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.
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/21 | Phase 4 | Completed | |||
2023/02/23 | Phase 4 | Completed | |||
2022/05/26 | Phase 1 | Completed | |||
2022/03/10 | Phase 1 | Completed | |||
2021/08/24 | Phase 3 | Recruiting | |||
2020/07/20 | Phase 2 | Completed | |||
2020/01/29 | Not Applicable | Completed | |||
2019/05/08 | Phase 4 | UNKNOWN | Joseph M. Still Research Foundation, Inc. | ||
2018/12/20 | N/A | Completed | |||
2018/01/03 | Early Phase 1 | UNKNOWN | HUANG XIANJIAN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Dr.Reddy's Laboratories Inc | 43598-405 | INTRAMUSCULAR, SUBCUTANEOUS, INTRAVENOUS | 10 mg in 1 mL | 5/30/2014 | |
| Sandoz Inc | 54643-9023 | INTRAVENOUS | 0.2 mg in 5 mL | 10/28/2016 | |
| Sandoz Inc | 54643-9015 | INTRAVENOUS | 150 ug in 10 mL | 10/28/2016 | |
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1537 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 2 mg in 1 mL | 1/30/2024 | |
| Square Pharmaceuticals Ltd. | 76483-052 | PARENTERAL | 1 mg in 0.5 mL | 4/28/2016 | |
| General Injectables & Vaccines, Inc | 52584-043 | PARENTERAL | 1 mg in 0.5 mL | 1/12/2017 | |
| Henry Schein, Inc. | 0404-9935 | PARENTERAL | 1 mg in 0.5 mL | 11/13/2023 | |
| ScieGen Pharmaceuticals Inc | 50228-333 | ORAL | 5 mg in 1 1 | 8/11/2023 | |
| General Injectables & Vaccines, Inc | 52584-240 | PARENTERAL | 1 mg in 0.5 mL | 1/12/2017 | |
| Sandoz Inc | 54643-7874 | INTRAVENOUS | 150 ug in 10 mL | 10/28/2016 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| VITALIPID N ADULT INJECTION | SIN05208P | INJECTION | 15 mcg/ml | 11/14/1990 | |
| VITALIPID N INFANT INJECTION | SIN05207P | INJECTION | 20 mcg/ml | 11/14/1990 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| KiddieCal | 332941 | Pharmametics Products A Division of Max Biocare Pty Ltd | Medicine | A | 3/31/2020 |
| BLACKMORES TOTAL CALCIUM MAGNESIUM + D3 | 289048 | Medicine | A | 5/17/2017 | |
| USANA HealthPak | 350153 | Medicine | A | 11/30/2020 | |
| Swisse Ultivite Women's High Potency Multivitamin | 369430 | Medicine | A | 6/16/2021 | |
| Daily Multi Multivitamin | 337216 | Medicine | A | 5/29/2020 | |
| SEA Swisse Ultivite E-SENTIAL Multivitamin | 343461 | Medicine | A | 9/14/2020 | |
| Quality Health Australia Daily Multi | 404880 | Pharmacare Laboratories Pty Ltd | Medicine | A | 2/15/2023 |
| Natal Care | 395834 | Medicine | A | 9/12/2022 | |
| ElementAll Diet | 447331 | Medicine | A | 5/1/2024 | |
| Priceline Women's Multi | 453994 | Medicine | A | 7/1/2024 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| VITAMIN K1 | 00781878 | Emulsion - Intramuscular
,
Subcutaneous
,
Intravenous | 2 MG / ML | 12/31/1989 | |
| VITAMIN K1 INJ 2MG/ML | hospira healthcare ulc | 00497541 | Solution - Intramuscular
,
Intravenous
,
Subcutaneous | 2 MG / ML | 12/31/1981 |
| ADEKS - DPS | axcan pharma inc | 02139650 | Drops - Oral | 0.1 MG / ML | 12/31/1995 |
| PHYTONADIONE INJ 2MG/ML | International Medication Systems Ltd. | 00243876 | Liquid - Intramuscular | 2 MG / ML | 12/31/1971 |
| VITAMIN K1 | 00804312 | Emulsion - Intramuscular
,
Subcutaneous
,
Intravenous | 10 MG / ML | 12/31/1989 | |
| VITAMIN K1 INJ 10MG/ML | hospira healthcare ulc | 00497568 | Solution - Intramuscular
,
Intravenous
,
Subcutaneous | 10 MG / ML | 12/31/1981 |
| MVC 9+4 INJ | lyphomed canada inc. | 00871990 | Liquid - Intravenous | 0.2 MG / 10 ML | 12/31/1990 |
| M.V.I. PAEDIATRIC | aventis pharma inc | 01927833 | Liquid - Intravenous | .2 MG / VIAL | 12/31/1988 |
| ADEKS TABLETS | axcan pharma inc | 02031388 | Tablet - Oral | 0.15 MG | 1/20/1998 |
| MULTI-12/K1 PEDIATRIC | 02242529 | Liquid - Intravenous | 0.2 MG / VIAL | 11/7/2000 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| KONAKION 10 mg/ml SOLUCION ORAL/SOLUCION INYECTABLE | 27262 | SOLUCIÓN ORAL E INYECTABLE | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| VITALIPID INFANTIL | Fresenius Kabi España, S.A.U. | 61021 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
| KONAKION 2 mg/0,2 ml PEDIATRICO SOLUCION ORAL/SOLUCION INYECTABLE | 21610 | SOLUCIÓN ORAL E INYECTABLE | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| KONAKION 10 MG/ML SOLUCION ORAL/SOLUCION INYECTABLE | 008776078IP | SOLUCIÓN ORAL E INYECTABLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| KONAKION 10 mg/ml SOLUCION ORAL/SOLUCION INYECTABLE | 8776078 | SOLUCIÓN ORAL E INYECTABLE | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| VITALIPID ADULTOS | Fresenius Kabi España, S.A.U. | 61020 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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