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Name:Magnesium Chloride
Manufacturer:Bioniche Pharma Usa Llc
Category:Prescription Marketed Drugs


MAGNESIUM CHLORIDE - magnesium chloride injection 
Bioniche Pharma USA 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.

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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 2951 mOsm/L.

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). 50 mL Multiple Dose Vial. Individually boxed.

Store at controlled room temperature 15°-30°C (59°-86°F).

Rx only.

Manufactured for:
Bioniche Pharma USA LLC,
Lake Forest, IL 60045

Manufactured by:
Bioniche Teo.,
Inverin, Co. Galway, Ireland.

Prepared: January 2000
Revised: May 2007

0546L102

  

PRINCIPAL DISPLAY PANEL - 200 mg/mL

50 mL Multiple
Dose Vial

NDC 67457-134-50

Magnesium
Chloride
Injection

200 mg/mL (20% w/v)
2.951 mOsmol/mL

FOR IV USE AFTER DILUTION

Manufactured for:
Bioniche Pharma USA LLC,
Lake Forest, IL 60045

Manufactured by:
Bioniche Teo.,
Inverin, Co. Galway, Ireland.

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
mOsmol/L.

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

WARNING: DO NOT USE IF A
PRECIPITATE IS PRESENT.

Store at controlled room temperature
15° -30°C (59° -85°F).

Rx only.

See insert for full prescribing
information.

Magnesium Chloride Injection 200 mg/mL Carton

MAGNESIUM CHLORIDE 
magnesium chloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-134
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MAGNESIUM CHLORIDE (MAGNESIUM CATION) MAGNESIUM CHLORIDE 200 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 9 mg  in 1 mL
BENZYL ALCOHOL 10 mg  in 1 mL
WATER  
HYDROCHLORIC ACID  
SODIUM HYDROXIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67457-134-50 1 VIAL, MULTI-DOSE ( VIAL) in 1 CARTON contains a VIAL, MULTI-DOSE
1 50 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (67457-134-50)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 05/13/2011

Labeler - Bioniche Pharma USA LLC (790384503)

Revised: 05/2007 Bioniche Pharma USA LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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