PAB® Container

For Intravenous Use Only

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 fill volumes. 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.

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 tamperproof barrier and the other is a blocked port. Refer to the DIRECTIONS FOR USE of the container to properly identify the ports.

No vapor barrier is necessary.

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.

Magnesium Sulfate in Water for Injection 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 5-7 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.

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.

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 I.V. to antagonize the effects of magnesium.

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.

Magnesium Sulfate in Water for Injection is supplied in 100 mL fill and 50 mL fill PAB® containers packaged 24 per case as follows:

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Avoid excessive heat. Protect from freezing.

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.

Rx only

Revised: July 2024 

PAB is a registered trademark of B. Braun Medical Inc.

CAUTION:  DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER POSSIBLE USE CENTRAL ROUTE.

Aseptic technique is required.

Before use, perform the following checks: Read the label. Ensure solution is the one ordered and is within the expiration date.

Inspect the solution in good light for cloudiness, haze or particulate matter; check the container for leakage or damage. Any container which is suspect should not be used.

Use only if solution is clear and container and seals are intact. Single dose plastic container. Discard unused portion. Consult Package Insert for complete product information.

WARNING: DO NOT USE PLASTIC CONTAINER IN SERIES CONNECTION.

This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.

1. Identify Two Ports (See Figure A).
   
   
2. To Attach Administration Set
   To aseptically remove the set port closure: hold container below the set port and grasp the foil tab between the thumb and forefinger then pull the tab in two steps as shown in Figure B Steps 1 and 2.
   
   
   
   
   
3. Push spike through the diaphragm of the port (See Figure C). Hang container using hole on the lower flap. Prime set in accordance with the Directions for Use provided with the set in use.
   
   

PAB® containers can be safely transported in a standard 6-inch carrier through a pneumatic tube system that is well maintained and running properly.

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862
Prepared in USA. API from USA or Czech Republic.

Y36-003-088     LD-475-2

NDC 0264-4204-52

Magnesium Sulfate
In Water for Injection
2 g/50 mL (40 mg/mL) 
(0.325 mEq Mg++/mL) 

2 g Total

 50 mL  PAB® Container    

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 Only. Usual
dosage: See prescribing information. Sterile, nonpyrogenic. Use only if solution
is clear and container is undamaged. Must not be used in series connections.

CAUTION: DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER
POSSIBLE USE CENTRAL ROUTE.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]
Avoid excessive heat. Protect from freezing.

REF D4204-52

Not made with natural rubber latex, DEHP or PVC.

Rx only   

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862. Prepared in USA.
API from USA or Czech Republic.

Y94-003-507    LD-476-2

LOT

EXP

NDC 0264-4205-52

Magnesium Sulfate
In Water for Injection
4 g/50 mL (80 mg/mL)
(0.65 mEq Mg++/mL) 

4 g Total

50 mL  PAB® Container    

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 Only. Usual
dosage: See prescribing information. Sterile, nonpyrogenic. Use only if solution
is clear and container is undamaged. Must not be used in series connections.

CAUTION: DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER
POSSIBLE USE CENTRAL ROUTE.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]
Avoid excessive heat. Protect from freezing.

REF D4205-52

Not made with natural rubber latex, DEHP or PVC.

Rx only   

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862. Prepared in USA.
API from USA or Czech Republic.

Y94-003-508   LD-477-2

LOT

EXP

NDC 0264-4206-54

Magnesium Sulfate
In Water for Injection
4 g/100 mL (40 mg/mL)
(0.325 mEq Mg++/mL) 

4 g Total

100 mL  PAB® Container    

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 Only. Usual dosage: See prescribing information.
Sterile, nonpyrogenic. Use only if solution is clear and container
is undamaged. Must not be used in series connections.

CAUTION: DO NOT ADD SUPPLEMENTARY MEDICATION.
WHENEVER POSSIBLE USE CENTRAL ROUTE.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]
Avoid excessive heat. Protect from freezing.

REF D4206-54

Not made with natural rubber latex, DEHP or PVC.

Rx only   

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862
Prepared in USA.
API from USA or Czech Republic.

Y94-003-509    LD-478-2

LOT

EXP