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  5. Label Information: Magnesium Chloride

FDA Label for Magnesium Chloride

View Indications, Usage & Precautions

Table of Contents

    1. DESCRIPTION
    2. ACTIONS
    3. INDICATIONS
    4. CONTRAINDICATIONS
    5. WARNING
    6. PRECAUTIONS
    7. PREGNANCY CATEGORY C
    8. ADVERSE REACTIONS
    9. DOSAGE AND ADMINISTRATION
    10. USUAL DOSAGE RANGE
    11. HOW SUPPLIED

Magnesium Chloride Product Label

The following document was submitted to the FDA by the labeler of this product Mylan Institutional Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 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


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