Sodium glycerophosphate: Difference between revisions
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{{DrugProjectFormSinglePage | {{DrugProjectFormSinglePage | ||
|authorTag= | |authorTag={{AV}} | ||
|genericName=sodium glycerophosphate | |||
|aOrAn=a | |||
|drugClass=[[potassium supplement]] | |||
|indicationType=prophylaxis | |||
|genericName= | |indication=adult patients and infants as a supplement in intravenous [[nutrition]] to meet the requirements of [[phosphate]] | ||
|adverseReactions=absence of drug reaction<!--Black Box Warning--> | |||
|blackBoxWarningTitle=Title | |||
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i> | |||
|aOrAn= | |||
a | |||
|drugClass= | |||
| | |||
| | |||
|adverseReactions= | |||
<!--Black Box Warning--> | |||
|blackBoxWarningTitle= | |||
Title | |||
|blackBoxWarningBody= | |||
<i><span style="color:#FF0000;">ConditionName: </span></i> | |||
* Content | * Content | ||
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<!--FDA-Labeled Indications and Dosage (Adult)--> | <!--FDA-Labeled Indications and Dosage (Adult)--> | ||
|fdaLIADAdult=*Sodium glycerophosphate is indicated in adult patients and infants as a supplement in intravenous nutrition to meet the requirements of [[phosphate]]. | |||
|fdaLIADAdult= | |||
* | |||
====Posology and method of administration==== | ====Posology and method of administration==== | ||
* | *Sodium glycerophosphate must not be given undiluted. | ||
=====Adults:===== | =====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 | *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)--> | <!--Off-Label Use and Dosage (Adult)--> | ||
<!--Guideline-Supported Use (Adult)--> | <!--Guideline-Supported Use (Adult)--> | ||
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |||
|offLabelAdultGuideSupport= | |||
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |||
<!--Non–Guideline-Supported Use (Adult)--> | <!--Non–Guideline-Supported Use (Adult)--> | ||
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |||
|offLabelAdultNoGuideSupport= | |||
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |||
<!--Pediatric Indications and Dosage--> | <!--Pediatric Indications and Dosage--> | ||
<!--FDA-Labeled Indications and Dosage (Pediatric)--> | <!--FDA-Labeled Indications and Dosage (Pediatric)--> | ||
|fdaLIADPed=*sodium glycerophosphate is indicated in adult patients and infants as a supplement in intravenous [[nutrition]] to meet the requirements of [[phosphate]]. | |||
|fdaLIADPed= | |||
* | |||
====Posology and method of administration==== | ====Posology and method of administration==== | ||
* | *Sodium glycerophosphate must not be given undiluted. | ||
=====Infants:===== | =====Infants:===== | ||
*The recommended dosage is individual. The recommended dose for infants and neonates is 1.0-1.5 mmol/Kg body weight/day. | *The recommended dosage is individual. The recommended dose for infants and neonates is 1.0-1.5 mmol/Kg body weight/day. | ||
Line 83: | Line 41: | ||
<!--Guideline-Supported Use (Pediatric)--> | <!--Guideline-Supported Use (Pediatric)--> | ||
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | |||
|offLabelPedGuideSupport= | |||
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | |||
<!--Non–Guideline-Supported Use (Pediatric)--> | <!--Non–Guideline-Supported Use (Pediatric)--> | ||
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | |||
|offLabelPedNoGuideSupport= | |||
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | |||
<!--Contraindications--> | <!--Contraindications--> | ||
|contraindications=*sodium glycerophosphate should not be given to patients in a state of dehydration or with [[hypernatraemia]], [[hyperphosphataemia]], severe [[renal insufficiency]] or [[shock]]. | |||
|contraindications= | |||
* | |||
<!--Warnings--> | <!--Warnings--> | ||
|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. | |||
<!--Clinical Trials Experience--> | <!--Clinical Trials Experience--> | ||
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label. | |||
|clinicalTrials= | |||
There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label. | |||
<!--Postmarketing Experience--> | <!--Postmarketing Experience--> | ||
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label. | |||
|postmarketing= | |||
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label. | |||
<!--Drug Interactions--> | <!--Drug Interactions--> | ||
|drugInteractions=*No interactions with other drugs have been observed, but a moderate fall in serum phosphate can be seen during carbohydrate infusions. | |||
|drugInteractions= | |||
* | |||
<!--Use in Specific Populations--> | <!--Use in Specific Populations--> | ||
|useInPregnancyFDA=*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. | |||
|useInPregnancyAUS=There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant. | |||
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery. | |||
|useInNursing=*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. | |||
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients. | |||
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients. | |||
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations. | |||
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations. | |||
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with [[renal impairment]]. | |||
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with [[hepatic impairment.]] | |||
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males. | |||
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are [[immunocompromised]]. | |||
*No adverse events are to be expected when | |||
|useInPed= | |||
There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients. | |||
|useInGeri= | |||
There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients. | |||
|useInGender= | |||
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations. | |||
|useInRace= | |||
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations. | |||
|useInRenalImpair= | |||
There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment. | |||
|useInHepaticImpair= | |||
There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment. | |||
|useInReproPotential= | |||
There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males. | |||
|useInImmunocomp= | |||
There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised. | |||
<!--Administration and Monitoring--> | <!--Administration and Monitoring--> | ||
|administration=* Intravenous | |||
|administration= | |monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label. | ||
* Intravenous | |||
|monitoring= | |||
There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label. | |||
<!--IV Compatibility--> | <!--IV Compatibility--> | ||
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label. | |||
|IVCompat= | |||
There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label. | |||
<!--Overdosage--> | <!--Overdosage--> | ||
|overdose=*No adverse effects of an overdose have been reported. Most patients in need of intravenous [[nutrition]] have an increased capacity to handle glycerophosphate. | |||
|overdose= | |||
*No adverse effects of an overdose have been reported. Most patients in need of intravenous nutrition have an increased capacity to handle glycerophosphate. | |||
<!--Pharmacology--> | <!--Pharmacology--> | ||
<!--Drug box 2--> | <!--Drug box 2--> | ||
|drugBox=<!--Mechanism of Action--> | |||
|drugBox= | |mechAction=<!--Structure--> | ||
|structure=* The active ingredient in 1 ml of sodium glycerophosphate correspond to | |||
:*Phosphate 1 mmol | |||
:*Sodium 2 mmol | |||
<!--Mechanism of Action--> | |||
|mechAction= | |||
<!--Structure--> | |||
|structure= | |||
* | |||
: | |||
<!--Pharmacodynamics--> | <!--Pharmacodynamics--> | ||
|PD=*Glycerophosphate is a metabolic intermediate in fat metabolism and any pharmacodynamic effects other than maintaining the normal metabolic pathways are unlikely. | |||
|PD= | |||
*Glycerophosphate is a metabolic intermediate in fat metabolism and any pharmacodynamic effects other than maintaining the normal metabolic pathways are unlikely. | |||
<!--Pharmacokinetics--> | <!--Pharmacokinetics--> | ||
|PK=*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--> | |||
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label. | |||
<!--Clinical Studies--> | |||
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label. | |||
<!--How Supplied--> | |||
<!-- | |howSupplied=*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. | ||
<!--Patient Counseling Information--> | <!--Patient Counseling Information--> | ||
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label. | |||
|fdaPatientInfo= | |||
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label. | |||
<!--Precautions with Alcohol--> | <!--Precautions with Alcohol--> | ||
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | |||
|alcohol= | |||
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | |||
<!--Brand Names--> | <!--Brand Names--> | ||
|brandNames=*Glycophos | |||
|brandNames= | |||
* | |||
<!--Look-Alike Drug Names--> | <!--Look-Alike Drug Names--> | ||
|lookAlike=<!--Drug Shortage Status--> | |||
|lookAlike= | |||
<!--Drug Shortage Status--> | |||
|drugShortage= | |drugShortage= | ||
}} | }} | ||
<!--Pill Image--> | <!--Pill Image--> | ||
<!--Label Display Image--> | <!--Label Display Image--> | ||
{{LabelImage | |||
|fileName={{PAGENAME}}01.png|This image is provided by the National Library of Medicine. | |||
}} | |||
{{LabelImage | {{LabelImage | ||
|fileName={{PAGENAME}}02.png|This image is provided by the National Library of Medicine. | |fileName={{PAGENAME}}02.png|This image is provided by the National Library of Medicine. |
Latest revision as of 17:09, 20 August 2015
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Aparna Vuppala, M.B.B.S. [2]
Disclaimer
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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
- 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
{{#ask: Page Name::Sodium glycerophosphate |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Sodium glycerophosphate |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
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.
{{#subobject:
|Label Page=Sodium glycerophosphate |Label Name=Sodium glycerophosphate01.png
}}
{{#subobject:
|Label Page=Sodium glycerophosphate |Label Name=Sodium glycerophosphate02.png
}}
{{#subobject:
|Label Page=Sodium glycerophosphate |Label Name=Sodium glycerophosphate03.png
}}