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https://www.readbyqxmd.com/read/27881103/demonstration-of-early-efficacy-results-of-the-delayed-release-combination-of-doxylamine-pyridoxine-for-the-treatment-of-nausea-and-vomiting-of-pregnancy
#1
Gideon Koren, Shannon Clark, Gary D V Hankins, Steve N Caritis, Jason G Umans, Menachem Miodovnik, Donald R Mattison, Ilan Matok
BACKGROUND: Nausea and vomiting of pregnancy (NVP) affects up to 80% of expecting mothers. In April 2013 the FDA approved the delayed-release combination of doxylamine succinate and pyridoxine hydrochloride (Diclegis®) for NVP, based in part, on the results of a phase III randomized trial demonstrating the efficacy of this drug combination [study drug marketed under the trade name Diclectin® in Canada and Diclegis® in the United States] compared to placebo in pregnant women. Study drug dosing occurred for 14 days, which is substantially longer than what has been performed in similar studies...
November 24, 2016: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/27798077/a-fatality-related-to-the-synthetic-opioid-u-47700-postmortem-concentration-distribution
#2
Iain M McIntyre, Ray D Gary, Sandra Joseph, Robert Stabley
In this case report, we present an evaluation of the distribution of postmortem concentrations of 3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide (U-47700) in a fatality attributed principally to the drug. A man who had a history of drug abuse was found unresponsive and not breathing on his bed. Drug paraphernalia, indicating drug insufflation, was located in the decedent's room. Toxicology screening tests in peripheral blood initially identified U-47700 using an alkaline drug screen with gas chromatography-mass spectrometry (GC-MS) following solid-phase extraction...
October 26, 2016: Journal of Analytical Toxicology
https://www.readbyqxmd.com/read/27731292/treatments-for-hyperemesis-gravidarum-and-nausea-and-vomiting-in-pregnancy-a-systematic-review-and-economic-assessment
#3
Amy O'Donnell, Catherine McParlin, Stephen C Robson, Fiona Beyer, Eoin Moloney, Andrew Bryant, Jennifer Bradley, Colin Muirhead, Catherine Nelson-Piercy, Dorothy Newbury-Birch, Justine Norman, Emma Simpson, Brian Swallow, Laura Yates, Luke Vale
BACKGROUND: Nausea and vomiting in pregnancy (NVP) affects up to 85% of all women during pregnancy, but for the majority self-management suffices. For the remainder, symptoms are more severe and the most severe form of NVP - hyperemesis gravidarum (HG) - affects 0.3-1.0% of pregnant women. There is no widely accepted point at which NVP becomes HG. OBJECTIVES: This study aimed to determine the relative clinical effectiveness and cost-effectiveness of treatments for NVP and HG...
October 2016: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/27701665/treatments-for-hyperemesis-gravidarum-and-nausea-and-vomiting-in-pregnancy-a-systematic-review
#4
Catherine McParlin, Amy O'Donnell, Stephen C Robson, Fiona Beyer, Eoin Moloney, Andrew Bryant, Jennifer Bradley, Colin R Muirhead, Catherine Nelson-Piercy, Dorothy Newbury-Birch, Justine Norman, Caroline Shaw, Emma Simpson, Brian Swallow, Laura Yates, Luke Vale
Importance: Nausea and vomiting affects approximately 85% of pregnant women. The most severe form, hyperemesis gravidarum, affects up to 3% of women and can have significant adverse physical and psychological sequelae. Objective: To summarize current evidence on effective treatments for nausea and vomiting in pregnancy and hyperemesis gravidarum. Evidence Review: Databases were searched to June 8, 2016. Relevant websites and bibliographies were also searched...
October 4, 2016: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/27512487/ondansetron-and-pregnancy-understanding-the-data
#5
REVIEW
Debra Kennedy
Nausea and vomiting of pregnancy (NVP) is a common condition affecting 75% of pregnant women. NVP generally commences early in the first trimester, peaking in severity between 7 and 12 weeks and in over 90% symptoms will have abated by week 20. Thus, the time when women are most likely to have NVP and require treatment coincides with the embryonic period when there is maximum susceptibility to any teratogenic risk. Following the thalidomide tragedy of 55 years ago there is a particular awareness and sensitivity about these potential risks, especially in relation to any medication used to treat NVP...
March 2016: Obstetric Medicine
https://www.readbyqxmd.com/read/27404374/development-and-validation-of-a-generic-high-performance-liquid-chromatography-for-the-simultaneous-separation-and-determination-of-six-cough-ingredients-robustness-study-on-core-shell-particles
#6
Ali Mohamed Yehia, Hebatallah Mohamed Essam
A generally applicable high-performance liquid chromatographic method for the qualitative and quantitative determination of pharmaceutical preparations containing phenylephrine hydrochloride, paracetamol, ephedrine hydrochloride, guaifenesin, doxylamine succinate, and dextromethorphan hydrobromide is developed. Optimization of chromatographic conditions was performed for the gradient elution using different buffer pH values, flow rates and two C18 stationary phases. The method was developed using a Kinetex® C18 column as a core-shell stationary phase with a gradient profile using buffer pH 5...
September 2016: Journal of Separation Science
https://www.readbyqxmd.com/read/27015372/detection-of-drugs-in-275-alcohol-positive-blood-samples-of-korean-drivers
#7
Eunmi Kim, Sanggil Choe, Juseon Lee, Moonhee Jang, Hyeyoung Choi, Heesun Chung
Since driving under the influence of drugs (DUID) is as dangerous as drink-driving, many countries regulate DUID by law. However, laws against the use of drugs while driving are not yet established in Korea. In order to investigate the type and frequency of drugs used by drivers in Korea, we analyzed controlled and non-controlled drugs in alcohol-positive blood samples. Total 275 blood samples were taken from Korean drivers, which were positive in roadside alcohol testing. The following analyses were performed: blood alcohol concentrations by GC; screening for controlled drugs by immunoassay and confirmation for positive samples by GC-MS...
August 2016: Forensic Science International
https://www.readbyqxmd.com/read/26945835/assessment-and-comparison-of-vitreous-humor-as-an-alternative-matrix-for-forensic-toxicology-screening-by-gc-ms
#8
Imir G Metushi, Robert L Fitzgerald, Iain M McIntyre
Alternative specimens have been occasionally considered as substitutes for whole blood for postmortem toxicology testing. We studied the applicability of vitreous humor, and evaluated whether it would be suitable to replace (or augment) whole blood for routine drug screening. Results showed that from 51 autopsy cases, we were able to identify an aggregate of 209 findings in whole blood compared with 169 in vitreous. The total number of compounds identified was 71 for whole blood and 60 for vitreous humor. Quantitative analysis showed that whole-blood concentrations of trazodone were several fold higher than vitreous humor concentrations (1...
May 2016: Journal of Analytical Toxicology
https://www.readbyqxmd.com/read/26657408/enantioseparation-of-six-antihistamines-with-immobilized-cellulose-chiral-stationary-phase-by-hplc
#9
Jie Zhou, Pei Luo, Shanshan Chen, Lingchang Meng, Chong Sun, Qiuzheng Du, Fang Sun
A stereoselective high performance liquid chromatography method has been developed for the chiral separation of the enantiomers of six antihistamines, doxylamine, carbinoxamine, dioxopromethazine, oxomemazine, cetirizine and hydroxyzine. The effects of mobile phase additive, column temperature and flow rate on the retention time and resolution were studied. Enantiomeric separation of cetirizine, doxylamine and hydroxyzine were achieved on cellulose tris-(3,5-dichlorophenylcarbamate) immobilized on silica gel chiral stationary phase known as Chiralpak IC (RS = 3...
April 2016: Journal of Chromatographic Science
https://www.readbyqxmd.com/read/26511271/sleep-health-and-appropriate-use-of-otc-sleep-aids-in-older-adults-recommendations-of-a-gerontological-society-of-america-workgroup
#10
Steven M Albert, Thomas Roth, Michael Toscani, Michael V Vitiello, Phyllis Zee
Getting a good night's sleep can be challenging for older adults with chronic medical conditions, which often interfere with sleep. As a result, many older adults turn to over-the-counter (OTC) sleep aids, that is, products with diphenhydramine or doxylamine. However, these products are indicated only for occasional difficulty with sleep, not for chronic use; and their safety and efficacy has not been well established in general and in older adults specifically. To engage national stakeholders in a discussion of OTC sleep aids in older adults, the Gerontological Society of America (GSA) convened a multidisciplinary workgroup...
October 28, 2015: Gerontologist
https://www.readbyqxmd.com/read/26469132/effect-of-oxidation-on-amine-based-pharmaceutical-degradation-and-n-nitrosodimethylamine-formation
#11
Xiaofeng Wang, Hongwei Yang, Beihai Zhou, Xiaomao Wang, Yuefeng Xie
Four pharmaceuticals (ranitidine, nizatidine, doxylamine, and carbinoxamine) were selected as model compounds to assess the efficiency of four oxidants (ozone (O3), chlorine (Cl2), chlorine dioxide (ClO2) and potassium permanganate (KMnO4)) on the removal of amine-based pharmaceutical and personal care products (PPCPs), as well as the reduction of their N-Nitrosodimethylamine formation potentials (NDMAFPs). The changes in PPCPs and their NDMAFPs during oxidation were quantified using various oxidants and dosages...
December 15, 2015: Water Research
https://www.readbyqxmd.com/read/26348534/interventions-for-nausea-and-vomiting-in-early-pregnancy
#12
REVIEW
Anne Matthews, David M Haas, Dónal P O'Mathúna, Therese Dowswell
BACKGROUND: Nausea, retching and vomiting are very commonly experienced by women in early pregnancy. There are considerable physical, social and psychological effects on women who experience these symptoms. This is an update of a review of interventions for nausea and vomiting in early pregnancy last published in 2014. OBJECTIVES: To assess the effectiveness and safety of all interventions for nausea, vomiting and retching in early pregnancy, up to 20 weeks' gestation...
2015: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/26243801/toxicology-findings-in-cases-of-hanging-in-the-city-and-county-of-san-francisco-over-the-3-year-period-from-2011-to-2013
#13
A C San Nicolas, N P Lemos
In postmortem cases where the cause of death is hanging, toxicological analyses may be considered unnecessary by some medical examiners, toxicologists, and other persons involved in medico-legal investigations because the cause of death seems "obvious." To ascertain if toxicological analyses are necessary when the cause of death is hanging, all 102 hanging cases (25 females; 77 males) from 2011 to 2013 that came under the jurisdiction of the San Francisco Office of the Chief Medical Examiner were examined from a total of 3912 sudden, unexpected, or violent death cases in the same period...
October 2015: Forensic Science International
https://www.readbyqxmd.com/read/26025164/ethylone-related-deaths-toxicological-findings
#14
Dayong Lee, Chris W Chronister, Jennifer Hoyer, Bruce A Goldberger
Synthetic cathinones are an emerging class of designer drugs, frequently with deceptive labels and a multitude of analogs to circumvent drug control regulations. Research regarding the pharmacological effects and toxicity of these amphetamine derivatives is scarce, heightening the risk to the public health and safety. The composition of synthetic cathinone products continually changes and laboratories began to notice ethylone-positive products in late 2011. This report presents nine postmortem cases in whom ethylone was identified...
September 2015: Journal of Analytical Toxicology
https://www.readbyqxmd.com/read/25930593/neurodevelopment-of-children-after-maternal-hospitalization-for-nausea-and-vomiting-of-pregnancy-252
#15
Irena Nulman, Caroline Maltepe, Dan Farine, Gideon Koren
INTRODUCTION: Child outcomes associated with severe maternal nausea and vomiting of pregnancy are understudied. The study objective was to determine child long-term neurodevelopment after maternal hospitalization for severe nausea and vomiting of pregnancy. METHODS: Motherisk NVP Helpline callers from 2006 to 2012 were identified from our prospectively collected database. Women with nausea and vomiting of pregnancy treated with doxylamine-pyridoxine (Diclectin/Diclegis) or with no pharmacotherapy were included...
May 2015: Obstetrics and Gynecology
https://www.readbyqxmd.com/read/25884778/maternal-safety-of-the-delayed-release-doxylamine-and-pyridoxine-combination-for-nausea-and-vomiting-of-pregnancy-a-randomized-placebo-controlled-trial
#16
RANDOMIZED CONTROLLED TRIAL
Gideon Koren, Shannon Clark, Gary D V Hankins, Steve N Caritis, Jason G Umans, Menachem Miodovnik, Donald R Mattison, Ilan Matok
BACKGROUND: Nausea and vomiting of pregnancy (NVP) is the most common medical condition in pregnancy, affecting up to 80% of expecting mothers. In April 2013 the FDA approved the delayed release combination of doxylamine succinate and -pyridoxine hydrochloride (Diclegis®) for NVP, following a phase 3 randomized trial in pregnant women. The fetal safety of this medication has been proven by numerous studies. However, because it is the only FDA-approved medication for NVP that is likely to be used by a large number of pregnant women, its maternal safety is an important public health question...
March 18, 2015: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/25822385/practical-selection-of-antiemetics-in-the-ambulatory-setting
#17
Zachary A Flake, Becky S Linn, Jaime R Hornecker
Nausea and vomiting are mediated primarily by three neurotransmitter pathways: visceral stimulation releases dopamine and serotonin; vestibular and central nervous system activation release histamine and acetylcholine; and chemoreceptor trigger zone activation releases dopamine and serotonin. Clinicians can improve the effectiveness and cost-effectiveness of treatments by targeting the appropriate pathways. Antihistamines and anticholinergics are most effective in patients with vestibular-mediated nausea secondary to vertigo...
March 1, 2015: American Family Physician
https://www.readbyqxmd.com/read/25785934/pro-arrhythmic-potential-of-oral-antihistamines-h1-combining-adverse-event-reports-with-drug-utilization-data-across-europe
#18
Elisabetta Poluzzi, Emanuel Raschi, Brian Godman, Ariola Koci, Ugo Moretti, Marija Kalaba, Bjorn Wettermark, Miriam Sturkenboom, Fabrizio De Ponti
BACKGROUND: There is appreciable utilisation of antihistamines (H1) in European countries, either prescribed by physician and purchased by patients for self-medication. Terfenadine and astemizole underwent regulatory restrictions in '90 because of their cardiac toxicity, but only scarce clinical data are available on other antihistamines. AIM: To investigate the pro-arrhythmic potential of antihistamines by combining safety reports of the FDA Adverse Event Reporting System (FAERS) with drug utilization data from 13 European Countries...
2015: PloS One
https://www.readbyqxmd.com/read/25783738/maternal-safety-of-the-delayed-release-doxylamine-and-pyridoxine-combination-for-nausea-and-vomiting-of-pregnancy-a-randomized-placebo-controlled-trial
#19
Gideon Koren, Shannon Clark, Gary D V Hankins, Steve N Caritis, Jason G Umans, Menachem Miodovnik, Donald R Mattison, Ilan Matok
BACKGROUND: Nausea and vomiting of pregnancy (NVP) is the most common medical condition in pregnancy, affecting up to 80% of expecting mothers. In April 2013 the FDA approved the delayed release combination of doxylamine succinate and -pyridoxine hydrochloride (Diclegis®) for NVP, following a phase 3 randomized trial in pregnant women. The fetal safety of this medication has been proven by numerous studies. However, because it is the only FDA-approved medication for NVP that is likely to be used by a large number of pregnant women, its maternal safety is an important public health question...
December 2015: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/25663469/comparing-pyridoxine-and-doxylamine-succinate-pyridoxine-hcl-for-nausea-and-vomiting-of-pregnancy-a-matched-controlled-cohort-study
#20
COMPARATIVE STUDY
Eliza Pope, Caroline Maltepe, Gideon Koren
Nausea and vomiting of pregnancy (NVP) is a common gestational condition. This is the first study to compare the use of vitamin B6 (pyridoxine) versus Diclectin (doxylamine succinate-pyridoxine HCl) for NVP symptoms. Participants were pregnant women with NVP who used either pyridoxine or doxylamine succinate-pyridoxine HCl for ≥4 days prior to calling the Motherisk NVP Helpline. Women receiving pyridoxine only (n = 80) were matched to a woman taking doxylamine succinate-pyridoxine HCl only (n = 80), accounting for potential confounders and baseline level of NVP, measured by the Pregnancy Unique Quantification of Emesis (PUQE) score...
July 2015: Journal of Clinical Pharmacology
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