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Drug ReportsPrednisolone tebutate
Prednisolone tebutate
Blephamide, Cetapred, Chloroptic-p, Hydeltra-tba, Metimyd, Neo-delta-cortef, Neo-hydeltrasol, Pred, Prednisolone, Prelone, Sulphrin, Vasocidin (prednisolone tebutate) is a small molecule pharmaceutical. Prednisolone tebutate was first approved as Chloroptic-p s.o.p. on 1982-01-01. It is used to treat adrenal insufficiency, ankylosing spondylitis, asthma, atopic dermatitis, and berylliosis amongst others in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
neoplasmsD009369
musculoskeletal diseasesD009140
digestive system diseasesD004066
respiratory tract diseasesD012140
nervous system diseasesD009422
eye diseasesD005128
urogenital diseasesD000091642
hemic and lymphatic diseasesD006425
hereditary congenital and neonatal diseases and abnormalitiesD009358
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Prednisolone tebutate
Tradename
Company
Number
Date
Products
HYDELTRA-TBAMerck & CoN-010562 DISCN1982-01-01
1 products
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FDA
EMA
Brand Name
Status
Last Update
blephamideNew Drug Application2013-11-15
econopred2006-09-11
orapredNew Drug Application2025-06-03
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
leukemia—D007938C95
brain neoplasmsEFO_0003833D001932C71
atopic dermatitisEFO_0000274D003876L20
ulcerative colitisEFO_0000729D003093K51
ankylosing spondylitisEFO_0003898D013167M45
nephrotic syndromeEFO_0004255D009404N04
multiple sclerosisEFO_0003885D009103G35
uveitisEFO_1001231D014605H20.9
sarcoidosisEFO_0000690D012507D80-D89
inflammationMP_0001845D007249—
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Agency Specific
FDA
EMA
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Patent Expiration
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FDA Information
Prednisolone Acetate, Flo-Pred, Taro
77993312028-10-11DPU-139, U-1068
ATC Codes
A: Alimentary tract and metabolism drugs
— A01: Stomatological preparations
— A01A: Stomatological preparations
— A01AC: Corticosteroids for local oral treatment
— A01AC04: Prednisolone
— A01AC54: Prednisolone, combinations
— A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
— A07E: Intestinal antiinflammatory agents
— A07EA: Corticosteroids acting locally
— A07EA01: Prednisolone
C: Cardiovascular system drugs
— C05: Vasoprotectives
— C05A: Agents for treatment of hemorrhoids and anal fissures for topical use
— C05AA: Corticosteroids, topical for treatment of hemorrhoids and anal fissures
— C05AA04: Prednisolone
D: Dermatologicals
— D07: Corticosteroids, dermatological preparations
— D07A: Corticosteroid dermatological preparations, plain
— D07AA: Corticosteroids, weak (group i)
— D07AA03: Prednisolone
— D07B: Corticosteroids, combinations with antiseptics
— D07BA: Corticosteroids, weak, combinations with antiseptics
— D07BA01: Prednisolone and antiseptics
— D07C: Corticosteroids, combinations with antibiotics
— D07CA: Corticosteroids, weak, combinations with antibiotics
— D07CA03: Prednisolone and antibiotics
— D07X: Corticosteroids, other combinations
— D07XA: Corticosteroids, weak, other combinations
— D07XA02: Prednisolone
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H02: Corticosteroids for systemic use
— H02A: Corticosteroids for systemic use, plain
— H02AB: Glucocorticoids, systemic
— H02AB06: Prednisolone
R: Respiratory system drugs
— R01: Nasal preparations
— R01A: Decongestants and other nasal preparations for topical use
— R01AD: Corticosteroid nasal preparations for topical use
— R01AD02: Prednisolone
— R01AD52: Prednisolone, combinations
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01B: Antiinflammatory agents, ophthalmologic
— S01BA: Corticosteroid ophthalmologic antiinflammatory agents, plain
— S01BA04: Prednisolone
— S01BB: Corticosteroids and mydriatics in combination
— S01BB02: Prednisolone and mydriatics
— S01C: Antiinflammatory agents and antiinfectives in combination
— S01CA: Corticosteroids and antiinfectives in combination, opthalmologic
— S01CA02: Prednisolone and antiinfectives
— S01CB: Corticosteroids/antiinfectives/mydriatics in combination
— S01CB02: Prednisolone
— S02: Otologicals
— S02B: Corticosteroid otologicals
— S02BA: Corticosteroids
— S02BA03: Prednisolone
— S02C: Corticosteroids and antiinfectives in combination, otologic
— S02CA: Corticosteroids and antiinfectives in combination
— S02CA01: Prednisolone and antiinfectives
— S03: Ophthalmological and otological preparations
— S03B: Corticosteroid ophthalmologic and otologic preparations
— S03BA: Corticosteroids
— S03BA02: Prednisolone
— S03C: Corticosteroids and antiinfectives in combination, opthalmologic and otologic
— S03CA: Corticosteroids and antiinfectives in combination
— S03CA02: Prednisolone and antiinfectives
V: Various drug classes in atc
— V03: All other therapeutic products
— V03A: All other therapeutic products
— V03AB: Antidotes
— V03AB05: Prednisolone and promethazine
HCPCS
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Clinical
Clinical Trials
2278 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InflammationD007249MP_0001845———1113
ConjunctivitisD003231—H10———1—1
Allergic conjunctivitisD003233EFO_0007141H10.44———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CataractD002386EFO_0001059H26.9—12—14
UveitisD014605EFO_1001231H20.9——1—12
Postoperative complicationsD011183————1——1
Eye infectionsD015817EFO_1001888———1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePrednisolone tebutate
INNprednisolone
Description
Prednisolone tebutate is a corticosteroid hormone.
Classification
Small molecule
Drug classsteroids (not prednisolone derivatives); prednisone and prednisolone derivatives
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(C)(C)CC(=O)OCC(=O)[C@@]1(O)CC[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)[C@H]3[C@@H](O)C[C@@]21C
Identifiers
PDB—
CAS-ID7681-14-3
RxCUI—
ChEMBL IDCHEMBL1200909
ChEBI ID8381
PubChem CID93055
DrugBankDB14632
UNII ID9PHQ9Y1OLM (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
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Trends
PubMed Central
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Additional graphs summarizing 742 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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698 adverse events reported
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