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Cure8 regulatory brief
Solu-Cortef FDA label update (2026-08-27)
Medications
Corticosteroids
Steroids
Regulatory Update
Adult patients
Clinicians
Patients On Biologics
Inflammatory bowel disease
Why This Matters
This FDA label page documents official prescribing information for SOLU-CORTEF (hydrocortisone), including explicit gastrointestinal/IBD indications (regional enteritis and ulcerative colitis) and IV/IM dosing guidance.
Patients and clinicians may encounter this drug as a short-term parenteral corticosteroid option in acute IBD scenarios.
Who Should Pay Attention
Adults with Crohn’s disease or ulcerative colitis facing acute severe flares; clinicians who manage IBD or acute inpatient exacerbations; hospital pharmacists and infusion teams.
Study Snapshot
Story typeRegulatory
Evidence typeRegulatory update
Study statusHuman prescription drug
Source depthRegulatory record
What To Know
This DailyMed entry is a regulatory drug-label record for SOLU-CORTEF (hydrocortisone sodium succinate).
It summarizes approved indications, recommended routes (IV/IM), dosing ranges, and general administration cautions (for example, inspect for particulates, do not mix with other solutions, and considerations for switching to longer-acting or oral corticosteroids after the emergency period).
The label explicitly names gastrointestinal uses relevant to IBD (regional enteritis/Crohn’s disease and ulcerative colitis) as situations where parenteral hydrocortisone may be used to “tide the patient over a critical period.” It also notes typical initial IV dosing (100–500 mg) and that high-dose IV therapy is generally continued only until stabilization, usually not beyond 48–72 hours, with guidance on tapering and monitoring for effects such as hypernatremia.
If you are looking for how this label change affects your care, discuss specifics with your clinician; this page reports regulatory prescribing information rather than individualized medical advice.
Keep In Mind
This is a regulatory drug-label document (DailyMed) and reflects approved indications and standardized dosing language. It is not clinical guidance tailored to an individual's situation. For decisions about use, dosing, and monitoring in IBD, consult your treating clinician.
Source Details
Review the original publication for the complete reporting, methods, and context.
Regulatory update
Evidence type derived from source or registry metadata.
PublicationopenFDA
PublisherU.S. Food and Drug Administration
SponsorPharmacia & Upjohn Company LLC
Study typeDrug Label Update
Indexed viaopenFDA
Source typeRegulatory record
PublishedAug 27, 2026, 12:00 AM
Content availableRegulatory record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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