Albumin Human20%

Albumin Human is a human plasma-derived protein solution used for intravenous volume replacement and correction of low blood Albumin Human levels. Its indications differ in strength of evidence:

Established / guideline-supported uses

• Hypovolemia and shock: emergency volume replacement to restore and maintain circulating blood volume when a colloid is indicated (e.g., after significant blood loss, in critically ill patients where crystalloids have not achieved or maintained the desired hemodynamic response).
• Large-volume paracentesis in cirrhosis with ascites: guideline-directed use of Albumin Human to prevent post-paracentesis circulatory dysfunction when more than 5 litres of ascitic fluid is removed.
• Spontaneous bacterial peritonitis (SBP) in cirrhotic patients: adjunct to antibiotic therapy (used together with antibiotics, not as monotherapy) to reduce the risk of renal impairment and improve survival.
• Hepatorenal syndrome: adjunct used together with vasoconstrictor therapy (e.g., terlipressin) as part of guideline-directed combination management.

Adjunct / supportive uses

• Burns (after the initial 24 hours): as an adjunct to crystalloid resuscitation in selected patients with major burns, once initial capillary permeability has begun to stabilize.
• Priming solution for cardiopulmonary bypass during open-heart surgery.
• Therapeutic plasma exchange (plasmapheresis): as a replacement fluid.
• Nephrotic syndrome with diuretic-resistant, severe edema: short-term adjunct with diuretics in selected refractory cases, under specialist supervision.

Use of Albumin Human should be guided by clinical assessment of intravascular volume status and, where relevant, serum Albumin Human levels, rather than by serum Albumin Human concentration alone.

Each unit of Albumin contains human albumin purified from pooled human plasma, formulated as a sterile, ready-to-use aqueous solution (commonly available as 5%, 20%, or 25% w/v concentrations, depending on the product). It is stabilized with sodium caprylate and/or N-acetyltryptophan and contains sodium as an electrolyte. It does not contain preservatives.

Albumin Human is the major protein found in human plasma, accounting for a large share of plasma oncotic (colloid osmotic) pressure. Pharmaceutical Albumin Human is manufactured from large pools of screened human plasma using a fractionation process (e.g., cold ethanol fractionation) followed by viral inactivation/removal steps such as pasteurization, to minimize the risk of transmitting infectious agents. It is supplied as a clear, slightly viscous, straw-to-amber colored sterile solution for intravenous infusion.

Albumin Human belongs to the class of plasma volume expanders (colloids) and is classified as a plasma-derived blood product.

Albumin is responsible for approximately 70–80% of the colloid osmotic (oncotic) pressure of human plasma. When infused intravenously, Albumin draws fluid from the interstitial space into the intravascular compartment, expanding plasma volume and improving cardiac output and tissue perfusion. Each gram of Albumin given as a 25% solution can draw approximately 18–20 mL of additional fluid into the circulation.

Albumin also acts as a carrier protein, binding and transporting various endogenous and exogenous substances (e.g., bilirubin, hormones, fatty acids, and many drugs) in the circulation, and contributes to acid-base buffering. The degree and duration of volume expansion depend on the concentration infused, the rate of infusion, and the patient's baseline intravascular volume status.

Albumin Human is administered by intravenous infusion only, using the administration set provided or a standard sterile infusion set. It should not be mixed with protein hydrolysates, amino acid solutions, or solutions containing alcohol. If dilution is required (e.g., for the 25% solution), it should only be diluted with 0.9% sodium chloride or 5% dextrose, as advised by the treating physician. The infusion rate should be adjusted to the indication and the patient's cardiovascular status, starting slowly and increasing as tolerated, with close monitoring for signs of fluid overload. Any partially used container should be discarded, as the solution contains no preservative.

Albumin Human has minimal significant pharmacokinetic drug-drug interactions, given its nature as a plasma protein rather than a small-molecule drug. Notable considerations include:

• Protein-bound drugs: because Albumin Human is a major plasma carrier protein, correcting low Albumin Human levels may theoretically alter the free (active) fraction of highly protein-bound drugs (e.g., certain anticoagulants, phenytoin); clinical monitoring is advised when co-administered with such drugs in patients with abnormal baseline Albumin Human.
• Other intravenous fluids/medications: Albumin Human should not be mixed in the same infusion line with other drugs, blood products, or solutions containing alcohol, as this may cause precipitation or inactivation.

Most reactions to Albumin Human are mild and infusion-related. Reported side effects include:

• Chills, fever, flushing
• Urticaria (hives), rash, pruritus
• Nausea, vomiting
• Hypotension or, less commonly, hypertension
• Tachycardia
• Headache
• Rare but serious: anaphylactic/anaphylactoid reactions, and fluid overload/pulmonary edema with rapid or excessive infusion (see Precautions and Warnings).

Albumin Human has not been evaluated in adequate, well-controlled studies in pregnant or lactating women. As a purified human plasma protein normally present in the body, Albumin Human is used in pregnancy and lactation when there is a clear medical indication (for example, severe hypoAlbumin Humanemia or specific obstetric complications), and only under direct physician/specialist supervision, with the potential benefit weighed against any potential risk. It should not be used in pregnancy or during breastfeeding without medical advice.

Fluid overload: Albumin Human, particularly the 20–25% hyperoncotic solutions, can rapidly expand intravascular volume. Rapid or excessive infusion may precipitate circulatory overload, pulmonary edema, or cardiac failure, especially in patients with cardiac disease, renal impairment, or hypertension. Infusion rate and volume status (including monitoring for signs such as increasing blood pressure, venous distension, or dyspnea) should be closely monitored, and the infusion slowed or stopped if such signs appear.

Hypersensitivity reactions: allergic and anaphylactic reactions can occur (see Side Effects). The infusion should be stopped immediately if signs of hypersensitivity develop, and appropriate treatment instituted.

Risk of infectious agent transmission: because Albumin Human is made from pooled human plasma, it carries a theoretical risk of transmitting infectious agents, including viruses and, in principle, other pathogens not yet identified or removed by current donor screening and manufacturing (including viral inactivation) processes. Modern manufacturing substantially reduces but cannot completely eliminate this risk. Any symptoms suggestive of infection following administration should be reported to a physician.

Dilutional effects: large volumes of Albumin Human can dilute other plasma constituents, including coagulation factors and red blood cells (hematocrit); coagulation status and hematocrit should be monitored when large volumes are administered.

Sodium content: standard Albumin Human solutions contain sodium, which requires caution in patients on a sodium-restricted diet.

Overdose or excessively rapid infusion of Albumin Human can lead to circulatory volume overload, with symptoms such as headache, dyspnea, venous distension, and, if severe, pulmonary edema or cardiac failure. If overdose is suspected or such symptoms occur, the infusion should be stopped immediately and the patient should seek immediate medical attention; supportive care (which may include oxygen and diuretics) will be provided by a healthcare professional. In case of accidental overdose, contact a physician, hospital emergency department, or poison control immediately rather than attempting home management.

Store as directed on the product label; most Albumin Human solutions are stored at room temperature (typically below 30°C) and should be protected from light and freezing. Do not use if the solution is turbid, discolored, or has been frozen. Keep out of reach of children, and discard any unused portion after opening, as the solution contains no preservative.

Elderly patients: use Albumin Human with caution, as elderly patients are more likely to have cardiac or renal impairment, increasing the risk of fluid overload; slower infusion rates and closer monitoring are advised.

Renal impairment: caution is required due to increased risk of fluid overload and, in oliguric/anuric patients, sodium and fluid accumulation; monitor volume status closely.

Hepatic impairment: patients with cirrhosis and ascites may be at higher risk of fluid retention; use per guideline-directed indications (e.g., paracentesis, SBP) with careful monitoring.

Pediatric patients: see Pediatric Uses.

Duration of treatment with Albumin Human is individualized and depends on the indication, the patient's hemodynamic and laboratory response, and resolution of the underlying condition (e.g., a single infusion for large-volume paracentesis, or repeated doses over several days for hypoAlbumin Humanemia or SBP). Treatment should be guided by ongoing clinical assessment rather than a fixed course length.

Albumin is classified as a human plasma-derived colloid / plasma volume expander (blood product).

Albumin exerts its therapeutic effect primarily through its colloid osmotic (oncotic) pressure, which draws and retains fluid within the intravascular space, thereby expanding plasma volume, supporting blood pressure and organ perfusion, and correcting some of the physiological consequences of hypoalbuminemia (such as third-spacing of fluid into tissues). It also functions as a transport protein for various endogenous and exogenous substances.

Safety and efficacy of Albumin Human in neonates, infants, and children have not been established in large controlled trials, but Albumin Human is used in pediatric practice (including in neonatal intensive care) for indications similar to those in adults (e.g., hypovolemia, hypoAlbumin Humanemia, exchange transfusion in neonatal hyperbilirubinemia) under specialist supervision, with dosing individualized by body weight and clinical response. Use in children should be directed and monitored by a pediatrician or pediatric intensivist.