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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Abbreviated New Drug Application (ANDA)
Prednisolone tebutate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| HYDELTRA-TBA | Merck & Co | N-010562 DISCN | 1982-01-01 | 1 products |
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EMA
Brand Name | Status | Last Update |
|---|---|---|
| blephamide | New Drug Application | 2013-11-15 |
| econopred | 2006-09-11 | |
| orapred | New Drug Application | 2025-06-03 |
| pediapred | New Drug Application | 2024-02-01 |
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Agency Specific
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Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Prednisolone Acetate, Flo-Pred, Taro | |||
| 7799331 | 2028-10-11 | DP | U-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
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney transplantation | D016030 | — | — | — | — | 1 | 4 | — | 5 |
| Liver transplantation | D016031 | EFO_0010682 | — | — | — | 1 | 2 | — | 3 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | 1 | 1 | 1 | — | 2 |
| Neoplasms | D009369 | — | C80 | — | 1 | — | 1 | — | 2 |
| Infections | D007239 | EFO_0000544 | — | — | — | 1 | 1 | — | 2 |
| Healthy volunteers/patients | — | — | — | 1 | 1 | — | 1 | — | 2 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | — | 1 | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | — | 1 | — | 1 |
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | — | — | — | 1 | — | 1 |
| Renal replacement therapy | D017582 | — | — | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | — | 2 | 1 | — | — | 3 |
| Intermediate uveitis | D015867 | EFO_1000986 | — | — | — | 1 | — | — | 1 |
| Follicular lymphoma | D008224 | — | C82 | — | — | 1 | — | — | 1 |
| Prostatic neoplasms | D011471 | — | C61 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 1 | 3 | — | — | — | 3 |
| Giant cell arteritis | D013700 | EFO_1001209 | M31.6 | — | 2 | — | — | 1 | 3 |
| Polymyalgia rheumatica | D011111 | EFO_0008518 | M35.3 | — | 2 | — | — | 1 | 3 |
| Arteritis | D001167 | EFO_0009011 | I77.6 | — | 1 | — | — | 1 | 2 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | — | 2 | — | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Stomatitis | D013280 | EFO_1001904 | K12.1 | — | 1 | — | — | — | 1 |
| Oral ulcer | D019226 | — | — | — | 1 | — | — | — | 1 |
| Animal mammary neoplasms | D015674 | — | — | — | 1 | — | — | — | 1 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Prednisolone tebutate |
| INN | prednisolone |
| Description | Prednisolone tebutate is a corticosteroid hormone. |
| Classification | Small molecule |
| Drug class | steroids (not prednisolone derivatives); prednisone and prednisolone derivatives |
| Image (chem structure or protein) |  |
| 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-ID | 7681-14-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200909 |
| ChEBI ID | 8381 |
| PubChem CID | 93055 |
| DrugBank | DB14632 |
| UNII ID | 9PHQ9Y1OLM (ChemIDplus, GSRS) |
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665 adverse events reported
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