Mosby's Drug Consult - Albumin, Normal Serum (Human)

Albumin, Normal Serum (Human) (0114)
[ al-byoo'-min ]

Ingredients:	Albumin, Normal Serum (Human)
Indications:	Burns; Cirrhosis; Hemolysis, newborn; Hypoalbuminemia; Hypoproteinemia; Hypovolemia; Nephrosis; Respiratory distress syndrome; Surgery, coronary bypass, adjunct
Pregnancy Category:	C
FDA Approved:	pre- 1938
Classes:	Plasma expanders
Brand Names:	Albapure - Indonesia, Taiwan ; Albital - Ecuador ; Albuman - Peru ; Albumer - AFRICA(Except South-africa ); Philippines, Thailand ; Albumex - AUSTRALIA ; Albumin 5% - Switzerland ; Albumin 5% Human - Germany ; Albumina Humana - Brazil ; Albuminar - Brazil, Hong-kong, Israel ; Albuminate - Indonesia ; Albumin Human Salzarm 25% - Germany ; Albutein 25% - Brazil, Hong-kong ; Biseko 5% - Switzerland ; Buminate 25% - Hong-kong ; Human Albumin - Austria ; Human Albumin "SSI" - Denmark ; Human Albumin 25% - Germany ; Humanalbumin 5% - Austria ; Human Albumin 5% - Czech-republic, Germany ; Plasmabumin - Canada ; Probialbumin - Mexico ; Seralbumin - Colombia, Costa-rica, Dominican-republic, El-salvador, Guatemala, Honduras, Nicaragua, Panama ; SRK - Switzerland ; Vialebex - France ;
DEA schedules:	(none)
Cost of therapy:	$415.00 ( Burns ; Buminate ; 25%; 100 ml ; 2 infusion bottles ; 100 ml ) $830.00 ( Hypo proteinemia ; Buminate ; 25%; 100 ml ; 4 infusion bottles ; 100 ml ) $415.00 ( Hypovolemia ; Buminate ; 25%; 100 ml ; 2 infusion bottles ; 100 ml )

DESCRIPTION

This product is derived from blood collected from volunteer donors by the American Red Cross Blood Services. The cost of processing, testing and packaging was paid by the Red Cross.
Albumin (Human), 5% solution, Albumarc 5%, contains in each 100 ml, 5 g of albumin prepared from pooled human venous plasma.
Albumin (Human), 25% solution, Albumarc 25%, contains in each 100 ml, 25 g of albumin prepared from pooled human venous plasma.
Albumin (Human), 5% and 25% solutions, were prepared using the Cohn cold ethanol fractionation process.^{1, 2}Albumin (Human), 5% solution, has been adjusted to physiological pH with sodium bicarbonate and/ or sodium hydroxide and has been stabilized with 0.004 M sodium caprylate and 0.004 M sodium acetyltryptophanate. Albumin (Human), 25% solution, has been adjusted to physiological pH with sodium bicarbonate and/ or sodium hydroxide and has been stabilized with 0.02 M sodium caprylate and 0.02 M sodium acetyltryptophanate. Both solutions contain 145 ± 15 mEq of sodium per liter. Albumin (Human), 5% and 25% solutions, contain no preservative and none of the coagulation factors of fresh whole blood or fresh plasma. The transparent or slightly opalescent solutions may have a greenish tint or may be a pale straw to amber in color.
In addition to sterilization by filtration, these products have been heated for 10 hours at 60°C in the final container. This procedure has been shown to be an effective method of inactivating hepatitis viruses in 25% solutions of albumin even when prepared from plasma known to contain transmissible hepatitis viruses.³
The processing of Albumin (Human), 5% solution, has removed blood group isoagglutinins to permit its administration without regard to the recipient's blood group. Albumin (Human), 5% and 25% solutions, must be administered INTRAVENOUSLY.

Albuminar 5%

Albumin (Human) 5%, Albuminar- 5 is a sterile solution of albumin obtained from large pools of adult human venous plasma by low temperature controlled fractionation according to the Cohn process. It is heated at 60°C for 10 hours and stabilized with 0.004 M sodium acetyltryptophanate and 0.004 M sodium caprylate.
Each 50 ml bottle of 5% solution contains 2.5 g of albumin in normal saline. Each 250 ml bottle of bottle solution contains 12.5 g of albumin in normal saline. Each 500 ml bottle of 5% solution contains 25 g of albumin in normal saline. Each 1000 ml bottle of 5% solution contains 50 g of albumin in normal saline. The 5% solution is osmotically equivalent with citrated plasma. The pH of the solution is adjusted to 6.9 ± 0.5 with sodium bicarbonate, sodium hydroxide, or acetic acid. Approximate concentrations of significant electrolytes per liter are: Sodium 130- 160 mEq; and Potassium- n.m.t. 1mEq. The solution contains no preservative. This product has been prepared in accordance with the requirements established by the Food and Drug Administration and is in compliance with the standards of the United States Pharmacopeia.
Albumin (Human) 5%, Albuminar- 5, is to be administered by the intravenous route.

Albuminar 25%

Albumin (Human) 25%, Albuminar- 25 is a sterile aqueous solution of albumin obtained from large pools of adult human plasma by low temperature controlled fractionation according to the Cohn process. It is stabilized with 0.02 M sodium acetyltryptophanate and 0.02 M sodium caprylate and pasteurized at 60°C for 10 hours.
Albumin (Human) 25%, Albuminar- 25 is a solution containing in each 100 ml, 25 g of serum albumin, osmotically equivalent to 500 ml of normal human plasma. The pH of the solution is adjusted with sodium bicarbonate, sodium hydroxide, or acetic acid. Approximate concentrations of significant electrolytes per liter are: sodium: 130- 160 mEq; and potassium: n.m.t. 1 mEq. The solution contains no preservative. This product has been prepared in accordance with the requirements established by the Food and Drug Administration and is in compliance with the standards of the United States Pharmacopeia.
Albumin (Human) 25%, Albuminar- 25 is to be administered by the intravenous route.

Storage: Store Albumin (Human), 5% or 25% solution, at room temperature, not to exceed 30°C (86°F). Avoid freezing to prevent damage to the bottle. Do not use after expiration date.

CLINICAL PHARMACOLOGY

Albumin is a highly soluble, ellipsoidal protein (MW: 66, 500), accounting for 70- 80% of the colloid osmotic pressure of plasma. It is, therefore, important in regulating the volume of circulating blood.^{4- 6}Albumin (Human), 5% solution, supplies the oncotic equivalent of approximately its volume of normal human plasma. Albumin (Human), 25% solution, supplies the oncotic equivalent of approximately 5 times its volume of human plasma. When injected intravenously, 5% albumin will increase the circulating plasma volume by an amount approximately equal to the volume infused. When injected intravenously, 25% albumin will draw approximately 3.5 times its volume of additional fluid into the circulation within 15 minutes, if the recipient is adequately hydrated.^{2, 7}In both solutions this extra fluid reduces hemoconcentration and decreases blood viscosity. The degree and duration of volume expansion depend upon the initial blood volume. When treating patients with diminished blood volume, the effect of infused albumin may persist for many hours. With Albumin (Human), 5% solution, in individuals with normal blood volumes, the hemodilution lasts for a much shorter time.
Albumin is also a transport protein and binds naturally occurring, therapeutic, and toxic materials in the circulation.^{4, 5}
Albumin is distributed throughout the extracellular water and more than 60% of the body albumin pool is located in the extravascular fluid compartment. The total body albumin in a 70 kg man is approximately 350 g; it has a circulating life span of 15 to 20 days, with a turnover of approximately 15 g/ day.⁵
The minimum serum albumin level necessary to prevent or reverse peripheral edema is unknown. Although it undoubtedly varies from patient to patient, there is some evidence that it falls near 2.5 g/ dl. This concentration provides a plasma oncotic pressure of 20 mm Hg (the equivalent of a total protein concentration of 5.2 g/ dl).^{6, 7}

INDICATIONS AND USAGE

Hypovolemia (with or without shock)

Hypovolemia is a possible indication for albumin administration. The effectiveness of 5% albumin in reversing hypovolemia depends largely upon its colloid osmotic pressure. The effectiveness of 25% albumin in reversing hypovolemia depends largely upon its ability to draw interstitial fluid into the circulation. Thus, it will be maximally effective only if the patient is well hydrated.²Generally, except where signs of overhydration and/ or edema are present, the treatment of acute blood volume deficit (shock) is best achieved by the administration of 5% plasma protein solution [5% Albumin (Human), 5% Plasma Protein Fraction (Human)]^{4- 7}or, by using 25% albumin with crystalloid solutions in an albumin- to- crystalloid volume ratio of 1:3 or 1:4.
Although crystalloid solutions or colloid- containing plasma substitutes may be used in the emergency treatment of shock, Albumin (Human), 5% and 25% solutions, have a longer intravascular half- life.^{4, 7- 9}
When the hypovolemia is long- standing and hypoalbuminemia exists in the presence of adequate hydration or edema, 25% albumin is preferable to 5% protein solutions.^{4, 6}
When the blood volume deficit is the result of hemorrhage, replacement with compatible red blood cells or whole blood should be undertaken as quickly as is possible.

Hypoalbuminemia

General

Hypoalbuminemia is another possible indication for albumin administration. Hypoalbuminemia may result from one or more of the following:⁵

Inadequate Production: Malnutrition, burns, major injury, congenital analbuminemia, liver disease, infection, malignancy, endocrine disorders.

Excessive Catabolism: Burns, major injury, pancreatitis, thyrotoxicosis, pemphigus, nephrosis.

Loss From the Body: Hemorrhage, excessive renal excretion, burn exudates, exudative enteropathy, exfoliative dermatoses.

Redistribution Within the Body: Major surgery, cirrhosis with ascites, various inflammatory conditions.

In almost every instance, treatment of the underlying disorder and emphasis on increased nutritional replacement of amino acids and/ or protein will be more likely to restore normal plasma albumin levels than will the transfusion of albumin- containing solutions.^{4, 6, 7}Whenever hypoalbuminemia results from excessive protein loss, the effect of albumin administration will be temporally unless the underlying disorder is reversed.
There are occasional patients with hypoproteinemia accompanying major infections or injuries, or severe pancreatitis, for whom reversal of the disorder cannot be accomplished quickly. In these situations, supplementation of nutritional protein intake with amino acid infusions may fail to restore serum albumin to adequate levels, and 5% or 25% albumin may be a useful therapeutic adjuvant.

Burns

The optimal mix of crystalloid and colloid solutions which should be administered following extensive burns remains the subject of continuing discussion.^{4, 7}During the initial 24 hours of therapy, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. Beyond 24 hours, albumin is generally used to replace the protein loss which accompanies any severe burn.^{4, 6, 7}

Adult Respiratory Distress Syndrome (ARDS) — Albumin (Human), 25% Solution

Several factors are usually involved in the development of ARDS.^{4, 6, 9}One of these is a hypoproteinemic state which may be causally related to the interstitial pulmonary edema characteristic of ARDS. Although uncertainty exists concerning the precise indications for albumin infusion in ARDS, when evidence of fluid overload in the lungs is accompanied by hypoalbuminemia, the administration of 25% albumin together with a diuretic may be of therapeutic value.⁶

Cirrhosi
	When repeated paracenteses are being performed for ascites and the fluid is not being reinfused, supplementary albumin infusion may be needed.⁷

Nephrosis — Albumin (Human), 25% Solution
	In patients with acute nephrosis who are receiving steroids and/ or diuretics, success in treatment of edema may be enhanced by raising plasma oncotic pressure through the administration of 25% albumin.^{4, 6}

Cardiopulmonary Bypass Surgery — Albumin (Human), 25% Solution
	The administration of 25% albumin prior to or during cardiopulmonary bypass surgery has been recommended although there are no clear data indicating its advantages over crystalloid solutions. Which is the most propitious time to infuse albumin is also unclear.^{4, 6, 10}

Hemolytic Disease of the Newborn (HDN) — Albumin (Human), 25% Solution
	In view of its transport role, 25% albumin may be administered in an attempt to bind and detoxify unconjugated bilirubin circulating in infants with severe HDN, thereby lessening the risk of kernicterus.⁴

Miscellaneous Indications for Albumin (Human), 5% Solution

- The administration of albumin prior to or during cardiopulmonary bypass surgery has been recommended although there are no clear data indicating its advantages over crystalloid solutions. Which is the most propitious time to infuse albumin is also unclear.^{4, 7, 10}

- When large volumes of packed red blood cells have been transfused to correct blood loss, 5% albumin may be administered in order to avoid the development of hypoalbuminemia.

Circumstances in Which Albumin Administration Is Usually Not Indicated

The internal redistribution of plasma albumin which accompanies major surgery only occasionally causes clinical evidence of hypovolemia or insufficient plasma oncotic pressure. Moreover, there is no evidence that this temporary redistribution adversely affects wound healing. Therefore, the administration of 5% or 25% albumin to such post- surgical patients is not usually indicated.
The sequestration of protein- rich fluid during the course of acute inflammatory conditions (peritonitis, pancreatitis, cellulitis) rarely causes significant morbidity due to hypovolemia, and treatment with albumin is rarely indicated.
Rarely does a valid reason exist for administering albumin to treat the stabilized hypoproteinemias accompanying chronic cirrhosis, chronic nephrosis, protein- losing enteropathy, malabsorption, or pancreatic insufficiency.^{4, 6, 7}However, when a patient in this category has to cope with a superimposed acute stress ( e.g., anesthesia, major infection, etc.) his hemodynamic state, oncotic deficit and fluid balance should be carefully assessed and appropriate measures taken, as indicated by the individual circumstances.^{6, 7}
There is no valid reason for the use of albumin as an intravenous nutrient.

CONTRAINDICATIONS
	The history of an allergic reaction to albumin is a specific contraindication to the use of this product.

WARNINGS

Albumin (Human), 5% solution, should be administered with great caution to patients with hypertension, cardiac disease, severe pulmonary infection, or severe chronic anemia. For the treatment of patients with hypoalbuminemia accompanied by peripheral edema, 25% albumin should be used.
Although the volume administered and the speed of infusion should be adapted to the patient, 5% albumin solution usually can be administered safely to older children and adults at the rate of 100 ml/ hour. Patients should always be carefully monitored in order to guard against the possibility of circulatory overload.
DO NOT USE IF TURBID. DO NOT BEGIN ADMINISTRATION MORE THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED. DISCARD PARTIALLY USED BOTTLES.
Albumin (Human), 25% solution, should be administered with great caution to patients with hypertension, cardiac disease, severe pulmonary infection, severe chronic anemia or, hypoalbuminemia with peripheral edema. If patients with hypertension or mild congestive failure are to be infused with concentrated albumin, the 25% solution should be diluted with 5% or 10% glucose solution to reduce the albumin concentration to 10%. This dilute solution can be administered safely at the rate of 100 ml/ hour. Patients should always be carefully monitored in order to guard against the possibility of circulatory overload.
DO NOT USE IF TURBID. DO NOT BEGIN ADMINISTRATION MORE THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED. DISCARD UNUSED PORTION.

PRECAUTIONS

General

The rise in blood pressure following 5% or 25% albumin infusion necessitates careful observation of the injured or post- operative patient in order to detect and treat severed blood vessels that may not have bled at the lower blood pressure.
The increase in blood volume which follows the administration of 5% or 25% albumin may cause a significant fall in hemoglobin concentration and red blood cell transfusion may become appropriate. Administer 25% albumin slowly (1 ml/ min) to patients with normal blood volume.

Laboratory Tests
	Although laboratory testing is not necessary in order to monitor the treatment of shock or moderate hypoalbuminemia, when Albumin (Human), 5% or 25% solution, is being administered for treatment of severe hypoproteinemia, periodic measurement of serum albumin levels is advisable.

Pregnancy Category C
	Animal reproduction studies have not been conducted with Albumin (Human), 5% or 25% solution. It is not known if Albumin (Human), 5% or 25% solution, can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. Albumin (Human), 5% or 25% solution, should be given to a pregnant woman only if clearly needed.

Pediatric Use
	Safety of this product has been demonstrated in children. Use in children is not associated with special hazards, if dose is appropriate for body weight.

ADVERSE REACTIONS
	Untoward reactions to Albumin (Human), 5% or 25% solutions, are extremely rare, although nausea, fever, chills, or urticaria may occasionally occur. Such symptoms usually disappear when the infusion is slowed or stopped for a short period of time.

DOSAGE AND ADMINISTRATION

Albumin (Human), 5% or 25% solution, must be administered INTRAVENOUSLY. It may be given without dilution, or it may be given in conjunction with, or combined with other parenteral solutions, such as whole blood, plasma, saline, glucose, or sodium lactate. The addition of one volume of albumin solution to four volumes of normal saline or 5% glucose gives a solution approximately isotonic and isosmotic with citrated plasma. Albumin solutions should not be mixed with protein hydrolysates or solutions containing alcohol.

Hypovolemic Shock

Although the volume of administered 5% albumin and the rate of infusion must be individualized, the initial treatment of acute hypovolemia should be in the range of 500- 750 ml of 5% albumin (25- 37.5 g) for adults or 12- 20 ml of 5% albumin per kilogram body weight (0.6- 1.0 g/ kg) for infants and children. The initial dose may be repeated after 15- 30 minutes, if the response is not adequate.
Although the volume of administered 25% albumin and the speed of infusion must be individualized, the initial treatment of acute hypovolemia should be in the range of 100- 200 ml of 25% albumin (25- 50 g) for adults or 2.5 to 5 ml of 25% albumin per kilogram body weight (0.6- 1.2 g/ kg) for children. The initial dose may be repeated after 10- 30 minutes, if the response is not adequate. For patients with significant plasma volume deficits, albumin replacement is best administered in the form of 5% Albumin (Human).

Hypoproteinemia With or Without Edema

Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. This total body albumin deficit must be considered when determining the amount of albumin necessary to reverse the hypoproteinemia. When using the patient's serum albumin concentration to estimate albumin deficit, the body albumin space should be calculated to be 80 to 100 ml/ kg body weight.^{4, 5, 7}Daily doses should not exceed 2 g of albumin per kilogram body weight.
When hypovolemia is long- standing and hypoalbuminemia exists in the presence of adequate hydration or edema, 25% albumin is usually preferable to 5% protein.⁴

Hemolytic Disease of the Newborn
	Albumin (Human), 25% solution, may be administered to jaundiced infants prior to exchange transfusion in a dose of 1 g/ kg body weight¹¹and it may be administered during the procedure.¹²

Administration
	Follow directions for use printed on the administration set container. Make certain that the administration set contains an adequate filter.

References

Albumin (Human), 5% Solution

1. Cohn EJ, Strong LE, Hughes WL, et al.: Preparation and properties of serum and plasma proteins. IV. A system for the separation into fractions of the protein and lipoprotein components of biological tissues and fluids. J Am Chem Soc 68:459- 475, 1946

2. Janeway CA: Human serum albumin: Historical review, inProceedings of the Workshop on Albumin. Sgouris JT and Rene A (eds), Bethesda, MD, DHEW Publication NIH 76- 925, 1975, pp 3- 21

3. Gerety RJ, Aronson DL: Plasma derivatives and viral hepatitis. Transfusion 22:347- 351, 1982

4. Finlayson JS: Albumin products. Sem Thromb Hemostas 6:85- 120, 1980

5. Peters T Jr: Serum albumin, in The Plasma Proteins, 2nd Edition, Vol 1. Putnam FW (ed), New York, Academic Press, 1975, pp 133- 181

6. Tullis JL: Albumin 1. Background and use. 2. Guidelines for clinical use. JAMA 237:355- 360, 460- 463, 1977

7. O'Riordan JP, Aebischer M, Darnborough J, etal.: The indication for the use of albumin, plasma protein solutions and plasma substitutes. Strasbourg (67006), France. Council of Europe- Public Health Committee Report, 1976 Programme. Coordinated Research in Blood Transfusion, 1978

8. Heyl JT, Gibson JG II, Janeway CA: Studies on the plasma proteins. V. The effect of concentrated solutions of human and bovine serum albumin on blood volume after acute blood loss in man. J Clin Invest 22:763- 773, 1943

9. Shoemaker WC, Hauser CJ: Critique of crystalloid versus colloid therapy in shock and shock lung. Crit Care Med 7:117- 124, 1979

10. Lowenstein E: Blood conservation in open heart surgery. Cleve Clin Q48:112- 125, 1981 (American Red Cross, Albumarc 5%, 10/ 93)

Albumin (Human), 25% Solution

2. Janeway CA: Human serum albumin: Historical review, inProceedings of the Workshop onAlbumin. Sgouris JT and Rene A (eds), Bethesda, MD, DHEW Publication NIH 76- 925, 1975, pp 3- 21

3. Gellis SS, Neefe JR, Stokes J Jr et al.: Chemical, clinical and immunological studies on the products of human plasma fractionation. XXXVI. Inactivation of the virus of homologous serum hepatitis in solutions of normal serum albumin by means of heat. J Clin Invest 27:239- 244, 1948

4. Finlayson JS: Albumin products. Sem Thromb Hemostas 6:85- 120, 1980

5. Peters T Jr: Serum albumin, in The Plasma Proteins, 2nd Edition, Vol 1. Putnam FW (ed), New York, Academic Press, 1975, pp 133- 181

6. Tullis JL: Albumin 1. Background and use. 2. Guidelines for clinical use. JAMA 237:355- 360, 460- 463, 1977

7. Silver H: Normal serum albumin and plasma protein fraction inBlood, Blood Components and Derivatives in Transfusion Therapy: A Technical Workshop. Washington, DC, American Association of Blood Banks, 1980, pp 89- 95

9. Shoemaker WC, Hauser CJ: Critique of crystalloid versus colloid therapy in shock and shock lung. Crit Care Med 7:117- 124, 1979

10. Lowenstein E: Blood conservation in open heart surgery. Cleve Clin Q 48:112- 125, 1981

11. Wood B, Comley A, Sherwell J: Effect of additional albumin administration during exchange transfusion on plasma albumin- binding capacity. Arch Dis Child 45:59- 62, 1970

12. Tsao YC, Yu VYH: Albumin in the management of neonatal hyperbilirubinemia. Arch Dis Child 47: 250- 256, 1972

PRODUCT IDENTIFICATION
	None Available

PATIENT DRUG CONSULT HANDOUT
	Albumin, Normal Serum (Human) (injection)

DESCRIPTION

Albuminar 5%

Albuminar 25%

CLINICAL PHARMACOLOGY

INDICATIONS AND USAGE

Hypovolemia (with or without shock)

Hypoalbuminemia

General

Burns

Adult Respiratory Distress Syndrome (ARDS) — Albumin (Human), 25% Solution

Cirrhosi

Nephrosis — Albumin (Human), 25% Solution

Cardiopulmonary Bypass Surgery — Albumin (Human), 25% Solution

Hemolytic Disease of the Newborn (HDN) — Albumin (Human), 25% Solution

Miscellaneous Indications for Albumin (Human), 5% Solution

Circumstances in Which Albumin Administration Is Usually Not Indicated

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

General

Laboratory Tests

Pregnancy Category C

Pediatric Use

ADVERSE REACTIONS

DOSAGE AND ADMINISTRATION

Hypovolemic Shock

Hypoproteinemia With or Without Edema

Hemolytic Disease of the Newborn

Administration

References

Albumin (Human), 5% Solution

Albumin (Human), 25% Solution

PRODUCT IDENTIFICATION

PATIENT DRUG CONSULT HANDOUT