Magnesium Sulfate in Plastic Container

Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.

Intravenous magnesium should not be given to mothers with toxemia of pregnancy during the two hours preceding delivery.

FETAL HARM: Continuous administration of magnesium sulfate beyond 5-7 days to pregnant women can lead to hypocalcemia and bone abnormalities in the developing fetus. These bone abnormalities include skeletal demineralization and osteopenia. In addition, cases of neonatal fracture have been reported. The shortest duration of treatment that can lead to fetal harm is not known. Magnesium sulfate should be used during pregnancy only if clearly needed.

If magnesium sulfate is given for treatment of preterm labor, the woman should be informed that the efficacy and safety of such use have not been established and that use of magnesium sulfate beyond 5-7 days may cause fetal abnormalities. Parenteral use in the presence of renal insufficiency may lead to magnesium intoxication.

Pregnancy (See WARNINGS and PRECAUTIONS) Teratogenic Effects Magnesium Sulfate in Water for Injection can cause fetal abnormalities when administered beyond 5-7 days to pregnant women. There are retrospective epidemiological studies and case reports documenting fetal abnormalities such as hypocalcemia, skeletal demineralization’s, osteopenia and other skeletal abnormalities with continuous maternal administration of magnesium sulfate for more than 5-7 days. 1-12 Magnesium Sulfate in Water for Injection should be used during pregnancy only if clearly needed.