Hydrocortisone acetate

Overview

Not Available

Background

Not Available

Indication

For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Also used to treat endocrine (hormonal) disorders (adrenal insufficiency, Addisons disease). It is also used to treat many immune and allergic disorders, such as arthritis, lupus, severe psoriasis, severe asthma, ulcerative colitis, and Crohn's disease.

Associated Conditions

Acute, Inflammatory Superficial Cutaneous Lesions caused by susceptible bacteria
Adrenocortical Insufficiency
Allergic Conjunctivitis (AC)
Anal inflammation
Androgenital syndrome
Conjunctivitis
Dermatitis infected
Diaper Dermatitis
Eczema infected
Episcleritis
Fissure;Anal
Haemorrhoids
Iridocyclitis
Iritis
Keratitis
Ocular Inflammation
Ocular Irritation
Postoperative pain
Proctitis
Pruritus
Pruritus Ani
Radiation Induced Proctitis
Rheumatoid Arthritis
Scleritis
Skin Infections
Skin Irritation
Superficial ocular bacterial infections caused by susceptible bacteria
Thyroiditis
Ulcerative Colitis
Anal eczema
Bacterial blepharitis
Corneal clouding
Corticosteroid responsive Dermatosis of the anal region
Corticosteroid-responsive dermatoses
Cryptitis
Localized uninfected hemorrhoids
Mild Anal Fissures
Pruritus associated with bowel movements
Skin and skin-structure infections caused by susceptible bacteria

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Clinical Trial of Anusol Ointment for Symptom Relief in Patients With Haemorrhoids	2021/12/15	NCT05157711	Phase 3	Completed	Church & Dwight Company, Inc.
The Healing Effects Of Honey and Hydrogel Products On The Diabetic Foot	2019/01/25	NCT03816618	Early Phase 1	Completed	Cyberjaya University College of Medical Sciences
Efficacy and Safety of Fucicort® Lipid Cream Compared to Combination Treatment With Fucidin® Cream Followed by Betamethasone (Lianbang Beisong®) Cream and Fucicort® Lipid Cream Vehicle in Clinically Infected Atopic Dermatitis/Eczema	2018/01/10	NCT03395132	Phase 3	Terminated	LEO Pharma
The Effect of Cortisol Administration on Neural Correlates of Emotion in Depression	2016/07/19	NCT02837432	Early Phase 1	Completed	Stanford University
Safety and Efficacy of Hydrocortisone and Lidocaine Treatment of Grade I and II Hemorrhoids	2016/02/24	NCT02689856	Phase 2	Completed	Citius Pharmaceuticals, Inc.
Pharmacokinetics and Bioavailability of Hydrocortisone Acetate Suppositories	2016/02/02	NCT02671058	Phase 1	Completed	Cristcot LLC
Fucidin® Cream in the Treatment of Impetigo	2009/09/30	NCT00986856	Phase 4	Terminated	LEO Pharma
The Safety of Proctofoam-HC in the Third Trimester of Pregnancy	2006/11/30	NCT00405288	N/A	Completed	The Hospital for Sick Children

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
ANUCORT-HC	Cosette Pharmaceuticals, Inc.	0713-0503	RECTAL	25 mg in 1 1	11/22/2023
Radiaura Skin Recovery	PureTek Corporation	59088-432	TOPICAL	10 mg in 1 g	1/11/2023
Lidotral 5 Percent and Hydrocortisone 1 Percent with Peptides and Arnica	PureTek Corporation	59088-319	TOPICAL	10 mg in 1 g	3/15/2024
Hydrocortisone Acetate	Vitruvias Therapeutics	69680-144	RECTAL	25 mg in 1 1	6/4/2021
Hydrocortisone Acetate	A-S Medication Solutions	50090-6331	RECTAL	25 mg in 1 1	2/12/2020
Neo Polycin HC	Padagis US LLC	0574-4144	OPHTHALMIC	10 mg in 1 g	11/9/2018
Hydrocortisone Acetate	Cameron Pharmaceuticals, Limited Liability Company	42494-342	RECTAL	30 mg in 1 1	7/1/2022
hydrocortisone acetate pramoxine hcl	Padagis Israel Pharmaceuticals Ltd	45802-144	TOPICAL	1 g in 100 g	3/15/2018
Hydrocortisone Acetate	Bryant Ranch Prepack	63629-1994	RECTAL	25 mg in 1 1	10/19/2021
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate	Physicians Total Care, Inc.	54868-6122	OPHTHALMIC	10 mg in 1 g	5/17/2010

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
HYDRODERM CREAM 1%	ICM PHARMA PTE. LTD.	SIN08804P	CREAM	1% w/w	7/3/1996
UCORT CREAM	Y S P INDUSTRIES (M) SDN BHD	SIN08726P	CREAM	10 mg/g	5/27/1996
HYDRODERM-C CREAM 1%	ICM PHARMA PTE. LTD.	SIN08790P	CREAM	1% w/w	7/3/1996
MICON-H CREAM	BEACONS PHARMACEUTICALS PTE. LTD.	SIN06454P	CREAM	1% w/w	7/17/1991
SW HYDROCORTISONE CREAM 1% w/w	SUNWARD PHARMACEUTICAL PRIVATE LIMITED, SUNWARD PHARMACEUTICAL SDN BHD	SIN03781P	CREAM	1% w/w	1/18/1990
HYDROCORTISONE CREAM 1% w/w	BEACONS PHARMACEUTICALS PTE. LTD.	SIN04767P	CREAM	1%	6/25/1990
FUCIDIN H CREAM	LEO Laboratories Limited	SIN10834P	CREAM	10 mg/g	3/24/1999
YSP HYDROCORT CREAM 1% W/W	Y S P INDUSTRIES (M) SDN BHD	SIN11172P	CREAM	10 mg/g	9/22/1999

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
PERMASOL CREAM	N/A	unicorn laboratories o/b american unicorn laboratories limited	N/A	N/A	12/21/1998
PANECIN CREAM	N/A	unicorn laboratories o/b american unicorn laboratories limited	N/A	N/A	1/21/1999
KAMBI CREAM	N/A	unicorn laboratories o/b american unicorn laboratories limited	N/A	N/A	1/21/1999
XYLMOL SUPPOSITORY	N/A	LOYAL ADVANCE LIMITED	N/A	N/A	6/29/2000
FATIK CREAM	N/A	unicorn laboratories o/b american unicorn laboratories limited	N/A	N/A	1/21/1999
ZOOTH CREAM	N/A	unicorn laboratories o/b american unicorn laboratories limited	N/A	N/A	1/21/1999
IKO CREAM	N/A	unicorn laboratories o/b american unicorn laboratories limited	N/A	N/A	1/21/1999
HC-MYCIL CREAM	N/A	unicorn laboratories o/b american unicorn laboratories limited	N/A	N/A	1/21/1999
EVAMAX CREAM	N/A	unicorn laboratories o/b american unicorn laboratories limited	N/A	N/A	1/21/1999
SURDERM CREAM	N/A	unicorn laboratories o/b american unicorn laboratories limited	N/A	N/A	1/21/1999

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
PHARMACY CARE ANTI FUNGAL CREAM PLUS HYDROCORTISONE clotrimazole 10 mg/g and hydrocortisone acetate 10 mg/g cream tube	255993	Nova Pharmaceuticals Australasia Pty Ltd	Medicine	A	8/18/2015
BLOOMS THE CHEMIST HYDROCORTISONE 1% CREAM hydrocortisone acetate 10 mg/g tube	295688	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	10/30/2017
HYDROCLOZOLE CREAM tube	473029	AdiraMedica Pty Ltd	Medicine	A	12/13/2024
AMCAL SKIN IRRITATION CREAM 1% hydrocortisone acetate 10mg/g cream tube (new formulation)	252633	Cipla Australia Pty Ltd	Medicine	A	8/4/2015
PHARMACY CHOICE CLOTRIMAZOLE & HYDROCORTISONE CREAM clotrimazole 10 mg/g and hydrocortisone acetate 10 mg/g tube	443929	Nova Pharmaceuticals Australasia Pty Ltd	Medicine	A	3/18/2024
APOHEALTH HYDROCORTISONE 1% CREAM hydrocortisone acetate 10 mg/g tube (reformulation)	443927	Neo Health (OTC) Pty Ltd	Medicine	A	3/18/2024
Sigmacort Cream 1%	19778	Aspen Pharmacare Australia Pty Ltd	Medicine	A	10/14/1991
Xyloproct Ointment Tube	12033	Aspen Pharmacare Australia Pty Ltd	Medicine	A	8/13/1991
CHEMISTS' OWN SKIN IRRITATION CREAM hydrocortisone acetate 10 mg/g cream tube	284795	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	1/18/2017
CANESTEN EXTRA ANTIFUNGAL ANTI-INFLAMMATORY CREAM tube	273715	Bayer Australia Ltd	Medicine	A	4/1/2016

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