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Valproic Acid Toxicity

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61. Acute pain management: scientific evidence (5th Edition)

Long-duration local anaesthetics 123 5.1.3 Local anaesthetic toxicity 126 5.2 Opioids 128 5.2.1 Neuraxial opioids 128 5.2.2 Peripheral opioids 131 Acute Pain Management: Scientific Evidence xiii CONTENTS 5.3 Adjuvant Drugs 133 5.3.1 Alpha-2 agonists 133 5.3.2 Adrenaline 134 5.3.3 Ketamine 135 5.3.4 Midazolam 136 5.3.5 Neostigmine 136 5.3.6 Magnesium 137 5.3.7 Botulinum toxin A 137 5.4 Anti-inflammatory drugs 138 5.4.1 Cortic osteroids 138 5.4.2 Non-steroidal anti-inflammatory drugs 139 References (...) 1.3 Proposed pathways of glucose-induced cellular toxicity 18 1.4 Acute pain management and rehabilitation 20 10.1 Faces Pain Scale — Revised 344SUMMARY Acute Pain Management: Scientific Evidence xix SUMMARY OF KEY MESSAGES A description of the levels of evidence and associated symbols can be found in the Introduction (see pages vi to vii). 1. PHYSIOLOGY AND PSYCHOLOGY OF ACUTE PAIN Psychological aspects of acute pain 1. Preoperative anxiety, catastrophising, neuroticism and depression

2020 National Health and Medical Research Council

63. Maternal, Fetal, and Child Outcomes of Mental Health Treatments in Women: A Systematic Review of Perinatal Pharmacologic Interventions

in proportion to the potential benefit” 21, p. 11 that the risks must be considered when deciding to use the drug. Through 2014, FDA also used to apply letter categories to drugs to indicate toxicity but has discontinued their use because of concerns about misinterpretation and oversimplification. 22 Clinical and Policy Context For women who are currently or planning to be pregnant, a critical question is whether the benefits for mother and fetus of treating psychiatric illness with pharmacologic (...) to continue treatment • Medication is warranted for symptoms or when relapse is of concern • Consider lithium for women with severe bipolar disorder • Antipsychotics are safer than mood stabilizers • Antidepressants are relatively safe but carry potential neonatal side effects Uncertainty • Discontinuing or reducing lithium dose just before delivery to avoid lithium toxicity in the infant (one guideline only) • Safety of typical vs. atypical antipsychotics • Safety of lamotrigine vs. other drugs Specific

2021 Effective Health Care Program (AHRQ)

64. Valproic Acid With Chemoradiotherapy for Pancreatic Cancer

Center Information provided by: Soroka University Medical Center Study Details Study Description Go to Brief Summary: This is non-randomized phase 2 study to evaluate toxicity and efficacy of valproic acid (VA) with concurrent chemoradiotherapy (CCRT) containing weekly gemcitabine in patients with unresectable locally advanced pancreatic cancer (ULAPC). All patients will be planned for three-dimensional conformal radiotherapy (3-DCRT). A total dose of 54 Gy will be delivered using 2 Gy daily (...) Valproic Acid With Chemoradiotherapy for Pancreatic Cancer Valproic Acid With Chemoradiotherapy for Pancreatic Cancer - 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. Valproic Acid With Chemoradiotherapy

2011 Clinical Trials

65. Low Dose CdA Combined With Valproic Acid (VPA) in Previously Treated B-cell Chronic Lymphocytic Leukemia(B-CLL)

) to overcome resistance of CLL cells. Valproic acid (VPA) is an inhibitor of histone deacetylase (HDAC) used as an anticonvulsant and mood-stabilizing drug for decades. VPA mediates apoptosis in CLL cells through caspase activation. VPA shows toxicity toward CLL cells displaying alterations in the p53 pathway. The combination of VPA with fludarabine or 2-Chlorodeoxyadenosine (CdA, Cladribine) results in synergistic loss of B-CLL cell viability, and significant increase in apoptosis. The highest index (...) Low Dose CdA Combined With Valproic Acid (VPA) in Previously Treated B-cell Chronic Lymphocytic Leukemia(B-CLL) Low Dose CdA Combined With Valproic Acid (VPA) in Previously Treated B-cell Chronic Lymphocytic Leukemia(B-CLL) - 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

2011 Clinical Trials

66. 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

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

69. 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)

70. Hypertension in pregnancy: Nifedipine

inhibitors including macrolide antibiotics (such as erythromycin), HIV protease inhibitors (such as ritonavir), azole antimycotics (such as ketoconazole), fluoxetine, nefazodone, valproic acid, cimetidine, diltiazem, and grapefruit juice — can lead to increased plasma concentration of nifedipine. Cytochrome P450 inducers such as phenytoin, carbamazepine, and phenobarbital — can lead to decreased plasma concentration of nifedipine. [ ; ] Dosing information A modified-release preparation should be used (...) with caution include: Other antihypertensives — nifedipine may increase their blood pressure-lowering effect. Betablockers — deterioration of heart failure has been observed in isolated cases. Digoxin — may lead to reduced digoxin clearance. The person should therefore be monitored for symptoms of digoxin toxicity such as confusion, nausea, anorexia, or disturbance of colour vision. If digoxin toxicity is suspected, measure serum digoxin levels and seek specialist advice if necessary. Cytochrome P450

2020 NICE Clinical Knowledge Summaries

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. 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

76. 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

77. 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

78. 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

79. 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

80. 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

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