magnesium sulfate in 5% dextrose injection, USP How Supplied/Storage and Handling | Pfizer Medical Information - US

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16 HOW SUPPLIED/STORAGE AND HANDLING

Magnesium Sulfate in 5% Dextrose Injection, USP is a clear 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†
* As the heptahydrate; † Osmolarity was calculated.
0.01 grams/mL (1%)	0409-6727-23	100 mL	1 gram	8.1 mEq	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.

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

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magnesium sulfate in 5% dextrose injection, USP Quick Finder

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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1 INDICATIONS AND USAGE

Magnesium Sulfate in 5% Dextrose Injection is indicated for:

Prevention of eclampsia in patients with preeclampsia
Treatment of seizures and prevention of recurrent...

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2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

Magnesium Sulfate in 5% Dextrose Injection is:

A clear solution....

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3 DOSAGE FORMS AND STRENGTHS

Magnesium Sulfate in 5% Dextrose Injection, USP is a clear and colorless to slightly yellow solution supplied in single-dose bags:

0.01 grams per mL (1%):...

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4 CONTRAINDICATIONS

Magnesium Sulfate in 5% Dextrose Injection is contraindicated in patients:

with heart block or myocardial damage
in diabetic coma
with myasthenia gravis...

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5 WARNINGS AND PRECAUTIONS

5.1 Fetal-Neonatal Toxicity with Prolonged Use

Continuous administration of magnesium sulfate beyond 5 to 7 days in pregnant women can lead...

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6 ADVERSE REACTIONS

The following adverse reactions have been identified in clinical studies or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always...

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7 DRUG INTERACTIONS

Table 1 presents the potential clinical impact of medications that may be commonly administered concomitantly with Magnesium Sulfate in 5% Dextrose Injection in the clinical setting.

...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Magnesium Sulfate in 5...

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10 OVERDOSAGE

Manifestations of magnesium toxicity include a drop in blood pressure, difficulty breathing, and disappearance of the patellar reflex. As serum magnesium rises above 4 mEq per liter, the deep tendon reflexes...

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11 DESCRIPTION

Magnesium Sulfate in 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate and dextrose in water for injection for intravenous use. Each 100 mL contains 1 gram of...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Magnesium prevents seizures in patients with preeclampsia and controls seizures in patients with eclampsia by...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with Magnesium Sulfate in 5% Dextrose Injection have not been performed to...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Magnesium Sulfate in 5% Dextrose Injection, USP is a clear solution supplied in single-dose flexible plastic containers (see Table 2).

...

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17 PATIENT COUNSELING INFORMATION

Magnesium Sulfate in 5% Dextrose Injection is typically administered to pregnancy women in emergent situations. When feasible, advise the patient and family of the following:

...

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Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.