Oral Vitamin K for Newborns
For parents who choose to forgo the intramuscular (IM) injection
The standard of care recommended by pediatric guidelines is a single intramuscular (IM) vitamin K injection at birth to prevent Vitamin K Deficiency Bleeding (VKDB). For families who decline IM vitamin K, our clinic offers a structured oral vitamin K protocol with counseling, informed consent, and follow-up.
Hospital IM Vitamin K: Common Formulation
Each 0.5 mL injection typically contains: phytonadione 1 mg, polyethylene glycol-15-hydroxystearate 7%, propylene glycol 2% in water for injection.
Potential hypersensitivity concerns (PEG)
- Hypersensitivity to polyethylene glycol in adults and children: an emerging challenge (Open-access review)
- PEG That Reaction: A Case Series of Allergy to Polyethylene Glycol (Case series)
True PEG allergy is uncommon; discuss your family history with your provider. Emergency care is required for any signs of anaphylaxis.
Adverse reactions listed in U.S. Prescribing Information (USPI)
| System | Reported reactions (from USPI) |
|---|---|
| Cardiac | Tachycardia, hypotension |
| General / Site | Generalized flushing; pain, swelling, tenderness at injection site |
| Hepatobiliary | Hyperbilirubinemia |
| Immune | Fatal hypersensitivity reactions, anaphylaxis (rare) |
| Neurologic | Dysgeusia, dizziness |
| Pulmonary | Dyspnea |
| Skin | Erythema, pruritic plaques, scleroderma-like lesions, erythema perstans |
| Vascular | Cyanosis |
Source: Hospira, Inc. Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP). Prescribing Information, revised May 2021 (LAB-1142-3.0). USPI link
FDA Black Box Warning (summary)
Reference: FDA label — AquaMEPHYTON® (phytonadione injectable emulsion, USP), revised Dec 2018. FDA label (PDF)
Clinical practice notes: In routine newborn prophylaxis, the IM route is widely used and severe reactions are very rare. Discuss benefits/risks with your provider.
Our Oral Vitamin K Option (for families declining IM)
Composition & Storage
- Active: Vitamin K1 (phytonadione)
- Vehicle: Olive oil
- Additives/Preservatives: None added
- Storage: Keep syringes in the refrigerator to preserve freshness
Dosing Schedule
- At birth: First dose, given at the first feeding
- 2–4 weeks of age: Repeat dose
- 6–8 weeks of age: Final dose
Adherence to the full series is essential. If a dose is spit up, vomited, or missed, contact your provider promptly for guidance.
Important Counseling Points
- Effectiveness: Pediatric societies state that IM vitamin K is more effective at preventing late VKDB than oral regimens. Oral vitamin K is offered here only for families who decline IM after counseling.
- Medical conditions: Babies with cholestasis, liver disease, poor absorption, chronic diarrhea or on certain medications (e.g., prolonged antibiotics) have a higher risk of VKDB with oral regimens — consult pediatrics.
- Watch for VKDB signs: bruising, bleeding from the umbilicus/circumcision site, pallor, blood in stool/urine, lethargy, persistent vomiting, or seizures — seek emergency care.
Pediatric Guideline (Canada): Canadian Paediatric Society. Vitamin K prophylaxis in newborns. CPS Position Statement
Next Steps & Informed Choice
We encourage parents to review the CPS guideline and speak with their pediatrician or family physician. If you decline IM vitamin K and wish to proceed with the oral series, we provide counseling, dosing syringes, and a clear follow-up plan.
About Excipients (“Adjuvants”) in IM Vitamin K
The standard IM vitamin K formulations use small amounts of excipients to keep vitamin K1 (phytonadione) dissolved and stable in water. Most newborns tolerate these ingredients; however, rare reactions have been reported in the literature. Families who wish to avoid these excipients sometimes prefer an oral vitamin K series with careful adherence and follow-up.
- Polyethylene glycol-15-hydroxystearate (PEG-15-HS) (a PEG surfactant/emulsifier): Rare hypersensitivity/anaphylaxis to PEGs has been documented in adults and children. See reviews and case reports: Bianchi 2022 (review), Wylon 2016 (case report).
- Propylene glycol (PG) (solvent, ~2% in some 0.5 mL IM doses): Generally recognized as safe, but high or prolonged exposures—especially in neonates—have been associated (in other drugs/contexts) with CNS effects or metabolic acidosis. These events are dose-related and rare at the small amounts used in IM vitamin K. References: Lim 2014 (review), De Cock 2012 (pharmacokinetics).
- Boxed safety warning for injectable phytonadione: The FDA label notes severe reactions (including fatalities) have occurred with IV and, rarely, IM administration—typically hypersensitivity-like reactions. These events are very uncommon in routine newborn prophylaxis. See official labels: FDA AquaMEPHYTON label (2018), Hospira/Pfizer USPI (2021).
Balanced perspective: IM vitamin K remains the most effective method to prevent vitamin K deficiency bleeding (VKDB), as supported by the Canadian Paediatric Society guideline. Oral vitamin K is less effective and requires multiple doses but may be chosen by some families who wish to avoid these excipients. We provide counseling, informed consent, and a dosing/monitoring plan for families choosing the oral series.