You are here: Home > Prescription(RX) Drugs > M > Magnesium Sulfate (General Injectables & Vaccines, Inc)|
magnesium sulfate heptahydrate injection
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
----------50% Magnesium Sulfate 4 mEq/mL Injection, USP 20 mL Single Dose Vial
An intravenous nutritional supplement to prevent or treat hypomagnesemia and a means for parenteral control of seizures in toxemia of pregnancy and acute nephritis in children.
Magnesium Sulfate Injection, USP is a sterile solution of magnesium sulfate heptahydrate in Water for Injection, USP administered by the intravenous or intramuscular routes as an electrolyte
The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment). Any unused portion remaining in container should be discarded within 24 hours of
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.
Magnesium (Mg++) is an important cofactor for enzymatic reactions and plays an important role in neurochemical transmission and muscular excitability.
As a nutritional adjunct in hyperalimentation, the precise mechanism of action for magnesium is uncertain. Early symptoms of hypomagnesemia (less than 1.5 mEq/liter) may develop as early as three to four days or within weeks. Predominant deficiency effects are neurological, e.g., muscle irritability, clonic twitching and tremors. Hypocalcemia and hypokalemia often follow low serum levels of magnesium. While there are large stores of magnesium present intracellularly and in the bones of adults, these stores often are not mobilized sufficiently to maintain plasma levels. Parenteral magnesium therapy repairs the plasma deficit and causes deficiency symptoms and signs to cease.
Magnesium prevents or controls convulsions by blocking neuromuscular transmission and decreasing the amount of acetylcholine liberated at the end plate by the motor nerve impulse.
As plasma magnesium rises above 4 mEq/liter, the deep tendon reflexes are first decreased and then disappear as the plasma level approaches 10 mEq/liter. At this level respiratory paralysis may occur. Heart block also may occur at this or lower plasma levels of magnesium.
Magnesium acts peripherally to produce vasodilation. With low doses only flushing and sweating occur, but larger doses cause lowering of blood pressure. The central and peripheral
With intravenous administration the onset of anticonvulsant action is immediate and lasts about 30 minutes. Following intramuscular administration the onset of action occurs in about one hour
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 or 3.0 mEq/liter) and the serum calcium (Ca++) level is normal (4.3 to
In total parenteral nutrition, 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 as a parenteral anticonvulsant for the prevention and control of seizures (convulsions) in severe toxemia of pregnancy. When used
Magnesium Sulfate Injection, USP may be used to control hypertension, encephalopathy and convulsions associated with acute nephritis in children. However, other drugs such as barbiturates,
Intravenous magnesium should not be given to mothers with toxemia of pregnancy during the two hours preceding delivery.
Intravenous use in eclampsia should be reserved for immediate control of life-threatening convulsions.
Parenteral use in the presence of renal insufficiency may lead to magnesium intoxication.
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum
Because magnesium is removed from the body solely by the kidneys, the drug should be used with caution in patients with renal impairment. Urine output should be maintained at a level of 100 mL every four hours. Monitoring serum magnesium levels and the patient’s clinical status is essential to avoid the consequences of overdosage in toxemia. Clinical indications of a safe dosage regimen include the presence of the patellar reflex (knee jerk) and absence of respiratory depression (approximately 16 breaths or more/minute). Serum magnesium levels usually sufficient to control convulsions range from 3 to 6 mg/100 mL (2.5 to 5.0 mEq/liter). The strength of the deep tendon reflexes begins to diminish when magnesium levels exceed 4 mEq/liter. Reflexes may be absent at 10 mEq magnesium/liter, where respiratory paralysis is a potential hazard. An injectable calcium salt should be immediately available to counteract the potential hazards of magnesium intoxication in eclampsia.
50% Magnesium Sulfate Injection, USP must be diluted to a concentration of 20% or less prior to I.V. infusion. Rate of administration should be slow and cautious, to avoid producing
Pregnancy Category A. Studies in pregnant women have not shown that magnesium sulfate injection increases the risk of fetal abnormalities if administered during all trimesters of pregnancy.
When administered by continuous intravenous infusion (especially for more than 24 hours preceding delivery) to control convulsions in toxemic mothers, the newborn may show signs of
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.
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
In adults intravenous administration of 5 to 10 mEq of 10% calcium gluconate will usually reverse respiratory depression or heart block due to magnesium intoxication. In extreme cases,
Hypermagnesemia in the newborn may require resuscitation and assisted ventilation via endotracheal intubation or intermittent positive pressure ventilation as well as intravenous calcium.
Dosage and Administration
Both intravenous and intramuscular administration are appropriate. Intramuscular administration of the undiluted 50% solution results in therapeutic plasma levels in 60 minutes, whereas I.V. doses will provide a therapeutic level almost immediately. The rate of I.V. injection should generally not exceed 1.5 mL of a 10% concentration (or its equivalent) per minute, except in severe eclampsia with seizures (see below).
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
In Magnesium Deficiency
In Nephritic Seizures
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 and container is undamaged. Discard unused portion.
To prevent needle-stick injuries, needles should not be recapped, purposely bent, or broken by hand.
Magnesium Sulfate Injection, USP is supplied in single-dose containers as follows:
Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.]
Revised: 09/2010 General Injectables & Vaccines, Inc
Reproduced with permission of U.S. National Library of Medicine
Copyright © 2018
|Over-the-counter (OTC) Drugs|