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
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/12/06 | Phase 4 | UNKNOWN | |||
2018/11/29 | Phase 1 | Completed | MC2 Therapeutics | ||
2018/11/06 | Phase 3 | Completed | Glenmark Pharmaceuticals Ltd. India | ||
2018/10/16 | Early Phase 1 | Completed | Edward Kasaraskis | ||
2018/10/11 | N/A | UNKNOWN | |||
2018/09/13 | Phase 1 | Completed | |||
2018/09/13 | Phase 1 | Completed | |||
2018/03/19 | Phase 1 | Completed | |||
2018/02/27 | Not Applicable | Completed | |||
2018/01/10 | Phase 3 | Terminated |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Proficient Rx LP | 63187-286 | TOPICAL | 0.5 mg in 1 g | 1/1/2021 | |
| H.J. Harkins Company, Inc. | 52959-124 | TOPICAL | 0.5 mg in 1 g | 1/3/2012 | |
| A-S Medication Solutions | 50090-3794 | TOPICAL | 1.2 mg in 1 g | 5/5/2022 | |
| Direct Rx | 72189-182 | TOPICAL | 0.5 mg in 1 g | 2/22/2021 | |
| Physicians Total Care, Inc. | 54868-4546 | TOPICAL | 0.64 mg in 1 g | 5/1/2012 | |
| A-S Medication Solutions | 50090-5260 | TOPICAL | 0.5 mg in 1 g | 10/18/2018 | |
| Bryant Ranch Prepack | 63629-8618 | TOPICAL | 0.5 mg in 1 g | 7/17/2023 | |
| RPK Pharmaceuticals, Inc. | 53002-9740 | TOPICAL | 0.5 mg in 1 g | 5/5/2021 | |
| Northstar Rx LLC. | 16714-996 | TOPICAL | 0.5 mg in 1 g | 11/24/2022 | |
| Physicians Total Care, Inc. | 54868-6292 | TOPICAL | 0.5 mg in 1 g | 10/3/2011 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| DAIVOBET OINTMENT | SIN12241P | OINTMENT | 0.5 mg/g | 3/27/2003 | |
| BETACYLIC OINTMENT | SIN15211P | OINTMENT | 0.5mg/g | 4/12/2017 | |
| UNIFLEX-N CREAM | SIN01930P | CREAM | 0.1% w/w | 6/23/1988 | |
| B-MYCIN CREAM | SIN14386P | CREAM | 0.5mg/g | 7/25/2013 | |
| GENTRISONE CREAM | SIN04989P | CREAM | 0.64 mg/g | 8/3/1990 | |
| BUFENCON INJECTION | SIN07795P | INJECTION | 2 mg/ml | 7/15/1994 |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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