MAGNESIUM CHLORIDE- magnesium chloride injection 
Mylan Institutional LLC

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.

----------

DESCRIPTION

Magnesium Chloride Injection is a sterile solution of Magnesium Chloride Hexahydrate in Water for Injection q.s. Each mL contains Magnesium Chloride Hexahydrate 200 mg, 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 2.951 mOsm/mL.

Contains 1.97 mEq of Mg++ and Cl- per mL.

The structural 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.

WARNING

Do not use if a precipitate is present.

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 whenever solution and container permit.

HOW SUPPLIED

Magnesium Chloride Injection 200 mg/mL (20% w/v).

NDC 67457-134-50
50 mL Multiple-Dose Vial. Individually boxed.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled
Room Temperature.]

Manufactured for:
Mylan Institutional LLC
Rockford, IL 61103

Manufactured by:
Mylan Institutional
Galway, Ireland

0546L104
REVISED FEBRUARY 2013
MI:MAGNIJ:R2

  

PRINCIPAL DISPLAY PANEL - 200 mg/mL

NDC 67457-134-50     50 mL

Magnesium
Chloride
Injection

200 mg/mL
(20% w/v)

2.951 mOsm/mL

For Intravenous Use After
Dilution

Rx only Multiple-Dose Vial

Manufactured for:
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.

Manufactured by:
Mylan Institutional
Galway, Ireland

MI:134:1C:R2

Mylan.com

Each mL contains: Magnesium
Chloride Hexahydrate 200 mg,
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
2.951 mOsm/mL.

Contains 1.97 mEq of Mg++ and CI¯
per mL.

WARNING: DO NOT USE IF A
PRECIPITATE IS PRESENT.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Usual Dosage: See accompanying
prescribing information.

Magnesium Chloride Injection 200 mg/mL (20 percent w/v) Carton Label
MAGNESIUM CHLORIDE 
magnesium chloride injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:67457-134
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 ALCOHOL10 mg  in 1 mL
WATER 
HYDROCHLORIC ACID 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67457-134-501 in 1 CARTON
150 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other03/14/2013
Labeler - Mylan Institutional LLC (790384502)

Revised: 3/2013
Document Id: 5d074715-0142-4e7f-af09-2956d21c675e
Set id: 2105d1c1-54ef-4d1a-a63c-b1619e8b50db
Version: 3
Effective Time: 20130314
 
Mylan Institutional LLC