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CNPR Certification
Chapter 6
Question | Answer |
---|---|
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. |
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