DOCSLIB.ORG

Potentially Inappropriate Proton-Pump Inhibitor Prescription in The

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Potentially Inappropriate Proton-Pump Inhibitor Prescription in The TAG0010.1177/1756284821998928Therapeutic Advances in GastroenterologyL Muheim, A Signorell 998928research-article20212021 Therapeutic Advances in Gastroenterology Original Research Ther Adv Gastroenterol Potentially inappropriate proton-pump 2021, Vol. 14: 1–10 DOI:https://doi.org/10.1177/1756284821998928 10.1177/ inhibitor prescription in the general 1756284821998928https://doi.org/10.1177/1756284821998928 © The Author(s), 2021. Article reuse guidelines: population: a claims-based retrospective sagepub.com/journals- time trend analysis permissions Leander Muheim , Andri Signorell, Stefan Markun, Corinne Chmiel, Stefan Neuner-Jehle, Eva Blozik, Pascale Ursprung, Thomas Rosemann and Oliver Senn Abstract Background: Proton-pump inhibitors (PPI) are among the most prescribed drugs worldwide, and a large body of evidence raises concerns about their inappropriate use. Previous estimates of inappropriate use varied due to different definitions and study populations. Aims: We aimed to measure the population-based incidence and time trends of PPI and potentially inappropriate PPI prescriptions (PIPPI) with a novel method, continuously assessing excessive cumulative doses based on clinical practice guidelines. We also assessed association of patient characteristics with PPI prescriptions and PIPPI. Methods: This was an observational study based on a large insurance claims database of persons aged >18 years with continuous claims records of ⩾12 months. The observation period was January 2012 to December 2017. We assessed the incidence and time trends of PPI prescriptions and PIPPI based on doses prescribed, defining ⩾11.5 g of pantoprazole dose equivalents during any consecutive 365 days (average daily dose >31 mg) as inappropriate. Results: Among 1,726,491 eligible persons, the annual incidence of PPI prescriptions increased from 19.7% (2012) to 23.0% (2017), (p = <0.001), and the incidence of PIPPI increased from 4.8% (2013) to 6.4% (2017), (p = <0.001). Age, male gender, drugs with bleeding risk and multimorbidity were independent determinants of PIPPI (p = <0.001 for all). Conclusions: This study provides evidence that one of the most prescribed drug groups is commonly prescribed inappropriately in the general population and that this trend is increasing. Multimorbidity and drugs with bleeding risks were strong determinants of PIPPI. Addressing PPI prescriptions exceeding guideline recommendations could reduce polypharmacy and improve patient safety. Correspondence to: Leander Muheim Institute of Primary Care, University of Zurich and Keywords: inappropriate, overuse, PPI, proton-pump inhibitors, polypharmacy University Hospital Zurich, Pestalozzistrasse 24, Zurich, 8091, Switzerland Received: 22 January 2021; revised manuscript accepted: 9 February 2021. [email protected] Andri Signorell Eva Blozik Introduction growing. Both potential side effects3–5 and poten- Department of Health Sciences, Helsana Group, Proton-pump inhibitors (PPI) are highly effective tially unnecessary expenditures6–8 are of increas- Switzerland antacid drugs1 and are among the most com- ing interest. Many initiatives and professional Stefan Markun Corinne Chmiel monly prescribed drugs worldwide. Pantoprazole, societies advise against the prolonged use of Stefan Neuner-Jehle one of the most popular examples, is the single PPI.9,10 Pascale Ursprung Thomas Rosemann most prescribed generic drug and generates the Oliver Senn highest overall generic drug cost in Switzerland.2 From a patient- and health-economics perspec- Institute of Primary Care, University of Zurich and As the use of PPI has been steadily increasing, tive, excessive average long-term doses seem most University Hospital Zurich, concerns about their inappropriate use have been relevant, as higher cumulative doses of PPI might Zurich, Switzerland journals.sagepub.com/home/tag 1 Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). Therapeutic Advances in Gastroenterology 14 produce more side effects3 and cause more unnec- Objectives essary costs. We defined our main objectives as follows: Yet inappropriate use of PPI remains widespread 1. Incidence of PPI prescriptions and time and is still increasing, as multiple studies in vari- trends thereof (period 2012–2017) ous settings show.11–14 Many previous estimates 2. Incidence of PIPPI and time trends of potentially inappropriate PPI prescriptions thereof (period 2013–2017, PIPPI is (PIPPI) are highly variable, but do not define defined as a result of the preceding year) inappropriateness based on continuous and 3. Association of patient characteristics cumulative doses prescribed on the patient with PIPPI (demographic characteristics, level.11,13 Accordingly, considerable uncertainty drugs with bleeding risk and number of remains about the valid extent of PIPPI within chronic conditions) in comparison to PPI the population. prescriptions Aims Assessment of proton-pump inhibitor We aimed to measure the population-based inci- prescribing dence and time trends of PPI prescriptions and The insurance claims cover all pharmacy and PIPPI by means of a novel method, which con- physician invoices of prescription drugs. PPI were tinuously assesses excessive cumulative doses identified by Anatomical Therapeutic Chemical based on clinical practice guidelines. We also (ATC) Classification codes A02BC. Incidence of assessed association of patient characteristics with PPI prescriptions was defined by any such pre- PIPPI in comparison to PPI prescriptions. scription during any calendar year. All health care invoices submitted to Helsana for reimbursement during the study period were considered. Methods Prescribed PPI doses of the various PPI products were converted into pantoprazole dose equivalents, Study design, data source and population thus referencing the most commonly prescribed In this retrospective analysis, we used claims PPI product in Switzerland. In an attempt to esti- data of a major Swiss health insurance company mate PPI prescribing in the context of clinical (‘Helsana group’) covering approximately 14% practice in Switzerland, doses of all the PPI agents of the Swiss population.15 All persons registered on the market were labelled as either maintenance in Switzerland are obliged by law to contract or therapeutic dose and then translated into pan- basic health insurance. Individuals who cannot toprazole dose equivalents of 20 mg and 40 mg, afford to pay the monthly premiums receive respectively. Detailed definitions of the various subsidies or full insurance coverage by their pantoprazole dose equivalents are listed under social services. Equal access to the full range of Supplemental Material (1). medical treatments including drugs is thereby granted to everyone, regardless of insurance status. Lower monthly premiums are available Definition and assessment of potentially when choosing different deductible schemes. inappropriate proton-pump inhibitor prescribing Deductibles range from 300 to 2500 Swiss Based on a literature review covering 34 clinical Francs (CHF) yearly. In addition, optional practice guidelines in 2017, we extracted PPI alternative health plans (managed care, tele- dosage and treatment regimens on 57 different medicine gatekeeping and others) enable lower PPI indications.16 Thereof we derived a 365-day monthly premiums. cumulative pantoprazole dose equivalent of 11.5 g as a cut-off for inappropriateness. This cut-off Our sample includes persons aged 18 or older reflects an evidence-based maximal-dose sce- whose records were available for at least 12 months nario, based on three hypothetical sequential from 1 January 2012 through 31 December 2017. phases: (1) an 8-week double-dose therapeutic Prescriptions of implausibly high cumulative treatment phase (2 × 40 mg of pantoprazole dose doses were excluded. equivalents, i.e. for severe erosive esophagitis), 2 journals.sagepub.com/home/tag L Muheim, A Signorell et al. (2) a 4-week tapering to a therapeutic dose calendar year as the denominator. In addition, (1 × 40 mg), (3) a maintenance dose (1 × 20 mg) the incidence of PIPPI among the incidental PPI for the remainder of the year. The resulting prescription group was calculated. Percentages cumulative yearly dose of 11.2 g of pantoprazole and mean values were used to describe categori- equivalents was rounded up to 11.5 g. PIPPI was cal and nominal data, respectively. Descriptive then determined by screening every observed per- statistics were used to provide characteristics of son day for a preceding 365-day cumulative dose all patients with PPI prescriptions. These data exceeding 11.5 g. To clarify we give a practical were grouped into PPI prescriptions (i.e. non- example: if 100 tablets pantoprazole 40 mg were PIPPI) and PIPPI groups. Chi-Squared tests for dispensed 1 December 2016, this corresponded trend in proportions were used to analyse changes to 4000 mg added to the balance sheet of one in proportions of PPI prescriptions and PIPPI patient. If the same patient repeated this process incidence. For bivariate comparisons between the twice (i.e. adding another 8000 mg and therefore PPI prescriptions and PIPPI groups, Kruskal– 12,000
Load more

Recommended publications
  • Treatment of Nausea in Pregnancy
    Heitmann et al. BMC Pregnancy and Childbirth (2015) 15:321 DOI 10.1186/s12884-015-0746-2 RESEARCH ARTICLE Open Access Treatment of nausea in pregnancy: a cross- sectional multinational web-based study of pregnant women and new mothers Kristine Heitmann1*, Lone Holst1, Angela Lupattelli2, Caroline Maltepe3 and Hedvig Nordeng2,4 Abstract Background: The factors related to the treatment of nausea during pregnancy have not yet been investigated in several countries simultaneously. The present study aimed to describe differences in self-reported nausea during pregnancy and the patterns of use for both conventional and herbal medicines across countries. The factors related to nausea and its treatment and the relationships between different self-reported co-morbidities and nausea were also investigated. Methods: This cross-sectional study used data collected by a web-based questionnaire distributed between October 2011 and February 2012 in several countries within five regions: Western, Northern, and Eastern Europe, North America, and Australia. Women who were pregnant or had a child less than one year old were eligible to participate. Results: A total of 9113 women were included in the study, whereof 6701 (73.5 %) had experienced nausea during pregnancy. Among respondents with nausea, conventional medicines were used by 1201 (17.9 %) women and herbal medicines by 556 (8.3 %) women. The extent of self-reported nausea and its treatment varied by country. Education, working status, and folic acid use were significantly associated with the use of conventional medicines against nausea. Respondents who had nausea also had a high burden of co-morbidity. Conclusion: The prevalence of nausea was high across all participating countries but its treatment varied, possibly due to cultural differences and differences in attitudes towards medicines.
    [Show full text]
  • G Genito Urinary System and Sex Hormones
    WHO/EMP/RHT/TSN/2018.2 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. Learning clinical pharmacology with the use of INNs and their stems. Geneva: World Health Organization; 2018 (WHO/EMP/RHT/TSN/2018.2). Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing.
    [Show full text]
  • Heft 55 Gastritis, Magen
    ROBERT KOCH INSTITUT Statistisches Bundesamt Nach wie vor sind Magenbeschwerden ein häufiges Gesundheitsproblem. Nach aktuellen Studien- ergebnissen des Robert Koch-Instituts hatten ein Fünftel der Erwachsenen in Deutschland schon einmal eine ärztlich diagnostizierte Gastritis, sieben Prozent schon einmal Magen- bzw. Zwölf- fingerdarmgeschwüre (Ulkus). Letztere sind eine schwerere Krankheitsform, bei der es zu ernsten Komplikationen kommen kann. Sowohl die Sicht auf die Ursachen von Gastritis und Ulkus als auch die anteilige Bedeutung der Risiken haben sich in den letzten Jahrzehnten erheblich verändert. Vor der in den 1980er-Jahren gelungenen Entdeckung der weit verbreiteten bakteriellen Besiedlung mit H. pylori und dessen Heft 55 Beitrag zur Entstehung von Entzündungen und Geschwüren wurde vor allem psychosomatischen Gastritis, Magen- und Ursachen eine große Bedeutung zugeschrieben. Während in Deutschland die Verbreitung von Zwölffingerdarmgeschwüre H. pylori stark zurückgeht, gewinnt die weiter zunehmende Anwendung von potenziell magen- schädigenden Arzneimitteln (z. B. NSAR und ASS) eine wachsende Bedeutung. Weitere Faktoren, wie Tabakkonsum, psychosoziale Belastungen und Ernährung, spielen aber auch eine Rolle, und das Zusammenwirken der Einflüsse ist sehr komplex. Mit den Protonenpumpenhemmern (PPI) stehen inzwischen hochwirksame Arzneimittel für die Behandlung und zur Prävention (»Magenschutz«) zur Verfügung. Aber auch deren anhaltend starker Verbrauchsanstieg ist nicht unproblematisch. © Robert Koch-Institut ISBN 978-3-89606-220-8
    [Show full text]
  • Summary of Product Characteristics
    Health Products Regulatory Authority Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Ranitidine 150 mg/10 ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ranitidine Hydrochloride 167.5mg/10ml (equivalent to Ranitidine 150mg/10ml) Ethanol = 810mg/10ml Sorbitol = 1.4g/10ml Sodium = 22 mg/10 ml For full list of excipients see Section 6.1 3 PHARMACEUTICAL FORM Oral Solution A straw coloured liquid with odour of mint 4 CLINICAL PARTICULARS 4.1 Therapeutic Indications Ranitidine is indicated for the treatment of duodenal ulcer and benign gastric ulcer, including that associated with non-steroidal anti-inflammatory agents. In addition, ranitidine is indicated for the prevention of NSAID (including aspirin) associated duodenal ulcers. Ranitidine is also indicated for the treatment of post-operative ulcer, Zollinger-Ellison Syndrome and treatment of oesophageal reflux disease including prevention of relapse. Ranitidine is indicated for the following conditions where reduction of gastric secretion and acid output is desirable; - the prophylaxis of gastro-intestinal haemorrhage from stress ulceration in seriously ill patients - the prophylaxis of recurrent haemorrhage in patients with bleeding peptic ulcers - before general anaesthesia in patients considered to be at risk of acid aspiration (Mendelson’s Syndrome), particularly obstetric patients during labour. Children (3 to 18 years) - Short term treatment of peptic ulcer - Treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro-oesophageal reflux disease. See section 4.4. Special warnings and precautions for use. 4.2 Posology and method of administration Posology Adults (including the elderly): Treatment of duodenal and gastric ulcer: The usual dosage is 150mg twice daily, taken in the morning and evening or a single bedtime dose of 300mg.
    [Show full text]
  • Analysis of Drug Utilization and Health Care Resource Consumption In
    Journal name: Biologics: Targets and Therapy Article Designation: Original Research Year: 2018 Volume: 12 Biologics: Targets and Therapy Dovepress Running head verso: Degli Esposti et al Running head recto: Biologic therapies utilization and healthcare resource in PsO and PsA open access to scientific and medical research DOI: http://dx.doi.org/10.2147/BTT.S168691 Open Access Full Text Article ORIGINAL RESEARCH Analysis of drug utilization and health care resource consumption in patients with psoriasis and psoriatic arthritis before and after treatment with biological therapies Luca Degli Esposti1 Objectives: To describe the therapeutic pathways of patients with psoriasis (PSO) and psoriatic Valentina Perrone1 arthritis (PsA) before and after treatment with biological therapies in a real-world setting and Diego Sangiorgi1 to determine the relative consumption of health care resources. Stefano Buda1 Design: Retrospective observational study. Margherita Andretta2 Setting: Real-life clinical setting in 5 Italian local health units. A total of 351 male and female patients with at least 1 prescription for a biologi- Maurizio Rossini3 Participants: cal drug from January 1, 2010 to December 31, 2013; patients with concomitant rheumatoid Giampiero Girolomoni4 For personal use only. arthritis, ankylosing spondylitis, or Crohn’s disease were excluded. 1 CliCon Srl, Health Economics and Results: The major health care cost (excluding drug costs) was represented by hospitaliza- Outcomes Research, Ravenna, Italy; 2Pharmaceutical Department Local tions, mainly related to PSO /PsA-associated disorders and cardiometabolic disorders. Use of Health Unit, ULSS 9 Scaligera, Verona, conventional drugs among biologics-naïve patients reached 50% in PSO and 80% in PsA; their 3 Italy; Department of Medicine, use decreased following initiation of biological therapy.
    [Show full text]
  • Treatment of Nausea and Vomiting During Pregnancy
    7UHDWPHQWRIQDXVHDDQGYRPLWLQJ GXULQJSUHJQDQF\ ZLWKVSHFLDOIRFXVRQDWWLWXGHVWRDQGXVHRISKDUPDFRORJLFDO WUHDWPHQW .ULVWLQH+HLWPDQQ Dissertation for the degree of philosophiae doctor (PhD) at the University of Bergen Dissertation date: © Copyright Kristine Heitmann The material in this publication is protected by copyright law. Year: 2016 Title: Treatment of nausea and vomiting during pregnancy - with special focus on attitudes to and use of pharmacological treatment Author: Kristine Heitmann Print: AiT Bjerch AS / University of Bergen In loving memory of my dearest mother Ingrid Medby Heitmann 4 Scientific environment This research project was carried out at the Research Group in Social Pharmacy, Department of Global Public Health and Primary Care and Centre for Pharmacy, University of Bergen. The work was financed by the Research Council of Norway (grant no. 195475). Main supervisor: Associate Professor Lone Holst, Department of Global Public Health and Primary Care and Centre for Pharmacy, University of Bergen. Co-supervisor: Professor Hedvig Nordeng, PharmacoEpidemiology and Drug Safety Research Group, School of Pharmacy, University of Oslo. I have participated in the National PhD School of Pharmacy and attended PhD courses at the University of Bergen. 5 Acknowledgements First and foremost, my heartfelt thanks to all the study participants who made this project possible. I wish to express my sincere gratitude to my supervisors, Associate Professor Lone Holst and Professor Hedvig Nordeng. I am deeply grateful for all your help, guidance and support during this PhD-project. You’re the best! I think you made an excellent “Team Supervisors”, complementing each other perfectly. Lone, contributing to all papers, you have supervised the whole project. Your guidance was especially important with respect to the qualitative part of this project.
    [Show full text]
  • Epidemiology of Nocturia
    KARI A. O. TIKKINEN Epidemiology of Nocturia Results from the FINNO Study ACADEMIC DISSERTATION To be presented, with the permission of the Faculty of Medicine of the University of Tampere, for public discussion in the Small Auditorium of Building M, Pirkanmaa Hospital District, Teiskontie 35, Tampere, on March 5th, 2010, at 12 o’clock. UNIVERSITY OF TAMPERE ACADEMIC DISSERTATION University of Tampere, Medical School Tampere University Hospital, Department of Urology University of Tampere, School of Public Health Helsinki University Central Hospital, Department of Urology Clinical Research Institute HUCH Ltd., Helsinki Finland Supervised by Reviewed by Professor Anssi Auvinen Adjunct Professor Pekka Hellström University of Tampere University of Oulu Finland Finland Professor Teuvo Tammela Professor Jaakko Kaprio University of Tampere University of Helsinki Finland Finland Distribution Tel. +358 3 3551 6055 Bookshop TAJU Fax +358 3 3551 7685 P.O. Box 617 [email protected] 33014 University of Tampere www.uta.fi/taju Finland http://granum.uta.fi Cover design by Juha Siro Acta Universitatis Tamperensis 1504 Acta Electronica Universitatis Tamperensis 942 ISBN 978-951-44-8019-5 (print) ISBN 978-951-44-8020-1 (pdf) ISSN-L 1455-1616 ISSN 1456-954X ISSN 1455-1616 http://acta.uta.fi Tampereen Yliopistopaino Oy – Juvenes Print Tampere 2010 Dedicated to the FINNO Study participants Table of contents Table of contents ....................................................................................................................... 4 List of original
    [Show full text]
  • Summary of Product Characteristics
    Irish Medicines Board Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Zantac 150mg Film -Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film -coated tablet contains 150mg ranitidine (as hydrochloride). For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film -coated tablet. Product imported from the UK: White, round, tablets, engraved ‘GX EC2 ’ on one side and plain on the other. 4 CLINICAL PARTICULARS 4.1 Therapeutic Indications In the treatment of duodenal ulcer and benign gastric ulcer including that associated with non -steroidal anti - inflammatory agents. Prevention of non -steroidal anti -inflammatory drug (including aspirin) associated duodenal ulcers, especially in patients with a history of peptic ulcer disease. Zantac Tablets are also indicated for treatment of post -operative ulcer, reflux oesophagitis, Zollinger -Ellison syndrome and other conditions where reduction of gastric acid secretion is likely to be beneficial. Children (3 to 18 years) • Short term treatment of peptic ulcer • Treatment of gastro -oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro - oesophageal reflux disease. 4.2 Posology and method of administration Adults (including the elderly) / Adolescents (12 years and over) The usual initial dosage in duodenal and benign gastric ulcer is 150mg twice daily or 300mg at night. This may be increased to ranitidine 300mg twice daily without an increased incidence of unwanted effects. Subsequently a maintenance dose of 150mg at night may be used. Smoking is associated with a higher rate of ulcer relapse, and such patients should be advised to stop smoking. In those who fail to comply with such advice, a dose of 300mg at night provides additional therapeutic benefit over the standard dose.
    [Show full text]
  • Evaluation of Carcinogenicity Studies of Medicinal Products for Human Use Authorised Via the European Centralised Procedure
    Regulatory Toxicology and Pharmacology xxx (2011) xxx–xxx Contents lists available at ScienceDirect Regulatory Toxicology and Pharmacology journal homepage: www.elsevier.com/locate/yrtph Evaluation of carcinogenicity studies of medicinal products for human use authorised via the European centralised procedure (1995–2009) ⇑ Anita Friedrich a, , Klaus Olejniczak b a Granzer Regulatory Consulting and Services, Zielstattstrasse 44, 81379 Munich, Germany b Federal Institute for Drugs and Medical Devices, Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, Germany article info abstract Article history: Carcinogenicity data of medicinal products for human use that have been authorised via the European Received 25 October 2010 centralised procedure (CP) between 1995 and 2009 were evaluated. Carcinogenicity data, either from Available online xxxx long-term rodent carcinogenicity studies, transgenic mouse studies or repeat-dose toxicity studies were available for 144 active substances contained in 159 medicinal products. Out of these compounds, 94 Keywords: (65%) were positive in at least one long-term carcinogenicity study or in repeat-dose toxicity studies. Medicinal products Fifty compounds (35%) showed no evidence of a carcinogenic potential. Out of the 94 compounds with Carcinogenicity positive findings in either carcinogenicity or repeat-dose toxicity studies, 33 were positive in both mice Rodents and rats, 40 were positive in rats only, and 21 were positive exclusively in mice. Long-term carcinogenic- ity studies in two rodent species were available for 116 compounds. Data from one long-term carcinoge- nicity study in rats and a transgenic mouse model were available for eight compounds. For 13 compounds, carcinogenicity data were generated in only one rodent species. One compound was exclu- sively tested in a transgenic mouse model.
    [Show full text]
  • DE/H/0946 Pantoprazole 20 Mg EN TXT – 06/2019 PRAC (+Excipients and Minor Editorial Changes)+ 08/2019 EPAR SUMMARY of PRODUCT CHARACTERISTICS
    Drug Product: Pantoprazole 20 mg DCP-946 Name of Document: 1.3.1 SPC and Labelling and Package Leaflet DE/H/0946 Pantoprazole 20 mg EN TXT – 06/2019 PRAC (+excipients and minor editorial changes)+ 08/2019 EPAR SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT [Invented Name] 20 mg gastro-resistant tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains: 20 mg of pantoprazole (equivalent to 22.6 mg pantoprazole sodium sesquihydrate) Excipients with known effect: 38.425 mg maltitol, soya lecithin and maximum of 1.84 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant tablet Yellow, oval tablet. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications [Invented Name] is indicated for use in adults and adolescents 12 years of age and above for: Symptomatic gastro-oesophageal reflux disease. Long-term management and prevention of relapse in reflux oesophagitis. [Invented Name] is indicated for use in adults for: Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment (see section 4.4). 4.2 Posology and method of administration Posology Adults and adolescents 12 years of age and above Symptomatic gastro-oesophageal reflux disease The recommended oral dose is one [Invented Name] 20 mg gastro-resistant tablet per day. Symptom relief is generally accomplished within 2-4 weeks. If this is not sufficient, symptom relief will normally be achieved within a further 4 weeks. When symptom relief has been achieved, reoccurring symptoms can be controlled using an on-demand regimen of 20 mg once daily, taking one tablet when required.
    [Show full text]
  • Heft 55 Gastritis, Magen- Und Zwölffingerdarmgeschwüre
    ROBERT KOCH INSTITUT Statistisches Bundesamt Nach wie vor sind Magenbeschwerden ein häufiges Gesundheitsproblem. Nach aktuellen Studien- ergebnissen des Robert Koch-Instituts hatten ein Fünftel der Erwachsenen in Deutschland schon einmal eine ärztlich diagnostizierte Gastritis, sieben Prozent schon einmal Magen- bzw. Zwölf- fingerdarmgeschwüre (Ulkus). Letztere sind eine schwerere Krankheitsform, bei der es zu ernsten Komplikationen kommen kann. Sowohl die Sicht auf die Ursachen von Gastritis und Ulkus als auch die anteilige Bedeutung der Risiken haben sich in den letzten Jahrzehnten erheblich verändert. Vor der in den 1980er-Jahren gelungenen Entdeckung der weit verbreiteten bakteriellen Besiedlung mit H. pylori und dessen Heft 55 Beitrag zur Entstehung von Entzündungen und Geschwüren wurde vor allem psychosomatischen Gastritis, Magen- und Ursachen eine große Bedeutung zugeschrieben. Während in Deutschland die Verbreitung von Zwölffingerdarmgeschwüre H. pylori stark zurückgeht, gewinnt die weiter zunehmende Anwendung von potenziell magen- schädigenden Arzneimitteln (z. B. NSAR und ASS) eine wachsende Bedeutung. Weitere Faktoren, wie Tabakkonsum, psychosoziale Belastungen und Ernährung, spielen aber auch eine Rolle, und das Zusammenwirken der Einflüsse ist sehr komplex. Mit den Protonenpumpenhemmern (PPI) stehen inzwischen hochwirksame Arzneimittel für die Behandlung und zur Prävention (»Magenschutz«) zur Verfügung. Aber auch deren anhaltend starker Verbrauchsanstieg ist nicht unproblematisch. © Robert Koch-Institut ISBN 978-3-89606-220-8
    [Show full text]
  • Summary of Product Characteristics
    Health Products Regulatory Authority Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Zantac 25 mg/ml Solution for Injection/Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ampoule contains ranitidine hydrochloride equivalent to 50 mg ranitidine in 2 ml i.e. 25 mg/ml. Each ampoule also contains 2.9 mg (0.09 mmol) of sodium and 0.6 mg (0.015 mmol) of potassium. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection/Infusion. A sterile, clear colourless to pale yellow aqueous solution. 4 CLINICAL PARTICULARS 4.1 Therapeutic Indications Zantac is used in the treatment of benign ulceration of the oesophagus, stomach, upper intestinal tract (including post-operative stomal area), and of the Zollinger-Ellison syndrome. In the management of conditions benefiting from reduced gastric acid secretion, such as reflux oesophagitis. As prophylaxis against: (i) acid aspiration (Mendelson’s) syndrome (ii) stress lesions of the upper gastrointestinal tract. (iii) recurrent haemorrhage from the upper gastrointestinal tract. Children (6 months to 18 years) ● Short term treatment of peptic ulcer. ● Treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro- oesophageal reflux disease. 4.2 Posology and method of administration Posology Adults (including the elderly) / Adolescents (12 years and over) Zantac Injection may be given either as a slow (over 2 minutes) intravenous injection of 50 mg, diluted to a volume of 20 ml, every six to eight hours as required until oral therapy can be introduced; or as an intermittent intravenous infusion at 25 mg per hour for two hours, repeated at six to eight hour intervals; or as an intramuscular injection of 50 mg every six to eight hours.
    [Show full text]