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Questions & Answers

Side Effects & Adverse Reactions

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 even at lower rates of administration.

Parenteral use in the presence of renal insufficiency may lead to magnesium intoxication. IV use in eclampsia should be reserved for immediate control of life-threatening convulsions.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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 level is usually below the lower limit of normal (1.5 to 2.5 mEq/L) and the serum calcium level is normal (4.3 to 5.3 mEq/L) 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 is also indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively.

History

There is currently no drug history available for this drug.

Other Information

Magnesium Sulfate Injection, USP 50% is a sterile, nonpyrogenic, concentrated solution of magnesium sulfate heptahydrate in Water for Injection, USP administered by the intravenous (IV) or intramuscular (IM) routes as an electrolyte replenisher or anticonvulsant. Must be diluted before IV use.

Each mL contains: Magnesium sulfate heptahydrate 500 mg; Water for Injection q.s. Sulfuric acid and/or sodium hydroxide may have been added for pH adjustment. The pH of a 5% solution is 6.0 (5.5 to 7.0). The 50% concentration has an osmolarity of 4.06 mOsmol/mL (calc.); 2.03 mM/mL magnesium sulfate anhydrous and 4.06 mEq/mL magnesium sulfate anhydrous.

The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single dose injection. When smaller doses are required the unused portion should be discarded with the entire unit.

Magnesium sulfate heptahydrate is chemically designated MgSO4 • 7H2O with a molecular weight of 246.47 and occurs as colorless crystals or white powder freely soluble in water.

Amicar Manufacturers


  • Clover Pharmaceuticals Corp.
    Amicar (Aminocaproic Acid) Solution Amicar (Aminocaproic Acid) Tablet [Clover Pharmaceuticals Corp.]

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