MAGNESIUM SULFATE IN DEXTROSE- magnesium sulfate injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838)

Available from:

WG Critical Care, LLC

INN (International Name):

MAGNESIUM SULFATE HEPTAHYDRATE

Composition:

MAGNESIUM SULFATE HEPTAHYDRATE 1 g in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Magnesium Sulfate in 5% Dextrose Injection, USP is indicated for: Magnesium Sulfate in 5% Dextrose Injection is contraindicated in patients: Risk Summary Magnesium Sulfate in 5% Dextrose Injection is indicated in pregnant women for the prevention of eclampsia in women with preeclampsia and the treatment of seizures and prevention of recurrent seizures in women with eclampsia. Fetal, neonatal, and maternal risks are discussed throughout the labeling. Clinical Considerations Labor or Delivery: Magnesium Sulfate in 5% Dextrose Injection is not approved for the treatment of pre-term labor. Administration of Magnesium Sulfate in 5% Dextrose Injection to pregnant women longer than 5 to 7 days may lead to hypocalcemia and bone abnormalities in the developing fetus, including skeletal demineralization and osteopenia [see Warnings and Precautions (5.1)] . The use of intravenous magnesium in pregnant women increases human milk magnesium concentrations only slightly and oral absorption of magnesium by the infant is poor. The effect of intravenous magnesium on milk production is unknown. The developmental and health benefits to the neonate of breastfeeding should be considered along with the mother's clinical need for Magnesium Sulfate in 5% Dextrose Injection and any potential adverse effects on the breastfed infant from Magnesium Sulfate in 5% Dextrose Injection or from the underlying maternal condition. The safety and effectiveness of Magnesium Sulfate in 5% Dextrose Injection have been established for the prevention of eclampsia in adolescents with preeclampsia and the treatment of seizures and prevention of recurrent seizures in adolescents with eclampsia. Dosing recommendation in pregnant adolescent patients are the same as for pregnant adult patients [see Dosage and Administration (2.2)] . Magnesium is excreted solely by the kidneys. Patients with severe renal impairment (urine output less than 100 mL per 4 hours) are at greater risk for increased magnesium concentrations that may lead to magnesium toxicity [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)] . In patients with severe renal impairment, dosage reduction is recommended and the maximum recommended dosage is lower than patients with normal renal function [see Dosage and Administration (2.3)] .

Product summary:

Magnesium Sulfate in 5% Dextrose Injection, USP is supplied in a single-dose, single port bag with an aluminum overwrap. The infusion bags and ports are not made with natural rubber latex. 44567-410-24 24 bags per carton 100 mL 1 gram 8.1 mEq 0.01 grams/mL (1%) 8.1 mEq/100 mL 333 mOsmol/ liter Storage WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] PROTECT FROM FREEZING

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MAGNESIUM SULFATE IN DEXTROSE- MAGNESIUM SULFATE INJECTION
WG CRITICAL CARE, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MAGNESIUM SULFATE IN
5% DEXTROSE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION.
MAGNESIUM SULFATE IN DEXTROSE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1941
INDICATIONS AND USAGE
Magnesium Sulfate in 5% Dextrose Injection, USP is indicated for (1):
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Supplied in a single-dose, single port bag: (3)
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions are flushing, sweating, hypotension,
depressed reflexes, flaccid
paralysis, hypothermia, circulatory collapse, cardiac and central
nervous system (CNS) depression
proceeding to respiratory paralysis and hypocalcemia. Bradycardia,
pulmonary edema, decreased
respiratory rate, lethargy, sedation, somnolence, visual disturbances,
and hypermagnesemia are also
reported (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT WG CRITICAL CARE, LLC
AT 1-866-562-
4708 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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Prevention of eclampsia in patients with preeclampsia (1)
Treatment of seizures and prevention of recurrent seizures in patients
with eclampsia (1)
Administer via intravenous infusion pump (2.1)
Recommended loading dosage is 4 to 6 grams over 15 minutes followed by
a recommended
maintenance dosage of 1 to 2 grams every hour; maximum recommended
dosage is 30 to 40 grams
over 24 hours (2.2)
Obtain serum magnesium concentrations and assess clinical status to
adjust the dose (2.2)
Administration beyond 5 to 7 days is not recommended (2.2, 5.1)
In patients with severe renal impairment and/or urine output less than
0.5 mL/kg/hour, administer a 4
gram loading dose followed by a maintenance dosage of 1 gram every
ho