PHYTONADIONE injection emulsion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Phytonadione (UNII: A034SE7857) (Phytonadione - UNII:A034SE7857)

Available from:

Cardinal Health

INN (International Name):

Phytonadione

Composition:

Phytonadione 1 mg in 0.5 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PHYTONADIONE- PHYTONADIONE INJECTION, EMULSION
CARDINAL HEALTH
----------
PHYTONADIONE INJECTABLE
EMULSION, USP
AQUEOUS COLLOIDAL SOLUTION OF VITAMIN K
Rx Only
WARNING — INTRAVENOUS USE
Severe reactions, including fatalities, have occurred during and
immediately after the parenteral
administration of Phytonadione. Typically these severe reactions have
resembled hypersensitivity
or anaphylaxis, including shock and cardiac and/or respiratory arrest.
Some patients have
exhibited these severe reactions on receiving Phytonadione for the
first time. The majority of
these reported events occurred following intravenous administration,
even when precautions have
been taken to dilute the Phytonadione and to avoid rapid infusion.
Therefore, the
INTRAVENOUS route should be restricted to those situations where
another route is not
feasible and the increased risk involved is considered justified.
DESCRIPTION
Phytonadione is a vitamin, which is a clear, yellow to amber, viscous,
odorless or nearly odorless
liquid. It is insoluble in water, soluble in chloroform and slightly
soluble in ethanol. It has a molecular
weight of 450.70.
Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical
formula is C
H
0
and its structural formula is:
Phytonadione Injectable Emulsion, USP, is a yellow, sterile, aqueous
colloidal solution of vitamin K1,
with a pH of 3.5 to 7.0. It is available for injection by the
intravenous, intramuscular, and subcutaneous
routes.
Each 0.5 mL contains 1 mg phytonadione (Vitamin K1), 10 mg polysorbate
80, 10.4 mg propylene
glycol, 0.17 mg sodium acetate anhydrous, and 0.00002 mL glacial
acetic acid. Additional glacial
1
31
46
2
acetic acid or sodium acetate anhydrous may have been added to adjust
pH to meet USP limits of 3.5 to
7.0. The air above the liquid in the individual containers has been
displaced by flushing with nitrogen
during the filling operation.
CLINICAL PHARMACOLOGY
Phytonadione aqueous colloidal solution of vitamin K
for parenteral injection, possesses the same type and degree of
act