PEDIAPRED
Pediapred (prednisolone sodium phosphate) is an oral glucocorticoid solution indicated for the management of a broad spectrum of endocrine, inflammatory, and autoimmune disorders in adult and pediatric patients. It is primarily used for severe or recalcitrant allergic states (e.g., asthma, contact dermatitis), dermatologic diseases (e.g., pemphigus, Stevens-Johnson syndrome), and respiratory conditions (e.g., sarcoidosis). Additionally, it is indicated for the treatment of neoplastic diseases (leukemias and lymphomas), hematologic disorders (e.g., idiopathic thrombocytopenic purpura), gastrointestinal diseases (e.g., ulcerative colitis), and to induce diuresis in nephrotic syndrome.
How PEDIAPRED Works
Prednisolone is a synthetic glucocorticoid that exerts potent anti-inflammatory and immunomodulatory effects. It diffuses across cell membranes and binds with high affinity to cytoplasmic glucocorticoid receptors (GR). The resulting ligand-receptor complex translocates to the nucleus, where it binds to specific DNA sequences called glucocorticoid response elements (GREs). This interaction modulates gene transcription, leading to the induction of anti-inflammatory proteins (such as lipocortin-1, which inhibits phospholipase A2) and the transrepression of pro-inflammatory transcription factors, including NF-κB and AP-1. These actions result in decreased production of inflammatory mediators (cytokines, interleukins, prostaglandins, and leukotrienes), reduced capillary permeability, and suppression of the humoral and cell-mediated immune responses.
Details
- Status
- Prescription
- First Approved
- 1986-05-28
- Routes
- ORAL
- Dosage Forms
- SOLUTION
PEDIAPRED Approval History
What PEDIAPRED Treats
10 indicationsPEDIAPRED is approved for 10 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Allergic Rhinitis
- Asthma
- Contact Dermatitis
- Atopic Dermatitis
- Serum Sickness
- Drug Hypersensitivity
- Pemphigus
- Bullous Dermatitis Herpetiformis
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Active Pipeline
Ongoing clinical trials by development phase
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.
PEDIAPRED FDA Label Details
ProIndications & Usage
FDA Label (PDF)Prednisolone Sodium Phosphate Oral Solution (15 mg Prednisolone per 5 mL) is indicated in the following conditions: 1. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. 2. Dermatologic Diseases Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides. 3. E...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.