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: |
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Intervention: |
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Examples: |
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Narcotics and/or Propofol | |
Clinical Impact: |
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Intervention: |
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Examples: |
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Dihydropyridine Calcium Channel Blockers | |
Clinical Impact: |
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Intervention: |
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Examples: |
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Drugs that May Induce Magnesium Loss | |
Clinical Impact: |
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Intervention: |
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Examples: |
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*For drug incompatibility information [see Dosage and Administration (2.4)].
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