Magnesium Sulfate in Dextrose (Page 2 of 4)

5.5 Aluminum Toxicity

Magnesium Sulfate in 5% Dextrose Injection contains aluminum that may be toxic (Magnesium Sulfate in 5% Dextrose Injection contains less than 25 mcg/L of aluminum). Aluminum may reach toxic concentrations with prolonged parenteral administration in patients with renal impairment.

Patients with renal impairment who receive parenteral concentrations of aluminum at greater than 4 to 5 mcg/kg/day, accumulate aluminum at concentrations associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

5.6 Exacerbation of Myasthenia Gravis

Magnesium Sulfate in 5% Dextrose Injection is contraindicated in patients with known myasthenia gravis.

Use of magnesium sulfate in patients with underlying myasthenia gravis can precipitate a myasthenic crisis. Myasthenic crisis is a life-threatening condition characterized by neuromuscular respiratory failure. Symptoms of myasthenic crisis may include difficulty swallowing, ptosis, facial droop, weakness and/or difficulty breathing that may require intubation.

If myasthenic crisis is suspected, discontinue use of Magnesium Sulfate in 5% Dextrose Injection immediately. Secure the patient’s airway. Consider intensive care unit admission and elective intubation, if respiratory failure is anticipated. Once the airway is secure, confirm the diagnosis. Therapies include plasmapheresis and plasma exchange or intravenous immunoglobulin (IVIG) and immunomodulating therapy in addition to high-dose glucocorticoids.

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 *

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)].

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