Magnesium Sulfate In Water For

FDA Drug Profile — Magnesium Sulfate

Drug Details

Generic Name
Magnesium Sulfate In Water For
Brand Names
Magnesium Sulfate
Application Number
ANDA216597
Sponsor
Amneal Pharmaceuticals LLC
NDC Codes
2
Dosage Forms
INJECTION
Routes
INTRAVENOUS
Active Ingredients
MAGNESIUM SULFATE HEPTAHYDRATE

Indications and Usage

INDICATIONS AND USAGE 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.

Warnings

WARNINGS FETAL HARM: Continuous administration of magnesium sulfate beyond 5 to 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 to 7 days may cause fetal abnormalities. Parenteral use in the presence of renal insufficiency may lead to magnesium intoxication.