DEXAMETHASONE
Dexamethasone is a potent synthetic glucocorticoid indicated for the management of a wide range of severe or incapacitating allergic, inflammatory, and neoplastic conditions. It is utilized across multiple specialties for patients with respiratory, dermatologic, gastrointestinal, ophthalmic, and renal diseases that are unresponsive to conventional treatments. Key indications include the control of severe allergic states (e.g., asthma, Stevens-Johnson syndrome), endocrine disorders (e.g., adrenal insufficiency, congenital adrenal hyperplasia), and the reduction of cerebral edema associated with malignancy or head injury. Additionally, it is employed in the palliative management of certain leukemias and lymphomas, the treatment of acquired hemolytic anemia, and as a diagnostic tool for adrenocortical hyperfunction.
How DEXAMETHASONE Works
Dexamethasone is a long-acting corticosteroid with primary glucocorticoid activity and minimal mineralocorticoid effects. It diffuses across cell membranes and binds to specific cytoplasmic glucocorticoid receptors. This receptor-ligand complex translocates to the nucleus, where it binds to glucocorticoid response elements (GREs) to modulate gene expression. It promotes the synthesis of anti-inflammatory proteins (such as lipocortins, which inhibit phospholipase A2) and suppresses the transcription of pro-inflammatory genes (including cytokines, interleukins, and adhesion molecules) by inhibiting transcription factors like NF-κB and AP-1. These actions result in reduced capillary permeability, decreased leukocyte migration, and overall suppression of the immune and inflammatory response.
Details
- Status
- Prescription
- First Approved
- 1971-10-20
- Routes
- ORAL, INJECTION, OPHTHALMIC
- Dosage Forms
- TABLET, ELIXIR, INJECTABLE, SUSPENSION/DROPS, SOLUTION
Companies
DEXAMETHASONE Approval History
What DEXAMETHASONE Treats
10 indicationsDEXAMETHASONE is approved for 10 conditions since its original approval in 1971. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
- Atopic Dermatitis
- Contact Dermatitis
- Drug Hypersensitivity
- Allergic Rhinitis
- Serum Sickness
- Dermatitis Herpetiformis
- Exfoliative Erythroderma
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Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DEXAMETHASONE FDA Label Details
ProIndications & Usage
A l l ergic States: Control of severe or incapacitating a llergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases: Bul l ous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunctio...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.