Magnesium Sulfate (Page 2 of 4)

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 possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular:

hypotension, circulatory collapse, cardiac depression including bradycardia

Central Nervous System:

central nervous system depression leading to respiratory paralysis, visual disturbances, flushing, sweating, hypothermia

Metabolic:

hypocalcemia with signs of tetany, hypermagnesemia

Neurologic:

lethargy, sedation, somnolence, myasthenic crisis

Neuromuscular:

depressed deep tendon reflexes, flaccid paralysis

Pulmonary:

decreased respiratory rate, pulmonary edema

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.

Table 1: Potential Clinically Significant Drug Interactions with Magnesium Sulfate in 5% Dextrose Injection *
*
For drug incompatibility information [see Dosage and Administration (2.4)].

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

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Magnesium Sulfate in 5% Dextrose Injection is indicated in pregnant women for the prevention of eclampsia in women with preeclampsia and the treatment of seizures and prevention of recurrent seizures in women with eclampsia. Fetal, neonatal, and maternal risks are discussed throughout the labeling.

Clinical Considerations

Labor or Delivery:

Magnesium Sulfate in 5% Dextrose Injection is not approved for the treatment of pre-term labor.

Administration of Magnesium Sulfate in 5% Dextrose Injection to pregnant women longer than 5 to 7 days may lead to hypocalcemia and bone abnormalities in the developing fetus, including skeletal demineralization and osteopenia [see Warnings and Precautions (5.1)].

8.2 Lactation

The use of intravenous magnesium in pregnant women increases human milk magnesium concentrations only slightly and oral absorption of magnesium by the infant is poor. The effect of intravenous magnesium on milk production is unknown. The developmental and health benefits to the neonate of breastfeeding should be considered along with the mother’s clinical need for Magnesium Sulfate in 5% Dextrose Injection and any potential adverse effects on the breastfed infant from Magnesium Sulfate in 5% Dextrose Injection or from the underlying maternal condition.

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