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magnesium sulfate in 5% dextrose injection, USP
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magnesium sulfate in 5% dextrose injection, USP Quick Finder
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...
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
Magnesium Sulfate in 5% Dextrose Injection is:
- A clear solution....
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 flexible plastic containers:
- 0.01 grams per mL...
4 CONTRAINDICATIONS
Magnesium Sulfate in 5% Dextrose Injection is contraindicated in patients:
- with heart block or myocardial damage
- in diabetic coma
- with myasthenia gravis...
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...
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...
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.
...8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Magnesium Sulfate in 5...
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...
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...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Magnesium prevents seizures in patients with preeclampsia and controls seizures in patients with eclampsia by...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies with Magnesium Sulfate in 5% Dextrose Injection have not been performed to...
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:
...To report an adverse event related to a Pfizer product 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 to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
(800)-332-1088.