Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Magnesium Sulfate in Water for Injection is supplied in 100 mL fill and 50 mL fill PAB ® containers packaged 24 per case as follows: NDC REF Fill Volume Total Magnesium Sulfate As the heptahydrate. Total Magnesium Ion Magnesium Sulfate Concentration Magnesium Ion Concentration Osmolarity (calc.) 0264-4206-54 D4206-54 100 mL Partial fill container 100 mL in 150 mL container. 4 g 32.5 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 mOsmol/Liter 0264-4204-52 D4204-52 50 mL Partial fill container 50 mL in 100 mL container. 2 g 16.25 mEq 4% (40 mg/mL) 16.25 mEq/50 mL 325 mOsmol/Liter 0264-4205-52 D4205-52 50 mL 4 g 32.5 mEq 8% (80 mg/mL) 32.5 mEq/50 mL 649 mOsmol/Liter 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.; PRINCIPAL DISPLAY PANEL 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 D4204-52 Container Label; PRINCIPAL DISPLAY PANEL 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 D4205-52 Container Label; PRINCIPAL DISPLAY PANEL 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 D4206-54 Container Label
- HOW SUPPLIED Magnesium Sulfate in Water for Injection is supplied in 100 mL fill and 50 mL fill PAB ® containers packaged 24 per case as follows: NDC REF Fill Volume Total Magnesium Sulfate As the heptahydrate. Total Magnesium Ion Magnesium Sulfate Concentration Magnesium Ion Concentration Osmolarity (calc.) 0264-4206-54 D4206-54 100 mL Partial fill container 100 mL in 150 mL container. 4 g 32.5 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 mOsmol/Liter 0264-4204-52 D4204-52 50 mL Partial fill container 50 mL in 100 mL container. 2 g 16.25 mEq 4% (40 mg/mL) 16.25 mEq/50 mL 325 mOsmol/Liter 0264-4205-52 D4205-52 50 mL 4 g 32.5 mEq 8% (80 mg/mL) 32.5 mEq/50 mL 649 mOsmol/Liter 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.
- PRINCIPAL DISPLAY PANEL 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 D4204-52 Container Label
- PRINCIPAL DISPLAY PANEL 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 D4205-52 Container Label
- PRINCIPAL DISPLAY PANEL 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 D4206-54 Container Label
Overview
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 MgSO 4 • 7H 2 O, colorless crystals or white powder freely soluble in water. Water for Injection, USP is chemically designated H 2 O. 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.
Indications & Usage
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.
Dosage & 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.
Warnings & Precautions
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.
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.
Drug Interactions
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
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