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

Stem definition	Drug id	CAS RN
Vitamin D analogues/derivatives	2840	67-97-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: Vitamin D3 cholecalciferol arachitol calciol calcirol colecalciferol	Derivative of 7-dehydroxycholesterol formed by ULTRAVIOLET RAYS breaking of the C9-C10 bond. It differs from ERGOCALCIFEROL in having a single bond between C22 and C23 and lacking a methyl group at C24. Some experts recommend maintaining recommended levels of vitamin D intake during the COVID-19 pandemic to maintain bone and muscle health and avoid deficiency. Efficacy of vitamin D supplementation in the prevention or treatment of COVID-19 has not been established. Molecular weight: 384.65 Formula: C27H44O CLOGP: 9.48 LIPINSKI: 1 HAC: 1 HDO: 1 TPSA: 20.23 ALOGS: -6.01 ROTB: 6 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

Vitamin D3
cholecalciferol
arachitol
calciol
calcirol
colecalciferol

Derivative of 7-dehydroxycholesterol formed by ULTRAVIOLET RAYS breaking of the C9-C10 bond. It differs from ERGOCALCIFEROL in having a single bond between C22 and C23 and lacking a methyl group at C24. Some experts recommend maintaining recommended levels of vitamin D intake during the COVID-19 pandemic to maintain bone and muscle health and avoid deficiency. Efficacy of vitamin D supplementation in the prevention or treatment of COVID-19 has not been established.

Molecular weight: 384.65
Formula: C27H44O
CLOGP: 9.48
LIPINSKI: 1
HAC: 1
HDO: 1
TPSA: 20.23
ALOGS: -6.01
ROTB: 6

Status: OFP

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

Drug dosage:

Dose	Unit	Route
20	mcg	O
10	mg	O
5	mg	O
10	mg	O

ADMET properties:

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Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.10 mg/mL	Benet LZ, Broccatelli F, Oprea TI

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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
Completed suicide	1485.47	11.32	120	844216	145553	62499133
Toxicity to various agents	1352.58	11.32	806	843530	246444	62398242
Pemphigus	644.52	11.32	4418	839918	179308	62465378
Systemic lupus erythematosus	616.22	11.32	4820	839516	204098	62440588
Drug abuse	596.84	11.32	119	844217	72399	62572287
Death	572.96	11.32	2795	841541	371586	62273100
Intentional overdose	563.59	11.32	145	844191	74007	62570679
Glossodynia	529.58	11.32	4131	840205	174745	62469941
Alopecia	475.99	11.32	6702	837634	330834	62313852
Drug interaction	450.10	11.32	1551	842785	227580	62417106

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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
Toxicity to various agents	621.19	10.85	539	315385	199823	34441184
Drug abuse	541.41	10.85	117	315807	98979	34542028
Completed suicide	524.07	10.85	122	315802	98046	34542961
Rheumatoid arthritis	319.11	10.85	912	315012	37326	34603681
Drug interaction	244.69	10.85	1130	314794	224816	34416191
Intentional overdose	200.36	10.85	72	315852	43602	34597405
Arthralgia	167.16	10.85	2305	313619	167736	34473271
Fatigue	164.41	10.85	4446	311478	366207	34274800
Hepatic function abnormal	151.41	10.85	108	315816	44255	34596752
Psoriatic arthropathy	137.66	10.85	443	315481	19355	34621652

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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
Completed suicide	1950.81	10.72	236	896581	245531	78602040
Toxicity to various agents	1942.20	10.72	1169	895648	420371	78427200
Drug abuse	1168.68	10.72	209	896608	162482	78685089
Drug interaction	688.96	10.72	2379	894438	412804	78434767
Intentional overdose	642.42	10.72	196	896621	105764	78741807
Rheumatoid arthritis	593.92	10.72	4198	892619	204272	78643299
Arthralgia	516.83	10.72	9164	887653	562639	78284932
Overdose	459.01	10.72	857	895960	183349	78664222
Death	431.24	10.72	4182	892635	562332	78285239
Arthropathy	423.96	10.72	3424	893393	173687	78673884

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A11CC05	ALIMENTARY TRACT AND METABOLISM VITAMINS VITAMIN A AND D, INCL. COMBINATIONS OF THE TWO Vitamin D and analogues
ATC	A11CC55	ALIMENTARY TRACT AND METABOLISM VITAMINS VITAMIN A AND D, INCL. COMBINATIONS OF THE TWO Vitamin D and analogues
ATC	M05BB03	MUSCULO-SKELETAL SYSTEM DRUGS FOR TREATMENT OF BONE DISEASES DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION Bisphosphonates, combinations
ATC	M05BB04	MUSCULO-SKELETAL SYSTEM DRUGS FOR TREATMENT OF BONE DISEASES DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION Bisphosphonates, combinations
ATC	M05BB05	MUSCULO-SKELETAL SYSTEM DRUGS FOR TREATMENT OF BONE DISEASES DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION Bisphosphonates, combinations
ATC	M05BB07	MUSCULO-SKELETAL SYSTEM DRUGS FOR TREATMENT OF BONE DISEASES DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION Bisphosphonates, combinations
ATC	M05BB08	MUSCULO-SKELETAL SYSTEM DRUGS FOR TREATMENT OF BONE DISEASES DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION Bisphosphonates, combinations
ATC	M05BB09	MUSCULO-SKELETAL SYSTEM DRUGS FOR TREATMENT OF BONE DISEASES DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION Bisphosphonates, combinations
ATC	M05BX53	MUSCULO-SKELETAL SYSTEM DRUGS FOR TREATMENT OF BONE DISEASES DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION Other drugs affecting bone structure and mineralization
CHEBI has role	CHEBI:77746	Homo sapiens metabolite

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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
Osteomalacia	indication	4598005	DOID:10573
Hypocalcemia	indication	5291005
Vitamin D deficiency	indication	34713006
Hypoparathyroidism	indication	36976004	DOID:11199
Rickets	indication	41345002	DOID:10609
Osteoporosis	indication	64859006	DOID:11476
Vitamin deficiency	indication	85670002
Postmenopausal osteoporosis	indication	102447009
Prevention of dental caries	indication	426482000
Glucocorticoid Induced Osteoporosis	indication

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🐶 Veterinary Drug Use

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🐶 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)

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Vitamin D3 receptor	Nuclear hormone receptor	P11473	VDR_HUMAN	AGONIST	EC50	9.68	CHEMBL	CHEMBL
Glycine receptor subunit alpha-1	Ion channel	P23415	GLRA1_HUMAN		EC50	6.40	CHEMBL
25-hydroxyvitamin D-1 alpha hydroxylase, mitochondrial	Enzyme	O15528	CP27B_HUMAN				WOMBAT-PK
Vitamin D 25-hydroxylase	Enzyme	Q6VVX0	CP2R1_HUMAN				WOMBAT-PK
Sterol 26-hydroxylase, mitochondrial	Enzyme	Q02318	CP27A_HUMAN				WOMBAT-PK
Vitamin D3 receptor	Nuclear hormone receptor		VDR_MOUSE		EC50	6.05	CHEMBL

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External reference:

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ID	Source
VD3	PDB_CHEM_ID
001014	NDDF
108943009	SNOMEDCT_US
1244014	RXNORM
1497	INN_ID
15676	MMSL
18414002	SNOMEDCT_US
199274	MMSL
1C6V77QF41	UNII
2747	IUPHAR_LIGAND_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
CitraNatal Harmony	HUMAN PRESCRIPTION DRUG LABEL	8	0178-0798	CAPSULE, GELATIN COATED	400 [iU]	ORAL	UNAPPROVED DRUG OTHER	11 sections
CitraNatal Harmony	HUMAN PRESCRIPTION DRUG LABEL	8	0178-0799	CAPSULE, GELATIN COATED	400 [iU]	ORAL	Unapproved drug other	11 sections
CitraNatal Harmony	HUMAN PRESCRIPTION DRUG LABEL	8	0178-0812	CAPSULE, GELATIN COATED	400 [iU]	ORAL	Unapproved drug other	11 sections
CitraNatal Harmony 3.0	HUMAN PRESCRIPTION DRUG LABEL	8	0178-0796	CAPSULE, GELATIN COATED	400 [iU]	ORAL	unapproved drug other	10 sections
CitraNatal Harmony 3.0	HUMAN PRESCRIPTION DRUG LABEL	8	0178-0796	CAPSULE, GELATIN COATED	400 [iU]	ORAL	unapproved drug other	10 sections
CitraNatal Medley	HUMAN PRESCRIPTION DRUG LABEL	8	0178-0896	CAPSULE, GELATIN COATED	200 [iU]	ORAL	unapproved drug other	10 sections
CitraNatal Medley	HUMAN PRESCRIPTION DRUG LABEL	8	0178-0896	CAPSULE, GELATIN COATED	200 [iU]	ORAL	unapproved drug other	10 sections
Dialyvite Supreme D	HUMAN PRESCRIPTION DRUG LABEL	13	10542-009	TABLET, COATED	2000 [iU]	ORAL	Unapproved drug other	7 sections
Dialyvite Supreme D	HUMAN PRESCRIPTION DRUG LABEL	13	10542-009	TABLET, COATED	2000 [iU]	ORAL	Unapproved drug other	7 sections
FOSAMAX PLUS D	HUMAN PRESCRIPTION DRUG LABEL	2	0006-0270	TABLET	5600 [iU]	ORAL	NDA	27 sections

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