Phytonadione

VITAMIN K1

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Pronunciation: fye-toe-na-DYE-oen

Phytonadione ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Phytonadione ballicule

What it isVitamin K1 cofactor restoring gamma-carboxylation of clotting factors; deficiency and warfarin reversal.

Why this oneUnlike factor replacement, it restores sustained clotting-factor production but does not act immediately.

What limits it⚑ IV administration can trigger severe hypersensitivity; urgent bleeding also needs clotting-factor replacement because vitamin K takes hours.

Pearls

IV normalizes INR in 12-24 hours; 4-factor PCC for major bleeding.
High INR without bleeding: oral preferred; SC absorption erratic.

Phytonadione molecular structure (skeletal formula) — Molecular structure: Phytonadione

FDA-approved for

vitamin K deficiency / warfarin reversal

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk1 / 4

Defining liabilityParenteral anaphylaxis and neonatal preservative toxicity

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Fatal hypersensitivity reactions incl. anaphylaxis with IV and IM injection (even when diluted, on first dose) — avoid IV/IM unless SC route not feasible and risk justified.

FDA dosing	Population	Start	Target	Max
Anticoagulant-induced hypoprothrombinemia (coumarin/indanedione)	Adults	2.5–10 mg or more SC (preferred), IM, or IV, once		Up to 25–50 mg as a single dose
Hypoprothrombinemia, other causes (antibacterials, salicylates/other drugs, impaired vitamin K absorption/synthesis)	Adults	2.5–25 mg or more SC (preferred), IM, or IV, once	Recheck INR at 6–8 h; repeat dose if INR still prolonged	Up to 50 mg as a single dose
Vitamin K-deficiency bleeding — prophylaxis	Neonates	0.5–1 mg once, within 1 h of birth		1 mg (single dose)
Vitamin K-deficiency bleeding — treatment	Neonates	1 mg SC or IM	INR should shorten in 2–4 h (no response suggests another diagnosis)	Undefined (consider higher doses if mother on oral anticoagulants)

Renal No dose adjustment labeled; contains aluminum — toxic accumulation with prolonged parenteral use if kidney function impaired (>4 to 5 mcg/kg/day)

Hepatic Repeated large doses not warranted in liver disease if initial response unsatisfactory

Not a clotting agent; effect not immediate (INR improvement 1–8 h) — add whole blood/components if bleeding severe. Use lowest effective dose; overcorrection restores pre-anticoagulation thrombotic risk. Monitor INR.

Instructions

SC route whenever possible; IV/IM only if SC not feasible and risk justified
IV: inject very slowly, not exceeding 1 mg/min
Dilute only with 0.9% NaCl, 5% dextrose, or 5% dextrose/NaCl (no benzyl alcohol–containing diluents); start immediately after dilution; discard unused diluted solution and ampul contents
Protect from light at all times
Pediatric/neonatal use: prefer benzyl alcohol–free formulation (this product contains 9 mg benzyl alcohol/mL)

Available strengths

inj 10 mg/mL
tab 5 mg

Cautions

Hypersensitivity reactions incl. fatal anaphylaxis with IV/IM use (even diluted, first dose)
Benzyl alcohol "gasping syndrome" in neonates/infants (9 mg/mL)
Cutaneous reactions (eczematous, scleroderma-like, urticaria; onset 1 day to 1 year)
Aluminum toxicity (impaired renal function, premature neonates)

Adverse reactions

Cyanosis
Diaphoresis
Dizziness
Dysgeusia
Dyspnea
Flushing
Hypotension
Tachycardia

Pregnancy Published studies show no clear association with adverse developmental outcomes; maternal vitamin K deficiency risks bleeding and rare fetal intracranial hemorrhage — prefer a benzyl alcohol-free formulation.

Lactation Phytonadione is present in breast milk; no data on breastfed child or milk production — prefer a preservative-free formulation.

Cost

Phytonadione (VITAMIN K1)

Strength		#/mo	generic $/unit	CostPlus
10 mg/mL	inj	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Phytonadione is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

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Self-check

Phytonadione: Does it restore clotting-factor production immediately?
No.
Phytonadione: What else is needed for urgent bleeding?
Clotting-factor replacement.