Sodium glycerophosphate

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Sodium glycerophosphate
Black Box Warning
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];

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Black Box Warning

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Sodium glycerophosphate is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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

Posology and method of administration

  • Glycophos 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 Glycophos 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)

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

Posology and method of administration

  • Glycophos 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

  • Condition1

Warnings

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content
  • Glycophos should be used with caution in patients with impaired renal function. The phosphate status of all patients should be monitored regularly.

Glycophos 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

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Animal reproduction studies or clinical investigations during pregnancy have not been carried out with Glycophos. 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 Glycophos is administered during pregnancy.


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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 Glycophos. 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 Glycophos 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

  • Oral
  • Intravenous

Monitoring

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

  • Description

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

Structure

This image is provided by the National Library of Medicine.

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

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

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

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