Global Medical Cures™ | Nexium- Pediatric PostMarketing Adverse Event Review
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Journal Club
Adaptive Covid-19 Treatment Trial 1 - A critical appraisal
Review of the ACTT - 1 trial from a critical and statistical analysis perspective
Journal Club
Adaptive Covid-19 Treatment Trial 1 - A critical appraisal
Review of the ACTT - 1 trial from a critical and statistical analysis perspective
Global Medical Cures™ | INTUNIV- Pediatric PostMarket Adverse Event ReviewGlobal Medical Cures™
Global Medical Cures™ | INTUNIV- Pediatric PostMarket Adverse Event Review
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Inappropriate drug use in hospitalized elderly patients of medicine and cardi...Apollo Hospitals
National committee on quality assurance, USA convened an expert consensus panel and identified the list of drugs which should be avoided in the elderly people. This resulting list of drugs after 2003 beers criteria were added to the 2006 Health Plan Employer Data and Information Set (HEDIS) to assess the drug prescribing in elderly people.
Saccharomyces boulardii in the prevention of antibiotic-associated diarrhoea ...Utai Sukviwatsirikul
Saccharomyces boulardii in the prevention of antibiotic-associated
diarrhoea in children: a randomized double-blind placebo-controlled
trial
M. KOTOWSKA, P. ALBRECHT & H. SZAJEWSKA
Department of Pediatric Gastroenterology and Nutrition, The Medical University of Warsaw, Warsaw, Poland
Accepted for publication 24 November 2004
Impact of potential inappropriate nsai ds use in chronic painAbout Silvia Ussai
Pain remains one of the main reasons for medical consultation worldwide: moderate- to severe-intensity pain occurs in 19% of adult Europeans, seriously affecting the quality of their social and working lives. Nonsteroidal anti-inflammatory drugs (NSAIDs) are not recommended for long-term use and a careful surveillance to monitor for toxicity and efficacy is critical.
Essential medicines are those medicines that satisfy the priority health care needs of the
population. WHO published the first essential medicine list in 1977 and has been updating it
every two years since. Nepal being a signatory of the Alma Ata declaration (1978) implemented the essential medicine
program with a first ever National List of Essential Medicines, NLEM in 1986. Since then NLEM revised five times (1992, 1997, 2002, 2011 and 2016) with the support from
WHO Nepal
Global Medical Cures™ | BREAST CANCER- Reducing the Risk with MedicineGlobal Medical Cures™
Global Medical Cures™ | BREAST CANCER- Reducing the Risk with Medicine
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Global Medical Cures™ | INTUNIV- Pediatric PostMarket Adverse Event ReviewGlobal Medical Cures™
Global Medical Cures™ | INTUNIV- Pediatric PostMarket Adverse Event Review
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Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Inappropriate drug use in hospitalized elderly patients of medicine and cardi...Apollo Hospitals
National committee on quality assurance, USA convened an expert consensus panel and identified the list of drugs which should be avoided in the elderly people. This resulting list of drugs after 2003 beers criteria were added to the 2006 Health Plan Employer Data and Information Set (HEDIS) to assess the drug prescribing in elderly people.
Saccharomyces boulardii in the prevention of antibiotic-associated diarrhoea ...Utai Sukviwatsirikul
Saccharomyces boulardii in the prevention of antibiotic-associated
diarrhoea in children: a randomized double-blind placebo-controlled
trial
M. KOTOWSKA, P. ALBRECHT & H. SZAJEWSKA
Department of Pediatric Gastroenterology and Nutrition, The Medical University of Warsaw, Warsaw, Poland
Accepted for publication 24 November 2004
Impact of potential inappropriate nsai ds use in chronic painAbout Silvia Ussai
Pain remains one of the main reasons for medical consultation worldwide: moderate- to severe-intensity pain occurs in 19% of adult Europeans, seriously affecting the quality of their social and working lives. Nonsteroidal anti-inflammatory drugs (NSAIDs) are not recommended for long-term use and a careful surveillance to monitor for toxicity and efficacy is critical.
Essential medicines are those medicines that satisfy the priority health care needs of the
population. WHO published the first essential medicine list in 1977 and has been updating it
every two years since. Nepal being a signatory of the Alma Ata declaration (1978) implemented the essential medicine
program with a first ever National List of Essential Medicines, NLEM in 1986. Since then NLEM revised five times (1992, 1997, 2002, 2011 and 2016) with the support from
WHO Nepal
Global Medical Cures™ | BREAST CANCER- Reducing the Risk with MedicineGlobal Medical Cures™
Global Medical Cures™ | BREAST CANCER- Reducing the Risk with Medicine
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Global Medical Cures™ | Prostate Cancer- TREATMENT CHOICES
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Global Medical Cures™ |Family Guide for Nutrition & Physical ActivityGlobal Medical Cures™
Global Medical Cures™ |Family Guide for Nutrition & Physical Activity
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Global Medical Cures™ | AGE RELATED MACULAR DEGENERATION
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Global Medical Cures™ | Prescription Painkiller Overdoses (Growing Epidemic A...Global Medical Cures™
Global Medical Cures™ | Prescription Painkiller Overdoses (Growing Epidemic Among Women)
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Global Medical Cures™ | New York State Disability Chartbook
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Global Medical Cures™ | Cholesterol Medicines
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Global Medical Cures™| Smokeless Tobacco: Guide for Quitting
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Overview of Diabetes (Type 2) Medications. Discuss this with your Healthcare provider. Only you and your healthcare provider can decide on what is best for you.
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Global Medical Cures™ | Womens health - Sexually Transmitted InfectionsGlobal Medical Cures™
Global Medical Cures™ | Womens health - Sexually Transmitted Infections
Lowering risk of sexually transmitted infections, symptoms to look out for, understanding treatment, and dealing with diagnosis.
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Global Medical Cures™ | BIPOLAR DISORDER
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Global Medical Cures™ | Fast Facts- Hip Replacement
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Global Medical Cures™ | Diabetic Retinopathy
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Global Medical Cures™ | Growing Up Drug Free- Parents Guide to PreventionGlobal Medical Cures™
Global Medical Cures™ | Growing Up Drug Free- Parents Guide to Prevention
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Global Medical Cures™ | What I Need To Know About HEPATITIS C
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Global Medical Cures™ | HIV and AIDS Medicines
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Global Medical Cures™ | Genetic Testing Handbook
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Global Medical Cures™ | Responding to America's Prescription Drug Abuse CrisisGlobal Medical Cures™
Global Medical Cures™ | Responding to America's Prescription Drug Abuse Crisis
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Efficacy and safety of two doses of oral midazolam as premedication in paedia...iosrphr_editor
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
Co-Chairs, Joseph K. Han, MD, and Seth J. Isaacs, MD, prepared useful Practice Aids pertaining to chronic rhinosinusitis with nasal polyps for this CME/MOC/CC/AAPA/IPCE activity titled “Biologics in CRSwNP: Putting a Paradigm Shift Into Practice.” For the full presentation, downloadable Practice Aids, and complete CME/MOC/CC/AAPA/IPCE information, and to apply for credit, please visit us at https://bit.ly/3Tq6n1G. CME/MOC/CC/AAPA/IPCE credit will be available until May 6, 2025.
THE EFFECTS OF PERIODONTAL TREATMENT ON DIABETIC PATIENTS: THE DIAPERIO RANDO...sDJKFhjh
While many systemic diseases have been considered to be associated with periodontitis, the link between diabetes and periodontitis has been the subject of the most intensive research over the past decades.
Both periodontitis and diabetes are highly prevalent in modern societies and have a negative impact on quality of life.
Periodontal therapy might help to reduce local inflammation, and consequently, the putative systemic entry of bacterial by- products (e.g., lipopolysaccharides from Gram - negative bacterial walls) and pro- inflammatory molecules.
CLINICAL PRACTICE GUIDELINEClinical Practice Guideline Th.docxclarebernice
CLINICAL PRACTICE GUIDELINE
Clinical Practice Guideline: The Diagnosis, Management,
and Prevention of Bronchiolitis
abstract
This guideline is a revision of the clinical practice guideline, “Diagnosis
and Management of Bronchiolitis,” published by the American Academy
of Pediatrics in 2006. The guideline applies to children from 1 through
23 months of age. Other exclusions are noted. Each key action state-
ment indicates level of evidence, benefit-harm relationship, and level
of recommendation. Key action statements are as follows: Pediatrics
2014;134:e1474–e1502
DIAGNOSIS
1a. Clinicians should diagnose bronchiolitis and assess disease se-
verity on the basis of history and physical examination (Evidence
Quality: B; Recommendation Strength: Strong Recommendation).
1b. Clinicians should assess risk factors for severe disease, such as
age less than 12 weeks, a history of prematurity, underlying car-
diopulmonary disease, or immunodeficiency, when making decisions
about evaluation and management of children with bronchiolitis
(Evidence Quality: B; Recommendation Strength: Moderate Rec-
ommendation).
1c. When clinicians diagnose bronchiolitis on the basis of history and
physical examination, radiographic or laboratory studies should
not be obtained routinely (Evidence Quality: B; Recommendation
Strength: Moderate Recommendation).
TREATMENT
2. Clinicians should not administer albuterol (or salbutamol) to in-
fants and children with a diagnosis of bronchiolitis (Evidence Qual-
ity: B; Recommendation Strength: Strong Recommendation).
3. Clinicians should not administer epinephrine to infants and children
with a diagnosis of bronchiolitis (Evidence Quality: B; Recommen-
dation Strength: Strong Recommendation).
4a. Nebulized hypertonic saline should not be administered to in-
fants with a diagnosis of bronchiolitis in the emergency depart-
ment (Evidence Quality: B; Recommendation Strength: Moderate
Recommendation).
4b. Clinicians may administer nebulized hypertonic saline to infants
and children hospitalized for bronchiolitis (Evidence Quality: B;
Recommendation Strength: Weak Recommendation [based on ran-
domized controlled trials with inconsistent findings]).
Shawn L. Ralston, MD, FAAP, Allan S. Lieberthal, MD, FAAP,
H. Cody Meissner, MD, FAAP, Brian K. Alverson, MD, FAAP, Jill E.
Baley, MD, FAAP, Anne M. Gadomski, MD, MPH, FAAP,
David W. Johnson, MD, FAAP, Michael J. Light, MD, FAAP,
Nizar F. Maraqa, MD, FAAP, Eneida A. Mendonca, MD, PhD,
FAAP, FACMI, Kieran J. Phelan, MD, MSc, Joseph J. Zorc, MD,
MSCE, FAAP, Danette Stanko-Lopp, MA, MPH, Mark A.
Brown, MD, Ian Nathanson, MD, FAAP, Elizabeth
Rosenblum, MD, Stephen Sayles III, MD, FACEP, and Sinsi
Hernandez-Cancio, JD
KEY WORDS
bronchiolitis, infants, children, respiratory syncytial virus,
evidence-based, guideline
ABBREVIATIONS
AAP—American Academy of Pediatrics
AOM—acute otitis media
CI—confidence interval
ED—emergency department
KAS—Key Action Statement
LOS—length of stay
MD—mean d ...
Chronic Rhinosinusitis and Its Impact on PregnancyAI Publications
Nasal congestion is the most common symptom of pregnancy rhinitis, which disappears once the baby is born. Pregnant patients with rhinitis report symptoms in 18 to 30 percent of cases. As a result, pregnant rhinitis may have a negative impact on the pregnancy and may result in obstructive sleep apnea, which may have an adverse effect on the outcome of the pregnancy. Previous studies on the prevalence of pregnant rhinitis at various stages of pregnancy have come up with conflicting results. The purpose of this study was to investigate the prevalence of rhinosinusitis during various stages of pregnancy. At a private hospital in the Kurdistan area of Iraq, a cross-sectional observation study of patients in the second and third trimesters of pregnancy was undertaken using the 22-item Sino-Nasal Outcome Test (SNOT-22). The participants were women in their second and third trimesters of pregnancy. The study comprised 76 patients who were considered to be at low risk of becoming pregnant. Thirty-two patients were in their second trimester of pregnancy and 44 patients were in their third trimester of pregnancy when the study was conducted. When comparing the third trimester to the second trimester, the average item scores for the complete questionnaire were considerably higher (P value =0.041), indicating a more severe deterioration of cognitive function. In both the second and third trimesters, a comparison between women with and without preexisting allergic rhinitis reveals that the allergic group has significantly higher SNOT-22 scores (P value =0.007). In individuals with rhinosinusitis, the risk of miscarriage was reduced in the third trimester (P value =0.011). Rhinosinusitis is less common in the third trimester of pregnancy when compared to the second trimester, as well as when compared to patients who do not have rhinosinusitis in the first place.
Lipid Screening in Childhood for Detection of Multifactorial DyslipidemiaGlobal Medical Cures™
Lipid Screening in Childhood for Detection of Multifactorial Dyslipidemia
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Skin Cancer Screening
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Global Medical Cures™ | USA Chartbook on HealthCare for Blacks
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Global Medical Cures™ | Older Americans- Key Indicators of Well Being Global Medical Cures™
Global Medical Cures™ | Older Americans- Key Indicators of Well Being
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Global Medical Cures™ | Staggering Increase in Generic Drugs PricingGlobal Medical Cures™
Global Medical Cures™ | Staggering Increase in Generic Drugs Pricing
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Global Medical Cures™ | Dangers & Consequences of Marijuana Abuse
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Global Medical Cures™ | Harmful Interactions
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Global Medical Cures™ | Medicines for Treating Depression
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Global Medical Cures™ | Women & Depression
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Global Medical Cures™ | National Strategy for Combating Antibiotic Resistant ...Global Medical Cures™
Global Medical Cures™ | National Strategy for Combating Antibiotic Resistant Bacteria
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Global Medical Cures™ | PCAST Report- Combating Antibiotic ResistanceGlobal Medical Cures™
Global Medical Cures™ | PCAST Report- Combating Antibiotic Resistance
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Global Medical Cures™ | Physical Activity Guidelines for Americans
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Global Medical Cures™ | Dietary Guidelines for Americans
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Global Medical Cures™ | Aging and your Eyes
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Global Medical Cures™ | Help your Child gain control over Asthma
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Global Medical Cures™ | Drugs approved for Bone Cancer
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Global Medical Cures™ | Drugs approved for Breast Cancer
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Global Medical Cures™| Drugs approved for Head and Neck Cancer
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Global Medical Cures™ | Drugs approved for Non Hodgkin Lymphoma
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Global Medical Cures™| Drugs approved for Pancreatic Cancer
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HOT NEW PRODUCT! BIG SALES FAST SHIPPING NOW FROM CHINA!! EU KU DB BK substit...GL Anaacs
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We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
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Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists
Global Medical Cures™ | Nexium- Pediatric PostMarketing Adverse Event Review
1. Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Surveillance and Epidemiology
Pediatric Postmarketing Adverse Event Review
Date: October 31, 2012
Reviewer(s): Thang La, PharmD, BCPS, Safety Evaluator
Division of Pharmacovigilance (DPV) 1
Ethan D. Hausman, MD, Medical Officer
Team Leader(s): Ann Mackey, RPh, MPH, Safety Evaluator Team
Leader, DPV 1
Division Director(s): Linda Scarazzini, MD, RPh, Director
DPV 1
Product Name(s): Nexium® (esomeprazole IV and delayed-release oral
suspension)
Pediatric
Approval Dates: December 15, 2011 (Nexium® oral suspension) (latest)
April 29, 2011 (Nexium® IV) (latest)
Application Type/Number: 021957 (Nexium® oral suspension)
021689 (Nexium® IV)
Applicant/Sponsor: AstraZeneca
OSE RCM #: 2012-1755 and 2012-1758
Reference ID: 3204251 1
2. CONTENTS
Executive Summary............................................................................................................ 2
1 Introduction................................................................................................................. 2
1.1 Background......................................................................................................... 2
1.2 Formulations and Indications.............................................................................. 2
1.3 Pediatric filing history......................................................................................... 3
1.4 Pediatric labeling (see appendix A for additional label details) ......................... 3
2 Methods and materials................................................................................................ 5
2.1 AERS Search Strategy........................................................................................ 5
3 Results and discussion ................................................................................................ 5
3.1 Nexium® powder for oral suspension (NDA 021957)....................................... 5
3.2 Nexium® IV (NDA 021689).............................................................................. 8
4 Conclusion ................................................................................................................ 11
5 Recommendations..................................................................................................... 11
6 Appendices................................................................................................................ 12
6.1 Appendix A: Pediatric Product Labeling (selected information from the label -
January 20, 2012 revision)............................................................................................ 12
6.2 Appendix B: Standard Searches....................................................................... 19
6.3 Appendix C: Adverse Event Reporting System (AERS) Database Description
20
Reference ID: 3204251 1
3. EXECUTIVE SUMMARY
In accordance with the Best Pharmaceuticals for Children Act (BPCA), the Division of
Pharmacovigilance (DPV) was asked to summarize post-marketing reports of adverse
events associated with the use of Nexium® IV and delayed-release oral suspension
formulations in pediatric patients (0-16 years of age). The main focus of this review is
pediatric deaths and pediatric reports of serious unlabeled adverse events with these
products.
The active ingredient in Nexium® is esomeprazole, the S-isomer of the proton pump
inhibitor (PPI) omeprazole. It is approved for the treatment of gastroesophageal reflux
disease (GERD) with erosive esophagitis in the pediatric population.
The Adverse Event Reporting System (AERS) database was searched for all reports of
adverse events (serious and non-serious) from the original approval dates up to the data-
lock date of June, 30, 2012. Pediatric reports represent approximately 25% (3 of 12) and
5% (6 of 124) of the total number of reports for the oral suspension and IV formulations,
respectively.
There were no reports of death in children that were attributed to the use of either
formulation. We identified no new serious unlabeled pediatric safety issues.
DPV recommends continued routine pharmacovigilance monitoring.
1 INTRODUCTION
1.1 BACKGROUND
The Division of Pharmacovigilance was asked to perform two safety reviews; one to
summarize post-marketing reports of adverse events associated with the use of Nexium®
IV in pediatric patients (0-16 years of age), and the other to summarize post-marketing
reports of adverse events associated with the use of Nexium® delayed-release oral
suspension formulations in pediatric patients (0-16 years of age). Per agreement with the
Office of Pediatric Therapeutics, this single review of both products fulfills both consult
requests.
1.2 FORMULATIONS AND INDICATIONS
Formulations:
Nexium® oral (esomeprazole magnesium) formulations:
• Delayed-Release oral suspension: 10mg, 20mg, and 40mg
• Delayed-Release capsules: 20mg and 40mg
Nexium® IV (esomeprazole sodium) formulations:
• 20mg and 40mg powder for injection in single-use vials
Reference ID: 3204251 2
4. Indications:
• Symptomatic treatment of GERD
• Healing and maintenance of healing of erosive esophagitis
• Risk reduction of NSAID-Associated gastric ulcer (oral formulations)
• H. pylori eradication to reduce risk of duodenal ulcer recurrence (oral
formulations)
• Pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
(oral formulations
1.3 PEDIATRIC FILING HISTORY
• April 28, 2006: First pediatric labeling approval for Nexium® capsules for
adolescents 12-17 years of age for short-term treatment of GERD based on
extrapolation from studies in adults, and safety and PK studies in adolescents.
• February 27, 2008: Pediatric label was expanded to include patients 1-11 years
for short-term treatment of GERD based on extrapolation from studies in adults,
and safety and PK studies in pediatric and adolescent patients.
• June 18, 2009: For Nexium® oral suspension, effectiveness for the treatment of
GERD was not supported by data from studies in neonates to 11 months.
• April 29, 2011: Nexium® IV label was expanded for the treatment of erosive
esophagitis due to GERD to include patients 1 month to 17 years based on studies
in adults, and PK and PD studies in pediatric patients.
• December 15, 2011: Nexium® oral suspension label was expanded to include
patients 1 month to < 1 year for short-term treatment (up to 6 weeks) of erosive
esophagitis due to GERD based on studies in adults and safety, PK, PD studies in
pediatric patients. Nexium® was already approved for the treatment of GERD in
adults and children 1 year or older.
1.4 PEDIATRIC LABELING
1
(SEE APPENDIX A FOR ADDITIONAL LABEL DETAILS)
• Indication and Usage: (Pediatric indications only)
Oral suspension:
Symptomatic treatment of GERD in children 1 year or older.
Short-term treatment (4-8 weeks) in healing of erosive esophagitis. An additional
4-8 week course may be considered. In infants 1 month to less than 1 year, short-
term treatment is up to 6 weeks.
IV formulation:
Short-term treatment of GERD with erosive esophagitis in adults and pediatric
patients 1 month to 17 years, as an alternative to oral therapy when oral therapy is
not possible or appropriate.
1
Labels of Axid® capsule/granule for oral suspension (NDA 021957, revision date 1/2012) and IV (NDA
021689, revision date 1/2012)
Reference ID: 3204251 3
5. • Dosage and Administration:
Table 1: Dosage and Administration
ORAL SUSPENSION:
12 to 17 years
Short-term Treatment of
GERD
20mg or 40mg Once Daily for up to 8
Weeks
1 to 11 years (doses over 1mg/kg/day have not been studied)
Short-term Treatment of
Symptomatic GERD
10 mg Once Daily for up to 8
Weeks
Healing of Erosive Esophagitis
weight < 20 kg 10 mg Once Daily for 8 Weeks
weight ≥ 20 kg 10 mg or 20 mg Once Daily for 8 Weeks
1 month to < 1 year (doses over 1.33mg/kg/day have not been studied)
Erosive esophagitis due to acid-mediated GERD
weight 3 kg to 5 kg 2.5 mg Once Daily for up to 6
Weeks
weight > 5 kg to 7.5 kg 5 mg Once Daily for up to 6
Weeks
weight >7.5 kg to 12 kg 10 mg Once Daily for up to 6
Weeks
IV FORMULATION (infused over 10 to 30 minutes):
1 year to 17 years
weight < 55 kg: 10 mg n/a
weight >55 kg 20 mg n/a
1 month to 1 year 0.5 mg/kg n/a
Reference ID: 3204251 4
6. 2 METHODS AND MATERIALS
2.1 AERS SEARCHSTRATEGY
The Adverse Event Rep01iing System (AERS) database was searched with the su·ategy
described in Table 2 (see Appendix B).
Table 2: AERS Search Strategy for Nexium® powder for oral suspension (NDA
021957)*
Date ofsearch July 20, 2012
Time period October 20, 2006 (Approval date) to June 30, 2012
Dmg Product NDA 021957
AERS Search Strate2)' for Nexium® IV (NDA 021689)*
Date ofsearch July 20, 2012
Time period March 31,2005 (Approval date) to June 30, 2012
Dmg Product NDA 021689
* See Appendix C for description of the AERS database.
3 RESULTS AND DISCUSSION
3.1 NEXIUM® POWDER FOR ORAL SUSPENSION(NDA 021957)
Reference ID: 3204251 5
7. Table 3: Cm de cmmts1
of AERS Rep01ts for Nexium® powder for oral suspension (NDA
021957)
From October 20, 2006 (Approval Date) to June 30, 2012
All rep01ts
cusi
Serious3
(US) Death (US)
Adults(? 17 yrs.) 2 (2) 1 (1) 0 (0)
Pediatrics (0-16 yrs.) 3 (1) 2 (0)4
0 (0)
Age lmknown (Null values) 7 (7) 1 (1)
5
0 (0)
Total 12 (10) 4 (2) 0 (0)
1
May include duplicates
2
US counts in parentheses
3
Serious adverse dmg experiences per regulat01y definition (CFR 314.80) include
outcomes of death, life-threatening, hospitalization (initial or prolonged), disability,
congenital anomaly, and other serious important medical events.
4
See Figure 1
5
No pediatric cases identified
The rep01ts with the age not reported describing death outcomes or non-fatal serious
outcomes included inadequate infonnation to determine age.
Figure 1 below summarizes the specific selection of cases for Nexium® powder for oral
suspension (NDA 021957)
Reference ID: 3204251 6
8. Total Serious Pediatr ic Reports (n= 2)
Pediatric (0-16 years) Serious Outcomes Cmde Reports (n = 2)0
Pediatric deaths (n= 0)0
I
(
~
) l
~
J
Duplicate Repmts (n = 0) Unduplicated Repmts (n = 2)
II
+
Excluded cases
(n=O)
+
Pediatric Case Selies
(n= 2)
The AERS database search did not identify any previously lmlabeled serious safety issues
for Nexium® powder for oral suspension.
Deaths: No death cases were found. The two serious cases are summarized below
(unlabeled tenns are in bold font).
Non-fatal Serious Adverse Events:
Case #7694034, foreign: A 4-month-old male baby with a hist01y ofreflux previously
treated with lansoprazole, ranitidine, and domperidone began esomeprazole 1Omg daily
for reflux esophagitis sometime in November 2010. The baby was rep01ied to develop
hypersomnia (closely related to the labeled te1m 'somnolence') with armmd 20 hours of
sleep a day at an undete1mined time after first exposure. Esomeprazole was the only dmg
taken. No other infonnation was provided. Reviewer's comment: Hypersomnia is
closely related to the labeled te1m somnolence. Additionally, the administered dose
could not be dete1mined.
Case #7016971, foreign: A 5-year-old female with a medical hist01y ofceliac disease,
asthma, anemia, and cow's milk protein intolerance experienced recunent of dianhea
while on Nexium® treatment. Her medications included esomeprazole (stmi date May
30, 2009), liquid iron (unknown stmi date), montelukast (unknown stmi date),
prednisone, and other minerals/vitamins/atnino acids supplements. The symptoms were
ascribed to ongoing celiac issues; however, diatThea reportedly resolved after
discontinuation of iron and Nexium®. Reviewer's comment: Since diatThea is a core
symptom ofceliac disease and since multiple medicines were stmied and discontinued
around the time ofthe event, a causal relationship with Nexium® cannot be established.
Reference ID: 3204251 7
9. 3.2 NEXIUM® IV (NDA 021689)
Table: Cmde cmmts1
of AERS Rep01ts for Nexium ® IV (NDA 021689)
From March 31, 2005 (Approval Date to June 30, 2012
All rep01ts Serious3
(US) Death (US)
(US)2
Adults(? 17 yrs.) 95 (17) 86(9) 11(1)
4
Pediatrics (0-16 yrs.) 6 (0) 2(0)6 (0)
Age unknown (Null values) 23(15) 0(0)9 (1i
124(32) 101 (10) 13(1)Total
1
May include duplicates
2 US cmmts in parentheses
3
Serious adverse dmg experiences per regulat01y definition (CFR 314.80) include outcomes
of death, life-threatening, hospitalization (initial or prolonged), disability, congenital
anomaly, and other serious imp01tant medical events.
4
See Figure 2 and 3
5
No pediau·ic cases identified.
Figure 2. Total Number of Pediatric Reports (including serious and non-serious)
for Nexium® IV, by year of FDA receipt (from March 31, 2005 [Approval Date] to
June 30, 2012 (n=6)
These numbers include data where age (0-16 years) is known and may contain duplicate
rep01ts.
2
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Reference ID: 3204251
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FDA Received Year
8
•••••••• -- ••.. • . ...-..
10. The rep01is with the age not reported describing death outcomes or non-fatal serious
outcomes included inadequate infonnation to determine age.
Figure 3 below summarizes the specific selection of cases for Nexium® IV (NDA
021689)
Total Serious Pediatric Reports (n= 6)
0 Pediatric (0-16 years) Serious Outcomes Cmde Reports (n = 6)
(Includes 2 deaths)
I
~ ~
Duplicate Repmts (n = 0) Unduplicated Repmts (n = 6)
( ) l J
I
't 't
Excluded Repmt s
(n = 0)
Pediatric Case Selies
(n = 6)
Includes 2 deaths
The AERS database search did not identify any major safety issues for Nexium® IV.
Overall, the case cmmts are low. Unlabeled events are in bold.
Deaths: Two deaths were rep01ied, one of which appeared attributable to complications
of intentional poly-phrumaceutical overdose rather than Nexium® administration, and the
second of which apperu·ed to be due to complications of pneumonia in a patient with HIV
infection. These cases ru·e summru·ized below.
Case #7966813, foreign: A 16-year-old male with a medical hist01y of heroin and
cocaine addiction was admitted on (bH
6
> for multiple drug intoxication and
overdose including colchicine, paracetamol (acetaminophen), roxithromycin (a macrolide
antibiotic not available in the US), oxazepam, opium, and caffeine. He experienced
worsening pulmonruy complications, deterioration of hepatic ftmction, and hematological
abn01malities despite multiple supp01i ive interventions including esomeprazole IV. His
condition worsened and he eventually died of vasoplegic shock. Reviewer's comment:
The patient appeared to die of multi-organ failm e due to intentional polyphannaceutical
overdose.
Case #8409876, foreign: A 've1y weak', 8-year-old girl with HIV infection was admitted
for aspiration pneumonia. She 'could not eat' and had 'blood in her stools'. No other
prior medical and phrumacotherapy information was available. Esomeprazole IV was
Reference ID: 3204251 9
11. provided for ‘one day.’ The patient later died of unknown causes; however, the time
course from Nexium® exposure to death cannot be determined. Reviewer’s comment:
The patient may have died due to complications of pneumonia; however there insufficient
clinical information to assess causality.
Non-fatal Serious Cases:
Case #6317786, foreign: A 10-month-old2
female with a history of severe GERD and
anastomotic stricture after surgical repair of esophageal atresia, experienced severe
pulmonary deterioration ‘immediately after’ esomeprazole was administered. A
similar event reportedly occurred approximately 6 months earlier when she experienced
mild facial edema and worsening respiratory distress (chess retraction, tachypnea,
wheezing) within 30-60 minutes of omeprazole administration. Supportive treatment
was provided and symptoms resolved after discontinuation of PPIs. There was no
reported treatment with corticosteroid or epinephrine. Reviewer’s comment: The events
described in this report appear to represent repeated PPI-related
hypersensitivity/anaphylactic reactions. Anaphylactic reaction, bronchospasm, dyspnea,
larynx edema, and facial edema are currently described in the Contraindications and
Adverse Reactions section of labeling
Case #7677779, foreign: A 10-month-old male patient was admitted on
for fever and purpura, which progressed to septic shock. He received hemodynamic
support with saline and dopamine, and was ventilated and sedated with sufentanil and
(b) (6)
ketamine. He was treated with ceftriaxone, then cefotaxime for possible meningococcal
meningitis. The next day esomeprazole IV was started, followed by furosemide IV and
bumetanide IV on the next day. During this time, his skin lesions ‘spread’ and stabilized
with around 22% body skin detachment. He was diagnosed with bullous epidermolysis.
All drugs, except sufentanil, ketamine, dobutamine, and noradrenaline were discontinued.
At the time of the report, he was improved but not fully recovered. Reviewer’s comment:
This patient’s skin lesions were present prior to first administration of esomeprazole
making this an unlikely drug event combination in this case.
Case #7125606, foreign: A 16-year-old male with acute myeloid leukemia developed
neurological events including cytotoxic edema, hemiplegia, facial palsy, and epileptic
fit after administration of chemotherapy including intrathecal methotrexate and
aracythine (cytarabine) as well as intravenous mitoxantrone. He also received multiple
other supportive drugs including analgesics, corticosteroids, antibiotics, and antifungal
drugs. Esomeprazole appears to have been provided as a cytoprotectant for the preceding
therapies. He recovered from the neurological events. Events resolved with supportive
care. Reviewer’s comment: Causality assessment is confounded by the underlying
medical condition and intrathecal administration of chemotherapy.
Case #8006883, foreign: A 6-year-old male received esomeprazole IV from February 2,
2011 for stress-induced peptic ulcer protection after a traumatic surgery for unknown
issue. On February 17, 2012, hemorrhagic gastritis was discovered during endoscopy.
2
Incorrectly reported and coded as 4-month-old at the time of report submission to AERS although the
narrative described a second exposure adverse event which occured 6 months after first exposure to PPI at
4 months of age.
Reference ID: 3204251 10
12. The reporter believed it was due to lack of esomeprazole efficacy. Reviewer’s comment:
Lack of efficacy is a risk with all drugs. There is insufficient clinical information (for
example, lack of surgical indication) to further assess causality.
4 CONCLUSION
This current DPV review of AERS reports do not identify any new clinically meaningful
pediatric safety concerns involving Nexium® IV (NDA 021689) and powder for oral
suspension (NDA 021957). The AERS searches were performed using the approval
dates rather than the later pediatric labeling dates to capture any prior potential off-label
pediatric use. To date the number of reports for Nexium® IV and powder for oral
suspension remains low and the adverse events captured are sufficiently described in the
label.
The previous review from DPV for the Pediatric Advisory Committee for PPIs in June of
2010 did not find any pediatric case for Nexium® powder for oral suspension (NDA
021957) and did not identify any unique or new pediatric safety issues for Nexium®
delayed-release capsule (NDA 021153).3
5 RECOMMENDATIONS
DPV identified no new clinically meaningful safety signals. DPV will continue routine
pharmacovigilance monitoring for Nexium® IV (NDA 021689) and powder for oral
suspension (NDA 021957).
3
Mackey A. Pediatric Post-marketing Adverse Event Review. DPV Review April 29, 2010. RCM# 2010
306
Reference ID: 3204251 11
13. 6 APPENDICES
6.1 APPENDIX A: PEDIATRIC PRODUCT LABELING (SELECTED INFORMATION FROM
THE LABEL - JANUARY 20, 2012 REVISION)
Indications and Usage: (section 1 of the label)
Oral suspension:
Treatment of Gastroesophageal Reflux Disease (GERD):
“Healing of Erosive Esophagitis
NEXIUM is indicated for the short-term treatment (4 to 8 weeks) in the healing and
symptomatic resolution of diagnostically confirmed erosive esophagitis. For those
patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week
course of NEXIUM may be considered.
In infants 1 month to less than 1 year, NEXIUM is indicated for short-term treatment (up
to 6 weeks) of erosive esophagitis due to acid-mediated GERD.
Maintenance of Healing of Erosive Esophagitis
NEXIUM is indicated to maintain symptom resolution and healing of erosive esophagitis.
Controlled studies do not extend beyond 6 months.
Symptomatic Gastroesophageal Reflux Disease
NEXIUM is indicated for short-term treatment (4 to 8 weeks) of heartburn and other
symptoms associated with GERD in adults and children 1 year or older.”
Risk Reduction of NSAID-Associated Gastric Ulcer:
“NEXIUM is indicated for the reduction in the occurrence of gastric ulcers associated
with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients
are considered to be at risk due to their age (≥ 60) and/or documented history of gastric
ulcers. Controlled studies do not extend beyond 6 months.”
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence:
“Triple Therapy (NEXIUM plus amoxicillin and clarithromycin): NEXIUM, in
combination with amoxicillin and clarithromycin, is indicated for the treatment of
patients with H. pylori infection and duodenal ulcer disease (active or history of within
the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce
the risk of duodenal ulcer recurrence.
In patients who fail therapy, susceptibility testing should be done. If resistance to
clarithromycin is demonstrated or susceptibility testing is not possible, alternative
antimicrobial therapy should be instituted.”
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome:
Reference ID: 3204251 12
14. “NEXIUM is indicated for the long-term treatment of pathological hypersecretory
conditions, including Zollinger-Ellison Syndrome.”
IV formulation:
“NEXIUM I.V. for Injection is indicated for the short-term treatment of GERD with
erosive esophagitis in adults and pediatric patients 1 month to 17 years, inclusively as an
alternative to oral therapy when oral NEXIUM is not possible or appropriate.”
Dosage and Administration: (section 2 of the label)
Oral suspension:
“NEXIUM is supplied as delayed-release capsules for oral administration or in packets
for preparation of delayed-release oral suspensions. The recommended dosages are
outlined in Table 1. NEXIUM should be taken at least one hour before meals.”
12 to 17 years
Short-term Treatment
of GERD
20 mg or 40 mg Once Daily for up to 8 Weeks
1 to 11 years (doses over 1mg/kg/day have not been studied)
Short-term Treatment of
Symptomatic GERD
10 mg Once Daily for up to 8
Weeks
Healing of Erosive Esophagitis
weight < 20 kg 10 mg Once Daily for 8 Weeks
weight ≥ 20 kg 10 mg or 20
mg
Once Daily for 8 Weeks
1 month to < 1 year (doses over 1.33mg/kg/day have not been studied)
Erosive esophagitis due to acid-
mediated GERD
weight 3 kg to 5 kg 2.5 mg Once Daily for up to 6 Weeks
weight > 5 kg to 7.5 kg 5 mg Once Daily for up to 6 Weeks
Reference ID: 3204251 13
15. weight >7.5 kg to 12 kg 10 mg Once Daily for up to 6 Weeks
“NEXIUM for Delayed-Release Oral Suspension should be administered as follows:
Empty the contents of a 2.5 mg or 5 mg packet into a container containing 5 mL of water.
For the 10 mg, 20 mg, and 40 mg strengths, the contents of a packet should be emptied
into a container containing 15 mL of water.
Stir.
Leave 2 to 3 minutes to thicken.
Stir and drink within 30 minutes.
If any medicine remains after drinking, add more water, stir, and drink immediately.
In cases where there is a need to use two packets, they may be mixed in a similar way by
adding twice the required amount of water or follow the mixing instructions provided by
your pharmacist or doctor.
For patients who have a nasogastric or gastric tube in place, NEXIUM For Delayed-
Release Oral Suspension can be administered as follows:
Add 5 mL of water to a catheter tipped syringe and then add the contents of a 2.5 mg or 5
mg NEXIUM packet. For the 10 mg, 20 mg, and 40 mg strengths, the volume of water in
the syringe should be 15 mL. It is important to only use a catheter tipped syringe when
administering NEXIUM through a nasogastric tube or gastric tube.
Immediately shake the syringe and leave 2 to 3 minutes to thicken.
Shake the syringe and inject through the nasogastric or gastric tube, French size 6 or
larger, into the stomach within 30 minutes.
Refill the syringe with an equal amount of water (5 mL or 15 mL).
Shake and flush any remaining contents from the nasogastric or gastric tube into the
stomach.”
IV formulation: infuse over 10 to 30 minutes
1 year to 17 years:
Body weight less than 55 kg: 10 mg
Body weight 55 kg or greater: 20 mg
1 month to less than 1 year of age: 0.5 mg/kg
“NEXIUM I.V. for Injection should not be administered concomitantly with any other
medications through the same intravenous site and or tubing. The intravenous line should
always be flushed with either 0.9% Sodium Chloride Injection, USP, Lactated Ringer’s
Injection, USP or 5% Dextrose Injection, USP both prior to and after administration of
NEXIUM I.V. for Injection.
The admixture should be stored at room temperature up to 30°C (86°F) and should be
administered within the designated time period as listed in the Table 1 below. No
refrigeration is required.
Reference ID: 3204251 14
16. Table 1
Diluent Administer within:
0.9% Sodium Chloride Injection, USP 12 hours
Lactated Ringer’s Injection, USP 12 hours
5% Dextrose Injection, USP 6 hours
Parenteral drug products should be inspected visually for particulate matter and
discoloration prior to administration, whenever solution and container permit.
As soon as oral therapy is possible or appropriate, intravenous therapy with NEXIUM
I.V. for Injection should be discontinued and the therapy should be continued orally.”
Warnings and Precautions: (section 5 of the label)
Risk of Concomitant Gastric Malignancy
“Symptomatic response to therapy with NEXIUM does not preclude the presence of
gastric malignancy.”
Atrophic Gastritis
“Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients
treated long-term with omeprazole, of which esomeprazole is an enantiomer.”
Bone Fracture
“Several published observational studies suggest that proton pump inhibitor (PPI) therapy
may be associated with an increased risk for osteoporosis-related fractures of the hip,
wrist, or spine. The risk of fracture was increased in patients who received high-dose,
defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients
should use the lowest dose and shortest duration of PPI therapy appropriate to the
condition being treated. Patients at risk for osteoporosis-related fractures should be
managed according to established treatment guidelines.” [see Dosage and Administration
and Adverse Reactions]
Hypomagnesemia
“Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients
treated with PPIs for at least three months, in most cases after a year of therapy. Serious
adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of
hypomagnesemia required magnesium replacement and discontinuation of the PPI.
For patients expected to be on prolonged treatment or who take PPIs with medications
such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care
professionals may consider monitoring magnesium levels prior to initiation of PPI
treatment and periodically.” [See Adverse Reactions]
Concomitant use of NEXIUM with St John’s Wort or Rifampin
Reference ID: 3204251 15
17. “Drugs which induce CYP2C19 or CYP3A4 (such as St John’s Wort or rifampin) can
substantially decrease esomeprazole concentrations [see Drug Interactions]. Avoid
concomitant use of NEXIUM with St John’s Wort or rifampin.”
Interactions with Investigations for Neuroendocrine Tumors
“Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in
gastric acidity. The increased CgA level may cause false positive results in diagnostic
investigations for neuroendocrine tumors. Providers should temporarily stop
esomeprazole treatment before assessing CgA levels and consider repeating the test if
initial CgA levels are high. If serial tests are performed (e.g. for monitoring), the same
commercial laboratory should be used for testing, as reference ranges between tests may
vary.”
Concomitant use of NEXIUM with Methotrexate
“Literature suggests that concomitant use of PPIs with methotrexate (primarily at high
dose; see methotrexate prescribing information) may elevate and prolong serum levels of
methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-
dose methotrexate administration a temporary withdrawal of the PPI may be considered
in some patients. [see Drug Interactions]”
Adverse Reactions: (section 6 of the label)
Clinial Trials Experience with IV Nexium®:
“Because clinical trials are conducted under widely varying conditions, adverse reaction
rates observed in the clinical trials of a drug cannot be directly compared to rates in the
clinical trials of another drug and may not reflect the rates observed in practice.
Adults
The safety of intravenous esomeprazole is based on results from clinical trials conducted
in three different populations including patients having symptomatic GERD with or
without a history of erosive esophagitis (n=199), patients with erosive esophagitis
(n=160), and healthy subjects (n=204). Adverse experiences occurring in >1% of
patients treated with intravenous esomeprazole (n=359) in trials are listed below by body
system:
Symptomatic GERD and Erosive Esophagitis Trials
The data described below reflect exposure to NEXIUM I.V for Injection in 359 patients.
NEXIUM I.V. for Injection was studied only in actively-controlled trials. The population
was 18 to 77 years of age; 45% Male, 52% Caucasian, 17% Black, 3% Asian, 28% Other,
and had either erosive reflux esophagitis (44%) or GERD (56%). Most patients received
doses of either 20 or 40 mg either as an infusion or an injection.
Table 2
Adverse reactions occurring at an incidence ≥ 1% in the NEXIUM I.V. group
Reference ID: 3204251 16
18. Adverse Reactions
% of patients
Esomeprazole
Intravenous
(n=359)
Headache 10.9
Flatulence 10.3
Nausea 6.4
Abdominal pain 5.8
Diarrhea 3.9
Mouth dry 3.9
Dizziness/vertigo 2.8
Constipation 2.5
Injection site reaction 1.7
Pruritus 1.1
Intravenous treatment with esomeprazole 20 and 40 mg administered as an injection or as
an infusion was found to have a safety profile similar to that of oral administration of
esomeprazole.
Pediatric
In a randomized, open-label, multi-national study to evaluate the pharmacokinetics of
repeated intravenous doses of once daily esomeprazole, esomeprazole was well tolerated
in pediatric patients 1 month to 17 years old, inclusive. The safety results are consistent
with the known safety profile of esomeprazole and no unexpected safety signals were
identified.”
Clinial Trials Experience with Oral Nexium®:
Adult
“The safety of oral NEXIUM was evaluated in over 15,000 patients (aged 18 to 84 years)
in clinical trials worldwide including over 8,500 patients in the United States and over
6,500 patients in Europe and Canada. Over 2,900 patients were treated in long-term
studies for up to 6-12 months. In general, NEXIUM was well tolerated in both short and
long-term clinical trials.
The safety in the treatment of healing of erosive esophagitis was assessed in four
randomized comparative clinical trials, which included 1,240 patients on NEXIUM 20
mg, 2,434 patients on NEXIUM 40 mg, and 3,008 patients on omeprazole 20 mg daily.
The most frequently occurring adverse events (≥1%) in all three groups were headache
(5.5, 5.0, and 3.8, respectively) and diarrhea (no difference among the three groups).
Reference ID: 3204251 17
19. Nausea, flatulence, abdominal pain, constipation, and dry mouth occurred at similar rates
among patients taking NEXIUM or omeprazole.
Additional adverse events that were reported as possibly or probably related to NEXIUM
with an incidence <1% are listed below by body system:
Body as a Whole: abdomen enlarged, allergic reaction, asthenia, back pain, chest pain,
chest pain substernal, facial edema, peripheral edema, hot flushes, fatigue, fever, flu-like
disorder, generalized edema, leg edema, malaise, pain, rigors;Cardiovascular: flushing,
hypertension, tachycardia; Endocrine: goiter; Gastrointestinal: bowel irregularity,
constipation aggravated, dyspepsia, dysphagia, dysplasia GI, epigastric pain, eructation,
esophageal disorder, frequent stools, gastroenteritis, GI hemorrhage, GI symptoms not
otherwise specified, hiccup, melena, mouth disorder, pharynx disorder, rectal disorder,
serum gastrin increased, tongue disorder, tongue edema, ulcerative stomatitis, vomiting;
Hearing: earache, tinnitus; Hematologic: anemia, anemia hypochromic, cervical
lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia; Hepatic:
bilirubinemia, hepatic function abnormal, SGOT increased, SGPT increased;
Metabolic/Nutritional: glycosuria, hyperuricemia, hyponatremia, increased alkaline
phosphatase, thirst, vitamin B12 deficiency, weight increase, weight decrease;
Musculoskeletal: arthralgia, arthritis aggravated, arthropathy, cramps, fibromyalgia
syndrome, hernia, polymyalgia rheumatica; Nervous System/Psychiatric: anorexia,
apathy, appetite increased, confusion, depression aggravated, dizziness, hypertonia,
nervousness, hypoesthesia, impotence, insomnia, migraine, migraine aggravated,
paresthesia, sleep disorder, somnolence, tremor, vertigo, visual field defect;
Reproductive: dysmenorrhea, menstrual disorder, vaginitis; Respiratory: asthma
aggravated, coughing, dyspnea, larynx edema, pharyngitis, rhinitis, sinusitis; Skin and
Appendages: acne, angioedema, dermatitis, pruritus, pruritus ani, rash, rash
erythematous, rash maculo-papular, skin inflammation, sweating increased, urticaria;
Special Senses: otitis media, parosmia, taste loss, taste perversion; Urogenital: abnormal
urine, albuminuria, cystitis, dysuria, fungal infection, hematuria, micturition frequency,
moniliasis, genital moniliasis, polyuria; Visual: conjunctivitis, vision abnormal.
Endoscopic findings that were reported as adverse events include: duodenitis,
esophagitis, esophageal stricture, esophageal ulceration, esophageal varices, gastric ulcer,
gastritis, hernia, benign polyps or nodules, Barrett’s esophagus, and mucosal
discoloration.
The incidence of treatment-related adverse events during 6- month maintenance treatment
was similar to placebo. There were no differences in types of related adverse events seen
during maintenance treatment up to 12 months compared to short-term treatment.
Two placebo-controlled studies were conducted in 710 patients for the treatment of
symptomatic gastroesophageal reflux disease. The most common adverse events that
were reported as possibly or probably related to NEXIUM were diarrhea (4.3%),
headache (3.8%), and abdominal pain (3.8%).
The following potentially clinically significant laboratory changes in clinical trials,
irrespective of relationship to NEXIUM, were reported in ≤ 1% of patients: increased
creatinine, uric acid, total bilirubin, alkaline phosphatase, ALT, AST, hemoglobin, white
blood cell count, platelets, serum gastrin, potassium, sodium, thyroxine and thyroid
stimulating hormone [see Clinical Pharmacology, Endocrine Effects for further
Reference ID: 3204251 18
20. information on thyroid effects]. Decreases were seen in hemoglobin, white blood cell
count,platelets, potassium, sodium, and thyroxine.”
Pediatric
“The safety of oral NEXIUM was evaluated in 316 pediatric and adolescent patients aged
1 to 17 years in four clinical trials for the treatment of symptomatic GERD [see Clinical
Studies]. In 109 pediatric patients aged 1 to 11 years, the most frequently reported (at
least 1%) treatment-related adverse reactions in these patients were diarrhea (2.8%),
headache (1.9%) and somnolence (1.9%). In 149 pediatric patients aged 12 to 17 years
the most frequently reported (at least 2%) treatment-related adverse reactions in these
patients were headache (8.1%), abdominal pain (2.7%), diarrhea (2%), and nausea (2%).
No new safety concerns were identified in pediatric patients.”
Postmarketing Experience:
“The following adverse reactions have been identified during post-approval use of
NEXIUM. Because these reactions are reported voluntarily from a population of
uncertain size, it is not always possible to reliably estimate their frequency or establish a
causal relationship to drug exposure.
Postmarketing Reports - There have been spontaneous reports of adverse events with
postmarketing use of esomeprazole. These reports occurred rarely and are listed below by
body system:
Blood And Lymphatic System Disorders: agranulocytosis, pancytopenia; Eye Disorders:
blurred vision; Gastrointestinal Disorders: pancreatitis; stomatitis; microscopic colitis;
Hepatobiliary Disorders: hepatic failure, hepatitis with or without jaundice; Immune
System Disorders: anaphylactic reaction/shock; Infections and Infestations: GI
candidiasis; Metabolism and nutritional disorders: hypomagnesemia; Musculoskeletal
And Connective Tissue Disorders: muscular weakness, myalgia, bone fracture; Nervous
System Disorders: hepatic encephalopathy, taste disturbance; Psychiatric Disorders:
aggression, agitation, depression, hallucination; Renal and Urinary Disorders: interstitial
nephritis; Reproductive System and Breast Disorders: gynecomastia; Respiratory,
Thoracic and Mediastinal Disorders: bronchospasm; Skin and Subcutaneous Tissue
Disorders: alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-
Johnson syndrome, toxic epidermal necrolysis (TEN, some fatal).
Other adverse events not observed with NEXIUM, but occurring with omeprazole can be
found in the omeprazole package insert, ADVERSE REACTIONS section.”
***** Please review the full labels of Nexium® IV and oral suspension for more details,
including information on pediatric studies*****
6.2 APPENDIX B: STANDARD SEARCHES
A. Adults (17 yrs and above)
1. All outcomes from approval date (no set criteria)
2. Serious outcomes from approval date
3. Death as an outcome from approval date
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21. B. Ages 0-16 yrs ONLY
1. Same as above 1-3
2. Retrieve case reports for hands-on review
6.3 APPENDIX C: ADVERSE EVENT REPORTING SYSTEM (AERS) DATABASE
DESCRIPTION
The Adverse Event Reporting System (AERS) is a computerized information database
designed to support the FDA's post-marketing safety surveillance program for drug and
therapeutic biologic products. The FDA uses AERS to monitor adverse events and
medication errors that might occur with these marketed products. The structure of AERS
complies with the international safety reporting guidance (ICH E2B) issued by the
International Conference on Harmonization. Adverse events in AERS are coded to terms
in the Medical Dictionary for Regulatory Activities terminology (MedDRA).
AERS data do have limitations. First, there is no certainty that the reported event was
actually due to the product. FDA does not require that a causal relationship between a
product and event be proven, and reports do not always contain enough detail to properly
evaluate an event. Further, FDA does not receive all adverse event reports that occur with
a product. Many factors can influence whether or not an event will be reported, such as
the time a product has been marketed and publicity about an event. Therefore, AERS
cannot be used to calculate the incidence of an adverse event in the U.S. population.
Reference ID: 3204251 20