Magnesium Sulfate in Water
Generic: MAGNESIUM SULFATE IN WATER
Basic Information
Manufacturer
Avenacy, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
f50f4e06-288c-4b5e-9260-f3fe0a210c0c
Indications & 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.
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 5-7 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.
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.
Adverse Reactions
ADVERSE REACTIONS The adverse effects of parenterally administered magnesium usually are the result of magnesium intoxication.
These include flushing, sweating, hypotension, depressed reflexes, flaccid paralysis, hypothermia, circulatory collapse, cardiac and central nervous system depression proceeding to respiratory paralysis.
Hypocalcemia with signs of tetany secondary to magnesium sulfate therapy for eclampsia has been reported.
To report SUSPECTED ADVERSE REACTIONS, contact Avenacy at 1-855-283-6229 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
These include flushing, sweating, hypotension, depressed reflexes, flaccid paralysis, hypothermia, circulatory collapse, cardiac and central nervous system depression proceeding to respiratory paralysis.
Hypocalcemia with signs of tetany secondary to magnesium sulfate therapy for eclampsia has been reported.
To report SUSPECTED ADVERSE REACTIONS, contact Avenacy at 1-855-283-6229 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .