Aminohippurate: Difference between revisions

Jump to navigation Jump to search
VisualWikitext
No edit summary
No edit summary
Line 3: Line 3:
|genericName=Aminohippurate sodium
|genericName=Aminohippurate sodium
|aOrAn=a
|aOrAn=a
|drugClass=Diagnostic Agent
|indicationType=diagnosis
|indicationType=diagnosis
|indication=effective renal plasma flow (ERPF)
|indication=effective renal plasma flow (ERPF)
Line 12: Line 13:
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>


* Content
 


<!--Adult Indications and Dosage-->
<!--Adult Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult=====Indications====
* Estimation of effective renal plasma flow.


* Dosing Information
* Measurement of the functional capacity of the renal tubular secretory mechanism.


:* Dosage
====Dosage====
For intravenous use only


=====Condition2=====
Clearance measurements using single injection techniques are generally inaccurate, particularly in the measurement of ERPF. For this reason, intravenous infusions at fixed rates are used to sustain the plasma PAH concentration at the desired level.


* Dosing Information
To measure ERPF, the concentration of PAH in the plasma should be maintained at 2 mg per 100 mL, which can be achieved with a priming dose of 6 to 10 mg/kg and an infusion dose of 10 to 24 mg/min.


:* Dosage
As a research procedure for the measurement of TmPAH, the plasma level of PAH must be sufficient to saturate the capacity of the tubular secretory cells. Concentrations from 40 to 60 mg per 100 mL are usually necessary.


=====Condition3=====
Technical details of these tests may be found in Smith {1}; Wesson {2}; Bauer {3}; Pitts{4}; and Schnurr {5}.


* Dosing Information
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit. NOTE: The normal color range for this product is a colorless to yellow/brown solution. The efficacy is not affected by color changes within this range.


:* Dosage
Calculations
Effective Renal Plasma Flow (ERPF)


=====Condition4=====
The clearance of PAH, which is extracted almost completely from the plasma during its passage through the renal circulation, constitutes a measure of ERPF. Hence:


* Dosing Information
ERPF = UPAHV/PPAH


:* Dosage
Where UPAH = concentration of PAH (mg/mL) in the urine


<!--Off-Label Use and Dosage (Adult)-->
V = rate of urine excretion (mL/min), and


<!--Guideline-Supported Use (Adult)-->
PPAH = plasma concentration of PAH (mg/mL).
|offLabelAdultGuideSupport======Condition1=====


* Developed by:  
Example:


* Class of Recommendation:
UPAH = 8.0 mg/mL


* Strength of Evidence:
V = 1.5 mL/min


* Dosing Information
PPAH = 0.02 mg/mL


:* Dosage
ERPF = 8.0 x 1.5/0.02 = 600 mL/min


=====Condition2=====
Based on PAH clearance studies, the normal values for ERPF are:


There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
men 675 ± 150 mL/min


<!--Non–Guideline-Supported Use (Adult)-->
women 595 ± 125 mL/min
|offLabelAdultNoGuideSupport======Condition1=====


* Dosing Information
Maximum Tubular Secretory
(TmPAH ) Mechanism


:* Dosage
The quantity of PAH secreted by the tubules (TmPAH) is given by the difference between the total rate of excretion (UPAHV) and the quantity filtered by the glomeruli (GFR x PPAH). Hence:


=====Condition2=====
TmPAH = UPAHV – (GFR x PPAH x 0.83)


There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
The factor, 0.83, corrects for that portion of PAH which is bound to plasma protein and hence is unfilterable.


<!--Pediatric Indications and Dosage-->
Example:


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
UPAH = 9.55 mg/mL
|fdaLIADPed======Condition1=====


* Dosing Information
V = 16.68 mL/min


:* Dosage
GFR = 120 mL/min


=====Condition2=====
PPAH = 0.60 mg/mL


There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
Then TmPAH = 9.55 x 16.68 – (120 x 0.60 x 0.83) = 100 mg/min.


<!--Off-Label Use and Dosage (Pediatric)-->
Average normal values of TmPAH are 80-90 mg/min.


<!--Guideline-Supported Use (Pediatric)-->
The value of the expression UPAHV, used in calculations of ERPF and TmPAH, may be found by determining the amount of PAH in a measured volume of urine excreted within a specific period of time.
|offLabelPedGuideSupport======Condition1=====


* Developed by:
These calculations are based on a body surface area of 1.73 m2. Corrections for variations in surface area are made by multiplying the values obtained for ERPF and TmPAH by 1.73/A, where A is the subject surface area.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


* Class of Recommendation:
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


* Strength of Evidence:
<!--Pediatric Indications and Dosage-->


* Dosing Information
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed=* Safety and effectiveness in pediatric patients have not been established.


:* Dosage
<!--Off-Label Use and Dosage (Pediatric)-->


=====Condition2=====
<!--Guideline-Supported Use (Pediatric)-->
 
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
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======Condition1=====
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Contraindications-->
<!--Contraindications-->
|contraindications=* Condition1
|contraindications=* Hypersensitivity to this product or to its components.


<!--Warnings-->
<!--Warnings-->
|warnings=* Description
|warnings=====Precautions====


====Precautions====
General
Intravenous solutions must be given with caution to patients with low cardiac reserve, since a rapid increase in plasma volume can precipitate congestive heart failure.


* Description
For measurement of ERPF, small doses of PAH are used. However, in research procedures to measure TmPAH, high plasma levels are required to saturate the capacity of the tubular cells. During these procedures, the intravenous administration of PAH solutions should be carried out slowly and with caution. The patient should be continuously observed for any adverse reactions.
 
Use caution when injecting this product into latex-sensitive individuals, since the vial stopper contains dry natural latex rubber that may cause allergic reactions.


<!--Adverse Reactions-->
<!--Adverse Reactions-->


<!--Clinical Trials Experience-->
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials=Hypersensitivity reactions including anaphylaxis, angioedema, urticaria, vasomotor disturbances, flushing, tingling, nausea, vomiting, and cramps may occur.


=====Body as a Whole=====
Patients may have a sensation of warmth or the desire to defecate or urinate during or shortly following initiation of infusion.
 
 
 
 
=====Cardiovascular=====
 
 
 
 
=====Digestive=====
 
 
 
 
=====Endocrine=====
 
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
 
=====Metabolic and Nutritional=====
 
 
 
 
=====Musculoskeletal=====
 
 
 
 
=====Neurologic=====
 
 
 
 
=====Respiratory=====
 
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
 
=====Special Senses=====
 
 
 
 
=====Urogenital=====
 
 
 
 
=====Miscellaneous=====
 
 
 
<!--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.


Line 249: Line 183:


<!--Drug Interactions-->
<!--Drug Interactions-->
|drugInteractions=* Drug
|drugInteractions=* Renal clearance measurements of PAH cannot be made with any significant accuracy in patients receiving sulfonamides, procaine, or thiazolesulfone. These compounds interfere with chemical color development essential to the analytical procedures.
:* Description
 
Probenecid depresses tubular secretion of certain weak acids such as PAH. Therefore, patients receiving probenecid will have erroneously low ERPF and TmPAH values.


<!--Use in Specific Populations-->
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|FDAPregCat=C
|useInPregnancyFDA=* Animal reproduction studies have not been done with PAH. It is also not known whether PAH can cause fetal harm when given to a pregnant woman or can affect reproduction capacity. PAH should be given to a pregnant woman only if clearly needed.
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''


There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
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.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInNursing=* It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PAH is administered to a nursing woman.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInPed=* Safety and effectiveness in pediatric patients have not been established.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGeri=* Clinical studies of PAH did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|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.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
Line 269: Line 205:


<!--Administration and Monitoring-->
<!--Administration and Monitoring-->
|administration=* Oral
|administration=* Intravenous
|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.


* Description


<!--IV Compatibility-->
<!--IV Compatibility-->
Line 280: Line 214:


<!--Overdosage-->
<!--Overdosage-->
|overdose====Acute Overdose===
|overdose=* The intravenous LD50 in female mice is 7.22 g/kg.
 
====Signs and Symptoms====
 
* Description
 
====Management====
 
* Description
 
===Chronic Overdose===
 
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacology-->
 
<!--Drug box 2-->
|drugBox=<!--Mechanism of Action-->
|drugBox=<!--Mechanism of Action-->
|mechAction=*  
|mechAction=*  


<!--Structure-->
<!--Structure-->
|structure=*  
|structure=* Aminohippurate sodium1 is an agent to measure effective renal plasma flow (ERPF). It is the sodium salt of para-aminohippuric acid, commonly abbreviated “PAH”. It is water soluble, lipid-insoluble, and has a pKa of 3.83. The empirical formula of the anhydrous salt is C9H9N2NaO3 and its structural formula is:
 
: [[File:Amminohippurate str.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
It is provided as a sterile, non-preserved 20 percent aqueous solution for injection, with a pH of 6.7 to 7.6. Each 10 mL contains: Aminohippurate sodium 2 g. Inactive ingredients: Sodium hydroxide to adjust pH, water for injection, q.s.


<!--Pharmacodynamics-->
<!--Pharmacodynamics-->
Line 309: Line 229:


<!--Pharmacokinetics-->
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
|PK=PAH is filtered by the glomeruli and is actively secreted by the proximal tubules. At low plasma concentrations (1.0 to 2.0 mg/100 mL), an average of 90 percent of PAH is cleared by the kidneys from the renal blood stream in a single circulation. It is ideally suited for measurement of ERPF since it has a high clearance, is essentially nontoxic at the plasma concentrations reached with recommended doses, and its analytical determination is relatively simple and accurate.
 
PAH is also used to measure the functional capacity of the renal tubular secretory mechanism or transport maximum (TmPAH). This is accomplished by elevating the plasma concentration to levels (40-60 mg/100 mL) sufficient to saturate the maximal capacity of the tubular cells to secrete PAH.
 
Inulin clearance is generally measured during TmPAH determinations since glomerular filtration rate (GFR) must be known before calculations of secretory Tm measurements can be done


<!--Nonclinical Toxicology-->
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
|nonClinToxic=Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been done to evaluate any effects upon fertility or carcinogenic potential of PAH.


<!--Clinical Studies-->
<!--Clinical Studies-->
Line 318: Line 243:


<!--How Supplied-->
<!--How Supplied-->
|howSupplied=*
|howSupplied=* No. 95 — Aminohippurate Sodium, 20 percent sterile solution for intravenous injection, is supplied as follows:
|packLabel=<!--Patient Counseling Information-->
 
NDC 0006-3395-11 in 10 mL vials.
|storage=* Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)
|packLabel= PRINCIPAL DISPLAY PANEL - CARTON - 10 ML SINGLE DOSE VIAL
 
: [[File:Amminohippurate PDP.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
====Ingredients and Appearance====
 
: [[File:Amminohippurate Ing and App.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
<!--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.


Line 326: Line 262:


<!--Brand Names-->
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title =  | url = }}</ref>
|brandNames=* AMINOHIPPURATE SODIUM  PAH®<ref>{{Cite web | title =  Aminohippurate sodium| url = http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a1975215-25f1-4c5a-878d-bcbf5326bb92}}</ref>


<!--Look-Alike Drug Names-->
<!--Look-Alike Drug Names-->
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
<!--Drug Shortage Status-->
|drugShortage=
|drugShortage=
}}
}}

Revision as of 13:09, 16 April 2015

Aminohippurate
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: Rabin Bista, M.B.B.S. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Overview

Aminohippurate is a Diagnostic Agent that is FDA approved for the diagnosis of effective renal plasma flow (ERPF). Common adverse reactions include Hypersensitivity reactions including anaphylaxis, angioedema, urticaria.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • Estimation of effective renal plasma flow.
  • Measurement of the functional capacity of the renal tubular secretory mechanism.

Dosage

For intravenous use only

Clearance measurements using single injection techniques are generally inaccurate, particularly in the measurement of ERPF. For this reason, intravenous infusions at fixed rates are used to sustain the plasma PAH concentration at the desired level.

To measure ERPF, the concentration of PAH in the plasma should be maintained at 2 mg per 100 mL, which can be achieved with a priming dose of 6 to 10 mg/kg and an infusion dose of 10 to 24 mg/min.

As a research procedure for the measurement of TmPAH, the plasma level of PAH must be sufficient to saturate the capacity of the tubular secretory cells. Concentrations from 40 to 60 mg per 100 mL are usually necessary.

Technical details of these tests may be found in Smith {1}; Wesson {2}; Bauer {3}; Pitts{4}; and Schnurr {5}.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit. NOTE: The normal color range for this product is a colorless to yellow/brown solution. The efficacy is not affected by color changes within this range.

Calculations Effective Renal Plasma Flow (ERPF)

The clearance of PAH, which is extracted almost completely from the plasma during its passage through the renal circulation, constitutes a measure of ERPF. Hence:

ERPF = UPAHV/PPAH

Where UPAH = concentration of PAH (mg/mL) in the urine

V = rate of urine excretion (mL/min), and

PPAH = plasma concentration of PAH (mg/mL).

Example:

UPAH = 8.0 mg/mL

V = 1.5 mL/min

PPAH = 0.02 mg/mL

ERPF = 8.0 x 1.5/0.02 = 600 mL/min

Based on PAH clearance studies, the normal values for ERPF are:

men 675 ± 150 mL/min

women 595 ± 125 mL/min

Maximum Tubular Secretory (TmPAH ) Mechanism

The quantity of PAH secreted by the tubules (TmPAH) is given by the difference between the total rate of excretion (UPAHV) and the quantity filtered by the glomeruli (GFR x PPAH). Hence:

TmPAH = UPAHV – (GFR x PPAH x 0.83)

The factor, 0.83, corrects for that portion of PAH which is bound to plasma protein and hence is unfilterable.

Example:

UPAH = 9.55 mg/mL

V = 16.68 mL/min

GFR = 120 mL/min

PPAH = 0.60 mg/mL

Then TmPAH = 9.55 x 16.68 – (120 x 0.60 x 0.83) = 100 mg/min.

Average normal values of TmPAH are 80-90 mg/min.

The value of the expression UPAHV, used in calculations of ERPF and TmPAH, may be found by determining the amount of PAH in a measured volume of urine excreted within a specific period of time.

These calculations are based on a body surface area of 1.73 m2. Corrections for variations in surface area are made by multiplying the values obtained for ERPF and TmPAH by 1.73/A, where A is the subject surface area.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

  • Safety and effectiveness in pediatric patients have not been established.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

  • Hypersensitivity to this product or to its components.

Warnings

Precautions

General Intravenous solutions must be given with caution to patients with low cardiac reserve, since a rapid increase in plasma volume can precipitate congestive heart failure.

For measurement of ERPF, small doses of PAH are used. However, in research procedures to measure TmPAH, high plasma levels are required to saturate the capacity of the tubular cells. During these procedures, the intravenous administration of PAH solutions should be carried out slowly and with caution. The patient should be continuously observed for any adverse reactions.

Use caution when injecting this product into latex-sensitive individuals, since the vial stopper contains dry natural latex rubber that may cause allergic reactions.

Adverse Reactions

Clinical Trials Experience

Hypersensitivity reactions including anaphylaxis, angioedema, urticaria, vasomotor disturbances, flushing, tingling, nausea, vomiting, and cramps may occur.

Patients may have a sensation of warmth or the desire to defecate or urinate during or shortly following initiation of infusion.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Aminohippurate 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

  • Renal clearance measurements of PAH cannot be made with any significant accuracy in patients receiving sulfonamides, procaine, or thiazolesulfone. These compounds interfere with chemical color development essential to the analytical procedures.

Probenecid depresses tubular secretion of certain weak acids such as PAH. Therefore, patients receiving probenecid will have erroneously low ERPF and TmPAH values.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

  • Animal reproduction studies have not been done with PAH. It is also not known whether PAH can cause fetal harm when given to a pregnant woman or can affect reproduction capacity. PAH should be given to a pregnant woman only if clearly needed.


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

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

Nursing Mothers

  • It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PAH is administered to a nursing woman.

Pediatric Use

  • Safety and effectiveness in pediatric patients have not been established.

Geriatic Use

  • Clinical studies of PAH did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Intravenous

Monitoring

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

IV Compatibility

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

Overdosage

  • The intravenous LD50 in female mice is 7.22 g/kg.

Pharmacology

There is limited information regarding Aminohippurate Pharmacology in the drug label.

Mechanism of Action

Structure

  • Aminohippurate sodium1 is an agent to measure effective renal plasma flow (ERPF). It is the sodium salt of para-aminohippuric acid, commonly abbreviated “PAH”. It is water soluble, lipid-insoluble, and has a pKa of 3.83. The empirical formula of the anhydrous salt is C9H9N2NaO3 and its structural formula is:
This image is provided by the National Library of Medicine.

It is provided as a sterile, non-preserved 20 percent aqueous solution for injection, with a pH of 6.7 to 7.6. Each 10 mL contains: Aminohippurate sodium 2 g. Inactive ingredients: Sodium hydroxide to adjust pH, water for injection, q.s.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Aminohippurate in the drug label.

Pharmacokinetics

PAH is filtered by the glomeruli and is actively secreted by the proximal tubules. At low plasma concentrations (1.0 to 2.0 mg/100 mL), an average of 90 percent of PAH is cleared by the kidneys from the renal blood stream in a single circulation. It is ideally suited for measurement of ERPF since it has a high clearance, is essentially nontoxic at the plasma concentrations reached with recommended doses, and its analytical determination is relatively simple and accurate.

PAH is also used to measure the functional capacity of the renal tubular secretory mechanism or transport maximum (TmPAH). This is accomplished by elevating the plasma concentration to levels (40-60 mg/100 mL) sufficient to saturate the maximal capacity of the tubular cells to secrete PAH.

Inulin clearance is generally measured during TmPAH determinations since glomerular filtration rate (GFR) must be known before calculations of secretory Tm measurements can be done

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been done to evaluate any effects upon fertility or carcinogenic potential of PAH.

Clinical Studies

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

How Supplied

  • No. 95 — Aminohippurate Sodium, 20 percent sterile solution for intravenous injection, is supplied as follows:

NDC 0006-3395-11 in 10 mL vials.

Storage

  • Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)

Images

Drug Images

{{#ask: Page Name::Aminohippurate |?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

PRINCIPAL DISPLAY PANEL - CARTON - 10 ML SINGLE DOSE VIAL

This image is provided by the National Library of Medicine.

Ingredients and Appearance

This image is provided by the National Library of Medicine.

{{#ask: Label Page::Aminohippurate |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Aminohippurate in the drug label.

Precautions with Alcohol

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

Brand Names

  • AMINOHIPPURATE SODIUM PAH®[1]

Look-Alike Drug Names

There is limited information regarding Aminohippurate 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.

  1. ↑ "Aminohippurate sodium".

{{#subobject: 

 |Page Name=Aminohippurate
 |Pill Name=No image.jpg
 |Drug Name=
 |Pill Ingred=|+sep=;
 |Pill Imprint=
 |Pill Dosage={{{dosageValue}}} {{{dosageUnit}}}
 |Pill Color=|+sep=;
 |Pill Shape=
 |Pill Size (mm)=
 |Pill Scoring=
 |Pill Image=
 |Drug Author=
 |NDC=

}}

{{#subobject: 

 |Label Page=Aminohippurate
 |Label Name=Aminohippurate11.png

}}

{{#subobject: 

 |Label Page=Aminohippurate
 |Label Name=Aminohippurate11.png

}}

Retrieved from "https://www.wikidoc.org/index.php?title=Aminohippurate&oldid=1088206"