Vosol hc, Plenadren(hydrocortisone)

Achromycin, Alkindi, Alphaderm, Calmurid, Casporyn, Cipro, Coly-mycin, Cor-oticin, Cortef, Cortenema, Cortifoam, Cortisporin, Efmody, Hydrocortone, Neo-cort-dome, Neo-cortef, Ophthocort, Otobiotic, Plenadren, Pramosone, Pyocidin, Solu-cortef, Terra-cortril, Vosol, Westcort, Xerese (hydrocortisone) is a small molecule pharmaceutical. Hydrocortisone was first approved as Vosol hc on 1982-01-01. It is used to treat adrenal insufficiency, congenital adrenal hyperplasia, contact dermatitis, facial dermatoses, and foot dermatoses amongst others in the USA. It has been approved in Europe to treat adrenal insufficiency and congenital adrenal hyperplasia. The pharmaceutical is active against glucocorticoid receptor. In addition, it is known to target mineralocorticoid receptor.

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Therapeutic Areas

Therapeutic Area	MeSH
musculoskeletal diseases	D009140
digestive system diseases	D004066
respiratory tract diseases	D012140
urogenital diseases	D000091642
cardiovascular diseases	D002318
hereditary congenital and neonatal diseases and abnormalities	D009358
skin and connective tissue diseases	D017437
nutritional and metabolic diseases	D009750
endocrine system diseases	D004700
immune system diseases	D007154

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Trade Name

FDA

EMA

Alkindi, Cortef, Cortenema, Cortifoam, Solu-cortef (generic drugs available since 1982-01-01, discontinued: , A-hydrocort, Acticort, Aeroseb-hc, Ala-cort, Balneol-hc, Beta-hc, Carmol, Cetacort, Cort-dome, Cortef, Cortril, Dermacort, Dricort, Eldecort, Epicort, Flexicort, Glycort, H-cort, Hemsol-hc, Hi-cor, Hydro-rx, Hydrocortone, Hytone, Micort-hc, Nogenic, Nutracort, Orabase hca, Penecort, Proctocort, Stie-cort, Synacort, Texacort, U-cort, Westcort)

Combinations

Casporyn, Cipro, Coly-mycin, Vosol, Xerese (generic drugs available since 1982-01-01, discontinued: Acetasol, Achromycin, Alphaderm, Calmurid, Cor-oticin, Cortisporin, Neo-cort-dome, Neo-cortef, Ophthocort, Orlex, Oticair, Otobione, Otobiotic, Otocort, Pediotic, Pramosone, Pyocidin, Terra-cortril)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Acetic acid

glacial

Hydrocortisone

Tradename	Company	Number	Date	Products
VOSOL HC	Akorn	N-012770 RX	1982-01-01	1 products, RLD, RS

Acetic acid

glacial

Hydrocortisone

Neomycin sulfate

Tradename	Company	Number	Date	Products
NEO-CORT-DOME	Bayer	N-050238 DISCN	1982-01-01	1 products

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Acyclovir

Hydrocortisone

Tradename	Company	Number	Date	Products
XERESE	Bausch Health Companies	N-022436 RX	2009-07-31	1 products, RLD, RS

Bacitracin zinc

Hydrocortisone

Neomycin sulfate

Polymyxin b sulfate

Tradename	Company	Number	Date	Products
CORTISPORIN	Casper Pharma	N-050416 DISCN	1982-01-01	1 products, RLD
CORTISPORIN	Monarch Pharmaceuticals	N-050168 DISCN	1984-05-04	1 products, RLD

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Chloramphenicol

Hydrocortisone acetate

Tradename	Company	Number	Date	Products
CHLOROMYCETIN HYDROCORTISONE	Parkedale Pharmaceuticals	N-050202 DISCN	1982-01-01	1 products

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Chloramphenicol

Hydrocortisone acetate

Polymyxin b sulfate

Tradename	Company	Number	Date	Products
OPHTHOCORT	Parkedale Pharmaceuticals	N-050201 DISCN	1982-01-01	1 products

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Ciprofloxacin hydrochloride

Hydrocortisone

Tradename	Company	Number	Date	Products
CIPRO HC	Novartis	N-020805 RX	1998-02-10	1 products, RLD, RS

Colistin sulfate

Hydrocortisone acetate

Neomycin sulfate

Thonzonium bromide

Tradename	Company	Number	Date	Products
COLY-MYCIN S	Endo	N-050356 RX	1982-01-01	1 products, RLD, RS

Hydrocortisone

Tradename	Company	Number	Date	Products
CORTENEMA	ANI PHARMS	N-016199 RX	1982-01-01	1 products, RLD, RS
ALKINDI SPRINKLE	Eton Pharmaceuticals	N-213876 RX	2020-09-29	4 products, RLD, RS
CORTEF	Pharmacia & Upjohn	N-008697 RX	1982-01-01	3 products, RLD

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Hydrocortisone

Neomycin sulfate

Tradename	Company	Number	Date	Products
NEO-CORT-DOME	Bayer	N-050237 DISCN	1984-06-05	2 products

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Hydrocortisone

Neomycin sulfate

Polymyxin b sulfate

Tradename	Company	Number	Date	Products
CASPORYN HC	Casper Pharma	N-060613 RX	1982-01-01	1 products, RLD, RS

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Hydrocortisone

Tetracycline hydrochloride

Tradename	Company	Number	Date	Products
ACHROMYCIN	Lederle Laboratories	N-050272 DISCN	1982-01-01	1 products

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Hydrocortisone acetate

Tradename	Company	Number	Date	Products
CORTIFOAM	Mylan	N-017351 RX	1982-02-10	1 products, RLD, RS

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Hydrocortisone acetate

Neomycin sulfate

Polymyxin b sulfate

Tradename	Company	Number	Date	Products
CORTISPORIN	Monarch Pharmaceuticals	N-050218 DISCN	1985-08-09	1 products, RLD

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Hydrocortisone cypionate

Tradename	Company	Number	Date	Products
CORTEF	Pharmacia & Upjohn	N-009900 DISCN	1982-01-01	1 products

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Hydrocortisone sodium phosphate

Tradename	Company	Number	Date	Products
HYDROCORTONE	Merck KGaA	N-012052 DISCN	1982-01-01	1 products, RLD

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Hydrocortisone sodium succinate

Tradename	Company	Number	Date	Products
SOLU-CORTEF	Pharmacia & Upjohn	N-009866 RX	1982-01-01	4 products, RLD, RS

Hydrocortisone valerate

Tradename	Company	Number	Date	Products
WESTCORT	Sun Pharmaceutical Industries	N-017950 DISCN	1982-01-01	1 products, RLD
WESTCORT	Sun Pharmaceutical Industries	N-018726 DISCN	1983-08-08	1 products, RLD

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Labels

FDA

EMA

Brand Name	Status	Last Update
ala-scalp	ANDA	2021-10-06
alkindi	New Drug Application	2022-02-08
anusol	ANDA	2021-02-02
casporyn hc	New Drug Application	2019-09-26
ciprofloxacin	ANDA	2023-06-09
coly-mycin	New Drug Application	2018-12-03
cortef	New Drug Application	2023-03-23
cortenema	New Drug Application	2018-11-27
cortifoam	New Drug Application	2020-08-13
cortisporin tc	New Drug Application	2019-01-15

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Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
adrenal insufficiency	—	D000309	—
congenital adrenal hyperplasia	—	D000312	E25.0
contact dermatitis	—	D003877	L25
facial dermatoses	—	D005148	—
foot dermatoses	—	D005533	—
hand dermatoses	—	D006229	—
hemorrhoids	EFO_0009552	D006484	K64
inflammation	MP_0001845	D007249	—
leg dermatoses	—	D007868	—
pruritus ani	—	D011538	L29.0

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Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Hydrocortisone, Alkindi Sprinkle, Eton
9649280	2034-05-12	DP	U-3075
9675559	2033-01-10		U-3075
9717740	2032-11-19		U-3075

ATC Codes

A: Alimentary tract and metabolism drugs

— A01: Stomatological preparations

— A01A: Stomatological preparations

— A01AC: Corticosteroids for local oral treatment

— A01AC03: Hydrocortisone

— A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents

— A07E: Intestinal antiinflammatory agents

— A07EA: Corticosteroids acting locally

— A07EA02: Hydrocortisone

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

— C05AA01: Hydrocortisone

D: Dermatologicals

— D07: Corticosteroids, dermatological preparations

— D07A: Corticosteroid dermatological preparations, plain

— D07AA: Corticosteroids, weak (group i)

— D07AA02: Hydrocortisone

— D07AB: Corticosteroids, moderately potent (group ii)

— D07AB02: Hydrocortisone butyrate

— D07AB11: Hydrocortisone buteprate

— D07AC: Corticosteroids, potent (group iii)

— D07AC16: Hydrocortisone aceponate

— D07B: Corticosteroids, combinations with antiseptics

— D07BA: Corticosteroids, weak, combinations with antiseptics

— D07BA04: Hydrocortisone and antiseptics

— D07BB: Corticosteroids, moderately potent, combinations with antiseptics

— D07BB04: Hydrocortisone butyrate and antiseptics

— D07C: Corticosteroids, combinations with antibiotics

— D07CA: Corticosteroids, weak, combinations with antibiotics

— D07CA01: Hydrocortisone and antibiotics

— D07X: Corticosteroids, other combinations

— D07XA: Corticosteroids, weak, other combinations

— D07XA01: Hydrocortisone

H: Systemic hormonal preparations, excl. sex hormones and insulins

— H02: Corticosteroids for systemic use

— H02A: Corticosteroids for systemic use, plain

— H02AB: Glucocorticoids, systemic

— H02AB09: Hydrocortisone

R: Respiratory system drugs

— R01: Nasal preparations

— R01A: Decongestants and other nasal preparations for topical use

— R01AD: Corticosteroid nasal preparations for topical use

— R01AD60: Hydrocortisone, combinations

S: Sensory organ drugs

— S01: Ophthalmologicals

— S01B: Antiinflammatory agents, ophthalmologic

— S01BA: Corticosteroid ophthalmologic antiinflammatory agents, plain

— S01BA02: Hydrocortisone

— S01BB: Corticosteroids and mydriatics in combination

— S01BB01: Hydrocortisone and mydriatics

— S01C: Antiinflammatory agents and antiinfectives in combination

— S01CA: Corticosteroids and antiinfectives in combination, opthalmologic

— S01CA03: Hydrocortisone and antiinfectives

— S01CB: Corticosteroids/antiinfectives/mydriatics in combination

— S01CB03: Hydrocortisone

— S02: Otologicals

— S02B: Corticosteroid otologicals

— S02BA: Corticosteroids

— S02BA01: Hydrocortisone

— S02C: Corticosteroids and antiinfectives in combination, otologic

— S02CA: Corticosteroids and antiinfectives in combination

— S02CA03: Hydrocortisone and antiinfectives

— S03: Ophthalmological and otological preparations

— S03C: Corticosteroids and antiinfectives in combination, opthalmologic and otologic

— S03CA: Corticosteroids and antiinfectives in combination

— S03CA04: Hydrocortisone and antiinfectives

HCPCS

Code	Description
J1700	Injection, hydrocortisone acetate, up to 25 mg
J1710	Injection, hydrocortisone sodium phosphate, up to 50 mg
J1720	Injection, hydrocortisone sodium succinate, up to 100 mg

Clinical

Clinical Trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Lymphoma	D008223		C85.9	11	39	23	1	9	80
Precursor cell lymphoblastic leukemia-lymphoma	D054198		C91.0	15	28	16	11	4	69
Prostatic neoplasms	D011471		C61	6	26	18	4	6	54
Healthy volunteers/patients	—			23	2	4	4	5	37
Rheumatoid arthritis	D001172	EFO_0000685	M06.9	3	13	9	11	1	36
Covid-19	D000086382		U07.1	—	7	15	3	9	31
Asthma	D001249	EFO_0000270	J45	2	4	7	10	8	31
Urinary tract infections	D014552	EFO_0003103	N39.0	—	4	10	13	4	31
Cataract	D002386	EFO_0001059	H26.9	—	2	8	17	2	28
Inflammation	D007249			4	3	7	9	5	26

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Leukemia	D007938		C95	11	49	19	—	10	80
Myelodysplastic syndromes	D009190		D46	10	30	5	—	5	46
Graft vs host disease	D006086		D89.81	5	19	9	—	5	35
Neoplasms	D009369		C80	6	6	5	—	3	20
Plasma cell neoplasms	D054219			3	10	2	—	5	20
Myeloid leukemia acute	D015470		C92.0	10	9	3	—	—	18
Non-hodgkin lymphoma	D008228		C85.9	3	13	1	—	—	15
Multiple myeloma	D009101		C90.0	4	6	3	—	—	13
Otitis externa	D010032	EFO_0009560	H60	1	3	7	—	—	10
Alcoholic hepatitis	D006519	EFO_1001345	K70.1	2	4	3	—	2	10

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Large b-cell lymphoma diffuse	D016403		C83.3	4	12	—	—	—	13
Myeloproliferative disorders	D009196		D47.1	3	7	—	—	3	13
Myelodysplastic-myeloproliferative diseases	D054437			1	8	—	—	2	11
B-cell chronic lymphocytic leukemia	D015451		C91.1	2	8	—	—	—	9
Fanconi anemia	D005199	Orphanet_84	D61.09	3	6	—	—	1	8
Neuroblastoma	D009447	EFO_0000621		1	5	—	—	—	6
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	—	1	—	—	5	6
Head and neck neoplasms	D006258			1	3	—	—	1	4
Anthrax	D000881		A22	2	2	—	—	—	4
Bcr-abl positive chronic myelogenous leukemia	D015464	EFO_0000340		1	4	—	—	—	4

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Uterine cervical neoplasms	D002583			1	—	—	—	5	6
Obesity	D009765	EFO_0001073	E66.9	3	—	—	—	2	5
Insulin resistance	D007333	EFO_0002614		1	—	—	—	4	5
Blood pressure	D001794	EFO_0004325		2	—	—	—	2	4
Pharmacokinetics	D010599			3	—	—	—	1	4
Therapeutic equivalency	D013810			3	—	—	—	—	3
T-cell lymphoma	D016399			2	—	—	—	—	2
Myositis	D009220	EFO_0000783	G72.49	1	—	—	—	1	2
Rhinoscleroma	D012226	EFO_0007470		2	—	—	—	—	2
Periapical periodontitis	D010485	EFO_1001391	K04.5	1	—	—	—	1	2

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hyperaldosteronism	D006929	HP_0011736	E26	—	—	—	—	3	3
Pregnancy	D011247	EFO_0002950	Z33.1	—	—	—	—	2	2
Intervertebral disc displacement	D007405	EFO_1001800		—	—	—	—	2	2
Heart failure	D006333	EFO_0003144	I50	—	—	—	—	2	2
Hypertension	D006973	EFO_0000537	I10	—	—	—	—	2	2
Osteomyelitis	D010019	EFO_0003102	M86	—	—	—	—	2	2
Pathologic dilatation	D004108			—	—	—	—	2	2
Regeneration	D012038			—	—	—	—	2	2
Peritonitis	D010538	EFO_0008588	K65	—	—	—	—	2	2
Post-concussion syndrome	D038223	EFO_1001827	F07.81	—	—	—	—	2	2

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	HYDROCORTISONE
INN	hydrocortisone
Description	Cortisol is a 17alpha-hydroxy-C21-steroid that is pregn-4-ene substituted by oxo groups at positions 3 and 20 and hydroxy groups at positions 11, 17 and 21. Cortisol is a corticosteroid hormone or glucocorticoid produced by zona fasciculata of the adrenal cortex, which is a part of the adrenal gland. It is usually referred to as the "stress hormone" as it is involved in response to stress and anxiety, controlled by corticotropin-releasing hormone (CRH). It increases blood pressure and blood sugar, and reduces immune responses. It has a role as an anti-inflammatory drug, an anti-allergic agent, an anti-asthmatic drug, a human metabolite, a mouse metabolite and a drug allergen. It is a 21-hydroxy steroid, an 11beta-hydroxy steroid, a 20-oxo steroid, a 3-oxo-Delta(4) steroid, a primary alpha-hydroxy ketone, a tertiary alpha-hydroxy ketone, a 17alpha-hydroxy-C21-steroid and a glucocorticoid. It derives from a hydride of a pregnane.
Classification	Small molecule
Drug class	cortisone derivatives
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	C[C@]12C[C@H](O)[C@H]3[C@@H](CCC4=CC(=O)CC[C@@]43C)[C@@H]1CC[C@]2(O)C(=O)CO

Identifiers

PDB	4P6X
CAS-ID	50-23-7
RxCUI	5492
ChEMBL ID	CHEMBL389621
ChEBI ID	17650
PubChem CID	5754
DrugBank	DB00741
UNII ID	WI4X0X7BPJ (ChemIDplus, GSRS)

Target

Agency Approved

NR3C1

Organism

Homo sapiens

Gene name

NR3C1

Gene synonyms

GRL

NCBI Gene ID

2908

Protein name

glucocorticoid receptor

Protein synonyms

Nuclear receptor subfamily 3 group C member 1, nuclear receptor subfamily 3 group C member 1 variant hGR-B(54), nuclear receptor subfamily 3 group C member 1 variant hGR-B(77), nuclear receptor subfamily 3 group C member 1 variant hGR-B(93), nuclear receptor subfamily 3, group C, member 1 (glucocorticoid receptor)

Uniprot ID

Q6N0A4

Mouse ortholog

Nr3c1 (14815)

glucocorticoid receptor (Q61629)

Alternate

NR3C2

Organism

Homo sapiens

Gene name

NR3C2

Gene synonyms

MCR, MLR

NCBI Gene ID

4306

Protein name

mineralocorticoid receptor

Protein synonyms

aldosterone receptor, mineralocorticoid receptor 1, mineralocorticoid receptor 2, mineralocorticoid receptor delta, Nuclear receptor subfamily 3 group C member 2

Uniprot ID

Q96KQ9

Mouse ortholog

Nr3c2 (110784)

mineralocorticoid receptor (Q8VII8)

Variants

Clinical Variant

No data

Financial

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Trends

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Safety

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Black-box warning for: Ciprofloxacin

Adverse Events

Top Adverse Reactions

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4,738 adverse events reported

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