CHLOROMAG- magnesium chloride injection, solution

Chloromag by

Drug Labeling and Warnings

Chloromag by is a Prescription medication manufactured, distributed, or labeled by Merit Pharmaceutical. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 MgCl26H2O.

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHLOROMAG 
magnesium chloride injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 30727-304
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CHLORIDE	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)	9 mg  in 1 mL
BENZYL ALCOHOL (UNII: LKG8494WBH)	1 mL  in 1 mL
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30727-304-90	50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product	06/11/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/11/2011

Labeler - Merit Pharmaceutical (093370369)

Registrant - Merit Pharmaceutical (093370369)

Establishment
Name	Address	ID/FEI	Business Operations
Merit Pharmaceutical		093370369	manufacture(30727-304)