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U.S. Department of Health and Human Services

Safety

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Metadate CD (methylphenidate HCl, USP) Extended-Release Capsules August 2008


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2008

 

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

CONTRAINDICATIONS

  • Hypersensitivity To Methylphenidate Or Other Excipients
  • Halogenated Anesthetics

PRECAUTIONS

  • Drug Testing
    • Metadate CD contains methylphenidate which may result in a positive result during drug testing.
  • Drug Interactions
    • Phenylbutazone (added)
    • In theory, there is a possibility that the clearance of methylphenidate might be affected by urinary pH...
  • Halogenated Anesthetics

ADVERSE REACTIONS

  • Postmarketing Experience
    • ...peripheral coldness, Raynaud’s phenomenon, reversible ischaemic neurological deficit (added)

CONTRAINDICATIONS

Hypersensitivity To Methylphenidate Or Other Excipients

...Metadate CD contains sucrose. Therefore, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.

Halogenated Anesthetics

There is a risk of sudden blood pressure increase during surgery. If surgery is planned, Metadate CD should not be taken on the day of the surgery.
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