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Vitamin K1

Generic Name
Vitamin K1
Brand Names
Aquamephyton, Infuvite, Infuvite Pediatric, Mephyton, Mvi Pediatric, Phytonadione
Drug Type
Small Molecule
Chemical Formula
C31H46O2
CAS Number
84-80-0
Unique Ingredient Identifier
S5Z3U87QHF

Overview

Vitamin K1, also called phylloquinone or phytonadione, is a fat soluble vitamin. Phylloquinone is a cofactor of the enzyme γ-carboxylase, which modifies and activates precursors to coagulation factors II, VII, IX, and X. It is indicated in the treatment of coagulation disorders due to faulty formation of coagulation factors II, VII, IX, and X caused by deficiency or interference in the activity of vitamin K. Phylloquinone has been synthesized since at least 1939, and was approved by the FDA prior to 1955.

Background

Vitamin K1, also called phylloquinone or phytonadione, is a fat soluble vitamin. Phylloquinone is a cofactor of the enzyme γ-carboxylase, which modifies and activates precursors to coagulation factors II, VII, IX, and X. It is indicated in the treatment of coagulation disorders due to faulty formation of coagulation factors II, VII, IX, and X caused by deficiency or interference in the activity of vitamin K. Phylloquinone has been synthesized since at least 1939, and was approved by the FDA prior to 1955.

Indication

Oral phylloquinone is indicated to treat prothrombin deficiency caused by coumarin or indanedione derivatives; and hypoprothrombinemia secondary to antibacterial therapy, salicylates, or obstructive jaundice or biliary fistulas with concomitant bile salt administration. Parenteral (intravenous, intramuscular, and subcutaneous) phylloquinone is indicated to treat coagulation disorders due to faulty formation of coagulation factors II, VII, IX, and X caused by vitamin K deficiency or some interference with vitamin K activity. These indications include the above indications as well as hypoprothrombinemia secondary to sprue, ulcerative colitis, celiac disease, intestinal resection, pancreatic cystic fibrosis, or regional enteritis; or hypoprothrombinemia caused by interference with vitamin k metabolism.

Associated Conditions

  • Coagulation Disorder
  • Hypoprothrombinemia
  • Hemorrhagic disease of the newborn

FDA Approved Products

Phytonadione
Manufacturer:Major Pharmaceuticals
Route:ORAL
Strength:5 mg in 1 1
Approved: 2019/08/08
NDC:0904-6882
Phytonadione
Manufacturer:Square Pharmaceuticals Ltd.
Route:PARENTERAL
Strength:1 mg in 0.5 mL
Approved: 2016/04/28
NDC:76483-052
Adult Infuvite Multiple Vitamins
Manufacturer:Sandoz Inc
Route:INTRAVENOUS
Strength:150 ug in 10 mL
Approved: 2016/10/28
NDC:54643-7874
Infuvite Adult Multiple Vitamins
Manufacturer:Sandoz Inc
Route:INTRAVENOUS
Strength:150 ug in 10 mL
Approved: 2016/03/17
NDC:54643-5649
Vitamin K1
Manufacturer:A-S Medication Solutions
Route:INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Strength:2 mg in 1 mL
Approved: 2021/04/29
NDC:50090-4523

Singapore Approved Products

VITALIPID N ADULT INJECTION
Manufacturer:FRESENIUS KABI AB
Form:INJECTION
Strength:15 mcg/ml
Online:Yes
Approved: 1990/11/14
Approval:SIN05208P
VITALIPID N INFANT INJECTION
Manufacturer:FRESENIUS KABI AB
Form:INJECTION
Strength:20 mcg/ml
Online:Yes
Approved: 1990/11/14
Approval:SIN05207P

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