Magnesium Sulfate

Magnesium Sulfate
SPL v29
SPL
SPL Set ID 22ca78b4-f5a3-4144-cf89-5f633acf1e6d
Route
INTRAVENOUS
Published
Effective Date 2022-12-27
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Magnesium Cation (80 mg)
Inactive Ingredients
Water Sulfuric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status
NDA Completed Since 2022-12-27 Until 2024-02-01
Description

Flexible Plastic Container For Intravenous Use Only Rx only

Indications and Usage

Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia 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.

Dosage and Administration

Magnesium Sulfate in Water for Injection 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 5-7 days can cause fetal abnormalities. In Eclampsia 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 Water for Injection may be administered intravenously. The rate of I.V. infusion should generally not exceed 150 mg/minute, or 3.75 mL of a 4% 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 I.V. dose, some clinicians administer 1 to 2 g/hour by constant I.V. 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 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.

Contraindications

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

Adverse Reactions

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.

How Supplied

Magnesium Sulfate in Water for Injection is supplied in single-dose flexible plastic containers as follows: NDC Number (Unit of Sale) Concentration Total Magnesium Sulfate As the heptahydrate. Total Magnesium Ion Magnesium Sulfate Concentration Magnesium Ion Concentration Osmolarity (calc.) NDC 0409-6729-23 Case of 24 single-dose flexible plastic containers 4 g/100 mL (40 mg/mL) 4 g 32.5 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 mOsmol/Liter NDC 0409-4121-50 Case of 50 single-dose flexible plastic containers 4 g/100 mL (40 mg/mL) 4 g 32.5 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 mOsmol/Liter NDC 0409-6729-03 Case of 24 single-dose flexible plastic containers 20 g/500 mL (40 mg/mL) 20 g 162.3 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 mOsmol/Liter NDC 0409-2050-20 Case of 20 single-dose flexible plastic containers 20 g/500 mL (40 mg/mL) 20 g 162.3 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 mOsmol/Liter NDC 0409-6729-09 Case of 12 single-dose flexible plastic containers 40 g/1000 mL (40 mg/mL) 40 g 325 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 mOsmol/Liter NDC 0409-3164-12 Case of 12 single-dose flexible plastic containers 40 g/1000 mL (40 mg/mL) 40 g 325 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 mOsmol/Liter NDC 0409-6729-24 Case of 24 single-dose flexible plastic containers 2 g/50 mL Partial fill container 50 mL volume in 100 mL container. (40 mg/mL) 2 g 16.25 mEq 4% (40 mg/mL) 16.25 mEq/50 mL 325 mOsmol/Liter NDC 0409-5239-60 Case of 60 single-dose flexible plastic containers 2 g/50 mL (40 mg/mL) 2 g 16.25 mEq 4% (40 mg/mL) 16.25 mEq/50 mL 325 mOsmol/Liter NDC 0409-6730-13 Case of 24 single-dose flexible plastic containers 4 g/50 mL (80 mg/mL) 4 g 32.5 mEq 8% (80 mg/mL) 32.5 mEq/50 mL 649 mOsmol/Liter NDC 0409-6730-60 Case of 60 single-dose flexible plastic containers 4 g/50 mL (80 mg/mL) 4 g 32.5 mEq 8% (80 mg/mL) 32.5 mEq/50 mL 649 mOsmol/Liter WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

Medication Information

Indications and Usage

Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia 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.

Dosage and Administration

Magnesium Sulfate in Water for Injection 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 5-7 days can cause fetal abnormalities.

In Eclampsia

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 Water for Injection may be administered intravenously. The rate of I.V. infusion should generally not exceed 150 mg/minute, or 3.75 mL of a 4% 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 I.V. dose, some clinicians administer 1 to 2 g/hour by constant I.V. 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 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.

Contraindications

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

Adverse Reactions

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.

How Supplied

Magnesium Sulfate in Water for Injection is supplied in single-dose flexible plastic containers as follows:

NDC Number

(Unit of Sale)

Concentration

Total Magnesium Sulfate

As the heptahydrate.

Total Magnesium Ion

Magnesium Sulfate

Concentration

Magnesium Ion Concentration

Osmolarity (calc.)

NDC 0409-6729-23

Case of 24 single-dose flexible plastic containers

4 g/100 mL

(40 mg/mL)

4 g

32.5 mEq

4% (40 mg/mL)

32.5 mEq/100 mL

325 mOsmol/Liter

NDC 0409-4121-50

Case of 50 single-dose flexible plastic containers

4 g/100 mL

(40 mg/mL)

4 g

32.5 mEq

4% (40 mg/mL)

32.5 mEq/100 mL

325 mOsmol/Liter

NDC 0409-6729-03

Case of 24 single-dose flexible plastic containers

20 g/500 mL

(40 mg/mL)

20 g

162.3 mEq

4% (40 mg/mL)

32.5 mEq/100 mL

325 mOsmol/Liter

NDC 0409-2050-20

Case of 20 single-dose flexible plastic containers

20 g/500 mL

(40 mg/mL)

20 g

162.3 mEq

4% (40 mg/mL)

32.5 mEq/100 mL

325 mOsmol/Liter

NDC 0409-6729-09

Case of 12 single-dose flexible plastic containers

40 g/1000 mL

(40 mg/mL)

40 g

325 mEq

4% (40 mg/mL)

32.5 mEq/100 mL

325 mOsmol/Liter

NDC 0409-3164-12

Case of 12 single-dose flexible plastic containers

40 g/1000 mL

(40 mg/mL)

40 g

325 mEq

4% (40 mg/mL)

32.5 mEq/100 mL

325 mOsmol/Liter

NDC 0409-6729-24

Case of 24 single-dose flexible plastic containers

2 g/50 mL

Partial fill container 50 mL volume in 100 mL container.


(40 mg/mL)

2 g

16.25 mEq

4% (40 mg/mL)

16.25 mEq/50 mL

325 mOsmol/Liter

NDC 0409-5239-60

Case of 60 single-dose flexible plastic containers

2 g/50 mL



(40 mg/mL)

2 g

16.25 mEq

4% (40 mg/mL)

16.25 mEq/50 mL

325 mOsmol/Liter

NDC 0409-6730-13

Case of 24 single-dose flexible plastic containers

4 g/50 mL



(80 mg/mL)

4 g

32.5 mEq

8% (80 mg/mL)

32.5 mEq/50 mL

649 mOsmol/Liter

NDC 0409-6730-60

Case of 60 single-dose flexible plastic containers

4 g/50 mL



(80 mg/mL)

4 g

32.5 mEq

8% (80 mg/mL)

32.5 mEq/50 mL

649 mOsmol/Liter

WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS.

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

Description

Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate 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 4% and 8% concentrations. See  HOW SUPPLIED section for the content and characteristics of available dosage forms and sizes.

Magnesium Sulfate, USP heptahydrate is chemically designated MgSO4 • 7H2O, colorless crystals or white powder freely soluble in water.

Water for Injection, USP is chemically designated H2O.

Water can permeate from inside the flexible plastic container into the overwrap 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.

Warnings

FETAL HARM: Continuous administration of magnesium sulfate beyond 5-7 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 5-7 days may cause fetal abnormalities.

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

Pregnancy

(See  WARNINGS and PRECAUTIONS )

Overdosage

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.

For Treatment of Overdose

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.

References
  • 1.
    Yokoyama K, Takahashi N, Yada Y. Prolonged maternal magnesium administration and bone metabolism in neonates. Early Human Dev. 2010; 86(3):187-91. Epub 2010 Mar 12.
  • 2.
    Wedig KE, Kogan J, Schorry EK et al. Skeletal demineralization and fractures caused by fetal magnesium toxicity. J Perinatol. 2006; 26(6):371-4.
  • 3.
    Nassar AH, Sakhel K, Maarouf H, et al. Adverse maternal and neonatal outcome of prolonged course of magnesium sulfate tocolysis. Acta Obstet Gynecol Scan. 2006;85(9):1099-103.
  • 4.
    Malaeb SN, Rassi A, Haddad MC. Bone mineralization in newborns whose mothers received magnesium sulphate for tocolysis of premature labor. Pediatr Radiol. 2004;34(5):384-6. Epub 2004 Feb 18.
  • 5.
    Matsuda Y, Maeda Y, Ito M, et al. Effect of magnesium sulfate treatment on neonatal bone abnormalities. Gynecol Obstet Invest. 1997; 44(2):82-8.
  • 6.
    Schanler RJ, Smith LG, Burns PA. Effects of long-term maternal intravenous magnesium sulfate therapy on neonatal calcium metabolism and bone mineral content. Gynecol Obstet Invest. 1997; 43(4):236-41.
  • 7.
    Santi MD, Henry GW, Douglas GL. Magnesium sulfate treatment of preterm labor as a cause of abnormal neonatal bone mineralization. J Pediatr Orthop. 1994; 14(2):249-53.
  • 8.
    Holocomb WL, Shackelford GD, Petrie RH. Magnesium tocolysis and neonatal bone abnormalities: a controlled study. Obstet Gynecol. 1991; 78(4):611-4.
  • 9.
    Cumming WA, Thomas VJ. Hypermagnesemia: a cause of abnormal metaphyses in the neonate. Am J Roentgenol. 1989; 152(5):1071-2.
  • 10.
    Lamm CL, Norton KL, Murphy RJ. Congenital rickets associated with magnesium sulfate infusion for tocolysis. J Pediatr. 1988; 113(6):1078-82.
  • 11.
    McGuinness GA, Weinstein MM, Cruikshank DP, et al. Effects of magnesium sulfate treatment on perinatal calcium metabolism. II. Neonatal responses. Obstet Gynecol. 1980;56(5):595-600.
  • 12.
    Riaz M, Porat R, Brodsky NL, et al. The effect of maternal magnesium sulfate treatment on newborns: a prospective controlled study. J Perinatol. 1998; 18(6 pt 1):449-54.

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

LAB-1087-3.0

Revised: 03/2022

     

Flexible Plastic Container

For Intravenous Use Only

Rx only

Precautions

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 Water for Injection should be administered slowly to avoid producing hypermagnesemia.

Nursing Mothers

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 Water for Injection is administered to a nursing mother.

Labor and Delivery

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 Water for Injection outside of its approved indication in pregnant women should be by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities.

Teratogenic Effects

Magnesium Sulfate in Water for Injection, can cause fetal abnormalities when administered beyond 5-7 days to pregnant women. There are retrospective epidemiological studies and case reports documenting fetal abnormalities such as hypocalcemia, skeletal demineralization’s, osteopenia and other l skeletal abnormalities with continuous maternal administration of magnesium sulfate for more than 5-7 days.1-12 Magnesium Sulfate in Water for Injection 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.

Clinical Pharmacology

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.

Pharmacokinetics:

Absorption: Intravenously administered magnesium is immediately absorbed.

Distribution: Approximately 1-2% 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.

Special Populations:

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

Cyclosporine

Digitalis

Alcohol

Amphotericin B

Diuretics

Cisplatin
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. )

Principal Display Panel 50 Ml Bag Label

50 mL

NDC 0409-6730-11

MAGNESIUM SULFATE

IN WATER FOR INJECTION

4 g/50 mL (80 mg/mL)

4g

TOTAL

EACH 50 mL CONTAINS MAGNESIUM SULFATE

HEPTAHYDRATE 4 g (EQUIVALENT TO 32.5 mEq

MAGNESIUM) IN WATER FOR INJECTION. MAY

CONTAIN SULFURIC ACID AND/OR SODIUM

HYDROXIDE FOR pH ADJUSTMENT.

pH 4.5 (3.5 to 6.5) 649 mOsmol/LITER (CALC.)

SINGLE-DOSE CONTAINER. DISCARD UNUSED

PORTION. FOR INTRAVENOUS USE.

RECOMMENDED DOSAGE: SEE PRESCRIBING

INFORMATION. STERILE, NONPYROGENIC. USE

ONLY IF SOLUTION IS CLEAR AND CONTAINER IS

UNDAMAGED. MUST NOT BE USED IN SERIES

CONNECTIONS.

Rx ONLY

IM-5199

3

V

CONTAINS DEHP

Hospira

DISTRIBUTED BY

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Principal Display Panel 100 Ml Bag Label

100 mL

NDC 0409-6729-41

MAGNESIUM SULFATE

IN WATER FOR INJECTION

4 g/100 mL (40 mg/mL)

4g

TOTAL

EACH 100 mL CONTAINS MAGNESIUM SULFATE

HEPTAHYDRATE 4 g (EQUIVALENT TO 32.5 mEq

MAGNESIUM) IN WATER FOR INJECTION. MAY

CONTAIN SULFURIC ACID AND/OR SODIUM

HYDROXIDE FOR pH ADJUSTMENT.

pH 4.5 (3.5 to 6.5) 325 mOsmol/LITER (CALC.)

SINGLE-DOSE CONTAINER. DISCARD UNUSED

PORTION. FOR INTRAVENOUS USE.

RECOMMENDED DOSAGE: SEE PRESCRIBING

INFORMATION. STERILE, NONPYROGENIC. USE

ONLY IF SOLUTION IS CLEAR AND CONTAINER IS

UNDAMAGED. MUST NOT BE USED IN SERIES

CONNECTIONS.

Rx ONLY

IM-5198

3

V

CONTAINS DEHP

Hospira

DISTRIBUTED BY

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Principal Display Panel 500 Ml Bag Label

500 mL

NDC 0409-6729-21

20 g

TOTAL

MAGNESIUM

SULFATE

IN WATER FOR INJECTION

20 g/500 mL (40 mg/mL)

EACH 100 mL CONTAINS MAGNESIUM SULFATE

HEPTAHYDRATE 4 g (EQUIVALENT TO 32.5 mEq

MAGNESIUM) IN WATER FOR INJECTION. MAY CONTAIN

SULFURIC ACID AND/OR SODIUM HYDROXIDE FOR pH

ADJUSTMENT.

pH 4.5 (3.5 to 6.5)

325 mOsmol/LlTER (CALC.)

SINGLE-DOSE CONTAINER. DISCARD UNUSED PORTION.

FOR INTRAVENOUS USE. RECOMMENDED DOSAGE: SEE

PRESCRIBING INFORMATION. STERILE, NONPYROGENIC.

USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS

UNDAMAGED. MUST NOT BE USED IN SERIES

CONNECTIONS.

Rx ONLY

3

V

CONTAINS DEHP

Hospira

IM-5196

DISTRIBUTED BY

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Principal Display Panel 1000 Ml Bag Label

1000 mL

NDC 0409-6729-31

MAGNESIUM

SULFATE

IN WATER FOR

INJECTION

40 g

TOTAL

40 g/1000 mL (40 mg/mL)

EACH 100 mL CONTAINS MAGNESIUM

SULFATE HEPTAHYDRATE 4 g (EQUIVALENT

TO 32.5 mEq MAGNESIUM) IN WATER FOR

INJECTION. MAY CONTAIN SULFURIC ACID

AND/OR SODIUM HYDROXIDE FOR pH

ADJUSTMENT.

pH 4.5 (3.5 to 6.5)

325 mOsmol/LITER (CALC.)

SINGLE-DOSE CONTAINER. DISCARD

UNUSED PORTION. FOR INTRAVENOUS

USE. RECOMMENDED DOSAGE: SEE

PRESCRIBING INFORMATION. STERILE,

NONPYROGENIC. USE ONLY IF SOLUTION

IS CLEAR AND CONTAINER IS

UNDAMAGED. MUST NOT BE USED IN

SERIES CONNECTIONS.

Rx ONLY

3

V

CONTAINS DEHP

DISTRIBUTED BY

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

IM-5197

Hospira

Principal Display Panel 2 G/50 Ml Bag Label

50 mL

NDC 0409-6729-11

MAGNESIUM SULFATE

IN WATER FOR INJECTION

2g

TOTAL

2 g/50 mL (40 mg/mL)

EACH 50 mL CONTAINS MAGNESIUM SULFATE

HEPTAHYDRATE 2 g (EQUIVALENT TO 16.25 mEq

MAGNESIUM) IN WATER FOR INJECTION. MAY

CONTAIN SULFURIC ACID AND/OR SODIUM

HYDROXIDE FOR pH ADJUSTMENT.

pH 4.5 (3.5 to 6.5) 325 mOsmol/LITER (CALC.)

SINGLE-DOSE CONTAINER. DISCARD UNUSED

PORTION. FOR INTRAVENOUS USE.

RECOMMENDED DOSAGE: SEE PRESCRIBING

INFORMATION. STERILE, NONPYROGENIC. USE

ONLY IF SOLUTION IS CLEAR AND CONTAINER IS

UNDAMAGED. MUST NOT BE USED IN SERIES

CONNECTIONS.

Rx ONLY

3

V

CONTAINS DEHP

Hospira

IM-5195

DISTRIBUTED BY HOSPIRA, INC.,

LAKE FOREST, IL 60045 USA

Principal Display Panel 4 G/100 Ml Bag Label

100 mL

NDC 0409-4121-01

Magnesium Sulfate

in Water for Injection

4 g

TOTAL

4 g/100 mL (40 mg/mL)

Each 100 mL contains magnesium sulfate heptahydrate 4 g (equivalent to

32.5 mEq magnesium) in water for injection. May contain sulfuric acid

and/or sodium hydroxide for pH adjustment.

pH 4.5 (3.5 to 6.5)

325 mOsmol/liter (CALC.)

Single-dose container. Discard unused portion. For intravenous use.

Recommended dosage: see prescribing information. Sterile, nonpyrogenic.

Use only if solution is clear and container is undamaged. Must not be used in

series connections.

Rx ONLY

5

PP

Distributed by Hospira, Inc.,

Lake Forest, IL 60045 USA

Hospira

12137-02

LOT:12345678

EXP:mm-yyyy

Principal Display Panel 20 G/500 Ml Bag Label

500 mL

NDC 0409-2050-01

Magnesium

Sulfate

in Water for Injection

20 g

TOTAL

20 g/500 mL (40 mg/mL)

Each 100 mL contains magnesium sulfate heptahydrate

4 g (equivalent to 32.5 mEq magnesium) in water for

injection. May contain sulfuric acid and/or sodium

hydroxide for pH adjustment. pH 4.5 (3.5 to 6.5)

325 mOsmol/Liter (CALC.)

Single-dose container. Discard unused portion. For

intravenous use. Recommended dosage: see prescribing

information. Sterile, nonpyrogenic. Use only if solution is

clear and container is undamaged. Must not be used in

series connections. Inspect bag by squeezing firmly. If

leaks are found, discard.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room

Temperature.] Protect from freezing.

Do not remove from overwrap until ready for use.

Rx ONLY

5

PP

Hospira

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

12145-02

LOT:12345678

EXP:mm-yyyy

Principal Display Panel 50 Ml Bag Pouch Label

50 mL

TO OPEN – TEAR AT NOTCH

NDC 0409-6730-11

MAGNESIUM SULFATE

IN WATER FOR INJECTION

4 g/50 mL (80 mg/mL)

4g

TOTAL

Each 50 mL contains magnesium sulfate heptahydrate 4 g (equivalent to 32.5 mEq

magnesium) in water for injection. May contain sulfuric acid and/or sodium hydroxide

for pH adjustment.

649 mOsmol/Liter (CALC.)

pH 4.5 (3.5 to 6.5)

DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER POSSIBLE USE CENTRAL

ROUTE.

Single-dose container. For intravenous use. Recommended dosage: See prescribing

information. Sterile, nonpyrogenic. Use only if solution is clear. After removing the

overwrap, check for minute leaks by squeezing container firmly. If leaks are found,

discard unit as sterility may be impaired. Must not be used in series connections.

The overwrap is a moisture barrier. Do not remove unit from overwrap until ready for

use. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP

Controlled Room Temperature.] Protect from freezing. See prescribing information.

Not Made With Natural Rubber Latex.

Rx only

7

OTHER

Distributed by

Hospira, Inc., Lake Forest, IL 60045 USA

F WR-1551

Hospira

Principal Display Panel 100 Ml Bag Pouch Label

100 mL

TO OPEN – TEAR AT NOTCH

NDC 0409-6729-41

MAGNESIUM SULFATE

IN WATER FOR INJECTION

4 g/100 mL (40 mg/mL)

4g

TOTAL

Each 100 mL contains magnesium sulfate heptahydrate 4 g (equivalent to 32.5 mEq

magnesium) in water for injection. May contain sulfuric acid and/or sodium hydroxide

for pH adjustment.

325 mOsmol/Liter (CALC.)

pH 4.5 (3.5 to 6.5)

DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER POSSIBLE USE CENTRAL

ROUTE.

Single-dose container. For intravenous use. Recommended dosage: See prescribing

information. Sterile, nonpyrogenic. Use only if solution is clear. After removing the

overwrap, check for minute leaks by squeezing container firmly. If leaks are found,

discard unit as sterility may be impaired. Must not be used in series connections.

The overwrap is a moisture barrier. Do not remove unit from overwrap until ready for

use. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP

Controlled Room Temperature.] Avoid excessive heat. Protect from freezing. See

prescribing information.

Not Made With Natural Rubber Latex.

Rx only

7

OTHER

Distributed by

Hospira, Inc., Lake Forest, IL 60045 USA

F WR-1550

Hospira

Principal Display Panel 40 G/1000 Ml Bag Label

1000 mL

NDC 0409-3164-01

Magnesium

Sulfate

in Water for Injection

40 g

TOTAL

40 g/1000 mL (40 mg/mL)

Each 100 mL contains magnesium sulfate

heptahydrate 4 g (equivalent to 32.5 mEq

magnesium) in water for injection. May

contain sulfuric acid and/or sodium hydroxide

for pH adjustment. pH 4.5 (3.5 to 6.5)

325 mOsmol/Liter (CALC.)

Single-dose container. Discard unused portion.

For intravenous use.

Recommended dosage:

See prescribing information.

Sterile, nonpyrogenic. Use only if solution is

clear and container is undamaged. Must not

be used in series connections.

Inspect bag by squeezing firmly.

If leaks are found, discard.

Store at 20 to 25°C (68 to 77°F).

[See USP Controlled Room

Temperature.] Protect from freezing.

Do not remove from overwrap until ready for use.

Rx ONLY

5

PP

Distributed by Hospira, Inc.

Lake Forest, IL 60045 USA

Hospira

12146-02

LOT:12345678

EXP:mm-yyyy

Principal Display Panel 50 Ml Bag Overwrap Back

Magnesium

Sulfate

in Water for Injection

4 g/50 mL

(80 mg/mL)

4 g

TOTAL

13088-01

Principal Display Panel 100 Ml Bag Overwrap Back

Magnesium

Sulfate

in Water for Injection

4 g/100 mL

(40 mg/mL)

4 g

TOTAL

13097-01

Principal Display Panel 2 G/50 Ml Bag Pouch Label

50 mL

TO OPEN – TEAR AT NOTCH

NDC 0409-6729-11

MAGNESIUM SULFATE

IN WATER FOR INJECTION

2 g

TOTAL

2 g/50 mL (40 mg/mL)

Each 50 mL contains magnesium sulfate heptahydrate 2 g (equivalent to 16.25 mEq

magnesium) in water for injection. May contain sulfuric acid and/or sodium hydroxide

for pH adjustment.

325 mOsmol/Liter (CALC.)

pH 4.5 (3.5 to 6.5)

DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER POSSIBLE USE CENTRAL

ROUTE.

Single-dose container. For intravenous use. Recommended dosage: See prescribing

information. Sterile, nonpyrogenic. Use only if solution is clear. After removing the

overwrap, check for minute leaks by squeezing container firmly. If leaks are found,

discard unit as sterility may be impaired. Must not be used in series connections.

The overwrap is a moisture barrier. Do not remove unit from overwrap until ready for

use. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP

Controlled Room Temperature.] Protect from freezing. See prescribing information. Not

Made With Natural Rubber Latex

Rx only

7

OTHER

Distributed by

Hospira, Inc., Lake Forest, IL 60045 USA

F WR-1549

Hospira

Carcinogenesis, Mutagenesis, Impairment of Fertility

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

Principal Display Panel 4 G/100 Ml Bag Pouch Label

100 mL

NDC 0409-4121-01

Magnesium Sulfate

in Water for Injection

4 g/100 mL (40 mg/mL)

4 g

TOTAL

Each 100 mL contains magnesium sulfate heptahydrate 4 g

(equivalent to 32.5 mEq magnesium) in water for injection. May

contain sulfuric acid and/or sodium hydroxide for pH adjustment.

325 mOsmol/Liter (CALC.)

pH 4.5 (3.5 to 6.5)

DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER

POSSIBLE USE CENTRAL ROUTE.

Single-dose container. For intravenous use. Recommended dosage:

See prescribing information. Sterile, nonpyrogenic. Use only if

solution is clear. After removing the overwrap, check for minute

leaks by squeezing container firmly. If leaks are found, discard unit

as sterility may be impaired. Must not be used in series connections.

The overwrap is a moisture barrier. Do not remove unit from overwrap

until ready for use. Use unit promptly when pouch is opened. Store at

20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Avoid

excessive heat. Protect from freezing. See prescribing information.

Not Made With Natural Rubber Latex

Rx ONLY

7

OTHER

Distributed by Hospira, Inc.,

Lake Forest, IL 60045 USA

Hospira

13093-01

Principal Display Panel 2 G/50 Ml Bag Overwrap Back

Magnesium

Sulfate

in Water for Injection

2 g/50 mL

(40 mg/mL)

2 g

TOTAL

13091-01

Principal Display Panel 40 Mg/ml Bag Overwrap 500 Ml

TO OPEN TEAR AT NOTCH

2

HDPE

DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING

THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY.

IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED.

RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE

HEAT. PROTECT FROM FREEZING. SEE INSERT.

98-4321-R14-3/98

Principal Display Panel 2 G/50 Ml Bag Label 0409 5239

50 mL

NDC 0409-5239-01

Magnesium Sulfate

in Water for Injection

2 g

TOTAL

2 g/50 mL (40 mg/mL)

Each 50 mL contains magnesium sulfate heptahydrate 2 g (equivalent to

16.25 mEq magnesium) in water for injection. May contain sulfuric acid

and/or sodium hydroxide for pH adjustment.

pH 4.5 (3.5 to 6.5)

325 mOsmol/liter (CALC.)

Single-dose container. Discard unused portion. For intravenous use.

Recommended dosage: see prescribing information. Sterile, nonpyrogenic.

Use only if solution is clear and container is undamaged. Must not be used in

series connections.

Rx ONLY

5

PP

Distributed by Hospira, Inc.,

Lake Forest, IL 60045 USA

Hospira

12136-02

LOT:12345678

EXP:mm-yyyy

Principal Display Panel 40 Mg/ml Bag Overwrap 1000 Ml

TO OPEN TEAR AT NOTCH

2

HDPE

DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING

THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY.

IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED.

RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE

HEAT. PROTECT FROM FREEZING. SEE INSERT.

98-4321-R14-3/98

Principal Display Panel 50 Ml Bag Label Ndc 0409 6730 50

50 mL

NDC 0409-6730-50

Magnesium Sulfate

in Water for Injection

4 g/50 mL (80 mg/mL)

4g

TOTAL

Each 50 mL contains magnesium sulfate heptahydrate 4 g (equivalent to

32.5 mEq magnesium) in water for injection. May contain sulfuric acid

and/or sodium hydroxide for pH adjustment.

pH 4.5 (3.5 to 6.5)

649 mOsmol/Liter (CALC.)

Single-dose container. Discard unused portion. For intravenous use.

Recommended dosage: See prescribing information. Sterile, nonpyrogenic.

Use only if solution is clear and container is undamaged. Must not be used in

series connections.

Rx ONLY

5

PP

Distributed by Hospira, Inc.,

Lake Forest, IL 60045 USA

Hospira

12165-02

LOT:12345678

EXP:mm-yyyy

Principal Display Panel 2 G/50 Ml Bag Pouch Label 0409 5239

50 mL

NDC 0409-5239-01

Magnesium Sulfate

in Water for Injection

2 g/50 mL (40 mg/mL)

2 g

TOTAL

Each 50 mL contains magnesium sulfate heptahydrate 2 g

(equivalent to 16.25 mEq magnesium) in water for injection. May

contain sulfuric acid and/or sodium hydroxide for pH adjustment.

325 mOsmol/Liter (CALC.)

pH 4.5 (3.5 to 6.5)

DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER

POSSIBLE USE CENTRAL ROUTE.

Single-dose container. For intravenous use. Recommended dosage:

See prescribing information. Sterile, nonpyrogenic. Use only if

solution is clear. After removing the overwrap, check for minute leaks

by squeezing container firmly. If leaks are found, discard unit as

sterility may be impaired. Must not be used in series connections.

The overwrap is a moisture barrier. Do not remove unit from overwrap

until ready for use. Use unit promptly when pouch is opened. Store at

20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Protect from freezing. See prescribing information.

Not Made With Natural Rubber Latex

Rx ONLY

7

OTHER

Distributed by Hospira, Inc.,

Lake Forest, IL 60045 USA

Hospira

13092-01

Principal Display Panel 50 Ml Bag Pouch Label Ndc 0409 6730 50

50 mL

NDC 0409-6730-50

Magnesium Sulfate

in Water for Injection

4 g/50 mL (80 mg/mL)

4 g

TOTAL

Each 50 mL contains magnesium sulfate heptahydrate 4 g

(equivalent to 32.5 mEq magnesium) in water for injection. May

contain sulfuric acid and/or sodium hydroxide for pH adjustment.

649 mOsmol/Liter (CALC.)

pH 4.5 (3.5 to 6.5)

DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER

POSSIBLE USE CENTRAL ROUTE.

Single-dose container. For intravenous use. Recommended dosage:

See prescribing information. Sterile, nonpyrogenic. Use only if

solution is clear. After removing the overwrap, check for minute

leaks by squeezing container firmly. If leaks are found, discard unit

as sterility may be impaired. Must not be used in series connections.

The overwrap is a moisture barrier. Do not remove unit from

overwrap until ready for use. Use unit promptly when pouch is

opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room

Temperature.] Protect from freezing. See prescribing information.

Not Made With Natural Rubber Latex.

Rx ONLY

7

OTHER

Distributed by Hospira, Inc.,

Lake Forest, IL 60045 USA

Hospira

13090-01

Structured Label Content

Warnings (WARNINGS)

FETAL HARM: Continuous administration of magnesium sulfate beyond 5-7 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 5-7 days may cause fetal abnormalities.

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

Pregnancy

(See  WARNINGS and PRECAUTIONS )

Overdosage (OVERDOSAGE)

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.

For Treatment of Overdose

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.

References (REFERENCES)
  • 1.
    Yokoyama K, Takahashi N, Yada Y. Prolonged maternal magnesium administration and bone metabolism in neonates. Early Human Dev. 2010; 86(3):187-91. Epub 2010 Mar 12.
  • 2.
    Wedig KE, Kogan J, Schorry EK et al. Skeletal demineralization and fractures caused by fetal magnesium toxicity. J Perinatol. 2006; 26(6):371-4.
  • 3.
    Nassar AH, Sakhel K, Maarouf H, et al. Adverse maternal and neonatal outcome of prolonged course of magnesium sulfate tocolysis. Acta Obstet Gynecol Scan. 2006;85(9):1099-103.
  • 4.
    Malaeb SN, Rassi A, Haddad MC. Bone mineralization in newborns whose mothers received magnesium sulphate for tocolysis of premature labor. Pediatr Radiol. 2004;34(5):384-6. Epub 2004 Feb 18.
  • 5.
    Matsuda Y, Maeda Y, Ito M, et al. Effect of magnesium sulfate treatment on neonatal bone abnormalities. Gynecol Obstet Invest. 1997; 44(2):82-8.
  • 6.
    Schanler RJ, Smith LG, Burns PA. Effects of long-term maternal intravenous magnesium sulfate therapy on neonatal calcium metabolism and bone mineral content. Gynecol Obstet Invest. 1997; 43(4):236-41.
  • 7.
    Santi MD, Henry GW, Douglas GL. Magnesium sulfate treatment of preterm labor as a cause of abnormal neonatal bone mineralization. J Pediatr Orthop. 1994; 14(2):249-53.
  • 8.
    Holocomb WL, Shackelford GD, Petrie RH. Magnesium tocolysis and neonatal bone abnormalities: a controlled study. Obstet Gynecol. 1991; 78(4):611-4.
  • 9.
    Cumming WA, Thomas VJ. Hypermagnesemia: a cause of abnormal metaphyses in the neonate. Am J Roentgenol. 1989; 152(5):1071-2.
  • 10.
    Lamm CL, Norton KL, Murphy RJ. Congenital rickets associated with magnesium sulfate infusion for tocolysis. J Pediatr. 1988; 113(6):1078-82.
  • 11.
    McGuinness GA, Weinstein MM, Cruikshank DP, et al. Effects of magnesium sulfate treatment on perinatal calcium metabolism. II. Neonatal responses. Obstet Gynecol. 1980;56(5):595-600.
  • 12.
    Riaz M, Porat R, Brodsky NL, et al. The effect of maternal magnesium sulfate treatment on newborns: a prospective controlled study. J Perinatol. 1998; 18(6 pt 1):449-54.

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

LAB-1087-3.0

Revised: 03/2022

     

Flexible Plastic Container

For Intravenous Use Only

Rx only

Description (DESCRIPTION)

Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate 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 4% and 8% concentrations. See  HOW SUPPLIED section for the content and characteristics of available dosage forms and sizes.

Magnesium Sulfate, USP heptahydrate is chemically designated MgSO4 • 7H2O, colorless crystals or white powder freely soluble in water.

Water for Injection, USP is chemically designated H2O.

Water can permeate from inside the flexible plastic container into the overwrap 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.

Precautions (PRECAUTIONS)

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 Water for Injection should be administered slowly to avoid producing hypermagnesemia.

How Supplied (HOW SUPPLIED)

Magnesium Sulfate in Water for Injection is supplied in single-dose flexible plastic containers as follows:

NDC Number

(Unit of Sale)

Concentration

Total Magnesium Sulfate

As the heptahydrate.

Total Magnesium Ion

Magnesium Sulfate

Concentration

Magnesium Ion Concentration

Osmolarity (calc.)

NDC 0409-6729-23

Case of 24 single-dose flexible plastic containers

4 g/100 mL

(40 mg/mL)

4 g

32.5 mEq

4% (40 mg/mL)

32.5 mEq/100 mL

325 mOsmol/Liter

NDC 0409-4121-50

Case of 50 single-dose flexible plastic containers

4 g/100 mL

(40 mg/mL)

4 g

32.5 mEq

4% (40 mg/mL)

32.5 mEq/100 mL

325 mOsmol/Liter

NDC 0409-6729-03

Case of 24 single-dose flexible plastic containers

20 g/500 mL

(40 mg/mL)

20 g

162.3 mEq

4% (40 mg/mL)

32.5 mEq/100 mL

325 mOsmol/Liter

NDC 0409-2050-20

Case of 20 single-dose flexible plastic containers

20 g/500 mL

(40 mg/mL)

20 g

162.3 mEq

4% (40 mg/mL)

32.5 mEq/100 mL

325 mOsmol/Liter

NDC 0409-6729-09

Case of 12 single-dose flexible plastic containers

40 g/1000 mL

(40 mg/mL)

40 g

325 mEq

4% (40 mg/mL)

32.5 mEq/100 mL

325 mOsmol/Liter

NDC 0409-3164-12

Case of 12 single-dose flexible plastic containers

40 g/1000 mL

(40 mg/mL)

40 g

325 mEq

4% (40 mg/mL)

32.5 mEq/100 mL

325 mOsmol/Liter

NDC 0409-6729-24

Case of 24 single-dose flexible plastic containers

2 g/50 mL

Partial fill container 50 mL volume in 100 mL container.


(40 mg/mL)

2 g

16.25 mEq

4% (40 mg/mL)

16.25 mEq/50 mL

325 mOsmol/Liter

NDC 0409-5239-60

Case of 60 single-dose flexible plastic containers

2 g/50 mL



(40 mg/mL)

2 g

16.25 mEq

4% (40 mg/mL)

16.25 mEq/50 mL

325 mOsmol/Liter

NDC 0409-6730-13

Case of 24 single-dose flexible plastic containers

4 g/50 mL



(80 mg/mL)

4 g

32.5 mEq

8% (80 mg/mL)

32.5 mEq/50 mL

649 mOsmol/Liter

NDC 0409-6730-60

Case of 60 single-dose flexible plastic containers

4 g/50 mL



(80 mg/mL)

4 g

32.5 mEq

8% (80 mg/mL)

32.5 mEq/50 mL

649 mOsmol/Liter

WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS.

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

Nursing Mothers

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 Water for Injection is administered to a nursing mother.

Adverse Reactions (ADVERSE REACTIONS)

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.

Contraindications (CONTRAINDICATIONS)

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

Labor and Delivery

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 Water for Injection outside of its approved indication in pregnant women should be by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities.

Teratogenic Effects

Magnesium Sulfate in Water for Injection, can cause fetal abnormalities when administered beyond 5-7 days to pregnant women. There are retrospective epidemiological studies and case reports documenting fetal abnormalities such as hypocalcemia, skeletal demineralization’s, osteopenia and other l skeletal abnormalities with continuous maternal administration of magnesium sulfate for more than 5-7 days.1-12 Magnesium Sulfate in Water for Injection 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.

Clinical Pharmacology (CLINICAL PHARMACOLOGY)

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.

Pharmacokinetics:

Absorption: Intravenously administered magnesium is immediately absorbed.

Distribution: Approximately 1-2% 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.

Special Populations:

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

Cyclosporine

Digitalis

Alcohol

Amphotericin B

Diuretics

Cisplatin
Indications and Usage (INDICATIONS AND USAGE)

Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia 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.

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. )

Dosage and Administration (DOSAGE AND ADMINISTRATION)

Magnesium Sulfate in Water for Injection 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 5-7 days can cause fetal abnormalities.

In Eclampsia

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 Water for Injection may be administered intravenously. The rate of I.V. infusion should generally not exceed 150 mg/minute, or 3.75 mL of a 4% 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 I.V. dose, some clinicians administer 1 to 2 g/hour by constant I.V. 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 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.

Principal Display Panel 50 Ml Bag Label (PRINCIPAL DISPLAY PANEL - 50 mL Bag Label)

50 mL

NDC 0409-6730-11

MAGNESIUM SULFATE

IN WATER FOR INJECTION

4 g/50 mL (80 mg/mL)

4g

TOTAL

EACH 50 mL CONTAINS MAGNESIUM SULFATE

HEPTAHYDRATE 4 g (EQUIVALENT TO 32.5 mEq

MAGNESIUM) IN WATER FOR INJECTION. MAY

CONTAIN SULFURIC ACID AND/OR SODIUM

HYDROXIDE FOR pH ADJUSTMENT.

pH 4.5 (3.5 to 6.5) 649 mOsmol/LITER (CALC.)

SINGLE-DOSE CONTAINER. DISCARD UNUSED

PORTION. FOR INTRAVENOUS USE.

RECOMMENDED DOSAGE: SEE PRESCRIBING

INFORMATION. STERILE, NONPYROGENIC. USE

ONLY IF SOLUTION IS CLEAR AND CONTAINER IS

UNDAMAGED. MUST NOT BE USED IN SERIES

CONNECTIONS.

Rx ONLY

IM-5199

3

V

CONTAINS DEHP

Hospira

DISTRIBUTED BY

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Principal Display Panel 100 Ml Bag Label (PRINCIPAL DISPLAY PANEL - 100 mL Bag Label)

100 mL

NDC 0409-6729-41

MAGNESIUM SULFATE

IN WATER FOR INJECTION

4 g/100 mL (40 mg/mL)

4g

TOTAL

EACH 100 mL CONTAINS MAGNESIUM SULFATE

HEPTAHYDRATE 4 g (EQUIVALENT TO 32.5 mEq

MAGNESIUM) IN WATER FOR INJECTION. MAY

CONTAIN SULFURIC ACID AND/OR SODIUM

HYDROXIDE FOR pH ADJUSTMENT.

pH 4.5 (3.5 to 6.5) 325 mOsmol/LITER (CALC.)

SINGLE-DOSE CONTAINER. DISCARD UNUSED

PORTION. FOR INTRAVENOUS USE.

RECOMMENDED DOSAGE: SEE PRESCRIBING

INFORMATION. STERILE, NONPYROGENIC. USE

ONLY IF SOLUTION IS CLEAR AND CONTAINER IS

UNDAMAGED. MUST NOT BE USED IN SERIES

CONNECTIONS.

Rx ONLY

IM-5198

3

V

CONTAINS DEHP

Hospira

DISTRIBUTED BY

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Principal Display Panel 500 Ml Bag Label (PRINCIPAL DISPLAY PANEL - 500 mL Bag Label)

500 mL

NDC 0409-6729-21

20 g

TOTAL

MAGNESIUM

SULFATE

IN WATER FOR INJECTION

20 g/500 mL (40 mg/mL)

EACH 100 mL CONTAINS MAGNESIUM SULFATE

HEPTAHYDRATE 4 g (EQUIVALENT TO 32.5 mEq

MAGNESIUM) IN WATER FOR INJECTION. MAY CONTAIN

SULFURIC ACID AND/OR SODIUM HYDROXIDE FOR pH

ADJUSTMENT.

pH 4.5 (3.5 to 6.5)

325 mOsmol/LlTER (CALC.)

SINGLE-DOSE CONTAINER. DISCARD UNUSED PORTION.

FOR INTRAVENOUS USE. RECOMMENDED DOSAGE: SEE

PRESCRIBING INFORMATION. STERILE, NONPYROGENIC.

USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS

UNDAMAGED. MUST NOT BE USED IN SERIES

CONNECTIONS.

Rx ONLY

3

V

CONTAINS DEHP

Hospira

IM-5196

DISTRIBUTED BY

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Principal Display Panel 1000 Ml Bag Label (PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label)

1000 mL

NDC 0409-6729-31

MAGNESIUM

SULFATE

IN WATER FOR

INJECTION

40 g

TOTAL

40 g/1000 mL (40 mg/mL)

EACH 100 mL CONTAINS MAGNESIUM

SULFATE HEPTAHYDRATE 4 g (EQUIVALENT

TO 32.5 mEq MAGNESIUM) IN WATER FOR

INJECTION. MAY CONTAIN SULFURIC ACID

AND/OR SODIUM HYDROXIDE FOR pH

ADJUSTMENT.

pH 4.5 (3.5 to 6.5)

325 mOsmol/LITER (CALC.)

SINGLE-DOSE CONTAINER. DISCARD

UNUSED PORTION. FOR INTRAVENOUS

USE. RECOMMENDED DOSAGE: SEE

PRESCRIBING INFORMATION. STERILE,

NONPYROGENIC. USE ONLY IF SOLUTION

IS CLEAR AND CONTAINER IS

UNDAMAGED. MUST NOT BE USED IN

SERIES CONNECTIONS.

Rx ONLY

3

V

CONTAINS DEHP

DISTRIBUTED BY

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

IM-5197

Hospira

Principal Display Panel 2 G/50 Ml Bag Label (PRINCIPAL DISPLAY PANEL - 2 g/50 mL Bag Label)

50 mL

NDC 0409-6729-11

MAGNESIUM SULFATE

IN WATER FOR INJECTION

2g

TOTAL

2 g/50 mL (40 mg/mL)

EACH 50 mL CONTAINS MAGNESIUM SULFATE

HEPTAHYDRATE 2 g (EQUIVALENT TO 16.25 mEq

MAGNESIUM) IN WATER FOR INJECTION. MAY

CONTAIN SULFURIC ACID AND/OR SODIUM

HYDROXIDE FOR pH ADJUSTMENT.

pH 4.5 (3.5 to 6.5) 325 mOsmol/LITER (CALC.)

SINGLE-DOSE CONTAINER. DISCARD UNUSED

PORTION. FOR INTRAVENOUS USE.

RECOMMENDED DOSAGE: SEE PRESCRIBING

INFORMATION. STERILE, NONPYROGENIC. USE

ONLY IF SOLUTION IS CLEAR AND CONTAINER IS

UNDAMAGED. MUST NOT BE USED IN SERIES

CONNECTIONS.

Rx ONLY

3

V

CONTAINS DEHP

Hospira

IM-5195

DISTRIBUTED BY HOSPIRA, INC.,

LAKE FOREST, IL 60045 USA

Principal Display Panel 4 G/100 Ml Bag Label (PRINCIPAL DISPLAY PANEL - 4 g/100 mL Bag Label)

100 mL

NDC 0409-4121-01

Magnesium Sulfate

in Water for Injection

4 g

TOTAL

4 g/100 mL (40 mg/mL)

Each 100 mL contains magnesium sulfate heptahydrate 4 g (equivalent to

32.5 mEq magnesium) in water for injection. May contain sulfuric acid

and/or sodium hydroxide for pH adjustment.

pH 4.5 (3.5 to 6.5)

325 mOsmol/liter (CALC.)

Single-dose container. Discard unused portion. For intravenous use.

Recommended dosage: see prescribing information. Sterile, nonpyrogenic.

Use only if solution is clear and container is undamaged. Must not be used in

series connections.

Rx ONLY

5

PP

Distributed by Hospira, Inc.,

Lake Forest, IL 60045 USA

Hospira

12137-02

LOT:12345678

EXP:mm-yyyy

Principal Display Panel 20 G/500 Ml Bag Label (PRINCIPAL DISPLAY PANEL - 20 g/500 mL Bag Label)

500 mL

NDC 0409-2050-01

Magnesium

Sulfate

in Water for Injection

20 g

TOTAL

20 g/500 mL (40 mg/mL)

Each 100 mL contains magnesium sulfate heptahydrate

4 g (equivalent to 32.5 mEq magnesium) in water for

injection. May contain sulfuric acid and/or sodium

hydroxide for pH adjustment. pH 4.5 (3.5 to 6.5)

325 mOsmol/Liter (CALC.)

Single-dose container. Discard unused portion. For

intravenous use. Recommended dosage: see prescribing

information. Sterile, nonpyrogenic. Use only if solution is

clear and container is undamaged. Must not be used in

series connections. Inspect bag by squeezing firmly. If

leaks are found, discard.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room

Temperature.] Protect from freezing.

Do not remove from overwrap until ready for use.

Rx ONLY

5

PP

Hospira

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

12145-02

LOT:12345678

EXP:mm-yyyy

Principal Display Panel 50 Ml Bag Pouch Label (PRINCIPAL DISPLAY PANEL - 50 mL Bag Pouch Label)

50 mL

TO OPEN – TEAR AT NOTCH

NDC 0409-6730-11

MAGNESIUM SULFATE

IN WATER FOR INJECTION

4 g/50 mL (80 mg/mL)

4g

TOTAL

Each 50 mL contains magnesium sulfate heptahydrate 4 g (equivalent to 32.5 mEq

magnesium) in water for injection. May contain sulfuric acid and/or sodium hydroxide

for pH adjustment.

649 mOsmol/Liter (CALC.)

pH 4.5 (3.5 to 6.5)

DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER POSSIBLE USE CENTRAL

ROUTE.

Single-dose container. For intravenous use. Recommended dosage: See prescribing

information. Sterile, nonpyrogenic. Use only if solution is clear. After removing the

overwrap, check for minute leaks by squeezing container firmly. If leaks are found,

discard unit as sterility may be impaired. Must not be used in series connections.

The overwrap is a moisture barrier. Do not remove unit from overwrap until ready for

use. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP

Controlled Room Temperature.] Protect from freezing. See prescribing information.

Not Made With Natural Rubber Latex.

Rx only

7

OTHER

Distributed by

Hospira, Inc., Lake Forest, IL 60045 USA

F WR-1551

Hospira

Principal Display Panel 100 Ml Bag Pouch Label (PRINCIPAL DISPLAY PANEL - 100 mL Bag Pouch Label)

100 mL

TO OPEN – TEAR AT NOTCH

NDC 0409-6729-41

MAGNESIUM SULFATE

IN WATER FOR INJECTION

4 g/100 mL (40 mg/mL)

4g

TOTAL

Each 100 mL contains magnesium sulfate heptahydrate 4 g (equivalent to 32.5 mEq

magnesium) in water for injection. May contain sulfuric acid and/or sodium hydroxide

for pH adjustment.

325 mOsmol/Liter (CALC.)

pH 4.5 (3.5 to 6.5)

DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER POSSIBLE USE CENTRAL

ROUTE.

Single-dose container. For intravenous use. Recommended dosage: See prescribing

information. Sterile, nonpyrogenic. Use only if solution is clear. After removing the

overwrap, check for minute leaks by squeezing container firmly. If leaks are found,

discard unit as sterility may be impaired. Must not be used in series connections.

The overwrap is a moisture barrier. Do not remove unit from overwrap until ready for

use. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP

Controlled Room Temperature.] Avoid excessive heat. Protect from freezing. See

prescribing information.

Not Made With Natural Rubber Latex.

Rx only

7

OTHER

Distributed by

Hospira, Inc., Lake Forest, IL 60045 USA

F WR-1550

Hospira

Principal Display Panel 40 G/1000 Ml Bag Label (PRINCIPAL DISPLAY PANEL - 40 g/1000 mL Bag Label)

1000 mL

NDC 0409-3164-01

Magnesium

Sulfate

in Water for Injection

40 g

TOTAL

40 g/1000 mL (40 mg/mL)

Each 100 mL contains magnesium sulfate

heptahydrate 4 g (equivalent to 32.5 mEq

magnesium) in water for injection. May

contain sulfuric acid and/or sodium hydroxide

for pH adjustment. pH 4.5 (3.5 to 6.5)

325 mOsmol/Liter (CALC.)

Single-dose container. Discard unused portion.

For intravenous use.

Recommended dosage:

See prescribing information.

Sterile, nonpyrogenic. Use only if solution is

clear and container is undamaged. Must not

be used in series connections.

Inspect bag by squeezing firmly.

If leaks are found, discard.

Store at 20 to 25°C (68 to 77°F).

[See USP Controlled Room

Temperature.] Protect from freezing.

Do not remove from overwrap until ready for use.

Rx ONLY

5

PP

Distributed by Hospira, Inc.

Lake Forest, IL 60045 USA

Hospira

12146-02

LOT:12345678

EXP:mm-yyyy

Principal Display Panel 50 Ml Bag Overwrap Back (PRINCIPAL DISPLAY PANEL - 50 mL Bag Overwrap Back)

Magnesium

Sulfate

in Water for Injection

4 g/50 mL

(80 mg/mL)

4 g

TOTAL

13088-01

Principal Display Panel 100 Ml Bag Overwrap Back (PRINCIPAL DISPLAY PANEL - 100 mL Bag Overwrap Back)

Magnesium

Sulfate

in Water for Injection

4 g/100 mL

(40 mg/mL)

4 g

TOTAL

13097-01

Principal Display Panel 2 G/50 Ml Bag Pouch Label (PRINCIPAL DISPLAY PANEL - 2 g/50 mL Bag Pouch Label)

50 mL

TO OPEN – TEAR AT NOTCH

NDC 0409-6729-11

MAGNESIUM SULFATE

IN WATER FOR INJECTION

2 g

TOTAL

2 g/50 mL (40 mg/mL)

Each 50 mL contains magnesium sulfate heptahydrate 2 g (equivalent to 16.25 mEq

magnesium) in water for injection. May contain sulfuric acid and/or sodium hydroxide

for pH adjustment.

325 mOsmol/Liter (CALC.)

pH 4.5 (3.5 to 6.5)

DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER POSSIBLE USE CENTRAL

ROUTE.

Single-dose container. For intravenous use. Recommended dosage: See prescribing

information. Sterile, nonpyrogenic. Use only if solution is clear. After removing the

overwrap, check for minute leaks by squeezing container firmly. If leaks are found,

discard unit as sterility may be impaired. Must not be used in series connections.

The overwrap is a moisture barrier. Do not remove unit from overwrap until ready for

use. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP

Controlled Room Temperature.] Protect from freezing. See prescribing information. Not

Made With Natural Rubber Latex

Rx only

7

OTHER

Distributed by

Hospira, Inc., Lake Forest, IL 60045 USA

F WR-1549

Hospira

Carcinogenesis, Mutagenesis, Impairment of Fertility

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

Principal Display Panel 4 G/100 Ml Bag Pouch Label (PRINCIPAL DISPLAY PANEL - 4 g/100 mL Bag Pouch Label)

100 mL

NDC 0409-4121-01

Magnesium Sulfate

in Water for Injection

4 g/100 mL (40 mg/mL)

4 g

TOTAL

Each 100 mL contains magnesium sulfate heptahydrate 4 g

(equivalent to 32.5 mEq magnesium) in water for injection. May

contain sulfuric acid and/or sodium hydroxide for pH adjustment.

325 mOsmol/Liter (CALC.)

pH 4.5 (3.5 to 6.5)

DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER

POSSIBLE USE CENTRAL ROUTE.

Single-dose container. For intravenous use. Recommended dosage:

See prescribing information. Sterile, nonpyrogenic. Use only if

solution is clear. After removing the overwrap, check for minute

leaks by squeezing container firmly. If leaks are found, discard unit

as sterility may be impaired. Must not be used in series connections.

The overwrap is a moisture barrier. Do not remove unit from overwrap

until ready for use. Use unit promptly when pouch is opened. Store at

20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Avoid

excessive heat. Protect from freezing. See prescribing information.

Not Made With Natural Rubber Latex

Rx ONLY

7

OTHER

Distributed by Hospira, Inc.,

Lake Forest, IL 60045 USA

Hospira

13093-01

Principal Display Panel 2 G/50 Ml Bag Overwrap Back (PRINCIPAL DISPLAY PANEL - 2 g/50 mL Bag Overwrap Back)

Magnesium

Sulfate

in Water for Injection

2 g/50 mL

(40 mg/mL)

2 g

TOTAL

13091-01

Principal Display Panel 40 Mg/ml Bag Overwrap 500 Ml (PRINCIPAL DISPLAY PANEL - 40 mg/mL Bag Overwrap - 500 mL)

TO OPEN TEAR AT NOTCH

2

HDPE

DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING

THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY.

IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED.

RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE

HEAT. PROTECT FROM FREEZING. SEE INSERT.

98-4321-R14-3/98

Principal Display Panel 2 G/50 Ml Bag Label 0409 5239 (PRINCIPAL DISPLAY PANEL -2 g/50 mL Bag Label - 0409-5239)

50 mL

NDC 0409-5239-01

Magnesium Sulfate

in Water for Injection

2 g

TOTAL

2 g/50 mL (40 mg/mL)

Each 50 mL contains magnesium sulfate heptahydrate 2 g (equivalent to

16.25 mEq magnesium) in water for injection. May contain sulfuric acid

and/or sodium hydroxide for pH adjustment.

pH 4.5 (3.5 to 6.5)

325 mOsmol/liter (CALC.)

Single-dose container. Discard unused portion. For intravenous use.

Recommended dosage: see prescribing information. Sterile, nonpyrogenic.

Use only if solution is clear and container is undamaged. Must not be used in

series connections.

Rx ONLY

5

PP

Distributed by Hospira, Inc.,

Lake Forest, IL 60045 USA

Hospira

12136-02

LOT:12345678

EXP:mm-yyyy

Principal Display Panel 40 Mg/ml Bag Overwrap 1000 Ml (PRINCIPAL DISPLAY PANEL - 40 mg/mL Bag Overwrap - 1000 mL)

TO OPEN TEAR AT NOTCH

2

HDPE

DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING

THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY.

IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED.

RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE

HEAT. PROTECT FROM FREEZING. SEE INSERT.

98-4321-R14-3/98

Principal Display Panel 50 Ml Bag Label Ndc 0409 6730 50 (PRINCIPAL DISPLAY PANEL - 50 mL Bag Label - NDC 0409-6730-50)

50 mL

NDC 0409-6730-50

Magnesium Sulfate

in Water for Injection

4 g/50 mL (80 mg/mL)

4g

TOTAL

Each 50 mL contains magnesium sulfate heptahydrate 4 g (equivalent to

32.5 mEq magnesium) in water for injection. May contain sulfuric acid

and/or sodium hydroxide for pH adjustment.

pH 4.5 (3.5 to 6.5)

649 mOsmol/Liter (CALC.)

Single-dose container. Discard unused portion. For intravenous use.

Recommended dosage: See prescribing information. Sterile, nonpyrogenic.

Use only if solution is clear and container is undamaged. Must not be used in

series connections.

Rx ONLY

5

PP

Distributed by Hospira, Inc.,

Lake Forest, IL 60045 USA

Hospira

12165-02

LOT:12345678

EXP:mm-yyyy

Principal Display Panel 2 G/50 Ml Bag Pouch Label 0409 5239 (PRINCIPAL DISPLAY PANEL -2 g/50 mL Bag Pouch Label - 0409-5239)

50 mL

NDC 0409-5239-01

Magnesium Sulfate

in Water for Injection

2 g/50 mL (40 mg/mL)

2 g

TOTAL

Each 50 mL contains magnesium sulfate heptahydrate 2 g

(equivalent to 16.25 mEq magnesium) in water for injection. May

contain sulfuric acid and/or sodium hydroxide for pH adjustment.

325 mOsmol/Liter (CALC.)

pH 4.5 (3.5 to 6.5)

DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER

POSSIBLE USE CENTRAL ROUTE.

Single-dose container. For intravenous use. Recommended dosage:

See prescribing information. Sterile, nonpyrogenic. Use only if

solution is clear. After removing the overwrap, check for minute leaks

by squeezing container firmly. If leaks are found, discard unit as

sterility may be impaired. Must not be used in series connections.

The overwrap is a moisture barrier. Do not remove unit from overwrap

until ready for use. Use unit promptly when pouch is opened. Store at

20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Protect from freezing. See prescribing information.

Not Made With Natural Rubber Latex

Rx ONLY

7

OTHER

Distributed by Hospira, Inc.,

Lake Forest, IL 60045 USA

Hospira

13092-01

Principal Display Panel 50 Ml Bag Pouch Label Ndc 0409 6730 50 (PRINCIPAL DISPLAY PANEL - 50 mL Bag Pouch Label - NDC 0409-6730-50)

50 mL

NDC 0409-6730-50

Magnesium Sulfate

in Water for Injection

4 g/50 mL (80 mg/mL)

4 g

TOTAL

Each 50 mL contains magnesium sulfate heptahydrate 4 g

(equivalent to 32.5 mEq magnesium) in water for injection. May

contain sulfuric acid and/or sodium hydroxide for pH adjustment.

649 mOsmol/Liter (CALC.)

pH 4.5 (3.5 to 6.5)

DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER

POSSIBLE USE CENTRAL ROUTE.

Single-dose container. For intravenous use. Recommended dosage:

See prescribing information. Sterile, nonpyrogenic. Use only if

solution is clear. After removing the overwrap, check for minute

leaks by squeezing container firmly. If leaks are found, discard unit

as sterility may be impaired. Must not be used in series connections.

The overwrap is a moisture barrier. Do not remove unit from

overwrap until ready for use. Use unit promptly when pouch is

opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room

Temperature.] Protect from freezing. See prescribing information.

Not Made With Natural Rubber Latex.

Rx ONLY

7

OTHER

Distributed by Hospira, Inc.,

Lake Forest, IL 60045 USA

Hospira

13090-01

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Source: dailymed · Ingested: 2026-02-15T02:18:22.166317 · Updated: 2026-03-14T22:49:49.558846