Magnesium Chloride Injection

MAGNESIUM CHLORIDE  - magnesium chloride injection, solution 
Claris Lifesciences Limited

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Magnesium Chloride Injection

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

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 whenever solution and container permit.

HOW SUPPLIED:

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

NDC 66860-040-01              50 mL Multiple Dose Vial        Individually boxed.

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

Manufactured by:

Claris Lifesciences Limited
Ahmedabad, Gujarat-382 213, INDIA

For:
CURA Pharmaceutical Co., Inc.
Eatontown, NJ 07724, USA

Issue Date:11/2004

IEE/C/4/Magnesium Chloride/00/4

Vial Label

NDC 66860-040-01

CURA Pharmaceutical Co., Inc.

MAGNESIUM
CHLORIDE

INJECTION

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

50 mL
MULTIPLE DOSE VIAL


Rx ONLY

50 mL MULTIPLE DOSE VIAL


MAGNESIUM CHLORIDE 
magnesium chloride   injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)68950-001
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 chloride 
benzyl alcohol 
hydrochloric acid 
sodium hydroxide 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
168950-001-011 VIAL In 1 CARTONcontains a VIAL, MULTI-DOSE
150 mL In 1 VIAL, MULTI-DOSEThis package is contained within the CARTON (68950-001-01)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/07/200911/04/2010

Labeler - Claris Lifesciences Limited (862172228)
Registrant - Claris Lifesciences Limited (862172228)
Establishment
NameAddressID/FEIOperations
Claris Lifesciences Limited918603338manufacture, analysis
Revised: 02/2011Claris Lifesciences Limited