Albumin ( Human)

Approved Indications:

• Hypovolemia:
  For plasma volume expansion and restoration in hypovolemic states resulting from surgery, trauma, shock, or burns, especially when crystalloids are insufficient.
• Hypoalbuminemia:
  In patients with low serum albumin due to:
• Liver cirrhosis
• Nephrotic syndrome
• Acute or chronic liver failure
• Malnutrition
• Acute respiratory distress syndrome (ARDS)
• Cardiopulmonary Bypass (CPB):
  Used in the priming solution during extracorporeal bypass procedures to maintain colloid osmotic pressure.
• Large-Volume Paracentesis in Cirrhosis:
  Administered post-procedure to prevent paracentesis-induced circulatory dysfunction.
• Acute Nephrosis (Nephrotic Syndrome):
  Used adjunctively with diuretics in patients unresponsive to diuretic therapy alone.
• Hemodialysis-Induced Hypotension:
  To stabilize blood pressure during dialysis in hypoalbuminemic or volume-depleted patients.
• Therapeutic Plasma Exchange (TPE):
  As a plasma replacement fluid during plasmapheresis procedures.
• Burns:
  For fluid resuscitation in burn patients after the first 24 hours when capillary permeability has stabilized.

Clinically Accepted Off-Label Uses:

• Septic Shock (with or without hypoalbuminemia):
  As an adjunct to crystalloids in patients requiring large-volume resuscitation.
• Prevention of Ovarian Hyperstimulation Syndrome (OHSS):
  In high-risk IVF patients to reduce the risk of fluid shift and ascites.

Formulations:

• Available as 5%, 20%, and 25% sterile solutions for intravenous use.

Adults:

Hypovolemia:

• 5% Albumin: 250–500 mL IV over 15–30 minutes. May repeat based on clinical response.
• 25% Albumin: 50–100 mL IV if fluid overload risk is high.

Hypoalbuminemia:

• 25% Albumin: 50–100 mL IV every 1–2 days, adjusted per albumin level and clinical condition.

Large-Volume Paracentesis:

• 6–8 g Albumin per liter of ascitic fluid removed (e.g., 25% Albumin: 20–40 mL per liter).

Burns:

• After 24 hours post-burn: 0.5–1 g/kg/day of Albumin IV, usually as 5% or 20% solution.

Cardiopulmonary Bypass:

• Typically 250–500 mL 5% Albumin used in the bypass circuit as a volume expander.

Pediatric Patients:

• Dose: 0.5–1 g/kg IV, depending on the indication.
• Infusion should be slower and closely monitored for volume overload.

Elderly Patients:

• Use adult doses with close monitoring due to higher risk of cardiac and renal complications.

Special Groups:

Renal Impairment:

• Use cautiously. Monitor fluid status and renal function to avoid overload.

Hepatic Impairment:

• Often indicated, especially in cirrhosis with ascites or spontaneous bacterial peritonitis.

Administration Route:

• Intravenous infusion via peripheral or central vein.

Infusion Rate:

• 5%: up to 5 mL/min
• 20–25%: up to 1–2 mL/min
• Slower infusion in elderly or at-risk patients

Albumin (Human) is a natural colloid and major plasma protein synthesized in the liver. When administered intravenously, it acts as a volume expander by increasing the oncotic pressure within the vasculature. This draws fluid from the interstitial and intracellular spaces into the circulation, rapidly increasing plasma volume. Additionally, Albumin binds various endogenous and exogenous substances, including hormones, bilirubin, fatty acids, and drugs, facilitating their transport. It also buffers pH and contributes to antioxidant defense. These effects make it therapeutically valuable in hypovolemia, hypoalbuminemia, and other critical conditions.

• Absorption: Not applicable (administered IV)
• Distribution:
• Approximately 30–40% remains intravascular within the first 2 hours.
• Gradually redistributes into the extravascular space over 24–48 hours.
• Volume of Distribution (Vd): ~0.1–0.15 L/kg
• Metabolism: Degraded primarily in the liver and reticuloendothelial system to amino acids.
• Elimination Half-Life:
• Normal conditions: 15–20 days
• Shortened in critical illness (e.g., burns, sepsis)
• Excretion: Minimal renal elimination; metabolic byproducts reused or excreted.

Pregnancy:

• FDA Category C (legacy classification)
• Animal studies have not shown fetal harm. No controlled data in humans. Use only if clearly indicated.

Lactation:

• Unknown whether excreted in human breast milk.
• Due to low risk and physiological compatibility, use is generally considered acceptable with caution, especially in neonates.

• Primary Class: Plasma Volume Expander
• Subclass: Natural Colloid / Blood Derivative
• Pharmacologic Type: Sterile, Heat-Treated Human Albumin Solution

• Known hypersensitivity to Albumin (Human) or excipients
• Severe anemia
• Pulmonary edema or overt fluid overload
• Congestive heart failure with normal/increased intravascular volume
• Uncontrolled hypertension (relative contraindication)

• Hypersensitivity Reactions:
• May occur rarely. Discontinue immediately if signs of anaphylaxis or urticaria develop.
• Hypervolemia or Hemodilution:
• Can lead to pulmonary edema or congestive heart failure. Monitor central venous pressure and electrolyte levels.
• Sodium Load:
• May exacerbate fluid retention in hepatic cirrhosis, CHF, or renal failure.
• Blood Pressure:
• Hypotension may occur during rapid infusion. Infuse slowly in at-risk populations.
• Infection Risk:
• Minimal risk exists despite viral inactivation steps. Use only products from reliable sources.
• Electrolyte Disturbance:
• May cause dilutional effects; monitor sodium, potassium, and calcium levels during treatment.

Common Adverse Effects (≥1%):

• Mild hypotension
• Fever
• Rash
• Nausea
• Flushing
• Chills

Less Common:

• Tachycardia
• Vomiting
• Headache
• Urticaria

Rare but Serious:

• Anaphylaxis
• Pulmonary edema
• Hypervolemia
• Hypokalemia
• Thromboembolism (rare)

Severity and Timing:

• Most side effects are infusion-related and appear within minutes to an hour.
• Risk increases with high doses or rapid infusion rates.

• Displacement of Protein-Bound Drugs:
• May alter plasma concentrations of drugs like warfarin, phenytoin, diazepam, and propranolol.
• Potentiation with Diuretics (e.g., Furosemide):
• Co-administration may enhance diuretic response in hypoalbuminemic patients.
• Fluid Compatibility:
• Do not mix with hydrolysates or ethanol-containing solutions.
• CYP Enzymes:
• No direct interaction with hepatic enzymes; Albumin is not metabolized via CYP pathways.

• Sepsis Management (Surviving Sepsis Campaign 2021):
• Albumin may be considered when patients require substantial crystalloid volumes.
• Liver Disease Guidelines (EASL, AASLD):
• Strong recommendation for use in large-volume paracentesis and spontaneous bacterial peritonitis.
• Safety Profile:
• No recent FDA black box warnings or major regulatory changes.

• Temperature: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C
• Humidity & Light: Store in a dry place, protect from light.
• Handling Instructions:
• Do not freeze.
• Inspect visually for particulate matter or discoloration before use.
• Use immediately after opening.
• Do not use if solution is cloudy or contains precipitate.
• Gently invert bottle to mix; do not shake vigorously.