Plasbumin Albumin (Human) 5 g/20mL Solution — NDC 13533-692-71 (Billing 13533-0692-71)

INDICATIONS AND USAGE Emergency Treatment of Hypovolemic Shock Plasbumin-25 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. [1] If the patient is dehydrated, additional crystalloids must be given, [4] or alternatively, Albumin (Human) 5%, USP (Plasbumin ® -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 Plasbumin-5 is to be preferred for the usual volume deficits, Plasbumin-25 with appropriate crystalloids may offer therapeutic advantages in oncotic deficits or in long-standing shock where treatment has been delayed. [2] 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. [2] 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 Plasbumin-25 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. [2,4,5] A similar situation can occur in sepsis or intensive care patients. Treatment with Plasbumin-25 may be of value in such cases. [2] Adult Respiratory Distress Syndrome (ARDS) [2,5] 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, Plasbumin-25 together with a diuretic may play a role in therapy.

Cardiopulmonary Bypass [2,6] 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 [2] 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 [2,3] The administration of Plasbumin-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 [7] 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 [2] 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 preexiste… [Excerpted — this section continues on DailyMed.]

DOSAGE AND ADMINISTRATION Plasbumin-25 should always be administered by intravenous infusion. Plasbumin-25 may be administered either undiluted or diluted in 0.9% Sodium Chloride or 5% Dextrose in Water. If sodium restriction is required, Plasbumin-25 should only be admin­istered either undiluted or diluted in a sodium-free carbohydrate solution such as 5% Dextrose in Water.

A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of adminis­tration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.

Hypovolemic Shock —For treatment of hypovolemic shock, the volume administered and the speed of infusion should be adapted to the response of the individual patient. Burns —After a burn injury (usually beyond 24 hours) there is a close correlation between the amount of albumin infused and the resultant increase in plasma colloid osmotic pressure. The aim should be to maintain the plasma albumin concen­tration in the region of 2.5 ± 0.5 g per 100 mL with a plasma oncotic pressure of 20 mm Hg (equivalent to a total plasma protein concentration of 5.2 g per 100 mL). [2] This is best achieved by the intravenous administration of Plasbumin-25.

The duration of therapy is decided by the loss of protein from the burned areas and in the urine. In addition, oral or parenteral feeding with amino acids should be initiated, as the long-term administration of albumin should not be considered as a source of nutrition. Hypoproteinemia With or Without Edema —Unless the underlying pathology responsible for the hypoproteinemia can be corrected, the intravenous administration of Plasbumin-25 must be considered purely symptomatic or supportive (see section Situations in Which Albumin Administration is Not Warranted ) . [2] The usual daily dose of albumin for adults is 50 to 75 g and for children 25 g.

Patients with severe hypoproteinemia who continue to lose albumin may require larger quantities. Since hypoproteinemic patients usually have approximately normal blood volumes, the rate of administration of Plasbumin-25 should not exceed 2 mL per minute, as more rapid injection may precipitate circulatory embarrassment and pulmonary edema. Other dosage recommendations are given under the specific indications referred to above.

Preparation for Administration Remove seal to expose stopper. Always swab stopper top immediately with a suitable antiseptic prior to entering vial. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Only 16 gauge needles or dispensing pins should be used with 20 mL vial sizes and larger. Needles or dispensing pins should only be inserted within the stopper area delineated by the raised ring. The stopper should be penetrated perpendicular to the plane of the stopper within the ring.