Dose: 1 mg/dose IM if gestational age > 35 weeks
            0.5 mg/dose IM if > 1000 grams             
            0.3 mg/dose IM if < 1000 grams
            (See comments for cholestasis and IV, PO, and subQ administration)

 

Frequency: Within one hour of birth.            

Comments: New recommendations (for SJMMC) are based on the package insert and change to computer-based order entry beginning 8/30/2009  (thanks K. Burch, Pharm. D.). Phytonadione 1 mg may be administered either IM or SQ for preventing hemorrhagic disease of the newborn. A higher dose may be necessary if the newborn's mother was recieving anticoagulant therapy (Prod Info Aquamephyton(R), 2002).  A single-dose of vitamin K 1 mg IM for all full-term infants; 0.5 mg IM for preterm infants weighing more than 1 kilogram but < 35 weeks; and 0.3 mg/kg IM for preterm infants weighing less than 1 kg administered soon after birth to prevent hemorrhagic disease of the newborn (Kleinman, 2009; Prod Info Aquamephyton(R), 2002).  An alternative intramuscular prophylactic dose of vitamin K1 at 0.2 milligrams (mg) was recommended for preterm infants weighing between 1 and 2 kilograms (kg) to prevent vitamin K deficiency bleeding (VKDB) while reducing the risk of hepatic overload (Clarke et al, 2006). The present dosage is for use at the time of birth to prevent hemorrhagic disease of the newborn. Phytonadione injection, USP, is approved for intravenous administration, AquaMephyton is not. The absorption of subcutaneous vitamin K is rapid and only slightly slower than intravenously administered vitamin K.  In addition to vitamin K, infants with symptomatic vitamin K deficiency or suspected vitamin K deficiency should also be treated with plasma products.  There are no data available to make definitive recommendations regarding the use of the vitamin thereafter. Further comments on vitamin K. None of the currently marketed oral vitamin preparations contain vitamin K. Pediatric MVI which is used in TPN will provide 200 mcg/day of vitamin K₁ to infants > 3 kg, 130 mcg/day to infants between 1 and 3 kg, and 60 mcg/day to infants < 1 kg. Infants with cholestasis will have increased and variable requirements. Current recommendations for oral doses range from 2.5 mg twice a week to 5 mg daily. Excessive administration of vitamins E and A can interfere with vitamin K metabolism and result in prolongation of the pro-time and predispose the patient to bleeding. 

Toxicity: Vitamin K should not be given IM to an infant who is bleeding, because large hematomas may form at the site of injection. . Vitamin K given by the IV route should be administered slowly because it may induce an anaphylactic reaction There is little information regarding vitamin K toxicity. In the 1950's large doses (72 mg) of vitamin K (menadione) were administered to mothers in labor. This use was associated with hyperbilirubinemia (due to RBC hemolysis) and possibly kernicterus. The problem appears to have resolved with the availability of the phylloquinone form of vitamin K and the smaller doses given to the infant. In animals, megadoses of the vitamin have produced anemia, polycythemia, splenomegaly, renal and hepatic damage, and death. Two studies in the early 1990s from Great Britain suggested that IM vitamin K (and not orally administered vitamin K) given at birth might be associated with an increased incidence of leukemia and cancer (Pediatric Alert 1996; 21:103). More recent studies have shown this not to be the case. In addition, several infants treated with oral vitamin K developed hemorrhagic disease of the newborn.

Preparation:
IV:  Vitamin K is available in a parenteral form (phytonadione-vitamin K₁) in 1 mg single use syringes. Discard after single use. Refrigerate, protect from light. The manufacturer recommends using only D5W, NS, and D5NS as diluents if intravenous infusion is necessary.

PO: The oral form (menadiol-vitamin K₃ derivative) is available as 5 mg scored tablet. Break in two and then use a scalpel blade to cut the remaining half tablet into two equal fragments with each quarter tablet providing 1.25 mg. Crush and add to formula.

Compatibility: Compatible with TPN (though in a D12.5, 2% amino acid solution, there was a 27% loss of phytonadione in a 24 hour period) and filter. Also compatible with D2.5W, D5W, D10W, dextrose-saline combinations, LR, dextrose-LR combinations, 0.45% sodium chloride, NS, amikacin, ampicillin, calcium gluconate, chloramphenicol, doxapram, epinephrine, famotidine, heparin, hydrocortisone, potassium chloride, and tolazoline.  Not compatible with dobutamine, phenytoin, and ranitidine.

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