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Valproic Acid Toxicity

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102. 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

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

107. 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

108. 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

109. 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

110. 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

111. 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

112. 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

113. 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

115. 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

116. 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

117. 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

118. Childhood Acute Lymphoblastic Leukemia Treatment (PDQ®): Health Professional Version

to be higher for children with Down syndrome. Rare germline variants with high penetrance. Germline variants that cause pathogenic changes in genes associated with ALL and that are observed in kindreds with familial ALL (i.e., large effect sizes) comprise another category of genetic predisposition to ALL. PAX5 . A germline variant in PAX5 that substitutes serine for glycine at amino acid 183 and that reduces PAX5 activity has been identified in several families that experienced multiple cases of ALL (...) .[ - ] Cytogenetic and genomic findings combined with minimal residual disease (MRD) results can define subsets of ALL with EFS rates exceeding 95% and, conversely, subsets with EFS rates of 50% or lower (refer to the and sections of this summary for more information). Despite the treatment advances in childhood ALL, numerous important biologic and therapeutic questions remain to be answered before the goal of curing every child with ALL with the least associated toxicity can be achieved. The systematic

2018 PDQ - NCI's Comprehensive Cancer Database

119. Canadian clinical practice guidelines for the management of anxiety, posttraumatic stress and obsessive-compulsive disorders

in fact be decreased [99,100]. Careful monitoring for evidence of self-harming or suicidal thoughts or behaviors is impor- tant inboth adult and pediatric patients. SSRIs and SNRIs are generally better tolerated and safer than TCAs and MAOIs, having less anticholinergic effects, toxicity, lethality, and psychomotor or cognitive impairment [85,101]. MAOIs are generally reserved for second- or third-line treatment because of side effects, drug interactions, and dietary restrictions [32]. Anxiolytics (...) therapies (see Sec- tions 3–9 for evidence and references). Anticonvulsants: Anticonvulsants are associated with gastrointestinal side effects, somnolence, weight gain, tremor, as well as dermatologic and hematologic side effects [111,118]. In addition, several anticonvulsants have a potential risk of serious rash, erythema multi- forme, Stevens-Johnson syndrome, or toxic epidermal necrolysis [111]. Regular monitoring of serum medica- tion levels and liver function is required for patients on divalproex

2014 CPG Infobase

120. Migraine: Drugs for the prevention of migraine

been reported with topiramate treatment. This risk is dose-related. In patients who develop unexplained lethargy or changes in mental status associated with topiramate monotherapy or adjunctive therapy, it is recommended to consider hyperammonemic encephalopathy and to measure serum ammonia levels. Hyperammonemia has been reported more frequently when topiramate is used concomitantly with valproic acid. Musculoskeletal disorders — joint disorders, and muscle weakness. Haematological disorders (...) result in an enhanced hypotensive effect. Ergotamine or related compounds — vasospastic reactions have been reported. Pregnancy and breastfeeding Pregnancy Avoid — beta-blockers may cause intra-uterine growth restriction, neonatal hypoglycaemia, and bradycardia. Manufacturer advises that propranolol should not be given in pregnancy unless essential. Breast feeding Amount present in breast milk likely too small to affect infants however there is a risk of possible toxicity due to beta-blockade

2018 NICE Clinical Knowledge Summaries

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