DEXAMETHASONE INTENSOL
Dexamethasone Intensol is a potent synthetic glucocorticoid indicated for the management of severe or incapacitating conditions across a broad range of therapeutic areas. Key indications include allergic states (e.g., asthma, Stevens-Johnson syndrome), endocrine disorders (e.g., adrenocortical insufficiency, hypercalcemia of malignancy), and gastrointestinal diseases (e.g., ulcerative colitis). It is also utilized for the palliative management of neoplastic diseases (leukemias and lymphomas), nervous system conditions (e.g., cerebral edema, acute exacerbations of multiple sclerosis), hematologic disorders (e.g., ITP, hemolytic anemia), and various ophthalmic, renal, and respiratory diseases.
How DEXAMETHASONE INTENSOL Works
Dexamethasone is a long-acting glucocorticoid that exerts its effects by binding to intracellular glucocorticoid receptors. Once bound, the receptor-ligand complex translocates to the cell nucleus, where it binds to specific DNA sequences (glucocorticoid response elements) to modulate gene transcription. This results in the up-regulation of anti-inflammatory proteins and the down-regulation of pro-inflammatory mediators, such as cytokines (IL-1, IL-6, TNF-alpha) and enzymes (COX-2). Its systemic effects include the suppression of leukocyte infiltration at inflammation sites, reduction of capillary permeability, and inhibition of the humoral and cell-mediated immune responses. Dexamethasone possesses minimal mineralocorticoid activity compared to natural cortisol.
Details
- Status
- Prescription
- First Approved
- 1983-09-01
- Routes
- ORAL
- Dosage Forms
- CONCENTRATE
DEXAMETHASONE INTENSOL Approval History
What DEXAMETHASONE INTENSOL Treats
10 indicationsDEXAMETHASONE INTENSOL is approved for 10 conditions since its original approval in 1983. 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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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 INTENSOL FDA Label Details
ProIndications & Usage
Allergic States Control of severe or incapacitating allergic 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 Bullous 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 conjunction with sy...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.