Magnesium Sulfate in Water 20 g/500mL
Magnesium Sulfate · INJECTION · WG Critical Care, LLC
Magnesium sulfate is an injectable medication given through a vein that is used to treat conditions such as seizures in pregnant women with preeclampsia, severe asthma attacks, and abnormal heart rhythms. It works by helping to relax muscles and stabilize nerve and heart function.
Key Facts
- Brand Name
- Magnesium Sulfate in Water
- Generic Name
- Magnesium Sulfate
- NDC Code (Product)
44567-422- Manufacturer
- WG Critical Care, LLC
- Strength
- 20 g/500mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA207350
- Marketing Start
- 01/09/2018
Recall History
Hospira, Inc.
Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.
Amneal Pharmaceuticals, LLC
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
Hospira Inc.
Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.
Pfizer Inc.
Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03, Lot 87903FW) that was found inside a case of Magnesium Sulfate in Water for Injection.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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.
Dosage & 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. S…
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.
Contraindications
CONTRAINDICATIONS Intravenous magnesium should not be given to mothers with toxemia of pregnancy during the two hours preceding delivery.
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.
Frequently Asked Questions
What is Magnesium Sulfate in Water used for?
Magnesium sulfate is an injectable medication given through a vein that is used to treat conditions such as seizures in pregnant women with preeclampsia, severe asthma attacks, and abnormal heart rhythms. It works by helping to relax muscles and stabilize nerve and heart function.
Is Magnesium Sulfate in Water a controlled substance?
Magnesium Sulfate in Water is not classified as a controlled substance by the DEA.
What is the generic name for Magnesium Sulfate in Water?
The generic name for Magnesium Sulfate in Water is Magnesium Sulfate. There are 11 other brand versions of Magnesium Sulfate.
What is the NDC code for Magnesium Sulfate in Water 20 g/500mL?
The NDC (National Drug Code) for Magnesium Sulfate in Water 20 g/500mL is 44567-422, listed by WG Critical Care, LLC.
Other Magnesium Sulfate in Water Dosages
Other Magnesium Brands
See all →- NuValu Epsom Salt100 g/100g72520-002
- Epsom Salt1 g/g42507-962
- Sal Inglesa EPSOM SALT1 g/g53145-580
- Magnesia sulphurica30 [hp_C]/30[hp_C]0220-3267
- Epsom Salt1 g/g55301-602
- Theraworx Relief Muscle Cramp and Spasm Relief6 [hp_X]/210mL61594-004
- PHUEL6 [hp_X]/mL61594-010
- Epsom Salt1 g/g70000-0021
- Magnesium Sulfate500 mg/mL0404-9903
- Epsom Salt1 g/g85828-602
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)