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 Inj ection is indicated for (1):
• Prevention of eclampsia in patients with preeclampsia (1)
• Treatment of seizures and prevention of recurrent seizures in patients with
eclampsia (1)
-----------------------DOSAGE AND ADMINISTRATION -----------------------
• 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 imp airment 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)
--------------------- DOSAGE FORMS AND STRENGTHS----------------------
Supplied in premixed single-dose bags: (3)
• 0.01 grams/mL (1%) in 100 mL bag containing 1 gram of magnesium
sulfate in 5% dextrose injection
------------------------------ CONTRAINDICATIONS ------------------------------
• Heart block or myocardial damage (4)
• Diabetic coma (4)
• Myasthenia gravis (4, 5.6)
----------------------- WARNINGS AND PRECAUTIONS------------------------
• Fetal-neonatal toxicity with prolonged use: Administration beyond 5 to
7 days is not recommended and can lead to hypocalcemia and bone
abnormalities (2.2 , 5.1)
• Risk of magnesium toxicity: Monitor magnesium concentrations and
clinical signs of magnesium toxicity including respiratory depression, an
injectable calcium salt should be immediately available to counteract
hazards, for significant toxicity stop Magnesium Sulfate in 5% Dextrose
Injection (5.2)
• Risk of elevated blood glucose: Solutions containing dextrose should be
used with caution in patients with known predi abetes or diabetes mellitus
(5.3)
• Co-administration with unapproved tocolytics: Do not use concomitantly
with beta adrenergic agents such as terbutaline and calcium channel
blockers such as nifedipine (5.4)
• Aluminum toxicity: Aluminum may reach toxic concentrations with
prolonged parenteral administration in patients with renal impairment (5.5)
• Exacerbation of Myasthenia Gravis: Use is contraindicated because use in
patients with underlying myasthenia gravis can precipitate a myasthenic
crisis (5.6)
------------------------------ 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 Hospira, Inc.
at 1-800-441-4100 or FDA at 1 -800-FDA-1088 or www.fda.gov/medwatch.
------------------------------ DRUG INTERACTIONS-------------------------------
• Neuromuscular blocking agents: Potentiat ion and prolongation of
neuromuscular blockade is possible with the concomitant use of
Magnesium Sulfate in 5% Dextrose Injection (7)
• Narcotics and/or propofol: Potentiation and prolongation of analgesia and
CNS depression is possible with the concomitant use of Magnesium Sulfate
in 5% Dextrose Injection (7)
• Dihydropyridine calcium channel blockers: An exaggerated hypotensive
response is possible with the concomitant use of Magnesium Sulfate in 5%
Dextrose Injection (7)
• Drugs that may induce magnesium loss with concomitant use of
Magnesium Sulfate in 5% Dextrose Inj ection: Alcohol, aminoglycosides,
amphotericin B, cisplatin, cyclosporine, digitalis, loop diuretics, and
thiazide diuretics (7)
----------------------- USE IN SPECIFIC POPULATIONS -----------------------
Patients with severe renal impairment and/or a urine output less than 100 m L
every 4 hours are at greater risk for increased magnesium concentrations that
may lead to toxicity (8.6)
See 17 for PATIENT COUNSELING INFORMATION
Revised: 4/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
2.2 Recommended Dosage
2.3 Dos age in Patients with Severe Renal Impairment
and/or Oliguria
2.4 Drug Incompatibilities
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Fetal-Neonatal Toxicity with Prolonged Use
5.2 Risk of Magnesium Toxicity
5.3 Risk of Elevated Blood Glucose
5.4 Co-administration with Unapproved Tocolytics
5.5 Aluminu m Toxicity
5.6 Exacerb ation of Myasthenia Gravis
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.6 Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitt ed from the full prescribing information are
not listed.
1
Reference ID: 4420039
