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Magnesium Sulfate in 5% Dextrose Injection USP | Magnesium Sulfate in 5% Dextrose [Fresenius Kabi USA, LLC] | BioPortfolio

13:39 EST 27th January 2019 | BioPortfolio
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For Intravenous Use Only

Rx only

Magnesium Sulfate in 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate and dextrose in water for injection.  Each 100 mL contains 1 g magnesium sulfate heptahydrate and dextrose, hydrous 5 g in water for injection.  May contain sulfuric acid and/or sodium hydroxide for pH adjustment.  The pH is 4.5 (3.5 to 6.5).  It is available in a 1% concentration.  See HOW SUPPLIED section for the content and characteristics of available dosage form and size.

Magnesium sulfate, USP heptahydrate is chemically designated MgSO • 7HO, colorless crystals or white powder freely soluble in water.

Dextrose, USP is chemically designated D-glucose, monohydrate, a hexose sugar freely soluble in water.  It has the following structural formula:

               

CHO• HO          M.W. 198.17

Water for injection, USP is chemically designated HO.

The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (free flex bag).  The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly.  Solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period.  The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.  Exposure to temperatures above 25ºC/77ºF 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.

Magnesium (Mg) is an important cofactor for enzymatic reactions and plays an important role in neurochemical transmission and muscular excitability.

Magnesium prevents or controls convulsions by blocking neuromuscular transmission and decreasing the amount of acetylcholine liberated at the end plate by the motor nerve impulse.  Magnesium is said to have a depressant effect on the central nervous system, but it does not adversely affect the mother, fetus or neonate when used as directed in eclampsia or pre-eclampsia.  Normal serum magnesium levels range from 1.3 to 2.1 mEq/liter.

As serum magnesium rises above 4 mEq/liter, the deep tendon reflexes are first decreased and then disappear as the serum level approaches 10 mEq/liter.  At this level respiratory paralysis may occur.  Heart block also may occur at this or lower serum levels of magnesium.

Magnesium acts peripherally to produce vasodilation.  With low doses only flushing and sweating occur, but larger doses cause lowering of blood pressure.  The central and peripheral effects of magnesium poisoning are antagonized to some extent by intravenous administration of calcium.

With intravenous administration the onset of anticonvulsant action is immediate and lasts about 30 minutes.  Following intramuscular administration the onset of action occurs in about one hour and persists for three to four hours.  Effective anticonvulsant serum levels range from 2.5 to 7.5 mEq/liter.

Absorption

Intravenously administered magnesium is immediately absorbed.

Distribution

Approximately 1 to 2% of total body magnesium is located in the extracellular fluid space.  Magnesium is 30% bound to albumin.

Metabolism

Magnesium is not metabolized.

Excretion

Magnesium is excreted solely by the kidney at a rate proportional to the serum concentration and glomerular filtration.

Renal Insufficiency

Magnesium is excreted solely by the kidney.  In patients with severe renal insufficiency, the dose should be lower and frequent serum magnesium levels must be obtained (see DOSAGE AND ADMINISTRATION ).

Hepatic Insufficiency

Magnesium is excreted solely by the kidney.  No dosing adjustments are necessary in hepatic insufficiency.

Drug-Drug Interactions

Drug induced renal losses of magnesium occur with the following drugs or drug classes:

            Aminoglycosides             Amphotericin B

            Cyclosporine                    Diuretics

            Digitalis                           Cisplatin

            Alcohol

Magnesium sulfate in 5% dextrose injection, USP is indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively.  When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant.  However, other effective drugs are available for this purpose.

Intravenous magnesium should not be given to mothers with toxemia of pregnancy during the two hours preceding delivery.

FETAL HARM: Continuous administration of magnesium sulfate beyond 5 to 7 days to pregnant women can lead to hypocalcemia and bone abnormalities in the developing fetus.  These bone abnormalities include skeletal demineralization and osteopenia.  In addition, cases of neonatal fracture have been reported.  The shortest duration of treatment that can lead to fetal harm is not known.  Magnesium sulfate should be used during pregnancy only if clearly needed.  If magnesium sulfate is given for treatment of preterm labor, the woman should be informed that the efficacy and safety of such use have not been established and that use of magnesium sulfate beyond 5 to 7 days may cause fetal abnormalities.

Parenteral use in the presence of renal insufficiency may lead to magnesium intoxication.

Because magnesium is removed from the body solely by the kidneys, the drug should be used with caution in patients with renal impairment.  Urine output should be maintained at a level of 100 mL every four hours.  Monitoring serum magnesium levels and the patient’s clinical status is essential to avoid the consequences of overdosage in toxemia.  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/minute).  Serum magnesium levels usually sufficient to control convulsions range from 3 to 6 mg/100 mL (2.5 to 5 mEq/liter).  The strength of the deep tendon reflexes begins to diminish when serum magnesium levels exceed 4 mEq/liter.  Reflexes may be absent at 10 mEq magnesium/liter, where respiratory paralysis is a potential hazard.  An injectable calcium salt should be immediately available to counteract the potential hazards of magnesium intoxication in eclampsia.

Magnesium sulfate in 5% dextrose injection, USP should be administered slowly to avoid producing hypermagnesemia.

Studies with magnesium sulfate in 5% dextrose injection, USP have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Teratogenic Effects

Pregnancy Category D  (see WARNINGS  and PRECAUTIONS )

See WARNINGS and PRECAUTIONS .  

Magnesium sulfate in 5% dextrose injection, USP can cause fetal abnormalities when administered beyond 5 to 7 days to pregnant women.  There are retrospective epidemiological studies and case reports documenting fetal abnormalities such as hypocalcemia, skeletal demineralizations, osteopenia and other skeletal abnormalities with continuous maternal administration of magnesium sulfate for more than 5 to 7 days.  Magnesium sulfate in 5% dextrose injection, USP should be used during pregnancy only if clearly needed.  If this drug is used during pregnancy the woman should be apprised of the potential harm to the fetus.

Nonteratogenic Effects

When administered by continuous IV infusion (especially for more than 24 hours preceding delivery) to control convulsions in a toxemic woman, the newborn may show signs of magnesium toxicity, including neuromuscular or respiratory depression (see OVERDOSAGE ).

Continuous administration of magnesium sulfate is an unapproved treatment for preterm labor.  The safety and efficacy of such use have not been established.  The administration of magnesium sulfate in 5% dextrose injection, USP outside of its approved indication in pregnant women should be by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities.

It is not known whether this drug is excreted in human milk.  Because many drugs are excreted in human milk, caution should be exercised when magnesium sulfate in 5% dextrose injection, USP is administered to a nursing woman.

The adverse effects of parenterally administered magnesium usually are the result of magnesium intoxication.  These include flushing, sweating, hypotension, depressed reflexes, flaccid paralysis, hypothermia, circulatory collapse, cardiac and central nervous system depression proceeding to respiratory paralysis.  Hypocalcemia with signs of tetany secondary to magnesium sulfate therapy for eclampsia has been reported.

Magnesium intoxication is manifested by a sharp drop in blood pressure and respiratory paralysis.  Disappearance of the patellar reflex is a useful clinical sign to detect the onset of magnesium intoxication.  In the event of overdosage, artificial ventilation must be provided until a calcium salt can be injected IV to antagonize the effects of magnesium.

Artificial respiration is often required.  Intravenous calcium, 10 to 20 mL of a 5% solution (diluted if desirable) with isotonic sodium chloride for injection) is used to counteract effects of hypermagnesemia.  Subcutaneous physostigmine, 0.5 to 1 mg may be helpful.

Hypermagnesemia in the newborn may require resuscitation and assisted ventilation via endotracheal intubation or intermittent positive pressure ventilation as well as IV calcium.

Magnesium sulfate in 5% dextrose injection, USP is intended for intravenous use only.  For the management of pre-eclampsia or eclampsia, intravenous infusions of dilute solutions of magnesium (1% to 8%) are often given in combination with intramuscular injections of 50% magnesium sulfate injection, USP.  Therefore, in the clinical conditions cited below, both forms of therapy are noted, as appropriate.  Continuous maternal administration of magnesium sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities.

In severe pre-eclampsia or eclampsia, the total initial dose is 10 to 14 g of magnesium sulfate.  To initiate therapy, 4 g of magnesium sulfate in 5% dextrose injection, USP may be administered intravenously.  The rate of IV infusion should generally not exceed 150 mg/minute, or 7.5 mL of a 2% concentration (or its equivalent) per minute, except in severe eclampsia with seizures.  Simultaneously, 4 to 5 g (32.5 to 40.6 mEq) of magnesium sulfate may be administered intramuscularly into each buttock using undiluted 50% magnesium sulfate injection, USP.  After the initial IV dose, some clinicians administer 1 to 2 g/hour by constant IV infusion.

Subsequent intramuscular doses of 4 to 5 g of magnesium sulfate may be injected into alternate buttocks every four hours, depending on the continuing presence of the patellar reflex, adequate respiratory function, and absence of signs of magnesium toxicity.  Therapy should continue until paroxysms cease.

A serum magnesium level of 6 mg/100 mL is considered optimal for control of seizures.  A total daily (24 hr) dose of 30 to 40 g magnesium sulfate should not be exceeded.  In the presence of severe renal insufficiency, frequent serum magnesium concentrations must be obtained, and the maximum recommended dosage of magnesium sulfate is 20 g per 48 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Do not administer unless solution is clear.  Discard unused portion.

Magnesium Sulfate in 5% Dextrose Injection, USP is supplied in a single-dose flexible plastic container as follows:

*As the heptahydrate.

WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS. The container closure is not made with natural rubber latex.  Non-PVC, Non-DEHP, Sterile.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].  Protect from freezing.

 
Product     

 
No.


 
NDC
 
No.


 
Size Container
 

 
Total
 
Magnesium Sulfate*


 
Total Magnesium Ion
 

 
Magnesium Sulfate*
 
Concentration


 
Magnesium Ion Concentration
 

 
Osmolarity (calc.)
 

 
610801
 

 
63323-108-01     
 

 
100 mL
 

 
1 g
 

 
8.1 mEq
 

 
1% (10 mg/mL)
 

 
8.1 mEq/100 mL
 

 
333 mOsmol/Liter
 

The brand names mentioned in this document are the trademarks of their respective owners.

Manufactured for:

 

Made in Norway

451340A

Revised: February 2015

Magnesium Sulfate 100 mL bag NDC 63323-108-01 Magnesium Sulfate in 5% Dextrose Injection, USP 1 g total in 100 mL    (0.081 mEq Mg/mL)  10 mg per mL For Intravenous Infusion Rx only

Manufacturer

Fresenius Kabi USA, LLC

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