Plasma concentrations after intravenous administration of phylloquinone (vitamin K(1)) in preterm and sick neonates

Area of Science:

• Neonatal Medicine
• Pharmacokinetics
• Pediatric Pharmacology

Background:

• Traditional vitamin K prophylaxis in neonates includes oral and intramuscular routes.
• Oral and intramuscular routes may be challenging in neonatal intensive care, especially for very small or sick infants.
• Data on plasma levels following intravenous vitamin K1 in neonates are lacking.

Purpose of the Study:

• To investigate neonatal plasma levels of phylloquinone (vitamin K1) after intravenous administration.
• To evaluate the feasibility and effectiveness of intravenous vitamin K1 prophylaxis in neonates where other routes are not practical.

Main Methods:

• A single intravenous dose of 0.3 mg/kg phylloquinone (vitamin K1) was administered to 18 neonates (14 preterms, 4 sick newborns).
• Plasma vitamin K1 concentrations were measured using gas chromatography-mass spectrometry (GC-MS).
• Blood samples were collected at two time points: approximately 23 hours and 112 hours post-administration.

Main Results:

• Mean plasma vitamin K1 concentrations were 191.3 ng/mL at the first sample (approx. 23 hours) and 98.7 ng/mL at the second sample (approx. 112 hours).
• These plasma levels are comparable to those reported for oral and intramuscular vitamin K1 administration in newborns.
• The results suggest that intravenous administration leads to sustained therapeutic levels of vitamin K1.

Conclusions:

• Intravenous administration of vitamin K1 results in plasma concentrations similar to oral and intramuscular routes in neonates.
• The findings support the manufacturer's recommendation of 0.4 mg/kg intravenous vitamin K1 for neonates when oral or intramuscular routes are not feasible.
• Intravenous vitamin K1 is a rational and effective alternative for neonatal prophylaxis.