Magnesium Sulfate 1 GM in 100 ML Injection
Generic Name: MAGNESIUM SULFATE HEPTAHYDRATE
Brand Name: Magnesium Sulfate in Dextrose
- Substance Name(s):
- MAGNESIUM SULFATE HEPTAHYDRATE
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.
OVERDOSAGE
Magnesium intoxication is manifested by a sharp drop in blood pressure and respiratory paralysis.
Disappearance of the patellar reflex is a useful clinical sign to detect the onset of magnesium intoxication.
In the event of overdosage, artificial ventilation must be provided until a calcium salt can be injected IV to antagonize the effects of magnesium.
For Treatment of Overdose Artificial respiration is often required.
Intravenous calcium, 10 to 20 mL of a 5% solution (diluted if desirable) with isotonic sodium chloride for injection) is used to counteract effects of hypermagnesemia.
Subcutaneous physostigmine, 0.5 to 1 mg may be helpful.
Hypermagnesemia in the newborn may require resuscitation and assisted ventilation via endotracheal intubation or intermittent positive pressure ventilation as well as IV calcium.
DESCRIPTION
Magnesium Sulfate in 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate and dextrose in water for injection.
Each 100 mL contains 1 or 2 g magnesium sulfate heptahydrate and dextrose, hydrous 5 g 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 1% and 2% concentrations.
See HOW SUPPLIED section for the content and characteristics of available dosage forms and sizes.
Magnesium Sulfate, USP heptahydrate is chemically designated MgSO4 • 7H2O, colorless crystals or white powder freely soluble in water.
Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 • H2O), a hexose sugar freely soluble in water.
It has the following structural formula: Molecular weight 198.17.
Water for Injection, USP is chemically designated H2O.
The flexible plastic container is fabricated from a specially formulated polyvinylchloride.
Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly.
Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.
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.
structural formula Dextrose, USP
HOW SUPPLIED
Magnesium Sulfate in 5% Dextrose Injection, USP is supplied in single-dose flexible plastic containers as follows: NDC No.
Size Container Total Magnesium Sulfate* Total Magnesium Ion Magnesium Sulfate* Concentration Magnesium Ion Concentration Osmolarity (calc.) 0409-6727-23 100 mL 1 g 8.1 mEq 1% (10 mg/mL) 8.1 mEq/100 mL 333 mOsmol/Liter 0409-6728-03 500 mL 10 g 81.1 mEq 2% (20 mg/mL) 16.2 mEq/100 mL 415 mOsmol/Liter 0409-6728-09 1000 mL 20 g 162.3 mEq 2% (20 mg/mL) 16.2 mEq/100 mL 415 mOsmol/Liter *As the heptahydrate.
WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS.
Store at 20 to 25°C (68 to 77°F).
[See USP Controlled Room Temperature.] Protect from freezing.
INDICATIONS AND USAGE
Magnesium Sulfate in 5% Dextrose Injection, USP 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 AND ADMINISTRATION
Magnesium Sulfate in 5% Dextrose Injection, USP 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 5% Dextrose Injection, USP may be administered intravenously.
The rate of I.V.
infusion should generally not exceed 150 mg/minute, or 7.5 mL of a 2% 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 1-2 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 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.