Chapter 6 | Package Insert Information Flashcards
The primary purpose of the package insert is to
provide practitioners with essential information they need to prescribe the drug safely and effectively for the care of patients
By FDA regulation, the insert must contain at least the following sections:
-description
-clinical pharmacology
-indications and usage
-contraindications
-warning/precautions
-adverse reactions
-drug abuse and dependence
-overdosage
-dosage and administration
-how supplied
Description label must contain
-proprietary name and the established name
-qualitative and/or quantitative ingredient information
Clinical Pharmacology label must contain information relating to the human clinical pharmacology and actions of the drugs in humans
-mechanism of action
-pharmacodynamics (biochemical or physiologic pharmacological effects of the drug, and any active metabolites)
-pharmacokinetics (Cmax, AUC, half-life, etc)
Indications and Usage label must state:
-the drug is indicated for the treatment, prevention, mitigation, cure, or diagnosis of a recognized disease or condition ; of a important manifestation of a recognized disease or condition ; for the relief of symptoms associated with recognized disease or syndrome ; for a particular indication only in conjunction with a primary mode of therapy ; must also state recommended usual dosage, usual dosage range, and an upper limit beyond which safety and effectiveness has not been established
Contraindications label
must describe situations in which the drug should not be used because the risk of use clearly outweighs any possible therapeutic benefit
warning/precaution label
must described clinically significant adverse reactions and other potential safely hazards
adverse reactions label
describes serious adverse reactions and potential safety hazards, limitations in how they should be used, and steps that should be taken if they occur
drug abuse and dependence label
-controlled substance
-abuse
-dependence
overdosage label
must described the signs, symptoms, and laboratory findings of acute overdoses and the general principals of treatment
dosage and administration label
includes the most commons dosage regimen and critical differences among population subsets, monitoring requirements, and other therapeutically important clinical pharmacological information
Which section of a drug’s package insert information covers the usual dosage range?
Indications and usage
Drug labels must include indications, usage information, and contraindications.
True
What should be included in the description section of a drug’s package insert information?
The drug’s proprietary name and the established name.
