Label Changes for:

Innopran XL (propranolol hydrochloride) extended release capsules

December 2009

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

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

CONTRAINDICATIONS (reworded)

  • Propranolol is contraindicated in:... 2) sinus bradycardia, sick sinus syndrome, and greater than first-degree block unless a permanent pacemaker is in place...

PRECAUTIONS

Antiarrythmics
  • The clearance of lidocaine and bupivacaine are significantly reduced with administration of propranolol. Lidocaine and bupivacaine toxicity has been reported following coadministration with propranolol.
Non-Cardiovascular Drugs
  • Anesthetic Agents: The clearance of local amide anesthetics (e.g. lidocaine, bupivacaine, mepivacaine) is reduced with administration of propranolol. Lidocaine and bupivacaine has been reported following coadministration with propranolol. Caution should be exercised when amide anesthetic agents are administered concomitantly with propranolol.
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