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Clinical parameters assessing the safety of older generation AEDs during lactation (Davanzo et al., 2013; Hale, 2019)

AEDTID [mg/kg/day]Oral therapeutic dose in infants [mg/kg/day]RID [%]Hale’s (2019) lactation risk categoriesDrug safety
CBZ0.710-203.8-5.9L2safe
CLN0.0020.1-0.22.8L3contraindicated
DZP0.05iv. 0.1-0.3 po. 0.5-10,88-7.14L3contraindicated
PHT0.45-80.6-7.7L2safe
ESM11.515-4031.4-73.5L4contraindicated
PB0.43-424L4moderately safe
PRM0.912-208.4-8.6L4moderately safe
VPA0.7limited data in the neonatal period available0.99-5.6L3safe

New generation antiepileptic drugs (AEDs) – pharmacokinetic and physicochemical characteristics and lactation risk categories

AEDt0.5[h]tmax [h]BA [%]MW [g/mol]RID [%]M/PPPB [%]Vd [L/kg]pKaHale’s (2019) lactation risk categories
LTG14–103 (mean 33 adults. monotherapy)1–4 (mean 2.5)982569.2-18.270.057-1.475509-1.35.7L2
OXC1.3–2.3 (OXC)9 (MHD)4.51002521.5-1.70.5400.710.7L3
LEV6–8 adults5–6 children1.3 adults0.5–1 children1001703.4-7.81<100.5-0.7_L2
LCM131–4100250NANA<150.612.47L3

Lactation risk categories (Hale, 2019)

L1Safest (compatible). Controlled studies in breastfeeding women have shown no negative effect on the child. Usually, non-absorbable drugs with low bioavailability
L2Safer (probably compatible). No harmful effects found. Safety identified in small human studies. Breastfeeding is allowed
L3Moderately safe (probably compatible). There are no controlled human studies. Some studies indicate a possible biological drug effect on the child. To be used, if the benefits outweigh the risks. This category covers all new, uncharted drugs
L4Potentially hazardous. Documented risk for child or lactation. To be used if they are necessary for the mother and cannot be replaced by other drugs
L5Hazardous. Significant harmful effects of the drug on the child, documented in human studies. Contraindicated in lactation

Old generation antiepileptic drugs (AEDs) – pharmacokinetic and physicochemical characteristics and lactation risk categories

AEDt0.5[h]tmax [h]BA [%]MW [g/mol]RID [%]M/PPPB [%]Vd [L/kg]pKaHale’s (2019) lactation risk categories
VPA10–15 adults6–10 children1-41001440.99-5.60.1-1.4 (mean 0.42)80-950.1-0.44.8L4
ESM48–60 adults16–58 children32–38 newborns4 single dose3–7 multiple doses10014131.4-73.5 (mean 62)mean 0.94<100.729.3L4
PHT7-42 (mean 22)4–1270-1002520.6-7.70.18-0.45890.52-1.198.3L2
CBZ18–54 single dose16–24 multiple dose4–16 adults (mean 8–9)4–6 children1002363.8-5.90.6970-8008-1.87L2
DZP20–50 (mean 43) adults20 children80 newborns30 prematures1-21002850.88-7.140.2-2.7 (mean 0.5)990.7-2.63.4L3
PB53–1402-480-1002322404-0.645–60 adults3-43 newborns0.5-0.67.2L4

Differences in composition of transitional and mature breast milk

ComponentTransitional milkmature milk
Lactose [g/L]20-3067
Glucose [g/L]0.2-1.00.2-0.3
Oligosaccharides [g/L]22-2412-14
Total proteins [g/L]169
Lactoferrin [g/L]3.531.94
slgA [g/L]2.02.0
IgM [g/L]0.120.2
IgG [g/L]0.340.05
Total lipids [%]23.5
Water soluble vitamins
Vitamin C [mg/L]100
Thiamine [mcg/L]200
Riboflavin [mcg/L]400-600
Niacin[mg/L]201.8-6.0
Folate [mcg/L]80-140
Vitamin B12 [mcg/L]0.50.5-1.0
Pantothenic acid [mg/L]2.0-2.5
Biotin5.0-9.0
Fat soluble vitamins
Retinol [mg/L]20.3-0.6
Carotenoids [mg/L]20.2-0.6
Vitamin K [mcg/L]2-52-3
Vitamin D [mcg/L]0.33
Vitamin E [mg/L]8-123-8
minerals
Calcium [mg/L]250200-250
Phosphorus [mg/L]120-160129-140
Sodium [mg/L]300-400120-250
Potassium [mg/L]600-700400-550
Chloride [m/L]600-800400-450
Iron [mg/L]0.5-1.00.3-0.9
Zinc [mg/L]8-121-3
Copper[mg/L]0.5-0.80.2-0.4
Manganese [mcg/L]5-63
Selenium [mcg/L]407-33

Clinical parameters assessing the safety of new generation AEDs during lactation (Davanzo et al., 2013; Hale, 2019)

AEDTID [mg/kg/day]Oral therapeutic dose in infants [mg/kg/day]RID [%]Hale’s (2019) lactation risk categoriesDrug safety
GBP1.710–15 (orly pediatric dose available)1.3-6.6L2moderately safe
LTG0.71–6 with valproic acid5–15 with enzyme inducing AEDs9.2L3moderately safe
LEV3.95-103.4-7.8L3moderately safe
OXCb.d.27.7–50 (< 18 years)1.5-1.7L3moderately safe
TGBb.d.<12 years limited data availableNAL3moderately safe
TPM0.31–6 (< 2 years)24.5L3moderately safe
VGB0.125-501.5-2.7L3moderately safe
ZNS1.95-828.9-36.8L4contraindicated
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Sujets de la revue:
Medicine, Clinical Medicine, other, Neurology, Pharmacology, Toxicology, Pharmacy, Clinical Pharmacy