prednisolone sodium phosphate Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
prednisone and prednisolone derivatives	4451	125-02-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: prednisolone sodium phosphate sodium prednisolone phosphate prednisolone phosphoric acid	Molecular weight: 440.43 Formula: C21H29O8P CLOGP: -0.05 LIPINSKI: 0 HAC: 8 HDO: 4 TPSA: 141.36 ALOGS: -3.01 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

prednisolone sodium phosphate
sodium prednisolone phosphate
prednisolone phosphoric acid

Molecular weight: 440.43
Formula: C21H29O8P
CLOGP: -0.05
LIPINSKI: 0
HAC: 8
HDO: 4
TPSA: 141.36
ALOGS: -3.01
ROTB: 4

Status: OFP

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

Drug dosage:

None

ADMET properties:

Property	Value	Reference
BA (Bioavailability)	82 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
Dec. 19, 1973	FDA	NOVARTIS

FDA Adverse Event Reporting System (Female)

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
Bedridden	89.44	37.50	26	1569	9133	46675334
Lower limb fracture	81.68	37.50	26	1569	12372	46672095
Foot fracture	70.03	37.50	26	1569	19556	46664911
Osteoporosis	63.86	37.50	30	1565	40578	46643889
Enterococcal sepsis	54.92	37.50	12	1583	1328	46683139
Hepatitis B reactivation	48.05	37.50	11	1584	1503	46682964
Meningitis cryptococcal	45.08	37.50	10	1585	1185	46683282
Mobility decreased	44.61	37.50	27	1568	60567	46623900
Loss of personal independence in daily activities	43.44	37.50	26	1569	57157	46627310
General physical health deterioration	43.39	37.50	34	1561	115735	46568732

FDA Adverse Event Reporting System (Male)

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
Choroiditis	155.51	33.50	27	1111	808	29950532
Endophthalmitis	133.26	33.50	30	1108	3450	29947890
Intraocular pressure increased	126.82	33.50	31	1107	5089	29946251
Uveitis	109.81	33.50	28	1110	5449	29945891
Visual acuity reduced	92.20	33.50	31	1107	15815	29935525
Eye pain	88.58	33.50	28	1110	11761	29939579
Condition aggravated	45.04	33.50	39	1099	137827	29813513
Hepatitis B reactivation	39.89	33.50	11	1127	2866	29948474
Meningomyelitis herpes	35.76	33.50	5	1133	33	29951307

Pharmacologic Action:

Source	Code	Description
CHEBI has role	CHEBI:50266	prodrugs
CHEBI has role	CHEBI:50857	anti-allergic agents
CHEBI has role	CHEBI:63562	glucocorticoid receptor agonists
CHEBI has role	CHEBI:66981	ophthalmologicals
CHEBI has role	CHEBI:67079	antiinflammatory agents
MeSH PA	D005938	Glucocorticoids
MeSH PA	D006728	Hormones

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Blepharoconjunctivitis	indication	68659002	DOID:2456
Iridocyclitis	indication	77971008
Bacterial conjunctivitis	indication	128350005	DOID:9700
Uveitis	indication	128473001	DOID:13141
Infective blepharitis	indication	312219000
Superficial Ocular Infection	indication
Ocular hypertension	contraindication	4210003	DOID:9282
Herpes simplex keratitis	contraindication	9389005
Herpes simplex dendritic keratitis	contraindication	29943008
Fungal infection of eye	contraindication	31194008
Severe myopia	contraindication	34187009
Tuberculosis of eye	contraindication	49107007
Diabetes mellitus	contraindication	73211009	DOID:9351
Open-angle glaucoma	contraindication	84494001	DOID:1067
Krukenberg spindle	contraindication	85430004
Anemia due to enzyme deficiency	contraindication	111577008
Deficiency of glucose-6-phosphate dehydrogenase	contraindication	124134002	DOID:2862
Eye infection	contraindication	128351009
Bacterial infection of eye	contraindication	128984004
Viral eye infection	contraindication	312132001
Vaccinia keratitis	contraindication	397552005
Porphyria	contraindication	418470004

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	1.75	acidic
pKa2	6.8	acidic
pKa3	12.78	acidic
pKa4	13.76	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN	AGONIST				DRUG LABEL	DRUG LABEL

External reference:

ID	Source
D00981	KEGG_DRUG
4017987	VUID
N0000146333	NUI
4017987	VANDF
C0138273	UMLSCUI
CHEBI:8379	CHEBI
CHEMBL1201231	ChEMBL_ID
CHEMBL1201014	ChEMBL_ID
C009022	MESH_SUPPLEMENTAL_RECORD_UI
IV021NXA9J	UNII
72078	PUBCHEM_CID
DB14631	DRUGBANK_ID
55062	RXNORM
16516	MMSL
44390	MMSL
5349	MMSL
002157	NDDF
96335004	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Prednisolone Sodium Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	0121-0759	SOLUTION	15 mg	ORAL	ANDA	20 sections
Prednisolone Sodium Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	0121-0773	SOLUTION	10 mg	ORAL	ANDA	20 sections
Prednisolone Sodium Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	0121-0777	SOLUTION	20 mg	ORAL	ANDA	20 sections
Prednisolone Sodium Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	0121-0902	SOLUTION	5 mg	ORAL	ANDA	17 sections
Prednisolone Sodium Phosphate Oral Solution	HUMAN PRESCRIPTION DRUG LABEL	1	0178-0582	SOLUTION	25 mg	ORAL	ANDA	16 sections
Prednisolone Sodium Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	11695-1431	SOLUTION/ DROPS	10 mg	OPHTHALMIC	ANDA	14 sections
Prednisolone Sodium Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	13925-166	SOLUTION	5 mg	ORAL	NDA	17 sections
PREDNISOLONE SODIUM PHOSPHATE	HUMAN PRESCRIPTION DRUG LABEL	1	13985-025	SOLUTION/ DROPS	10 mg	OPHTHALMIC	ANDA	14 sections
Prednisolone Sodium Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	17856-0759	SOLUTION	15 mg	ORAL	ANDA	19 sections
Sulfacetamide Sodium and Prednisolone Sodium Phosphate	HUMAN PRESCRIPTION DRUG LABEL	2	21695-186	SOLUTION	2.50 mg	OPHTHALMIC	ANDA	18 sections
Sulfacetamide Sodium and Prednisolone Sodium Phosphate	HUMAN PRESCRIPTION DRUG LABEL	2	24208-317	SOLUTION/ DROPS	2.30 mg	OPHTHALMIC	ANDA	20 sections
PREDNISOLONE SODIUM PHOSPHATE	HUMAN PRESCRIPTION DRUG LABEL	1	24208-715	SOLUTION/ DROPS	10 mg	OPHTHALMIC	ANDA	14 sections
Prednisolone Sodium Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	42254-102	SOLUTION	15 mg	ORAL	ANDA	11 sections
Prednisolone Sodium Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	42799-812	SOLUTION	10 mg	ORAL	ANDA	20 sections
Prednisolone Sodium Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	42799-813	SOLUTION	20 mg	ORAL	ANDA	20 sections
Prednisolone Sodium Phosphate Oral Solution	HUMAN PRESCRIPTION DRUG LABEL	1	44523-182	SOLUTION	25 mg	ORAL	ANDA	16 sections
Prednisolone Sodium Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	50090-0955	SOLUTION	15 mg	ORAL	ANDA	10 sections
Prednisolone Sodium Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	50090-1582	SOLUTION	15 mg	ORAL	ANDA	19 sections
Prednisolone Sodium Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	50383-040	SOLUTION	5 mg	ORAL	ANDA	19 sections
Prednisolone Sodium Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	50436-0759	SOLUTION	15 mg	ORAL	ANDA	19 sections
Sulfacetamide Sodium and Prednisolone Sodium Phosphate	HUMAN PRESCRIPTION DRUG LABEL	2	53002-8690	SOLUTION/ DROPS	2.30 mg	OPHTHALMIC	ANDA	19 sections
Prednisolone Sodium Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	54868-5242	SOLUTION	15 mg	ORAL	ANDA	11 sections
OrapredODT	Human Prescription Drug Label	1	59212-700	TABLET, ORALLY DISINTEGRATING	10 mg	ORAL	NDA	25 sections
OrapredODT	Human Prescription Drug Label	1	59212-701	TABLET, ORALLY DISINTEGRATING	15 mg	ORAL	NDA	25 sections
OrapredODT	Human Prescription Drug Label	1	59212-702	TABLET, ORALLY DISINTEGRATING	30 mg	ORAL	NDA	25 sections
Prednisolone Sodium Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	60432-212	SOLUTION	15 mg	ORAL	ANDA	10 sections
Prednisolone Sodium Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	62135-330	SOLUTION	5 mg	ORAL	ANDA	16 sections
Prednisolone Sodium Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	63187-215	SOLUTION	15 mg	ORAL	ANDA	20 sections
Prednisolone Sodium Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	65162-667	SOLUTION	15 mg	ORAL	ANDA	12 sections
Prednisolone Sodium PhosphateODT	Human Prescription Drug Label	1	66993-844	TABLET, ORALLY DISINTEGRATING	10 mg	ORAL	NDA AUTHORIZED GENERIC	25 sections