DOCSLIB.ORG

Tindamax® (Tinidazole) Tablets for Oral Use • Seizures and Neuropathy Have Been Reported

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Tindamax® (Tinidazole) Tablets for Oral Use • Seizures and Neuropathy Have Been Reported HIGHLIGHTS OF PRESCRIBING INFORMATION • First trimester of pregnancy (4, 8.1) These highlights do not include all the information needed to use • Nursing mothers, unless breast-feeding is interrupted during tinidazole Tindamax® safely and effectively. See full prescribing information for therapy and for 3 days following the last dose (4, 8.3) Tindamax®. -----------------------WARNINGS AND PRECAUTIONS------------------------ Tindamax® (tinidazole) tablets for oral use • Seizures and neuropathy have been reported. Discontinue Tindamax if Initial U.S. Approval: 2004 abnormal neurologic signs develop (5.1) To reduce the development of drug-resistant bacteria and maintain the • Vaginal candidiasis may develop with Tindamax and require treatment effectiveness of Tindamax and other antibacterial drugs, Tindamax should be with an antifungal agent (5.2) used only to treat or prevent infections that are proven or strongly suspected to • Use Tindamax with caution in patients with blood dyscrasias. Tindamax be caused by bacteria. may produce transient leukopenia and neutropenia (5.3, 7.3) WARNING: POTENTIAL RISK FOR CARCINOGENICITY See full prescribing information for complete boxed warning. ------------------------------ADVERSE REACTIONS------------------------------- Carcinogenicity has been seen in mice and rats treated chronically with Most common adverse reactions for a single 2 g dose of tinidazole (incidence metronidazole, another nitroimidazole agent (13.1). Although such data >1%) are metallic/bitter taste, nausea, weakness/fatigue/malaise, have not been reported for tinidazole, the two drugs are structurally dyspepsia/cramps/epigastric discomfort, vomiting, anorexia, headache, related and have similar biologic effects. Use should be limited to dizziness and constipation (6.1) approved indications only. To report SUSPECTED ADVERSE REACTIONS, contact ----------------------------RECENT MAJOR CHANGES----------------------- Mission Pharmacal Company at 1-800-298-1087 or FDA at 1-800-FDA- 1088 or www.fda.gov/medwatch Indications and Usage, Bacterial Vaginosis (1.4) 5/2007 Dosage and Administration, Bacterial Vaginosis (2.6) 5/2007 ------------------------------DRUG INTERACTIONS------------------------------- The following drug interactions were reported for metronidazole, a ----------------------------INDICATIONS AND USAGE--------------------------- chemically-related nitroimidazole and may therefore occur with tinidazole: Tindamax is a nitroimidazole antimicrobial indicated for: • Warfarin and other oral coumarin anticoagulants: Anticoagulant dosage • Trichomoniasis (1.1) • may need adjustment during and up to 8 days after tinidazole therapy Giardiasis: in patients age 3 and older (1.2) • (7.1) Amebiasis: in patients age 3 and older (1.3) • • Alcohol-containing beverages/preparations: Avoid during and up to 3 Bacterial Vaginosis: in non-pregnant, adult women (1.4, 8.1) days after tinidazole therapy (7.1) ----------------------DOSAGE AND ADMINISTRATION----------------------- • Lithium: Monitor serum lithium concentrations (7.1) • Trichomoniasis: a single 2 g oral dose taken with food. Treat sexual • Cyclosporine, tacrolimus: Monitor for toxicities of these partners with the same dose and at the same time (2.3) immunosuppressive drugs (7.1) • Giardiasis: Adults: a single 2 g dose taken with food. Pediatric patients • Fluorouracil: Monitor for fluorouracil-associated toxicities (7.1) older than three years of age: a single dose of 50 mg/kg (up to 2 g) with • Phenytoin, fosphenytoin: Adjustment of anticonvulsant and/or food (2.4) tinidazole dose(s) may be needed (7.1, 7.2) • Amebiasis, Intestinal: Adults: 2 g per day for 3 days with food. Pediatric • CYP3A4 inducers/inhibitors: Monitor for decreased tinidazole effect or patients older than three years of age: 50 mg/kg/day (up to 2 g per day) increased adverse reactions (7.2) for 3 days with food (2.5). Amebic liver abscess: Adults: 2 g per day for -----------------------USE IN SPECIFIC POPULATIONS------------------------ 3-5 days with food. Pediatric patients older than three years of age: • Pediatric Use: Data on tinidazole use in children is limited to treatment 50/mg/kg/day (up to 2 g per day) for 3-5 days with food (2.5) • of giardiasis and amebiasis in patients age 3 and older (8.4) Bacterial vaginosis: Non-pregnant, adult women: 2 g once daily for 2 • Hemodialysis patients: If tinidazole is administered the same day and days taken with food, or 1 g once daily for 5 days taken with food (2.6) prior to hemodialysis, administer an additional ½ dose after end of ---------------------DOSAGE FORMS AND STRENGTHS---------------------- hemodialysis (8.6, 12.3) Tablets: 250 mg and 500 mg (3) See 17 for PATIENT COUNSELING INFORMATION -------------------------------CONTRAINDICATIONS------------------------------ Revised: 5/2007 • Prior history of hypersensitivity to tinidazole or other nitroimidazole derivatives (4, 6.1, 6.2) _______________________________________________________________________________________________________________________________________ FULL PRESCRIBING INFORMATION: CONTENTS* 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy WARNING: POTENTIAL RISK FOR CARCINOGENICITY 8.3 Nursing Mothers 1 INDICATIONS AND USAGE 8.4 Pediatric Use 1.1 Trichomoniasis 8.5 Geriatric Use 1.2 Giardiasis 8.6 Renal Impairment 1.3 Amebiasis 8.7 Hepatic Impairment 1.4 Bacterial Vaginosis 10 OVERDOSAGE 2 DOSAGE AND ADMINISTRATION 11 DESCRIPTION 2.1 Dosing Instructions 12 CLINICAL PHARMACOLOGY 2.2 Compounding of the Oral Suspension 12.1 Mechanism of Action 2.3 Trichomoniasis 12.3 Pharmacokinetics 2.4 Giardiasis 12.4 Microbiology 2.5 Amebiasis 13 NONCLINICAL TOXICOLOGY 2.6 Bacterial Vaginosis 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 3 DOSAGE FORMS AND STRENGTHS 13.2 Animal Toxicology and/or Pharmacology 4 CONTRAINDICATIONS 14 CLINICAL STUDIES 5 WARNINGS AND PRECAUTIONS 14.1 Trichomoniasis 5.1 Neurological Adverse Reactions 14.2 Giardiasis 5.2 Vaginal Candidiasis 14.3 Intestinal Amebiasis 5.3 Blood Dyscrasia 14.4 Amebic Liver Abscess 5.4 Drug Resistance 14.5 Bacterial Vaginosis 6 ADVERSE REACTIONS 16 HOW SUPPLIED/STORAGE AND HANDLING 6.1 Clinical Studies Experience 17 PATIENT COUNSELING INFORMATION 6.2 Postmarketing Experience 17.1 Administration of Drug 7 DRUG INTERACTIONS 17.2 Alcohol Avoidance 7.1 Potential Effects of Tinidazole on Other Drugs 17.3 Drug Resistance 7.2 Potential Effects of Other Drugs on Tinidazole *Sections or subsections omitted from the full prescribing information are not 7.3 Laboratory Test Interactions listed ______________________________________________________________________________________________________________________________________ FULL PRESCRIBING INFORMATION with food. There are limited pediatric data on durations of therapy exceeding 3 days, although a small number of children were treated for 5 days without WARNING: POTENTIAL RISK FOR CARCINOGENICITY additional reported adverse reactions. Children should be closely monitored Carcinogenicity has been seen in mice and rats treated chronically with when treatment durations exceed 3 days. metronidazole, another nitroimidazole agent (13.1). Although such data 2.6 Bacterial Vaginosis have not been reported for tinidazole, the two drugs are structurally related The recommended dose in non-pregnant females is a 2 g oral dose once and have similar biologic effects. Its use should be reserved for the daily for 2 days taken with food or a 1 g oral dose once daily for 5 days taken conditions described in INDICATIONS AND USAGE (1). with food. The use of tinidazole in pregnant patients has not been studied for bacterial vaginosis. 1 INDICATIONS AND USAGE 1.1 Trichomoniasis 3 DOSAGE FORMS AND STRENGTHS Tinidazole is indicated for the treatment of trichomoniasis caused by • 250 mg tablets are pink, round, scored tablets, with TM debossed on one Trichomonas vaginalis. The organism should be identified by appropriate side and 250 on the other diagnostic procedures. Because trichomoniasis is a sexually transmitted • 500 mg tablets are pink, oval, scored tablets, with TM debossed on one disease with potentially serious sequelae, partners of infected patients should side and 500 on the other be treated simultaneously in order to prevent re-infection [see Clinical Studies (14.1)]. 4 CONTRAINDICATIONS 1.2 Giardiasis The use of tinidazole is contraindicated: Tinidazole is indicated for the treatment of giardiasis caused by Giardia • In patients with a previous history of hypersensitivity to tinidazole or duodenalis (also termed G. lamblia) in both adults and pediatric patients older other nitroimidazole derivatives. Reported reactions have ranged in than three years of age [see Clinical Studies (14.2)]. severity from urticaria to Stevens-Johnson syndrome [see Adverse 1.3 Amebiasis Reactions (6.1, 6.2)]. Tinidazole is indicated for the treatment of intestinal amebiasis and amebic • During first trimester of pregnancy [see Use in Specific Populations liver abscess caused by Entamoeba histolytica in both adults and pediatric (8.1)]. patients older than three years of age. It is not indicated in the treatment of • In nursing mothers: Interruption of breast-feeding is recommended asymptomatic cyst passage [see Clinical Studies (14.3, 14.4)]. during tinidazole therapy and for 3 days following the last dose [see Use 1.4 Bacterial Vaginosis in Specific Populations (8.3)]. Tinidazole is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific 5 WARNINGS
Load more

Recommended publications
  • National Antibiotic Consumption for Human Use in Sierra Leone (2017–2019): a Cross-Sectional Study
    Tropical Medicine and Infectious Disease Article National Antibiotic Consumption for Human Use in Sierra Leone (2017–2019): A Cross-Sectional Study Joseph Sam Kanu 1,2,* , Mohammed Khogali 3, Katrina Hann 4 , Wenjing Tao 5, Shuwary Barlatt 6,7, James Komeh 6, Joy Johnson 6, Mohamed Sesay 6, Mohamed Alex Vandi 8, Hannock Tweya 9, Collins Timire 10, Onome Thomas Abiri 6,11 , Fawzi Thomas 6, Ahmed Sankoh-Hughes 12, Bailah Molleh 4, Anna Maruta 13 and Anthony D. Harries 10,14 1 National Disease Surveillance Programme, Sierra Leone National Public Health Emergency Operations Centre, Ministry of Health and Sanitation, Cockerill, Wilkinson Road, Freetown, Sierra Leone 2 Department of Community Health, Faculty of Clinical Sciences, College of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown, Sierra Leone 3 Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organization, 1211 Geneva, Switzerland; [email protected] 4 Sustainable Health Systems, Freetown, Sierra Leone; [email protected] (K.H.); [email protected] (B.M.) 5 Unit for Antibiotics and Infection Control, Public Health Agency of Sweden, Folkhalsomyndigheten, SE-171 82 Stockholm, Sweden; [email protected] 6 Pharmacy Board of Sierra Leone, Central Medical Stores, New England Ville, Freetown, Sierra Leone; [email protected] (S.B.); [email protected] (J.K.); [email protected] (J.J.); [email protected] (M.S.); [email protected] (O.T.A.); [email protected] (F.T.) Citation: Kanu, J.S.; Khogali, M.; 7 Department of Pharmaceutics and Clinical Pharmacy & Therapeutics, Faculty of Pharmaceutical Sciences, Hann, K.; Tao, W.; Barlatt, S.; Komeh, College of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown 0000, Sierra Leone 8 J.; Johnson, J.; Sesay, M.; Vandi, M.A.; Directorate of Health Security & Emergencies, Ministry of Health and Sanitation, Sierra Leone National Tweya, H.; et al.
    [Show full text]
  • Identification of Leishmania Donovani Inhibitors from Pathogen Box Compounds of Medicine for Malaria Venture
    bioRxiv preprint doi: https://doi.org/10.1101/716134; this version posted July 26, 2019. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under aCC-BY 4.0 International license. Identification of Leishmania donovani inhibitors from pathogen box compounds of Medicine for Malaria Venture Markos Tadele1¶, Solomon M. Abay2¶*, Eyasu Makonnen2,4, Asrat Hailu3 1 Ethiopian institute of agricultural research, Animal health research program, Holetta, Ethiopia 2Department of Pharmacology and clinical pharmacy, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia 3Department of Microbiology, Immunology and Parasitology, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia 4Center for Innovative Drug Development and Therapeutic Trials for Africa (CDT Africa), College of Health Sciences, Addis Ababa University * Corresponding author Email: [email protected], [email protected] ¶ These authors contributed equally to this work. Author Contributions Conceptualization and design the experiment: MT, SMA, EM, AH Investigation: MT, SMA, AH Data analysis: MT, SMA Funding acquisition and reagents contribution: SMA, AH Supervision: SMA, EM, AH Writing – original draft: MT Writing – review & editing: MT, SMA, EM, AH 1 | P a g e bioRxiv preprint doi: https://doi.org/10.1101/716134; this version posted July 26, 2019. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under aCC-BY 4.0 International license.
    [Show full text]
  • AMEG Categorisation of Antibiotics
    12 December 2019 EMA/CVMP/CHMP/682198/2017 Committee for Medicinal Products for Veterinary use (CVMP) Committee for Medicinal Products for Human Use (CHMP) Categorisation of antibiotics in the European Union Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals Agreed by the Antimicrobial Advice ad hoc Expert Group (AMEG) 29 October 2018 Adopted by the CVMP for release for consultation 24 January 2019 Adopted by the CHMP for release for consultation 31 January 2019 Start of public consultation 5 February 2019 End of consultation (deadline for comments) 30 April 2019 Agreed by the Antimicrobial Advice ad hoc Expert Group (AMEG) 19 November 2019 Adopted by the CVMP 5 December 2019 Adopted by the CHMP 12 December 2019 Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. Categorisation of antibiotics in the European Union Table of Contents 1. Summary assessment and recommendations .......................................... 3 2. Introduction ............................................................................................ 7 2.1. Background ........................................................................................................
    [Show full text]
  • The Nitroimidazole Family of Drugs
    Br J Vener Dis: first published as 10.1136/sti.54.2.69 on 1 April 1978. Downloaded from British Journal of Venereal Diseases, 1978, 54, 69-71 Editorial The nitroimidazole family of drugs In 1955 an antibiotic complex isolated from a operative infection caused by susceptible anaerobes, strain of Streptomyces on the island of Reunion particularly in gynaecological surgery, appendi- was found by research workers of Rhone-Poulenc in cectomy, and colonic surgery. Paris to contain a trichomonacidal antibiotic- Real innovations in chemotherapy, such as azomycin. It had previously been isolated in Japan metronidazole, always attract attention from other (Maeda et al., 1953) and identified as 2-nitroimi- research groups. Although interest was slow to dazole (Ia see Table) (Nakamura, 1955). At the develop, research workers have sought analogous, time, and for some years after, this remarkably structurally-modified compounds which might afford simple compound defied synthesis, but it stimulated some advantage in clinical use-for example, the workers at Rhone-Poulenc to prepare and test greater potency, better tolerance and freedom from the activity of the more readily accessible isomeric side effects, a broader spectrum of action, a longer 5-nitroimidazoles (II). It was their good fortune in duration of action, or in some other characteristic. 1957 to find that these isomers were more active This effort has been concerned with important antiprotozoal agents than the natural product veterinary uses of 5-nitroimidazoles as well as the (Cosar and Julou, 1959). In a series of 150 related applications in human medicine. compounds, the one with a P-hydroxyethyl group Metronidazole has been a difficult target to in the 1-position gave the best compromise between improve upon, but several other drugs of this activity and toxicity and this brand of metroni- chemical family have been introduced to clinical dazole was introduced as Flagyl.
    [Show full text]
  • The Organic Chemistry of Drug Synthesis
    The Organic Chemistry of Drug Synthesis VOLUME 2 DANIEL LEDNICER Mead Johnson and Company Evansville, Indiana LESTER A. MITSCHER The University of Kansas School of Pharmacy Department of Medicinal Chemistry Lawrence, Kansas A WILEY-INTERSCIENCE PUBLICATION JOHN WILEY AND SONS, New York • Chichester • Brisbane • Toronto Copyright © 1980 by John Wiley & Sons, Inc. All rights reserved. Published simultaneously in Canada. Reproduction or translation of any part of this work beyond that permitted by Sections 107 or 108 of the 1976 United States Copyright Act without the permission of the copyright owner is unlawful. Requests for permission or further information should be addressed to the Permissions Department, John Wiley & Sons, Inc. Library of Congress Cataloging in Publication Data: Lednicer, Daniel, 1929- The organic chemistry of drug synthesis. "A Wiley-lnterscience publication." 1. Chemistry, Medical and pharmaceutical. 2. Drugs. 3. Chemistry, Organic. I. Mitscher, Lester A., joint author. II. Title. RS421 .L423 615M 91 76-28387 ISBN 0-471-04392-3 Printed in the United States of America 10 987654321 It is our pleasure again to dedicate a book to our helpmeets: Beryle and Betty. "Has it ever occurred to you that medicinal chemists are just like compulsive gamblers: the next compound will be the real winner." R. L. Clark at the 16th National Medicinal Chemistry Symposium, June, 1978. vii Preface The reception accorded "Organic Chemistry of Drug Synthesis11 seems to us to indicate widespread interest in the organic chemistry involved in the search for new pharmaceutical agents. We are only too aware of the fact that the book deals with a limited segment of the field; the earlier volume cannot be considered either comprehensive or completely up to date.
    [Show full text]
  • Principios Activos Fotosensibles
    PRINCIPIOS ACTIVOS FOTOSENSIBLES PROTEGE A TUS PRODUCTOS DE LA FOTODEGRADACIÓN PRINCIPIOS ACTIVOS FOTOSENSIBLES Adenosine Carbamazepine Digitoxin Heptacaine Methaqualone-1-oxide Phenothiazines Sulfisomidine Tinidazole Vitamin D Adrenaline Carbisocaine Digoxin Hexachlorophane Methotrexate Phenylbutazone Sulpyrine Tolmetin Vitamin E Adriamycin Carboplatin Dihydroergotamin Hydralazine Metronidazole Phenylephrine Suprofen Tretinoin Vitamin K1 Amidopyrin Carmustine Dihydropyridines Mifepristone Phenytoin Triamcinolone Vitamin K2 Hydrochlorothiazide Suramin Amidinohydrazones Cefotaxime Diltiazem Hydrocortisone Minoxidil Physostigmine Triamterene Warfarin Amiloride Cefuroxime axetil Diosgenin Mitomycin C Piroxicam Tauromustine (TCNU) Trifluoperazine Hydroxychloroquine Terbutaline 4-Aminobenzoic acid Cephaeline Diphenhydramine Hypochloride Mitonafide Pralidoxime Trimethoprim Aminophenazone Cephalexine Dipyridamole Ibuprofen Mitoxantrone Prednisolone Tetracyclines Ubidecarenone Thiazide Aminophylline Cephradine Dithranol Imipramin Molsidomine Primaquine Vancomycin Thiocolchicoside Aminosalicylic acid Chalcone Dobutamin Indapamide Morphine Proguanil Vinblastine Thioridazine Amiodarone Chloramphenicol Dopamine Indomethacin Nalidixic acid Promazine Vitamin A Thiorphan Amodiaquine Chlordiazepoxide Dothiepin Indoprofen Naproxen Promethazine Vitamin B (see also Thiothixene Amonafide Chloroquine Doxorubicin Isoprenaline Neocarzinostatin Proxibarbital riboflavine) Tiaprofenic acid Amphotericin B Chlorpromazine DTIC Isopropylamino- Nimodipine Psoralen
    [Show full text]
  • Anew Drug Design Strategy in the Liht of Molecular Hybridization Concept
    www.ijcrt.org © 2020 IJCRT | Volume 8, Issue 12 December 2020 | ISSN: 2320-2882 “Drug Design strategy and chemical process maximization in the light of Molecular Hybridization Concept.” Subhasis Basu, Ph D Registration No: VB 1198 of 2018-2019. Department Of Chemistry, Visva-Bharati University A Draft Thesis is submitted for the partial fulfilment of PhD in Chemistry Thesis/Degree proceeding. DECLARATION I Certify that a. The Work contained in this thesis is original and has been done by me under the guidance of my supervisor. b. The work has not been submitted to any other Institute for any degree or diploma. c. I have followed the guidelines provided by the Institute in preparing the thesis. d. I have conformed to the norms and guidelines given in the Ethical Code of Conduct of the Institute. e. Whenever I have used materials (data, theoretical analysis, figures and text) from other sources, I have given due credit to them by citing them in the text of the thesis and giving their details in the references. Further, I have taken permission from the copyright owners of the sources, whenever necessary. IJCRT2012039 International Journal of Creative Research Thoughts (IJCRT) www.ijcrt.org 284 www.ijcrt.org © 2020 IJCRT | Volume 8, Issue 12 December 2020 | ISSN: 2320-2882 f. Whenever I have quoted written materials from other sources I have put them under quotation marks and given due credit to the sources by citing them and giving required details in the references. (Subhasis Basu) ACKNOWLEDGEMENT This preface is to extend an appreciation to all those individuals who with their generous co- operation guided us in every aspect to make this design and drawing successful.
    [Show full text]
  • Evidence of Pyrimethamine and Cycloguanil Analogues As Dual Inhibitors of Trypanosoma Brucei Pteridine Reductase and Dihydrofolate Reductase
    pharmaceuticals Article Evidence of Pyrimethamine and Cycloguanil Analogues as Dual Inhibitors of Trypanosoma brucei Pteridine Reductase and Dihydrofolate Reductase Giusy Tassone 1,† , Giacomo Landi 1,†, Pasquale Linciano 2,† , Valeria Francesconi 3 , Michele Tonelli 3 , Lorenzo Tagliazucchi 2 , Maria Paola Costi 2 , Stefano Mangani 1 and Cecilia Pozzi 1,* 1 Department of Biotechnology, Chemistry and Pharmacy, Department of Excellence 2018–2022, University of Siena, via Aldo Moro 2, 53100 Siena, Italy; [email protected] (G.T.); [email protected] (G.L.); [email protected] (S.M.) 2 Department of Life Science, University of Modena and Reggio Emilia, via Campi 103, 41125 Modena, Italy; [email protected] (P.L.); [email protected] (L.T.); [email protected] (M.P.C.) 3 Department of Pharmacy, University of Genoa, Viale Benedetto XV n.3, 16132 Genoa, Italy; [email protected] (V.F.); [email protected] (M.T.) * Correspondence: [email protected]; Tel.: +39-0577-232132 † These authors contributed equally to this work. Abstract: Trypanosoma and Leishmania parasites are the etiological agents of various threatening Citation: Tassone, G.; Landi, G.; neglected tropical diseases (NTDs), including human African trypanosomiasis (HAT), Chagas disease, Linciano, P.; Francesconi, V.; Tonelli, and various types of leishmaniasis. Recently, meaningful progresses in the treatment of HAT, due to M.; Tagliazucchi, L.; Costi, M.P.; Trypanosoma brucei (Tb), have been achieved by the introduction of fexinidazole and the combination Mangani, S.; Pozzi, C. Evidence of therapy eflornithine–nifurtimox. Nevertheless, due to drug resistance issues and the exitance of Pyrimethamine and Cycloguanil animal reservoirs, the development of new NTD treatments is still required.
    [Show full text]
  • The Organic Chemistry of Drug Synthesis
    THE ORGANIC CHEMISTRY OF DRUG SYNTHESIS VOLUME 3 DANIEL LEDNICER Analytical Bio-Chemistry Laboratories, Inc. Columbia, Missouri LESTER A. MITSCHER The University of Kansas School of Pharmacy Department of Medicinal Chemistry Lawrence, Kansas A WILEY-INTERSCIENCE PUBLICATION JOHN WILEY AND SONS New York • Chlchester • Brisbane * Toronto • Singapore Copyright © 1984 by John Wiley & Sons, Inc. All rights reserved. Published simultaneously in Canada. Reproduction or translation of any part of this work beyond that permitted by Section 107 or 108 of the 1976 United States Copyright Act without the permission of the copyright owner is unlawful. Requests for permission or further information should be addressed to the Permissions Department, John Wiley & Sons, Inc. Library of Congress Cataloging In Publication Data: (Revised for volume 3) Lednicer, Daniel, 1929- The organic chemistry of drug synthesis. "A Wiley-lnterscience publication." Includes bibliographical references and index. 1. Chemistry, Pharmaceutical. 2. Drugs. 3. Chemistry, Organic—Synthesis. I. Mitscher, Lester A., joint author. II. Title. [DNLM 1. Chemistry, Organic. 2. Chemistry, Pharmaceutical. 3. Drugs—Chemical synthesis. QV 744 L473o 1977] RS403.L38 615M9 76-28387 ISBN 0-471-09250-9 (v. 3) Printed in the United States of America 10 907654321 With great pleasure we dedicate this book, too, to our wives, Beryle and Betty. The great tragedy of Science is the slaying of a beautiful hypothesis by an ugly fact. Thomas H. Huxley, "Biogenesis and Abiogenisis" Preface Ihe first volume in this series represented the launching of a trial balloon on the part of the authors. In the first place, wo were not entirely convinced that contemporary medicinal (hemistry could in fact be organized coherently on the basis of organic chemistry.
    [Show full text]
  • Stability Indicating HPLC Method for Simultaneous Estimation of Rifaximin and Metronidazole Hydrochloride Tablet Dosage Form Panchal Hemanshi*1, Thakkar Divya2 1
    J Pharm Sci Bioscientific Res. 2018. 8 (2):123-129 ISSN NO. 2271-3681 Stability Indicating HPLC Method for Simultaneous Estimation of Rifaximin and Metronidazole Hydrochloride Tablet Dosage Form Panchal Hemanshi*1, Thakkar Divya2 1. Research Scholar, Quality Assurance, KB Raval institute of pharmacy, Gandhinagar, Gujarat, India 2. Assistant Professor, Dept. of Quality Assurance, KB Raval institute of pharmacy, Gandhinagar, Gujarat, India Article history: ABSTRACT: Received 20 March 2018 A simple, rapid, economical, precise and accurate Stability indicating RP-HPLC Revised 29 April 2018 Accepted 02 May 2018 method for simultaneous estimation of Metronidazole and Rifaximin in their Available online 30 Jun 2018 combined dosage form has been developed. A reverse phase high performance liquid chromatographic method was developed for the Citation: simultaneous estimation of Metronidazole and Rifaximin in Their Combined Panchal H., Thakkar D. Patel K. R. Stability Indicating HPLC Method for Simultaneous Dosage Form has been developed. The separation was achieved by LC- 20 AT C18 Estimation of Rifaximin and Metronidazole (250mm x 4.6 mm x 2.6 µm) column and Buffer (Potassium Phosphate, pH 5.0): Hydrochloride Tablet Dosage Form. J Acetonitrile (60:40) as mobile phase, at a flow rate of 1 ml/min. Detection was Pharm Sci Bioscientific Res. 2018. carried out at 233 nm. Retention time of Rifaximin and Metronidazole were found 8(2):123-129 to be 3.713 min and 6.107 min respectively. The method has been validated for linearity, accuracy and precision. Linearity observed for Metronidazole 10-30 μg/ml and for Rifaximin 5-15 μg/ml. Developed method was found to be accurate, precise and rapid for simultaneous estimation of Metronidazole And Rifaximin In Their Combined Dosage Form.
    [Show full text]
  • Alphabetical Listing of ATC Drugs & Codes
    Alphabetical Listing of ATC drugs & codes. Introduction This file is an alphabetical listing of ATC codes as supplied to us in November 1999. It is supplied free as a service to those who care about good medicine use by mSupply support. To get an overview of the ATC system, use the “ATC categories.pdf” document also alvailable from www.msupply.org.nz Thanks to the WHO collaborating centre for Drug Statistics & Methodology, Norway, for supplying the raw data. I have intentionally supplied these files as PDFs so that they are not quite so easily manipulated and redistributed. I am told there is no copyright on the files, but it still seems polite to ask before using other people’s work, so please contact <[email protected]> for permission before asking us for text files. mSupply support also distributes mSupply software for inventory control, which has an inbuilt system for reporting on medicine usage using the ATC system You can download a full working version from www.msupply.org.nz Craig Drown, mSupply Support <[email protected]> April 2000 A (2-benzhydryloxyethyl)diethyl-methylammonium iodide A03AB16 0.3 g O 2-(4-chlorphenoxy)-ethanol D01AE06 4-dimethylaminophenol V03AB27 Abciximab B01AC13 25 mg P Absorbable gelatin sponge B02BC01 Acadesine C01EB13 Acamprosate V03AA03 2 g O Acarbose A10BF01 0.3 g O Acebutolol C07AB04 0.4 g O,P Acebutolol and thiazides C07BB04 Aceclidine S01EB08 Aceclidine, combinations S01EB58 Aceclofenac M01AB16 0.2 g O Acefylline piperazine R03DA09 Acemetacin M01AB11 Acenocoumarol B01AA07 5 mg O Acepromazine N05AA04
    [Show full text]
  • Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices DIX to the HTSUS—Continued
    20558 Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices DEPARMENT OF THE TREASURY Services, U.S. Customs Service, 1301 TABLE 1.ÐPHARMACEUTICAL APPEN- Constitution Avenue NW, Washington, DIX TO THE HTSUSÐContinued Customs Service D.C. 20229 at (202) 927±1060. CAS No. Pharmaceutical [T.D. 95±33] Dated: April 14, 1995. 52±78±8 ..................... NORETHANDROLONE. A. W. Tennant, 52±86±8 ..................... HALOPERIDOL. Pharmaceutical Tables 1 and 3 of the Director, Office of Laboratories and Scientific 52±88±0 ..................... ATROPINE METHONITRATE. HTSUS 52±90±4 ..................... CYSTEINE. Services. 53±03±2 ..................... PREDNISONE. 53±06±5 ..................... CORTISONE. AGENCY: Customs Service, Department TABLE 1.ÐPHARMACEUTICAL 53±10±1 ..................... HYDROXYDIONE SODIUM SUCCI- of the Treasury. NATE. APPENDIX TO THE HTSUS 53±16±7 ..................... ESTRONE. ACTION: Listing of the products found in 53±18±9 ..................... BIETASERPINE. Table 1 and Table 3 of the CAS No. Pharmaceutical 53±19±0 ..................... MITOTANE. 53±31±6 ..................... MEDIBAZINE. Pharmaceutical Appendix to the N/A ............................. ACTAGARDIN. 53±33±8 ..................... PARAMETHASONE. Harmonized Tariff Schedule of the N/A ............................. ARDACIN. 53±34±9 ..................... FLUPREDNISOLONE. N/A ............................. BICIROMAB. 53±39±4 ..................... OXANDROLONE. United States of America in Chemical N/A ............................. CELUCLORAL. 53±43±0
    [Show full text]