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U.S. Department of Health and Human Services

Safety

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Depo-Medrol (methylprednisolone acetate injectable suspension, USP)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

Entire Label Revision; sections are rearranged and the terminology revised for some of the diseases/conditions

 

WARNINGS

  • General
  • Cardio-renal
  • Endocrine
  • Infections
    • General
  • Ophthalmic

 

PRECAUTIONS

 

DRUG INTERACTIONS

 

ADVERSE REACTIONS

 

WARNINGS

  • General
  • Cardio-renal
  • Endocrine
  • Infections
    • General
    • Fungal Infections
    • Special pathogens
    • Tuberculosis
    • Vaccinations
    • Viral Infections
  • Ophthalmic

 

PRECAUTIONS

  • General
    • This product, like many other steroid formulations, is sensitive to heat. Therefore, it should not be autoclaved when it is desirable to sterilize the outside of the vial.
  • Cardio-renal
  • Endocrine
  • Gastrointestinal
  • Parenteral Administration
  • Musculoskeletal
  • Neuro-psychiatric
  • Ophthalmic
  • Information for the Patient

 

DRUG INTERACTIONS

  • Aminoglutethimide...
  • Amphotericin B injection and potassium- depleting agents...
  • Antibiotics...
  • Anticholinesterases...
  • Anticoagulants, oral...
  • Antidiabetics...
  • Antitubercular drugs...
  • Cholestyramine...
  • Cyclosporine...
  • Digitalis glycosides...
  • Estrogens, including oral contraceptives...
  • Hepatic Enzyme Inducers...
  • Hepatic Enzyme Inhibitors...
  • Ketoconazole...
  • Non-steroidal anti-inflammatory agents (NSAIDs)...
  • Skin Tests: Corticosteroids may suppress reactions to skin tests.
  • Vaccines...

 

ADVERSE REACTIONS

  • Allergic reactions..
  • Cardiovascular..
  • Dermatologic..
  • Endocrine..
  • Fluid and electrolyte disturbances..
  • Gastrointestinal..
  • Metabolic..
  • Musculoskeletal..
  • Neurologic/Psychiatric..
  • Ophthalmic..
  • Other..
  • The following adverse reactions have been reported with the following routes of administration
    • Intrathecal/Epidural...
    • Intranasal..
    • Ophthalmic..
    • Miscellaneous injection sites: (scalp, tonsillar fauces, sphenopalatine ganglion): Blindness