Table 4

Drug products causing excipient exposure above the cut-off values, the number of patients exposed and the corresponding median (range) daily exposure per product and age group

Generic drug nameBrand drug nameRoute of administrationDrug concentrationEthanol concentration (mg/mL)Age groupNo. of patientsEthanol (mg/kg/day) MedianRange
AlprostadilProstin VRIntravenous0.5 mg/mL790Neonates718.714.0–80.6
Infants and toddlers264.814.4–144
Amphotericin BFungizonePer os100 mg/mL4.21Neonates30.90.8–1.0
Infants and toddlers60.60.4–2.1
ClemastineTavegylIntravenous1 mg/mL70Infants and toddlers36.36.2–6.4
DiazepamRectioleRectal2 mg/mL100Infants and toddlers21.81.8–1.9
DigoxinLanoxin PG ElixerPer os0.05 mg/mL81.7Infants and toddlers15.4
NystatinLabazPer os100 000 U/mL7.9Preterms723.89.7–48.9
Infants and toddlers37.81.9–11.8
Propylene glycol concentration (mg/mL) Propylene glycol (mg/kg/day) Median
CaffeineNon-commercial liquidPer os10 mg/mL9.1Preterms164.84.3–9.2
Neonates44.63.3–9.5
DiclofenacGenericIntravenous25 mg/mL200Infants and toddlers372.870.6–81.0
FurosemideNon-commercial liquidPer os2 mg/mL9.1Preterms44.83.9–5.6
Neonates713.15.7–26.4
HydrochlorothiazideNon-commercial liquidPer os0.5 mg/mL9.1Preterms48.06.9–16.4
ItraconazoleTrisporal liquidPer os10 mg/mL103.6Children152.1
LorazepamTemestaIntravenous4 mg/mL823Infants and toddlers282.364.6–123.5
Potassium chlorideNon-commercial liquidPer os1 mmol/mL6.1Neonates113.3
PropranololNon-commercial liquidPer os1 mg/mL2.275Preterms14.42.5–5.1
Propyl paraben concentration (mg/mL) Propyl paraben (mg/kg/day) Median
ParacetamolDARO liquidPer os24 mg/mL0.56Infants and toddlers32.12.0–2.1
Children12.12.0–2.1