DOCSLIB.ORG

WHO Pharmaceuticals Newsletter Provides You

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
WHO Pharmaceuticals Newsletter Provides You 2018 WHO Pharmaceuticals No.6 NEWSLETTER The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicines WHO Vision for Medicines Safety and legal actions taken by regulatory authorities around No country left behind: the world. It also provides signals based on information worldwide pharmacovigilance for safer medicines, safer patients derived from the WHO global database of individual case safety reports, VigiBase. This newsletter also includes a short report from the The aim of the Newsletter is to disseminate regulatory 41st Annual Meeting of Representatives of National information on the safety of Pharmacovigilance Centres participating in the WHO pharmaceutical products, Programme for International Drug Monitoring and from based on communications received from our network of an Advanced Workshop for Strengthening national pharmacovigilance centres Pharmacovigilance (PV) Systems. and other sources such as specialized bulletins and journals, as well as partners in WHO. The information is produced in the form of résumés in English, full texts of which may be obtained on request from: Safety and Vigilance: Medicines, EMP-HIS, World Health Organization, 1211 Geneva 27, Switzerland, Contents E-mail address: [email protected] This Newsletter is also available at: Regulatory matters http://www.who.int/medicines Safety of medicines Signal Feature © 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 Pharmaceuticals Newsletter No.6, 2018: World Health Organization; 2018. 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. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. Printed in Switzerland Table of Contents Regulatory Matters Fingolimod .................................................................................... 5 Fluoroquinolone and quinolone antibiotics ......................................... 5 HMG-CoA reductase inhibitors and fibrates: co-administration ............. 5 Hydrochlorothiazide ....................................................................... 6 Insulin-containing products: cartridges and pre-filled pens .................. 6 Ketoconazole ................................................................................ 6 Lamotrigine .................................................................................. 6 Lenvatinib .................................................................................... 7 Ponatinib ...................................................................................... 7 Ritonavir ...................................................................................... 7 Secukinumab ................................................................................ 7 Zoster and Influenza vaccines ......................................................... 7 Safety of medicines Daclizumab beta ............................................................................ 9 Dolutegravir ................................................................................. 9 Fentanyl (transdermal patches) ....................................................... 9 Fluoroquinolones ......................................................................... 10 Nusinersen ................................................................................. 10 Rivaroxaban ............................................................................... 10 Ruxolitinib .................................................................................. 10 Sildenafil .................................................................................... 10 Signal Aflibercept and deep vein thrombosis/pulmonary embolism ............... 12 Brivudine and 5-fluorouracil – Persistence of a fatal drug-drug interaction .................................................................................. 20 Ceftriaxone and Hepatitis in Patients 75 Years and Older ................... 24 Feature 41st Annual Meeting of Representatives of National Pharmacovigilance Centres participating in the WHO Programme for International Drug Monitoring, Geneva 6-8 November 2018 ......................................... 32 WHO Pharmaceuticals Newsletter No. 6, 2018 3 Table of Contents Advanced Workshop for Strengthening Pharmacovigilance (PV) Systems and PV Preparedness Geneva, Switzerland, 3-7 December .... 35 WHO Pharmaceuticals Newsletter No. 6, 2018 4 Regulatory Matters Fingolimod The restrictions were made fibrates: co- following recommendations Risk of worsening of made by the administration multiple sclerosis after Pharmacovigilance Risk Assessment Committee (PRAC). Risk of rhabdomyolysis: stopping PRAC evaluated the adverse contraindication removed. USA. The US Food and Drug effects of fluoroquinolone and Japan. The Ministry of Health, Administration (FDA) has quinolone antibiotics. The Labour and Welfare (MHLW) updated the prescribing review incorporated the views and the Pharmaceuticals and information for fingolimod of patients, health-care Medical Devices Agency (Gilenya®) to include a professionals and academics (PMDA) have announced that warning about the risk of presented at EMA’s public the package inserts for worsening of multiple sclerosis hearing. hydroxymethylglutaryl- (MS) when the medicine is PRAC recommended that some coenzyme A (HMG-CoA) stopped. medicines, including all those reductase inhibitors (statins: Fingolimod is indicated for the that contain a quinolone atorvastatin (Lipitor®), treatment of relapsing MS. antibiotic (cinoxacin, simvastatin (Lipovas®), flumequine, nalidixic acid and pitavastatin (Livalo®), Health-care professionals pipemidic acid), should be pravastatin (Mevalotin®), should inform patients before removed from the market as fluvastatin (Lochol®), starting treatment about the they are authorised for rosuvastatin (Crestor®), potential risk of a severe infections that should no longer amlodipine increase in disability after be treated with quinolones. basilate/atorvastatin stopping fingolimod. PRAC recommendations (Caduet®) and outlined situations in which the Also, patients should be ezetimibe/atorvastatin remaining fluoroquinolone carefully observed for evidence (Atozet®)) and fibrates antibiotics should not be used of an exacerbation of their MS (clinofibrate (Lipoclin®), (e.g. to treat infections that and treated appropriately when clofibrate (Clofibrate®), might get better without fingolimod is stopped. fenofibrate (Tricor® and treatment); and emphasized Lipidil®), bezafibrate Reference: that fluoroquinolones should be (Bezatol®) and pemafibrate Safety Alerts for Human used with caution in patients at (Parmodia®)) should be Medical Products, US FDA, risk (e.g. the elderly, patients
Load more

Recommended publications
  • The Protean Neurologic Manifestations of Varicella-Zoster Virus Infection
    REVIEW MARIA A. NAGEL, MD DONALD H. GILDEN, MD Department of Neurology, University of Departments of Neurology and Microbiology, Colorado Health Sciences Center, Denver University of Colorado Health Sciences Center, Denver The protean neurologic manifestations of varicella-zoster virus infection ■ ABSTRACT ARICELLA-ZOSTER VIRUS (VZV) is an V exclusively human, highly neurotropic Multiple neurologic complications may follow the alphaherpesvirus. Primary infection causes reactivation of varicella-zoster virus (VZV), including chickenpox, after which the virus becomes herpes zoster (also known as zoster or shingles), latent in cranial nerve ganglia, dorsal root postherpetic neuralgia, vasculopathy, myelitis, necrotizing ganglia, and autonomic ganglia along the retinitis, and zoster sine herpete (pain without rash). entire neuraxis. Decades later, VZV can reac- These conditions can be difficult to recognize, especially tivate to cause a number of neurologic condi- as several can occur without rash. tions. This article discusses the protean manifes- ■ KEY POINTS tations of VZV reactivation and their diagno- sis and treatment. The most common sequela of herpes zoster is postherpetic neuralgia, which can persist for months and ■ VZV REACTIVATION sometimes years after the rash resolves. HAS MANY MANIFESTATIONS VZV vasculopathy can present as transient ischemic VZV reactivation can produce a number of neurologic complications: attacks, ischemic or hemorrhagic stroke, or aneurysm. •Herpes zoster (shingles), manifesting as pain and rash in up to three dermatomes Vasculopathy and neurologic complications of VZV are • Postherpetic neuralgia, the most common best diagnosed by detecting VZV DNA in bodily fluids or sequela of zoster, is pain that persists for tissues or anti-VZV immunoglobulin G in the months and sometimes years after the rash cerebrospinal fluid.
    [Show full text]
  • Inclusion and Exclusion Criteria for Each Key Question
    Supplemental Table 1: Inclusion and exclusion criteria for each key question Chronic HBV infection in adults ≥ 18 year old (detectable HBsAg in serum for >6 months) Definition of disease Q1 Q2 Q3 Q4 Q5 Q6 Q7 HBV HBV infection with infection and persistent compensated Immunoactive Immunotolerant Seroconverted HBeAg HBV mono-infected viral load cirrhosis with Population chronic HBV chronic HBV from HBeAg to negative population under low level infection infection anti-HBe entecavir or viremia tenofovir (<2000 treatment IU/ml) Adding 2nd Stopped antiviral therapy antiviral drug Interventions and Entecavir compared Antiviral Antiviral therapy compared to continued compared to comparisons to tenofovir therapy therapy continued monotherapy Q1-2: Clinical outcomes: Cirrhosis, decompensated liver disease, HCC and death Intermediate outcomes (if evidence on clinical outcomes is limited or unavailable): HBsAg loss, HBeAg seroconversion and Outcomes HBeAg loss Q3-4: Cirrhosis, decompensated liver disease, HCC, relapse (viral and clinical) and HBsAg loss Q5: Renal function, hypophosphatemia and bone density Q6: Resistance, flare/decompensation and HBeAg loss Q7: Clinical outcomes: Cirrhosis, decompensated liver disease, HCC and death Study design RCT and controlled observational studies Acute HBV infection, children and pregnant women, HIV (+), HCV (+) or HDV (+) persons or other special populations Exclusions such as hemodialysis, transplant, and treatment failure populations. Co treatment with steroids and uncontrolled studies. Supplemental Table 2: Detailed Search Strategy: Ovid Database(s): Embase 1988 to 2014 Week 37, Ovid MEDLINE(R) In-Process & Other Non- Indexed Citations and Ovid MEDLINE(R) 1946 to Present, EBM Reviews - Cochrane Central Register of Controlled Trials August 2014, EBM Reviews - Cochrane Database of Systematic Reviews 2005 to July 2014 Search Strategy: # Searches Results 1 exp Hepatitis B/dt 26410 ("hepatitis B" or "serum hepatitis" or "hippie hepatitis" or "injection hepatitis" or 2 178548 "hepatitis type B").mp.
    [Show full text]
  • CDK4/6 Inhibitors in Breast Cancer Treatment: Potential Interactions with Drug, Gene and Pathophysiological Conditions
    Review CDK4/6 Inhibitors in Breast Cancer Treatment: Potential Interactions with Drug, Gene and Pathophysiological Conditions Rossana Roncato 1,*,†, Jacopo Angelini 2,†, Arianna Pani 2,3,†, Erika Cecchin 1, Andrea Sartore-Bianchi 2,4, Salvatore Siena 2,4, Elena De Mattia 1, Francesco Scaglione 2,3,‡ and Giuseppe Toffoli 1,‡ 1 1 Experimental and Clinical Pharmacology Unit, Centro di Riferimento Oncologico (CRO), IRCCS, 33081 Aviano, Italy; [email protected] (E.C.); [email protected] (E.D.M.); [email protected] (G.T.) 2 Department of Oncology and Hemato-Oncology, Università degli Studi di Milano, 20122 Milan, Italy; [email protected] (J.A.); [email protected] (A.P.); [email protected] (A.S-B.); [email protected] (S.S.); [email protected] (F.S.) 3 Clinical Pharmacology Unit, ASST Grande Ospedale Metropolitano Niguarda, Piazza dell'Ospedale Maggiore 3, 20162 Milan, Italy 4 Department of Hematology and Oncology, Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy * Correspondence: [email protected]; Tel.:+390434659130 † These authors contributed equally. ‡ These authors share senior authorship. Int. J. Mol. Sci. 2020, 21, x; doi: www.mdpi.com/journal/ijms Int. J. Mol. Sci. 2020, 21, x 2 of 8 Table S1. Co-administered agents categorized according to their potential risk for Drug-Drug interaction (DDI) in combination with CDK4/6 inhibitors (CDKis). Colors suggest the risk of DDI with CDKis: green, low risk DDI; orange, moderate risk DDI; red, high risk DDI. ADME, absorption, distribution, metabolism, and excretion; GI, Gastrointestinal; TdP, Torsades de Pointes; NTI, narrow therapeutic index. * Cardiological toxicity should be considered especially for ribociclib due to the QT prolongation.
    [Show full text]
  • Prediction of Premature Termination Codon Suppressing Compounds for Treatment of Duchenne Muscular Dystrophy Using Machine Learning
    Prediction of Premature Termination Codon Suppressing Compounds for Treatment of Duchenne Muscular Dystrophy using Machine Learning Kate Wang et al. Supplemental Table S1. Drugs selected by Pharmacophore-based, ML-based and DL- based search in the FDA-approved drugs database Pharmacophore WEKA TF 1-Palmitoyl-2-oleoyl-sn-glycero-3- 5-O-phosphono-alpha-D- (phospho-rac-(1-glycerol)) ribofuranosyl diphosphate Acarbose Amikacin Acetylcarnitine Acetarsol Arbutamine Acetylcholine Adenosine Aldehydo-N-Acetyl-D- Benserazide Acyclovir Glucosamine Bisoprolol Adefovir dipivoxil Alendronic acid Brivudine Alfentanil Alginic acid Cefamandole Alitretinoin alpha-Arbutin Cefdinir Azithromycin Amikacin Cefixime Balsalazide Amiloride Cefonicid Bethanechol Arbutin Ceforanide Bicalutamide Ascorbic acid calcium salt Cefotetan Calcium glubionate Auranofin Ceftibuten Cangrelor Azacitidine Ceftolozane Capecitabine Benserazide Cerivastatin Carbamoylcholine Besifloxacin Chlortetracycline Carisoprodol beta-L-fructofuranose Cilastatin Chlorobutanol Bictegravir Citicoline Cidofovir Bismuth subgallate Cladribine Clodronic acid Bleomycin Clarithromycin Colistimethate Bortezomib Clindamycin Cyclandelate Bromotheophylline Clofarabine Dexpanthenol Calcium threonate Cromoglicic acid Edoxudine Capecitabine Demeclocycline Elbasvir Capreomycin Diaminopropanol tetraacetic acid Erdosteine Carbidopa Diazolidinylurea Ethchlorvynol Carbocisteine Dibekacin Ethinamate Carboplatin Dinoprostone Famotidine Cefotetan Dipyridamole Fidaxomicin Chlormerodrin Doripenem Flavin adenine dinucleotide
    [Show full text]
  • New Zealand Data Sheet – Tradename (Active Ingredient)
    NEW ZEALAND DATA SHEET NEW ZEALAND DATA SHEET FLUOROURACIL EBEWE (FLUOROURACIL) 1. PRODUCT NAME Fluorouracil Ebewe 50 mg/mL solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Fluorouracil Ebewe 250 mg/5 mL contains 250 mg fluorouracil*. Fluorouracil Ebewe 500 mg/10 mL contains 100 mg fluorouracil*. Fluorouracil Ebewe 1000 mg/20 mL contains 1000 mg fluorouracil. Fluorouracil Ebewe 2500 mg/50 mL contains 2500 mg fluorouracil. Fluorouracil Ebewe 5000 mg/100 mL contains 5000 mg fluorouracil. For the full list of excipients, see Section 6.1 List of excipients. *Not supplied in New Zealand 3. PHARMACEUTICAL FORM Fluorouracil Ebewe is a sterile solution of fluorouracil for use as an intravenous infusion or injection. The pH of the fluorouracil injection solution is approximately 8.9. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Alone or in combination, for the palliative treatment of malignant tumours, particularly of the breast, colon or rectum; and in the treatment of gastric, primary hepatic, pancreatic, uterine (cervical particularly), ovarian and bladder carcinomas. Fluorouracil should only be used when other proven measures have failed or are considered impractical. 4.2. DOSE AND METHOD OF ADMINISTRATION General Directions Fluorouracil Ebewe contains no antimicrobial agent. The product is for single use in one patient only. Discard any residue. To reduce microbiological hazard, use as soon as practicable after reconstitution/preparation. If storage is necessary, hold at 2°C to 8°C for not more than 24 hours after preparation. Administration should be completed within 24 hours of preparation of the infusion and any residue discarded according to the guidelines for the disposal of cytotoxic drugs (see Section 6.6 Special precautions for disposal).
    [Show full text]
  • PRODUCT INFORMATION Brivudine Item No
    PRODUCT INFORMATION Brivudine Item No. 29448 CAS Registry No.: 69304-47-8 Formal Name: 5-[(1E)-2-bromoethenyl]-2′-deoxy-uridine OH Synonym: BVDU OH MF: C11H13BrN2O5 H Br FW: 333.1 N O Purity: ≥98% UV/Vis.: λ: 251, 294 nm max OO Supplied as: A crystalline solid N Storage: -20°C H Stability: ≥2 years Information represents the product specifications. Batch specific analytical results are provided on each certificate of analysis. Laboratory Procedures Brivudine is supplied as a crystalline solid. A stock solution may be made by dissolving the brivudine in the solvent of choice, which should be purged with an inert gas. Brivudine is soluble in organic solvents such as ethanol, DMSO, and dimethyl formamide (DMF). The solubility of brivudine in ethanol is approximately 10 mg/ml and approximately 30 mg/ml in DMSO and DMF. Further dilutions of the stock solution into aqueous buffers or isotonic saline should be made prior to performing biological experiments. Ensure that the residual amount of organic solvent is insignificant, since organic solvents may have physiological effects at low concentrations. Organic solvent-free aqueous solutions of brivudine can be prepared by directly dissolving the crystalline solid in aqueous buffers. The solubility of brivudine in PBS, pH 7.2, is approximately 0.5 mg/ml. We do not recommend storing the aqueous solution for more than one day. Description Brivudine is a thymidine analog and inhibitor of herpes simplex virus 1 (HSV-1) and varicella-zoster virus (VZV) viral replication.1,2 Following conversion to a 5’-triphosphate form by viral kinases, brivudine is incorporated into viral DNA, inhibiting viral DNA polymerases and inducing strand breakage.2 Brivudine (0.02-0.04 μg/ml) inhibits VZV replication in primary human fibroblasts and inhibits cytopathogenic 1,3 effects of the KOS HSV-1 strain in a panel of cell lines (MIC50s = 0.007-0.4 μg/ml).
    [Show full text]
  • Silibinin Component for the Treatment of Hepatitis Silbininkomponente Zur Behandlung Von Hepatitis Composant De Silibinine Pour Le Traitement De L’Hépatite
    (19) & (11) EP 2 219 642 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 31/357 (2006.01) A61P 1/16 (2006.01) 21.09.2011 Bulletin 2011/38 A61P 31/12 (2006.01) (21) Application number: 08849759.9 (86) International application number: PCT/EP2008/009659 (22) Date of filing: 14.11.2008 (87) International publication number: WO 2009/062737 (22.05.2009 Gazette 2009/21) (54) SILIBININ COMPONENT FOR THE TREATMENT OF HEPATITIS SILBININKOMPONENTE ZUR BEHANDLUNG VON HEPATITIS COMPOSANT DE SILIBININE POUR LE TRAITEMENT DE L’HÉPATITE (84) Designated Contracting States: (56) References cited: AT BE BG CH CY CZ DE DK EE ES FI FR GB GR WO-A-02/067853 GB-A- 2 167 414 HR HU IE IS IT LI LT LU LV MC MT NL NO PL PT RO SE SI SK TR • POLYAK STEPHEN J ET AL: "Inhibition of T- cell inflammatory cytokines, hepatocyte NF-kappa B (30) Priority: 15.11.2007 EP 07022187 signaling, and HCV infection by standardized 15.11.2007 US 988168 P silymarin" GASTROENTEROLOGY, vol. 132, no. 25.03.2008 EP 08005459 5, May 2007 (2007-05), pages 1925-1936, XP002477920 ISSN: 0016-5085 (43) Date of publication of application: • MAYER K E ET AL: "Silymarin treatment of viral 25.08.2010 Bulletin 2010/34 hepatitis: A systematic review" JOURNAL OF VIRAL HEPATITIS 200511 GB, vol. 12, no. 6, (60) Divisional application: November 2005 (2005-11), pages 559-567, 11005445.9 XP002477921 ISSN: 1352-0504 1365-2893 • CHAVEZ M L: "TREATMENT OF HEPATITIS C (73) Proprietor: Madaus GmbH WITH MILK THISTLE?" JOURNAL OF HERBAL 51067 Köln (DE) PHARMACOTHERAPY, HAWORTH HERBAL PRESS, BINGHAMTON, US, vol.
    [Show full text]
  • Tenofovir, Another Inexpensive, Well-Known and Widely Available Old Drug Repurposed for SARS-COV-2 Infection
    pharmaceuticals Review Tenofovir, Another Inexpensive, Well-Known and Widely Available Old Drug Repurposed for SARS-COV-2 Infection Isabella Zanella 1,2,* , Daniela Zizioli 1, Francesco Castelli 3 and Eugenia Quiros-Roldan 3 1 Department of Molecular and Translational Medicine, University of Brescia, 25123 Brescia, Italy; [email protected] 2 Clinical Chemistry Laboratory, Cytogenetics and Molecular Genetics Section, Diagnostic Department, ASST Spedali Civili di Brescia, Piazzale Spedali Civili 1, 25123 Brescia, Italy 3 University Department of Infectious and Tropical Diseases, University of Brescia and ASST Spedali Civili di Brescia, Piazzale Spedali Civili 1, 25123 Brescia, Italy; [email protected] (F.C.); [email protected] (E.Q.-R.) * Correspondence: [email protected]; Tel.: +39-030-399-6806 Abstract: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is spreading worldwide with different clinical manifestations. Age and comorbidities may explain severity in critical cases and people living with human immunodeficiency virus (HIV) might be at particularly high risk for severe progression. Nonetheless, current data, although sometimes contradictory, do not confirm higher morbidity, risk of more severe COVID-19 or higher mortality in HIV-infected people with complete access to antiretroviral therapy (ART). A possible protective role of ART has been hypothesized to explain these observations. Anti-viral drugs used to treat HIV infection have been repurposed for COVID-19 treatment; this is also based on previous studies on severe acute respiratory syndrome virus (SARS-CoV) and Middle East respiratory syndrome virus (MERS-CoV). Among Citation: Zanella, I.; Zizioli, D.; them, lopinavir/ritonavir, an inhibitor of viral protease, was extensively used early in the pandemic Castelli, F.; Quiros-Roldan, E.
    [Show full text]
  • The Evolution of Antiviral Therapy for External Ocular Viral Infections Over Twenty-Five Years
    Cornea 19(5): 673–680, 2000. © 2000 Lippincott Williams & Wilkins, Inc., Philadelphia The Evolution of Antiviral Therapy for External Ocular Viral Infections Over Twenty-five Years Y. Jerold Gordon, M.D. Purpose. To review the past 25 years of the evolution of antiviral levels on the corneal surface. By 1975, IDU was the treatment of therapy for the treatment of common external ocular viral infec- choice for herpetic epithelial keratitis worldwide. However, the tions (herpes simplex virus type 1, varicella-zoster virus, and ad- shortcomings of topical IDU therapy: significant toxicity (super- enovirus). Methods. A broad-based literature review in the fields ficial punctate keratitis, chemical conjunctivitis, and punctal oc- of virology, antiviral research, and ophthalmology will be carried clusion) and frequent hypersensitivity reactions, limited its useful- out. The pathogenesis of the major external ocular viral infections ness. As an insoluble agent, it had no therapeutic effect on herpetic and history of antiviral development will be cited. Important con- ceptual breakthroughs as well as historical landmarks will be em- stromal keratitis or iritis. Today, IDU is used infrequently in de- phasized. Results. The successful development of effective anti- veloped nations because it has been replaced by better drugs. How- virals to treat the most common external ocular viral infections ever, it remains effective and is used in developing nations where have dramatically reduced morbidity and sight loss. The immune cost issues are critical. pathogenesis of herpetic stromal keratitis is better understood. In the mid-1970s, several promising strategies to treat HSV Conclusions. Remarkable progress in the development of antiviral epithelial keratitis failed.
    [Show full text]
  • Interactions with HBV Treatment
    www.hep-druginteractions.org Interactions with HBV Treatment Charts revised September 2021. Full information available at www.hep-druginteractions.org Page 1 of 6 Please note that if a drug is not listed it cannot automatically be assumed it is safe to coadminister. ADV, Adefovir; ETV, Entecavir; LAM, Lamivudine; PEG IFN, Peginterferon; RBV, Ribavirin; TBV, Telbivudine; TAF, Tenofovir alafenamide; TDF, Tenofovir-DF. ADV ETV LAM PEG PEG RBV TBV TAF TDF ADV ETV LAM PEG PEG RBV TBV TAF TDF IFN IFN IFN IFN alfa-2a alfa-2b alfa-2a alfa-2b Anaesthetics & Muscle Relaxants Antibacterials (continued) Bupivacaine ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ Cloxacillin ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ Cisatracurium ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ Dapsone ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ Isoflurane ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ Delamanid ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ Ketamine ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ Ertapenem ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ Nitrous oxide ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ Erythromycin ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ Propofol ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ Ethambutol ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ Thiopental ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ Flucloxacillin ◆ ◆ ◆ ◆ ◆ ◆ Tizanidine ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ Gentamicin ◆ ◆ ◆ ◆ ◆ ◆ Analgesics Imipenem ◆ ◆ ◆ ◆ ◆ ◆ ◆ Aceclofenac ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ Isoniazid ◆ ◆ ◆ ◆ ◆ ◆ Alfentanil ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ Levofloxacin ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ Aspirin ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ Linezolid ◆ ◆ ◆ ◆ ◆ ◆ Buprenorphine ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ Lymecycline ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ Celecoxib ◆ ◆ ◆ ◆ ◆ ◆ ◆ Meropenem ◆ ◆ ◆ ◆ ◆ ◆ Codeine ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ for distribution. for Methenamine ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ Dexketoprofen ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ Metronidazole ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ Dextropropoxyphene ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ Moxifloxacin ◆ ◆ ◆
    [Show full text]
  • Surveillance of Antimicrobial Consumption in Europe 2013-2014 SURVEILLANCE REPORT
    SURVEILLANCE REPORT SURVEILLANCE REPORT Surveillance of antimicrobial consumption in Europe in Europe consumption of antimicrobial Surveillance Surveillance of antimicrobial consumption in Europe 2013-2014 2012 www.ecdc.europa.eu ECDC SURVEILLANCE REPORT Surveillance of antimicrobial consumption in Europe 2013–2014 This report of the European Centre for Disease Prevention and Control (ECDC) was coordinated by Klaus Weist. Contributing authors Klaus Weist, Arno Muller, Ana Hoxha, Vera Vlahović-Palčevski, Christelle Elias, Dominique Monnet and Ole Heuer. Data analysis: Klaus Weist, Arno Muller and Ana Hoxha. Acknowledgements The authors would like to thank the ESAC-Net Disease Network Coordination Committee members (Marcel Bruch, Philippe Cavalié, Herman Goossens, Jenny Hellman, Susan Hopkins, Stephanie Natsch, Anna Olczak-Pienkowska, Ajay Oza, Arjana Tambić Andrasevic, Peter Zarb) and observers (Jane Robertson, Arno Muller, Mike Sharland, Theo Verheij) for providing valuable comments and scientific advice during the production of the report. All ESAC-Net participants and National Coordinators are acknowledged for providing data and valuable comments on this report. The authors also acknowledge Gaetan Guyodo, Catalin Albu and Anna Renau-Rosell for managing the data and providing technical support to the participating countries. Suggested citation: European Centre for Disease Prevention and Control. Surveillance of antimicrobial consumption in Europe, 2013‒2014. Stockholm: ECDC; 2018. Stockholm, May 2018 ISBN 978-92-9498-187-5 ISSN 2315-0955
    [Show full text]
  • Drug Interaction Studies on New Drug Applications: Current Situations and Regulatory Views in Japan
    Drug Metab. Pharmacokinet. 25 (1): 3–15 (2010). Review Drug Interaction Studies on New Drug Applications: Current Situations and Regulatory Views in Japan Naomi NAGAI* Office of New Drug IV, Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan Full text of this paper is available at http://www.jstage.jst.go.jp/browse/dmpk Summary: Drug interaction studies on new drug applications (NDAs) for new molecular entities (NMEs) ap- proved in Japan between 1997 and 2008 are examined in the Pharmaceuticals and Medical Devices Agency (PMDA). The situations of drug interaction studies in NDAs have changed over the past 12 years, especially in metabolizing enzyme and transporter-based drug interactions. Materials and approaches to study drug- metabolizing enzyme-based drug interactions have improved, and become more rational based on mechanis- tic theory and new technologies. On the basis of incremental evidence of transporter roles in human phar- macokinetics, transporter-based drug interactions have been increasingly studied during drug development and submitted in recent NDAs. Some recently approved NMEs include transporter-based drug interaction in- formation in their package inserts (PIs). The regulatory document ``Methods of Drug Interaction Studies,'' in addition to recent advances in science and technology, has also contributed to plan and evaluation of drug in- teraction studies in recent new drug development. This review summarizes current situations and further dis- cussionpointsondruginteractionstudiesinNDAsinJapan. Keywords:
    [Show full text]