Cerebyx Label.pdf

020450s020lbl.pdf
Preview of Cerebyx Label
🔗 Source: accessdata.fda.gov
📊 Size: 304 KB
👤 Author: fda/cder
⬇️ Downloads: 86

Summary

CEREBYX (fosphenytoin sodium injection) is a prodrug of phenytoin, with 1.5 mg of fosphenytoin sodium equivalent to 1 mg of phenytoin sodium. The rate of IV administration should not exceed 150 mg phenytoin sodium equivalents (PE) per minute due to the risk of severe hypotension and cardiac arrhythmias. Fosphenytoin is converted to phenytoin, with a half-life of approximately 15 minutes, and is extensively bound to human plasma proteins. The volume of distribution increases with dose and rate, and fosphenytoin is metabolized to phenytoin, phosphate, and formate. IM administration generates systemic phenytoin concentrations similar to oral phenytoin sodium, while IV administration has complex pharmacokinetics. A dose of 15-20 mg PE/kg infused at 100-150 mg PE/min yields plasma free phenytoin concentrations similar to those achieved with an equivalent dose of phenytoin sodium.

Description

CEREBYX (fosphenytoin sodium injection) is a prodrug of phenytoin, with 1.5 mg of fosphenytoin sodium equivalent to 1 mg of phenytoin sodium.

Technical Information

  • File Format: PDF
  • File Size: 304 KB
  • Pages: 23
  • Language: EN
  • Author: fda/cder
  • Total Downloads: 86
  • Last Updated: 1 week ago

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