ALBURX ALBUMIN (HUMAN) 12.5 g/250mL Solution — NDC 44206-310-50 (Billing 44206-0310-50)

3. INDICATIONS AND USAGE

3.1Shock The definitive treatment of major hemorrhage is the transfusion of red blood cells restoring a normal oxygen transport capacity of the blood. Since, however, the life-threatening event in major hemorrhage is the loss of blood volume and not the erythrocyte deficit, the blood volume can, as an emergency measure, be supported by AlbuRx ® 5, Albumin (Human) 5% solution or another rapidly acting plasma substitute if blood is not immediately available. This will restore cardiac output and abolish circulatory failure with tissue anoxia.

Though a four- to fivefold volume of crystalloids may be equally effective, their administration takes more time and creates a general overload with sodium and water. In the presence of dehydration, electrolyte solutions such as Ringer's lactate should be administered in conjunction with albumin.

3.2Burns Apart from damage to the respiratory tract, the development of burn shock is the most life-threatening event in the immediate care of the burned patient. Therapy during the first 24 hours is directed at the administration of large volumes of crystalloid solutions and lesser amounts of AlbuRx ® 5, Albumin (Human) 5% solution to maintain an adequate plasma volume and protein (colloid) content. For continuation of therapy beyond 24 hours, larger amounts of AlbuRx ® 5, Albumin (Human) 5% solution and lesser amounts of crystalloid are generally used.

16 An optimum regimen for the use of Albumin (Human), electrolytes, and fluid in the early treatment of burns has, however, not yet been established.

3.3Pancreatitis and peritonitis AlbuRx ® 5, Albumin (Human) 5% solution is useful in the early therapy of shock associated with acute hemorrhagic pancreatitis and peritonitis. It has been found that the correction of the blood volume deficit and adequate fluid therapy are mandatory in the acute stage of pancreatitis and peritonitis when there is loss of fluid into the peritoneal cavity or the retroperitoneal space. 1

3.4Postoperative albumin loss It is now recognized that intra-operative damage to capillary walls by blunt handling and sharp dissection of tissues leads to substantial postoperative losses of circulating albumin, over and above those due to bleeding. Forty to eighty percent of the intravascular albumin mass may thus be lost after radical dissections for malignant disease, surgery of the colon and rectum, and reconstructive procedures involving the aorta and major iliac vessels. 4,7,14 AlbuRx ® 5, Albumin (Human) 5% solution is a suitable agent for the correction of the resultant loss of plasma volume and in this situation may be superior to electrolyte solutions in maintaining early postoperative pulmonary function.

13 However, temporary redistribution of protein is usually not an indication for Albumin (Human).

3.5Hypoproteinemia with an oncotic deficit In subacute or chronic hypoproteinemia, efforts should always be made to determine the underlying cause and to improve circulating protein levels by dietary means. Most commonly, such states are due to protein-calorie malnutrition, defective absorption in gastrointestinal disorders, faulty albumin synthesis in chronic hepatic failure, increased protein catabolism postoperatively or with sepsis, and abnormal renal losses of albumin with chronic kidney disease. In all these situations, the circulating plasma volume is usually maintained by the renal retention of sodium and water, but this is associated with tissue edema due to the hypoalbuminemia with an oncotic deficit.

The cutaneous edema lowers the oxygen tension of wounds and may thus impair the healing process 3 , and the oncotic deficit favors the development of interstitial pulmonary edema 2 and the intestinal accumulation of fluids, which may progress to a paralytic ileus. 7 Though relief of the basic pathology is the definitive mode of therapy for the restoration of the plasma protein content, this process takes time to become effective, and the rapid… [Excerpted — this section continues on DailyMed.]

8. DOSAGE AND ADMINISTRATION AlbuRx ® 5, Albumin (Human) 5% solution must be administered intravenously. The venipuncture site should not be infected or traumatized, and should be prepared with standard aseptic technique.

The solution is compatible with whole blood or packed red cells as well as the usual electrolyte and carbohydrate solutions intended for intravenous use. By contrast, it should not be mixed with protein hydrolysates, amino acid mixtures, or solutions containing alcohol. It is ready for use as contained in the bottle and may be given without regard to the blood group of the recipient.

Upon administration of AlbuRx ® 5, Albumin (Human) 5% solution, there is a rapid increase of the plasma volume about equal to the volume infused. The initial dose for adults is 250 or 500 mL. The rate of infusion and the total volume administered are determined by the condition and response of the patient.

A rate of 1–2 mL per minute is usually suitable in the absence of overt shock, whereas the capacity of the administration set is the only limit in the exsanguinated patient. During resuscitation, constant monitoring of the patient provides the guidelines for treatment. For children, a dose of 10 to 15 mL per pound body weight is usually adequate and close surveillance of the young patient is essential.

Since patients – notably those with sepsis or severe multiple injuries – often need a circulating blood volume exceeding the prediction derived from their body weight, treatment should always be guided by the hemodynamic response and not by blood volume calculations or measurements. 5 Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.