PHYTONADIONE injection, emulsion PHYTONADIONE injection, emulsion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857)

Available from:

Teligent Pharma, Inc.

INN (International Name):

PHYTONADIONE

Composition:

PHYTONADIONE 2 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Phytonadione is indicated for the treatment of the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity: - anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives; - hypoprothrombinemia due to antibacterial therapy; - hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis; - other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates. Phytonadione is indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates. Hypersensitivity to phytonadione or any other component of this medication. [see WARNINGS AND PRECAUTIONS (5.1)]. Risk Summary   Phytonadione c

Product summary:

Phytonadione is a yellow, sterile, aqueous colloidal solution and is supplied in a package of 25 as follows: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect Phytonadione from light. Store container in closed original carton until contents have been used. NOTE : Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.  

Authorization status:

New Drug Application

Summary of Product characteristics

PHYTONADIONE- PHYTONADIONE INJECTION, EMULSION
TELIGENT PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PHYTONADIONE SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR PHYTONADIONE_._
PHYTONADIONE INJECTION, FOR INTRAVENOUS, INTRAMUSCULAR, AND
SUBCUTANEOUS USE.
INITIAL U.S. APPROVAL: 1960
WARNING – HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND
INTRAMUSCULAR USE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
FATAL HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS, HAVE OCCURRED
DURING AND IMMEDIATELY AFTER
INTRAVENOUS AND INTRAMUSCULAR INJECTION OF PHYTONADIONE. REACTIONS
HAVE OCCURRED DESPITE
DILUTION TO AVOID RAPID INFUSION AND UPON FIRST AND SUBSEQUENT DOSES.
AVOID THE INTRAVENOUS AND
INTRAMUSCULAR ROUTES OF ADMINISTRATION UNLESS THE SUBCUTANEOUS ROUTE
IS NOT FEASIBLE AND THE SERIOUS RISK
IS JUSTIFIED. (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions, Cutaneous Reactions (5.3) 03/2018
INDICATIONS AND USAGE
Phytonadione is indicated for the treatment of the following
coagulation disorders which are due to faulty formation of
factors II, VII, IX and X when caused by vitamin K deficiency or
interference with vitamin K activity.
Anticoagulant-induced hypoprothrombinemia deficiency caused by
coumarin or indanedione derivatives; (1.1)
Hypoprothrombinemia due to antibacterial therapy; (1.1)
Hypoprothrombinemia secondary to factors limiting absorption or
synthesis of vitamin K, e.g., obstructive jaundice,
biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal
resection, cystic fibrosis of the pancreas, and regional
enteritis; (1.1)
Other drug-induced hypoprothrombinemia where it is definitely shown
that the result is due to interference with
vitamin K metabolism, e.g., salicylates. (1.1)
Phytonadione is indicated for prophylaxis and treatment of vitamin
K-deficiency bleeding in neonates. (1.2)
DOSAGE AND ADMINISTRATION
Administer Phytonadione by the subcutaneous route, whenever possible.
(2.1