Pharmacotherapeutic Group: blood substitutes and plasma protein fractions. ATC Code: B05AA01.
Pharmacology: Pharmacodynamics: Human albumin accounts quantitatively for more than half of the total protein in the plasma and represents about 10% of the protein synthesis activity of the liver.
Physico-chemical data: Human albumin 200 or 250 g/l has a corresponding hyperoncotic effect.
The most important physiological function of albumin results from its contribution to oncotic pressure of the blood and transport function. Albumin stabilises circulating blood volume and is a carrier of hormones, enzymes, medicinal products and toxins.
Pharmacokinetics: Under normal conditions the total exchangeable albumin pool is 4-5 g/kg body weight, of which 40-45% is present intravascularly and 55-60% in the extravascular space. Increased capillary permeability will alter albumin kinetics and abnormal distribution may occur in conditions such as severe burns or septic shock.
Under normal conditions, the average half-life of albumin is about 19 days. The balance between synthesis and breakdown is normally achieved by feedback regulation. Elimination is predominantly intracellular and due to lysosome proteases.
In healthy subjects, less than 10% of infused albumin leaves the intravascular compartment during the first 2 hours following infusion. There is considerable individual variation in the effect on plasma volume. In some patients the plasma volume can remain increased for some hours. However, in critically ill patients, albumin can leak out of the vascular space in substantial amounts at an unpredictable rate.
Toxicology: Preclinical safety data: Human albumin is a normal constituent of human plasma and acts like physiological albumin.
In animals, single-dose toxicity testing is of little relevance and does not permit the evaluation of toxic or lethal doses or of a dose-effect-relationship. Repeated-dose toxicity testing is impracticable due to the development of antibodies to heterologous protein in animal models.
To date, human albumin has not been reported to be associated with embryo-fetal toxicity, oncogenic or mutagenic potential.
No signs of acute toxicity have been described in animal models.