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Valproic Acid Toxicity

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101. CRACKCast E091 – Pancreas

of GI bleeding Bowel obstruction correction Treatment of acute cholangitis / venous thrombosis Wisecracks Question 1) Specifically list 10 drug causes of pancreatitis. Cannabis Codeine Dapsone Enalapril Furosemide Isoniazid Metronidazole Pravastatin Procainamide Simvastatin Sulfamethoxazole Tetracycline Valproic acid These are some of the class Ia drugs – from Uptodate – where people have developed pancreatitis on a re-challenge of the drug and other causes of pancreatitis have been ruled out (e.g (...) pancreatitis? Causes Toxic-metabolic ETOH abuse Smoking Obstructive Genetic Autoimmune Post-necrotic acute pancreatitis Idiopathic Diagnosis: Clinical features, laboratory analysis, imaging tests – still the best rule of thumb However, lab tests are less helpful: Amylase and lipase may not rise to the same degree or may be normal Liver function tests may be elevated due to concurrent ETOH abuse / biliary obstruction due to cirrhosis Likely have chronic hypoalbuminemia, hypocalcemia, hyperglycemia X-rays

2017 CandiEM

103. Bipolar disorder: assessment and management

] [2018] 1.6.6 Follow the recommendations on using antipsychotics in section 1.10 and be aware of the potential interactions between valproate [18] and fluoxetine, lamotrigine and olanzapine. [2018] [2018] 1.6.7 T ake into account toxicity in overdose when prescribing psychotropic medication during periods of high suicide risk. Assess the need to limit the quantity of medication supplied to reduce the risk to life if the person overdoses. Re Reviewing treatment for bipolar depression viewing treatment

2014 National Institute for Health and Clinical Excellence - Clinical Guidelines

104. Antenatal and postnatal mental health: clinical management and service guidance

, whether preterm or full term, which are physically traumatic (for example, instrumental or assisted deliveries or emergency caesarean sections, severe perineal tears, postpartum haemorrhage) and births that are experienced as traumatic, even when the delivery is obstetrically straightforward. V Valproate alproate Refers to 3 formulations of valproate available in the UK: sodium valproate and valproic acid (licensed for the treatment of epilepsy) and semi-sodium valproate (licensed for the treatment (...) of acute mania and continuation treatment in people whose mania responds to treatment). Both Antenatal and postnatal mental health: clinical management and service guidance (CG192) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 13 of 50semi-sodium and sodium valproate are metabolised to valproic acid (also known as valproate), which is the pharmacologically active component. Valproate must not be used in pregnancy

2014 National Institute for Health and Clinical Excellence - Clinical Guidelines

105. Folic acid

eating normally more difficult. Also, bone marrow depression (inducing leukopenia and thrombocytopenia) and acute kidney and liver failure have been reported. , under the drug name , a form of folate (formyl-THF), can help "rescue" or reverse the toxic effects of methotrexate. Folinic acid is not the same as folic acid. Folic acid supplements have little established role in cancer chemotherapy. Cases of severe adverse effects of accidental substitution of folic acid for folinic acid have been (...) [ ] The risk of toxicity from folic acid is low, because folate is a water-soluble vitamin and is regularly removed from the body through urine. One potential issue associated with high doses of folic acid is that it has a masking effect on the diagnosis of due to vitamin B 12 deficiency. An additional concern raised was that low vitamin B 12 status in combination with high folic acid intake appeared to increase the risk of cognitive impairment. The IOM sets ULs for vitamins and minerals when evidence

2012 Wikipedia

106. Uptravi (selexipag) - pulmonary arterial hypertension

Endothelin receptor antagonist GC Gas Chromatography GCP Good Clinical Practice GLP good laboratory practice GMP Good Manufacturing Practice HCl Hydrochloric acid HIV Human immunodeficiency virus HPAH Heritable pulmonary arterial hypertension (formerly familial PAH) HPLC(/DAD) High performance liquid chromatography (/Diode Array Detector) ICH International Conference on Harmonisation IMP Investigational medicinal product IPAH Idiopathic pulmonary arterial hypertension IPC In-process control IP receptor (...) manufacturing process, therefore the CHMP recommended that further stability data from the first three continuous Process Verification Batches to demonstrate consistent quality of the active substance should be provided. The stability of the active substance was also investigated one batch under stress conditions according to the Notes for Guidance Q1A (R2) and ICH Q1B. Samples were exposed to heat and moisture, light (solid state and solution), acidic, basic and oxidising conditions. Hydrolysis occurred

2016 European Medicines Agency - EPARs

107. Alcohol: Adult Unhealthy Drinking

, or a viable plan for self-management? – If no, consider linking patient with Social Work to help develop this plan. Emergent situations: unplanned, acute withdrawal Occasionally, patients may stop drinking on their own. Consider directing a patient to an emergency department for possible inpatient medical or psychiatric treatment if the patient presents with: • Acute toxicity (e.g., altered mental status) that cannot be safely managed in an outpatient setting. • A coexisting medical condition (...) Restless Miserable Problems with memory Tremor (shakes) Nausea Heart pounding Sleep disturbance Sweating 22 Determining whether medical management is necessary Most cases of mild alcohol withdrawal do not require medical intervention (Kattimani 2013). Unnecessary prophylaxis or treatment of may lead to unintentional consequences including excessive sedation, falls, respiratory depression, propylene glycol toxicity, and delirium. To determine whether medication management is needed: • Evaluate

2016 Kaiser Permanente Clinical Guidelines

108. British Association for Psychopharmacology consensus guidance on the use of psychotropic medication preconception, in pregnancy and postpartum

(e.g. (NICE, 2015b)). • Consider high dose folic acid (5 mg/d) where folate- lowering drugs are used, although the evidence for its benefit has not been shown (Wlodarczyk et al., 2012) and there is a possibility that folate may decrease the efficacy of other drugs such as lamotrigine in bipolar disorder (Geddes et al., 2016). • Although there may be some potential advantages of changing medications early in pregnancy, by mid–trimes- ter there might be fewer, if any, advantages in changing (...) that these adverse neonatal outcomes are not attributable to antidepressants toxicity McAllister-Williams et al. 13 or withdrawal but rather to the underlying maternal disorder or concurrent exposures. One naturalistic observation study com- pared the outcomes of neonates exposed to SSRIs in the last 14 days of pregnancy and neonates exposed in pregnancy but not in the last two weeks, and found an increased risk of neonatal respi- ratory distress in the last-exposed group (Warburton et al., 2010). However, when

2017 British Association for Psychopharmacology

109. Intuniv - guanfacine

Nicotinamide adenine dinucleotide Phosphate NMT Not more than NOAEL/NOEL No-observed adverse effect level/No-observed effect level MS Mass spectrometry OECD Organisation for Economic Co-operation and Development PBT Persistence, Bioaccumulation, Toxicity PCTFE Polychlorotrifluoroethene PEC Predicted Environmental Concentration P-gp P-glycoprotein Ph.Eur. European Pharmacopoeia Assessment report EMA/CHMP/534329/2015 Page 3/86 pKa Negative base - 10 logarithm of the acid dissociation constant PNEC (...) /86 List of abbreviations 5-HT 5-Hydroxytryptamine ADHD Attention deficit/ hyperactivity disorder API Active Pharmaceutical Ingredient ASMF Active Substance Master File AUC Area Under the Concentration-time Curve BOLD Blood oxygenation level dependent cDNA Complementary deoxyribonucleic acid C max Maximum value of the concentration time curve CNS Central nervous system CYP450 Cytochrome P450 DDD Defined daily dose DILUTION Dilution factor DOSE ai Maximum daily dose consumed per inhabitant DT50

2015 European Medicines Agency - EPARs

110. Cresemba - isavuconazole

for concentrate for solution for infusion are: mannitol and sulfuric acid, as described in section 6.1 of the SmPC. Other ingredients of the hard capsules are: capsule contents: magnesium citrate (anhydrous), microcrystalline cellulose, talc, anhydrous colloidal silica, stearic acid; Capsule shell: hypromellose, water, red iron oxide (E172), titanium dioxide (E171), gellan gum, potassium acetate, disodium edetate, sodium laurilsulfate; Printing ink: shellac, propylene glycol, potassium hydroxide, black iron (...) . The safety of isavuconazonium sulfate in animals has been evaluated by the oral or by the intravenous route. All pivotal toxicity studies were performed in compliance with the principles of Good Laboratory Practice (GLP). Most of the early dose-range finding or pilot studies were performed as non-GLP studies, but in GLP-accredited laboratories and according to their standards. 2.3.2. Pharmacology Isavuconazonium sulfate is a water soluble prodrug of the antifungal triazole, isavuconazole. Following oral

2015 European Medicines Agency - EPARs

111. Ravicti - glycerol phenylbutyrate

. Conclusions on the clinical safety 71 2.8. Risk Management Plan 71 2.9. Pharmacovigilance 80 Pharmacovigilance system 80 2.10. Product information 81 2.10.1. User consultation 81 2.10.2. Additional monitoring 81 Assessment report EMA/676925/2015 Page 3/89 3. Benefit-Risk Balance 81 4. Recommendations 85 5. References 87 Assessment report EMA/676925/2015 Page 4/89 List of abbreviations µg microgram µmol micromole 14C carbon radiolabel 4-PBA 4-phenylbutyric acid or phenylbutyrate (PBA) AA amino acid ADRs (...) authorization application mL milliliter MTD maximum tolerated dose NAGS N-acetylglutamate synthase NaPAA sodium phenylacetate NaPBA sodium phenylbutyrate NDA new drug application NOAEL no observed adverse effect level NOEL no effect level ODD orphan drug designation OLFS open-label fixed-sequence OTC ornithine transcarbamylase PAA phenylacetate/phenylacetic acid PAA phenylacetic acid PAG phenylacetylglycine PAGN phenylacetylglutamine PBA (formerly 4-)phenylbutyrate/(formerly 4-)phenylbutyric acid PBA

2015 European Medicines Agency - EPARs

112. Addyi - Flibanserin

in labeling. 4.2 Reproductive Toxicity Data in pregnancy were obtained from pregnant rats and rabbits; the July 16, 2015 pharm/tox review discussed the following data: Data in rats: During organogenesis, pregnant rats administered 400 mg/kg/day dose (the highest dose tested) was associated with “significant maternal toxicity as evidenced by severe clinical signs and marked reductions in weight gain during dosing. Decreased fetal weights, increases in the incidence of decreased ossification (...) of the forelimbs and increased lumbar vertebrae, and two fetuses with anophthalmia were observed in the litters of high dose dams.” The no observed adverse effect level (NOAEL) for maternal and embryofetal toxicity was 80 mg/kg/day (15 times clinical exposure based on area under the curve, AUC). When pregnant rats were given flibanserin during Day 6 to Lactation Day 21 to assess peri- and post-natal development, all doses administered resulted in sedation and decreases in body weight gain during pregnancy

2015 FDA - Drug Approval Package

116. Urinary tract infection (lower) - women

resistance. Sample containers with boric acid preservative should be filled to the marked line. If urine dipstick is negative for nitrite and positive for leukocyte, UTI is equally likely to other diagnosis. Send urine for culture to confirm diagnosis. If urine dipstick is negative for all nitrite, leukocyte and RBC, UTI is less likely. No need to send sample for urine culture — consider other diagnoses. A sample should be sent for urine culture in all women with suspected lower UTI who: Are pregnant (...) or leukocytes and blood are positive [ ]. Use of symptoms and dipsticks to diagnose UTI is not completely reliable — severity of symptoms must be considered in each specific case and appropriate safety-netting put in place [ ]. Urine samples in universal containers should be cultured within 4 hours of collection, refrigerated, or sent in a container with boric acid preservative [ ]. Boric acid can affect urine dipstick tests and cause false negative culture if urine is not filled to correct mark on specimen

2019 NICE Clinical Knowledge Summaries

118. HPLC-DAD Quantification of Flucytosine (5-Fluorocytosine)

-methylcytosine) and a precipitating agent (trichloroacetic acid) are added and mixed successively into a plasma sample. The tubes are centrifuged, then a 10 µL aliquot is injected into the HPLC-DAD system in isocratic mode with detection at 266 nm. Threshold values are as follows: ? Ineffectiveness (and risk of secondary resistance): less than 25 ?g/mL ? Optimal therapeutic level: 30 to 80 ?g/mL ? Risk of toxicity: greater than 100 ?g/mL Other authors report different threshold values. 2.4 Licence (...) Tolbutamide X Tricyclic antidepressants X Valproic acid 499 µmol/L Warfarin X *HPLC-DAD method.

2015 Canadian Agency for Drugs and Technologies in Health - Rapid Review

119. Acute pain management: scientific evidence (3rd 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

2015 National Health and Medical Research Council

120. Childhood Astrocytomas Treatment (PDQ®): Health Professional Version

at specific amino acids in histone genes, and together these account for approximately one-half of pediatric high-grade gliomas. The following pediatric high-grade glioma subgroups were identified on the basis of their DNA methylation patterns, and they show distinctive molecular and clinical characteristics:[ ] H3.3 ( H3F3A ) and H3.1 ( HIST1H3B and, rarely, HIST1H3C ) mutation at K27: The Histone K27–mutated cases occur predominantly in middle childhood (median age, approximately 10 years), are almost

2018 PDQ - NCI's Comprehensive Cancer Database

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