FDA

Magnesium Sulfate in Dextrose 5% in Plastic Container

Approved 11 Aug 2020InjectionInjectable

The FDA lists this product in 7 strengths and forms.

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Indications

Magnesium Sulfate in 5% Dextrose Injection is indicated for:

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

Contraindications

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

with heart block or myocardial damage
in diabetic coma
with myasthenia gravis [see Warnings and Precautions (5.6)]
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 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)

Indications

Magnesium Sulfate in 5% Dextrose Injection is indicated for:

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

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 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)

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. Table 1 : Potential Clinically Significant Drug Interactions with Magnesium Sulfate in 5% Dextrose Injection* Neuromuscular Blocking Agents Clinical Impact:

Potentiation and prolongation of neuromuscular blockade is possible with the concomitant use of magnesium sulfate and neuromuscular blocking agents [see Clinical Pharmacology (12.2)] .
The underlying mechanism of this interaction may involve suppression of peripheral neuromuscular function by decreasing acetylcholine release, reduction of endplate sensitivity, and decreased muscle fiber excitability with magnesium sulfate therapy. Intervention:
Monitor respiration and the depth of neuromuscular blockade frequently (e.g., train-of-four monitoring) when a neuromuscular blocking agent is used concomitantly with Magnesium Sulfate in 5% Dextrose Injection.
Adjust the dosage of the neuromuscular blocking agent accordingly to maintain the desired level of musculoskeletal activity. The amount of reversal agent(s) required to achieve adequate reversal of the neuromuscular blocking agent(s) may also be increased. Examples:
Depolarizing neuromuscular blockers: succinylcholine
Non-depolarizing neuromuscular blockers: atracurium, cisatracurium, pancuronium, rocuronium, vecuronium Narcotics and/or Propofol Clinical Impact:
Potentiation and prolongation of analgesia and CNS depression is possible with the concomitant use of Magnesium Sulfate in 5% Dextrose Injection with narcotics and/or propofol. The potential for magnesium sulfate to affect other CNS depressants is unknown [see Clinical Pharmacology (12.2)] .
The underlying mechanism of this interaction may involve antagonism of N-methyl-D-aspartate (NMDA) by magnesium sulfate therapy. Intervention:
Monitor the depth of CNS depression frequently using a reliable instrument.
Adjust the narcotic and/or propofol dosage accordingly to maintain the desired level of analgesia and sedation. Examples:
Narcotics and propofol Dihydropyridine Calcium Channel Blockers Clinical Impact:
An exaggerated hypotensive response is possible with the concomitant use of Magnesium Sulfate in 5% Dextrose Injection with dihydropyridine calcium channel blockers. The potential for magnesium sulfate to affect other calcium channel blockers (e.g., diltiazem and verapamil) is unknown [see Clinical Pharmacology (12.2)] . Intervention:
Monitor vital signs (heart rate, blood pressure, respiration) frequently.
Supportive care and/or discontinuation of the calcium channel blocker may be required. Examples:
Amlodipine, clevidipine, felodipine, isradipine, nicardipine, nifedipine, nimodipine, and nisoldipine Drugs that May Induce Magnesium Loss Clinical Impact:
Reduced magnesium concentrations may impact efficacy Intervention:
Monitor magnesium concentrations frequently and adjust the Magnesium Sulfate in 5% Dextrose Injection dosage to maintain concentrations in the target range [see Dosage and Administration (2)] . Examples:
Alcohol, aminoglycosides, amphotericin B, cisplatin, cyclosporine, digitalis, loop diuretics, thiazide diuretics *For drug incompatibility information [see Dosage and Administration (2.4)] .
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)

Magnesium Sulfate in Dextrose 5% in Plastic Container

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

Magnesium Sulfate in Dextrose 5% in Plastic Container

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

5.1Fetal-Neonatal Toxicity with Prolonged Use

5.2Risk of Magnesium Toxicity

5.3Risk of Elevated Blood Glucose

5.4Co-administration with Unapproved Tocolytics Do

5.5Aluminum Toxicity Magnesium Sulfate in 5% Dextrose

5.6Exacerbation of Myasthenia Gravis Magnesium Sulfate in 5% Dextrose

Interactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary Magnesium Sulfate in 5% Dextrose

Adverse reactions

Composition

Strengths and forms

Official product information

At a glance