also described. Conclusion: Although slowly developing, the field of anticraving drugs is getting into shape as a promising entity of a pharmaceutical class of drugs. Then, the author addressed on the underused issues of those recommended, and suggested anticraving drugs by the practice guideline of the American Psychiatric Association. -
Gabapentinoids: Pharmacokinetics, Pharmacodynamics and Considerations for Clinical Practice
912496BJP British Journal of PainChincholkar Special Issue Article British Journal of Pain 1 –11 Gabapentinoids: pharmacokinetics, © The British Pain Society 2020 Article reuse guidelines: sagepub.com/journals-permissions pharmacodynamics and considerations DOI:https://doi.org/10.1177/2049463720912496 10.1177/2049463720912496 for clinical practice journals.sagepub.com/home/bjp Mahindra Chincholkar Abstract The gabapentinoids are often recommended as first-line treatments for the management of neuropathic pain. The differing pharmacodynamic and pharmacokinetic profiles can have implications for clinical practice. This article has summarised these key differences. In addition to their use in managing neuropathic pain, gabapentinoids are increasingly being used for off-label conditions despite the lack of evidence. Prescription rates for off-label conditions have overtaken that for on-label use. Similarly, the use of gabapentinoids in the perioperative period is now embedded in clinical practice despite conflicting evidence. This article summarises the risks associated with this increasing use. There is increasing evidence of the potential to cause harm in vulnerable populations such as the elderly and increasing prevalence of abuse. The risk of respiratory depression in combination with opioids is of particular concern in the context of the current opioid crisis. This article describes the practical considerations involved that might help guide appropriate prescribing practices. Keywords Gabapentin, pregabalin, pain management, adverse effects, pharmacology Introduction movement, sleep disorders, headaches, alcohol with- drawal syndrome, chronic back pain, fibromyalgia, vis- The gabapentinoid drugs gabapentin and pregabalin ceral pain and acute postoperative pain.4,5 The rate of are antiepileptic drugs that are considered as first-line new prescriptions is increasing and tripled in England 1 treatments for the management of neuropathic pain. -
Gabapentin Enacarbil (Horizant) Monograph
Gabapentin enacarbil (Horizant) Monograph ® Gabapentin Enacarbil (Horizant ) National Drug Monograph March 2012 VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives The purpose of VA PBM Services drug monographs is to provide a comprehensive drug review for making formulary decisions. These documents will be updated when new clinical data warrant additional formulary discussion. Documents will be placed in the Archive section when the information is deemed to be no longer current. Executive Summary: Gabapentin enacarbil (Horizant®) is a prodrug of gabapentin which binds with high affinity to the α2δ subunit of voltage-activated calcium channels in vitro studies. It is unknown how the binding of gabapentin enacarbil (GEn) to the α2δ subunit corresponds to the treatment of restless leg syndrome (RLS) symptoms. Indication: GEn is FDA approved for treatment of RLS. Pharmacokinetics: GEn is primarily excreted by the kidneys and neither gabapentin nor GEn is substrate, inhibitor, or inducer of the major CYP450 system. In addition, GEn is not an inhibitor or substrate of p-glycoprotein in vitro. Dose: The recommended dosage is 600 mg once daily taken with food at about 5 PM. Efficacy: Several studies examining GEn have shown efficacy over placebo in patients with RLS; improvement in RLS symptoms was observed within 7 days of starting treatment.6-8, 12-14 Three studies demonstrated 1200 mg/day GEn significantly reduced International Restless Legs Syndrome (IRLS) scale total score and improved Clinical Global Impression– Improvement (CGI-I) scale compared with placebo.6-8 Two studies demonstrated efficacy at lower dose of 600 mg/day GEn; however, another study did not.7,12,13 These results are comparable to those seen with dopamine agonists.8,12 Adverse Drug Events: Commonly reported adverse effects for the approved dose of 600 mg/day GEn are somnolence, sedation and dizziness. -
( 12 ) United States Patent
US010131766B2 (12 ) United States Patent (10 ) Patent No. : US 10 , 131, 766 B2 Hazen et al. (45 ) Date of Patent: Nov . 20 , 2018 ( 54 ) UNSATURATED POLYESTER RESIN 6 ,619 ,886 B1 9 /2003 Harrington 6 ,692 , 802 B1 2 / 2004 Nava SYSTEM FOR CURED IN - PLACE PIPING 7 , 135 ,087 B2 11/ 2006 Blackmore et al. 7 ,799 ,228 B2 9 /2010 Bomak et al . (71 ) Applicant : Interplastic Corporation , Saint Paul, 8 , 047, 238 B2 11/ 2011 Wiessner et al . MN (US ) 8 ,053 ,031 B2 11/ 2011 Stanley et al. 8 ,092 ,689 B2 1 / 2012 Gosselin (72 ) Inventors : Benjamin R . Hazen , Roseville , MN 8 , 298 , 360 B2 10 / 2012 Da Silveira et al. 8 ,418 , 728 B1 4 / 2013 Kiest , Jr . (US ) ; David J . Herzog , Maple Grove , 8 ,586 ,653 B2 11 / 2013 Klopsch et al. MN (US ) ; Louis R . Ross, Cincinnati , 8 ,636 , 869 B2 1 / 2014 Wiessner et al . OH (US ) ; Joel R . Weber , Moundsview , 8 ,741 , 988 B2 6 /2014 Klopsch et al. MN (US ) 8 , 877 , 837 B2 11/ 2014 Yu et al. 9 ,068 , 045 B2 6 /2015 Nava et al. 9 ,074 , 040 B2 7 / 2015 Turshani et al. ( 73 ) Assignee : Interplastic Corporation , St. Paul , MN 9 , 150 , 709 B2 10 / 2015 Klopsch et al . (US ) 9 , 207 , 155 B1 12 / 2015 Allouche et al. 9 ,273 ,815 B2 3 / 2016 Gillanders et al. ( * ) Notice : Subject to any disclaimer, the term of this 9 , 371, 950 B2 6 / 2016 Hairston et al. patent is extended or adjusted under 35 9 , 550 , 933 B2 1 /2017 Chatterji et al .