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Gayatri C Patel, Megha Kasarwala
BACKGROUND: The purpose of this study was to investigate the application of a controlled porosity osmotic tablet (CPOT) utilizing solid dispersion (SD) of poorly soluble drug. The patents on Cyclobenzaprine HCl (US4968507 A) and Venlafaxine salts (EP 2085078 A1) helped in selection of drug and polymers. METHOD: The SDs having different ratio of drug to carrier (PVP K 30) were prepared by kneading method and optimized. Effect of three independent variables, total amount of osmogen (mannitol& potassium chloride), total amount of polymer (polyethylene oxide WSR 301, hydroxy propyl methyl cellulose K100 M), and polymer1: polymer 2 ratio was investigated using Box Behnken design...
October 4, 2016: Recent Patents on Drug Delivery & Formulation
Robert L Findling, Kiki Chang, Adelaide Robb, Vicki J Foster, Joseph Horrigan, Alok Krishen, Art Wamil, John E Kraus, Melissa DelBello
OBJECTIVE: This study aimed to compare the efficacy of lamotrigine versus placebo in 10- to 17-year-olds with bipolar I disorder (BP-I) who were receiving conventional bipolar disorder treatment. METHOD: In this randomized withdrawal trial, patients with BP-I of at least moderate severity received lamotrigine during an ≤18-week open-label phase. Patients who maintained a stable lamotrigine dose for ≥2 weeks and Clinical Global Impression-Bipolar Severity of Illness (CGI-BP[S]) score of ≤3 for ≥6 consecutive weeks were randomized to double-blind lamotrigine or placebo for ≤36 weeks...
December 2015: Journal of the American Academy of Child and Adolescent Psychiatry
Gail D Anderson, Russell P Saneto
Modified-release or extended-release (XR) formulations are used to decrease the frequency of dosing for drugs with rapid elimination, to improve convenience and adherence. Use of a modified-release formulation can decrease the peak to trough fluctuations in serum concentrations and theoretically improve the therapeutic benefit of the drug, by decreasing adverse events associated with the higher peak concentrations. Once-daily formulations of lamotrigine (Lamictal XR(®)), levetiracetam (Keppra XR(®)), oxcarbazepine (Oxtellar XR(®), Apydan(®) extent) and topiramate (Qudexy XR™, Trokendi XR™) are approved for the treatment of focal and/or generalized onset seizures...
August 2015: CNS Drugs
Tricia Y Ting, Wenlei Jiang, Robert Lionberger, Jessica Wong, Jace W Jones, Maureen A Kane, Allan Krumholz, Robert Temple, James E Polli
OBJECTIVE: To test the current U.S. Food and Drug Administration (FDA) bioequivalence standard in a comparison of generic and brand-name drug pharmacokinetic (PK) performance in "generic-brittle" patients with epilepsy under clinical use conditions. METHODS: This randomized, double-blind, multiple-dose, steady-state, fully replicated bioequivalence study compared generic lamotrigine to brand-name Lamictal in "generic-brittle" patients with epilepsy (n = 34) who were already taking lamotrigine...
September 2015: Epilepsia
Soundarya Vaithianathan, Siddarth Raman, Wenlei Jiang, Tricia Y Ting, Maureen A Kane, James E Polli
The therapeutic equivalence of generic and brand name antiepileptic drugs has been questioned by neurologists and the epilepsy community. A potential contributor to such concerns is pharmaceutical quality. The objective was to assess the biopharmaceutic risk of brand name Lamictal 100 mg tablets and generic lamotrigine 100 mg tablets from several manufacturers. Lamotrigine was characterized in terms of the Biopharmaceutics Classification System (BCS), including aqueous solubility and Caco-2 permeability. A panel of pharmaceutical quality tests was also performed on three batches of Lamictal, three batches of Teva generic, and one batch of each of four other generics: appearance, identity, assay, impurity, uniformity of dosage units, disintegration, dissolution, friability, and loss on drying...
July 6, 2015: Molecular Pharmaceutics
Thomas Kampfrath, Penny Peng, Valli Vairavan, Dayong Lee
CLINICAL HISTORY: HASH(0x4dc90b0) PATIENT: 41-year-old Hispanic woman. Chief Complaint: Pain in the neck, joints, and shoulders that started in August 2013. History of Present Illness: The patient has a history of psychiatric illness. Her primary care physician from an outside facility had prescribed alprazolam (Xanax) to treat her depression. The patient reported that in 2011 she experienced pain in the right side of her back and was diagnosed with sciatica. In addition, she was diagnosed with systemic lupus erythematosus (SLE) based on a positive finding for antinuclear antibodies (ANA) and double-stranded DNA (ds-DNA)...
2015: Laboratory Medicine
Jessica M Wong, Jace W Jones, Wenlei Jiang, James E Polli, Maureen A Kane
BACKGROUND: Recent concerns have been raised by neurologists and patients with epilepsy regarding the bioequivalence of generic lamotrigine to the brand Lamictal. Bioequivalence studies require the quantification of lamotrigine in human plasma, including in the presence of other drugs, for studies that will use patients with epilepsy rather than healthy volunteers. METHODS: Lamotrigine was extracted from plasma through a simple protein precipitation and analyzed by fast liquid chromatography coupled to heated electrospray ionization with tandem mass spectrometric detection...
April 2015: Therapeutic Drug Monitoring
Charles L Bowden, Vivek Singh
INTRODUCTION: Over the past decade the use of lamotrigine in bipolar disorder has increased. However, the evidence base suggests a more limited role for lamotrigine as part of an overall treatment regimen in bipolar disorder. AREAS COVERED: We reviewed publications of randomized clinical trials of lamotrigine, emphasizing studies in bipolar disorder. The low burden of adverse effects with lamotrigine has been confirmed in these studies. Its lack of benefit in acute mania is established...
December 2012: Expert Opinion on Pharmacotherapy
S Perez-Lloret, L Olmos, F de Mena, P Pieczanski, J J Rodriguez Moncalvo
UNLABELLED: OBEJCTIVE: To compare the bioavailability of two 50-mg lamotrigine dispersible tablet formulations (Epilepax®, Ivax-TEVA Argentina Laboratories, Argentina, as a test formulation, and Lamictal®, GlaxoSmithKline, UK, as a reference formulation) in 24 healthy male volunteers. MATERIAL AND METHODS: This study was a randomized, 2-period, 2-sequence crossover design that was open for subjects and investigators, but blind for the bioanalytical lab. Serum samples were obtained over a 120-h interval...
October 2012: Arzneimittel-Forschung
D Bornand, C Surber, C Meier, H Plagge
At discharge of a 72 year old epileptic patient from the hospital, the clinician prescribed the switch from Orfiril® to Lamictal®. The general practitioner misinterpreted the confusing medication list and made handwritten changes. Later on, family members of the patient observed a discrepancy between the handwritten comments of the general practitioner and the medication list of the clinician. The medication could be re-evaluated in cooperation with the hospital pharmacy and the general practitioner. An early interdisciplinary collaboration would help improving patient safety...
February 29, 2012: Praxis
Vishal Patel, Dennis J Cordato, Manu Dias, Roy G Beran
PURPOSE: Lamotrigine (LTG) is an anti epileptic medication (AEM) for which blood levels are helpful for optimal dosing. In late 2010, patients attending an epilepsy clinic were becoming toxic without obvious cause. This paper reports altered levels without change in regimen and provides unexpected findings. METHODS: Patients with elevated LTG blood levels were assessed to determine change in AEM regimen or generic substitution. Method of blood level determination was reviewed and the company (GlaxoSmithKline) contacted regarding change in source of medication...
February 2012: Epilepsy Research
Mladena Lalic, Ana Pilipovic, Svetlana Golocorbin-Kon, Ksenija Gebauer-Bukurov, Ksenija Bozic, Momir Mikov, Jelena Cvejic
BACKGROUND: Since 2005, the antiepileptic drug lamotrigine has been present in the market in various generic products, in addition to the original brand of Lamictal®. The linear pharmacokinetics and wide therapeutic window of lamotrigine enable seizure-free patients to easily switch from brand to generic antiepileptic drugs. OBJECTIVE: The aim of this study was to investigate the extent of variations in lamotrigine serum concentrations between two immediate-release tablet formulations...
2011: Drugs in R&D
Matthew J Geraci, James Peele, Stacey L McCoy, Brad Elias
BACKGROUND: This report describes two cases with unexplained positive results for phencyclidine (PCP). AIMS: This case will correlate lamotrigine (Lamictal®) use with false-positive results for PCP on a rapid urine toxicology screen. METHODS: Case 1: A 62-year-old male arrived to the emergency department in extreme psychosis. All positive results on the urine drug screen could be accounted for except PCP. A comprehensive drug screen was performed to confirm PCP use, but returned negative...
2010: International Journal of Emergency Medicine
(no author information available yet)
These two brand names are too similar, while the international non-proprietary names (INNs) are clearly different: lamotrigine (an antiepileptic) and terbinafine (an antifungal drug).
August 2010: Prescrire International
Robert H Howland
This article describes several examples where the development of drugs and devices for use in psychiatry followed from initial serendipitous observations. The potential psychotropic properties of chlorpromazine (Thorazine(®)) were first noted in surgical patients when the drug was being investigated as a potentiator of anesthesia. Similar findings were noted with iproniazid (Marsilid(®)), developed for the treatment of tuberculosis, and the drug was later released for clinical use as an antidepressant agent...
October 2010: Journal of Psychosocial Nursing and Mental Health Services
Tapani Keränen, Annamari Sorri, Eeva Moilanen, Pauli Ylitalo
OBJECTIVE: The effects of single and repeated doses of oral activated charcoal (OAC) on the absorption and elimination of the antiepileptic drugs, lamotrigine (CAS 84057-84-1, LTG, Lamictal) and oxcarbazepine (CAS 28721-07-5, OXC, Trileptal) were studied in healthy volunteers to assess the therapeutic potential of OAC in the treatment of LTG and OXC overdose. METHODS: In three open, randomized, cross-over sessions with > or = 14 days washout, LTG 100 mg and OXC 600 mg were given orally, each to 6 subjects...
2010: Arzneimittel-Forschung
Piotr J Bilski, M A Wolak, V Zhang, D E Moore, C F Chignell
Lamotrigine (LTG) [3,5-diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine], an anticonvulsant and antidepressant drug Lamictal, produces a (photo)toxic response in some patients. LTG absorbs UV light, generating singlet oxygen (1O2) with a quantum yield of 0.22 in CH2Cl2, 0.11 in MeCN and 0.01 in D2O. A small production of superoxide radical anion was also detected in acetonitrile. Thus, LTG is a moderate photosensitizer producing phototoxicity and oxidizing linoleic acid. LTG is a weak 1O2 quencher (k(q) = 3.2 x 10(5) M(-1) s(-1) in MeCN), but its photodecomposition products in dimethyl sulfoxide (DMSO) quenched 1O2 very efficiently...
November 2009: Photochemistry and Photobiology
Ignacio Valencia, Agustín Legido
In this paper we review the current information regarding the use of new antiepileptic drugs (AEDs) used as monotherapy in children. We specifically include the following AEDs: lamotrigine (Lamictal), topiramate (Topamax), zonisamide (Zonegran), levetiracetam (Keppra), and oxcarbazepine (Trileptal). All of these AEDs have a broad spectrum of action in the treatment of partial and generalized seizures, except Oxcarbazepine, which is effective only in partial seizures. It is unclear whether or not monotherapy with the new AEDs offers higher efficacy and/or lower side effects compared to classic AEDs (phenobarbital, phenytoin, carbamazepine, or valproate) thereby significantly improving the quality of life in children with epilepsy...
2009: Medicina
L R Zenkov, P A Konstantinov, I Iu Shiriaeva, V N Miasnikov, E B Sirazitdinova, S I Shevel'chisnkiĭ
Clinical correlates of so-called "benign epileptiform spikes in children", centro-temporal (rolandic) spikes and occipital spikes, have been studied in 200 children, aged 3-17 years, with mental, behavioral and neuropsychological disorders without epileptic seizures (non-paroxysmal epileptic disorders). Centro-temporal spikes prevailing in the left hemisphere were observed in older children and predominantly related to verbal and speech disorders. Occipital spikes were observed in younger children mainly in the right hemisphere being related to non-verbal and neuropsychological disorders...
2007: Zhurnal Nevrologii i Psikhiatrii Imeni S.S. Korsakova
Jacques LeLorier, Mei Sheng Duh, Pierre Emmanuel Paradis, Dominick Latrémouille-Viau, Patrick Lefebvre, Ranjani Manjunath, Odile Sheehy
BACKGROUND: Generic substitution may not always save health care costs for antiepileptic drugs (AED). OBJECTIVE: (1) To examine the economic impacts of generic substitution of lamotrigine in Canada; and (2) to convert observed Canadian costs to a United States (US) setting. METHODS: Health claims from Québec's health plan (RAMQ) between 08/2002 and 07/2006 were analyzed. Patients with > or = 1 epilepsy claim and treated with branded lamotrigine (Lamictal) before generic entry were selected...
April 2008: Current Medical Research and Opinion
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