Label Changes for:

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

August 2008

Changes have been made to the CONTRAINDICATIONS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.


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.


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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