Chapter 6 | Package Insert Information Flashcards

1
Q

The primary purpose of the package insert is to

A

provide practitioners with essential information they need to prescribe the drug safely and effectively for the care of patients

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2
Q

By FDA regulation, the insert must contain at least the following sections:

A

-description
-clinical pharmacology
-indications and usage
-contraindications
-warning/precautions
-adverse reactions
-drug abuse and dependence
-overdosage
-dosage and administration
-how supplied

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3
Q

Description label must contain

A

-proprietary name and the established name

-qualitative and/or quantitative ingredient information

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4
Q

Clinical Pharmacology label must contain information relating to the human clinical pharmacology and actions of the drugs in humans

A

-mechanism of action
-pharmacodynamics (biochemical or physiologic pharmacological effects of the drug, and any active metabolites)
-pharmacokinetics (Cmax, AUC, half-life, etc)

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5
Q

Indications and Usage label must state:

A

-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

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6
Q

Contraindications label

A

must describe situations in which the drug should not be used because the risk of use clearly outweighs any possible therapeutic benefit

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7
Q

warning/precaution label

A

must described clinically significant adverse reactions and other potential safely hazards

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8
Q

adverse reactions label

A

describes serious adverse reactions and potential safety hazards, limitations in how they should be used, and steps that should be taken if they occur

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9
Q

drug abuse and dependence label

A

-controlled substance
-abuse
-dependence

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10
Q

overdosage label

A

must described the signs, symptoms, and laboratory findings of acute overdoses and the general principals of treatment

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11
Q

dosage and administration label

A

includes the most commons dosage regimen and critical differences among population subsets, monitoring requirements, and other therapeutically important clinical pharmacological information

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12
Q

Which section of a drug’s package insert information covers the usual dosage range?

A

Indications and usage

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13
Q

Drug labels must include indications, usage information, and contraindications.

A

True

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14
Q

What should be included in the description section of a drug’s package insert information?

A

The drug’s proprietary name and the established name.

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