ALBUTEIN INFUSION 25% [SIN01178P]

Product Info

ALBUTEIN INFUSION 25%

[SIN01178P]

INDICATIONS AND USAGE:
Albutein® 25% is indicated:

1. For treatment of hypovolemic shock.^2,4

2. As an adjunct in hemodialysis for patients undergoing long-term dialysis or for those patients who are fluid-overloaded and cannot tolerate substantial volumes of salt solution for therapy of shock or hypotension.¹

3. In cardiopulmonary bypass procedures; however, the optimum regimen of fluids has not been established.

Conditions in which Albutein® 25% MAY BE indicated:

• Adult respiratory distress syndrome (ARDS).^1,5

• Major injury or surgery resulting in increased albumin loss or inadequate synthesis.^1,6

• Acute nephrosis but responding to cyclophosphamide or steroid therapy. Steroid therapy may increase edema which may respond to combined therapy of albumin with a diuretic.¹

• Acute liver failure or ascites where the therapeutic use is regulated by the individual circumstances.¹

Unless the pathologic condition responsible for hypoalbuminemia can be corrected, administration of albumin can afford only symptomatic relief. There is NO valid reason for the use of albumin as an intravenous nutrient.
Pediatric Use: Albutein® 25% is indicated in conjunction with exchange transfusion in the treatment of neonatal hyperbilirubinemia. The pediatric use of Albutein® 25% has not been clinically evaluated. Therefore, physicians should weigh the risks and benefits of the use of Albutein® 25% in the pediatric population.

REFERENCES:
1. Tullis, J.L., Albumin: 1. Background and Use, 2. Guidelines for Clinical Use, JAMA, 237:355–360, 460–463, 1977.
2. Finlayson, J.S., Albumin Products, Semin Thromb Hemo, 6:85–120, 1980.
4. Hauser, C.J., et. al., Oxygen Transport Responses to Colloids and Crystalloids in Critically Ill Surgical Patients, Surg Gyn Obs, 150:811–816, June 1980.
5. Shoemaker, W.C., et. al., Comparison of the Relative Effectiveness of Colloids and Crystalloids in Emergency Resuscitation, Am J Surg, 142:73–84, July 1981.
6. Peters, T., Jr., Serum Albumin in: The Plasma Proteins, 1:133–181, 1975.

DOSAGE AND ADMINISTRATION:
Albutein® 25% is administered intravenously. The total dosage will vary with the individual. In adults, an initial infusion of 100 mL is suggested. Additional amounts may be administered as clinically indicated.
In the treatment of the patient in shock with greatly reduced blood volume, Albutein® 25% may be administered as rapidly as necessary in order to improve the clinical condition and restore normal blood volume. This may be repeated in 15–30 minutes if the initial dose fails to prove adequate. In the patient with a slightly low or normal blood volume, the rate of administration should be 1 mL per minute.
If dilution of Albutein® 25% is clinically desirable, compatible diluents include sterile 0.9% Sodium Chloride solution or sterile 5% Dextrose in Water.⁸
Pediatric Use: The pediatric use of Albutein® 25% has not been clinically evaluated. The dosage will vary with the clinical state and body weight of the individual. Typically, a dose one-quarter to one-half the adult dose may be administered, or dosage may be calculated on the basis of 0.6 to 1.0 gram per kilogram of body weight (2.4 to 4 mL of Albutein® 25%). For jaundiced infants suffering from hemolytic disease of the newborn, the appropriate dose of binding of free serum bilirubin is 1 gram per kilogram of body weight which may be administered during the procedure.⁹ The usual rate of administration is children should be one-quarter the adult rate.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

REFERENCES:
8. Albumin Human. In AHFS Drug Information, 1144–1146, 1998.
9. Tsao, Y.C., Yu, V.Y.H., Albumin in the Management of Neonatal Hyperbilirubinemia, Arch Dis Childhood, 47:250–256, 1972.

CONTRAINDICATIONS:
Albutein® 25% is contraindicated in patients with severe anemia or cardiac failure in the presence of normal or increased intravascular volume.
The use of Albutein® 25% is contraindicated in patients with a history of allergic reactions to albumin.