Magnesium Sulfate in 5% Dextrose Injection 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)

• 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 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)

Supplied in premixed single-dose flexible plastic containers: (3)

• 0.01 grams/mL (1%) in 100 mL flexible plastic container containing 1 gram of magnesium sulfate in 5% dextrose injection

• 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 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 prediabetes 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)

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 1-800-FDA-1088 or www.fda.gov/medwatch.

• Neuromuscular blocking agents: Potentiation 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 Injection: Alcohol, aminoglycosides, amphotericin B, cisplatin, cyclosporine, digitalis, loop diuretics, and thiazide diuretics (7)

Patients with severe renal impairment and/or a urine output less than 100 mL every 4 hours are at greater risk for increased magnesium concentrations that may lead to toxicity (8.6)