MAGNESIUM CHLORIDE
-
magnesium chloride injection
Bioniche Pharma USA LLC
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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 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
Teratogenic Effects
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). 50 mL Multiple Dose Vial. Individually boxed.
Store at controlled room temperature 15°-30°C (59°-86°F).
Rx only.
Manufactured for:
Bioniche Pharma USA LLC,
Lake Forest, IL 60045
Manufactured by:
Bioniche Teo.,
Inverin, Co. Galway, Ireland.
Prepared: January 2000
Revised: May 2007
0546L102
PRINCIPAL DISPLAY PANEL - 200 mg/mL
50 mL Multiple
Dose Vial
NDC 67457-134-50
Magnesium
Chloride
Injection
200 mg/mL (20% w/v)
2.951 mOsmol/mL
FOR IV USE AFTER DILUTION
Manufactured for:
Bioniche Pharma USA LLC,
Lake Forest, IL 60045
Manufactured by:
Bioniche Teo.,
Inverin, Co. Galway, Ireland.
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
mOsmol/L.
Contains 1.97 mEq of Mg++ and
CI- per mL.
WARNING: DO NOT USE IF A
PRECIPITATE IS PRESENT.
Store at controlled room temperature
15° -30°C (59° -85°F).
Rx only.
See insert for full prescribing
information.
| MAGNESIUM CHLORIDE
magnesium chloride injection |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 05/13/2011 | ||
| Labeler - Bioniche Pharma USA LLC (790384503) |