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Package insert: drug interactions
-Two more drugs react with each other
-how and why drugs interact
-when interacting that should be avoided
Package insert: drug abuse and dependence
Schedule classification, abuse/addiction and tolerance potential of drug
Package insert: overdosage
Signs symptoms, treatments of overdosing
Package insert: clinical pharmacology
Used by pharmacist/prescribers
How the drug works (mechanism of action)
How drug is absorbed metabolized eliminated by body
,Package insert: non-clinical toxicology
Used by pharmacist/prescribers
If it affects fertility or causes cancer
Package insert: clinical studies
Used by, pharmacist prescribers
How well drug for approved indications
Package insert: How supplied
Med dosage form
Storage handling
Description of appearance
What is the Orange Book?
Approved Drug Products with Therapeutic Equivalence Evaluations
Which drug info resource contains a compilation of package inserts?
Prescribers digital reference
Off-label use
Prescribing the medication for an unapproved indication
,Which pregnancy category is considered the riskiest?
x
Handbook on Injectable Drugs
Used to determine the compatibility of medications that will be used in an IV
bag. Shows the compatability, solubility, and stability of medications
Which drug information resource defines the standards for medications, such
as dosage forms and excipients?
United States Pharmacopeia/National Formulary
The first letter B in an orange book reading code indicates?
Non-therapeutic equivalence
, Which section of package insert contains the most important prescribing
info that can be found quickly?
Highlights
Therapeutically equivalent
When a generic medication is identical in active ingredients, strength and
dosage, form and bio equivalent(absorption and release the same in
thebody) as the brand name.
Therapeutic alternatives
Different active ingredient, same drug, similar to prescribed product
Post marketing experience
Side effects that occurred after the drug hit the market
Sections of NDC number
First: Manufacture
Middle: medication
name
End: package size and type
The TIRF program is specific for:
Outpatients taking immediate-release fentanyl. (Transmucosal Immediate
Release Fentanyl)