Nova Scotia, and First Nations and Inuit Health Branch of Health Canada 1997-1998 to 2003-2004
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The Role for Pre-Polymerized Sucralfate In
ISSN: 2692-5400 DOI: 10.33552/AJGH.2020.02.000531 Academic Journal of Gastroenterology & Hepatology Review Article Copyright © All rights are reserved by Ricky Wayne McCullough The Role for Pre-Polymerized Sucralfate in Management of Erosive and Non-Erosive Gastroesophageal Reflux Disease – High Potency Sucralfate-Mucin Barrier for Enteric Cytoprotection Ricky Wayne McCullough1,2* 1Translational Medicine Clinic and Research Center, USA 2Department of Internal Medicine and Emergency Medicine, Warren Alpert Brown University School of Medicine, USA *Corresponding author: Ricky Wayne McCullough, Translational Medicine Clinic and Received Date: April 13, 2020 Research Center, Storrs Connecticut, USA. Published Date: April 22, 2020 Abstract Pre-polymerized sucralfate, sometimes called high potency sucralfate or polymerized cross-linked sucralfate is a new sucralfate formulation recognizedClinical by outcomes the US FDAfrom in standard 2005. Positive sucralfate clinical do not data justify from a threerole in randomized the management controlled of erosive trials and using non-erosive pre-polymerized gastroesophageal sucralfate refluxfor GERD disease. and each of which cause classic mucosal reactions in the esophageal epithelium. These reactions are symptomatic but may or may not involve erosions. NERD was first reported in 2014 AGA’s Digestive Disease Week (DDW). Gastric refluxate contains protonic acid, dissolved bile acids and proteases Pre-polymerizedBeing non-systemic, sucralfate the utilizes entire biophysical clinical effect means of toany exclude sucralfate all three rests irritants in the fromsurface epithelial concentration mucosa. of sucralfate achieved. Pre-polymerized sucralfate, presented in 2014 DDW, and discussed here, achieves a surface concentration that is 800% greater than standard sucralfate on normal mucosal lining and 2,400% greater on inflamed or acid-injured mucosa, making it most certainly, a high potency sucralfate. -
Lansoprazole Delayed-Release Orally Disintegrating Tablets PI
HIGHLIGHTS OF PRESCRIBING INFORMATION • Patients receiving rilpivirine-containing products. (4, 7) Dual Therapy: Lansoprazole delayed-release orally disintegrating tablets/amoxicillin Administration with Water in an Oral Syringe 6.1 Clinical Trials Experience In clinical trials using combination therapy with lansoprazole plus amoxicillin and clarithromycin, women. Because animal reproduction studies are not always predictive of human response, this 8.6 Hepatic Impairment These highlights do not include all the information WARNINGS AND PRECAUTIONS Lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin as dual 1. Place a 15 mg tablet in oral syringe and draw up 4 mL of water, or place a 30 mg tablet Because clinical trials are conducted under widely varying conditions, adverse reaction rates and lansoprazole plus amoxicillin, no increased laboratory abnormalities particular to these drug drug should be used during pregnancy only if clearly needed [see Nonclinical Toxicology (13.2)]. In patients with various degrees of chronic hepatic impairment the exposure to lansoprazole was needed to use LANSOPRAZOLE DELAYED- • Gastric Malignancy: In adults, symptomatic therapy is indicated in adults for the treatment of patients with H. pylori infection and duodenal in oral syringe and draw up 10 mL of water. observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of combinations were observed. See full prescribing information for clarithromycin before using in pregnant women. increased compared to healthy subjects with normal hepatic function [see Clinical Pharmacology RELEASE ORALLY DISINTEGRATING TABLETS response with lansoprazole does not preclude ulcer disease (active or one year history of a duodenal ulcer) who are either allergic or intolerant 2. -
Does Your Patient Have Bile Acid Malabsorption?
NUTRITION ISSUES IN GASTROENTEROLOGY, SERIES #198 NUTRITION ISSUES IN GASTROENTEROLOGY, SERIES #198 Carol Rees Parrish, MS, RDN, Series Editor Does Your Patient Have Bile Acid Malabsorption? John K. DiBaise Bile acid malabsorption is a common but underrecognized cause of chronic watery diarrhea, resulting in an incorrect diagnosis in many patients and interfering and delaying proper treatment. In this review, the synthesis, enterohepatic circulation, and function of bile acids are briefly reviewed followed by a discussion of bile acid malabsorption. Diagnostic and treatment options are also provided. INTRODUCTION n 1967, diarrhea caused by bile acids was We will first describe bile acid synthesis and first recognized and described as cholerhetic enterohepatic circulation, followed by a discussion (‘promoting bile secretion by the liver’) of disorders causing bile acid malabsorption I 1 enteropathy. Despite more than 50 years since (BAM) including their diagnosis and treatment. the initial report, bile acid diarrhea remains an underrecognized and underappreciated cause of Bile Acid Synthesis chronic diarrhea. One report found that only 6% Bile acids are produced in the liver as end products of of British gastroenterologists investigate for bile cholesterol metabolism. Bile acid synthesis occurs acid malabsorption (BAM) as part of the first-line by two pathways: the classical (neutral) pathway testing in patients with chronic diarrhea, while 61% via microsomal cholesterol 7α-hydroxylase consider the diagnosis only in selected patients (CYP7A1), or the alternative (acidic) pathway via or not at all.2 As a consequence, many patients mitochondrial sterol 27-hydroxylase (CYP27A1). are diagnosed with other causes of diarrhea or The classical pathway, which is responsible for are considered to have irritable bowel syndrome 90-95% of bile acid synthesis in humans, begins (IBS) or functional diarrhea by exclusion, thereby with 7α-hydroxylation of cholesterol catalyzed interfering with and delaying proper treatment. -
Carafate, Tablet
NEW ZEALAND DATA SHEET CARAFATE 1. Product Name Carafate, 1 g, tablet. 2. Qualitative and Quantitative Composition Each tablet contains 1 g sucralfate For the full list of excipients, see section 6.1. 3. Pharmaceutical Form Carafate is a white, uncoated capsule-shaped tablet. One side is plain, the other embossed with the word ‘CARAFATE’. Dimensions: 20 mm x 9 mm x 7mm 4. Clinical Particulars 4.1 Therapeutic indications Treatment of acute, non-malignant gastric ulcer and duodenal ulcer. Maintenance therapy to prevent the recurrence of duodenal ulcers. 4.2 Dose and method of administration Acute ulcerous conditions The recommended adult dose of Carafate for duodenal ulcer and gastric ulcer is 1 g tablet three times a day, one hour before meals and one 1 g tablet at bedtime or two 1 g tablets twice daily taken before breakfast and at bedtime (for up to 8 weeks). For relief of pain, antacids may be added to the treatment. However, they should not be taken within two hours before or after sucralfate intake. In duodenal ulcer, while healing with sucralfate often occurs within two to four weeks, treatment should be continued for up to 8 weeks unless healing has been demonstrated by x-ray and/or endoscopic examination. In the case of gastric ulcers an alternative treatment should be considered if no objective improvement is observed following 6 weeks of sucralfate therapy. Large gastric ulcers that show a progressive healing tendency may require the full 8 weeks of therapy. Maintenance treatment To reduce the risk of recurrence of duodenal ulcers, the recommended dose is one 1 g tablet before breakfast and one at bedtime (for up to 12 months). -
Patient Instructions for Colonoscopy and Upper GI Endoscopy
GASTROENTEROLOGY Patient Instructions for Colonoscopy and Upper GI Endoscopy This handout will help you get ready for your procedures. It has information about: Where to go for your procedures What are the procedures and why are they done Preparing ahead of time for your procedures Bowel preparation instructions Medication and diet instructions before your procedures What to expect during your procedures WHERE TO GO FOR YOUR COLONOSCOPY/UPPER ENDOSCOPY UVM Medical Center 111 Colchester Ave Endoscopy Outpatient Clinic West Pavilion, Level 4 Burlington, VT 05401 Check in at registration first: Level 3, Main Lobby WHAT IS A COLONOSCOPY? A colonoscopy is an examination of the colon (large intestine) using a specialized video camera called an endoscope. This instrument is inserted into the rectum and advanced up into your large intestine until it meets the small intestine. It shows images of the lining of the large intestine. Tissue samples (biopsies) may be taken during the test. This test can help diagnose and potentially treat: Early signs of cancer in the colon and rectum, specifically remove these abnormal growths called polyps Causes of unexplained changes in bowel habits Causes of inflamed tissue, abnormal growths, ulcers and bleeding WHAT IS AN UPPER ENDOSCOPY? Also known as: Esophagogastroduodenoscopy; EGD, Gastroscopy. An upper GI endoscopy is an examination of the upper gastrointestinal (GI) tract using a specialized video camera called an endoscope. This instrument is inserted down the throat and shows images of the lining -
Patent Application Publication ( 10 ) Pub . No . : US 2019 / 0192440 A1
US 20190192440A1 (19 ) United States (12 ) Patent Application Publication ( 10) Pub . No. : US 2019 /0192440 A1 LI (43 ) Pub . Date : Jun . 27 , 2019 ( 54 ) ORAL DRUG DOSAGE FORM COMPRISING Publication Classification DRUG IN THE FORM OF NANOPARTICLES (51 ) Int . CI. A61K 9 / 20 (2006 .01 ) ( 71 ) Applicant: Triastek , Inc. , Nanjing ( CN ) A61K 9 /00 ( 2006 . 01) A61K 31/ 192 ( 2006 .01 ) (72 ) Inventor : Xiaoling LI , Dublin , CA (US ) A61K 9 / 24 ( 2006 .01 ) ( 52 ) U . S . CI. ( 21 ) Appl. No. : 16 /289 ,499 CPC . .. .. A61K 9 /2031 (2013 . 01 ) ; A61K 9 /0065 ( 22 ) Filed : Feb . 28 , 2019 (2013 .01 ) ; A61K 9 / 209 ( 2013 .01 ) ; A61K 9 /2027 ( 2013 .01 ) ; A61K 31/ 192 ( 2013. 01 ) ; Related U . S . Application Data A61K 9 /2072 ( 2013 .01 ) (63 ) Continuation of application No. 16 /028 ,305 , filed on Jul. 5 , 2018 , now Pat . No . 10 , 258 ,575 , which is a (57 ) ABSTRACT continuation of application No . 15 / 173 ,596 , filed on The present disclosure provides a stable solid pharmaceuti Jun . 3 , 2016 . cal dosage form for oral administration . The dosage form (60 ) Provisional application No . 62 /313 ,092 , filed on Mar. includes a substrate that forms at least one compartment and 24 , 2016 , provisional application No . 62 / 296 , 087 , a drug content loaded into the compartment. The dosage filed on Feb . 17 , 2016 , provisional application No . form is so designed that the active pharmaceutical ingredient 62 / 170, 645 , filed on Jun . 3 , 2015 . of the drug content is released in a controlled manner. Patent Application Publication Jun . 27 , 2019 Sheet 1 of 20 US 2019 /0192440 A1 FIG . -
Mini-Reviews and Perspectives
Mini-Reviews and Perspectives Persistent Reflux Symptoms in the Proton Pump Inhibitor Era: The Changing Face of Gastroesophageal Reflux Disease EVAN S. DELLON and NICHOLAS J. SHAHEEN Center for Esophageal Diseases and Swallowing and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina iven the widespread use of potent acid suppressive Despite the common nature of incomplete control of Gtherapies and primary caregivers’ increasing com- GERD symptoms on PPI therapy, a universal definition fort with prescribing these medications at high doses, the for “PPI-refractory GERD” is lacking. Is a subject PPI patient population presenting to gastroenterologists for refractory after incomplete control at once daily dosing? symptoms of gastroesophageal reflux disease (GERD) has Should twice daily (BID) or other regimens be required changed. Whereas previous consultation often revolved before a subject is considered refractory? Previous work around the control of erosive disease and other mucosal demonstrates that a substantial number of subjects (as manifestations of GERD, and terminated with the prescrip- high as 32%) on daily PPI continue to demonstrate ab- tion of proton pump inhibitor (PPI) therapy, gastroenter- normal distal esophageal acid exposures, and that this ologists often now only enter the scene after failure of PPI proportion can be lowered to single digits by increasing therapy, for symptoms either resistant or only partially standard therapy to BID PPI.6,7 However, US Food and responsive to these medications. Because of the high pro- Drug Administration-approved dosing of these medica- portion of subjects with esophagitis who are healed with tions does not extend to BID therapy. -
Pharmaceutical Appendix to the Harmonized Tariff Schedule
Harmonized Tariff Schedule of the United States Basic Revision 3 (2021) Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE Harmonized Tariff Schedule of the United States Basic Revision 3 (2021) Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 2 Table 1. This table enumerates products described by International Non-proprietary Names INN which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service CAS registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. -
Pediatric REVIEW
DIVISION OF GASTROENTEROLOGY PRODUCTS MEDICAL OFFICER REVIEW Application Type: NDA Submission Number: 20-406/067 21-281/024 21-428/017 Letter Date: 04-25-08 Stamp Date: 04-28-08 PDUFA Goal Date: 10-28-08 Reviewer Name: Ali Niak, M.D. Reviewer Completion Date: 10-27-08 Established Name: Lansoprazole (Proposed) Trade Name: Prevacid Pediatric Suspension Therapeutic Class: Proton Pump Inhibitor Applicant: TAP Pharmaceutical Products, Inc. Priority Designation: Standard Formulation: Oral Suspension Dosing Regimen: 0.2-0.3 mg/kg/day for infants ≤ 10 weeks of age or 1.0-1.5 mg/kg/day > 10 weeks of age Indication: treatment of symptomatic GERD patients Intended Population: Pediatric patients, > 28 days since birth (preterm infants with corrected age of at least 44 weeks) but < 12 months of age at Dosing Day 1 TABLE OF CONTENTS 1. RECOMMENDATIONS/RISK BENEFIT ANALYSIS ……………………..5 1.1 Recommendation on Regulatory Action ……………………...………….5 1.2 Risk Benefit Analysis …………………………………………………….5 1.3 Recommendations for Postmarketing Risk Management Activities ……..5 1.4 Recommendations for other Postmarketing Study Commitments ………..5 2. INTRODUCTION AND REGULATORY BACKGROUND ………………...5 2.1 Product Information ………………………………………………………7 2.2 Currently Available Treatment for Indication ……………………………8 2.3 Availability of Proposed Active Ingredient in the United States …………8 2.4 Important Issues With Consideration to Related Drugs ………………….9 2.5 Summary of Presubmission Regulatory Activity Related to this Submission ……………………………………………………………….9 2.6 Other Relevant Background Information …………………………….....10 3. ETHICS AND GOOD CLINICAL PRACTICES …………………………...11 3.1 Submission Quality and Integrity ………………………………….……11 3.2 Compliance with Good Practices ………………………………………..11 3.3 Financial Disclosures ……………………………………………………11 4. -
Esomeprazole, NDA 22-101
CLINICAL REVIEW DIVISION OF GASTROENTEROLOGY PRODUCTS Application Type NDA Submission Number 22-101/000 Letter Date Sept. 27, 2006 Stamp Date Sept. 29, 2006 PDUFA Goal Date July 29, 2007 Reviewer Name Wen-Yi Gao, M.D., Ph.D. Review Completion Date July 19, 2007 Established Name Esomeprazole magnesium (Proposed) Trade Name Nexium Therapeutic Class Proton Pump Inhibitor Applicant AstraZeneca Priority Designation S Formulation Delayed-Release Granules for Oral Suspension Dosing Regimen 10 mg once daily for up to 8 weeks Indication Short-term treatment of symptomatic GERD and erosive esophagitis Intended Population 1 to 11 years of age Clinical Review Wen-Yi Gao, M.D., Ph.D. NDA 22-101/000 Nexium (esomeprazole) Table of Contents CLINICAL REVIEW..................................................................................................................................................1 1 EXECUTIVE SUMMARY................................................................................................................................5 1.1 RECOMMENDATION ON REGULATORY ACTION ...........................................................................................5 1.2 RECOMMENDATION ON POSTMARKETING ACTIONS ....................................................................................5 1.2.1 Risk Management Activity ....................................................................................................................5 1.3 SUMMARY OF CLINICAL FINDINGS ..............................................................................................................6 -
Atorvastatin Calcium)
PRODUCT INFORMATION LIPITOR® (atorvastatin calcium) NAME OF THE MEDICINE LIPITOR atorvastatin (as calcium) 10 mg, 20 mg, 40 mg and 80 mg tablets. LIPITOR contains the active ingredient atorvastatin calcium. The structural formula of atorvastatin calcium is shown below: CH3 CH3 CH OH OH O O CH CH CH C NHC 2 - N CH2 CH2 CH2 O •Ca 2+ •3H2 O F 2 Chemical name: [R-(R*,R*)]-2-(4-fluorophenyl)-ß,-dihydroxy-5-(1-methylethyl)- 3-phenyl-4-[(phenylamino) carbonyl] -1H-pyrrole -1-heptanoic acid, calcium salt (2:1) Molecular formula: (C33H34FN2O5)2Ca.3H2O Molecular weight: 1209.42 CAS registry number: 134523-03-8. DESCRIPTION Atorvastatin calcium is a white to off-white crystalline powder that is practically insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile, slightly soluble in ethanol and freely soluble in methanol. LIPITOR tablets contain atorvastatin calcium equivalent to 10, 20, 40 and 80 mg atorvastatin. The tablets also contain the following inactive ingredients: calcium carbonate, microcrystalline cellulose, lactose, croscarmellose sodium, polysorbate 80, hydroxypropylcellulose, magnesium stearate, Opadry White YS-1-7040 and Simethicone Emulsion. Version: pfplipit10613 Supersedes: pfplipit10512 Page 1 of 20 PHARMACOLOGY Mechanism of Action Atorvastatin is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl-glutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. Triglycerides (TG) and cholesterol in the liver are incorporated into very low density lipoprotein (VLDL) and released into the plasma for delivery to peripheral tissues. -
Anatomical Classification Guidelines V2020 EPHMRA ANATOMICAL
EPHMRA ANATOMICAL CLASSIFICATION GUIDELINES 2020 Anatomical Classification Guidelines V2020 "The Anatomical Classification of Pharmaceutical Products has been developed and maintained by the European Pharmaceutical Marketing Research Association (EphMRA) and is therefore the intellectual property of this Association. EphMRA's Classification Committee prepares the guidelines for this classification system and takes care for new entries, changes and improvements in consultation with the product's manufacturer. The contents of the Anatomical Classification of Pharmaceutical Products remain the copyright to EphMRA. Permission for use need not be sought and no fee is required. We would appreciate, however, the acknowledgement of EphMRA Copyright in publications etc. Users of this classification system should keep in mind that Pharmaceutical markets can be segmented according to numerous criteria." © EphMRA 2020 Anatomical Classification Guidelines V2020 CONTENTS PAGE INTRODUCTION A ALIMENTARY TRACT AND METABOLISM 1 B BLOOD AND BLOOD FORMING ORGANS 28 C CARDIOVASCULAR SYSTEM 35 D DERMATOLOGICALS 50 G GENITO-URINARY SYSTEM AND SEX HORMONES 57 H SYSTEMIC HORMONAL PREPARATIONS (EXCLUDING SEX HORMONES) 65 J GENERAL ANTI-INFECTIVES SYSTEMIC 69 K HOSPITAL SOLUTIONS 84 L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS 92 M MUSCULO-SKELETAL SYSTEM 102 N NERVOUS SYSTEM 107 P PARASITOLOGY 118 R RESPIRATORY SYSTEM 120 S SENSORY ORGANS 132 T DIAGNOSTIC AGENTS 139 V VARIOUS 141 Anatomical Classification Guidelines V2020 INTRODUCTION The Anatomical Classification was initiated in 1971 by EphMRA. It has been developed jointly by Intellus/PBIRG and EphMRA. It is a subjective method of grouping certain pharmaceutical products and does not represent any particular market, as would be the case with any other classification system.