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
S (Water solubility) 0.22 mg/mL Bocci G, Oprea TI, Benet LZ

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
Hepatitis B reactivation 275.04 30.78 54 2446 3083 63483439
Acute hepatic failure 142.10 30.78 45 2455 18282 63468240
Bedridden 123.65 30.78 36 2464 11015 63475507
Foot fracture 100.03 30.78 37 2463 23877 63462645
Lower limb fracture 99.57 30.78 37 2463 24184 63462338
Osteoporosis 83.35 30.78 42 2458 57296 63429226
Loss of personal independence in daily activities 70.03 30.78 45 2455 97245 63389277
Immobile 64.84 30.78 19 2481 5924 63480598
Hyponatraemic seizure 53.55 30.78 10 2490 433 63486089
Enterococcal sepsis 52.53 30.78 12 2488 1406 63485116
Keratopathy 50.26 30.78 10 2490 606 63485916
Therapeutic product effect incomplete 46.86 30.78 39 2461 125017 63361505
Fracture 45.96 30.78 20 2480 19564 63466958
Mobility decreased 45.85 30.78 38 2462 121121 63365401
Heart sounds 45.47 30.78 10 2490 986 63485536
Prolonged expiration 44.52 30.78 10 2490 1086 63485436
Tonsillar disorder 44.01 30.78 10 2490 1143 63485379
Meningitis cryptococcal 42.25 30.78 10 2490 1367 63485155
General physical health deterioration 41.33 30.78 45 2455 201357 63285165
Oesophageal disorder 36.84 30.78 10 2490 2363 63484159
Respiration abnormal 34.61 30.78 12 2488 6405 63480117
Osteonecrosis 32.77 30.78 17 2483 24513 63462009
Depressive symptom 31.44 30.78 10 2490 4092 63482430

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 279.08 37.88 47 1290 1168 34954426
Intraocular pressure increased 231.31 37.88 51 1286 5332 34950262
Endophthalmitis 217.58 37.88 45 1292 3463 34952131
Uveitis 193.55 37.88 47 1290 7488 34948106
Visual acuity reduced 171.23 37.88 50 1287 16099 34939495
Eye pain 171.05 37.88 48 1289 13414 34942180
Condition aggravated 83.08 37.88 64 1273 192132 34763462
Product use issue 43.25 37.88 28 1309 63188 34892406

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 257.45 26.02 46 3607 1335 79739400
Intraocular pressure increased 199.16 26.02 52 3601 9153 79731582
Endophthalmitis 181.89 26.02 45 3608 6383 79734352
Uveitis 147.25 26.02 47 3606 16783 79723952
Visual acuity reduced 139.56 26.02 52 3601 29417 79711318
Eye pain 120.49 26.02 50 3603 37528 79703207
Chorioretinopathy 90.99 26.02 21 3632 2210 79738525
Bedridden 86.48 26.02 29 3624 12050 79728685
Hepatitis B reactivation 74.37 26.02 22 3631 6086 79734649
Condition aggravated 73.95 26.02 102 3551 501022 79239713
Foot fracture 69.57 26.02 29 3624 21952 79718783
Lower limb fracture 68.04 26.02 29 3624 23186 79717549
Osteoporosis 55.04 26.02 33 3620 54079 79686656
Osteonecrosis 53.95 26.02 27 3626 31068 79709667
Hyponatraemic seizure 49.79 26.02 10 3643 545 79740190
Keratopathy 47.41 26.02 11 3642 1183 79739552
Loss of personal independence in daily activities 46.28 26.02 38 3615 102542 79638193
Pneumocystis jirovecii pneumonia 44.28 26.02 24 3629 32484 79708251
Heart sounds 44.26 26.02 10 3643 956 79739779
Enterococcal sepsis 42.93 26.02 12 3641 2714 79738021
Tonsillar disorder 41.57 26.02 10 3643 1256 79739479
Prolonged expiration 41.53 26.02 10 3643 1261 79739474
Immobile 39.27 26.02 14 3639 6959 79733776
Post transplant lymphoproliferative disorder 39.22 26.02 16 3637 11448 79729287
Oesophageal disorder 34.19 26.02 10 3643 2657 79738078
Cytomegalovirus infection 30.88 26.02 21 3632 42623 79698112
Hypogammaglobulinaemia 30.87 26.02 14 3639 12937 79727798
Meningomyelitis herpes 30.62 26.02 5 3648 83 79740652
Respiration abnormal 30.56 26.02 12 3641 7776 79732959
Strongyloidiasis 30.45 26.02 10 3643 3888 79736847
Hepatic failure 28.26 26.02 23 3630 61189 79679546
Hyperglycaemia 27.48 26.02 24 3629 70311 79670424
Appetite disorder 27.15 26.02 11 3642 7728 79733007
Mobility decreased 26.05 26.02 30 3623 122145 79618590

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
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
535 INN_ID
5755 PUBCHEM_CID
D011239 MESH_DESCRIPTOR_UI

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 0121-0759 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 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 16 sections
PREDNISOLONE SODIUM PHOSPHATE HUMAN PRESCRIPTION DRUG LABEL 1 24208-715 SOLUTION/ DROPS 10 mg OPHTHALMIC ANDA 16 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 42799-812 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 Human Prescription Drug Label 1 42799-813 SOLUTION 20 mg ORAL ANDA 20 sections
Prednisolone Sodium Phosphate Human Prescription Drug Label 1 42799-815 SOLUTION 15 mg ORAL ANDA 20 sections
Prednisolone Sodium Phosphate Human Prescription Drug Label 1 42799-816 SOLUTION 25 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 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 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