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Valproic Acid Toxicity

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61. Practice Parameter update: Managment issues for women with epilepsy - Focus on pregnancy: Vitamin K, folic acid, blood levels, and breastfeeding

1980;18:31–42. 18. Nau H, Rating D, Koch S, Hauser I, Helge H. Valproic acid and its metabolites: Placental transfer, neonatal phar- macokinetics, transfer via mother’s milk and clinical status in neonates of epileptic mothers. J Pharmacol Exp Ther 1981;219:768–777. 19. Takeda A, Okada H, Tanaka H, et al. Protein binding of four antiepileptic drugs in maternal and umbilical cord serum. Epilepsy Res 1992;13:147–151. 20. Ishizaki T, Yokochi K, Chiba K, et al. Placental transfer of anticonvulsants (...) (phenobarbital, phenytoin, valproic acid) and elimination from neonates. Pediatr Pharmacol 1981;1:291–303. 148 Neurology 73 July 14, 200921. Gomita Y, Furuno K, Akaki Y, et al. Phenobarbital in sera of epileptic mothers and their infants. Am J Ther 1995;2: 968–971. 22. YerbyMS,FrielPN,McCormickK,etal.Pharmacokinet- ics of anticonvulsants in pregnancy: alterations in plasma protein binding. Epilepsy Res 1990;5:223–228. 23. Tomson T, Palm R, Ka ¨lle ´n K, et al. Pharmacokinetics of levetiracetam during

2009 American Epilepsy Society

62. Management issues for women with epilepsy-focus on pregnancy: vitamin k, folic acid, blood levels, and breastfeeding

on the timing of the return to the prepregnancy pharmacokinetic state after pregnancy. One study demonstrated that following an empiric postpartum taper schedule of LTG reduced the occurrence of postpartum toxicity, but more systematic information is needed regarding the pharmacokinetic alterations in AED metabolism postpartum for all AEDs in order to determine the management of AED dosing in the postpartum period. RECOMMENDATIONS FOR FUTURE RESEARCH The issue of whether preconceptional folic acid (...) phenobarbital, PEMA and hydroxyphenobarbital in neonates and infants of epileptic mothers. Eur J Clin Pharmacol 1980 ; 18 : 31 –42. Nau H, Rating D, Koch S, Hauser I, Helge H. Valproic acid and its metabolites: Placental transfer, neonatal pharmacokinetics, transfer via mother’s milk and clinical status in neonates of epileptic mothers. J Pharmacol Exp Ther 1981 ; 219 : 768 –777. Takeda A, Okada H, Tanaka H, et al. Protein binding of four antiepileptic drugs in maternal and umbilical cord serum. Epilepsy

2009 American Academy of Neurology

63. Pregabalin (Lyrica or other brands) and gabapentin (Neurontin or other brands): known dangers and uncertainties during pregnancy

in children Prescrire Int 2020 ; 29 (211) : 13-20. Short-term effects of in utero exposure to antiepileptics other than valproic acid Prescrire Int 2020 ; 29 (211) : 16-17. | | | Prescrire Your change of address has been received and will be processed promptly but will not appear instantaneously Prescrire Your message has been sent (...) malformations. Children exposed in utero to pregabalin or gabapentin in the second and third trimesters of pregnancy were found to have a higher incidence of preterm birth, low birth weight, signs of drug toxicity (drowsiness, difficulty sucking, diarrhoea), withdrawal symptoms and admission to a neonatal intensive care unit. In the long term, mental and behavioural disorders are more frequent after in utero exposure to pregabalin than in unexposed children. The data on gabapentin is too scant to rule out

2020 Prescrire

64. Drug-Induced Liver Injury

induced by valproic acid, with children less than 10years old having a higher risk of developing DILI and children less than 2 having the highest risk of a fatal outcome, possibly due to differences in drug metabo- lism and reduced plasma protein binding. 69,70 In addition to susceptibility, age also seems to have an effect on DILI phenotype with younger patients more commonly developing hepatocellular injury, while older patients are more prone to a cholestatic pattern of injury. 64,71 Interestingly (...) characteristicsofthedrugareimportant,particularlylipophilic- ity and drug biotransformation. This exposes the liver to reac- tive metabolites which can covalently bind to proteins, induce oxidative stress, activate signal transduction pathways (e.g. mitogen-activated protein (MAP) kinases) and result in orga- nelle stress (e.g. mitochondrial or endoplasmic reticulum (ER) stress), interfere with bile acid transport and either lead to lethal consequences (necrosis or apoptosis) or induce adaptive responses which dampen

2019 European Association for the Study of the Liver

65. Diagnosis and Treatment of Clinical Alzheimer’s-Type Dementia

(citalopram*) Insufficient SOE (citalopram,* mirtazapine, sertraline) Cholinesterase inhibitor No difference (low SOE) Likelihood 30% CMAI improvement: RR, 0.96 (0.56-1.62) for donepezil NR NR NR Anti- convulsant Insufficient SOE (valproic acid) NR NR NR CATD=clinical Alzheimer’s-type dementia; CMAI=Cohen-Mansfield Agitation Inventory; NR=not reported; NS=no statistically significant difference; RR=relative risk; SAE=serious adverse event; SOE=strength of evidence *Citalopram was dosed up to 30 mg/day (...) Acids 121 Key Messages 121 Baseline Study Characteristics 121 Outcomes 121 Additional Supplements 122 Key Messages 122 Baseline Study Characteristics 123 Primary Outcomes 123 Chapter 8. Key Question 5: Prescription Drugs Versus Other Active Treatments for Cognition, Function, and Quality of Life 124 Prescription Drugs Versus Prescription Drugs 124 Galantamine Versus Donepezil 124 Memantine Versus Donepezil 126 Memantine Versus Antipsychotics 127 Supplements Versus Prescription Drugs 128 Key Messages

2020 Effective Health Care Program (AHRQ)

67. Managing Patients with Epilepsy during COVID-19 - Pharmacotherapy-related Recommendations

). Long half-life (~40 days) – plan to increase maintenance medication or add supplemental coverage for 2-3 following completion of therapy Worsens hypoglycemia Pediatric patients may have increased sensitivity Lopinavir/ritonavir (Kaletra) Decreased exposure of COVID drug caused by: carbamazepine, phenytoin, phenobarbital, primidone, valproic acid Carbamazepine, cannabidiol, clonazepam, clobazam lamotrigine, phenobarbital, primidone Liquid formulation contains 42.4% ethanol and 15.3% propylene glycol (...) . Although rare, Asian descent patients at higher risk for propylene glycol toxicity and potential breakthrough seizures Efficacy for treatment of COVID-19 not definitely established Strong CYP3A4 interactions Nitazoxinide No known drug interactions Nausea, abdominal pain, headache, urine discoloration No known seizure-inducing effects Oseltamivir Nausea/vomiting, headache Decreases seizure threshold No data to date support use in the treatment of COVID-19 Remdesivir (investigational drug) Unknown

2020 American Epilepsy Society

68. Bevacizumab, Chemotherapy and Valproic Acid in Advanced Sarcomas

if there is no residual toxicity from previous treatments. Toxicity must be graded as 0 or 1 prior to study. Patients must have had disease progression on or following their most recent treatment regimen or on presentation for the first time with locally advanced unresectable or metastatic disease. 1.All subtypes of sarcoma are eligible for the trial. Exclusion Criteria: Prior use of Bevacizumab for the treatment of cancer. Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer. Patients who (...) Bevacizumab, Chemotherapy and Valproic Acid in Advanced Sarcomas Bevacizumab, Chemotherapy and Valproic Acid in Advanced Sarcomas - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Bevacizumab, Chemotherapy

2010 Clinical Trials

69. Temsirolimus and Valproic Acid in Treating Young Patients With Relapsed Neuroblastoma, Bone Sarcoma, or Soft Tissue Sarcoma

of temsirolimus, valproate, and VEGF-A with toxicity and disease response. To evaluate the ability of selected member divisions of a newly developed North Carolina-based pediatric oncology consortium to cooperate in clinical trials. OUTLINE: This a multicenter, dose-escalation study of temsirolimus. Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22 and oral valproic acid* 3 times daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease (...) progression or unacceptable toxicity. Blood samples are collected at baseline and periodically during study for pharmacokinetic and VEGF-A studies. Tumor tissue samples from archived biopsy are also analyzed for IGF-IR, mTOR expression, HDAC, and autophagy biomarkers. After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 2 years, and then every 6 months for 2 years. NOTE: * Doses of valproic acid are titrated beginning 3-7 days prior to starting

2010 Clinical Trials

70. Valproic Acid With Chemoradiotherapy for Non-Small-Cell Lung Cancer

and oral valproic acid (VA)will be started at the first day of RT. Follow up will be conducted every 3 months after completion of the study treatment. Toxicity will be assessed using CTCAE, based on clinical examination and laboratory tests during the study treatment and at follow up visits. Response to treatment will be evaluated using RECIST criteria. Overall and progression free survival (OS and PFS) will be estimated using the Kaplan-Meier method. Condition or disease Intervention/treatment Phase (...) Lung Cancer Study Start Date : February 2011 Estimated Primary Completion Date : February 2013 Estimated Study Completion Date : February 2015 Resource links provided by the National Library of Medicine related topics: related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Valproic acid, Chemoradiotherapy Drug: Valproic acid 800mg per day for entire period of RT Other Name: Sodium valproate Outcome Measures Go to Primary Outcome Measures : Toxicity [ Time Frame: 24

2010 Clinical Trials

71. Placenta Transfer and Toxicokinetics of Valproic Acid in Pregnant Cynomolgus Monkeys Full Text available with Trip Pro

Placenta Transfer and Toxicokinetics of Valproic Acid in Pregnant Cynomolgus Monkeys Placenta transfer study in non-human primate (NHP) is one of the crucial components in the assessment of developmental toxicity because of the similarity between NHP and humans. To establish the method to determine placenta transfer in non-human primate, toxicokinetics of valproic acid (VPA) , a drug used to treat epilepsy in pregnant women, were determined in pregnant cynomolgus monkeys. After mating

2010 Toxicological research

72. Guidance on the clinical management of anxiety disorders, specifically focusing on diagnosis and treatment strategies

and GAD, but their use raises concerns about side effects, tolerability and danger in overdose. TCAs should generally be reserved for patients who have not responded to, or been unable to tolerate, SSRIs and SNRIs. The irreversible monoamine oxidase inhibitors (MAOIs) have proven efficacy in SAD and panic disorder. However, their use in the treatment of these disorders has been lim- ited, due to significant potential adverse effects, the need for dietary restrictions, toxicity in overdose

2018 Royal Australian and New Zealand College of Psychiatrists

73. Guanfacine (Intuniv) for attention deficit hyperactivity disorder Full Text available with Trip Pro

with valproic acid can lead to increased levels of valproate. Sedative effects may be increased if guanfacine is taken at the same time as other CNS depressants. Long-term safety In a 2-year, open-label extension of two guanfacine Phase III randomised controlled trials in 214 participants with ADHD aged 6–17 years, TEAEs leading to discontinuation were reported in seven (3.3%) participants. These were somnolence (two participants), aggression, first-degree atrioventricular block, dizziness, drug abuse (...) to 24 hours for the development of more serious toxicity (including coma, bradycardia, and hypotension) due to the possibility of delayed onset of these symptoms. For information about reporting adverse reactions to the TGA, or to report suspected adverse reactions online, see the . Drug interactions Guanfacine is a substrate of CYP3A4/3A5 and caution is required if it is co-administered with CYP3A4/3A5 inducers (such as rifampicin) and inhibitors (such as ketoconazole). Co-administration

2019 National Prescribing Service Limited (Australia)

74. Allopurinol / lesinurad (Duzallo) - Gout

5/100 PRAC Pharmacovigilance Risk assessment Committee PRO Patient reported outcome PSUR Periodic Safety Update Report PT Preferred Term pUA Plasma uric acid (also referred to as plasma urate) PV Pharmacovigilance PVA Polyvinyl alcohol PVC polyvinyl chloride PVDC polyvinylidene chloride PYE Person years of exposure QbD Quality by design QD Once daily RH Relative Humidity RMP Risk Management Plan SAE Serious adverse event sCr Serum creatinine SMs Starting materials SmPC Summary of Product (...) Characteristics SOC System Organ Class sUA Serum uric acid (also referred to as serum urate) SURI Selective UA reabsorption inhibitor TEAE Treatment emergent adverse event TTC Threshold of Toxicological Concern UA Uric acid ULT Urate-lowering therapy URAT1 Uric acid transporter 1 US United States USP United States Pharmacopoeia UV Ultraviolet XOI Xanthine oxidase inhibitor XRPD X-ray powder diffraction Assessment report EMA/474026/2018 Page 6/100 1. Background information on the procedure 1.1. Submission

2018 European Medicines Agency - EPARs

75. Clonazepam

and clonazepam . 1612 Carroll W M WM Walsh P J PJ eng Case Reports Journal Article England Br Med J 0372673 0007-1447 0 Benzodiazepinones 5PE9FDE8GB Clonazepam 614OI1Z5WI Valproic Acid C1LJO185Q9 5 (...) -Hydroxytryptophan AIM IM Brain. 1978 Mar;101(1):143-62 638722 Brain. 1977 Sep;100(3):455-87 412560 5-Hydroxytryptophan therapeutic use Adult Benzodiazepinones therapeutic use Clonazepam therapeutic use Drug Therapy, Combination Female Humans Hypoxia, Brain complications Myoclonus drug therapy etiology (...) Valproic Acid therapeutic use PMC1608844 1978 12 9 1978 12 9 0 1 1978 12 9 0 0 ppublish 365292 PMC1608844 1978 14. Clonazepam add-on therapy for refractory epilepsy in adults and children [Cochrane Protocol] Clonazepam add-on therapy for refractory epilepsy in adults and children [Cochrane Protocol] PROSPERO International prospective register of systematic reviews Clonazepam add-on therapy for refractory epilepsy in adults and children [Cochrane Protocol] Lin Song, Fang Liu, Ruoqi Zhang, Huanhuan Ji

2018 Trip Latest and Greatest

76. Lithium

Psychotropic Drugs 614OI1Z5WI Valproic Acid IM Int J Geriatr Psychiatry. 2001 Oct;16(10):1004-9 11607947 J Clin Psychiatry. 2002 Oct;63(10):942-7 12416605 BMJ. 2003 May 3;326(7396):960-1 12727769 Psychiatry Clin Neurosci. 2004 Feb;58(1):25-9 2015 15. Every reason to discontinue lithium 26092398 2015 06 20 2015 06 20 2017 02 20 2 1 2014 Dec International journal of bipolar disorders Int J Bipolar Disord Every reason to discontinue lithium . 12 10.1186/s40345-014-0012-y Lithium as a gold standard therapy (...) suffering from bipolar disorders and preventing acute suicidal and manic episodes. But there is a fine line – a narrow 2014 6. Lithium toxicity - emergency management 2017 7. Lithium Use in Pregnancy and the Risk of Cardiac Malformations. Background There has been concern that exposure to lithium early in pregnancy may be associated with a marked increase in the risk of Ebstein's anomaly (a right ventricular outflow tract obstruction defect) in infants and overall congenital cardiac defects, but data

2018 Trip Latest and Greatest

78. Psychiatric Aspects of Infertility

infertility treatment. Ginekologia polska, 88(2), pp.109–112. Golub, M. et al., 2005. NTP-CERHR Expert Panel Report on the reproductive and developmental toxicity of amphetamine and methamphetamine. Birth defects research. Part B, Developmental and reproductive toxicology, 74(6), pp.471–584. Gotlib, D. et al., 2017. Valproic Acid in Women and Girls of Childbearing Age. Current psychiatry reports, 19(9), p.58. Hall, E. & Steiner, M., 2013. Serotonin and female psychopathology. Women’s health , 9(1), pp.85 (...) be increased by treatment with certain mood stabilizers. Studies show a significantly higher rate of menstrual cycle disorders, hyperandrogenism and PCOS (which have been associated with infertility), in women receiving prolonged valproate therapy for bipolar disorder (Okanovic & Zivanovic 2016; Gotlib et al. 2017; Morrell et al. 2003). Given the risk of teratogenic effects (e.g., neural tube defects), valproic acid should be avoided in women planning a pregnancy (Gotlib et al. 2017). Additionally, given

2019 American Psychiatric Association

79. CRACKCast E206 – Seizures

IM or IV at max rate of 150 mg/min Valproic Acid 20-40 mg/kg at 3-6 mg/kg/min Keppra 1000-3000 mg of 15 minutes If the seizure still has not stopped with second line therapies: Intubation and EEG recommended Treat with one of the following third-line medications: Pentobarbitol 5 mg/kg IV at 1-5 mg/kg/hr, then 0.5-3.0 mg/kg/hr infusion as needed Phenobarbitol 20 mg/kg IV at 50-75 mg/min Midazolam 0.2mg/kg IV, then 0.1-0.4 mg/kg/hr Propofol 2 mg/kg IV at 2-5 mg/kg/hr, then 5-10 mg/kg/hr as needed (...) activity and increased synchronicity allows you to both explain the initial presentation and progression of seizure activity. Seizures can be characterized as falling into one of the categories: Primary versus Secondary Primary seizures are by definition unprovoked and not linked to some inciting event Secondary seizures occur as the result of some underlying pathophysiologic process such as toxic ingestion, trauma, metabolic disturbances, structural lesions etc… Generalized versus Focal Generalized

2019 CandiEM

80. Brivaraceta

treatment ? 1 to 3 AEDs in a stable dosage with or without VNS from = 4 weeks (phenobarbital and primidone for at least 3 months) before baseline period: carbamazepine, clobazam, clonazepam, diazepam, ethosuximide, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, pregabalin, primidone, tiagabine, topiramate, valproic acid, zonisamide ? VNS was allowed and was not counted as AED VNS had to be in place = 9 months before study inclusion ? benzodiazepines were allowed (...) : Institute’s calculation: sodium valproate + valproic acid + magnesium valproate + valpromide. d: Institute’s calculation: phenytoin + phenytoin sodium. CBZ: carbamazepine; CLB: clobazam; CZP: clonazepam; FAS: full analysis set; GBP: gabapentin; ITT: intention to treat; LEV: levetiracetam; LTG: lamotrigine; OXC: oxcarbazepine; PB: phenobarbital; PGB: pregabalin; PHT: phenytoin; PRM: primidone; TPM: topiramate; VPA: valproate; ZNS: zonisamide The patient characteristics were balanced within the studies

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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