Magnesium Chloride Injection

MAGNESIUM CHLORIDE  - magnesium chloride injection, solution 
American Therapeutic Medicines Inc.

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Magnesium Chloride Injection

200 mg/mL (20% w/v)

(2.951 mOsmol/mL)

FOR IV USE AFTER DILUTION

Rx ONLY

DESCRIPTION

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.

ACTIONS

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.

INDICATIONS

As an electrolyte replenisher in magnesium deficiencies.

CONTRAINDICATIONS

Magnesium Chloride Injection should not be administered if there is renal impairment, marked myocardial disease or to comatose patients.

WARNINGS

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.

PRECAUTIONS

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.

PREGNANCY

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.

ADVERSE REACTIONS

Flushing, sweating, sharply lowered blood pressure, hypothermia, stupor, and ultimately respiratory depression.

DOSAGE AND ADMINISTRATION

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.

USUAL DOSAGE RANGE

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.

HOW SUPPLIED

Magnesium Chloride Injection 200 mg/mL (20% w/v),50 mL, Multiple Dose Vial, in trays of twenty-five.

NDC 42005-102-50

Store in controlled room temperature 15oC – 30oC (59o – 86oF).

Rx ONLY

MD381-0043

Manufactured for:

American Therapeutic Medicines Inc. Santa Ana, CA 92704 U.S.A.

image of vial label


MAGNESIUM CHLORIDE 
magnesium chloride   injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)42005-102
Route of AdministrationINTRAVENOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM CHLORIDE (MAGNESIUM CATION) MAGNESIUM CHLORIDE200 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE9 mg  in 1 mL
BENZYL ALCOHOL1 mL  in 100 mL
SODIUM HYDROXIDE 
HYDROCHLORIC ACID 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
142005-102-5025 VIAL In 1 CARTONcontains a VIAL, MULTI-DOSE
150 mL In 1 VIAL, MULTI-DOSEThis package is contained within the CARTON (42005-102-50)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/01/200912/30/2010

Labeler - American Therapeutic Medicines Inc. (134632103)
Revised: 03/2011American Therapeutic Medicines Inc.