The following Structured Product Label (SPL) was submitted to the FDA by Mylan Institutional Llc for the product Magnesium Chloride (NDC 67457-134). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, actions, indications, contraindications, warning, precautions, pregnancy category c, adverse reactions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
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.
As an electrolyte replenisher in magnesium deficiencies.
Magnesium Chloride Injection should not be administered if there is renal impairment, marked myocardial disease or to comatose patients.
Do not use if a precipitate is present.
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.
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.
Flushing, sweating, sharply lowered blood pressure,hypothermia, stupor and ultimately respiratory depression.
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.
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.
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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