Label: MAGNESIUM CHLORIDE- magnesium chloride injection
- NDC Code(s): 67457-134-50
- Packager: Mylan Institutional LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Updated March 14, 2013
If you are a consumer or patient please visit this version.
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•6H2OClose
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.Close
As an electrolyte replenisher in magnesium deficiencies.Close
Magnesium Chloride Injection should not be administered if there is renal impairment, marked myocardial disease or to comatose patients.Close
Do not use if a precipitate is present.Close
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 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.Close
- 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.Close
- 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.Close
- HOW SUPPLIED
Magnesium Chloride Injection 200 mg/mL (20% w/v).
50 mL Multiple-Dose Vial. Individually boxed.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled
Mylan Institutional LLC
Rockford, IL 61103
REVISED FEBRUARY 2013
PRINCIPAL DISPLAY PANEL - 200 mg/mL
NDC 67457-134-50 50 mL
For Intravenous Use After
Rx only Multiple-Dose Vial
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.
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
Total osmolarity equivalent to
Contains 1.97 mEq of Mg++ and CI¯
WARNING: DO NOT USE IF A
PRECIPITATE IS PRESENT.
Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Usual Dosage: See accompanyingClose
- INGREDIENTS AND APPEARANCE
magnesium chloride injection
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-134 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) 10 mg in 1 mL WATER (UNII: 059QF0KO0R) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67457-134-50 1 in 1 CARTON 1 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 03/14/2013 Labeler - Mylan Institutional LLC (790384502)