volume 26 supplement 2 october 2003 USP Veterinary Pharmaceutical Information Monographs – Antibiotics USP VETERINARY PHARMACEUTICAL INFORMATION MONOGRAPHS – ANTIBIOTICS CONTENTS v Introduction 1 Aminoglycosides (Veterinary—Systemic) 33 Aminopenicillins (Veterinary—Intramammary-Local) 36 Aminopenicillins (Veterinary—Systemic) 46 Amoxicillin and Clavulanate (Veterinary—Systemic) 51 Cephalosporins (Veterinary—Systemic) 71 Cephapirin (Veterinary—Intramammary-Local) 74 Chloramphenicol (Veterinary—Systemic) 79 Erythromycin (Veterinary—Intramammary-Local) 81 Florfenicol (Veterinary—Systemic) 87 Fluoroquinolones (Veterinary—Systemic) 109 Lincosamides (Veterinary—Systemic) 119 Macrolides (Veterinary—Systemic) 144 Metronidazole (Veterinary—Systemic) 149 Penicillin G (Veterinary—Intramammary-Local) 151 Penicillin G (Veterinary—Systemic) 161 Pirlimycin (Veterinary—Intramammary-Local) 164 Potentiated Sulfonamides (Veterinary—Systemic) 185 Pyrimethamine (Veterinary—Systemic) 191 Rifampin (Veterinary—Systemic) 202 Spectinomycin (Veterinary—Systemic) 207 Sulfonamides (Veterinary—Systemic) 225 Tetracyclines (Veterinary—Systemic) 253 Indications Index 257 Dosing Index 262 Veterinary Brand and Generic Name Index 269 Human Brand and Generic Name Index Introduction v Introduction WHAT’S DIFFERENT ABOUT A USP DRUG INFORMATION included where it may be helpful. Each draft chapter or monograph is MONOGRAPH then put through a review process that includes USP Veterinary The Veterinary Medicine Expert Committee on Drug Information Medicine Committee members, regulatory representatives, pharma- gratefully acknowledges the financial support of its parent organiza- ceutical manufacturers, ad hoc specialists, and public review. At tion, the United States Pharmacopeia, to publish these monographs. It present, USP monographs are the only drug information source in also is appreciative to the Food Animal Residue Avoidance Databank veterinary medicine undergoing such extensive expert review, (FARAD) for supplying slaughter and milk withdrawal information a process through which the credibility of the information is where extra-label drug use in food animals is noted. This information is maintained. provided in cooperation with MICROMEDEX, a Thomson Healthcare USP drug information is a work-in-progress. The information is in Company. constant revision and is a continuous collection of the current judgments of experts in the use of medications. The following chapters have been developed over 7 years, with information added and revised, USP history, organizational structure, and publications as necessary. In pursuit of its mission to promote public health, the United States Pharmacopeia (USP) develops authoritative information about the appropriate use of medicines, including those used in animals. This Unique features non-government, not-for-profit organization draws on a long-standing This special issue of the Journal of Veterinary Pharmacology and dedication to public involvement in the establishment of scientific Therapeutics contains a series of drug information monographs on standards. USP achieves its goals through the contributions of antimicrobials used in veterinary medicine. What makes this volunteers representing health care professions, as well as science, information different from other sources of veterinary drug informa- academia, the U.S. government, the pharmaceutical industry, and tion? A succinct listing would include: consumer organizations. • The incorporation of extra-label and label indications and dosages USP was established in 1820 with the primary goal of setting standards for all domestic species. See the section below, ‘‘Finding the specific for the identity, strength, and quality of medicinal compounds and this drug information you need; Label and extra-label uses,’’ for details remains at the core of the organization. Currently, USP provides on how this information is differentiated. standards for more than 3,800 prescription and non-prescription • The inclusion of slaughter and milk withdrawals when extra-label drugs, nutritional and dietary supplements, veterinary drugs, and drug use in food animals is considered an acceptable option for health care products. These standards are published in the United therapy. Withdrawal times have been provided by FARAD for the States Pharmacopeia (USP) and the National Formulary (NF), which are specified conditions noted. officially recognized in the Federal Food, Drug, and Cosmetic Act (21 • The inclusion of information about both U.S. and Canadian U.S.C. § 321 et seq.). USP also produces Reference Standards, which veterinary drug products. are an integral part of USP’s standards program. • The grouping of indications into three categories. The ‘‘Accepted’’ The development of USP information on the best use of medications was category indicates that clear evidence exists to support use of the begun in 1970, growing out of the public process of developing quality drug for a particular purpose. ‘‘Acceptance not established’’ standards. USP information advisory panels were created to assure (potentially useful) indicates that use of the drug for an indication that the information under development is evidence-based, consensus- may be worthy of consideration if superior therapies do not exist, established, practical, and clinically relevant. This work was expanded but the evidence is either scant or subject to concern based on into a separate public health program and in 1980, the first USP DIÒ experimental design. If a use is viewed as ineffective or has been was published. Today, in association with MICROMEDEX, USP replaced by clearly superior therapies, the indication is deemed continues to provide oversight and approval of drug information ‘‘Unaccepted.’’ These categorizations are applied to label and extra- content in the USP DIÒ database, which covers nearly all medicines in label uses. the U.S. and Canada. • The use of tables of scientific evidence to address controversial issues during the review process, particularly relative to extra-label drug use. The veterinary drug information monograph creation process • Review of the information by a Food and Drug Administration (FDA) Very soon after the USP DIÒ was first published, an advisory panel on liaison to the committee. Although comments made by the FDA are veterinary medicine was created. Since 1982, veterinary pharmacol- taken quite seriously, those opinions are nonbinding on the USP. ogists, veterinary pharmacists, and other specialists have contributed The information contained in these monographs should not be their time and expertise in creating and revising drug information considered an endorsement or ‘‘acceptance’’ by the FDA as to a through USP’s unique process. This drug information is developed by given use or dosage. exhaustive compilation of approved product label information and also • The review of each monograph by the USP Veterinary Medicine collection and analysis of publicly available data on each drug from Committee. This committee consists of 10 to 15 volunteers research studies and clinical reports. Careful attention is paid to recognized as experts in pharmacology, internal medicine, or species differentiating species-specific information. With the agreement of discipline(s). MICROMEDEX, information from the human USP DIÒ database is Ó 2003 Thomson MICROMEDEX All rights reserved vi Introduction Finding the specific drug information you need ACKNOWLEDGEMENTS The following individuals are recognized for their contributions and Label and extra-label uses support towards the production of this body of work: The Indications section of each drug monograph is designed to provide information about indications in drug product labeling in the U.S. and USP Staff Canada. Extra-label indications for which clinical and research data Roger Williams, MD (CEO and Executive Vice President, USP) have been evaluated are also included. Indications found in product Ian DeVeau, PhD (Senior Scientist, Veterinary Drugs, Information and labeling are listed first. Brackets around an indication signify that it is Standards Development, USP) not found in any product labeling in the U.S. at the time of last major Amy S. Neal, DVM (USP consultant, writer and editor) revision. Some indications are followed by a superscript 1, meaning Jerome A. Halperin, BS, MPH, MS (former CEO and Executive Vice they are not included in Canadian product labeling. President, USP) Keith Johnson (former Director, Drug Information Division, USP) Examples of bracket and superscript 1 placement in the monographs: David Nash, DVM (former Director, Veterinary Medicine, Information [Pneumonia, bacterial (treatment)] An extra-label use in the U.S. and Standards Development, USP) An indication is included in E. Kathryn Meyer, VMD (former Drug Information Specialist and Canadian product labeling. Coordinator, Veterinary Practitioners’ Reporting Program, Pneumonia, bacterial (treatment)1 An indication found in U.S. USP) product labeling but not in Canadian product labeling. 2000 to 2005 Veterinary Medicine Committee [Pneumonia, bacterial (treatment)]1 An extra-label use in both the Cory Langston, DVM, PhD, DACVCP, Chair U.S. and Canada. Michael D. Apley, DVM, PhD, BS, DACVCP Dawn M. Boothe, BS, MS, DVM, PhD, DACVCP, DACVIM Species and dosage forms Terrence P. Clark, DVM, PhD, DACVCP Within each category of the Indications section the information is arranged Gigi F. Davidson, BS, RPh, DICVP in a hierarchy as follows: indication, followed by the species to which Patricia Dowling, DVM,