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Flashcards in lactation/pregnancy Deck (81)
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1

what 5 aspects must be considered in regards to pregnancy/lactation and medications?

1. Drug safety during pregnancy and lactation
2. Drug toxicity during pregnancy
3. Physiological changes during pregnancy that may affect drug action and kinetics
4. Cross-placental transfer of drug molecules and their metabolites
5. Excretion in breast milk

2

__% of pregnant women are exposed to teratogenic medications with __% of children born with physical or mental birth defects. why is this important?

6%, 3%
risk of exposure to these meds is small but IMPACTFUL when there is exposure

3

FDA published the _____________to address the limitation of prescription drug labeling

Pregnancy and Lactation Labeling Rule (PLLR)

4

what was the previous FDA labeling for drugs with regards to pregnancy risk?

A-->X
this was misleading, those assumed A was safer than X but this wasn't ENTIRELY true...

5

what are the old FDA labels for drugs? A-X? (weeds maybe)

A: studies have failed to demonstrate a risk to the fetus in the first trimester
B: animal studies FAILED to demonstrate risk to fetus. no adequate and well-controlled studies in pregnant women
C. animal studies showed adverse effect to fetus, no adequate and well-controlled studies in humans
D. positive evidence of HUMAN fetal risk, benefits MAY warrant use
X: positive evidence HUMAN fetal risk, risks outweigh benefits

6

what changed in the new FDA labeling?

more options with more information from pt taken into account... " risk categories replaced with narrative sections"

7

best resource for information on drugs in pregnancy?

Briggs

8

when is the most dangerous exposure time for a teratogen?

first 8 weeks

9

teratogen effect in the first 2 weeks of fetal development?

"all or none": if a drug is a teratogen will either terminate pregnancy or have no effect

10

teratogen effect in wks 3-8 wks of fetal development?

most devastating defects. this is the most critical time of development

11

weeks 9-40 of fetal development, what is happening?

growth and developmental function

12

what defect can aminoglycosides (GNATS) cause?

8th cranial nerve tox- vestibular dysfunction

13

what defect can Alkylating Agents (Cyclophosphamide) (chemo agents) cause?

Absence of digits, multiple anomalies

14

Antiepileptic Drugs (Valproate, carbamazepine, phenytoin, phenobarbital) defects?

neural tube defects and others

15

Isotretinoin (for acne) defects ?

multiple severe birth defects

16

warfarin defects?

Bone deformities, fetal hemorrhage

17

statin defects?

spina bifida

18

alcohol abuse defects?

fetal alc syndrome, microcephaly

19

cocaine and nicotine defects?

low birth weight, pre-term birth

20

what about the gut in pregnancy causes altered drug absorption?

INCREASED PH ( absorption of weak acids and bases altered) &
N/V and DELAYED GASTRIC EMPTYING (general drug abs altered)

21

how can drug distribution change b.c of pregnancy?

Increased body fat increases volume of distribution of fat soluble medications
Fat soluble medications have a decrease in elimination due to the greater volume of distribution

22

how can metabolism of drugs change b/c of pregnancy?

Mixed effects with increases and decreases in CYP450 enzymes and changes in transport proteins

23

how can excretion of drugs change b/c of pregnancy?

Increases in maternal plasma volume, cardiac output, and GFR increase – subsequently decreases plasma concentrations of renally eliminated medications

24

5 PK properties that influence placental drug transfer?

1. lipid solubility
2. molecular size
3. placental transporters
4. protein binding
5.placental & fetal drug metabolism

25

how does lipid solubility effect placental drug transfer?

Lipophilic and un-ionized drugs diffuse across placenta and enter fetal circulation

26

how does molecular size effect placental drug transfer?

smaller (low molecular weight) = crosses more easily

27

how do placental transporters effect placental drug transfer?

P-glycoprotein transporter pumps drug back into maternal circulation

28

how does protein binding effect placental drug transfer?

High maternal protein binding decreases transfer across placenta

29

for pregnancy, eliminate all ____ meds

non-essential

30

two vaccines for pregnant women

flu and Tdap (Tdap for each pregnancy a woman has)