Albumin (human) 5%

Name: Albumin (human) 5%

Description

Albumin (Human) 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma. The solution is approximately isotonic and isooncotic with human plasma. The effective oncotic pressure of the solution depends largely on its albumin content. Sodium bicarbonate is used to adjust the pH to 6.9 ± 0.5. The sodium content of the solution ranges between 130 and 160 meq/L. 0.08 millimole sodium caprylate/g albumin and 0.08 millimole sodium N- acetyltryptophanate/g albumin are added as stabilizers to prevent denaturation during heating. The solution has been heat-treated at 60°C for 10 hours for inactivation of hepatitis viruses.

Clinical Pharmacology

Albumin is a very soluble, globular protein (MW 66,500) accounting for 70-80% of the colloid osmotic pressure of plasma. Albumin (Human) 5% is an effective and long acting agent for plasma volume expansion. The rationale for this is the Starling concept of the capillary balance of hydrostatic and oncotic pressure gradients across the capillary walls as the determinant of the fluid-i.e., volume-distribution between the intravascular and interstitial compartments (10). Albumin is distributed throughout the extracellular water; 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 320 g. Albumin has a half life of 15-20 days in the circulation (2,7) with a turnover of approximately 15 g per day.

When injected intravenously, Albumin (Human) 5% will increase the circulating plasma volume by an amount approximately equal to the amount infused. The additional fluid will reduce the hemoconcentration and decrease blood viscosity. The degree and duration of volume expansion depend upon the initial blood volume. In patients with diminished blood volume, the effect of infused Albumin (Human) may persist many hours. The hemodilution lasts for a much shorter time when albumin is administered to individuals with normal blood volume.

Albumin is a transport protein which binds naturally occurring therapeutic and toxic materials in the circulation. The binding properties of albumin may, in special circumstances, provide an indication for its clinical use. For such purposes, however, Albumin (Human) 25% should be used.

Contraindications

The use of Albumin (Human) is contraindicated in patients with a history of an incompatibility reaction to such preparations (see Adverse Reactions ). In addition, the Albumin (Human) may be contraindicated in patients with cardiac failure, pulmonary edema or severe anemia because of the risk of acute circulatory overload. Also, Albumin (Human) has been reported to contain trace amounts of aluminum (4,5). Accumulations of aluminum in patients with chronic renal insufficiencies has led to toxic manifestations such as hypercalcemia, vitamin D-refractory osteodystrophy, anemia, and severe progressive encephalopathy (5,6,13). Therefore, when large volumes of Albumin (Human) are contemplated for administration to such patients, serious consideration of these potential risks relative to the anticipated benefits should be given.

Adverse Reactions

Though very rare, adverse reactions such as chills, fever, tachycardia, hypotension, urticaria, skin rash and nausea may occur (3,8,9,11). These symptoms may disappear if the infusion is slowed or stopped for a short period of time. If necessary, the intravenous administration of 50 to 200 mg of prednisolone may be useful (9).

References

  1. CLOWES, G.H.A., Jr., VUCINIC, M., and WEIDNER, M.G.: Ann. Surg. 163, 866 (1996).
  2. JANEWAY, C.A. In: Sgouris, J.T. and Rene A. (eds.): Proceedings of the Workshop on Albumin, DHEW Publication No. (NIH) 76-925, U.S. Government Printing Office, Washington, D.C., p. 3-21 (1976).
  3. LOWENSTEIN, E. In: Sgouris, J.T. and Rene A. (eds.): Proceedings of the Workshop on Albumin, DHEW Publication No. (NIH) 76-925, U.S. Government Printing Office, Washington, D.C., p. 302 (1976).
  4. MAHARAJ, D., FELL, G.S., BOYCE, B.F., NG, J.P., SMITHE, G.D., BOULTON-JONES, J.M., CUMMING, R.L., and DAVIDSON, J.F.: Brit. Med. J. 295, 693-696 (1987).
  5. MILLINER, D.S., SHINABERGER, J.H., SHUMAN, P., and COBURN, J.W.: N. Engl. J. Med. 312, 165-167 (1985).
  6. OTT, S.M., MALONEY, N.A., KLEIN, G.L., ALFREY, A.C., AMENT, M.E., COBURN, J.W., and SHERRAND, D.J.: Ann. of Inter. Med. 98, 910-914 (1983).
  7. PETERS, T., Jr., In: Putnam, F.W. (ed.): Plasma Proteins, 2nd Edition, Vol. 1, Academic Press, New York, p. 133-181 (1975).
  8. RING, J. and MESSMER, K.: Lancet 1, 466 (1977).
  9. RING, J., SEIFERT, J., LOB, G., COULIN, K., and BRENDEL, W.: W. Klin, Wschr. 52, 595 (1974).
  10. STARLING, E.H.: J. Physiol. (London) 19, 312 (1896).
  11. TULLIS, J.L.: J.A.M.A. 237, 355 (1977).
  12. TULLIS, J.L.: J.A.M.A. 237, 460 (1977).
  13. WILLIS, M.R., and SAVORY, J.A.: Lancet 2, 29-34 (1983).

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