ALBUTEIN 20% Infusion/Solution for

What is ALBUTEIN 20%

ALBUTEIN 20% is a sterile, hyperoncotic intravenous solution of human albumin, derived from human plasma. It contains 20 grams of albumin per 100 mL, so each 50 mL bottle contains 10 g of albumin.

• Generic name: Albumin (Human), plasma protein fraction.
• Pharmaceutical form: Solution for intravenous infusion.
• Concentration: 20% (i.e., 20 g/100 mL).
• Packaging: 50 mL glass bottle (single-use).

It is produced from pooled human plasma and undergoes rigorous purification and viral inactivation steps, including cold ethanol fractionation and pasteurization, ensuring safety from infectious transmission.

Clinical uses:

• Treatment of hypovolemia when volume expansion is required
• Management of hypoalbuminemia in conditions like liver cirrhosis, nephrotic syndrome, or protein-losing enteropathy
• Large-volume paracentesis-associated circulatory dysfunction prevention
• Treatment of burns, shock, or adult respiratory distress syndrome (ARDS)
• Supportive therapy during cardiopulmonary bypass surgery
• Acute nephrosis, hemolytic disease of the newborn (in exchange transfusion), or sepsis with low albumin

ALBUTEIN 20% is a hyperoncotic solution, meaning it draws fluid from the interstitial to the intravascular compartment more effectively than 5% albumin. It is used when a potent plasma volume expander is needed, especially in patients with fluid overload risk.

How to use ALBUTEIN 20%

ALBUTEIN 20% is administered by intravenous infusion and should be used under medical supervision, in a hospital or clinic setting. The dose and rate of infusion depend on the individual patient's condition and response.

• Preparation before administration:
  • Allow the bottle to reach room temperature before use (do not heat or shake).
  • Inspect visually—solution should be clear to slightly opalescent. Discard if cloudy or contains particulates.
  • Use aseptic technique to puncture the rubber stopper.
• Route: Intravenous (IV) infusion only.
• Infusion rate:
  • Standard: 1–2 mL/min (50–100 mL/hr), depending on clinical indication.
  • In emergencies: May be infused faster (up to 3–4 mL/min) under continuous monitoring.
• Dilution (optional):
  • May be diluted with isotonic saline or 5% dextrose if necessary.
  • Do not mix with sterile water or solutions with alcohol/amino acids.
• During infusion:
  • Monitor vital signs, urine output, blood pressure, and central venous pressure if available.
  • Check for signs of fluid overload (dyspnea, pulmonary rales, distended neck veins).

Once opened, the bottle should be used immediately and any unused portion discarded. ALBUTEIN 20% is a single-use product.

Mode of Action ALBUTEIN 20%

ALBUTEIN 20% exerts its therapeutic effects by restoring and maintaining plasma oncotic pressure. Albumin is the most abundant plasma protein and plays key physiological roles.

• Colloid osmotic pressure:
  • Albumin maintains ~80% of plasma oncotic pressure.
  • ALBUTEIN 20% is hyperoncotic—causes fluid to shift from interstitial to intravascular space.
• Volume expansion:
  • Each 1 mL of ALBUTEIN 20% can draw ~3–4 mL of interstitial fluid into circulation.
  • This effect makes it especially useful in patients with low plasma volume and edema.
• Carrier protein:
  • Binds and transports various substances: fatty acids, bilirubin, hormones, and many drugs.
  • Serves as a buffer and contributes to maintaining acid-base balance.

The effect on circulating volume lasts several hours, depending on the patient’s condition and capillary permeability. In hypoalbuminemia, ALBUTEIN restores normal oncotic pressure and reduces third spacing of fluid, improving hemodynamics and tissue perfusion.

ALBUTEIN 20% Interactions ALBUTEIN 20%

Human albumin itself has minimal pharmacological interactions, but due to its binding properties and fluid-shifting effects, certain clinical considerations apply.

• Drug displacement interactions:
  • Albumin binds to many drugs—especially acidic ones like warfarin, phenytoin, and valproate.
  • Administration may increase free (active) levels of such drugs by displacing them from albumin binding sites.
• Electrolyte balance:
  • Albumin infusion may dilute plasma electrolytes, especially sodium, potassium, and calcium.
  • Monitor serum electrolytes and correct imbalances as needed.
• Volume status-related interactions:
  • Diuretics or ACE inhibitors may enhance risk of hypotension or renal dysfunction during volume shifts.
  • Monitor renal function and hemodynamics when combining with these agents.
• Compatibility:
  • Compatible with isotonic saline and 5% dextrose.
  • Do not mix with sterile water (may cause hemolysis) or other IV medications.

Always review patient medication history and electrolyte status before starting ALBUTEIN 20% therapy, especially in critically ill or elderly patients.

Dosage of ALBUTEIN 20%

Dosage must be individualized based on the patient’s weight, condition, fluid status, and response to treatment. The goal is to restore or maintain intravascular volume or serum albumin levels.

• Hypovolemia (due to shock, trauma, surgery):
  • Adults: 100–200 mL (20–40 g albumin) over 1–2 hours, repeat if needed.
  • Children: 1–2 g/kg body weight (5–10 mL/kg).
• Hypoalbuminemia (e.g., cirrhosis, nephrotic syndrome):
  • Usually 0.5–1 g/kg albumin per day for several days.
  • ALBUTEIN 20% allows for smaller fluid volume, ideal in fluid-restricted patients.
• Large-volume paracentesis:
  • 6–8 g of albumin per liter of ascitic fluid removed.
  • Use 50 mL (10 g) ALBUTEIN 20% for every 1.25–1.7 L drained.
• Burns (after 24h):
  • 0.5–1 g/kg/day as part of total fluid therapy.
• Cardiopulmonary bypass / Hemodialysis / ARDS:
  • Doses vary: often 50–100 mL (10–20 g) during or post-procedure.

Monitoring is essential. Adjust based on hemodynamics, urine output, serum albumin, and oncotic pressure. Do not exceed 2 g/kg/day total albumin unless absolutely necessary.

Possible side effects of ALBUTEIN 20%

ALBUTEIN 20% is generally well-tolerated. Adverse effects are rare and often related to infusion rate, volume overload, or individual sensitivity.

• Common reactions (mild, infusion-related):
  • Flushing, fever, chills, urticaria, nausea, vomiting
  • Headache, tachycardia, hypotension
• Serious side effects (less common):
  • Hypersensitivity reactions—rash, wheezing, bronchospasm
  • Anaphylaxis—rare but life-threatening; requires immediate treatment
  • Pulmonary edema—due to rapid or excessive volume expansion
• Laboratory changes:
  • Electrolyte imbalances (hypokalemia, hyponatremia)
  • Hemodilution—may lower hematocrit temporarily

To minimize risks:

• Infuse slowly, especially in elderly or cardiac-compromised patients.
• Monitor for allergic reactions during the first 15–30 minutes.
• Check electrolytes and fluid status before and during therapy.

Discontinue immediately if signs of anaphylaxis or pulmonary overload appear. Emergency equipment should be available during administration.

ALBUTEIN 20% Contraindications ALBUTEIN 20%

Use of ALBUTEIN 20% is contraindicated in the following conditions:

• Absolute contraindications:
  • Known hypersensitivity to albumin or any component of the product
  • Severe anemia (may worsen oxygen-carrying capacity)
  • Severe congestive heart failure or pulmonary edema not due to hypovolemia
• Relative contraindications (use with caution):
  • Chronic renal failure—monitor for volume overload
  • Hypertension or history of stroke—risk of fluid shifts
  • Bleeding disorders or variceal bleeding
  • Pregnancy—use only if benefit outweighs risk
• Pediatrics and geriatrics:
  • Use cautiously; adjust dose and monitor closely.

Careful assessment of fluid balance, cardiovascular status, and serum albumin is essential before initiating ALBUTEIN 20% therapy.

Storage of ALBUTEIN 20%

Proper storage is crucial to preserve the safety and efficacy of ALBUTEIN 20%.

• Temperature:
  • Store between 2 °C and 30 °C (36 °F to 86 °F).
  • Do not freeze. Freezing can damage the protein structure.
• Light protection:
  • Store in original packaging to protect from light.
• Handling:
  • Do not shake the bottle—can denature albumin.
  • Do not use if solution appears cloudy or contains particulates.
• Shelf life:
  • Refer to the expiry date on the label.
  • Discard any unused solution after opening—single-use vial only.
• Disposal:
  • Dispose of in accordance with local medical waste regulations.

Keep out of reach of children. Do not use past expiry or if the seal is compromised.