Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Magnesium Sulfate in 5% Dextrose Injection, USP is supplied in a single-dose, single port bag with an aluminum overwrap. The infusion bags and ports are not made with natural rubber latex. NDC Number Packaging Configuration Container Size Total Magnesium Sulfate As the heptahydrate; Total Magnesium Ion Magnesium Sulfate Concentration Magnesium Ion Concentration Osmolarity Osmolarity was calculated. 44567-410-24 24 bags per carton 100 mL 1 gram 8.1 mEq 0.01 grams/mL (1%) 8.1 mEq/100 mL 333 mOsmol/ liter Storage WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] PROTECT FROM FREEZING; PRINCIPAL DISPLAY PANEL - 100 mL Bag Overwrap NDC 44567-410-24 100 mL Magnesium Sulfate in 5% Dextrose Injection, USP (0.081 mEq Mg++/mL) 10 mg/mL 1 g Total Magnesium Sulfate in Dextrose Injection 1 g label image
- 16 HOW SUPPLIED/STORAGE AND HANDLING Magnesium Sulfate in 5% Dextrose Injection, USP is supplied in a single-dose, single port bag with an aluminum overwrap. The infusion bags and ports are not made with natural rubber latex. NDC Number Packaging Configuration Container Size Total Magnesium Sulfate As the heptahydrate; Total Magnesium Ion Magnesium Sulfate Concentration Magnesium Ion Concentration Osmolarity Osmolarity was calculated. 44567-410-24 24 bags per carton 100 mL 1 gram 8.1 mEq 0.01 grams/mL (1%) 8.1 mEq/100 mL 333 mOsmol/ liter Storage WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] PROTECT FROM FREEZING
- PRINCIPAL DISPLAY PANEL - 100 mL Bag Overwrap NDC 44567-410-24 100 mL Magnesium Sulfate in 5% Dextrose Injection, USP (0.081 mEq Mg++/mL) 10 mg/mL 1 g Total Magnesium Sulfate in Dextrose Injection 1 g label image
Overview
Magnesium Sulfate in 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate and dextrose in water for injection for intravenous use. Each 100 mL contains 1 gram of magnesium sulfate heptahydrate and dextrose, hydrous 5 grams in water for injection [see How Supplied/Storage and Handling (16) ] . Magnesium Sulfate in 5% Dextrose Injection, USP may contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). Magnesium Sulfate, USP heptahydrate is chemically known as sulfuric acid magnesium salt (1:1), heptahydrate and chemically designated MgSO 4 ∙ 7H 2 O, with a molecular weight of 246.47. It occurs as colorless crystals or white powder freely soluble in water. Dextrose, USP is chemically designated D-glucose, monohydrate, a hexose sugar freely soluble in water. The molecular formula is C 6 H 12 O 6 ∙ H 2 O and the molecular weight is 198.17. It has the following structural formula: Water for Injection, USP is chemically designated H 2 O. Water can permeate from inside the flexible plastic container (polyvinylchloride) into the overwrap [see Dosage and Administration (2.1) ] but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Chemical Structure
Indications & Usage
Magnesium Sulfate in 5% Dextrose Injection, USP 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, USP 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 )
Dosage & Administration
• 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 ) 2.1 Important Administration Instructions Magnesium Sulfate in 5% Dextrose Injection is: • A clear solution. Visually inspect Magnesium Sulfate in 5% Dextrose Injection for particulate matter and discoloration prior to administration. Do not administer unless solution is clear and colorless to slightly yellow. • For intravenous use only • Administered via intravenous infusion pump Magnesium Sulfate in 5% Dextrose Injection does not require dilution prior to intravenous administration. After removing the overwrap, check for minute leaks by squeezing the container fully. Do not administer Magnesium Sulfate in 5% Dextrose Injection if there is a leak or there is greater than 2 mL of water in the overwrap [see Description (11) ]. Do not administer Magnesium Sulfate in 5% Dextrose Injection with incompatible drugs through the same intravenous line [see Dosage and Administration (2.4) ] . Do not use Magnesium Sulfate in 5% Dextrose Injection in series connections. 2.2 Recommended Dosage • The recommended loading dosage of Magnesium Sulfate in 5% Dextrose Injection in patients with eclampsia or preeclampsia is 4 to 6 grams over 15 minutes followed by a recommended maintenance dosage of 1 to 2 grams every hour. • Obtain serum magnesium concentrations and assess clinical status to adjust the dosage. • In patients with eclampsia, consider targeting the maintenance dosage to achieve serum magnesium concentrations of 3 to 6 mg per 100 mL (2.5 to 5 mEq per liter). For patients with recurrent eclampsia, consider giving an additional 2 gram intravenous bolus. • For patients with eclampsia, therapy should continue until seizures cease. • The maximum recommended dosage is 30 to 40 grams of magnesium sulfate over 24 hours. • Administration of Magnesium Sulfate in 5% Dextrose Injection beyond 5 to 7 days is not recommended [see Warnings and Precautions (5.1) ] . 2.3 Dosage in Patients with Severe Renal Impairment and/or Oliguria • In patients with severe renal impairment and/or a urine output less than 0.5 mL/kg/hour, initiate Magnesium Sulfate in 5% Dextrose Injection with a 4 gram loading dose followed by a maintenance dosage of 1 gram every hour. • Titrate the magnesium sulfate maintenance dosage to maintain concentrations in the target range through frequent monitoring of magnesium concentrations and observation for clinical signs of magnesium toxicity (e.g., facial edema, diminished strength of deep tendon reflexes, respiratory depression). A lower maintenance dosage requirement is likely in these patients. • Do not exceed the maximum recommended dosage of 20 grams of Magnesium Sulfate in 5% Dextrose Injection over 48 hours. 2.4 Drug Incompatibilities Magnesium Sulfate in 5% Dextrose Injection is not compatible with administration of a variety of solutions and forms precipitates of magnesium salts. Before using Magnesium Sulfate in 5% Dextrose Injection with another parenteral product, investigate potential incompatibilities. Incompatible products that should not be coadministered include salicylates and alkali carbonates.
Warnings & 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 ) 5.1 Fetal-Neonatal Toxicity with Prolonged Use Continuous administration of magnesium sulfate beyond 5 to 7 days in pregnant women can lead to hypocalcemia and bone abnormalities in the developing fetus, including skeletal demineralization and osteopenia. In addition, cases of neonatal fracture have been reported. Neonates of women receiving Magnesium Sulfate in 5% Dextrose Injection (especially with prolonged maternal use) are at risk for magnesium toxicity including hyporeflexia, hypotonia, and respiratory depression. There is one reported case of neonatal death as the result of magnesium toxicity after transplacental exposure. The shortest duration of magnesium sulfate treatment that can lead to fetal harm is not known. Administration of Magnesium Sulfate in 5% Dextrose Injection beyond 5 to 7 days is not recommended. 5.2 Risk of Magnesium Toxicity Patients receiving Magnesium Sulfate in 5% Dextrose Injection are at risk for magnesium toxicity including respiratory depression, acute renal failure and rarely, pulmonary edema. Monitor clinical signs of magnesium toxicity (for example, facial edema, diminished strength of deep tendon reflexes, respiratory depression) and magnesium concentrations during infusions of Magnesium Sulfate in 5% Dextrose Injection. Clinical indications of a safe dosage regimen include the presence of the patellar reflex (knee jerk) and absence of respiratory depression (approximately 16 breaths or more per minute). Serum magnesium concentrations usually sufficient to control convulsions range from 3 to 6 mg per 100 mL (2.5 to 5 mEq per liter). The strength of the deep tendon reflexes begins to diminish when serum magnesium concentrations exceed 4 mEq per liter. Reflexes may be absent at concentration of 10 mEq per liter, at which point respiratory paralysis is a potential hazard. An injectable calcium salt should be immediately available to counteract the potential hazards of magnesium toxicity in patients with preeclampsia and eclampsia. If there is significant magnesium toxicity, stop the Magnesium Sulfate in 5% Dextrose Injection infusion and recheck serum magnesium concentration. Patients with renal impairment are at greater risk of magnesium toxicity because magnesium is excreted by the body solely by the kidneys [see Use in Specific Populations (8.6) ] . Urine output should be maintained at a level of 100 mL per 4 hours. Monitoring serum magnesium levels and the patient's clinical status is essential to avoid the consequences of overdosage in patients with preeclampsia. Discontinuation of the magnesium infusion is recommended when urine output is less than 100 mL every 4 hours to avoid magnesium toxicity, especially if serum creatinine is increasing progressively. 5.3 Risk of Elevated Blood Glucose Solutions containing dextrose should be used with caution in patients with known prediabetes or diabetes mellitus given the risk of elevated blood glucose. 5.4 Co-administration with Unapproved Tocolytics Do not use Magnesium Sulfate in 5% Dextrose Injection with unapproved tocolytics (e.g., beta adrenergic agents such as terbutaline, or with calcium channel blockers such as nifedipine). Serious adverse events including pulmonary edema and hypotension have occurred [see Drug Interactions (7) ] . 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.
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 )
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 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 WG Critical Care, LLC at 1-866-562-4708 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 • 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 )
Storage & Handling
Storage WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] PROTECT FROM FREEZING
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