phytomenadione 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	2843	84-80-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: vitamin K1 phytomenadione vitamin K phytonadione phytylmenadione phytylmenaquinone phylloquinone	A lipid cofactor that is required for normal blood clotting. Several forms of vitamin K have been identified: VITAMIN K 1 (phytomenadione) derived from plants, VITAMIN K 2 (menaquinone) from bacteria, and synthetic naphthoquinone provitamins, VITAMIN K 3 (menadione). Vitamin K 3 provitamins, after being alkylated in vivo, exhibit the antifibrinolytic activity of vitamin K. Green leafy vegetables, liver, cheese, butter, and egg yolk are good sources of vitamin K. Molecular weight: 450.71 Formula: C31H46O2 CLOGP: 11.69 LIPINSKI: 1 HAC: 2 HDO: 0 TPSA: 34.14 ALOGS: -6.88 ROTB: 14 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

vitamin K1
phytomenadione
vitamin K
phytonadione
phytylmenadione
phytylmenaquinone
phylloquinone

A lipid cofactor that is required for normal blood clotting. Several forms of vitamin K have been identified: VITAMIN K 1 (phytomenadione) derived from plants, VITAMIN K 2 (menaquinone) from bacteria, and synthetic naphthoquinone provitamins, VITAMIN K 3 (menadione). Vitamin K 3 provitamins, after being alkylated in vivo, exhibit the antifibrinolytic activity of vitamin K. Green leafy vegetables, liver, cheese, butter, and egg yolk are good sources of vitamin K.

Molecular weight: 450.71
Formula: C31H46O2
CLOGP: 11.69
LIPINSKI: 1
HAC: 2
HDO: 0
TPSA: 34.14
ALOGS: -6.88
ROTB: 14

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
20	mg	O
20	mg	P

ADMET properties:

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Property	Value	Reference
t_half (Half-life)	7.30 hours	Lombardo F, Berellini G, Obach RS
CL (Clearance)	1.60 mL/min/kg	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.32 L/kg	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
May 18, 2000	FDA	SANDOZ

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Infective pulmonary exacerbation of cystic fibrosis	204.48	13.92	69	9588	8748	63470617
International normalised ratio increased	79.91	13.92	62	9595	46363	63433002
Coagulopathy	62.63	13.92	39	9618	20505	63458860
Multiple organ dysfunction syndrome	55.59	13.92	55	9602	56697	63422668
Cystic fibrosis	54.25	13.92	20	9637	3276	63476089
Sepsis	51.16	13.92	87	9570	153036	63326329
Renal vascular thrombosis	47.06	13.92	8	9649	46	63479319
Ascites	46.58	13.92	43	9614	40685	63438680
Cholestasis	39.45	13.92	34	9623	29400	63449965
Factor V inhibition	37.63	13.92	8	9649	168	63479197

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Appendicolith	425.87	14.92	149	12984	8452	34935346
Appendicitis	373.84	14.92	157	12976	14650	34929148
Ascites	308.49	14.92	201	12932	46370	34897428
Cardiogenic shock	291.69	14.92	159	12974	26459	34917339
Stress	253.86	14.92	152	12981	30195	34913603
Multiple organ dysfunction syndrome	235.49	14.92	209	12924	76357	34867441
Abdominal distension	219.37	14.92	179	12954	58313	34885485
Ventricular fibrillation	194.56	14.92	116	13017	22838	34920960
Blood phosphorus increased	185.18	14.92	79	13054	7642	34936156
Infective pulmonary exacerbation of cystic fibrosis	177.83	14.92	74	13059	6727	34937071

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Appendicolith	479.15	13.38	148	20155	8403	79715682
Appendicitis	374.25	13.38	155	20148	20639	79703446
Ascites	363.50	13.38	231	20072	75331	79648754
Infective pulmonary exacerbation of cystic fibrosis	337.66	13.38	126	20177	12725	79711360
Multiple organ dysfunction syndrome	304.69	13.38	249	20054	119997	79604088
Cardiogenic shock	300.84	13.38	166	20137	41748	79682337
Ventricular fibrillation	206.11	13.38	118	20185	31808	79692277
Abdominal distension	203.76	13.38	198	20105	119452	79604633
Sepsis	199.34	13.38	291	20012	269137	79454948
Blood phosphorus increased	192.44	13.38	79	20224	10268	79713817

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	B02BA01	BLOOD AND BLOOD FORMING ORGANS ANTIHEMORRHAGICS VITAMIN K AND OTHER HEMOSTATICS Vitamin K
CHEBI has role	CHEBI:23357	cofactor
CHEBI has role	CHEBI:76924	plant metabolites
CHEBI has role	CHEBI:77746	Homo sapiens metabolite
CHEBI has role	CHEBI:24020	fat-soluble vitamins
CHEBI has role	CHEBI:75771	Mus musculus metabolites
FDA CS	M0022806	Vitamin K
FDA EPC	N0000175966	Warfarin Reversal Agent
FDA EPC	N0000180191	Vitamin K
FDA PE	N0000175965	Increased Prothrombin Activity

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Hypocalcemia	indication	5291005
Osteoporosis	indication	64859006	DOID:11476
Factor II deficiency	indication	73975000
Postmenopausal osteoporosis	indication	102447009
Prevention of Neonatal Hemorrhagic Disease	indication
Antibiotic-Induced Hypoprothrombinemia	indication
Neonatal Hemorrhagic Disease	indication
Vitamin K Deficiency Induced Hypoprothrombinemia	indication
Anticoagulant-Induced Prothrombin Deficiency	indication
Obstruction of bile duct	off-label use	30144000

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

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Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Alpha-synuclein	Transporter	P37840	SYUA_HUMAN		IC50	4.82		CHEMBL

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External reference:

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ID	Source
PQN	PDB_CHEM_ID
001038	NDDF
001042	NDDF
11258	RXNORM
1433	MMSL
15677	MMSL
177	INN_ID
199215	MMSL
4017772	VUID
4017772	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Adult Infuvite Multiple Vitamins for Infusion	HUMAN PRESCRIPTION DRUG LABEL	13	54643-5649	INJECTION, SOLUTION	150 ug	INTRAVENOUS	NDA	17 sections
Mephyton	HUMAN PRESCRIPTION DRUG LABEL	1	0187-1704	TABLET	5 mg	ORAL	NDA	22 sections
Mephyton	HUMAN PRESCRIPTION DRUG LABEL	1	0187-1704	TABLET	5 mg	ORAL	NDA	22 sections
MEPHYTON	HUMAN PRESCRIPTION DRUG LABEL	1	21695-168	TABLET	5 mg	ORAL	NDA	21 sections
Mephyton	HUMAN PRESCRIPTION DRUG LABEL	1	50090-1753	TABLET	5 mg	ORAL	NDA	20 sections
PEDIATRIC INFUVITE MULTIPLE VITAMINS FOR INFUSION	HUMAN PRESCRIPTION DRUG LABEL	13	54643-5646	INJECTION, SOLUTION	0.20 mg	INTRAVENOUS	NDA	19 sections
PEDIATRIC INFUVITE MULTIPLE VITAMINS FOR INFUSION	HUMAN PRESCRIPTION DRUG LABEL	13	54643-5646	INJECTION, SOLUTION	0.20 mg	INTRAVENOUS	NDA	19 sections
PHYTONADIONE	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9935	INJECTION, EMULSION	1 mg	PARENTERAL	ANDA	16 sections
PHYTONADIONE	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9935	INJECTION, EMULSION	1 mg	PARENTERAL	ANDA	16 sections
PHYTONADIONE	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9969	INJECTION, EMULSION	10 mg	INTRAMUSCULAR	ANDA	12 sections

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