ALBUTEIN 20% Infusion/Solution for

What is ALBUTEIN 20%

ALBUTEIN 20% is a sterile, concentrated colloid solution of human albumin—one of the main plasma proteins—derived from pooled human plasma. Each 100 mL glass bottle contains 20 g of albumin prepared for intravenous use.

• Product class: Colloid volume expander (hyperoncotic plasma protein solution).
• Manufacturing: Produced via plasma fractionation and viral inactivation (e.g., pasteurization).
• Indications: Used to treat conditions involving low blood volume, low serum albumin, or capillary leakage, including:
  • Hypovolemia due to trauma, hemorrhage, burns, or surgery
  • Hypoalbuminemia (e.g., cirrhosis, nephrotic syndrome) with edema or fluid imbalances
  • Supportive therapy in ARDS, cardiopulmonary bypass, and ovarian hyperstimulation syndrome
  • Prevention of circulatory dysfunction after large-volume paracentesis
  • Exchange transfusion support in hemolytic disease of newborns
• Packaging: 100 mL single-use glass bottle; no preservative—use immediately after opening.
• Clinical setting: Administered under close medical supervision in hospital settings.

ALBUTEIN 20% is particularly useful when rapid expansion of intravascular volume is needed with a minimal infusion volume.

How to use ALBUTEIN 20%

ALBUTEIN 20% is administered via intravenous infusion. It must be handled and administered by trained healthcare professionals following hospital protocols.

• Pre‑infusion preparation:
  • Visually inspect: Should be clear to slightly opalescent; discard if cloudy or particulate. :contentReference[oaicite:1]{index=1}
  • Allow to reach room temperature before use; do not shake or freeze. :contentReference[oaicite:2]{index=2}
  • Use full aseptic technique; pierce stopper with sterile spike.
• Administration:
  • IV infusion only; may infuse undiluted or diluted in 0.9% saline/5% dextrose. :contentReference[oaicite:3]{index=3}
  • Typical infusion rate: 1–2 mL/min (≈20–40 g/hour). In emergencies, rate may be increased under continuous monitoring. :contentReference[oaicite:4]{index=4}
  • Infuse slowly in patients with cardiac/pulmonary impairment to avoid volume overload.
• Monitoring:
  • Vital signs: blood pressure, heart rate, respiratory rate, temperature
  • Fluid balance: urine output, CVP if available
  • Watch for signs of volume overload: edema, lung crackles, difficulty breathing
• Post‑infusion:
  • Discard any unused solution—single-use only. :contentReference[oaicite:5]{index=5}

Infusion rate and dosage should be adjusted per patient's condition, underlying comorbidities, and response.

Mode of Action ALBUTEIN 20%

ALBUTEIN 20% restores oncotic pressure and intravascular volume through its high albumin content:

• Oncotic pressure: Albumin accounts for ~80% of plasma colloid osmotic pressure. At 20% concentration, it draws fluid from interstitial space into circulation. :contentReference[oaicite:6]{index=6}
• Volume expansion: Each mL infused can pull ~3–4 mL of fluid into plasma, effectively increasing preload and improving perfusion in hypovolemia. :contentReference[oaicite:7]{index=7}
• Carrier and buffering functions: Albumin transports hormones, fatty acids, bilirubin, and many drugs; also supports pH buffering. :contentReference[oaicite:8]{index=8}
• Edema reduction: Particularly useful after capillary leakage, helping move fluid back into circulation and reducing third-spacing. :contentReference[oaicite:9]{index=9}

The effect is rapid and sustained, as long as capillary integrity is preserved; monitoring for fluid balance and hemodynamic response is crucial.

ALBUTEIN 20% Interactions ALBUTEIN 20%

Although albumin itself has no pharmacologic interactions, it can affect other drugs and physiological parameters:

• Protein‑bound drug displacement: High doses may displace drugs like warfarin, phenytoin, valproate—potentially increasing active drug levels. :contentReference[oaicite:10]{index=10}
• Electrolyte shifts: Rapid volume expansion can dilute serum sodium, potassium, calcium—regular monitoring required. :contentReference[oaicite:11]{index=11}
• ACE inhibitors/diuretics: May amplify hypotensive effects or renal dysfunction—monitor blood pressure and renal function. :contentReference[oaicite:12]{index=12}
• Co-administration: Compatible with blood, crystalloids, and plasma expanders but avoid dilution with water or protein/amino acid solutions. :contentReference[oaicite:13]{index=13}

No direct drug-drug interactions exist, but monitoring for fluid balance and hemodynamic effects is essential, especially in critically ill or polypharmacy patients.

Dosage of ALBUTEIN 20%

Dosage is tailored to indication, body weight, and patient response. Daily total should not exceed 2 g/kg. Below are typical adult regimens:

• Hypovolemia/shock: 20–25 g initially (≈100–125 mL). If circulation remains unstable after 15–30 min, repeat dose as needed. :contentReference[oaicite:14]{index=14}
• Hypoalbuminemia: 50–75 g per day (250–375 mL). :contentReference[oaicite:15]{index=15}
• Paracentesis: 8 g per 1 000 mL ascitic fluid removed—approximately 40 mL per liter removed. :contentReference[oaicite:16]{index=16}
• ARDS: 25 g IV over 30 minutes; may repeat every 8 h for up to 3 days. :contentReference[oaicite:17]{index=17}
• Ovarian hyperstimulation: 50–100 g over 4 h; repeat q4–12 h until stable. :contentReference[oaicite:18]{index=18}
• Hemolytic disease of newborn: 1 g/kg prior/during exchange transfusion. :contentReference[oaicite:19]{index=19}
• Burns (post‑24 h): 25 g initially; adjust to maintain serum protein ≥5.2 g/dL. :contentReference[oaicite:20]{index=20}

Infusion rate: generally 1–2 mL/min (~1–2 g albumin/min); adjust based on condition and tolerance. :contentReference[oaicite:21]{index=21}

Possible side effects of ALBUTEIN 20%

Although generally safe, albumin infusion may cause mild to serious adverse reactions:

• Common (infusion‑related): Fever, chills, flushing, nausea, vomiting, headache, hypotension, tachycardia. :contentReference[oaicite:22]{index=22}
• Volume overload: Edema, pulmonary congestion, and exacerbation of heart failure/renal issues—monitor for signs. :contentReference[oaicite:23]{index=23}
• Allergic/anaphylactic reactions: Urticaria, bronchospasm, hypotension; life-threatening anaphylaxis is rare. :contentReference[oaicite:24]{index=24}
• Hemodilution: Reduced hematocrit; may require red cell transfusion in bleeding patients. :contentReference[oaicite:25]{index=25}
• Electrolyte imbalance: Dilution of serum electrolytes—monitor sodium, potassium, calcium. :contentReference[oaicite:26]{index=26}

Infuse slowly; monitor vitals and labs. If serious reactions occur, discontinue infusion and initiate emergency response.

ALBUTEIN 20% Contraindications ALBUTEIN 20%

• Absolute contraindications:
  • Hypersensitivity to albumin or formulation components. :contentReference[oaicite:27]{index=27}
  • Severe anemia (can worsen oxygen delivery due to dilution). :contentReference[oaicite:28]{index=28}
  • Uncompensated congestive heart failure or pulmonary edema. :contentReference[oaicite:29]{index=29}
• Use with caution in:
  • Renal impairment (risk of fluid retention)
  • Hypertension (risk of volume-induced BP rise)
  • Bleeding diatheses or esophageal varices
  • Pregnancy and breastfeeding—use only if benefit outweighs risk. :contentReference[oaicite:30]{index=30}
• Pediatrics: Dosing based on body weight; careful monitoring required. :contentReference[oaicite:31]{index=31}

Evaluate each patient’s volume, cardiac/renal status before initiating therapy and monitor closely throughout.

Storage of ALBUTEIN 20%

• Temperature: Store between 2–25 °C (36–77 °F); do not freeze. :contentReference[oaicite:32]{index=32}
• Light protection: Keep in original carton.
• Handling:
  • Avoid shaking the bottle to prevent foam and protein denaturation.
  • Use only clear, particulate-free bottles.
  • Once opened, use immediately and discard unused portion. :contentReference[oaicite:33]{index=33}
• Expiry: Follow label date; do not use after expiry.
• Disposal: Dispose per biomedical waste regulations; do not flush. :contentReference[oaicite:34]{index=34}

Secure storage out of children’s reach—as with all biological products.