Water for Injection
Therapeutic agent (verify pharmacological class)
What it is used for
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.
Possible side effects
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.
Storage
HOW SUPPLIED Magnesium Sulfate in Water for Injection is clear and colorless solution filled in intravenous bag and are supplied as 2 g/50 mL (40 mg/mL) and 4 g/100 mL (40 mg/mL). Each 50 mL contains 2 g of magnesium sulfate heptahydrate, USP (equivalent to 16.25 mEq magnesium) in water for injection and each 100 mL contains 4 g of magnesium sulfate heptahydrate, USP (equivalent to 32.5 mEq magnesium) in water for injection. It is available as follows: Strength Each Unit of Sale 2 g/50 mL (40 mg/mL) NDC 70121-1719-1 1 Single-dose Intravenous Bag in an Overwrap NDC 70121-1719-9 Unit of 24 NDC 70121-1719-2 Unit of 15 4 g/100 mL (40 mg/mL) NDC 70121-1720-1 1 Single-dose Intravenous Bag in an Overwrap NDC 70121-1720-9 Unit of 24 NDC 70121-1720-3 Unit of 12 For more details, please see below table: NDC No. Size Total Magnesium Sulfate Total Magnesium Ion Magnesium Sulfate Concentration Magnesium Ion Concentration Osmolarity (cal.) 70121-1719-1 50 mL 2 g 16.25 mEq 40 mg/mL 16.25 mEq/50 mL 325 mOsmol/Liter 70121-1720-1 100 mL 4 g 32.5 mEq 40 mg/mL 32.5 mEq/100 mL 325 mOsmol/Liter WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing.
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