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Pharmacology - Unit 1 - part 3

Terms in this set (23)

___ ___ ___ are administered by a needle and syringe and typically referred to by the type of container in which the drug is supplied
Injectable dosage forms
___ are dosage forms in which the drug is contained within a small, airtight thin glass bottle which is opened by snapping the narrow neck of the ampule bottle - do not contain any preservatives and therefore it is meant to be used completely at one time
ampules
___ are thicker glass bottles with rubber stoppers through which the drug is withdrawn with a sterile needle and syringe
vials
___ ___ : multiple doses can be withdrawn over time; example: injectiable anesthetic agents or antibiotics
multidose vials
__-__ ___ : all the drug is used at one time; example: vaccines
single-dose vials
The most accurate drug information for a particular product, including the most recent changes in the drug formulation, dosages, or warnings/precautions, will be found in the ___ ___ or ___ ___, which is the manufacturer's documentation that is inserted into or attached to each botle, package, or box of medication
drug insert (or) package insert
___ ___ will contain the info that is mandated by the FDA regulations for veterinary drugs, but will ONLY contain that info for which the manufacturer has done the mandated testing or otherwise documented in compliance with FDA requirements; this info in the and printed on the drug label would be considered to be the ___ ___
drug insert; label information
Veterinarians often use drugs in an ___-___ manner, meaning they are using the drug in a manner other than the FDA approved dose, route of administration, disease/condition, or specie
extra-label
___-___ or ___-___ use of veterinary drugs is permissible by federal law under certain circumstances
extra-label (or) off-label
In order for a drug to be legally use in an extra-label manner in veterinary medicine, the following conditions must be met:
- a licensed veterinarian must ___ ___ ___
- a valid ____ (acronym) must exist
- the health of the animal would be ___ if the drug is not used; the use of the drug to enhance ___ of ___ animals is strictly prohibited
- No ___ ___ veterinary drug can already exist; and if such drug exists, the veterinarian determines that for that particular patient in the VCPR the existing drug or its dosage form would be ___ ___
-a licensed veterinarian must order the drug
-a valid VCPR [veterinarian-client-patient relationship] must exist
-the health of the animal would be threatened if the drug is not used; the use of the drug to enhance production of food animals is strictly prohibited
- No FDA approved veterinary drug can already exist; and if such drug exists, the veterinarian determines that fo that particular patient in the VCPR the existing drug or its dosage form would be clinically ineffective
ELDU in food animals:
An extended ___ ___ or ___ ___ (time between last dose and when the animal can be slaughtered for meat or food products such as eggs or milk can be used) supported by scientific documentation (if available and applicable) must be used in any animal treated with the drug
(-Vet must also make sure that the is observed and that if the safety of this drug in human food is not available, the animal can not enter the human food supply)
-withdrawal period (or) withdrawal time
Any drug that is used in an extra-label manner must contain the following info on the label of the container in which the drug is dispensed:
- name and address of the prescribing vet
- established name of the active ingredient int he drug (not the trade name); if more than one ingredient is used, all ingredients must be listed
- detailed info about how the drug is to be administered including the specie on which it is to be used, the specific animals that re to be treated (IDs such as ear tag #), what dosage and frequency, the route by which the drug is to be administered, and the duration of therapy
- any cautionary statements form the vet (warning of potential harm to person administering the drug, threat to environment if spilled, etc.)
- a specific withdrawl time (time between last dose and when animal can be sent to market) or discard time for milk, eggs, or any human food which might be derived from treated animals
In most compiled drug references or ___ ___ there is a fairly standardized set of terms and symbols used to describe the drug charactertistics
drug formularies
USP is a non-governmental organizatoin that sets the standards for quality, purity, and consistency of drug manufacture for any drugs sold in the US. "USP" designation in the nonproprietary name stands for the..
United States Pharmocoepia
The ___ ___, which is the part of the drug that produces the intended beneficial effect, is identified by the generic name of the drug
active ingredient
___ ___ include excipients, any preservatives, stabilizers, liquid media, or other additives that make up the dosage form, are also listed in the composition statement
inert ingredients
The ___ is the approved reason for which the drug can be used; manufacturer must state specifically
indication
___ ___ : any effect of the drug other than its intended beneficial effect; can range from mildly annoying to potentially fatal
side effect
___ ___ ___ : a type of side effect that is detrimental to the patient and results from the patient's response to the chemical or physical properties of the drug
adverse drug reaction (ADR)
____ : either describes a mild adverse reaction, some predictable change in clinical state or the patient's condition, or some other effect that typically doesn't require much medical intervention
precaution
____ : about more serious or frequent side effects than those found in the precautions section and constitute adverse drug effects that could potentially do significant harm to the patient
warning
____ ____ ____ : the strongest warning the FDA can require a drug manufacturer to include in their drug information
black box warnings
____ : circumstances or conditions in which the drug should not be used; (example: giving penicillin to an animal or person who has severe and life-threatening allergic reactions to penicillin)
contraindications
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