Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Magnesium Sulfate in Water for Injection is supplied in single-dose flexible plastic containers as follows: NDC No. Size Container Total Magnesium Sulfate As the heptahydrate. Total Magnesium Ion +Magnesium Sulfate Concentration Magnesium Ion Concentration Osmolarity (calc.) 72572-511-40 50 mL 2 g 16.25 mEq 4% (40 mg/mL) 16.25 mEq/50 mL 325 mOsmol/Liter WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label NDC 72572- 511 -40 Rx Only Magnesium Sulfate in Water for Injection 50 mL 2 g/50 mL (40 mg/mL) 2g Total For Intravenous Infusion Single-Dose Container – Discard unused portion. Each 50 mL of sterile, nonpyrogenic solution 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.) Recommended dosage: See prescribing information. Use only if solution is clear and container is undamaged. Must not be used in series connections. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. VIAFLO container is not made with natural rubber latex, DEHP, or PVC. Dist by: Civica Inc. Lehi, Utah 84043 Mfd by: Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in Spain Recycle 07 logo UN-35-05-076 Barcode (01) 10372572511404 DO NOT USE THIS PORT Do not use this port▼ logo UCE8001 LOT EXP Overpouch Label NDC 72572- 511 -40 TO OPEN – TEAR AT NOTCH Rx Only Magnesium Sulfate in Water for Injection 50 mL 2g/50 mL (40 mg/mL) 2g Total For Intravenous Infusion. Single-Dose Container – Discard unused portion. Each 50 mL of sterile, nonpyrogenic solution 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. Recommended dosage: See prescribing information. Use only if solution is clear and container is undamaged. 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 promptly once overpouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. VIAFLO container is not made with natural rubber latex, DEHP, or PVC. 2D Barcode (91)SA1001013 Distributed by: Civica, Inc. Lehi, Utah 84043 Manufactured by: Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in Spain (See Solution Container for Lot and Exp) Civica Logo Barcode (01) 10372572511404 UCE80011 SA-10-01-013 Magnesium Sulfate in Water Representative Container Label 72572-511-40 Magnesium Sulfate in Water Representative Overpouch Label 72572-511-40
- HOW SUPPLIED Magnesium Sulfate in Water for Injection is supplied in single-dose flexible plastic containers as follows: NDC No. Size Container Total Magnesium Sulfate As the heptahydrate. Total Magnesium Ion +Magnesium Sulfate Concentration Magnesium Ion Concentration Osmolarity (calc.) 72572-511-40 50 mL 2 g 16.25 mEq 4% (40 mg/mL) 16.25 mEq/50 mL 325 mOsmol/Liter WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label NDC 72572- 511 -40 Rx Only Magnesium Sulfate in Water for Injection 50 mL 2 g/50 mL (40 mg/mL) 2g Total For Intravenous Infusion Single-Dose Container – Discard unused portion. Each 50 mL of sterile, nonpyrogenic solution 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.) Recommended dosage: See prescribing information. Use only if solution is clear and container is undamaged. Must not be used in series connections. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. VIAFLO container is not made with natural rubber latex, DEHP, or PVC. Dist by: Civica Inc. Lehi, Utah 84043 Mfd by: Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in Spain Recycle 07 logo UN-35-05-076 Barcode (01) 10372572511404 DO NOT USE THIS PORT Do not use this port▼ logo UCE8001 LOT EXP Overpouch Label NDC 72572- 511 -40 TO OPEN – TEAR AT NOTCH Rx Only Magnesium Sulfate in Water for Injection 50 mL 2g/50 mL (40 mg/mL) 2g Total For Intravenous Infusion. Single-Dose Container – Discard unused portion. Each 50 mL of sterile, nonpyrogenic solution 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. Recommended dosage: See prescribing information. Use only if solution is clear and container is undamaged. 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 promptly once overpouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. VIAFLO container is not made with natural rubber latex, DEHP, or PVC. 2D Barcode (91)SA1001013 Distributed by: Civica, Inc. Lehi, Utah 84043 Manufactured by: Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in Spain (See Solution Container for Lot and Exp) Civica Logo Barcode (01) 10372572511404 UCE80011 SA-10-01-013 Magnesium Sulfate in Water Representative Container Label 72572-511-40 Magnesium Sulfate in Water Representative Overpouch Label 72572-511-40
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 a 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 MgSO 4 • 7H 2 O, colorless crystals or white powder freely soluble in water. Water for Injection, USP is chemically designated H 2 O. VIAFLO container is a flexible plastic container fabricated from a multilayer sheeting composed of Polypropylene (PP), Polyamide (PA) and Polyethylene (PE). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. Exposure to temperatures above 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.
Indications & 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 & 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 Pre-Eclampsia or 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 intravenous 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. After the initial intravenous dose, some clinicians administer 1 to 2 g/hour by constant intravenous infusion. Subsequent intramuscular doses of 4 to 5 g of magnesium sulfate may be injected into alternate buttocks every four hours, depending on the continuing presence of the patellar reflex, adequate respiratory function, and absence of signs of magnesium toxicity. Therapy should continue until paroxysms cease. A serum magnesium level of 6 mg/100 mL is considered optimal for control of seizures. A total daily (24 hr) dose of 30 to 40 g magnesium sulfate should not be exceeded. In the presence of severe renal insufficiency, frequent serum magnesium concentrations must be obtained and the maximum recommended dosage of magnesium sulfate is 20 g per 48 hours. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless solution is clear. Discard unused portion.
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.
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