DOCSLIB.ORG

< INVENTED NAME > See Annex1 Film-Coated Tablet 2. Q

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
< INVENTED NAME > See Annex1 Film-Coated Tablet 2. Q SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT < INVENTED NAME > see annex1 film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 Film-coated tablet contains 400 mg norfloxacin. Excipient with known effects Each film-coated tablet contains 0.5 mg sunset yellow (E110) and 3.36 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Round, orange film-coated tablet, with an engraved line on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications < INVENTED NAME > is indicated for the treatment of the following infections caused by norfloxacin-susceptible bacteria (see sections 4.2 and 5.1): Uncomplicated acute cystitis. In uncomplicated acute cystitis < INVENTED NAME > should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections. Urethritis including cases due to susceptible Neisseria gonorrhoeae Complicated urinary tract infections (except complicated pyelonephritis) Complicated acute cystitis Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 Posology and method of administration Posology The dosage depends on the susceptibility of the pathogens and severity of the disease, see recommended dosage in the table below. Susceptibility of the causative organism to the treatment should be tested (if possible), although therapy may be initiated before the results are available. In case of suspected failure of therapy, microbiological investigation for possible bacterial resistance should be undertaken. 1 Dosage in adults Diagnosis Dosage Therapy duration2 Usual dosage for 400 mg twice daily 3 days uncomplicated acute cystitis3 Usual dosage for 400 mg twice daily 7 - 10 days1 urinary tract infections Complicated urinary tract 400 mg twice daily Normally 2 -3 weeks2 infections4 1 Symptoms accompanying urinary tract infections such as burning on passing water or fever and pain subside after only one to two days. Nevertheless, the recommended length of treatment should be fully adhered to. 2 Treatment longer than 3 weeks should be guided by evaluation of response of the patient taking into account official therapeutic guidelines and assessment of the risk of development of resistance. 3 This condition is considered to be met in women. 4 Excluding acute or chronic complicated pyelonephritis (see section 4.4) The tablets should not be divided. Dosage for patients with renal insufficiency < INVENTED NAME > is suitable for treatment of patients with renal insufficiency. In patients with severe impaired renal function, the advantages and disadvantages of the use of < INVENTED NAME > should be carefully weighed up in each individual case. For patients with a creatinine clearance = 30 ml/min x 1.73 m2 the recommended dosage is 1 < INVENTED NAME > film-coated tablet daily. At this dosage, fluid and tissue concentrations exceed the MICs of most norfloxacin- susceptible pathogens responsible for urinary tract infections. Older people Pharmacokinetic studies have shown no evidence of differences in norfloxacin pharmacokinetics in older people, apart from a slight prolongation of half-life. In the absence of renal impairment no adjustment of dosage is necessary for older people (see section 4.4 Cardiac disorders). Paediatric population < INVENTED NAME > is not recommended for use in children or growing adolescents (see 4.3 Contraindications). Method of administration The film coated tablets should be swallowed with sufficient fluid (e.g. a glass of water) at least one hour before or two hours after a meal or ingestion of milk. The film-coated tablets should preferably be taken in the morning and evening. If only one dose is to be administered daily, this should always be taken at the same time of day. 4.3 Contraindications Hypersensitivity to the active substance or to any related quinolone antibacterials, the colouring agent sunset yellow (E110) or to any of the excipients listed in section 6.1. Concomitant administration of norfloxacin and tizanidine (see section 4.5). Tendinitis and/or tendon rupture Norfloxacin is contraindicated in patients with a history of tendinitis and/or tendon rupture related to fluoroquinolone administration (see. 4.4 and 4.8). 2 Use in pregnancy and lactation and in children and growing adolescents Norfloxacin must not be used by children and growing adolescents or by pregnant and lactating women. This is because safety and efficacy have not yet been sufficiently established for these groups of patients (see sections 4.6 and 5.3). 4.4 Special warnings and precautions for use The use of norfloxacin should be avoided in patients who have experienced serious adverse reactions in the past when using quinolone or fluoroquinolone containing products (see section 4.8). Treatment of these patients with norfloxacin should only be initiated in the absence of alternative treatment options and after careful benefit/risk assessment (see also section 4.3). Whenever a systemic infection is suspected norfloxacin tablets should not be used to treat any urinary infection due to the relatively low systemic availability of oral norfloxacin. Prolonged, disabling and potentially irreversible serious adverse drug reactions Very rare cases of prolonged (continuing months or years), disabling and potentially irreversible serious adverse drug reactions affecting different, sometimes multiple, body systems (musculoskeletal, nervous, psychiatric and senses) have been reported in patients receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk factors. Norfloxacin should be discontinued immediately at the first signs or symptoms of any serious adverse reaction and patients should be advised to contact their prescriber for advice. Hypersensitivity reactions Serious and occasionally fatal hypersensitivity (anaphylactic or anaphylactoid) reactions, some following the first dose, have been reported in patients receiving quinoline therapy (see section 4.8). In such cases, therapy with norfloxacin must be discontinued immediately and appropriate emergency action must be started (e.g. antihistamines, glucocorticosteroids, sympathomimetics and ventilation if necessary). Hepatic failure Cases of hepatic necrosis and life-threatening hepatic failure have been reported with norfloxacin (see section 4.8). In the event of any signs and symptoms of hepatic disease (such as anorexia, jaundice, dark urine, pruritus, or tender abdomen), treatment should be discontinued. Tendinitis and tendon rupture Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment. The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants, and those treated concurrently with corticosteroids. Therefore, concomitant use of corticosteroids should be avoided. At the first sign of tendinitis (e.g. painful swelling, inflammation) the treatment with norfloxacin should be discontinued and alternative treatment should be considered. The affected limb(s) should be appropriately treated (e.g. immobilisation). Corticosteroids should not be used if signs of tendinopathy occur. Use in patients with epilepsy and other CNS disorders In the case of epileptics and patients with existing CNS disorders (e.g. a low convulsive threshold, a history of convulsions, reduced cerebral blood flow, changes to brain structure or stroke), norfloxacin should only be given if the benefit clearly outweighs the risk, because of the possibility of CNS side effects in these patients. 3 Convulsions have been reported in rare cases in patients receiving norfloxacin. Norfloxacin may lead to exacerbations and aggravation of the symptoms in patients with known or suspected psychiatric disorders, hallucinations and/or confusion (see section 4.8). The usually appropriate emergency measures are indicated (e.g. keeping airways free, administer anticonvulsants). Peripheral neuropathy Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysaesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones. Patients under treatment with norfloxacin should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop in order to prevent the development of potentially irreversible condition (see section 4.8). Pseudomembranous colitis The occurrence of severe and persistent diarrhoea during or after therapy may be an evidence for very rarely observed pseudomembranous colitis (see section 4.8). In such cases therapy must be stopped immediately and a suitable therapy (e.g. antibiotic with proven clinical efficacy) has to be started. Drugs inhibiting peristalsis are contraindicated. Cardiac disorders Caution should be taken when using fluoroquinolones, including norfloxacin, in patients with known risk factors for prolongation of the QT interval such as, for example: congenital long QT syndrome concomitant use of drugs that are known to prolong the QT interval (e.g. Class IA and III anti-arrhythmics,
Load more

Recommended publications
  • WHO Report on Surveillance of Antibiotic Consumption: 2016-2018 Early Implementation ISBN 978-92-4-151488-0 © World Health Organization 2018 Some Rights Reserved
    WHO Report on Surveillance of Antibiotic Consumption 2016-2018 Early implementation WHO Report on Surveillance of Antibiotic Consumption 2016 - 2018 Early implementation WHO report on surveillance of antibiotic consumption: 2016-2018 early implementation ISBN 978-92-4-151488-0 © 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. WHO report on surveillance of antibiotic consumption: 2016-2018 early implementation. Geneva: World Health Organization; 2018. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data.
    [Show full text]
  • Trend Analysis of Antibiotics Consumption Using WHO Aware Classification in Tertiary Care Hospital
    International Journal of Basic & Clinical Pharmacology Bhardwaj A et al. Int J Basic Clin Pharmacol. 2020 Nov;9(11):1675-1680 http:// www.ijbcp.com pISSN 2319-2003 | eISSN 2279-0780 DOI: https://dx.doi.org/10.18203/2319-2003.ijbcp20204493 Original Research Article Trend analysis of antibiotics consumption using WHO AWaRe classification in tertiary care hospital Ankit Bhardwaj*, Kaveri Kapoor, Vivek Singh Saraswathi institute of Medical Sciences, Pilakhuwa, Hapur, Uttar Pradesh, India Received: 21 August 2020 Accepted: 21 September 2020 *Correspondence: Dr. Ankit Bhardwaj, Email: [email protected] Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. ABSTRACT Background: Aim of the study was to assess trend in antibiotics consumption pattern from 2016 to 2019 using AWaRe classification, ATC and Defined daily dose methodology (DDD) in a tertiary care hospital. Antibiotics are crucial for treating infectious diseases and have significantly improved the prognosis of patients with infectious diseases, reducing morbidity and mortality. The aim of the study is to classify the antibiotic based on WHO AWaRe classification and compare their four-year consumption trends. The study was conducted at a tertiary care center, Pilakhuwa, Hapur. Antibiotic procurement data for a period of 4 years (2016-2019) was collected from the Central medical store. Methods: This is a retrospective time series analysis of systemic antibiotics with no intervention at patient level. Antibiotic procurement was taken as proxy for consumption assuming that same has been used.
    [Show full text]
  • Pharmacology-2/ Dr
    1 Pharmacology-2/ Dr. Y. Abusamra Pharmacology-2 Quinolones, trimethoprim & sulfonamides Dr. Yousef Abdel - Kareem Abusamra Faculty of Pharmacy Philadelphia University 2 3 LEARNING OUTCOMES After completing studying this chapter, the student should be able to: Classify the drugs into subgroups such as quinolones and sulfonamides. Recognize the bacterial spectrum of all these antibiotic and antibacterial groups. Summarize the most remarkable pharmacokinetic features of these drugs. Numerate the most important side effects associated with these agents. Select the antibiotic of choice to be used in certain infections, as associated with the patient status including comorbidity, the species of bacteria causing the infection and concurrently prescribed drugs. Reason some remarkable clinical considerations related to the use or contraindication or precaution of a certain drug. Illustrate the mechanism of action of each of these drugs. • Following synthesis of na lidixic a c id in the early 1960s, continued modification of the quinolone nucleus expanded the spectrum of activity, improved pharmacokinetics, and stabilized compounds against common mechanisms of resistance. • Overuse resulted in rising rates of resistance in gram-negative and gram-positive organisms, increased frequency of Clostridium difficile infections, and identification of numerous tough adverse effects. • Consequently, these agents have been relegated to second-line options for various indications. 4 Pharmacology-2/ Dr. Y. Abusamra Only will be mentioned here 5 Pharmacology-2/ Dr. Y. Abusamra Most bacterial species maintain two distinct type II topoisomerases that assist with deoxyribonucleic acid Topoisomerases: Supercoiling Unwinding (DNA) replication: . DNA gyrase {supercoiling} and . Topoisomerase IV {Unwinding}. Following cell wall entry through porin channels, fluoroquinolones bind to these enzymes and interfere with DNA ligation.
    [Show full text]
  • Effects of Norfloxacin and Rifampicin on Growth and Streptolysin S Production in Hemolytic Streptococci
    Effects of Norfloxacin and Rifampicin on Growth and Streptolysin S Production in Hemolytic Streptococci Akira Taketo Department of Biochemistry I, Fukui Medical School, Matsuoka, Fukui 910—11, Japan and Yoriko Taketo Department of Pharmacology, School of Medicine, Kanazawa University, Kanazawa Ishikawa 920, Japan Z. Naturforsch. 40c, 647—651 (1985); received April 19/May 28, 1985 Streptolysin S, Norfloxacin, Rifampicin, Streptococcus pyogenes Norfloxacin, a nalidixic acid analogue, inhibited streptolysin S (SLS) production when added to young streptococcal culture. DNA synthesis was mainly affected, but increment of cell mass, RNA and protein was also significantly reduced in streptococci treated with norfloxacin. In stationary phase cells and in the washed resting bacteria, the toxin production was resistant to the drug. Pretreatment with norfloxacin did not abolish the cellular capacity to produce SLS. Al­ though extracellular SLS was detectable at log phase of streptococcal growth, enhanced produc­ tion of the toxin occurred upon cessation of coccal multiplication. In contrast to norfloxacin, lower concentration of rifampicin inhibited SLS production, even added at late log or early stationary phase. Roles of growth phase, medium and carrier in induction of SLS production were analyzed as well. Introduction synthesis by the carrier is deficient, although RNA or oligonucleotide added as the carrier for SLS is often Streptococcal growth and SLS production are not designated as “inducer”. affected by nalidixic acid [1], an inhibitor of DNA In order to address these questions, effects of in­ gyrase. The toxin production, which requires certain hibitors of nucleic acid synthesis have been tested, carrier substance such as RNA [2] or detergent [3], is and influences of culture conditions such as carrier insensitive to novobiocin as well [1], and possible supplementation and medium shift have been ex­ role of DNA gyrase in SLS messenger RNA syn­ amined, on macromolecular synthesis or SLS-pro- thesis remains to be elucidated.
    [Show full text]
  • Trends in Antibiotic Utilization in Eight Latin American Countries, 1997–2007
    Investigación original / Original research Trends in antibiotic utilization in eight Latin American countries, 1997–2007 Veronika J. Wirtz,1 Anahí Dreser,1 and Ralph Gonzales 2 Suggested citation Wirtz VJ, Dreser A, Gonzales R. Trends in antibiotic utilization in eight Latin American Countries, 1997–2007. Rev Panam Salud Publica. 2010;27(3):219–25. ABSTRACT Objective. To describe the trends in antibiotic utilization in eight Latin American countries between 1997–2007. Methods. We analyzed retail sales data of oral and injectable antibiotics (World Health Or- ganization (WHO) Anatomic Therapeutic Chemical (ATC) code J01) between 1997 and 2007 for Argentina, Brazil, Chile, Colombia, Mexico, Peru, Uruguay, and Venezuela. Antibiotics were aggregated and utilization was calculated for all antibiotics (J01); for macrolides, lin- cosamindes, and streptogramins (J01 F); and for quinolones (J01 M). The kilogram sales of each antibiotic were converted into defined daily dose per 1 000 inhabitants per day (DID) ac- cording to the WHO ATC classification system. We calculated the absolute change in DID and relative change expressed in percent of DID variation, using 1997 as a reference. Results. Total antibiotic utilization has increased in Peru, Venezuela, Uruguay, and Brazil, with the largest relative increases observed in Peru (5.58 DID, +70.6%) and Venezuela (4.81 DID, +43.0%). For Mexico (–2.43 DID; –15.5%) and Colombia (–4.10; –33.7%), utilization decreased. Argentina and Chile showed major reductions in antibiotic utilization during the middle of this period. In all countries, quinolone use increased, particularly sharply in Venezuela (1.86 DID, +282%). The increase in macrolide, lincosaminde, and streptogramin use was greatest in Peru (0.76 DID, +82.1%), followed by Brazil, Argentina, and Chile.
    [Show full text]
  • Disabling and Potentially Permanent Side Effects Lead to Suspension Or Restrictions of Quinolone and Fluoroquinolone Antibiotics
    11 March 2019 EMA/175398/2019 Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics On 15 November 2018, EMA finalised a review of serious, disabling and potentially permanent side effects with quinolone and fluoroquinolone antibiotics given by mouth, injection or inhalation. The review incorporated the views of patients, healthcare professionals and academics presented at EMA’s public hearing on fluoroquinolone and quinolone antibiotics in June 2018. EMA’s human medicines committee (CHMP) endorsed the recommendations of EMA’s safety committee (PRAC) and concluded that the marketing authorisation of medicines containing cinoxacin, flumequine, nalidixic acid, and pipemidic acid should be suspended. The CHMP confirmed that the use of the remaining fluoroquinolone antibiotics should be restricted. In addition, the prescribing information for healthcare professionals and information for patients will describe the disabling and potentially permanent side effects and advise patients to stop treatment with a fluoroquinolone antibiotic at the first sign of a side effect involving muscles, tendons or joints and the nervous system. Restrictions on the use of fluoroquinolone antibiotics will mean that they should not be used: to treat infections that might get better without treatment or are not severe (such as throat infections); to treat non-bacterial infections, e.g. non-bacterial (chronic) prostatitis; for preventing traveller’s diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder); to treat mild or moderate bacterial infections unless other antibacterial medicines commonly recommended for these infections cannot be used. Importantly, fluoroquinolones should generally be avoided in patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic.
    [Show full text]
  • First Order Derivative Spectrophotometric Method for Simultaneous Estimation of Metronidazole and Norfloxacin in Their Combined Dosage Form
    International Journal of Applied and Natural Sciences (IJANS) ISSN(P): 2319-4014; ISSN(E): 2319-4022 Vol. 2, Issue 5, Nov 2013, 21-26 © IASET FIRST ORDER DERIVATIVE SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF METRONIDAZOLE AND NORFLOXACIN IN THEIR COMBINED DOSAGE FORM RAJYA LAKSHMI CH1 & RAMBABU C2 1Department of Chemistry, Vishnu Institute of Technology, Bhimavaram, Andhra Pradesh, India 2Department of Chemistry, Acharya Nagarjuna University, Guntur, Andhra Pradesh, India ABSTRACT Derivative spectroscopy offers a useful approach for the analysis of drugs in mixtures. In this study First order derivative spectrophotometric method was developed for the simultaneous determination of Metronidazole (MET) and Norfloxacin (NOR) in bulk and combined tablet dosage form. The derivative spectra for both the methods were obtained in methanol and the linearity was obtained in the concentration range of 1.25 – 6.25 µg/ml for Metronidazole and 1.0 - 5.0µg/ml for Norfloxacin. The zero order spectra are obtained at wavelengths 311nm for Metronidazole and 283nm for Norfloxacin. First order derivative spectrophotometric method was based on the determination of both the drugs at their respective zero crossing point (ZCP). The determinations were made at 216 nm (ZCP of Norfloxacin) for Metronidazole and 209 nm (ZCP of Metronidazole) for Norfloxacin. The mean recovery was 99.8 and 100.7 for Metronidazole and Norfloxacin respectively. The method was found to be simple, sensitive, accurate and precise and was applicable for the simultaneous determination of Metronidazole and Norfloxacin in pharmaceutical tablet dosage form. The results of analysis have been validated statistically and by recovery studies. KEYWORDS: Metronidazole, Norfloxacin, Zero Order Spectra, First Order Spectra, Zero Crossing Point Validation INTRODUCTION Metronidazole (MET), chemically known as 2-(2-methyl-5-nitro-1H- imidazol-1-yl) ethanol (figure 1) is an antibiotic, antiprotozoal, amoebicidal, bactericidal and trichomonicidal.
    [Show full text]
  • Pharmacogenomic Associations Tables
    Pharmacogenomic Associations Tables Disclaimer: This is educational material intended for health care professionals. This list is not comprehensive for all of the drugs in the pharmacopeia but focuses on commonly used drugs with high levels of evidence that the CYPs (CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A4 and CYP3A5 only) and other select genes are relevant to a given drug’s metabolism. If a drug is not listed, there is not enough evidence for inclusion at this time. Other CYPs and other genes not described here may also be relevant but are out of scope for this document. This educational material is not intended to supersede the care provider’s experience and knowledge of her or his patient to establish a diagnosis or a treatment plan. All medications require careful clinical monitoring regardless of the information presented here. Table of Contents Table 1: Substrates of Cytochrome P450 (CYP) Enzymes Table 2: Inhibitors of Cytochrome P450 (CYP) Enzymes Table 3: Inducers of Cytochrome P450 (CYP) Enzymes Table 4: Alternate drugs NOT metabolized by CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A4 or CYP3A5 enzymes Table 5: Glucose-6-Phosphate Dehydrogenase (G6PD) Associated Drugs and Compounds Table 6: Additional Pharmacogenomic Genes & Associated Drugs Table 1: Substrates of Cytochrome P450 (CYP) Enzymes Allergy Labetalol CYP2C19 Immunosuppressives Loratadine CYP3A4 Lidocaine CYP1A2 CYP2D6 Cyclosporine CYP3A4/5 Analgesic/Anesthesiology CYP3A4/5 Sirolimus CYP3A4/5 Losartan CYP2C9 CYP3A4/5 Codeine CYP2D6 activates Tacrolimus CYP3A4/5 Lovastatin
    [Show full text]
  • Fluoroquinolone Use in Paediatrics: Focus on Safety and Place in Therapy
    18th Expert Committee on the Selection and Use of Essential Medicines (2011) Fluoroquinolone Use in Paediatrics: Focus on Safety and Place in Therapy Jennifer A. Goldman, M.D. 1,2, Gregory L. Kearns, Pharm.D., Ph.D. 1,3,4 Departments of Pediatrics 1 and Pharmacology 3, University of Missouri – Kansas City and the Divisions of Pediatric Infectious Disease 2 and Clinical Pharmacology and Medical Toxicology, 4 Children’s Mercy Hospital, Kansas City, MO, USA Commissioned work for the Guidelines Group for the Revision of the “Guidance for National Tuberculosis Programmes on the Management of Tuberculosis in Children”, World Health Organization, 30-31 March 2010, Geneva, Switzerland 1 I. Introduction The first quinolone, nalidixic acid, was developed in the 1960s and was used (off- label) in pediatric therapeutics without restriction. Consequent to their broad spectrum of antimicrobial (including anti-mycobacterial) effect and perceived excellent safety profile, there was considerable hope and expectation that this class of antibiotics would find an important place in pediatric therapeutics. However, reports of quinolone-associated injury in weight bearing joints of juvenile animals resulted not only in an apparent contraindication to their use in human infants and children but also, completely derailed their formal development by pharmaceutical companies for use in pediatrics. While this situation resulted from a genuine concern for safety seemingly supported by relevant experimental findings, it served initially to remove a potentially useful
    [Show full text]
  • Common Study Protocol for Observational Database Studies WP5 – Analytic Database Studies
    Arrhythmogenic potential of drugs FP7-HEALTH-241679 http://www.aritmo-project.org/ Common Study Protocol for Observational Database Studies WP5 – Analytic Database Studies V 1.3 Draft Lead beneficiary: EMC Date: 03/01/2010 Nature: Report Dissemination level: D5.2 Report on Common Study Protocol for Observational Database Studies WP5: Conduct of Additional Observational Security: Studies. Author(s): Gianluca Trifiro’ (EMC), Giampiero Version: v1.1– 2/85 Mazzaglia (F-SIMG) Draft TABLE OF CONTENTS DOCUMENT INFOOMATION AND HISTORY ...........................................................................4 DEFINITIONS .................................................... ERRORE. IL SEGNALIBRO NON È DEFINITO. ABBREVIATIONS ......................................................................................................................6 1. BACKGROUND .................................................................................................................7 2. STUDY OBJECTIVES................................ ERRORE. IL SEGNALIBRO NON È DEFINITO. 3. METHODS ..........................................................................................................................8 3.1.STUDY DESIGN ....................................................................................................................8 3.2.DATA SOURCES ..................................................................................................................9 3.2.1. IPCI Database .....................................................................................................9
    [Show full text]
  • Noroxin® (Norfloxacin)
    TABLETS NOROXIN® (NORFLOXACIN) WARNING: Fluoroquinolones, including NOROXIN®, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (See WARNINGS). To reduce the development of drug-resistant bacteria and maintain the effectiveness of NOROXIN∗ and other antibacterial drugs, NOROXIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION NOROXIN (Norfloxacin) is a synthetic, broad-spectrum antibacterial agent for oral administration. Norfloxacin, a fluoroquinolone, is 1-ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3­ quinolinecarboxylic acid. Its empirical formula is C H FN O and the structural formula is: 16 18 3 3 Norfloxacin is a white to pale yellow crystalline powder with a molecular weight of 319.34 and a melting point of about 221°C. It is freely soluble in glacial acetic acid, and very slightly soluble in ethanol, methanol and water. NOROXIN is available in 400-mg tablets. Each tablet contains the following inactive ingredients: cellulose, croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, and titanium dioxide. Norfloxacin, a fluoroquinolone, differs from non-fluorinated quinolones by having a fluorine atom at the 6 position and a piperazine moiety at the 7 position. CLINICAL PHARMACOLOGY In fasting healthy volunteers, at least 30-40% of an oral dose of NOROXIN is absorbed. Absorption is rapid following single doses of 200 mg, 400 mg and 800 mg.
    [Show full text]
  • Annual Report of Antibiotic and Antimycotic Consumption 2019
    Schweizerisches Zentrum für Antibiotikaresistenzen Centre suisse pour le contrôle de l’Antibioresistance Centro svizzero per la resistenza agli antibiotici Swiss Centre for Antibiotic Resistance Annual report of antibiotic and antimycotic consumption 2019 Spitalzentrum Oberwallis Background ANRESIS collects antimicrobial consumption data that can be used as a basis for stewardship and monitoring programs. The WHO lays out the roles of surveillance data on antimicrobial consumption by [1]: • identifying and providing early warning to changes in antimicrobial use • developing interventions to address the problems • monitoring the outcomes of interventions • assessing the quality of prescribing in terms of adherence to practice guidelines • raising awareness among healthcare professionals and policy-makers about the inappropriate use of antimicrobial use Method In this report antimicrobial consumption corresponds to the quantity of antimicrobials dispensed from hospital pharmacies to the hospital wards. The measurement of antibiotic and antimycotic consumption is based on the Anatomical Therapeutical Chemical (ATC)/ Defined daily dose (DDD) methodology of the WHO [2]. The following classes of antimicrobials are included in the monitoring: ATC code Description J01 Antibacterials for systemic use J04A Drugs for treatment of tuberculosis J02 Antimycotics for systemic use A07AA Intestinal antibiotics P01AB Nitroimidazole derivates are included in J01 The antibiotic consumption is expressed as the number of DDDs per 100 bed-days. The DDD is the international standard measurement for drug utilization studies and is the assumed average maintenance dose per day for a drug used for its main indication in adults. The DDD is a technical unit and does not necessarily correspond to the recommended or prescribed daily dose; it is inaccurate in pediatric population and patients with renal failure.
    [Show full text]