Hydrocortisone

Overview

Hydrocortisone, or cortisol, is a glucocorticoid secreted by the adrenal cortex. Hydrocortisone is used to treat immune, inflammatory, and neoplastic conditions. It was discovered in the 1930s by Edward Kendall and named Compound F, or 17-hydroxycorticosterone. Hydrocortisone was granted FDA approval on 5 August 1952.

Indication

Otic solutions are indicated for infections of the external auditory canal caused by susceptible organisms and with inflammation. Hydrocortisone tablets are indicated for certain endocrine, rheumatic, collagen, allergic, ophthalmic, respiratory, hematologic, neoplastic, edematous, gastrointestinal, and other conditions. A hydrocortisone enema is indicated for ulcerative colitis, a topical ointment with antibiotics is indicated for corticosteroid responsive dermatoses with infections, and a topical cream with acyclovir is indicated to treat cold sores. Oral granules of hydrocortisone are used as a replacement therapy for Adrenocortical Insufficiency (AI) in children under 17 years of age.

Associated Conditions

Acute Gouty Arthritis
Acute Leukemia
Acute Otitis Externa
Adrenal Insufficiency
Allergic Conjunctivitis (AC)
Allergic Rhinitis (AR)
Allergic corneal marginal ulcers
Ankylosing Spondylitis (AS)
Aspiration Pneumonitis
Asthma
Atopic Dermatitis
Berylliosis
Bullous dermatitis herpetiformis
Chorioretinitis
Choroiditis
Congenital Adrenal Hyperplasia (CAH)
Congenital Hypoplastic Anemia
Contact Dermatitis
Crohn's Disease (CD)
Dermatitis
Dermatomyositis (DM)
Dermatosis
Drug hypersensitivity reaction
Epicondylitis
Erythroblastopenia
Fissure;Anal
Haemorrhoids
Herpes Labialis
Hypercalcemia of Malignancy
Immune Thrombocytopenia (ITP)
Infection of the Fenestration Cavity
Infection of the Mastoidectomy Cavity
Iridocyclitis
Iritis
Itching caused by Hemorrhoids
Itching of the Anus
Keratitis
Leukemias
Loeffler's syndrome
Lymphoma
Lymphomas NEC
Mycosis Fungoides (MF)
Ophthalmia, Sympathetic
Optic Neuritis
Pain caused by Hemorrhoids
Pemphigus
Posterior Uveitis
Posttraumatic Osteoarthritis
Primary adrenocortical insufficiency
Proctitis
Proteinuria
Pruritis of the skin
Psoriatic Arthritis
Rectal inflammations NEC
Rheumatic heart disease, unspecified
Rheumatoid Arthritis
Rheumatoid Arthritis, Juvenile
Secondary adrenocortical insufficiency
Secondary thrombocytopenia
Serum Sickness
Severe Seborrheic Dermatitis
Skin Diseases
Stevens-Johnson Syndrome
Synovitis
Systemic Lupus Erythematosus
Trichinosis
Tuberculous Meningitis
Ulcerative Colitis
Acquired immune hemolytic anemia
Acute Bursitis
Acute Tenosynovitis
Acute rheumatic carditis
Anterior eye segment inflammation
Cryptitis
Disseminated Pulmonary Tuberculosis (TB)
Exfoliative erythroderma
Fulminating Pulmonary Tuberculosis
Non-suppurative Thyroiditis
Severe Erythema multiforme
Severe Psoriasis
Subacute Bursitis
Superficial infection of the external auditory canal with inflammation
Symptomatic Sarcoidosis
Systemic Dermatomyositis
Varicella-zoster virus acute retinal necrosis

Clinical Trials

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Title	Posted	Study ID	Phase	Status	Sponsor
Effect of Ciclosporin Eyedrops on Sjögren Syndrome	2020/10/22	NCT04597762	Not Applicable	Completed	Hospital Hietzing
HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome	2020/10/19	NCT04591990	Phase 3	Recruiting	Assistance Publique - Hôpitaux de Paris
Days Alive and Out of Hospital for Patients With Sepsis	2020/09/28	NCT04567433	N/A	Completed	The George Institute for Global Health, Australia
Effects of Topical Low Dose Preservative-free Hydrocortisone on Intraocular Pressure	2020/09/02	NCT04536129	Not Applicable	Completed	University of Molise
Comparisons of Different Forms of Glucocorticoid on the Recovery of Reproductive Function in Patients With 21α-hydroxylase Deficiency	2020/09/02	NCT04536662	Phase 4	UNKNOWN	Shanghai Jiao Tong University School of Medicine
Triple Therapy in Septic Shock Patients	2020/08/11	NCT04508946	Phase 3	Completed	Air Force Specialized Hospital, Cairo, Egypt
Evaluation of the Role of Hydrocortisone Either Alone or Combined With Fludrocortisone in the Outcome of Septic Shock in Adults	2020/07/30	NCT04492280	Phase 4	Completed	Ain Shams University
The Potential Therapeutic Role of Hydroxyethyl Starch and Hydrocortisone in Acute Aluminum Phosphide Poisoning	2020/07/10	NCT04465539	Not Applicable	Completed	Tanta University
Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)	2020/07/02	NCT04456439	N/A	AVAILABLE	Mesoblast International Sàrl
Hydrocortisone Per-treatment Decrease Side Effects of Protamine Sulfate	2020/06/17	NCT04435912	Early Phase 1	Completed	University of Jordan

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
HYDROCORTISONE 0.5% / HYDROQUINONE 4% / TRETINOIN 0.025%	Sincerus Florida, LLC	72934-6102	TOPICAL	0.5 g in 100 g	5/17/2019
Hydrocortisone	Asclemed USA, Inc.	76420-110	ORAL	5 mg in 1 1	4/10/2021
HYDROCORTISONE	STAT Rx USA LLC	16590-121	TOPICAL	10 mg in 1 g	7/3/2012
Hydrocortisone	Chartwell RX, LLC	62135-186	ORAL	20 mg in 1 1	1/18/2023
Hydrocortisone	Unit Dose Services	50436-2143	TOPICAL	25 mg in 1 g	7/10/2014
Hydrocortisone	Crown Laboratories	0316-0193	TOPICAL	25 mg in 1 g	10/24/2023
Hydrocortisone	Bryant Ranch Prepack	63629-8666	TOPICAL	25 mg in 1 g	7/18/2023
ALKINDI SPRINKLE	Eton Pharmaceuticals, Inc.	71863-118	ORAL	1 mg in 1 1	2/28/2024
Hydrocortisone	Greenstone LLC	59762-0074	ORAL	10 mg in 1 1	1/23/2024
Hydrocortisone	Mylan Pharmaceuticals Inc.	59762-0074	ORAL	10 mg in 1 1	1/23/2024

EMA Drug Approvals

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HSA Drug Approvals

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NMPA Drug Approvals

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PPB Drug Approvals

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TGA Drug Approvals

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Health Canada Drug Approvals

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CIMA AEMPS Drug Approvals

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Philippines FDA Drug Approvals

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Saudi SFDA Drug Approvals

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Malaysia NPRA Drug Approvals

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UK EMC Drug Information

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