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Sodium glycerophosphate

From Wikidoc - Reading time: 5 min

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Aparna Vuppala, M.B.B.S. [2]

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Overview

Sodium glycerophosphate is a potassium supplement that is FDA approved for the prophylaxis of adult patients and infants as a supplement in intravenous nutrition to meet the requirements of phosphate. Common adverse reactions include absence of drug reaction.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • Sodium glycerophosphate is indicated in adult patients and infants as a supplement in intravenous nutrition to meet the requirements of phosphate.

Posology and method of administration

  • Sodium glycerophosphate must not be given undiluted.
Adults:
  • The recommended dosage is individual. The recommended daily dosage of phosphate during intravenous nutrition would normally be 10-20 mmol. This can be met by using 10-20 ml of sodium glycerophosphate added to the infusion solution or to the admixture for which compatibility has been proved.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sodium glycerophosphate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sodium glycerophosphate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

  • sodium glycerophosphate is indicated in adult patients and infants as a supplement in intravenous nutrition to meet the requirements of phosphate.

Posology and method of administration

  • Sodium glycerophosphate must not be given undiluted.
Infants:
  • The recommended dosage is individual. The recommended dose for infants and neonates is 1.0-1.5 mmol/Kg body weight/day.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sodium glycerophosphate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sodium glycerophosphate in pediatric patients.

Contraindications

Warnings

  • sodium glycerophosphate should be used with caution in patients with impaired renal function. The phosphate status of all patients should be monitored regularly.

sodium glycerophosphate must not be given undiluted.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Sodium glycerophosphate in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Sodium glycerophosphate in the drug label.

Drug Interactions

  • No interactions with other drugs have been observed, but a moderate fall in serum phosphate can be seen during carbohydrate infusions.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Animal reproduction studies or clinical investigations during pregnancy have not been carried out with sodium glycerophosphate. However, the requirements of phosphate in a pregnant woman are slightly increased compared to non-pregnant women.No adverse events are to be expected when sodium glycerophosphate is administered during pregnancy.


Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sodium glycerophosphate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Sodium glycerophosphate during labor and delivery.

Nursing Mothers

  • Animal reproduction studies or clinical investigations during pregnancy have not been carried out with sodium glycerophosphate. However, the requirements of phosphate in a pregnant woman are slightly increased compared to non-pregnant women.
  • No adverse events are to be expected when sodium glycerophosphate is administered during pregnancy.

Pediatric Use

There is no FDA guidance on the use of Sodium glycerophosphate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Sodium glycerophosphate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Sodium glycerophosphate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Sodium glycerophosphate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Sodium glycerophosphate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Sodium glycerophosphate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Sodium glycerophosphate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Sodium glycerophosphate in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Intravenous

Monitoring

There is limited information regarding Monitoring of Sodium glycerophosphate in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Sodium glycerophosphate in the drug label.

Overdosage

  • No adverse effects of an overdose have been reported. Most patients in need of intravenous nutrition have an increased capacity to handle glycerophosphate.

Pharmacology

There is limited information regarding Sodium glycerophosphate Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Sodium glycerophosphate Mechanism of Action in the drug label.

Structure

  • The active ingredient in 1 ml of sodium glycerophosphate correspond to
  • Phosphate 1 mmol
  • Sodium 2 mmol

Pharmacodynamics

  • Glycerophosphate is a metabolic intermediate in fat metabolism and any pharmacodynamic effects other than maintaining the normal metabolic pathways are unlikely.

Pharmacokinetics

  • To become available it is necessary for the phosphate group to be hydrolysed from the glycerophosphate molecule. The hydrolysis occurs maximally at a plasma concentration of >0.7 mmol/l. Assuming that all hydrolysis of glycerophosphate takes place in plasma, about 12-15 mmol of sodium glycerophosphate will be hydrolysed each day in individuals with normal serum alkaline phosphatase.
  • No pharmacokinetical data is available for infants, however with the recommended dosage hyperphosphataemia is unlikely.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Sodium glycerophosphate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Sodium glycerophosphate in the drug label.

How Supplied

  • sodium glycerophosphate may only be added to or mixed with other medicinal products for which compatibility has been documented. See 5.6.
  • Shelf life is 3 years
  • Special precautions for storage
  • Do not store above 25°C. Do not freeze.
  • Nature and contents of container
8Polypropylene vial.
  • Pack size: 10 x 20 ml
  • Instructions for use/handling
  • sodium glycerophosphate must not be given undiluted.

Storage

There is limited information regarding Sodium glycerophosphate 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 Sodium glycerophosphate in the drug label.

Precautions with Alcohol

  • Alcohol-Sodium glycerophosphate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • Glycophos

Look-Alike Drug Names

There is limited information regarding Sodium glycerophosphate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

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


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