NDC 0264-4400 Magnesium Sulfate In Dextrose

Magnesium Sulfate Heptahydrate

NDC Product Code 0264-4400

NDC 0264-4400-54

Package Description: 24 CONTAINER in 1 CASE > 100 mL in 1 CONTAINER

NDC Product Information

Magnesium Sulfate In Dextrose with NDC 0264-4400 is a a human prescription drug product labeled by B. Braun Medical Inc.. The generic name of Magnesium Sulfate In Dextrose is magnesium sulfate heptahydrate. The product's dosage form is injection, solution and is administered via intravenous form.

Labeler Name: B. Braun Medical Inc.

Dosage Form: Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Magnesium Sulfate In Dextrose Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MAGNESIUM SULFATE HEPTAHYDRATE 10 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SULFURIC ACID (UNII: O40UQP6WCF)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Magnesium Ion Exchange Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Inhibition Small Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: B. Braun Medical Inc.
Labeler Code: 0264
FDA Application Number: ANDA207966 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-27-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Magnesium Sulfate In Dextrose Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1 Indications And Usage

  • Magnesium Sulfate in 5% Dextrose Injection is indicated for:Prevention of eclampsia in patients with preeclampsiaTreatment of seizures and prevention of recurrent seizures in patients with eclampsia

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 onlyAdministered via intravenous infusion pumpMagnesium Sulfate in 5% Dextrose Injection does not require dilution prior to intravenous administration.Check for minute leaks by squeezing the container fully. Do not administer Magnesium Sulfate in 5% Dextrose Injection if there is a leak [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.

3 Dosage Forms And Strengths

  • Magnesium Sulfate in 5% Dextrose Injection, USP is a clear and colorless to slightly yellow solution supplied in single-dose bags:0.01 grams per mL (1%): 100 mL bag containing 1 gram of magnesium sulfate in 5% dextrose injectionEach 100 mL contains 5 grams of hydrous dextrose in Water for Injection.

4 Contraindications

  • Magnesium Sulfate in 5% Dextrose Injection is contraindicated in patients:with heart block or myocardial damagein diabetic comawith myasthenia gravis [see Warnings and Precautions (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.

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 bradycardiaCentral Nervous System:central nervous system depression leading to respiratory paralysis, visual disturbances, flushing, sweating, hypothermiaMetabolic:hypocalcemia with signs of tetany, hypermagnesemiaNeurologic:lethargy, sedation, somnolence, myasthenic crisisNeuromuscular:depressed deep tendon reflexes, flaccid paralysisPulmonary: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 InjectionFor drug incompatibility information [see Dosage and Administration (2.4)].Neuromuscular Blocking AgentsClinical 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: succinylcholineNon-depolarizing neuromuscular blockers: atracurium, cisatracurium, pancuronium, rocuronium, vecuroniumNarcotics and/or PropofolClinical 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 propofolDihydropyridine Calcium Channel BlockersClinical 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 nisoldipineDrugs that May Induce Magnesium LossClinical Impact:Reduced magnesium concentrations may impact efficacyIntervention: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

8.2 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.

8.4 Pediatric Use

The safety and effectiveness of Magnesium Sulfate in 5% Dextrose Injection have been established for the prevention of eclampsia in adolescents with preeclampsia and the treatment of seizures and prevention of recurrent seizures in adolescents with eclampsia. Dosing recommendation in pregnant adolescent patients are the same as for pregnant adult patients [see Dosage and Administration (2.2)].

8.6 Renal Impairment

Magnesium is excreted solely by the kidneys. Patients with severe renal impairment (urine output less than 100 mL per 4 hours) are at greater risk for increased magnesium concentrations that may lead to magnesium toxicity [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)]. In patients with severe renal impairment, dosage reduction is recommended and the maximum recommended dosage is lower than patients with normal renal function [see Dosage and Administration (2.3)].

10 Overdosage

Manifestations of magnesium toxicity include a drop in blood pressure, difficulty breathing, and disappearance of the patellar reflex. As serum magnesium rises above 4 mEq per liter, the deep tendon reflexes decrease. As the serum magnesium level approaches 10 mEq per liter, the tendon reflexes disappear and respiratory paralysis may occur [see Warnings and Precautions (5.2)]. Other signs and symptoms of magnesium overdosage include flushing, sweating, hypotension, weakness, hypothermia, circulatory collapse, cardiac and central nervous system depression proceeding to respiratory paralysis, cardiac arrest, and prolongation of PR and QRS intervals. Patients with renal impairment and underlying neuromuscular diseases such as myasthenia gravis may experience magnesium intoxication at lower magnesium concentrations (Magnesium Sulfate in 5% Dextrose Injection is contraindicated in patients with myasthenia gravis).If patient is experiencing magnesium toxicity, immediately discontinue Magnesium Sulfate in 5% Dextrose Injection. Artificial respiration may be required. Administer an injectable calcium salt to counteract the potential hazards of magnesium toxicity [see Warnings and Precautions (5.2)].Hypermagnesemia in the newborn (after administration of Magnesium Sulfate in 5% Dextrose Injection to the mother) may require resuscitation and assisted ventilation via endotracheal intubation or intermittent positive pressure ventilation as well as intravenous calcium.

11 Description

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 MgSO4 ∙ 7H2O, 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 C6H12O6 ∙ H2O and the molecular weight is 198.17. It has the following structural formula:Water for Injection, USP is chemically designated H2O.Not made with natural rubber latex, DEHP or PVC.The plastic container is a copolymer of ethylene and propylene  formulated and developed for parenteral drugs. The copolymer contains no plasticizers. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers.The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set covered by a tamper proof barrier and the other is a blocked port. Refer to the directions for use of the container to properly identify the ports [see How Supplied/Storage and handling (16)].No vapor barrier is necessary.

12.1 Mechanism Of Action

Magnesium prevents seizures in patients with preeclampsia and controls seizures in patients with eclampsia by blocking neuromuscular transmission and decreasing the amount of acetylcholine liberated at the end plate by the motor nerve impulse. Magnesium has a depressant effect on the central nervous system [see Drug Interactions (7)]. Magnesium acts peripherally to produce vasodilation.

12.2 Pharmacodynamics

With intravenous administration of magnesium sulfate the onset of anticonvulsant action is immediate and lasts about 30 minutes. The estimated magnesium concentration (above baseline) required to elicit half-maximum effect (EC50) on systolic and diastolic blood pressure in pregnant women with preeclampsia that received intravenous magnesium sulfate therapy was reported to be 1.5 and 1.8 mEq per liter (1.9 and 2.2 mg per dL), respectively, in a published study. Effective anticonvulsant serum concentrations range from 2.5 to 7.5 mEq per liter.

13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility

Studies with Magnesium Sulfate in 5% Dextrose Injection have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

16 How Supplied/Storage And Handling

Magnesium Sulfate in 5% Dextrose Injection, USP is a clear solution supplied in single-dose 100 mL fill PAB® containers packaged 24 per case (see Table 2).PAB is a registered trademark of B. Braun Medical Inc.Table 2: How Supplied Information Magnesium SulfateAs the heptahydrate; Concentration NDC NumberREF: Container SizePartial fill container 100 mL in 150 mL. Total Magnesium Sulfate Total Magnesium Ion Magnesium Ion Concentration OsmolarityOsmolarity was calculated.0.01 grams/mL (1%)0264-4400-54 D4400-54 100 mL1 gram8.1 mEq8.1 mEq/100 mL333 mOsmol/liter

17 Patient Counseling Information

Magnesium Sulfate in 5% Dextrose Injection is typically administered to pregnancy women in emergent situations. When feasible, advise the patient and family of the following:

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