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Albumin (human) 20% solution
Dr. Dalia K. Zaafar
Lecturer of clinical pharmacy
MTI University
What is albumin
• Albumin is an important factor in regulation of
plasma volume and tissue fluid balance
through its contribution to the colloid oncotic
pressure of plasma [1]
• Albumin is a highly soluble globular protein
with a relatively low molecular weight (66,500
Dalton) and exerts 70–80% of the colloid
oncotic pressure of normal plasma [2]
• IV administration of concentrated albumin
human solution causes a shift of fluid from the
interstitial spaces into the circulation and a
slight increase in the concentration of plasma
proteins [1]
What is albumin
• When used for treatment of hypovolemia, most
effective in well-hydrated patients. [3]
• Not considered and not used as an IV nutrition
source. [3]
• Binds and functions as a carrier of intermediate
metabolites (including bilirubin), trace metals,
some drugs, dyes, fatty acids, hormones, and
enzymes, thus affecting the transport,
inactivation, and/or exchange of tissue
products [2]
What is albumin human 20%
• A protein colloid; a sterile solution of
serum albumin prepared by fractionating
pooled plasma from healthy human
donors [1]
• It is a 20% sterile solution of albumin in
an aqueous diluent. [4]
• Stabilized with 0.02 M sodium caprylate
and 0.02 M acetyl tryptophan and
buffered with sodium carbonate. [4]
What is albumin human 20%
• The approximate sodium content of the
product is 145 meq/L. [2]
• Must be administered intravenously.
• Made from pooled human venous plasma
using the Cohn cold ethanol fractionation
process. [1]
INDICATIONS AND CLINICAL USE
• The oncotic and colloid properties of
albumin solution are used to restore and
maintain circulating blood volume, when
needed. [5]
• The choice of albumin over other colloid
or crystalloid solutions will depend on the
clinical situation of the individual patient,
according to current therapeutic
guidelines and recommendations. [5]
INDICATIONS AND CLINICAL USE
1- Emergency treatment of hypovolemic
shock
Albumin 20% is hyper oncotic and on
intravenous infusion will expand the plasma
volume by an additional three to four times the
volume actually administered, by withdrawal of
fluid from the interstitial spaces, in case of
normally interstitially hydrated patient, or in
case of interstitial edema, while for dehydrated
patients an additional crystalloids must be
given, or monitor hemodynamic response to
prevent circulatory overload [6]
INDICATIONS AND CLINICAL USE
1- Emergency treatment of hypovolemic
shock
• The total dose should not exceed the
normal level of albumin (about 2 g/kg).
• Albumin (Human) 5% is be preferred for
the usual volume deficits
• Albumin 20% with appropriate
crystalloids may offer therapeutic
advantages in oncotic deficits or in long-
standing shock where treatment has
been delayed [6]
INDICATIONS AND CLINICAL USE
1- Emergency treatment of hypovolemic
shock
• Albumin human should not be
considered a substitute for blood or blood
components when oxygen-carrying
capacity is reduced and/or when
replenishment of clotting factors or
platelets is necessary.
• Transfusion with whole blood or packed
RBCs is required in patients with active
hemorrhage or substantial anemia [5]
INDICATIONS AND CLINICAL USE
1- Emergency treatment of hypovolemic
shock
• Theoretical advantages of colloids
include greater retention in the
intravascular space, more effective and
rapid plasma volume expansion, and
reduced risk of pulmonary edema.
• Colloids generally have not been shown
to be more effective than crystalloids, and
costs associated with colloids are
substantially higher than those
associated with crystalloids. [6]
INDICATIONS AND CLINICAL USE
1- Emergency treatment of hypovolemic
shock
• Based on current evidence, albumin
human appears to offer no survival
advantage over crystalloids for fluid
resuscitation [6]
INDICATIONS AND CLINICAL USE
2- Neonatal hemolytic disease
• It may be indicated to administer albumin
20% prior to exchange transfusion, in order
to bind free bilirubin, in order to lessen 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 [7]
INDICATIONS AND CLINICAL USE
3- Acute liver failure
In rapid loss of liver function, administration
of albumin may serve in supporting the
colloid osmotic pressure of the plasma and
binding excess plasma bilirubin [7]
INDICATIONS AND CLINICAL USE
4- Acute nephrosis & nephrotic syndrome
• Used as an adjunct to diuretic therapy to
treat edema in patients with acute
nephrosis refractory to cyclophosphamide
and steroid therapy.
• Cardinal features of nephrotic syndrome
include albuminuria, hypoalbuminemia, and
edema.
• Decreased hepatic production and
increased renal catabolism are responsible
for hypoalbuminemia and renal sodium
retention is responsible for edema.[6]
INDICATIONS AND CLINICAL USE
4- Acute nephrosis & nephrotic syndrome
• Principal goal of therapy is treating the
underlying cause.
• Diuretic therapy is treatment of choice for
symptomatic management.
• UHC guidelines recommend short-term
adjunctive use of albumin human with
diuretics in adults with nephrotic syndrome
who have acute, severe peripheral and/or
pulmonary edema unresponsive to
diuretics alone. [7]
INDICATIONS AND CLINICAL USE
5- Adult respiratory distress syndrome
• It is characterized by deficient
oxygenation caused by pulmonary
interstitial edema. Albumin 20% with
diuretics play together a role in therapy
when clinical signs of hypoproteinemia
and fluid volume overload exist. [7]
Contraindications
• should not be given to patients who are
hypersensitive to albumin or to any
ingredient in the formulation or
component of the container.
• should not be given to patients at special
risk of developing circulatory overload like
patients with a history of congestive
cardiac failure, renal insufficiency or
stabilized chronic anemia [5]
When is albumin administration not warranted??
1- 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.[4]
2- undernutrition as albumin infusion is not
justified to be used as a source of protein
nutrition. [4]
Precautions
1- Albumin solution must not be diluted with sterile
water for injection as this may cause hemolysis
and acute renal failure in recipient. [3]
2- Use immediately after vial or container is
opened, and discard if >4 hours have elapsed
since container was first entered.[3]
3- albumin solution may contain more than 200
μg/L of aluminum. It shouldn’t be used to treat
infants or patients on hemodialysis.[2]
4- A rapid rise in blood pressure may follow the
administration of a colloid with positive oncotic
activity necessitates careful observation. [4]
Special populations
1- Pregnant Woman
Category C: consider potential risks and
benefits for the specific patient [7]
2- Nursing Women
It is not known whether it can cause harm to the
fetus or nursing child. It should be given to a
pregnant or nursing woman only if the benefit
outweighs any potential risk. [7]
3- Pediatrics
safety has been demonstrated in children
receiving dosage appropriate for body weight
Albumin isn’t preferred to be used in neonates
Specific drug interaction
ACE Inhibitors
Increased risk of atypical reactions
(flushing, hypotension) to ACE inhibitors in
patients undergoing therapeutic plasma
exchange with albumin human replacement
So it is recommended to withhold ACE
inhibitors for 24 hours prior to albumin
human administration [7]
Compatibility
• Can be administered in conjunction with
whole blood or plasma, or with dextrose,
sodium lactate, or sodium chloride
injections.
• Can’t be mixed with parenteral nutrient
solutions, protein hydrolysates, amino
acid solutions, or solutions containing
alcohol as proteins may precipitate in the
solutions. [6]
Doses & dose adjustment
• The infusion rate must be adjusted to
individual requirements, based on initial
assessment and monitoring of the
patient’s status.
• It should normally not exceed 1 to 2
mL/minute.
• The volume administered and the speed
of infusion should be adapted to the
response of the individual patient. [7]
Overdosage
To date, there have been no reported cases
of overdose
Albumin 20% is hyper-oncotic, so patients
should be monitored against the possibility
of circulatory overload.
In such case, provide standard supportive
treatment as necessary.
Hypervolemia may occur if the dosage and
rate of infusion are too high.
If hypervolemia is suspected, stop the
infusion immediately and carefully monitor
the patient’s hemodynamic parameters [7]
References
1-Food and Drug Administration Center for Biologics
Evaluation and Research: Personal communication; 1998
May and Oct.
2-Trissel LA. Handbook on injectable drugs. 15th ed.
Bethesda, MD: American Society of Health-System
Pharmacists, Inc; 2009:15-17
3-Talecris Biotherapeutics. Plasbumin-25 (albumin [human]
25%, USP) prescribing information. Research Triangle Park,
NC; 2010 Apr.
4-Alderson P, Bunn F, Lefebvre C et al. Human albumin
solution for resuscitation and volume expansion in critically ill
patients. Cochrane Database Syst Rev. 2002; :CD001208.
http://www.ncbi.nlm.nih.gov/pubmed/11869596?dopt=Abstrac
tPlus
http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcen
trez&artid=4171455&blobtype=pdf
References
5-Wilkes MM, Navickis RJ. Patient survival after human
albumin administration. A meta-analysis of randomized,
controlled trials. Ann Intern Med. 2001; 135:149-64.
http://www.ncbi.nlm.nih.gov/pubmed/11487482?dopt=Abstrac
tPlus
6-Vincent JL, Navickis RJ, Wilkes MM. Morbidity in
hospitalized patients receiving human albumin: a meta-
analysis of randomized, controlled trials. Crit Care Med. 2004;
32:2029-38.
http://www.ncbi.nlm.nih.gov/pubmed/15483411?dopt=Abstrac
tPlus
7- US Food and Drug Administration (FDA). Safety of albumin
administration in critically ill patients. From FDA website.
2005 May 16. Accessed on December 16, 2008.
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/
BloodSafety/ucm095539.htm
Albumin 20%

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Albumin 20%

  • 1. Albumin (human) 20% solution Dr. Dalia K. Zaafar Lecturer of clinical pharmacy MTI University
  • 2. What is albumin • Albumin is an important factor in regulation of plasma volume and tissue fluid balance through its contribution to the colloid oncotic pressure of plasma [1] • Albumin is a highly soluble globular protein with a relatively low molecular weight (66,500 Dalton) and exerts 70–80% of the colloid oncotic pressure of normal plasma [2] • IV administration of concentrated albumin human solution causes a shift of fluid from the interstitial spaces into the circulation and a slight increase in the concentration of plasma proteins [1]
  • 3. What is albumin • When used for treatment of hypovolemia, most effective in well-hydrated patients. [3] • Not considered and not used as an IV nutrition source. [3] • Binds and functions as a carrier of intermediate metabolites (including bilirubin), trace metals, some drugs, dyes, fatty acids, hormones, and enzymes, thus affecting the transport, inactivation, and/or exchange of tissue products [2]
  • 4. What is albumin human 20% • A protein colloid; a sterile solution of serum albumin prepared by fractionating pooled plasma from healthy human donors [1] • It is a 20% sterile solution of albumin in an aqueous diluent. [4] • Stabilized with 0.02 M sodium caprylate and 0.02 M acetyl tryptophan and buffered with sodium carbonate. [4]
  • 5. What is albumin human 20% • The approximate sodium content of the product is 145 meq/L. [2] • Must be administered intravenously. • Made from pooled human venous plasma using the Cohn cold ethanol fractionation process. [1]
  • 6. INDICATIONS AND CLINICAL USE • The oncotic and colloid properties of albumin solution are used to restore and maintain circulating blood volume, when needed. [5] • The choice of albumin over other colloid or crystalloid solutions will depend on the clinical situation of the individual patient, according to current therapeutic guidelines and recommendations. [5]
  • 7. INDICATIONS AND CLINICAL USE 1- Emergency treatment of hypovolemic shock Albumin 20% is hyper oncotic and on intravenous infusion will expand the plasma volume by an additional three to four times the volume actually administered, by withdrawal of fluid from the interstitial spaces, in case of normally interstitially hydrated patient, or in case of interstitial edema, while for dehydrated patients an additional crystalloids must be given, or monitor hemodynamic response to prevent circulatory overload [6]
  • 8. INDICATIONS AND CLINICAL USE 1- Emergency treatment of hypovolemic shock • The total dose should not exceed the normal level of albumin (about 2 g/kg). • Albumin (Human) 5% is be preferred for the usual volume deficits • Albumin 20% with appropriate crystalloids may offer therapeutic advantages in oncotic deficits or in long- standing shock where treatment has been delayed [6]
  • 9. INDICATIONS AND CLINICAL USE 1- Emergency treatment of hypovolemic shock • Albumin human should not be considered a substitute for blood or blood components when oxygen-carrying capacity is reduced and/or when replenishment of clotting factors or platelets is necessary. • Transfusion with whole blood or packed RBCs is required in patients with active hemorrhage or substantial anemia [5]
  • 10. INDICATIONS AND CLINICAL USE 1- Emergency treatment of hypovolemic shock • Theoretical advantages of colloids include greater retention in the intravascular space, more effective and rapid plasma volume expansion, and reduced risk of pulmonary edema. • Colloids generally have not been shown to be more effective than crystalloids, and costs associated with colloids are substantially higher than those associated with crystalloids. [6]
  • 11. INDICATIONS AND CLINICAL USE 1- Emergency treatment of hypovolemic shock • Based on current evidence, albumin human appears to offer no survival advantage over crystalloids for fluid resuscitation [6]
  • 12. INDICATIONS AND CLINICAL USE 2- Neonatal hemolytic disease • It may be indicated to administer albumin 20% prior to exchange transfusion, in order to bind free bilirubin, in order to lessen 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 [7]
  • 13. INDICATIONS AND CLINICAL USE 3- Acute liver failure In rapid loss of liver function, administration of albumin may serve in supporting the colloid osmotic pressure of the plasma and binding excess plasma bilirubin [7]
  • 14. INDICATIONS AND CLINICAL USE 4- Acute nephrosis & nephrotic syndrome • Used as an adjunct to diuretic therapy to treat edema in patients with acute nephrosis refractory to cyclophosphamide and steroid therapy. • Cardinal features of nephrotic syndrome include albuminuria, hypoalbuminemia, and edema. • Decreased hepatic production and increased renal catabolism are responsible for hypoalbuminemia and renal sodium retention is responsible for edema.[6]
  • 15. INDICATIONS AND CLINICAL USE 4- Acute nephrosis & nephrotic syndrome • Principal goal of therapy is treating the underlying cause. • Diuretic therapy is treatment of choice for symptomatic management. • UHC guidelines recommend short-term adjunctive use of albumin human with diuretics in adults with nephrotic syndrome who have acute, severe peripheral and/or pulmonary edema unresponsive to diuretics alone. [7]
  • 16. INDICATIONS AND CLINICAL USE 5- Adult respiratory distress syndrome • It is characterized by deficient oxygenation caused by pulmonary interstitial edema. Albumin 20% with diuretics play together a role in therapy when clinical signs of hypoproteinemia and fluid volume overload exist. [7]
  • 17. Contraindications • should not be given to patients who are hypersensitive to albumin or to any ingredient in the formulation or component of the container. • should not be given to patients at special risk of developing circulatory overload like patients with a history of congestive cardiac failure, renal insufficiency or stabilized chronic anemia [5]
  • 18. When is albumin administration not warranted?? 1- 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.[4] 2- undernutrition as albumin infusion is not justified to be used as a source of protein nutrition. [4]
  • 19. Precautions 1- Albumin solution must not be diluted with sterile water for injection as this may cause hemolysis and acute renal failure in recipient. [3] 2- Use immediately after vial or container is opened, and discard if >4 hours have elapsed since container was first entered.[3] 3- albumin solution may contain more than 200 μg/L of aluminum. It shouldn’t be used to treat infants or patients on hemodialysis.[2] 4- A rapid rise in blood pressure may follow the administration of a colloid with positive oncotic activity necessitates careful observation. [4]
  • 20. Special populations 1- Pregnant Woman Category C: consider potential risks and benefits for the specific patient [7] 2- Nursing Women It is not known whether it can cause harm to the fetus or nursing child. It should be given to a pregnant or nursing woman only if the benefit outweighs any potential risk. [7] 3- Pediatrics safety has been demonstrated in children receiving dosage appropriate for body weight Albumin isn’t preferred to be used in neonates
  • 21. Specific drug interaction ACE Inhibitors Increased risk of atypical reactions (flushing, hypotension) to ACE inhibitors in patients undergoing therapeutic plasma exchange with albumin human replacement So it is recommended to withhold ACE inhibitors for 24 hours prior to albumin human administration [7]
  • 22. Compatibility • Can be administered in conjunction with whole blood or plasma, or with dextrose, sodium lactate, or sodium chloride injections. • Can’t be mixed with parenteral nutrient solutions, protein hydrolysates, amino acid solutions, or solutions containing alcohol as proteins may precipitate in the solutions. [6]
  • 23. Doses & dose adjustment • The infusion rate must be adjusted to individual requirements, based on initial assessment and monitoring of the patient’s status. • It should normally not exceed 1 to 2 mL/minute. • The volume administered and the speed of infusion should be adapted to the response of the individual patient. [7]
  • 24. Overdosage To date, there have been no reported cases of overdose Albumin 20% is hyper-oncotic, so patients should be monitored against the possibility of circulatory overload. In such case, provide standard supportive treatment as necessary. Hypervolemia may occur if the dosage and rate of infusion are too high. If hypervolemia is suspected, stop the infusion immediately and carefully monitor the patient’s hemodynamic parameters [7]
  • 25. References 1-Food and Drug Administration Center for Biologics Evaluation and Research: Personal communication; 1998 May and Oct. 2-Trissel LA. Handbook on injectable drugs. 15th ed. Bethesda, MD: American Society of Health-System Pharmacists, Inc; 2009:15-17 3-Talecris Biotherapeutics. Plasbumin-25 (albumin [human] 25%, USP) prescribing information. Research Triangle Park, NC; 2010 Apr. 4-Alderson P, Bunn F, Lefebvre C et al. Human albumin solution for resuscitation and volume expansion in critically ill patients. Cochrane Database Syst Rev. 2002; :CD001208. http://www.ncbi.nlm.nih.gov/pubmed/11869596?dopt=Abstrac tPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcen trez&artid=4171455&blobtype=pdf
  • 26. References 5-Wilkes MM, Navickis RJ. Patient survival after human albumin administration. A meta-analysis of randomized, controlled trials. Ann Intern Med. 2001; 135:149-64. http://www.ncbi.nlm.nih.gov/pubmed/11487482?dopt=Abstrac tPlus 6-Vincent JL, Navickis RJ, Wilkes MM. Morbidity in hospitalized patients receiving human albumin: a meta- analysis of randomized, controlled trials. Crit Care Med. 2004; 32:2029-38. http://www.ncbi.nlm.nih.gov/pubmed/15483411?dopt=Abstrac tPlus 7- US Food and Drug Administration (FDA). Safety of albumin administration in critically ill patients. From FDA website. 2005 May 16. Accessed on December 16, 2008. http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ BloodSafety/ucm095539.htm