Magnesium Sulfate
Generic: MAGNESIUM SULFATE
Basic Information
Manufacturer
Hospira, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAMUSCULAR
FDA Set ID
d4b5863a-efb9-4551-a9ad-2b06e8666d87
Indications & Usage
INDICATIONS AND USAGE Magnesium Sulfate Injection, USP is suitable for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia.
In such cases, the serum magnesium (Mg ++ ) level is usually below the lower limit of normal (1.5 to 2.5 mEq/liter) and the serum calcium (Ca ++ ) level is normal (4.3 to 5.3 mEq/liter) or elevated.
In total parenteral nutrition (TPN), magnesium sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy.
Magnesium Sulfate Injection, USP is also indicated for the prevention and control of seizures (convulsions) in pre-eclampsia and eclampsia, respectively.
In such cases, the serum magnesium (Mg ++ ) level is usually below the lower limit of normal (1.5 to 2.5 mEq/liter) and the serum calcium (Ca ++ ) level is normal (4.3 to 5.3 mEq/liter) or elevated.
In total parenteral nutrition (TPN), magnesium sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy.
Magnesium Sulfate Injection, USP is also indicated for the prevention and control of seizures (convulsions) in pre-eclampsia and eclampsia, respectively.
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.
ALUMINUM TOXICITY: This product contains aluminum that may be toxic.
Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired.
Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity.
Tissue loading may occur at even lower rates of administration.
Parenteral use in the presence of renal insufficiency may lead to magnesium intoxication.
Intravenous use in the eclampsia should be reserved for immediate control of life-threatening convulsions.
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.
ALUMINUM TOXICITY: This product contains aluminum that may be toxic.
Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired.
Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity.
Tissue loading may occur at even lower rates of administration.
Parenteral use in the presence of renal insufficiency may lead to magnesium intoxication.
Intravenous use in the eclampsia should be reserved for immediate control of life-threatening convulsions.
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.
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.