MAGNESIUM SULFATE IN DEXTROSE- magnesium sulfate heptahydrate 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:

Mylan Institutional LLC

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. Th

Product summary:

Magnesium Sulfate in 5% Dextrose Injection, USP is a clear, colorless solution supplied in single-dose flexible plastic containers (see Table 2). Table 2: How Supplied Information Magnesium Sulfate* Concentration NDC Number Container Size Total Magnesium Sulfate* Total Magnesium Ion Magnesium Ion Concentration Osmolarity** 0.01 grams/mL (1%) 67457-567-00 100 mL 1 gram 8.1 mEq 8.1 mEq/100 mL 333 mOsmol/liter *As the heptahydrate; **Osmolarity was calculated Storage Store at 20° to 25°C (68° 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 HEPTAHYDRATE
INJECTION, SOLUTION
MYLAN INSTITUTIONAL 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 is indicated for (1):
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Supplied in premixed single-dose bags: (3)
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
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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 grams to 6 grams over 15 minutes
followed by a recommended maintenance
dosage of 1 grams to 2 grams every hour; maximum recommended dosage is
30 grams 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
20 grams over 48 hours (2.3)
Do not administer Magnesium Sulfate in 5% Dextrose Injection with
incompatible drugs through the same
intravenous line, specifically with salicylates and alkali carbonates
(2.4)
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0.01 grams/mL (1%) in 100 mL bag containing 1 gram of Magnesium
Sulfate in 5% Dextrose Injection, USP
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Heart block or myocardial damage (4)
Diabetic coma (4)
Myasthenia gravis (4, 5.6)
Fetal-neonatal toxicity with prolonged use: Administration beyond 5 to
7 days is not recommended and can lead to
h