MAGNESIUM SULFATE IN DEXTROSE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hospira, Inc.

INN (International Name):

MAGNESIUM SULFATE HEPTAHYDRATE

Composition:

MAGNESIUM SULFATE HEPTAHYDRATE 10 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Magnesium Sulfate in 5% Dextrose Injection 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

Product summary:

Magnesium Sulfate in 5% Dextrose Injection, USP is a clear solution supplied in single-dose flexible plastic containers (see Table 2). NDC 0409-6727-23 Case of 24 single-dose flexible plastic containers 1 g/100 mL (10 mg/mL) 1 g 8.1 mEq 0.01 g/mL (1%) 8.1 mEq/100 mL 333 mOsmol/liter NDC 0409-6727-50 Case of 50 single-dose flexible plastic containers 1 g/100 mL (10 mg/mL) 1 g 8.1 mEq 0.01 g/mL (1%) 8.1 mEq/100 mL 333 mOsmol/liter Storage Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

Authorization status:

New Drug Application

Summary of Product characteristics

MAGNESIUM SULFATE IN DEXTROSE- MAGNESIUM SULFATE IN DEXTROSE
INJECTION,
SOLUTION
HOSPIRA, INC.
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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 is indicated for (1):
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Supplied in premixed single-dose flexible plastic containers: (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 PFIZER INC., AT
1-800-438-1985 OR FDA AT
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
hour; do not exceed the
maximum recommended dosage of 2