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.
Background
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
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 | |||
2024/02/20 | Not Applicable | Recruiting | Gaziler Physical Medicine and Rehabilitation Education and Research Hospital |
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 |
|---|---|---|---|---|---|
| Betamethasone Acetate Liniments | 国药准字H32025478 | 化学药品 | 搽剂 | 7/21/2020 | |
| Betamethasone Dipropionate Cream | 国药准字H20060760 | 化学药品 | 乳膏剂 | 1/12/2021 | |
| Betamethasone Tablets | 国药准字H22021221 | 化学药品 | 片剂 | 6/15/2022 | |
| Betamethasone Tablets | 国药准字H32021071 | 化学药品 | 片剂 | 8/24/2020 | |
| Betamethasone Tablets | 国药准字H21022868 | 化学药品 | 片剂 | 8/26/2020 | |
| Betamethasone Tablets | 国药准字H50020445 | 化学药品 | 片剂 | 7/14/2020 | |
| Betamethasone Tablets | 国药准字H22022532 | 化学药品 | 片剂 | 7/27/2021 | |
| Betamethasone Tablets | 国药准字H12020936 | 化学药品 | 片剂 | 8/31/2020 | |
| Betamethasone Tablets | 国药准字H32020366 | 化学药品 | 片剂 | 6/24/2020 | |
| Betamethasone Tablets | 国药准字H41020115 | 化学药品 | 片剂 | 11/25/2019 |
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 |