Label Changes for:

Magnesium Sulfate Injection, USP, 50 percent

May 2013

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

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

Magnesium Sulfate in Dextrose 5% Injection, USP
Magnesium Sulfate Injection, USP, 50%
Magnesium Sulfate in Water for Injection, USP, in Flexible Plastic Container

 

May 2013

WARNINGS

Fetal Harm
  • continuous administration of magnesium sulfate beyond 5 to 7 days to pregnant women can cause fetal harm

PRECAUTIONS

Pregnancy

Teratogenic Effects:

  • Pregnancy Category D (See WARNINGS and PRECAUTIONS)

Nonteratogenic Effects

  • When administered by continuous IV infusion (especially for more than 24 hours preceding delivery) to control convulsions in a toxemic woman, the newborn may show signs of magnesium toxicity, including neuromuscular or respiratory depression (see OVERDOSAGE).

Labor and Delivery

  • ..... administration of Magnesium Sulfate for the unapproved treatment of preterm labor should be performed by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities.
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