Albumin: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{KS}}
|genericName=albumin
|aOrAn=a
|aOrAn=a
|indicationType=treatment
|indicationType=treatment
|hasBlackBoxWarning=Yes
|indication=emergency treatment of hypovolemic shock,burn therapy,hypoproteinemia with or without edema,adult respiratory distress syndrome,acute liver failure,neonatal hemolytic disease,acute nephrosis
|adverseReactions=<!--Black Box Warning-->
|adverseReactions=Hypersensitivity reaction
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
Line 12: Line 14:


<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult===Indications==


* Dosing Information
'''Emergency Treatment of Hypovolemic Shock'''


:* Dosage
* Albuked 20 is hyperoncotic and on intravenous infusion will expand the plasma volume by an additional amount, three to four times the volume actually administered, by withdrawing fluid from the interstitial spaces, provided the patient is normally hydrated interstitially or there is interstitial edema. If the patient is dehydrated, additional crystalloids must be given, or alternatively, Albumin (Human) 5%, USP (Albuked™ 5) should be used. The patient’s hemodynamic response should be monitored and the usual precautions against circulatory overload observed. The total dose should not exceed the level of albumin found in the normal individual; i.e., about 2 g per kg body weight in the absence of active bleeding. Although Albuked  is to be preferred for the usual volume deficits, Albuked 20 with appropriate crystalloids may offer therapeutic advantages in oncotic deficits or in long-standing shock where treatment has been delayed.


=====Condition2=====
* Removal of ascitic fluid from a patient with cirrhosis may cause changes in cardiovascular function and even result in hypovolemic shock. In such circumstances, the use of an albumin infusion may be required to support the blood volume.


* Dosing Information
'''Burn Therapy'''


:* Dosage
* An optimal therapeutic regimen with respect to the administration of colloids, crystalloids, and water following extensive burns has not been established. During the first 24 hours after sustaining thermal injury, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. Beyond 24 hours Albuked 20 can be used to maintain plasma colloid osmotic pressure.


=====Condition3=====
'''Hypoproteinemia With or Without Edema'''


* Dosing Information
* During major surgery, patients can lose over half of their circulating albumin with the attendant complications of oncotic deficit.A similar situation can occur in sepsis or intensive care patients. Treatment with Albuked 20 may be of value in such cases.


:* Dosage
'''Adult Respiratory Distress Syndrome (ARDS)'''


=====Condition4=====
* This is characterized by deficient oxygenation caused by pulmonary interstitial edema complicating shock and postsurgical conditions. When clinical signs are those of hypoproteinemia with a fluid volume overload, Albuked 20 together with a diuretic may play a role in therapy.


* Dosing Information
'''Cardiopulmonary Bypass'''


:* Dosage
* With the relatively small priming volume required with modern pumps, preoperative dilution of the blood using albumin and crystalloid has been shown to be safe and well-tolerated. Although the limit to which the hematocrit and plasma protein concentration can be safely lowered has not been defined, it is common practice to adjust the albumin and crystalloid pump prime to achieve a hematocrit of 20% and a plasma albumin concentration of 2.5 g per 100 mL in the patient.


<!--Off-Label Use and Dosage (Adult)-->
'''Acute Liver Failure'''


<!--Guideline-Supported Use (Adult)-->
* In the uncommon situation of rapid loss of liver function with or without coma, administration of albumin may serve the double purpose of supporting the colloid osmotic pressure of the plasma as well as binding excess plasma bilirubin.
|offLabelAdultGuideSupport======Condition1=====


* Developed by:
'''Neonatal Hemolytic Disease'''


* Class of Recommendation:
* The administration of Albuked 20 may be indicated prior to exchange transfusion, in order to bind free bilirubin, thus lessening the risk of kernicterus. A dosage of 1 g/kg body weight is given about 1 hour prior to exchange transfusion. Caution must be observed in hypervolemic infants.


* Strength of Evidence:
'''Sequestration of Protein Rich Fluids'''


* Dosing Information
* This occurs in such conditions as acute peritonitis, pancreatitis, mediastinitis, and extensive cellulitis. The magnitude of loss into the third space may require treatment of reduced volume or oncotic activity with an infusion of albumin.


:* Dosage
'''Erythrocyte Resuspension'''


=====Condition2=====
* Albumin may be required to avoid excessive hypoproteinemia during certain types of exchange transfusion, or with the use of very large volumes of previously frozen or washed red cells. About 25 g of albumin per liter of erythrocytes is commonly used, although the requirements in preexistent hypoproteinemia or hepatic impairment can be greater. Albuked 20 is added to the isotonic suspension of washed red cells immediately prior to transfusion.


There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
'''Acute Nephrosis'''


<!--Non–Guideline-Supported Use (Adult)-->
* Certain patients may not respond to cyclophosphamide or steroid therapy. The steroids may even aggravate the underlying edema. In this situation a loop diuretic and 100 mL Albuked 20 repeated daily for 7 to 10 days may be helpful in controlling the edema and the patient may then respond to steroid treatment.
|offLabelAdultNoGuideSupport======Condition1=====


* Dosing Information
'''Renal Dialysis'''


:* Dosage
* Although not part of the regular regimen of renal dialysis, Albuked 20 may be of value in the treatment of shock or hypotension in these patients. The usual volume administered is about 100 mL, taking particular care to avoid fluid overload as these patients are often fluid overloaded and cannot tolerate substantial volumes of salt solution.


=====Condition2=====
'''Situations in Which Albumin Administration is Not Warranted'''


There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
* In chronic nephrosis, infused albumin is promptly excreted by the kidneys with no relief of the chronic edema or effect on the underlying renal lesion. It is of occasional use in the rapid “priming” diuresis of nephrosis. Similarly, in hypoproteinemic states associated with chronic cirrhosis, malabsorption, protein-losing enteropathies, pancreatic insufficiency, and undernutrition, the infusion of albumin as a source of protein nutrition is not justified.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Pediatric Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|fdaLIADPed======Condition1=====


* Dosing Information


:* Dosage


=====Condition2=====


There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 


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


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


There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Contraindications-->
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
|contraindications=* Condition1


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


====Precautions====
|warnings=


* Description


<!--Adverse Reactions-->
<!--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.
=====Body as a Whole=====




=====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.


=====Body as a Whole=====




Line 244: Line 144:


<!--Drug Interactions-->
<!--Drug Interactions-->
|drugInteractions=* Drug
:* Description
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
Line 269: Line 165:
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


* Description
 


<!--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-->
|overdose====Acute Overdose===


====Signs and Symptoms====
|overdose=There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.


* Description


====Management====


* Description


===Chronic Overdose===
|structure=


There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.


<!--Pharmacology-->


<!--Drug box 2-->
|drugBox=<!--Mechanism of Action-->
|mechAction=*


<!--Structure-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
|structure=*


: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


<!--Pharmacodynamics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.


<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.


<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
|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.
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.


<!--How Supplied-->
 
|howSupplied=*
|howSupplied=*
|packLabel=<!--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-->
 
|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-->
 
|brandNames=* ®<ref>{{Cite web | title =  | url = }}</ref>
|brandNames=* ®<ref>{{Cite web | title =  | url = }}</ref>



Revision as of 17:42, 10 March 2015

Albumin
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: Kiran Singh, M.D. [2]

Disclaimer

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Overview

Albumin is a {{{drugClass}}} that is FDA approved for the treatment of emergency treatment of hypovolemic shock,burn therapy,hypoproteinemia with or without edema,adult respiratory distress syndrome,acute liver failure,neonatal hemolytic disease,acute nephrosis. Common adverse reactions include Hypersensitivity reaction.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Emergency Treatment of Hypovolemic Shock

  • Albuked 20 is hyperoncotic and on intravenous infusion will expand the plasma volume by an additional amount, three to four times the volume actually administered, by withdrawing fluid from the interstitial spaces, provided the patient is normally hydrated interstitially or there is interstitial edema. If the patient is dehydrated, additional crystalloids must be given, or alternatively, Albumin (Human) 5%, USP (Albuked™ 5) should be used. The patient’s hemodynamic response should be monitored and the usual precautions against circulatory overload observed. The total dose should not exceed the level of albumin found in the normal individual; i.e., about 2 g per kg body weight in the absence of active bleeding. Although Albuked is to be preferred for the usual volume deficits, Albuked 20 with appropriate crystalloids may offer therapeutic advantages in oncotic deficits or in long-standing shock where treatment has been delayed.
  • Removal of ascitic fluid from a patient with cirrhosis may cause changes in cardiovascular function and even result in hypovolemic shock. In such circumstances, the use of an albumin infusion may be required to support the blood volume.

Burn Therapy

  • An optimal therapeutic regimen with respect to the administration of colloids, crystalloids, and water following extensive burns has not been established. During the first 24 hours after sustaining thermal injury, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. Beyond 24 hours Albuked 20 can be used to maintain plasma colloid osmotic pressure.

Hypoproteinemia With or Without Edema

  • During major surgery, patients can lose over half of their circulating albumin with the attendant complications of oncotic deficit.A similar situation can occur in sepsis or intensive care patients. Treatment with Albuked 20 may be of value in such cases.

Adult Respiratory Distress Syndrome (ARDS)

  • This is characterized by deficient oxygenation caused by pulmonary interstitial edema complicating shock and postsurgical conditions. When clinical signs are those of hypoproteinemia with a fluid volume overload, Albuked 20 together with a diuretic may play a role in therapy.

Cardiopulmonary Bypass

  • With the relatively small priming volume required with modern pumps, preoperative dilution of the blood using albumin and crystalloid has been shown to be safe and well-tolerated. Although the limit to which the hematocrit and plasma protein concentration can be safely lowered has not been defined, it is common practice to adjust the albumin and crystalloid pump prime to achieve a hematocrit of 20% and a plasma albumin concentration of 2.5 g per 100 mL in the patient.

Acute Liver Failure

  • In the uncommon situation of rapid loss of liver function with or without coma, administration of albumin may serve the double purpose of supporting the colloid osmotic pressure of the plasma as well as binding excess plasma bilirubin.

Neonatal Hemolytic Disease

  • The administration of Albuked 20 may be indicated prior to exchange transfusion, in order to bind free bilirubin, thus lessening the risk of kernicterus. A dosage of 1 g/kg body weight is given about 1 hour prior to exchange transfusion. Caution must be observed in hypervolemic infants.

Sequestration of Protein Rich Fluids

  • This occurs in such conditions as acute peritonitis, pancreatitis, mediastinitis, and extensive cellulitis. The magnitude of loss into the third space may require treatment of reduced volume or oncotic activity with an infusion of albumin.

Erythrocyte Resuspension

  • Albumin may be required to avoid excessive hypoproteinemia during certain types of exchange transfusion, or with the use of very large volumes of previously frozen or washed red cells. About 25 g of albumin per liter of erythrocytes is commonly used, although the requirements in preexistent hypoproteinemia or hepatic impairment can be greater. Albuked 20 is added to the isotonic suspension of washed red cells immediately prior to transfusion.

Acute Nephrosis

  • Certain patients may not respond to cyclophosphamide or steroid therapy. The steroids may even aggravate the underlying edema. In this situation a loop diuretic and 100 mL Albuked 20 repeated daily for 7 to 10 days may be helpful in controlling the edema and the patient may then respond to steroid treatment.

Renal Dialysis

  • Although not part of the regular regimen of renal dialysis, Albuked 20 may be of value in the treatment of shock or hypotension in these patients. The usual volume administered is about 100 mL, taking particular care to avoid fluid overload as these patients are often fluid overloaded and cannot tolerate substantial volumes of salt solution.

Situations in Which Albumin Administration is Not Warranted

  • In chronic nephrosis, infused albumin is promptly excreted by the kidneys with no relief of the chronic edema or effect on the underlying renal lesion. It is of occasional use in the rapid “priming” diuresis of nephrosis. Similarly, in hypoproteinemic states associated with chronic cirrhosis, malabsorption, protein-losing enteropathies, pancreatic insufficiency, and undernutrition, the infusion of albumin as a source of protein nutrition is not justified.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Albumin in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Albumin Contraindications in the drug label.

Warnings

There is limited information regarding Albumin Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

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



Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

There is limited information regarding Albumin Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Albumin with respect to nursing mothers.

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

IV Compatibility

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

Overdosage

There is limited information regarding Chronic Overdose of Albumin in the drug label.

Pharmacology

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

Mechanism of Action

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

Structure

There is limited information regarding Albumin Structure in the drug label.

Pharmacodynamics

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

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Albumin in the drug label.

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Albumin Storage in the drug label.

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Albumin 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.

  1. Empty citation (help)
  2. "http://www.ismp.org". External link in |title= (help)

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