Print Page   |   Sign In   |   Register
What's in a Monograph
Share |

What You'll Find in USP Veterinary Pharmaceutical

Information Monographs

Label and extra-label uses

Indications:

The Indications section of each drug monograph is designed to provide information about indications in drug product labeling in the U.S. and Canada. Extra-label indications for which clinical and research data has been evaluated are also included. Indications found on product labeling are listed first. Many Veterinary Pharmaceutical Information monographs on this Web site will have the original designations for extra-label uses, as explained in this paragraph.

Original designations for extra-label uses

Brackets around an indication signify that it is not found in any product labeling in the U.S. at the time of last revision. Some indications are followed with a superscript 1, meaning that they are not included in Canadian product labeling. Examples of brackets and superscript 1 use in the monographs:

[Pneumonia, bacterial (treatment)] An indication found in Canadian product labeling, but not in U.S. product labeling.
Pneumonia, bacterial (treatment) An indication found in U.S. product labeling but, not in Canadian product labeling.
[Pneumonia, bacterial (treatment)]1 An indication not found in either U.S. or Canadian product labeling.

New style for extra-label uses

USP is improving readability of the monographs. As part of this ongoing process, new designations for extra-label uses appear in the most recently updated monographs. An ELUS precedes indications that are not found in any product label in the U.S. at the time of last revision. Some indications are preceded by an ELCAN, meaning that they are not included in Canadian product labeling. The same designations are used for extra-label species and dosage forms, in the hierarchy that was used for the original brackets and superscript 1 designations, as described below under Species and dosage forms.

Examples in the monographs:

EL USPneumonia, bacterial (treatment)EL An extra-label use in the U.S.
An indication exists in Canadian product labeling.
EL CANPneumonia, bacterial (treatment)EL An extra-label use in Canada.
An indication exists in U.S. product labeling.
EL US,CANPneumonia, bacterial (treatment)EL An extra-label use in both the U.S. and Canada.

Please check back to see more improvements as the monographs are revised.

Species and dosage forms:

In the Indications section, you will also see species and drug dosage forms with extra-label designations. These designations have the same meaning for species and dosage forms as they do for indications; however, to decrease clutter and confusion only the highest level is given a designation (indication > species > dosage form).

Dosing

In the USP Veterinary Pharmaceutical Information monographs, dosage forms are always listed separately to provide an opportunity to list specific information for each type of product. In the Dosage Forms section, indications and species are given extra-label designations following the same rules applied in the Indications section, except that they reflect the labeling of the specific dosage form. Dosages listed are not always label dosages even if the species is on the product label. If you are using a dose recommended for a food-producing species, always check the product labeling for dosing and withdrawal time information.

Label and extra-label withdrawal times

Established product label withdrawal times are listed after dosages listed for food-producing species in the Dosage Forms section in each monograph. But be sure to consult the approved labeling on the product you are using for the specific government established dose and withdrawal time. Extra-label withdrawal recommendations are listed for each extra-label dose recommended for food-producing animals. As always, veterinarians will use their own clinical judgment, following the guidelines of the Animal Medicinal Drug Use Clarification Act, to determine a safe extra-label withdrawal time.

Human data

Because of limited availability, in some cases, of information for animal species, in 1994 the USP Veterinary Medicine Advisory Panel judged that it would be helpful to include human data in the monographs on drugs for use in animals. The panel chose to extract information from the monographs in the USP DI, which is made available in cooperation with MICROMEDEX, Inc. This extracted human information, including human drug interactions, laboratory value alterations, and side/adverse effects, can be seen in the corresponding sections of each veterinary monograph.

Back to Monographs Home Page

Membership Management Software Powered by YourMembership  ::  Legal