prednisolone sodium phosphate 🐶 Veterinary Use | 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
  • prednisolone phosphate
  • 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 106.82 35.73 31 1972 9336 50593785
Hepatitis B reactivation 101.07 35.73 22 1981 2065 50601056
Lower limb fracture 94.01 35.73 31 1972 14215 50588906
Foot fracture 83.58 35.73 31 1972 20060 50583061
Osteoporosis 74.39 35.73 36 1967 44843 50558278
Loss of personal independence in daily activities 61.94 35.73 37 1966 70013 50533108
Enterococcal sepsis 53.74 35.73 12 1991 1263 50601858
Keratopathy 52.96 35.73 10 1993 458 50602663
Immobile 45.72 35.73 14 1989 5040 50598081
Mobility decreased 45.41 35.73 32 1971 79916 50523205
Meningitis cryptococcal 44.04 35.73 10 1993 1135 50601986
General physical health deterioration 42.35 35.73 39 1964 142395 50460726
Therapeutic product effect incomplete 41.54 35.73 32 1971 91483 50511638

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 232.46 38.48 39 1089 949 29572450
Endophthalmitis 191.24 38.48 39 1089 2809 29570590
Intraocular pressure increased 187.36 38.48 42 1086 4747 29568652
Uveitis 162.64 38.48 39 1089 5908 29567491
Eye pain 141.34 38.48 40 1088 11555 29561844
Visual acuity reduced 140.12 38.48 42 1086 14834 29558565
Condition aggravated 70.62 38.48 52 1076 146243 29427156
Hepatitis B reactivation 38.59 38.48 11 1117 3218 29570181

FDA Adverse Event Reporting System (Geriatric)

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 211.65 25.61 38 3147 1049 64494498
Intraocular pressure increased 157.77 25.61 43 3142 8259 64487288
Endophthalmitis 156.18 25.61 39 3146 5326 64490221
Uveitis 118.78 25.61 38 3147 12670 64482877
Visual acuity reduced 111.25 25.61 44 3141 27097 64468450
Eye pain 98.08 25.61 42 3143 31583 64463964
Chorioretinopathy 89.76 25.61 21 3164 2176 64493371
Bedridden 85.37 25.61 28 3157 10081 64485466
Hepatitis B reactivation 77.59 25.61 22 3163 4867 64490680
Lower limb fracture 77.35 25.61 28 3157 13517 64482030
Condition aggravated 73.74 25.61 91 3094 372335 64123212
Foot fracture 69.37 25.61 28 3157 18129 64477418
Osteoporosis 57.72 25.61 32 3153 42048 64453499
Osteonecrosis 54.52 25.61 27 3158 28202 64467345
Keratopathy 51.26 25.61 11 3174 769 64494778
Loss of personal independence in daily activities 46.28 25.61 34 3151 72420 64423127
Pneumocystis jirovecii pneumonia 46.26 25.61 24 3161 27610 64467937
Enterococcal sepsis 43.10 25.61 12 3173 2482 64493065
Post transplant lymphoproliferative disorder 40.91 25.61 16 3169 9528 64486019
Immobile 36.45 25.61 13 3172 6002 64489545
Hypogammaglobulinaemia 32.95 25.61 14 3171 10285 64485262
Hyponatraemic seizure 32.55 25.61 7 3178 494 64495053
Strongyloidiasis 31.99 25.61 10 3175 3080 64492467
Meningomyelitis herpes 31.69 25.61 5 3180 61 64495486
Mobility decreased 31.10 25.61 29 3156 85811 64409736
Hyperglycaemia 28.90 25.61 24 3161 60944 64434603
Hirsutism 27.93 25.61 7 3178 966 64494581
Tonsillar disorder 27.73 25.61 7 3178 994 64494553
Therapeutic product effect incomplete 26.55 25.61 29 3156 103453 64392094
Heart sounds 25.87 25.61 6 3179 597 64494950

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
FDA MoA N0000175450 Corticosteroid Hormone Receptor Agonists
FDA EPC N0000175576 Corticosteroid
MeSH PA D005938 Glucocorticoids
MeSH PA D006728 Hormones
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000970 Antineoplastic Agents
MeSH PA D018931 Antineoplastic Agents, Hormonal
CHEBI has role CHEBI:35472 anti-inflammatory drugs
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:35705 immunosuppressive agents
CHEBI has role CHEBI:37962 adrenergic agents
CHEBI has role CHEBI:49103 drug metabolites
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:50266 Prodrugs
CHEBI has role CHEBI:50857 anti-allergic drugs
CHEBI has role CHEBI:63562 glucocorticoid receptor agonists
CHEBI has role CHEBI:66981 ophthalmology drugs
CHEBI has role CHEBI:67079 anti-inflammatory agents

Drug Use | Suggest Off label Use Form| |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




🐶 Veterinary Drug Use

SpeciesUseRelation
Cats Superficial ocular inflammations or infections limited to the conjunctiva or the anterior segment of the eye, such as those associated with allergic reactions or gross irritants Indication
Dogs Superficial ocular inflammations or infections limited to the conjunctiva or the anterior segment of the eye, such as those associated with allergic reactions or gross irritants Indication
Dogs Treatment when a rapid adrenal glucocorticoid and/or anti-inflammatory effect is necessary Indication

🐶 Veterinary products

ProductApplicantIngredients
Hydeltrone Ointment Boehringer lngelheim Animal Health USA Inc. 2
Prednis-A-Vet Injection Bimeda Animal Health Limited 1

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
4017988 VANDF
CHEBI:8379 CHEBI
CHEBI:8378 CHEBI
TUA PDB_CHEM_ID
CHEMBL1201014 ChEMBL_ID
C009022 MESH_SUPPLEMENTAL_RECORD_UI
IV021NXA9J UNII
441409 PUBCHEM_CID
5755 PUBCHEM_CID
DB14631 DRUGBANK_ID
DB00860 DRUGBANK_ID
34374 RXNORM
16516 MMSL
37825 MMSL
44390 MMSL
5347 MMSL
5349 MMSL
59710 MMSL
d00084 MMSL
002155 NDDF
002157 NDDF
116601002 SNOMEDCT_US
52388000 SNOMEDCT_US
96335004 SNOMEDCT_US
C0138273 UMLSCUI
C0032950 UMLSCUI
CHEMBL1201231 ChEMBL_ID
D011239 MESH_DESCRIPTOR_UI
535 INN_ID

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 24 sections
OrapredODT Human Prescription Drug Label 1 59212-701 TABLET, ORALLY DISINTEGRATING 15 mg ORAL NDA 24 sections
OrapredODT Human Prescription Drug Label 1 59212-702 TABLET, ORALLY DISINTEGRATING 30 mg ORAL NDA 24 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 24 sections