From the Guidelines
Newborns should receive a single intramuscular injection of 0.5-1 mg of vitamin K1 (phytonadione) on the first day of life, and 400 IU of vitamin D3 (cholecalciferol) orally per day, starting at hospital discharge, to prevent vitamin K deficiency bleeding and ensure adequate serum vitamin D concentration. This recommendation is based on the American Academy of Pediatrics guidelines, as outlined in the study published in Pediatrics in 2005 1. The intramuscular vitamin K1 dose is crucial for preventing vitamin K deficiency bleeding, which can be a serious condition in newborns.
For vitamin D3 supplementation, the dose of 400 IU per day is recommended for all infants consuming less than 28 ounces of commercial infant formula per day, including both exclusively and partially breastfed infants 1. This supplementation is essential for maintaining adequate serum vitamin D concentrations, particularly in breastfed infants, as breast milk contains insufficient vitamin D.
Key points to consider:
- Vitamin K1 should be administered intramuscularly, as oral vitamin K is not recommended due to variable absorption 1.
- Vitamin D3 supplementation should start at hospital discharge and continue throughout infancy.
- Parents should administer vitamin D drops directly into the infant's mouth or mix with a small amount of expressed breast milk or formula.
- It is essential to follow the recommended dosages to prevent vitamin K deficiency bleeding and ensure adequate serum vitamin D concentration, which are critical for blood clotting and bone development, respectively.
From the FDA Drug Label
The American Academy of Pediatrics recommends that vitamin K1 be given to the newborn. A single intramuscular dose of phytonadione 0. 5 to 1 mg within one hour of birth is recommended. There is no information about Vitamin D3 (cholecalciferol) dosage for newborns in the provided drug label. For Vitamin K1 (phytonadione), the recommended dosage for newborns is:
- A single intramuscular dose of 0.5 to 1 mg within one hour of birth for prophylaxis of Hemorrhagic Disease of the Newborn 2.
From the Research
Vitamin K1 (Phytonadione) for Newborns
- The recommended dosage of vitamin K1 for newborns is 1 mg, administered intramuscularly, as it is the most effective method of preventing hemorrhagic disease of the newborn (HDNB) 3.
- An oral regimen of 1 to 2 mg, given at the first feeding, and repeated at 2 to 4 weeks and 8 weeks, may be an acceptable alternative, but needs further testing in large clinical trials 3.
- A study found that oral administration of 2 mg of vitamin K1 at birth is effective in preventing HDNB, and can be applied routinely, especially in breast-fed infants 4.
Vitamin D3 (Cholecalciferol) for Newborns
- There is no direct evidence in the provided studies regarding the recommended dosage of vitamin D3 for newborns.
Administration and Safety
- Vitamin K should be administered to all neonates at birth or immediately afterwards, with the route of administration, dosage, and number of doses depending on the individual case 5.
- Oral administration of vitamin K is less effective than intramuscular prophylaxis for the prevention of late VKDB, but is still a viable option 5.
- The risk of childhood cancer associated with vitamin K administration has not been substantiated, but a low potential risk of lymphoblastic leukemia cannot be ruled out 3, 5.
- Parental refusal of vitamin K prophylaxis is increasingly common, and it is critical that healthcare providers and the public be made aware of the risks of vitamin K deficiency bleeding (VKDB) 6.
Plasma Concentrations
- A study found that plasma concentrations of vitamin K1 after oral administration at birth were significantly lower than after intramuscular injection, but still provided adequate protection against early HDNB 7.