Magnesium Sulfate Safety Labeling Changes
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
- continuous administration of magnesium sulfate beyond 5 to 7 days to pregnant women can cause fetal harm
- Pregnancy Category D (See WARNINGS and PRECAUTIONS)
- 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.