MAGNESIUM SULFATE
Magnesium Sulfate Injection is indicated for replacement therapy in patients with magnesium deficiency, particularly acute hypomagnesemia presenting with signs of tetany. It is also utilized as an additive in total parenteral nutrition (TPN) to prevent or correct magnesium depletion that may arise during the course of therapy. Additionally, the medication is used in obstetric care for the prevention and control of seizures associated with pre-eclampsia and eclampsia.
How MAGNESIUM SULFATE Works
The specific mechanism of action for Magnesium Sulfate is not specified in the provided FDA labeling. The source text does not identify a particular biological target or describe the physiological process by which the drug produces its therapeutic effects. Consequently, the exact biological pathway for its use in magnesium replacement or seizure control is not detailed in this documentation.
Details
- Status
- Prescription
- First Approved
- 1986-09-08
- Routes
- INTRAMUSCULAR, INTRAVENOUS, INJECTION
- Dosage Forms
- SOLUTION, INJECTABLE
MAGNESIUM SULFATE Approval History
What MAGNESIUM SULFATE Treats
6 indicationsMAGNESIUM SULFATE is approved for 6 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Magnesium Deficiency
- Hypomagnesemia
- Tetany
- Seizures
- Pre-Eclampsia
- Eclampsia
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Trial Timeline
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MAGNESIUM SULFATE FDA Label Details
ProIndications & Usage
FDA Label (PDF)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 Injecti...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.