Prednisolone tebutate

Blephamide, Cetapred, Chloroptic-p, Cortalone, Delta-cortef, Fernisolone-p, Hydeltra-tba, Meti-derm, Metimyd, Neo-delta-cortef, Neo-hydeltrasol, Pred, Prelone, Sterane, Sulphrin, Sulster, 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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Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
neoplasms	D009369
musculoskeletal diseases	D009140
digestive system diseases	D004066
respiratory tract diseases	D012140
nervous system diseases	D009422
eye diseases	D005128
urogenital diseases	D000091642
hemic and lymphatic diseases	D006425
hereditary congenital and neonatal diseases and abnormalities	D009358

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Trade Name

FDA

EMA

Omnipred, Orapred, Pediapred, Pred, Pred mild (generic drugs available since 1982-01-01, discontinued: Cortalone, Delta-cortef, Econopred, Fernisolone-p, Flo-pred, Hydeltra-tba, Hydeltrasol, Inflamase, Inflamase mild, Meti-derm, Meticortelone, Metreton, Predair, Prelone, Sterane)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Gentamicin sulfate

Prednisolone acetate

Tradename	Company	Number	Date	Products
PRED-G	Allergan	N-050586 DISCN	1988-06-10	1 products, RLD
PRED-G	Allergan	N-050612 DISCN	1989-12-01	1 products, RLD

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Neomycin sulfate

Polymyxin b sulfate

Prednisolone acetate

Tradename	Company	Number	Date	Products
POLY-PRED	Allergan	N-050081 DISCN	1982-01-01	1 products

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Neomycin sulfate

Prednisolone sodium phosphate

Tradename	Company	Number	Date	Products
NEO-HYDELTRASOL	Merck KGaA	N-050378 DISCN	1982-01-01	1 products

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Prednisolone

Tradename	Company	Number	Date	Products
STERANE	Mylan	N-009996 DISCN	1982-01-01	1 products
DELTA-CORTEF	Pharmacia & Upjohn	N-009987 DISCN	1982-01-01	1 products
METI-DERM	Merck Sharp & Dohme	N-010209 DISCN	1982-01-01	1 products

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Prednisolone acetate

Tradename	Company	Number	Date	Products
PRED FORTE	AbbVie	N-017011 RX	1982-01-01	1 products, RLD, RS
PRED MILD	AbbVie	N-017100 RX	1982-01-01	1 products, RLD, RS
OMNIPRED	Novartis	N-017469 RX	1982-01-01	1 products, RLD, RS

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Prednisolone acetate

Sulfacetamide sodium

Tradename	Company	Number	Date	Products
BLEPHAMIDE	Allergan	N-012813 DISCN	1982-01-01	1 products, RLD
METIMYD	Merck Sharp & Dohme	N-010210 DISCN	1982-01-01	2 products

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Prednisolone sodium phosphate

Tradename	Company	Number	Date	Products
ORAPRED ODT	Concordia Laboratories	N-021959 RX	2006-06-01	3 products, RLD, RS
PEDIAPRED	Seton Pharmaceuticals	N-019157 RX	1986-05-28	1 products, RLD, RS

Show 2 discontinued

Prednisolone sodium phosphate

Sulfacetamide sodium

Tradename	Company	Number	Date	Products
VASOCIDIN	Novartis	N-018988 DISCN	1988-08-26	1 products, RLD

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Prednisolone tebutate

Tradename	Company	Number	Date	Products
HYDELTRA-TBA	Merck KGaA	N-010562 DISCN	1982-01-01	1 products

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Labels

FDA

EMA

Brand Name	Status	Last Update
blephamide	New Drug Application	2013-11-15
econopred		2006-09-11
orapred	New Drug Application	2022-02-16
pediapred	New Drug Application	2020-01-29
prednisolone sodium phosphate	ANDA	2023-05-25

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
adrenal insufficiency	—	D000309	—
ankylosing spondylitis	EFO_0003898	D013167	M45
asthma	EFO_0000270	D001249	J45
atopic dermatitis	EFO_0000274	D003876	L20
berylliosis	EFO_0007168	D001607	J63.2
brain neoplasms	EFO_0003833	D001932	C71
collagen diseases	—	D003095	—
conjunctivitis	—	D003231	H10
dermatitis herpetiformis	—	D003874	L13.0
edema	—	D004487	R60.9

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Agency Specific

FDA

EMA

Expiration	Code
PREDNISOLONE, PREDNISOLONE, AUROBINDO PHARMA LTD
2023-11-18	CGT

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

— 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

No data

Clinical

Clinical Trials

57 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Post-traumatic stress disorders	D013313	EFO_0001358	F43.1	1	2	3	4	10	20
Alcoholism	D000437	EFO_0003829	F10.1	3	6	1	1	3	12
Suicidal ideation	D059020	EFO_0004320	R45.851	—	—	—	1	1	2
Dreams	D004325			—	—	—	1	1	2
Post-traumatic headache	D051298		G44.3	1	1	—	1	—	2
Allergic rhinitis	D065631		J30.9	—	—	—	1	—	1
Tachyphylaxis	D013618			—	—	—	1	—	1
Liver cirrhosis	D008103	EFO_0001422	K74.0	—	—	—	1	—	1
Portal hypertension	D006975	EFO_0000666	K76.6	—	—	—	1	—	1
Gastrointestinal hemorrhage	D006471		K92.2	—	—	—	1	—	1

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Sleep wake disorders	D012893		G47	—	—	1	—	3	4
Scorpion stings	D065008			—	—	1	—	—	1
Kidney calculi	D007669	EFO_0004253	N20.0	—	—	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hypertension	D006973	EFO_0000537	I10	2	1	—	—	—	3
Alzheimer disease	D000544	EFO_0000249	F03	—	1	—	—	2	3
Combat disorders	D003130			1	1	—	—	2	3
Fibrosis	D005355			—	1	—	—	—	1
Chronic hepatitis c	D019698	EFO_0004220	B18.2	—	1	—	—	—	1
Alcohol withdrawal delirium	D000430	EFO_1000800		1	1	—	—	—	1
Problem behavior	D000066553			—	1	—	—	—	1
Traumatic stress disorders acute	D040701	EFO_0005223	F43.0	—	1	—	—	—	1
Neurogenic urinary bladder	D001750	HP_0000011	N31	1	1	—	—	—	1
Covid-19	D000086382		U07.1	—	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Anxiety disorders	D001008	EFO_0006788	F41.1	1	—	—	—	1	2
Healthy volunteers/patients	—			1	—	—	—	1	2
Cigarette smoking	D000073865			1	—	—	—	—	1
Cardiovascular diseases	D002318	EFO_0000319	I98	1	—	—	—	—	1
Anxiety	D001007	EFO_0005230	F41.1	1	—	—	—	—	1
Heart failure	D006333	EFO_0003144	I50	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Sleep initiation and maintenance disorders	D007319		F51.01	—	—	—	—	2	2
Wounds and injuries	D014947		T14.8	—	—	—	—	1	1
Pain	D010146	EFO_0003843	R52	—	—	—	—	1	1
Substance-related disorders	D019966	EFO_0003890	F13	—	—	—	—	1	1
Chronic disease	D002908			—	—	—	—	1	1
Brain injuries	D001930		S06.9	—	—	—	—	1	1
Alcohol-related disorders	D019973		F10	—	—	—	—	1	1
Depression	D003863		F33.9	—	—	—	—	1	1
Cognitive dysfunction	D060825		G31.84	—	—	—	—	1	1
Mood disorders	D019964	EFO_0004247	F30-F39	—	—	—	—	1	1

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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	34376
ChEMBL ID	CHEMBL1200909
ChEBI ID	8381
PubChem CID	93055
DrugBank	DB14632
UNII ID	9PHQ9Y1OLM (ChemIDplus, GSRS)

Target

Agency Approved

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Alternate

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Variants

Clinical Variant

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Financial

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Trends

PubMed Central

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Safety

Black-box Warning

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Adverse Events

Top Adverse Reactions

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1,338 adverse events reported

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