MAGNESIUM CHLORIDE - magnesium chloride injection, solution
American Therapeutic Medicines Inc.
----------Magnesium Chloride Injection
200 mg/mL (20% w/v)
FOR IV USE AFTER DILUTION
Magnesium Chloride Injection is a sterile solution of Magnesium Chloride Hexahydrate in Water for Injection q.s. Each mL contains Magnesium Chloride Hexahydrate 200mg, Sodium Chloride 9 mg, Benzyl Alcohol 1% as a preservative, Water for Injection q.s. pH adjusted with Hydrochloric Acid and/or Sodium Hydroxide. Total osmolarity equivalent to 2951 mOsmol/L.
Each mL of Magnesium Chloride Injection contains 1.97 mEq of Mg++ and Cl-.
The molecular formula is MgCl2•6H2O.
Magnesium is the second most plentiful cation within cellular fluids. It is an important activator of many enzyme systems, and deficits are accompanied by a variety of functional disturbances.
As an electrolyte replenisher in magnesium deficiencies.
Magnesium Chloride Injection should not be administered if there is renal impairment, marked myocardial disease or to comatose patients.
Do not use if a precipitate is present.
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.
The usual precautions for parenteral administration should be observed. Administer with caution if flushing and sweating occurs. A preparation of a calcium salt should be readily available for intravenous injection to counteract potential serious signs of magnesium intoxication. As long as deep tendon reflexes are active it is probable that the patient will not develop respiratory paralysis. Respiration and blood pressure should be carefully observed during and after administration of Magnesium Chloride Injection.
Teratogenic Effects: Pregnancy category C.
Animal reproduction studies have not been conducted with magnesium chloride. It is also not known whether magnesium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Magnesium chloride should be given to a pregnant woman only if clearly needed.
Flushing, sweating, sharply lowered blood pressure, hypothermia, stupor, and ultimately respiratory depression.
For intravenous infusion: 4 grams in 250 mL of 5% Dextrose Injection, at a rate not exceeding 3 mL per minute. Serum magnesium levels should serve as a guide to continued dosage.
1 to 40 grams daily.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, as the solution and container permit.
Magnesium Chloride Injection 200 mg/mL (20% w/v),50 mL, Multiple Dose Vial, in trays of twenty-five.
Store in controlled room temperature 15oC – 30oC (59o – 86oF).
American Therapeutic Medicines Inc. Santa Ana, CA 92704 U.S.A.
magnesium chloride injection, solution
|Marketing Category||Application Number or Monograph Citation||Marketing Start Date||Marketing End Date|
|unapproved drug other||05/01/2009||12/30/2010|
|Labeler - American Therapeutic Medicines Inc. (134632103)|