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Drug ReportsHydrocortisone probutate
Hydrocortisone probutate
Alkindi, Efmody, Pandel, Plenadren (hydrocortisone probutate) is a small molecule pharmaceutical. Hydrocortisone probutate was first approved as Pandel on 1997-02-28. 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.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
digestive system diseasesD004066
respiratory tract diseasesD012140
urogenital diseasesD000091642
cardiovascular diseasesD002318
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
nutritional and metabolic diseasesD009750
endocrine system diseasesD004700
immune system diseasesD007154
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Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Hydrocortisone probutate
Tradename
Company
Number
Date
Products
PANDELANI PharmaceuticalsN-020453 DISCN1997-02-28
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
OTC monograph not final2012-08-24
141016 hydrocortisone 0.5% / hydroquinone 4% / tretinoin 0.025%unapproved drug other2020-07-02
141017 hydrocortisone 0.5% / hydroquinone 6% / tretinoin 0.025%unapproved drug other2020-07-02
141060 hydrocortisone 0.5% / hydroquinone 4% / tretinoin 0.025%unapproved drug other2020-07-02
141061 hydrocortisone 0.5% / hydroquinone 8% / tretinoin 0.025%unapproved drug other2020-07-02
999 itch relievingOTC monograph not final2016-11-14
advanced anti-itch therapyOTC monograph not final2016-06-14
afassco 1% hydrocortisoneOTC monograph not final2023-01-12
aftate hydrocortisone creamOTC monograph not final2016-03-31
ala-scalpANDA2025-01-08
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Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
shock—D012769R57.1
ulcerative colitisEFO_0000729D003093K51
pruritus ani—D011538L29.0
inflammationMP_0001845D007249—
adrenal insufficiency—D000309—
rheumatic diseases—D012216M79.0
status asthmaticus—D013224—
contact dermatitis—D003877L25
facial dermatoses—D005148—
hemorrhoidsEFO_0009552D006484K64
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Agency Specific
FDA
EMA
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Patent Expiration
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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
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Clinical
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Atrial fibrillationD001281EFO_0000275I48.0———1—1
Indications Phases 3
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Indications Phases 2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AsthmaD001249EFO_0000270J451————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic kidney failureD007676EFO_0003884N18.9————11
Renal insufficiencyD051437HP_0000083N19————11
Kidney transplantationD016030——————11
HyperparathyroidismD006961EFO_0008506E21.3————11
Secondary hyperparathyroidismD006962EFO_1001173—————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameHydrocortisone probutate
INNhydrocortisone
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 classcortisone derivatives
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCCC(=O)O[C@]1(C(=O)COC(=O)CC)CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@]4(C)[C@H]3[C@@H](O)C[C@@]21C
Identifiers
PDB—
CAS-ID72590-77-3
RxCUI—
ChEMBL IDCHEMBL1200953
ChEBI ID31675
PubChem CID5754
DrugBankDB00741
UNII IDWI4X0X7BPJ (ChemIDplus, GSRS)
Target
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Variants
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Financial
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Trends
PubMed Central
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Safety
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90,561 adverse events reported
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