title: Vitamin K1 concentration in breast-fed neonates after oral or intramuscular administration of a single dose of a new mixed-micellar preparation of phylloquinone.
abstract: The plasma disposition of a new mixed-micellar preparation (KONAKION MM, Roche) of phylloquinone (vitamin K1) has been studied in 25 healthy, fully breast-fed, newborn babies, randomized to receive a single dose of either 1.5 mg i.m. (11 babies) or 3 mg p.o. (14 babies). Venous blood samples were collected at 25 h, 4 days, and 24 days. After p.o. administration, the median plasma phylloquinone concentration increased to 89 ng/ml after 24 h, then decreased to 51 ng/ml after 4 days; the respective concentrations after i.m. injection were 146 ng/ml and 34 ng/ml. The higher plasma phylloquinone level in the i.m. group after 24 h was not statistically significant compared with that of the p.o. group, but the reversed higher concentration in the p.o. group after 4 days was significant (p < 0.01). After 24 days the median plasma phylloquinone had decreased to 0.44 ng/ml (range 0.19-1.44) and 1.05 ng/ml (range 0.37-1.87) in the p.o. and i.m. groups, respectively. There was a significant difference between these plasma concentrations (p < 0.01). They were within or above the reference adult fasting range (0.17-0.68 ng/ml). The narrow range of plasma concentrations at 24 h and 4 days suggests a greater consistency of absorption from this micellar preparation than from other emulsion-based preparations. Further studies are required to assess the long-term protection of a single oral dose against late hemorrhagic disease of the newborn. Until such time, breast-fed babies given this preparation orally should receive (an) additional dose(s).
authors.affiliation: Children's Hospital, Lucerne, Switzerland.
authors.forename: G
authors.initials: G
authors.lastname: Schubiger
authors.forename: O
authors.initials: O
authors.lastname: Tönz
authors.forename: J
authors.initials: J
authors.lastname: Grüter
authors.forename: M J
authors.initials: MJ
authors.lastname: Shearer
mesh_terms: D000284:Administration, Oral; D001942:Breast Feeding; D005260:Female; D006207:Half-Life; D006801:Humans; D007231:Infant, Newborn / Q000097:blood / Q000378:metabolism*; D007273:Injections, Intramuscular; D008297:Male; D008823:Micelles; D011897:Random Allocation; D013997:Time Factors; D010837:Vitamin K 1 / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D014813:Vitamin K Deficiency / Q000517:prevention & control
chemical_list: D008823:Micelles; D010837:Vitamin K 1