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What are the factors that can influence individual differences in medication
responses?
Age
Weight
Sex
Disease
Route of Administration
Pregnancy Risk Category A
Adequate well controlled studies in pregnant women have not shown an increased risk
of fetal abnormalities to the fetus in any trimester of pregnancy
Pregnancy Risk Category B
Animal studies have revealed no evidence of harm to the fetus; however there are no
adequate and well controlled studies in pregnant women
OR
Animal studies have shown an adverse effect, but adequate and well controlled studies
in pregnant women have failed to demonstrate risk to the fetus in any trimester
Pregnancy Risk Category C
Animal studies have shown an adverse effect and there are no adequate and well
controlled studies in pregnant women
OR
No animal studies have been conducted and there are no adequate and well controlled
studies in pregnant women
Pregnancy Risk Category D
Adequate well controlled or observation studies in pregnant women have demonstrated
a risk to the fetus
However potential benefits may outweigh the risk to the fetus. If needed in a life-
threatening situation or a serious disease, the drug may be acceptable in if safe drugs
cannot be use or are ineffective.
Pregnancy Risk Category X
Adequate well controlled or observational studies in animals or pregnant women have
demonstrated positive evidence of fetal abnormalities or risks
The use of the product is contraindicated in women who are or may become pregnant.
Pregnancy Risk Category N
The drug is not classified by the FDA
Half-life
time required for the body to eliminate 50% of a drug
Pharmacokinetics
study of drug transit (or activity) after administration. These activities include absorption,
distribution, metabolism, excretion. Subcomponents include transport, first-pass effect
during absorption, and half-life during excretion of the drug.
First-pass effect
, action by which an oral drug is absorbed and carried directly to the liver, where it is
inactivated by enzymes before it enters the general bloodstream.
Pharmacodynamics
the study of the drug mechanisms that produce biochemical or physiologic changes in
the body
What are the reasons that medication dosages may be decreased?
Liver failure
Kidney Failure
Children due to immature kidneys
Older adults dues to diminished kidney function
What are the are the 2 main mechanisms by which a drug exerts its action?
Alteration in cellular function - a medication has to bind to a receptor on the surface of a
cell to produce
- Agonist
-Antagonist
Alteration in cellular environment physically or chemically
Onset
the time between administration of the drug and onset of its therapeutic effect
Peak
when absorption rate equals the elimination rate (not always the time of peak response)
Duration
length of time the drug produces a therapeutic effect
Teratogen
drug or substance that causes abnormal development of the fetus, leading to
deformaties
Therapeutic effect/response
the expected/wanted response from the medication
Adverse reaction/consequence
undesirable drug effect
Allergic reaction/hypersensitivity
immediate hypersensitive reaction by immune system; it presents as itching, hives,
swelling and difficulty breathing
Anaphylactic shock
sudden, severe hypersensitivity reaction with symptoms that progress rapidly and may
result in death if not treated; also called anaphylactic reaction or anaphylactoid reaction
Angioedema
localized wheals or swellings in subcutaneous tissues or mucous membranes, which
may be due to an allergic response; also called angioneurotic edema
Idiosyncratic reaction/idiosyncrasy
Any unusual or abnormal reaction to a drug. It is any reaction that is different from the
one normally expected from a specific drug does
Ex. pt is given a drug to help him sleep but instead the pt remains wide awake after
taking it
Drug tolerance
decrease responses to a drug requiring an increase in dosage to achieve the desired
effect