50% MAGNESIUM SULFATE 500 mg/mL
50% MAGNESIUM SULFATE · INJECTION, SOLUTION · HF Acquisition Co. LLC, DBA Health First
50% MAGNESIUM SULFATE is a injection, solution containing 50% magnesium sulfate at 500 mg/mL, taken intramuscular. Manufactured by HF Acquisition Co. LLC, DBA Health First.
Key Facts
- Brand Name
- 50% MAGNESIUM SULFATE
- Generic Name
- 50% MAGNESIUM SULFATE
- NDC Code (Product)
51662-1235- Manufacturer
- HF Acquisition Co. LLC, DBA Health First
- Strength
- 500 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA075151
- Marketing Start
- 08/25/2018
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
Indications and Usage Magnesium Sulfate Injection, USP is suitable for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. In such cases, the serum magnesium (Mg++) level is usually below the lower limit of normal (1.5 to 2.5 mEq/liter) and the serum calcium (Ca++) level is normal (4.3 to 5.3 mEq/liter) or elevated. In total parenteral nutrition (TPN), magnesium sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy. Magnesium Sulfate Injection, USP is also indicated for the prevention and control of seizures (convulsions) in pre-eclampsia and eclampsia, respectively.
Dosage & Administration
Dosage and Administration Dosage of magnesium sulfate must be carefully adjusted according to individual requirements and response, and administration of the drug should be discontinued as soon as the desired effect is obtained. Both intravenous and intramuscular administration are appropriate. Intramuscular administration of the undiluted 50% solution results in therapeutic plasma levels in 60 minutes, whereas intravenous doses will provide a therapeutic level almost immediately. The rate of intravenous injection should generally not exceed 150 mg/minute (1.5 mL of a 10% concentration or its equivalent), except in severe eclampsia with seizures (see below). Continuous maternal administration of magnesium sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities. Solutions for intravenous infusion must be diluted to a concentration of 20% or less prior to administration. The diluents commonly used are 5% Dextrose Injection, USP and 0.9% Sodium Chloride Injection, USP. Deep intramuscular injection of the undiluted (50%) solution is appropriate for adults, but the solution should be diluted to a 20% or less concentration prior to such injection in children. In Magnesium D…
Warnings
Warnings FETAL HARM: Continuous administration of magnesium sulfate beyond 5 to 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 to 7 days may cause fetal abnormalities. ALUMINUM TOXICITY: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater th…
Contraindications
Contraindications Parenteral administration of the drug is contraindicated in patients with heart block or myocardial damage.
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 50% MAGNESIUM SULFATE used for?
50% MAGNESIUM SULFATE contains 50% MAGNESIUM SULFATE. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is 50% MAGNESIUM SULFATE a controlled substance?
50% MAGNESIUM SULFATE is not classified as a controlled substance by the DEA.
What is the generic name for 50% MAGNESIUM SULFATE?
The generic name for 50% MAGNESIUM SULFATE is 50% MAGNESIUM SULFATE. There are no other listed brand versions of 50% MAGNESIUM SULFATE.
What is the NDC code for 50% MAGNESIUM SULFATE 500 mg/mL?
The NDC (National Drug Code) for 50% MAGNESIUM SULFATE 500 mg/mL is 51662-1235, listed by HF Acquisition Co. LLC, DBA Health First.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)