Source: FDA, National Drug Code (US) Revision Year: 2020
For restoration and maintenance of circulating blood volume where hypovolemia is demonstrated and colloid use is appropriate. When hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20-25% albumin solutions should be used.1,2,3
Acute liver failure is a special situation in which both hypovolemia and hypoalbuminemia can be present. ALBUTEIN 20% can be used in such cases.1
ALBUTEIN 20% may be of value in the treatment of shock or hypotension in renal dialysis patients.1
Preoperative dilution of blood using albumin and crystalloid can be used in cardiopulmonary bypass procedures. Albumin also may be used in the priming fluid.4,5,6
ALBUTEIN 20% may be used to treat peripheral edema in patients with acute nephrosis who are refractory to cyclophosphamide, corticosteroid therapy or diuretics.1,2,7
ALBUTEIN 20% may be indicated for subjects with hypoalbuminemia who are critically ill and/or actively bleeding. When albumin deficit is the result of excessive protein loss, the effect of ALBUTEIN 20% administration will be temporary unless the underlying disorder is reversed.8,9,10Septic patients and patients undergoing major surgery may lose more than half of their circulating plasma volume.1,11 Treatment with ALBUTEIN 20% may be of value in such cases, especially when plasma colloid oncotic pressure is abnormally low.1
In the first 24 hours after thermal injury, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. Beyond 24 hours, ALBUTEIN 20% can be used to maintain plasma colloid osmotic pressure.2,12,13 Protein loss from the third space due to infection (acute peritonitis, pancreatitis, mediastinitis or extensive cellulitis) may require treatment with an infusion of albumin.14,15
ALBUTEIN 20% may be used as a plasma volume expander in fluid management relating to severe forms of ovarian hyperstimulation syndrome.16,17
ALBUTEIN 20% is indicated for the treatment of neonatal hyperbilirubinemia. It may be used prior to or during an exchange procedure in an attempt to bind free bilirubin and enhance its excretion.18,19,20
ALBUTEIN 20% infusions may be indicated in conjunction with diuretics to correct fluid overload and hypoproteinemia associated with ARDS.6,21
ALBUTEIN 20% may be used to maintain cardiovascular function following removal of large volumes of ascitic fluid after paracentesis due to cirrhotic ascites.2,22,23,24
For Intravenous Use Only
Adjust the concentration, dosage and infusion rate of the albumin preparation to the patient’s individual requirements.
The dose required depends on the patient’s body weight, severity of injury/illness and on continuing fluid and protein losses. Use adequacy of circulating blood volume, not plasma albumin levels, to determine the dose required.
| Indication | Dose |
|---|---|
| Hypovolemia | Adults: Initial dose of 20 g. If hemodynamic stability is not achieved within 15 to 30 minutes, an additional dose may be given. Hemodilution may follow administration of ALBUTEIN 20%. Anemia resulting from hemorrhage should be corrected by administration of compatible red blood cells or compatible whole blood. For acute liver failure: initial dose of 12 to 25 g. An infusion rate of 1-2 mL per minute is usually indicated. For renal dialysis, the initial dose should not exceed 20 g and patients should be carefully observed for signs of fluid overload. |
| Cardiopulmonary bypass procedures | Adults: Initial dose of 25 g. Additional amounts may be administered as clinically indicated. |
| Acute nephrosis | Adults: 25 g together with diuretic once a day for 7-10 days. |
| Hypoalbuminemia | Adults: 50 to 75 g For pre- and post-operative hypoproteinemia: 50 to 75 g. In burns, therapy usually starts with administration of large volumes of crystalloid solution to maintain plasma volume. After 24 hours: initial dose of 25 g and dose adjustment to maintain plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g per 100 mL. Third space protein loss due to infection: initial dose of 50 to 100 g. An infusion rate of 1-2 mL per minute is usually indicated in the absence of shock. Treatment should always be guided by hemodynamic response. |
| Ovarian hyperstimulation syndrome | Adults: 50 g to 100 g over 4 hours and repeated at 4-12 hour intervals as necessary, when infusion of normal saline fails to achieve or maintain hemodynamic stability and urine output. |
| Neonatal hyperbilirubinemia | 1 g per kilogram body weight prior to or during exchange transfusion. |
| Adult respiratory distress syndrome (ARDS) | Adults: 25 g over 30 minutes and repeated at 8 hours for 3 days, if necessary. |
| Prevention of central volume depletion after paracentesis due to cirrhotic ascites | Adults: 8 g for every 1000 mL of ascitic fluid removed. |
Intravenous use only
ALBUTEIN 20% is stable for three years provided the storage temperature does not exceed 30°C. Protect from freezing.
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