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

Stem definitionDrug idCAS RN
prednisone and prednisolone derivatives 4451 125-02-0

Description:

MoleculeDescription

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:

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

Approvals:

DateAgencyCompanyOrphan
Dec. 19, 1973 FDA NOVARTIS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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)

DiseaseRelationSNOMED_IDDOID
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 levelDissociation constantType (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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Glucocorticoid receptor Nuclear hormone receptor AGONIST DRUG LABEL DRUG LABEL

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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