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* Description
* '''Fetal Harm'''
:* Continuous administration of magnesium sulfate beyond 5 to 7 days to pregnant women can lead to hypocalcemia and bone abnormalities in the developing fetus. These bone abnormalities include skeletal demineralization and osteopenia. In addition, cases of neonatal fracture have been reported. The shortest duration of treatment that can lead to fetal harm is not known. Magnesium sulfate should be used during pregnancy only if clearly needed. If magnesium sulfate is given for treatment of preterm labor, the woman should be informed that the efficacy and safety of such use have not been established and that use of magnesium sulfate beyond 5 to 7 days may cause fetal abnormalities.
 
* '''Aluminum Toxicity'''
 
:* This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
:* Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
:* Parenteral use in the presence of renal insufficiency may lead to magnesium intoxication. IV use in the eclampsia should be reserved for immediate control of life-threatening convulsions.


====Precautions====
====Precautions====

Revision as of 18:56, 12 July 2014

Magnesium sulfate (injection)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi

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Overview

Magnesium sulfate (injection) is a sterile solution of magnesium sulfate in water for Injection that is FDA approved for the {{{indicationType}}} of magnesium deficiency, pre-eclampsia, eclampsia, barium poisoning, seizures associated with epilepsy, glomerulonephritis, or hypothyroidism, paroxysmal atrial tachycardia, and cerebral edema. Common adverse reactions include flushing, sweating, hypotension, depressed reflexes, flaccid paralysis, hypothermia, circulatory collapse, and cardiac and central nervous system depression proceeding to respiratory paralysis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Magnesium Deficiency
  • Dosing Information
  • In the treatment of mild magnesium deficiency, the usual adult dose is 1 g, equivalent to 8.12 mEq of magnesium (2 mL of the 50% solution) injected intramuscularly every six hours for four doses (equivalent to a total of 32.5 mEq of magnesium per 24 hours).
  • For severe hypomagnesemia, as much as 250 mg (approximately 2 mEq) per kg of body weight (0.5 mL of the 50% solution) may be given intramuscularly within a period of four hours if necessary. Alternatively, 5 g (approximately 40 mEq) can be added to one liter of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP for slow intravenous infusion over a three-hour period. In the treatment of deficiency states, caution must be observed to prevent exceeding the renal excretory capacity.
Hyperalimentation
  • Dosing Information
  • In total parenteral nutrition, maintenance requirements for magnesium are not precisely known.
  • The maintenance dose used in adults ranges from 8 to 24 mEq (1 to 3 g) daily.
Pre-Eclampsia or Eclampsia
  • Dosing Information
  • In severe pre-eclampsia or eclampsia, the total initial dose is 10 to 14 g of magnesium sulfate. Intravenously, a dose of 4 to 5 g in 250 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP may be infused. Simultaneously, intramuscular doses of up to 10 g (5 g or 10 mL of the undiluted 50% solution in each buttock) are given. Alternatively, the initial intravenous dose of 4 g may be given by diluting the 50% solution to a 10 or 20% concentration; the diluted fluid (40 mL of a 10% solution or 20 mL of a 20% solution) may then be injected intravenously over a period of three to four minutes. Subsequently, 4 to 5 g (8 to 10 mL of the 50% solution) are injected intramuscularly into alternate buttocks every four hours as needed, depending on the continuing presence of the patellar reflex and adequate respiratory function. Alternatively, after the initial I.V. dose, some clinicians administer 1 to 2 g/hour by constant I.V. infusion. Therapy should continue until paroxysms cease. A serum magnesium level of 6 mg/100 mL is considered optimal for control of seizures. A total daily (24 hr) dose of 30 to 40 g should not be exceeded. In the presence of severe renal insufficiency, the maximum dosage of magnesium sulfate is 20 grams/48 hours and frequent serum magnesium concentrations must be obtained. Continuous use of magnesium sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities.
Barium Poisoning
  • Dosing Information
  • 1–2 g intravenous
Seizures Associated with Epilepsy, Glomerulonephritis or Hypothyroidism
  • Dosing Information
  • 1 g IV or IM
Paroxysmal Atrial Tachycardia
  • Magnesium should be used only if simpler measures have failed and there is no evidence of myocardial damage.
  • Dosing Information
  • 3–4 g (30 to 40 mL of a 10% solution) administered IV over 30 seconds with extreme caution.
Cerebral Edema
  • Dosing Information
  • 2.5 g (25 mL of a 10% solution) intravenous

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Magnesium sulfate (injection) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Magnesium sulfate (injection) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Hyperalimentation
  • Dosing Information
  • For infants, the dosing range is 2 to 10 mEq (0.25 to 1.25 g) daily.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Magnesium sulfate (injection) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Magnesium sulfate (injection) in pediatric patients.

Contraindications

  • Parenteral administration of the drug is contraindicated in patients with heart block or myocardial damage.

Warnings

  • Fetal Harm
  • Continuous administration of magnesium sulfate beyond 5 to 7 days to pregnant women can lead to hypocalcemia and bone abnormalities in the developing fetus. These bone abnormalities include skeletal demineralization and osteopenia. In addition, cases of neonatal fracture have been reported. The shortest duration of treatment that can lead to fetal harm is not known. Magnesium sulfate should be used during pregnancy only if clearly needed. If magnesium sulfate is given for treatment of preterm labor, the woman should be informed that the efficacy and safety of such use have not been established and that use of magnesium sulfate beyond 5 to 7 days may cause fetal abnormalities.
  • Aluminum Toxicity
  • This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
  • Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
  • Parenteral use in the presence of renal insufficiency may lead to magnesium intoxication. IV use in the eclampsia should be reserved for immediate control of life-threatening convulsions.

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Magnesium sulfate (injection) in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Magnesium sulfate (injection) in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Magnesium sulfate (injection) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Magnesium sulfate (injection) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Magnesium sulfate (injection) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Magnesium sulfate (injection) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Magnesium sulfate (injection) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Magnesium sulfate (injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Magnesium sulfate (injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Magnesium sulfate (injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Magnesium sulfate (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Magnesium sulfate (injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Magnesium sulfate (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Magnesium sulfate (injection) in the drug label.

Condition1
  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Magnesium sulfate (injection) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Magnesium sulfate (injection) in the drug label.

Pharmacology

There is limited information regarding Magnesium sulfate (injection) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Magnesium sulfate (injection)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Magnesium sulfate (injection) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Magnesium sulfate (injection) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Magnesium sulfate (injection) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Magnesium sulfate (injection) in the drug label.

Condition1
  • Description

How Supplied

Storage

There is limited information regarding Magnesium sulfate (injection) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Magnesium sulfate (injection) in the drug label.

Precautions with Alcohol

  • Alcohol-Magnesium sulfate (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • MAGNESIUM SULFATE®[1]

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. "MAGNESIUM SULFATE (magnesium sulfate heptahydrate) injection, solution".
  2. "http://www.ismp.org". External link in |title= (help)


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