QUIZ 6 Flashcards
What drugs may require dose adjustment d/t differences in volume of distribution?
- antiepileptics
- antibiotics
What occurs embryologically from conception to 31 days?
development of head and CNS
What occurs embryologically from 31 to 71 days?
growth development of palate and ears
What occurs embryologically from 71 days to term?
internal organ development and growth
What are typical effects of teratogens?
- restricted growth or death of fetus
- carcinogenesis
- malformation in organ structure or function
What are pharmacokinetic principles to consider?
1) protein binding
2) T 1/2: shorter > longer
3) volume of distribution: high = distributed in greater concentrations
4) pKa = pH
5) bioavailability = how much in blood stream
6) IV = most active
7) IM/SubQ
8) PO - must account for GI
What are lactation risk categories?
L1: safe; not PO bioavailable L2 L3: +/- data L4: maybe benefits > risks; no alternatives L5: CONTRAINDICATED
What are medication properties to consider in lactation?
1) PO bioavailability
2) milk/plasma ratio: if >1, drug concentrates in milk
3) molecular weight
4) protein binding
5) T 1/2
What makes a medication preferable for breastfeeding?
- low PO bioavailability
- low milk/plasma ratio (<1)
- high molecular weight
- high protein binding
- short T 1/2 (take AFTER breastfeeding)
What makes a medication not preferable for breastfeeding?
- high milk/plasma ratio (>1)
- low molecular weight (MW<200)
- low protein binding
- long T 1/2 *avoid extended release
After which date must drugs have the new label?
July 1, 2015
What happens to drugs approved on or after June 30, 2001?
3 years to change labeling
What occurs to drugs approved prior to June 30, 2001?
Pregnancy category removed; no other changes mandatory
What were the old pregnancy labeling subcategories?
- 1 pregnancy
- 2 labor and delivery
- 3 nursing mothers
What are the new pregnancy labeling subcategories?
- 1 pregnancy AND L&D
- 2 lactation
- 3 females and males of reproductive potential
What does the new 8.1 category include?
1) pregnancy exposure registry and contact information
2) risk summary: risk of adverse developmental outcomes
3) clinical considerations: risk/benefit counseling
4) data: human and animal