"FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit. There are no"...
Magnesium sulfate (magnesium sulfate (magnesium sulfate injection) injection) should be given very cautiously in the presence of serious impairment of renal function since it is excreted almost entirely by the kidneys.
The principle hazard in parenteral magnesium therapy is the production of abnormally high levels of magnesium in the plasma. Such high levels may cause flushing, sweating, hypotension, circulatory collapse and depression of cardiac and central nervous system function. The most immediate danger to life is respiratory depression.
During the period of parenteral therapy with magnesium salts, the patient should be watched carefully. A preparation of calcium, such as the gluconate or gluceptate should be at hand for intravenous administration as an antidote.
In the presence of severe renal insufficiency, no more than 20 grams of magnesium should be given within a forty-eight hour period. In eclampsia, however, renal function is not seriously impaired and magnesium may be more rapidly excreted.
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 than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
When barbiturates, narcotics, or other hypnotics (or systemic anesthetics) are to be given in conjunction with magnesium, their dosage should be adjusted with caution because of the additive central depressive effects of magnesium.
Pregnancy - Teratogenic effects: Pregnancy category C. Animal reproduction studies have not been conducted with Magnesium Sulfate Injection, USP 50%. It is also not known whether Magnesium Sulfate Injection, USP 50% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Magnesium Sulfate Injection, USP 50% should be given to a pregnant woman only if clearly needed.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/11/2008
Additional Magnesium Sulfate Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.