Phytonadione for Injection
(Phytonadione Injectable Emulsion, USP)
1 mg/0.5 mL and 10 mg/mL
AVIAL ABLE
IN VIAL S
To place your order, please contact your wholesaler OR by
contacting Cipla USA at 844-CIPLA US (844-247-5287)
PHYTONADIONE WHOLESALER/DISTRIBUTOR ORDER ENTRY NUMBERS
NDC
STRENGTH
AMERISOURCEBERGEN
CARDINAL
MCKESSON
MORRIS & DICKSON
69097-0709-96
1 mg/0.5 mL
10269358
5787999
2619450
219287
69097-0708-96
10 mg/mL
10269520
5788005
2619468
219337
DETAILS
GENERIC NAME1
Phytonadione Injectable Emulsion, USP
NDC #’s 1
69097-0709-96
69097-0708-96
STRENGTH1
1 mg/0.5 mL
10 mg/mL
STORAGE1
Store at 20ºC to 25ºC (68ºF to 77ºF)
ORDER SIZE1
10 Single-Dose Vials in a carton
CASE SIZE 1
24
Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059
Customer Service Tel.: 844-CIPLA US (844-247-5287) Email: Cipla.CS@cipla.com
DECEMBER 2023 CUSAI-12182023-01
REFERENCES:
1. Phytonadione Injection Prescribing Information, Cipla USA. 03/2022.
www.ciplausa.com
Medical Information:
- Report Adverse Events/Side Effects
- Report Product Complaints
- Submit Medical Inquiries:
Contact Us:
1-866-604-3268 DrugSafety@cipla.com
INDICATIONS1
Treatment of Hypoprothrombinemia Due to Vitamin K
Deficiency or Interference: Phytonadione injectable
emulsion 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.
Prophylaxis and Treatment of Vitamin K-Deficiency
Bleeding in Neonates: Phytonadione injectable emulsion
is indicated for prophylaxis and treatment of vitamin K
deficiency bleeding in neonates.
BOXED WARNING1
WARNING - HYPERSENSITIVITY REACTIONS WITH
INTRAVENOUS AND INTRAMUSCULAR USE: Fatal
hypersensitivity reactions, including anaphylaxis,
have occurred during and immediately after intravenous
and intramuscular injection of phytonadione injectable
emulsion. Reactions have occurred despite dilution
to avoid rapid intravenous infusion and upon first dose.
Avoid the intravenous and intramuscular routes of
administration unless the subcutaneous route is not
feasible and the serious risk is justified.
Please see www.ciplausa.com
for full prescribing information and
Important Safety Information.