Phytonadione
M.v.i, Phytonadione, Vitamin K1, Vitaped (phytonadione) is a small molecule pharmaceutical. Phytonadione was first approved as Mephyton on 1982-01-01.
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New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ascorbic acid
+
Biotin
+
Cyanocobalamin
+
Dexpanthenol
+
Ergocalciferol
+
Folic acid
+
Niacinamide
+
Phytonadione
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Pyridoxine hydrochloride
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Riboflavin 5'-phosphate sodium
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Thiamine hydrochloride
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Vitamin a
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Vitamin e
Ascorbic acid
+
Biotin
+
Cyanocobalamin
+
Ergocalciferol
+
Folic acid
+
Niacinamide
+
Pantothenic acid
+
Phytonadione
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Pyridoxine
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Riboflavin
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Thiamine
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Vitamin a palmitate
+
Vitamin e
Phytonadione
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MEPHYTON | Bausch Health Companies | N-010104 DISCN | 1982-01-01 | 1 products, RLD |
| AQUAMEPHYTON | PAI Pharma | N-012223 DISCN | 1982-01-01 | 2 products, RLD |
| KONAKION | Roche | N-011745 DISCN | 1982-01-01 | 2 products |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| adult infuvite multiple vitamins | New Drug Application | 2019-05-14 |
| adult infuvite multiple vitamins for infusion pharmacy bulk | New Drug Application | 2013-01-01 |
| infuvite adult multiple vitamins | New Drug Application | 2019-05-14 |
| mephyton | New Drug Application | 2020-11-17 |
| pediatric infuvite multiple vitamins | New Drug Application | 2019-05-14 |
| pediatric infuvite multiple vitamins for infusion | New Drug Application | 2016-03-28 |
| pediatric infuvite multiple vitamins for infusion pharmacy bulk | New Drug Application | 2012-01-24 |
| phytonadione | ANDA | 2024-09-24 |
| vitalipid n | unapproved drug for use in drug shortage | 2023-09-07 |
| vitamin k1 | ANDA | 2021-07-26 |
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Indications
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Agency Specific
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Patent Expiration
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HCPCS
Code | Description |
|---|---|
| J3430 | Injection, phytonadione (vitamin k), per 1 mg |
Clinical
Clinical Trials
461 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | 1 | 11 | 14 | 17 | 76 | 118 |
| Thrombosis | D013927 | — | — | 1 | 8 | 15 | 7 | 27 | 57 |
| Thromboembolism | D013923 | HP_0001907 | — | — | 4 | 12 | 5 | 25 | 44 |
| Hemorrhage | D006470 | MP_0001914 | R58 | 1 | 3 | 11 | 5 | 20 | 39 |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | — | 4 | 9 | 4 | 21 | 36 |
| Venous thrombosis | D020246 | HP_0004936 | I82.40 | 1 | 6 | 8 | 4 | 11 | 29 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 1 | 1 | 3 | 4 | 17 | 25 |
| Embolism | D004617 | — | — | — | 1 | 6 | 6 | 11 | 23 |
| Calcinosis | D002114 | — | — | — | 2 | 4 | 7 | 7 | 20 |
| Pulmonary embolism | D011655 | HP_0002204 | I26 | — | 1 | 6 | 5 | 8 | 19 |
Show 56 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart valve diseases | D006349 | EFO_0009551 | I08 | — | 4 | 1 | — | 3 | 7 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 3 | 4 | — | 1 | 7 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | 1 | 1 | — | 6 | 7 |
| Carcinoma | D002277 | — | C80.0 | 1 | 1 | 1 | — | 4 | 6 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | — | 1 | 1 | — | 5 | 6 |
| Covid-19 | D000086382 | — | — | — | 1 | 1 | — | 2 | 4 |
| Metabolic bone diseases | D001851 | HP_0000938 | — | 1 | — | 2 | — | 1 | 4 |
| Inflammation | D007249 | MP_0001845 | — | — | — | 1 | — | 3 | 4 |
| Rheumatic heart disease | D012214 | EFO_1001161 | I09.9 | — | — | 3 | — | — | 3 |
| Intracranial thrombosis | D020767 | — | — | — | 1 | 1 | — | 1 | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 7 | 2 | — | — | 9 | 17 |
| Antiphospholipid syndrome | D016736 | EFO_0002689 | D68.61 | — | 1 | — | — | 4 | 5 |
| Vascular stiffness | D059289 | — | — | — | 1 | — | — | 4 | 5 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | 2 | — | — | — | 3 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | — | — | 2 | 3 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | — | 1 | — | — | 2 | 3 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | 1 | — | — | — | 2 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 1 | 1 | — | — | — | 2 |
| Pancreatitis | D010195 | HP_0001733 | K85 | 1 | 1 | — | — | — | 2 |
| Chronic pancreatitis | D050500 | EFO_0000342 | K86.1 | 1 | 1 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arthritis | D001168 | HP_0001369 | M05-M14 | 3 | — | — | — | 1 | 4 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 3 | — | — | — | — | 3 |
| Melanoma | D008545 | — | — | 3 | — | — | — | — | 3 |
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | 1 | — | — | — | 2 | 3 |
| Psoriasis | D011565 | EFO_0000676 | L40 | 3 | — | — | — | — | 3 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 3 | — | — | — | — | 3 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 2 | — | — | — | — | 2 |
| Fallopian tube neoplasms | D005185 | — | — | 2 | — | — | — | — | 2 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 2 | — | — | — | — | 2 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | 2 | — | — | — | — | 2 |
Show 26 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 6 | 6 |
| Ischemic stroke | D000083242 | — | — | — | — | — | — | 5 | 5 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | — | — | 4 | 4 |
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | — | — | — | 4 | 4 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | — | 4 | 4 |
| Fibrosis | D005355 | — | — | — | — | — | — | 4 | 4 |
| Hip fractures | D006620 | EFO_0003964 | S72.00 | — | — | — | — | 3 | 3 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 3 | 3 |
| Insulin resistance | D007333 | HP_0000855 | — | — | — | — | — | 3 | 3 |
| Overweight | D050177 | — | E66.3 | — | — | — | — | 3 | 3 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Phytonadione |
| INN | phytomenadione |
| Description | Phylloquinone is a member of the class of phylloquinones that consists of 1,4-naphthoquinone having methyl and phytyl groups at positions 2 and 3 respectively. The parent of the class of phylloquinones. It has a role as a cofactor, a plant metabolite and a human metabolite. It is a vitamin K and a member of phylloquinones. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC1=C(C/C=C(\C)CCC[C@H](C)CCC[C@H](C)CCCC(C)C)C(=O)c2ccccc2C1=O |
Identifiers
| PDB | — |
| CAS-ID | 84-80-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1550 |
| ChEBI ID | 18067 |
| PubChem CID | 5284607 |
| DrugBank | DB01022 |
| UNII ID | S5Z3U87QHF (ChemIDplus, GSRS) |
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Phytonadione – Amphastar Pharmaceuticals
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Estimated US medical usage
Phytonadione
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
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Additional graphs summarizing 7,439 documents
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Safety
Black-box Warning
Black-box warning for: Vitamin k1, Vitamin k1 - phytonadione, Vitamin k1 phytonadione
Adverse Events
Top Adverse Reactions
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1,558 adverse events reported
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