DOCSLIB.ORG

Valproate Atry 2005; 5: 19

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Valproate Atry 2005; 5: 19 508 Antiepileptics 2. Kirov G, Tredget J. Add-on topiramate reduces weight in overweight Valpromide (rINN) patients with affective disorders: a clinical case series. BMC Psychi- Valproate atry 2005; 5: 19. Available at: http://www.biomedcentral.com/ Valproato. Dipropilacetamida; Dipropylacetamide; Valpromida; Valpromi- content/pdf/1471-244X-5-19.pdf (accessed 09/06/08) dum. 2-Propylvaleramide. 3. Khazaal Y, et al. Long-term topiramate treatment of psychotrop- Вальпроат ic drug-induced weight gain: a retrospective chart review. Gen Вальпромид Hosp Psychiatry 2007; 29: 446–9. NOTE. Valproate is a generic term applied to valproic acid and its salts and esters. C8H17NO = 143.2. 4. Eliasson B, et al. Weight loss and metabolic effects of topiramate CAS — 2430-27-5. in overweight and obese type 2 diabetic patients: randomized ATC — N03AG02. double-blind placebo-controlled trial. Int J Obes 2007; 31: Valproic Acid (BAN, USAN, rINN) 1140–7. ATC Vet — QN03AG02. Abbott-44089; Acide valproïque; Ácido dipropilacético; Ácido Psychiatric disorders. Topiramate has been tried in several valproico; Acidum valproicum; Kyselina valproová; Valproiinihap- 1 _ Adverse Effects psychiatric disorders, including schizophrenia (p.955), dis- po; Valproik Asit; Valproine˙ rugštis; Valproinsav; Valproinsyra. 2- turbed behaviour2 (p.954), post-traumatic stress disorder3 Propylvaleric acid; 2-Propylpentanoic acid. The most frequently reported adverse effects associat- (p.953), and social anxiety disorder4 (see Phobic Disorders, ed with valproate therapy are gastrointestinal distur- 5-7 Вальпроевая Кислота p.953). It has also been tried in binge eating. For its use in bi- bances, particularly at the start of therapy; enteric-coat- polar disorder see above. C8H16O2 = 144.2. 1. Tiihonen J, et al. Topiramate add-on in treatment-resistant schiz- CAS — 99-66-1. ed formulations, taking doses with meals, and starting ophrenia: a randomized, double-blind, placebo-controlled, ATC — N03AG01. with low doses may minimise symptoms. There may crossover trial. J Clin Psychiatry 2005; 66: 1012–15. ATC Vet — QN03AG01. be increased appetite, and weight gain is common. 2. Nickel MK, et al. Topiramate treatment of aggression in female borderline personality disorder patients: a double-blind, place- Less common adverse effects include oedema, head- bo-controlled study. J Clin Psychiatry 2004; 65: 1515–19. ache, reversible prolongation of bleeding time, and 3. Berlant JL. Prospective open-label study of add-on and mono- H3C therapy topiramate in civilians with chronic nonhallucinatory thrombocytopenia. Leucopenia and bone marrow de- posttraumatic stress disorder. BMC Psychiatry 2004; 4: 24. OH pression have been reported. Neurological adverse ef- Available at: http://www.biomedcentral.com/content/pdf/ H3C 1471-244X-4-24.pdf (accessed 09/06/08) fects including ataxia, tremor, sedation, lethargy, con- 4. Van Ameringen M, et al. An open trial of topiramate in the treat- O fusion, and more rarely encephalopathy and coma, ment of generalized social phobia. J Clin Psychiatry 2004; 65: have occasionally been reported, although these are of- 1674–8. Pharmacopoeias. In Eur. (see p.vii) and US. 5. Nickel C, et al. Topiramate treatment in bulimia nervosa pa- ten associated with too high a starting dose, increasing tients: a randomized, double-blind, placebo-controlled trial. Int J Ph. Eur. 6.2 (Valproic Acid). A colourless or very slightly yel- Eat Disord 2005; 38: 295–300. low, slightly viscous, clear liquid. Very slightly soluble in water; doses too rapidly, or use with other antiepileptics. Very 6. Tata AL, Kockler DR. Topiramate for binge-eating disorder as- miscible with alcohol and with dichloromethane. It dissolves in rare cases of extrapyramidal symptoms or reversible sociated with obesity. Ann Pharmacother 2006; 40: 1993–7. dilute solutions of alkali hydroxides. Store in airtight containers. dementia associated with cerebral atrophy have been 7. Claudino AM, et al. Double-blind, randomized, placebo-control- USP 31 (Valproic Acid). A colourless to pale yellow, slightly vis- reported. Increased alertness may occur, which is gen- led trial of topiramate plus cognitive-behavior therapy in binge- cous, clear liquid having a characteristic odour. Slightly soluble eating disorder. J Clin Psychiatry 2007; 68: 1324–32. erally considered beneficial, but occasionally aggres- in water; freely soluble in alcohol, in acetone, in chloroform, in Tremor. A beta blocker is often the first drug used in patients ether, in methyl alcohol, in benzene, in n-heptane, and in 1N sion, hyperactivity, and behavioural disturbances have with essential tremor who require regular treatment (p.1231); sodium hydroxide; slightly soluble in 0.1N hydrochloric acid. been reported. Hearing loss has been noted. There may 1,2 however, topiramate has also been tried. Store in airtight glass, stainless steel, or polyethylene containers. occasionally be rashes, and, rarely, hirsutism, acne, 1. Galvez-Jimenez N, Hargreave M. Topiramate and essential trem- or. Ann Neurol 2000; 47: 837–8. toxic epidermal necrolysis and Stevens-Johnson syn- 2. Ondo WG, et al. Topiramate in essential tremor: a double-blind, Sodium Valproate (BANM, rINNM) drome or erythema multiforme. Transient hair loss, placebo-controlled trial. Neurology 2006; 66: 672–7. Abbott-44090; Natrii valproas; Natrio valproatas; Natriumval- sometimes with regrowth of curly hair, has occurred. Preparations proaatti; Natriumvalproat; Nátrium-valproát; Natrium-valproát; Irregular periods, amenorrhoea, and gynaecomastia NIK-240; Sodium, valproate de; Sodyum Valproat; Valproate de Proprietary Preparations (details are given in Part 3) have been reported rarely. Arg.: Neutop; Topamac; Topictal; Topirex; Austral.: To p a m a x ; Austria: Sodium; Valproate Sodium (USAN); Valproato sódico. Sodium 2- To p a m a x ; Belg.: To p a m a x ; Braz.: To p a m a x ; Canad.: To p a m a x ; Chile: propylvalerate; Sodium 2-propylpentanoate. Liver dysfunction including hepatic failure has occa- Topamax; Toprel; Cz.: To p a m a x ; To p i r a g i s ; Denm.: Epitomax; Topimax; Натрий Вальпроат sionally been reported, usually in the first few months Fin.: To p i m a x ; Fr.: Epitomax; Ger.: To p am ax ; Gr.: To p a m a c ; Hong Kong: To p a m a x ; Hung.: To p a m a x ; India: To p a m a c ; To p a m a t e ; Indon.: To p a m ax ; C8H15NaO2 = 166.2. of treatment, and requires valproate withdrawal; there Irl.: Topamax; Israel: Topamax; Ital.: Topamax; Malaysia: To p a m a x ; CAS — 1069-66-5. have been fatalities. Elevation of liver enzyme values Mex.: To p a m a x ; Neth.: Epitomax; Topamax; Norw.: To p i m a x ; NZ: ATC — N03AG01. is common but normally transient and dose-related. To p a m a x ; Philipp.: Topamax; Pol.: To p a m a x ; Port.: To p a m ax ; To p t r i x ; ATC Vet — QN03AG01. Rus.: To p a m a x ( Топамакс); S.Afr.: To p a m a x ; Singapore: To p a m a x ; Hyperammonaemia has occurred, even in the absence Spain: Bipomax; Topamax; Swed.: Topimax; Switz.: Topamax; Thai.: Pharmacopoeias. In Chin., Eur. (see p.vii), Int., Jpn., and US. of overt hepatic failure, and is sometimes associated To p a m a x ; Turk.: To p a m a x ; UK: To pa m ax ; USA: To p a m a x ; Venez.: Ph. Eur. 6.2 (Sodium Valproate). A white or almost white, hy- To p a m a x . groscopic, crystalline powder. Very soluble in water; slightly to with neurological symptoms; hyperglycinaemia has freely soluble in alcohol. Store in airtight containers. also been reported. Pancreatitis has also been reported USP 31 (Divalproex Sodium). A white to off-white powder. Sol- rarely, and fatalities have occurred; plasma amylase Trimethadione (BAN, rINN) uble in acetone; practically insoluble in acetonitrile; very soluble should be measured if there is acute abdominal pain, Trimetadion; Trimetadiona; Trimetadionas; Trimetadioni; Tri- in chloroform; freely soluble in ethyl ether and in methyl alcohol. Store in airtight containers. although the value of serum amylase as a diagnostic methadion; Triméthadione; Trimethadionum; Trimethinum; tool has been questioned—see Effects on the Pancreas, Troxidone. 3,5,5-Trimethyl-1,3-oxazolidine-2,4-dione. Valproate Pivoxil (rINN) below. In a few patients there have been reports of re- Триметадион CHF-1504; Valproato de pivoxilo; Valproato pivoxilo; Val- versible defects in renal tubular function (Fanconi’s C6H9NO3 = 143.1. syndrome). CAS — 127-48-0. proatum Pivoxilum. Hydroxymethyl 2-propylvalerate pivalate. ATC — N03AC02. Вальпроат Пивоксил Congenital malformations have been reported in ATC Vet — QN03AC02. C14H26O4 = 258.4. infants born to women who had received antiepileptics CAS — 77372-61-3. including valproate during pregnancy. ATC — N03AG01. H3C O ATC Vet — QN03AG01. Inflammatory reactions and pain have been reported at O the injection site after intravenous doses. H C 3 Valproate Semisodium (rINN) N Incidence of adverse effects. Adverse effects were present in Abbott-50711; Divalproex Sodium (USAN); Semisodium Val- 71 of 88 children receiving sodium valproate monotherapy1 and, O CH 3 proate (BAN); Valproate Semisodique; Valproato semisódico; Val- although average doses in these patients were significantly high- proatum Seminatricum. 2-Propylvaleric acid—Sodium 2-propyl- er than in the 17 with no adverse effects, no difference in the plas- Pharmacopoeias. In Eur. (see p.vii), Int., and Jpn. valerate (1:1); Sodium hydrogen bis(2-propylvalerate) oligomer. ma concentrations was observed between the 2 groups. Ph. Eur. 6.2 (Trimethadione). Colourless or almost colourless crystals. Soluble in water; very soluble in alcohol. Protect from Вальпроат Семинатрий • Behavioural alterations seen in 56 included irritability, longer and deeper sleep, superficial sleep, hyperactivity, being more light. C16H31NaO4 = 310.4. CAS — 76584-70-8. alert, lassitude, drowsiness, being more sociable, calmness, Profile ATC — N03AG01. being happier, absent mindedness, being sadder, aggressive- Trimethadione is an oxazolidinedione antiepileptic that has been ATC Vet — QN03AG01. ness, being more skillful, and docility; it was emphasised that given in the treatment of absence seizures refractory to other an- stimulatory reactions were as frequent as depressant effects tiepileptics.
Load more

Recommended publications
  • Eslicarbazepine Acetate Longer Procedure No
    European Medicines Agency London, 19 February 2009 Doc. Ref.: EMEA/135697/2009 CHMP ASSESSMENT REPORT FOR authorised Exalief International Nonproprietary Name: eslicarbazepine acetate longer Procedure No. EMEA/H/C/000987 no Assessment Report as adopted by the CHMP with all information of a commercially confidential nature deleted. product Medicinal 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: [email protected] http://www.emea.europa.eu TABLE OF CONTENTS 1. BACKGROUND INFORMATION ON THE PROCEDURE........................................... 3 1.1. Submission of the dossier ...................................................................................................... 3 1.2. Steps taken for the assessment of the product..................................................................... 3 2. SCIENTIFIC DISCUSSION................................................................................................. 4 2.1. Introduction............................................................................................................................ 4 2.2. Quality aspects ....................................................................................................................... 5 2.3. Non-clinical aspects................................................................................................................ 8 2.4. Clinical aspects....................................................................................................................
    [Show full text]
  • Zonegran, INN-Zonisamide
    SCIENTIFIC DISCUSSION 1. Introduction Many patients (30 to 40% of the overall population with epilepsy) continue to have seizures in spite of receiving antiepileptic drug (AED) treatment. The prevalence of active epilepsy, 5-10/1000, is one of the highest among serious neurological disorders with more than 50 million people affected worldwide. Two peaks of incidence are observed, in early childhood and among elderly people. Some patients will have life-long epilepsy. International classifications, such as the International League Against Epilepsy (ILAE) classification recognise many epileptic diseases or syndromes and each of them can be expressed clinically by one or several seizure groupings. Partial epilepsies (localisation related) are the more frequent, accounting for more than 60% of the epilepsies, and they include most of the difficult-to-treat patients. In terms of seizure types, partial epilepsies include simple partial seizures (without impairment of consciousness), complex partial seizures (with impairment of consciousness and often more disabling) and secondarily generalized tonic-clonic seizures. The symptoms are a function of the localisation of the site of seizure onset in the brain (epileptogenic zone) and of the propagation pathways of the abnormal discharge. Therapeutic management usually follows a staged approach with newly diagnosed patients starting prophylactic treatment with a single drug, and several alternative drugs may be tried in the event of lack of efficacy or poor tolerability. For patients not responding to several attempts of monotherapy, combinations of antiepileptic drugs are generally employed early in the management process. Uncontrolled epilepsy is associated with cognitive deterioration, psychosocial dysfunction, dependent behaviour, restricted lifestyle, poor quality of life and excess mortality, in particular from sudden unexpected death in epilepsy patients (SUDEP).
    [Show full text]
  • Mechanisms of Action of Antiepileptic Drugs
    Review Mechanisms of action of antiepileptic drugs Epilepsy affects up to 1% of the general population and causes substantial disability. The management of seizures in patients with epilepsy relies heavily on antiepileptic drugs (AEDs). Phenobarbital, phenytoin, carbamazepine and valproic acid have been the primary medications used to treat epilepsy for several decades. Since 1993 several AEDs have been approved by the US FDA for use in epilepsy. The choice of the AED is based primarily on the seizure type, spectrum of clinical activity, side effect profile and patient characteristics such as age, comorbidities and concurrent medical treatments. Those AEDs with broad- spectrum activity are often found to exert an action at more than one molecular target. This article will review the proposed mechanisms of action of marketed AEDs in the US and discuss the future of AEDs in development. 1 KEYWORDS: AEDs anticonvulsant drugs antiepileptic drugs epilepsy Aaron M Cook mechanism of action seizures & Meriem K Bensalem-Owen† The therapeutic armamentarium for the treat- patients with refractory seizures. The aim of this 1UK HealthCare, 800 Rose St. H-109, ment of seizures has broadened significantly article is to discuss the past, present and future of Lexington, KY 40536-0293, USA †Author for correspondence: over the past decade [1]. Many of the newer AED pharmacology and mechanisms of action. College of Medicine, Department of anti epileptic drugs (AEDs) have clinical advan- Neurology, University of Kentucky, 800 Rose Street, Room L-455, tages over older, so-called ‘first-generation’ First-generation AEDs Lexington, KY 40536, USA AEDs in that they are more predictable in their Broadly, the mechanisms of action of AEDs can Tel.: +1 859 323 0229 Fax: +1 859 323 5943 dose–response profile and typically are associ- be categorized by their effects on the neuronal [email protected] ated with less drug–drug interactions.
    [Show full text]
  • Valproic Acid and Its Amidic Derivatives As New Antivirals Against Alphaherpesviruses
    viruses Review Valproic Acid and Its Amidic Derivatives as New Antivirals against Alphaherpesviruses Sabina Andreu 1,2,* , Inés Ripa 1,2, Raquel Bello-Morales 1,2 and José Antonio López-Guerrero 1,2 1 Departamento de Biología Molecular, Universidad Autónoma de Madrid, Cantoblanco, 28049 Madrid, Spain; [email protected] (I.R.); [email protected] (R.B.-M.); [email protected] (J.A.L.-G.) 2 Centro de Biología Molecular Severo Ochoa, Spanish National Research Council—Universidad Autónoma de Madrid (CSIC-UAM), Cantoblanco, 28049 Madrid, Spain * Correspondence: [email protected] Academic Editor: Maria Kalamvoki Received: 14 November 2020; Accepted: 25 November 2020; Published: 26 November 2020 Abstract: Herpes simplex viruses (HSVs) are neurotropic viruses with broad host range whose infections cause considerable health problems in both animals and humans. In fact, 67% of the global population under the age of 50 are infected with HSV-1 and 13% have clinically recurrent HSV-2 infections. The most prescribed antiherpetics are nucleoside analogues such as acyclovir, but the emergence of mutants resistant to these drugs and the lack of available vaccines against human HSVs has led to an imminent need for new antivirals. Valproic acid (VPA) is a branched short-chain fatty acid clinically used as a broad-spectrum antiepileptic drug in the treatment of neurological disorders, which has shown promising antiviral activity against some herpesviruses. Moreover, its amidic derivatives valpromide and valnoctamide also share this antiherpetic activity. This review summarizes the current research on the use of VPA and its amidic derivatives as alternatives to traditional antiherpetics in the fight against HSV infections.
    [Show full text]
  • Chapter 25 Mechanisms of Action of Antiepileptic Drugs
    Chapter 25 Mechanisms of action of antiepileptic drugs GRAEME J. SILLS Department of Molecular and Clinical Pharmacology, University of Liverpool _________________________________________________________________________ Introduction The serendipitous discovery of the anticonvulsant properties of phenobarbital in 1912 marked the foundation of the modern pharmacotherapy of epilepsy. The subsequent 70 years saw the introduction of phenytoin, ethosuximide, carbamazepine, sodium valproate and a range of benzodiazepines. Collectively, these compounds have come to be regarded as the ‘established’ antiepileptic drugs (AEDs). A concerted period of development of drugs for epilepsy throughout the 1980s and 1990s has resulted (to date) in 16 new agents being licensed as add-on treatment for difficult-to-control adult and/or paediatric epilepsy, with some becoming available as monotherapy for newly diagnosed patients. Together, these have become known as the ‘modern’ AEDs. Throughout this period of unprecedented drug development, there have also been considerable advances in our understanding of how antiepileptic agents exert their effects at the cellular level. AEDs are neither preventive nor curative and are employed solely as a means of controlling symptoms (i.e. suppression of seizures). Recurrent seizure activity is the manifestation of an intermittent and excessive hyperexcitability of the nervous system and, while the pharmacological minutiae of currently marketed AEDs remain to be completely unravelled, these agents essentially redress the balance between neuronal excitation and inhibition. Three major classes of mechanism are recognised: modulation of voltage-gated ion channels; enhancement of gamma-aminobutyric acid (GABA)-mediated inhibitory neurotransmission; and attenuation of glutamate-mediated excitatory neurotransmission. The principal pharmacological targets of currently available AEDs are highlighted in Table 1 and discussed further below.
    [Show full text]
  • (12) Patent Application Publication (10) Pub. No.: US 2010/014.3507 A1 Gant Et Al
    US 2010.0143507A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2010/014.3507 A1 Gant et al. (43) Pub. Date: Jun. 10, 2010 (54) CARBOXYLIC ACID INHIBITORS OF Publication Classification HISTONE DEACETYLASE, GABA (51) Int. Cl. TRANSAMINASE AND SODIUM CHANNEL A633/00 (2006.01) A 6LX 3/553 (2006.01) A 6LX 3/553 (2006.01) (75) Inventors: Thomas G. Gant, Carlsbad, CA A63L/352 (2006.01) (US); Sepehr Sarshar, Cardiff by A6II 3/19 (2006.01) the Sea, CA (US) C07C 53/128 (2006.01) A6IP 25/06 (2006.01) A6IP 25/08 (2006.01) Correspondence Address: A6IP 25/18 (2006.01) GLOBAL PATENT GROUP - APX (52) U.S. Cl. .................... 424/722:514/211.13: 514/221; 10411 Clayton Road, Suite 304 514/456; 514/557; 562/512 ST. LOUIS, MO 63131 (US) (57) ABSTRACT Assignee: AUSPEX The present invention relates to new carboxylic acid inhibi (73) tors of histone deacetylase, GABA transaminase, and/or PHARMACEUTICALS, INC., Sodium channel activity, pharmaceutical compositions Vista, CA (US) thereof, and methods of use thereof. (21) Appl. No.: 12/632,507 Formula I (22) Filed: Dec. 7, 2009 Related U.S. Application Data (60) Provisional application No. 61/121,024, filed on Dec. 9, 2008. US 2010/014.3507 A1 Jun. 10, 2010 CARBOXYLIC ACID INHIBITORS OF HISTONE DEACETYLASE, GABA TRANSAMNASE AND SODIUM CHANNEL 0001. This application claims the benefit of priority of Valproic acid U.S. provisional application No. 61/121,024, filed Dec. 9, 2008, the disclosure of which is hereby incorporated by ref 0004 Valproic acid is extensively metabolised via erence as if written herein in its entirety.
    [Show full text]
  • IJBCP International Journal of Basic & Clinical Pharmacology Antiepileptic
    Print ISSN: 2319-2003 | Online ISSN: 2279-0780 IJBCP International Journal of Basic & Clinical Pharmacology DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20161495 Review Article Antiepileptic drugs: newer targets and new drugs Vihang S. Chawan, Abhishek M. Phatak*, Kalpesh V. Gawand, Sagar V. Badwane, Sagar S. Panchal Department of Pharmacology, TNMC and BYL Nair Ch. Hospital Mumbai, Maharashtra, India ABSTRACT Received: 10 March 2016 Epilepsy is a common neurological disorder affecting 0.5-1% of the population Accepted: 15 April 2016 in India. Majority of patients respond to currently available antiepileptic drugs (AEDs), but a small percentage of patients have shown poor and inadequate *Correspondence to: response to AEDs in addition to various side effects and drug interactions while Dr. Abhishek Madan Phatak, on therapy. Thus there is a need to develop more effective AEDs in drug Email: abhishekphatak9288 resistant epilepsy which have a better safety profile with minimal adverse @gmail.com effects. The United States food and drug administration (USFDA) has approved eslicarbazepine acetate, ezogabine, perampanel and brivaracetam which have Copyright: © the author(s), shown a promising future as better AEDs and drugs like ganaxolone, intranasal publisher and licensee Medip diazepam, ICA- 105665, valnoctamide, VX-765, naluzotan are in the pipeline. Academy. This is an open- access article distributed under Keywords: Epilepsy, Newer antiepileptic drugs, Eslicarbazepine Acetate, the terms of the Creative Ezogabine (Retigabine), Perampanel, Brivaracetam, Naluzotan Commons Attribution Non- Commercial License, which permits unrestricted non- commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. INTRODUCTION to AEDs or those patient who have suffered from recurrent seizures, may require surgery.
    [Show full text]
  • Therapeutic Drug Monitoring of Antiepileptic Drugs by Use of Saliva
    REVIEW ARTICLE Therapeutic Drug Monitoring of Antiepileptic Drugs by Use of Saliva Philip N. Patsalos, FRCPath, PhD*† and Dave J. Berry, FRCPath, PhD† INTRODUCTION Abstract: Blood (serum/plasma) antiepileptic drug (AED) therapeu- Measuring antiepileptic drugs (AEDs) in serum or tic drug monitoring (TDM) has proven to be an invaluable surrogate plasma as an aid to personalizing drug therapy is now a well- marker for individualizing and optimizing the drug management of established practice in the treatment of epilepsy, and guidelines patients with epilepsy. Since 1989, there has been an exponential are published that indicate the particular features of epilepsy and increase in AEDs with 23 currently licensed for clinical use, and the properties of AEDs that make the practice so beneficial.1 recently, there has been renewed and extensive interest in the use of The goal of AED therapeutic drug monitoring (TDM) is to saliva as an alternative matrix for AED TDM. The advantages of saliva ’ fl optimize a patient s clinical outcome by supporting the man- include the fact that for many AEDs it re ects the free (pharmacolog- agement of their medication regimen with the assistance of ically active) concentration in serum; it is readily sampled, can be measured drug concentrations/levels. The reason why TDM sampled repetitively, and sampling is noninvasive; does not require the has emerged as an important adjunct to treatment with the expertise of a phlebotomist; and is preferred by many patients, AEDs arises from the fact that for an individual patient
    [Show full text]
  • Anticonvulsants
    Clinical Pharmacy Program Guidelines for Anticonvulsants Program Prior Authorization - Anticonvulsants Medication Aptiom (eslicarbazepine), Briviact (brivaracetam), Fycompa (perampanel), Vimpat (lacosamide), Gabitril (tiagabine), Banzel (rufinamide), Onfi (clobazam), Epidiolex (cannabidiol), Sympazan (clobazam), Sabril, (vigabatrin), Diacomit (stiripentol), Xcopri (cenobamate), Fintepla (fenfluramine) Markets in Scope Arizona, California, Colorado, Hawaii, Nevada, New Jersey, New York, New York EPP, Pennsylvania- CHIP, Rhode Island, South Carolina Issue Date 6/2016 Pharmacy and 10/2020 Therapeutics Approval Date Effective Date 12/2020 1. Background: Aptiom (eslicarbazepine acetate), Briviact (brivaracetam), Vimpat (lacosamide) and Xcopri are indicated in the treatment of partial-onset seizures. Banzel (rufinamide), Onfi (clobazam), and Sympazan (clobazam) are indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS). There is some clinical evidence to support the use of clobazam for refractory partial onset seizures. Diacomit (stiripentol) is indicated for seizures associated with Dravet syndrome in patients taking clobazam. Epidiolex (cannabadiol) is indicated for seizures associated with Lennox-Gastaut syndrome, Dravet syndrome or tuberous sclerosis complex. Fintepla (fenfluramine) is indicated for the treatment of seizures associated with Dravet syndrome. Fycompa (perampanel) is indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures and as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures. Gabitril (tiagabine) is indicated ad adjunctive therapy in the treatment of partial-onset seizures. Confidential and Proprietary, © 2020 UnitedHealthcare Services Inc. Sabril (vigabatrin) is indicated as adjunctive therapy for refractory complex partial seizures in patients who have inadequately responded to several alternative treatments and for infantile spasms for whom the potential benefits outweigh the risk of vision loss.
    [Show full text]
  • Membrane Stabilizer Medications in the Treatment of Chronic Neuropathic Pain: a Comprehensive Review
    Current Pain and Headache Reports (2019) 23: 37 https://doi.org/10.1007/s11916-019-0774-0 OTHER PAIN (A KAYE AND N VADIVELU, SECTION EDITORS) Membrane Stabilizer Medications in the Treatment of Chronic Neuropathic Pain: a Comprehensive Review Omar Viswanath1,2,3 & Ivan Urits4 & Mark R. Jones4 & Jacqueline M. Peck5 & Justin Kochanski6 & Morgan Hasegawa6 & Best Anyama7 & Alan D. Kaye7 Published online: 1 May 2019 # Springer Science+Business Media, LLC, part of Springer Nature 2019 Abstract Purpose of Review Neuropathic pain is often debilitating, severely limiting the daily lives of patients who are affected. Typically, neuropathic pain is difficult to manage and, as a result, leads to progression into a chronic condition that is, in many instances, refractory to medical management. Recent Findings Gabapentinoids, belonging to the calcium channel blocking class of drugs, have shown good efficacy in the management of chronic pain and are thus commonly utilized as first-line therapy. Various sodium channel blocking drugs, belonging to the categories of anticonvulsants and local anesthetics, have demonstrated varying degrees of efficacy in the in the treatment of neurogenic pain. Summary Though there is limited medical literature as to efficacy of any one drug, individualized multimodal therapy can provide significant analgesia to patients with chronic neuropathic pain. Keywords Neuropathic pain . Chronic pain . Ion Channel blockers . Anticonvulsants . Membrane stabilizers Introduction Neuropathic pain, which is a result of nervous system injury or lives of patients who are affected. Frequently, it is difficult to dysfunction, is often debilitating, severely limiting the daily manage and as a result leads to the progression of a chronic condition that is, in many instances, refractory to medical This article is part of the Topical Collection on Other Pain management.
    [Show full text]
  • Comparison of the Effects of Zonisamide, Ethosuximide and Pregabalin in the Chronic Constriction Injury Induced Neuropathic Pain in Rats
    [Downloaded free from http://www.amhsr.org] Original Article Comparison of the Effects of Zonisamide, Ethosuximide and Pregabalin in the Chronic Constriction Injury Induced Neuropathic Pain in Rats Goyal S, Singla S, Kumar D, Menaria G Department of Pharmacology, Pacific College of Pharmacy, Pacific University, Udaipur, Rajasthan, India Address for correspondence: Dr. Sachin Goyal, Abstract Department of Pharmacology, Background: Evidence has been generated that various anticonvulsant agents provide relief Pacific College of Pharmacy, Pacific University, of several chronic pain syndromes and therefore as an alternative to opioids, nonsteroidal Udaipur ‑ 313 024, Rajasthan, India. anti‑inflammatory, and tricyclic antidepressant drugs in the treatment of neuropathic pain. The E‑mail: [email protected] results of these studies thus raise the question of whether all anticonvulsant drugs or particular mechanistic classes may be efficacious in the treatment of neuropathic pain syndromes. Aim: The aim was to compare the clinically used anticonvulsant drugs which are differ in their mechanism of action in a chronic pain model, the chronic constriction injury, in order to determine if all anticonvulsants or only particular mechanistic classes of anticonvulsants are analgesic. Materials and Methods: The study included zonisamide, ethosuximide and pregabalin. All compounds were anticonvulsant with diverse mechanism of actions. The peripheral neuropathic pain was induced by chronic constriction injury of the sciatic nerve in male Sprague‑Dawley rats. Zonisamide (80 and 40 mg/kg), ethosuximide (300 and 100 mg/kg), pregabalin (50 and 20 mg/kg), and saline was administered intraperitoneally in respective groups in a blinded, randomized manner from postoperative day (POD) 7‑13. Paw withdrawal duration to spontaneous pain, chemical allodynia and mechanical hyperalgesia and paw withdrawal latency to mechanical allodynia and thermal hyperalgesia were tested before drug administration on POD7 and after administration on POD 7, 9, 11 and 13.
    [Show full text]
  • Center for Drug Evaluation and Research
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 22-006 PHARMACOLOGY REVIEW(S) Tertiary Pharmacology Review By: Paul C. Brown, Ph.D., ODE Associate Director for Pharmacology and Toxicology OND IO NDA: 20-427 and 22-006 Submission date: December 28, 2007 (Complete response) Drug: vigabatrin Sponsor: Ovation Pharmaceuticals Indication: 20-427: refractory complex partial seizures in adults 22-006: infantile spasms Reviewing Division: Division of Neurology Products Introductory Comments: The regulatory history of these two NDAs is summarized in the supervisory pharm/tox review. The pharm/tox review of NDA 20-427 found the nonclinical information adequate to support approval. The pharm/tox reviewer for NDA 22-006 did not find the nonclinical information adequate to support approval primarily based on evidence that juvenile animals were sensitive to neurotoxic effects of vigabatrin. The pharm/tox supervisor recognized this concern but did not object to the approval of NDA 22-006 based on the clinical benefit of vigabatrin in infantile spasms which is a serious indication with no other approved therapy. The supervisor recommended that additional studies on the retinal damage and neurotoxicity induced by vigabatrin be conducted as postmarketing requirements. This includes the following studies: 1. A toxicology study in the juvenile rat examining the potential of vigabatrin exposure during development to produce neuronal damage. 2. A juvenile animal toxicology study of vigabatrin in a non-rodent species. 3. A study examining the effect of taurine on vigabatrin-induced retinal damage in rodent. Conclusions: I have discussed these NDAs with the division pharm/tox supervisor and agree that they may be approved from a pharm/tox perspective.
    [Show full text]