Sodium glycerophosphate

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:  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

* sodium glycerophosphate should not be given to patients in a state of dehydration or with hypernatraemia, hyperphosphataemia, severe renal insufficiency or shock.

## 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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