Overview
Betamethasone is a long-acting corticosteroid with immunosuppressive and antiinflammatory properties. It can be used topically to manage inflammatory skin conditions such as eczema, and parenterally to manage several disease states including autoimmune disorders. Betamethasone has potent glucocorticoid activity and negligible mineralocorticoid activity.
Indication
As a member of the corticosteroid family, betamethasone is indicated for the treatment of several inflammatory conditions. As topical monotherapy, betamethasone is indicated to relieve pruritic and inflammatory symptoms of corticosteroid-responsive-dermatoses. Betamethasone can be used topically in combination with a vitamin D analog such as calcipotriene to treat plaque psoriasis. The corticosteroid is also available as an injectable suspension and can be used to manage a range of inflammatory conditions including endocrine disorders, gastrointestinal disorders, and rheumatic disorders among other conditions.
Associated Conditions
- Acute Gouty Arthritis
- Adrenocortical Insufficiency
- Alopecia Areata (AA)
- Ankylosing Spondylitis (AS)
- Atopic Dermatitis
- Berylliosis
- Blepharitis allergic
- Blepharoconjunctivitis
- Bullous dermatitis herpetiformis
- Bursitis
- Congenital Adrenal Hyperplasia (CAH)
- Congenital Hypoplastic Anemia
- Conjunctivitis
- Dermatomyositis (DM)
- Dermatosis
- Discoid Lupus Erythematosus (DLE)
- Edema of the cerebrum
- Epicondylitis
- Episcleritis
- External ear inflammation
- Eye allergy
- Hypercalcemia of Malignancy
- Inflammatory Reaction of the ear
- Iridocyclitis
- Iritis
- Itching caused by Allergies
- Keloids Scars
- Keratitis
- Keratitis interstitial
- Keratoconjunctivitis
- Leukemias
- Lichen Planus (LP)
- Lichen simplex chronicus
- Lupus Erythematosus
- Lymphoma
- Multiple sclerosis exacerbation
- Mycosis Fungoides (MF)
- Necrobiosis lipoidica diabeticorum
- Nephrotic Syndrome
- Ocular Inflammation
- Ocular injuries
- Ophthalmia, Sympathetic
- Pemphigus
- Plaque psoriasis of the body
- Plaque psoriasis of the scalp
- Polymyositis
- Post Surgical Ocular Inflammation
- Pruritus
- Psoriasis
- Psoriasis Vulgaris (Plaque Psoriasis)
- Psoriatic Arthritis
- Psoriatic plaque
- Pulmonary Tuberculosis (TB)
- Pure Red Cell Aplasia
- Regional Enteritis
- Rheumatoid Arthritis
- Rheumatoid Arthritis, Juvenile
- Scleritis
- Secondary thrombocytopenia
- Severe Asthma
- Severe Atopic Dermatitis
- Skin Infections
- Stevens-Johnson Syndrome
- Systemic Lupus Erythematosus
- Temporal Arteritis
- Trichinosis
- Tuberculous Meningitis
- Ulcerative Colitis
- Uveitis
- Verrucous Lichen Planus (LP)
- Acquired immune hemolytic anemia
- Acute nonspecific tenosynovitis
- Acute rheumatic carditis
- Bacterial blepharitis
- Corticosteroid-responsive dermatoses
- Eczematous rash
- Exfoliative erythroderma
- Granuloma annulare lesions
- Idiopathic eosinophilic pneumonias
- Non-suppurative Thyroiditis
- Ocular bacterial infections
- Severe Allergic rhinitis
- Severe Contact dermatitis
- Severe Serum sickness
- Severe Transfusion Reactions
- Severe drug hypersensitivity reactions
- Superficial ocular infections
- Symptomatic Sarcoidosis
- Synovitis of osteoarthritis
Research Report
[Betamethasone (DB00443): A Comprehensive Pharmacological and Clinical Monograph]
Section 1: Introduction and Drug Identification
1.1 Overview and Historical Context
Betamethasone is a potent, long-acting synthetic corticosteroid belonging to the glucocorticoid class of steroid hormones.[1] It is a fluorinated derivative of prednisolone, engineered to possess high glucocorticoid (anti-inflammatory) activity while exhibiting negligible mineralocorticoid (salt-retaining) effects.[2] This selective pharmacological profile makes it a cornerstone therapeutic agent for managing a vast spectrum of inflammatory, allergic, and autoimmune disorders.
The development of betamethasone represents a significant milestone in medicinal chemistry. Patented in 1958 and subsequently approved for medical use in the United States in 1961, it provided clinicians with a powerful new tool for controlling inflammation.[1] Its enduring clinical importance is underscored by its inclusion on the World Health Organization's (WHO) List of Essential Medicines, specifically for its cream and ointment formulations, which are considered fundamental for a basic health system.[1] Its widespread use continues to this day; in 2022, it was the 263rd most commonly prescribed medication in the United States, accounting for over 1 million prescriptions.[1]
Chemically, betamethasone is a stereoisomer of dexamethasone, another widely used synthetic corticosteroid. The two molecules share the same chemical formula and atomic connectivity but differ in the three-dimensional arrangement of the methyl group at the C-16 position of the steroid nucleus.[1] In betamethasone, this group is in the beta (
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/06 | Not Applicable | Not yet recruiting | Ankara Etlik City Hospital | ||
2025/01/22 | Phase 2 | Completed | |||
2025/01/21 | Not Applicable | Active, not recruiting | |||
2024/10/16 | Phase 3 | Recruiting | Queen Mary Hospital, Hong Kong | ||
2024/10/04 | Phase 2 | Recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2024/09/19 | Not Applicable | Recruiting | Yunus Burak Bayır | ||
2024/07/30 | Phase 3 | Not yet recruiting | |||
2024/07/18 | N/A | Completed | |||
2024/03/27 | Phase 1 | Completed | |||
2024/02/20 | Not Applicable | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| STAT RX USA LLC | 16590-032 | TOPICAL | .64 mg in 1 g | 8/11/2010 | |
| DR. THROWER'S SKINCARE, INC. | 69299-301 | TOPICAL | 0.5 g in 100 g | 5/22/2015 | |
| Taro Pharmaceuticals U.S.A., Inc. | 51672-1310 | TOPICAL | 0.5 mg in 1 g | 12/1/2020 | |
| Physicians Total Care, Inc. | 54868-0973 | TOPICAL | 0.5 mg in 1 g | 1/3/2012 | |
| E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0267 | TOPICAL | 0.5 mg in 1 mL | 6/4/2019 | |
| Organon LLC | 78206-124 | TOPICAL | 0.5 mg in 1 g | 2/23/2022 | |
| Prasco Laboratories | 66993-938 | TOPICAL | 0.5 mg in 1 g | 12/12/2022 | |
| Rebel Distributors Corp | 21695-333 | TOPICAL | 0.64 mg in 1 g | 12/18/2008 | |
| RPK Pharmaceuticals, Inc. | 53002-8450 | TOPICAL | 1.2 mg in 1 g | 12/17/2020 | |
| Proficient Rx LP | 63187-276 | TOPICAL | 1.2 mg in 1 g | 11/1/2019 |
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 |
|---|---|---|---|---|---|
| DIPROCEL OINTMENT 0.05% | SIN03842P | OINTMENT | 0.5 mg/g | 2/12/1990 | |
| AXCEL BETAMETHASONE CREAM 0.1% w/w | SIN10969P | CREAM | 0.1% w/w | 6/5/1999 | |
| DERMASONE CREAM 0.05% | SIN08792P | CREAM | 0.05% w/w | 7/3/1996 | |
| DERMASONE CREAM 0.025% | SIN08794P | CREAM | 0.025% w/w | 7/3/1996 | |
| UNIFLEX CREAM 0.05% w/w | SIN10658P | CREAM | 0.05% w/w | 1/9/1999 | |
| BEPROSONE CREAM 0.05% | SIN09056P | CREAM | 0.05% w/w | 12/9/1996 | |
| BEPROSALIC OINTMENT | SIN09029P | OINTMENT | 0.05% w/w | 11/28/1996 | |
| UNIFLEX CREAM 0.025% w/w | SIN07620P | CREAM | 0.025% w/w | 1/25/1994 | |
| DIPROSONE CREAM 0.05% | SIN04025P | CREAM | 0.5 mg/g | 3/20/1990 | |
| DERMANOL-C CREAM 0.1% | SIN08795P | CREAM | 0.1% w/w | 7/3/1996 |
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 |
|---|---|---|---|---|---|
| GENTRISONE CREAM | N/A | N/A | N/A | 11/13/1989 | |
| TOLNAFU CREAM | N/A | N/A | N/A | 3/16/2011 | |
| BETAGENT CREAM | N/A | N/A | N/A | 11/13/1989 | |
| EURORECTAL OINTMENT | N/A | N/A | N/A | 2/16/1995 | |
| GENBESON CREAM | N/A | N/A | N/A | 11/25/2010 | |
| BETACO CREAM | N/A | N/A | N/A | 6/9/1994 | |
| CLOZODERMA CREAM | N/A | N/A | N/A | 8/6/1990 | |
| BEGENZOLE CREAM | N/A | N/A | N/A | 2/26/2020 | |
| MYDERM CREAM | N/A | N/A | N/A | 2/14/2020 | |
| ZOCON TAB | N/A | N/A | N/A | 2/15/2008 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| BETNOVATE 1/2 ONT 0.05% | glaxo canada inc | 00012378 | Ointment - Topical | .05 % | 12/31/1965 |
| BETAMETHASONE VALERATE LOT 0.1% USP | pharmaco canada inc. | 00726486 | Lotion - Topical | 1.22 MG / G | 12/31/1987 |
| BETNESOL EYE AND EAR DROPS | glaxo canada inc | 00012173 | Drops - Otic
,
Ophthalmic | .1 % | 12/31/1963 |
| BETNESOL RETENTION ENEMAS | glaxo canada inc | 00012181 | Enema - Rectal | 5 MG / 100 ML | 12/31/1964 |
| BETNOVATE CRM 0.1% | glaxo canada inc | 00011924 | Cream - Topical | .1 % | 12/31/1965 |
| BETNOVATE ONT 0.1% | glaxo canada inc | 00012386 | Ointment - Topical | .1 % | 12/31/1965 |
| RHOPROSONE OINT 0.05% | rhodiapharm inc | 01942077 | Ointment - Topical | .05 % | 12/31/1992 |
| OCCLUCORT FILM FORMING LOT 0.05 | genderm corporation | 00769614 | Lotion - Topical | .05 % | 12/31/1990 |
| RHOPROLENE GLYCOL CREAM 0.5MG/GM | rhodiapharm inc | 01942107 | Cream - Topical | 0.5 MG / G | 12/31/1992 |
| BETAPRONE LOTION 0.05% | neolab inc | 02048159 | Lotion - Topical | .64 MG / G | 12/31/1994 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| BETAMETASONA SONPHAR 0,5 MG/ML GOTAS ORALES EN SOLUCION EFG | Laboratorios Sonphar S.L. | 80594 | GOTAS ORALES EN SOLUCIÓN | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| CELECREM 0,5 mg/g CREMA | Galenicum Derma S.L.U. | 41645 | CREMA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| CELECREM 1 mg/g CREMA | Galenicum Derma S.L.U. | 40206 | CREMA | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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