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CNPR Certification

Chapter 6

By FDA regulation, the insert must contain at least the following 10 sections: 1)Description 2)Clinical Pharmacology 3)Indications and Usage 4)Contraindications 5)Warning/Precautions 6)Adverse Reactions 7)Drug Abuse and Dependence 8)Overdosage 9)Dosage and Administration 10) How Supplied
In package inserts, what is in the description? 1)Proprietary name and established name 2)Qualitative and/or qualitative ingredient information.
In package inserts, what is the clinical pharmacology? 1)Mechanism of action 2)Pharmacodynamics 3)Pharmacokinetics
In package inserts, what is in the indications and usage section? 1)Explains what the drug is used for specifically. 2)Usual dosage, dosage range, and upper dosage limit.
In package inserts, what is in the contraindications section? Describes situations in which the drug should NOT be used due to risk outweighing any possible therapeutic benefits.
In package inserts, what is in the warning/precautions section? Describes any clinically significant adverse reactions and other potential safety hazards.
In the package inserts, what is in the Drug Abuse and Dependence section? 1)Controlled Substance:If the drug is controlled by the Drug Enforcement Administration 2)Abuse: the types of abuse that can occur with the drug and the adverse reactions pertinent to them. 3)Dependence: describe effects resulting from dependence.
In the package inserts, what is in the Overdosage section? Describe signs, symptoms, and laboratory findings of acute overdoses and the general principles of treatment.
In the package inserts, what is in the How Supplied section? Concise summary of information concerning the products dosage forms.
In the package inserts, what is in the Adverse reactions section? describe serious adverse reactions and potential safety hazards, limitations in how they should be used, and steps that should be taken if they occur.
In the package inserts, what is in the Dosage and Administration section? Includes the most common dosage regimens and critical differences among population subset, monitory requirements.
Created by: dgvoss


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