SPL v7
SPL
SPL Set ID 2105d1c1-54ef-4d1a-a63c-b1619e8b50db
Route
INTRAVENOUS
Published
Effective Date 2021-10-15
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Magnesium Cation (200 mg)
Inactive Ingredients
Sodium Chloride Benzyl Alcohol Water Hydrochloric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2013-03-14

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 MgCl 2 •6H 2 O

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.

Contraindications

Magnesium Chloride Injection should not be administered if there is renal impairment, marked myocardial disease or to comatose patients.

Adverse Reactions

Flushing, sweating, sharply lowered blood pressure, hypothermia, stupor and ultimately respiratory depression.

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


Medication Information

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.

Contraindications

Magnesium Chloride Injection should not be administered if there is renal impairment, marked myocardial disease or to comatose patients.

Adverse Reactions

Flushing, sweating, sharply lowered blood pressure, hypothermia, stupor and ultimately respiratory depression.

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

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.

Warning

Do not use if a precipitate is present.

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.

Indications

As an electrolyte replenisher in magnesium deficiencies.

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.

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.

Principal Display Panel 200 Mg/ml

NDC 67457-134-50     50 mL

Magnesium

Chloride

Injection

200 mg/mL

(20% w/v)

2.951 mOsm/mL

For Intravenous Use After

Dilution

Rx only Multiple-Dose Vial

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 CI¯

per mL.

WARNING: DO NOT USE IF A

PRECIPITATE IS PRESENT.

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room

Temperature.]

Usual Dosage: See accompanying

prescribing information.

Manufactured for:

Mylan Institutional LLC

Morgantown, WV 26505 U.S.A.

Manufactured by:

Mylan Institutional

Galway, Ireland

MI:134:1C:R5

Mylan.com


Structured Label Content

Actions (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.

Warning (WARNING)

Do not use if a precipitate is present.

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.

Description (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

Indications (INDICATIONS)

As an electrolyte replenisher in magnesium deficiencies.

Precautions (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.

How Supplied (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

Adverse Reactions (ADVERSE REACTIONS)

Flushing, sweating, sharply lowered blood pressure, hypothermia, stupor and ultimately respiratory depression.

Contraindications (CONTRAINDICATIONS)

Magnesium Chloride Injection should not be administered if there is renal impairment, marked myocardial disease or to comatose patients.

Usual Dosage Range (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.

Dosage and Administration (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.

Principal Display Panel 200 Mg/ml (PRINCIPAL DISPLAY PANEL - 200 mg/mL)

NDC 67457-134-50     50 mL

Magnesium

Chloride

Injection

200 mg/mL

(20% w/v)

2.951 mOsm/mL

For Intravenous Use After

Dilution

Rx only Multiple-Dose Vial

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 CI¯

per mL.

WARNING: DO NOT USE IF A

PRECIPITATE IS PRESENT.

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room

Temperature.]

Usual Dosage: See accompanying

prescribing information.

Manufactured for:

Mylan Institutional LLC

Morgantown, WV 26505 U.S.A.

Manufactured by:

Mylan Institutional

Galway, Ireland

MI:134:1C:R5

Mylan.com


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