Prescribing information (package insert) - Magnesium Chloride
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
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
Morgantown, WV 26505
Manufactured by:
Mylan Institutional
Galway, Ireland
1084L101
Revised: 10/2021
MI:MAGNIJ:R4