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 ALBUKED [Albumin (Human), USP] is available in two concentrations, 5% (ALBUKED 5) and 25% (ALBUKED 25), for the following indications:

  • Emergency Treatment of Hypovolemic Shock:
    • ALBUKED 5 is iso-oncotic with normal plasma and on intravenous infusion will expand the circulating blood volume by an amount approximately equal to the volume infused; ALBUKED 25 is hyperoncotic and on intravenous infusion will usually expand the plasma volume by a greater amount, up to three to four times the volume actually administered. If the patient is dehydrated, additional crystalloid fluids must be given, or alternatively, ALBUKED 5 could be used.
    • In conditions associated mainly with a volume deficit, ALBUKED 5 is best administered; but where there is an oncotic deficit or treatment of shock has been delayed, ALBUKED 25 may be preferred.
    • Appropriate additional crystalloid should be administered, the hemodynamic response of the patient should be monitored and the usual precautions against circulatory overload observed. The total dose should not generally exceed about 2 g per kg body weight, in the absence of on-going losses.
    • Crystalloid solutions in volumes several times greater than that of ALBUKED 5 needed may be effective in treating shock, particularly in younger individuals who have no preexisting illness. Older patients, especially those with preexisting debilitating conditions, or where the state of shock has existed for some time before active therapy could be instituted, may also benefit from crystalloid solutions or ALBUKED 5, as they may not tolerate hyperalbuminemia.
    • Removal of ascitic fluid from a patient with cirrhosis may cause changes in cardiovascular function and even result in hypovolemic shock; the use of albumin therapy may be required to support the blood volume.
  • Burn Therapy: The optimal therapeutic regimen with respect to the administration of colloids, crystalloids, and water following extensive burns must be individualized. 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 25 can be used in addition 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 an oncotic deficit. A similar situation can occur in sepsis or intensive care patients.  Treatment with ALBUKED 25 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 25 together with a diuretic may be useful.
  • 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 25 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 with ALBUKED 5 or increased oncotic activity with an infusion of ALBUKED 25.
  • 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 25g of albumin per liter of erythrocytes is commonly used, although the requirements in preexistent hypoproteinemia or hepatic impairment can be greater.  ALBUKED 25 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 ALKBUKED 25 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 25 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.  

Please refer to the Full Prescribing Information for ALBUKED 5 and ALBUKED 25 for more information.


INDICATIONS AND USAGE

ALBUKED (Albumin [Human], USP) is available in two concentrations, 5% (ALBUKED 5) and 25% (ALBUKED 25), for the following indications: emergency treatment of hypovolemic shock, burn therapy, hypoproteinemia with or without edema, adult respiratory distress syndrome (ARDS), cardiopulmonary bypass, acute liver failure, sequestration of protein rich fluids. See Indications for additional information.

Situations in Which ALBUKED 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. 

IMPORTANT SAFETY INFORMATION