Albusol

Hypovolemia

Albusol (Human) 20% is indicated in the emergency treatment of hypovolemia with or without shock. Its effectiveness in reversing hypovolemia depends largely upon its ability to draw interstitial fluid into the circulation. It is most effective in patients who are well hydrated. When blood volume deficit is the result of hemorrhage, compatible red blood cells or whole blood should be administered as quickly as possible. [1, 2]

When hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20% - 25% Albusol solutions should be used. [1 ]

Hypoalbuminemia

For subjects with hypoalbuminemia who are critically ill and/or are bleeding actively, Albusol (Human) 20% infusions may be indicated. [3 ] When Albusol deficit is the result of excessive protein loss, the effect of administration of Albusol (Human) 20% will be temporary unless the underlying disorder is reversed.

Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites (Treatment Adjunct)

Albusol (Human) 20% may be used to maintain cardiovascular function following the removal of large volumes of ascitic fluid after paracentesis due to cirrhotic ascites. [2 ]

Ovarian Hyperstimulation Syndrome (OHSS)

Albusol (Human) 20% may be used as a plasma expander in fluid management relating to severe forms of ovarian hyperstimulation syndrome (OHSS). [7, 8]

Adult Respiratory Distress Syndrome (ARDS) (Treatment Adjunct)

Albusol (Human) 20% infusions may be indicated in conjunction with diuretics to correct the fluid volume overload associated with ARDS. [5 ]

Acute Nephrosis (Treatment Adjunct)

Albusol (Human) 20% may be used to treat edema in patients with acute nephrosis who are refractory to cyclophosphamide and corticosteroid therapy. [1 ]

Hemolytic Disease of the Newborn (HDN)

Albusol (Human) 20% is indicated in the treatment of hyperbilirubinemia. It may be used prior to or during an exchange procedure in an attempt to bind free and to enhance its removal. [6 ]

Albusol is a protein produced by the liver that circulates in plasma (the clear liquid portion of your blood). Medicinal Albusol is made of plasma proteins from human blood. This medicine works by increasing plasma volume or levels of Albusol in the blood.

Albusol is used to replace blood volume loss resulting from trauma such as a severe burns or an injury that causes blood loss. This medicine is also used to treat low Albusol levels caused by surgery, dialysis, abdominal infections, liver failure, pancreatitis, respiratory distress, bypass surgery, ovarian problems caused by fertility drugs, and other many other conditions.

Albusol may also be used for purposes not listed in this medication guide.

Usual Adult Dose for Peritonitis

Albusol 5%:

Initial dose: 250 or 500 mL IV at a rate of 1 to 2 mL per minute in the absence of overt shock. The capacity of the administration set is the only limit in the exsanguinated patient. The rate of infusion and total volume administered are determined by the condition and response of the patient. The initial dose may be followed by additional Albusol within 15 to 30 minutes if the response is inadequate.

Albusol 25%:

Initial dose: The patient may require 200 to 300 mL IV to reduce edema and to bring serum protein values to normal. Since such patients usually have approximately normal blood volume, doses of more than 100 mL of Albusol 25% should not be given faster than 100 mL IV over 30 to 45 minutes to avoid circulatory overload. If slower administration is desired, 200 mL of Albusol 25% may be mixed with 300 mL of 10% dextrose solution and administered by continuous drip at a rate of 100 mL an hour IV.

Usual Adult Dose for Shock

Albusol 5%:

Initial dose: 250 or 500 mL IV at a rate of 1 to 2 mL per minute in the absence of overt shock. The capacity of the administration set is the only limit in the exsanguinated patient. The rate of infusion and total volume administered are determined by the condition and response of the patient. The initial dose may be followed by additional Albusol within 15 to 30 minutes if the response is inadequate.

Albusol 25%:

Initial dose: The patient may require 200 to 300 mL IV to reduce edema and to bring serum protein values to normal. Since such patients usually have approximately normal blood volume, doses of more than 100 mL of Albusol 25% should not be given faster than 100 mL IV over 30 to 45 minutes to avoid circulatory overload. If slower administration is desired, 200 mL of Albusol 25% may be mixed with 300 mL of 10% dextrose solution and administered by continuous drip at a rate of 100 mL an hour IV.

Usual Adult Dose for Pancreatitis

Albusol 5%:

Initial dose: 250 or 500 mL IV at a rate of 1 to 2 mL per minute in the absence of overt shock. The capacity of the administration set is the only limit in the exsanguinated patient. The rate of infusion and total volume administered are determined by the condition and response of the patient. The initial dose may be followed by additional Albusol within 15 to 30 minutes if the response is inadequate.

Albusol 25%:

Initial dose: The patient may require 200 to 300 mL IV to reduce edema and to bring serum protein values to normal. Since such patients usually have approximately normal blood volume, doses of more than 100 mL of Albusol 25% should not be given faster than 100 mL IV over 30 to 45 minutes to avoid circulatory overload. If slower administration is desired, 200 mL of Albusol 25% may be mixed with 300 mL of 10% dextrose solution and administered by continuous drip at a rate of 100 mL an hour IV.

Usual Adult Dose for Burns - External

Albusol 5%:

Initial dose: 250 or 500 mL IV at a rate of 1 to 2 mL per minute in the absence of overt shock. The capacity of the administration set is the only limit in the exsanguinated patient. The rate of infusion and total volume administered are determined by the condition and response of the patient. The initial dose may be followed by additional Albusol within 15 to 30 minutes if the response is inadequate.

Albusol 25%:

Initial dose: The patient may require 200 to 300 mL IV to reduce edema and to bring serum protein values to normal. Since such patients usually have approximately normal blood volume, doses of more than 100 mL of Albusol 25% should not be given faster than 100 mL IV over 30 to 45 minutes to avoid circulatory overload. If slower administration is desired, 200 mL of Albusol 25% may be mixed with 300 mL of 10% dextrose solution and administered by continuous drip at a rate of 100 mL an hour IV.

Usual Adult Dose for Hypoproteinemia

Albusol 5%:

Initial dose: 250 or 500 mL IV at a rate of 1 to 2 mL per minute in the absence of overt shock. The capacity of the administration set is the only limit in the exsanguinated patient. The rate of infusion and total volume administered are determined by the condition and response of the patient. The initial dose may be followed by additional Albusol within 15 to 30 minutes if the response is inadequate.

Albusol 25%:

Initial dose: The patient may require 200 to 300 mL IV to reduce edema and to bring serum protein values to normal. Since such patients usually have approximately normal blood volume, doses of more than 100 mL of Albusol 25% should not be given faster than 100 mL IV over 30 to 45 minutes to avoid circulatory overload. If slower administration is desired, 200 mL of Albusol 25% may be mixed with 300 mL of 10% dextrose solution and administered by continuous drip at a rate of 100 mL an hour IV.

Usual Adult Dose for Postoperative Albusol Loss

Albusol 5%:

Initial dose: 250 or 500 mL IV at a rate of 1 to 2 mL per minute in the absence of overt shock. The capacity of the administration set is the only limit in the exsanguinated patient. The rate of infusion and total volume administered are determined by the condition and response of the patient. The initial dose may be followed by additional Albusol within 15 to 30 minutes if the response is inadequate.

Albusol 25%:

Initial dose: The patient may require 200 to 300 mL IV to reduce edema and to bring serum protein values to normal. Since such patients usually have approximately normal blood volume, doses of more than 100 mL of Albusol 25% should not be given faster than 100 mL IV over 30 to 45 minutes to avoid circulatory overload. If slower administration is desired, 200 mL of Albusol 25% may be mixed with 300 mL of 10% dextrose solution and administered by continuous drip at a rate of 100 mL an hour IV.

Usual Pediatric Dose for Peritonitis

Albusol 5%:

Initial dose: 10 to 15 mL per pound (4.5 to 6.8 mL per kg) of body weight IV is usually adequate accompanied by close surveillance of the child.

Usual Pediatric Dose for Shock

Albusol 5%:

Initial dose: 10 to 15 mL per pound (4.5 to 6.8 mL per kg) of body weight IV is usually adequate accompanied by close surveillance of the child.

Usual Pediatric Dose for Pancreatitis

Albusol 5%:

Initial dose: 10 to 15 mL per pound (4.5 to 6.8 mL per kg) of body weight IV is usually adequate accompanied by close surveillance of the child.

Usual Pediatric Dose for Burns - External

Albusol 5%:

Initial dose: 10 to 15 mL per pound (4.5 to 6.8 mL per kg) of body weight IV is usually adequate accompanied by close surveillance of the child.

Usual Pediatric Dose for Hypoproteinemia

Albusol 5%:

Initial dose: 10 to 15 mL per pound (4.5 to 6.8 mL per kg) of body weight IV is usually adequate accompanied by close surveillance of the child.

Usual Pediatric Dose for Postoperative Albusol Loss

Albusol 5%:

Initial dose: 10 to 15 mL per pound (4.5 to 6.8 mL per kg) of body weight IV is usually adequate accompanied by close surveillance of the child.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

When undiluted Albusol 25% solution is administered to patients with normal blood volume, the rate of infusion should be slow enough (1 mL per minute) to prevent too rapid expansion of plasma volume.

The amount of Albusol and duration of therapy in the treatment of shock should be based on the responsiveness of the patient as indicated by blood pressure, degree of pulmonary congestion, and hematocrit. The initial dose may be followed by additional Albusol within 15 to 30 minutes if the response is inadequate. If there is continued loss of protein, it may be desirable to give packed red blood cells.

In the treatment of burns, an optimal regimen using Albusol, crystalloids, electrolytes, and water has not been established. Suggested therapy during the first 24 hours includes administration of large volumes of crystalloid solution to maintain an adequate plasma volume. Continuation of therapy beyond 24 hours usually requires more Albusol and less crystalloid solution to prevent marked hemoconcentration and maintain electrolyte balance. Duration of treatment varies depending upon the extent of protein loss through renal excretion, denuded areas of skin, and decreased Albusol synthesis. Attempts to raise the Albusol level above 4 g/100 mL may only result in an increased rate of catabolism.

Precautions

When dosing Albusol, the 5% solution should be used in hypovolemic patients or intravascularly-depleted patients and the 25% solution should be used in patients in whom fluid and sodium intake is restricted.

Additional fluids should accompany or follow the administration of Albusol if the patient is dehydrated.

Administration of large quantities of Albusol should be supplemented with or replaced by packed red blood cells to combat the relative anemia which would follow such use.

Albusol should be administered with caution to patients with low cardiac reserve or with no Albusol deficiency because a rapid increase in plasma volume may cause circulatory compromise (e.g., hypertension, hypotension, or pulmonary edema). In cases of hypertension, a slower rate of administration is desired: 200 mL of Albusol solution may be mixed with 300 mL of 10% dextrose solution and administered at a rate of 10 g of Albusol (100 mL) per hour.

No clinical studies using Albusol 25% have been conducted in pediatric patients. Safety and effectiveness in pediatric patients (less than 18 years old) have not been established. However, extensive experience suggests that children respond to Albusol 25% in the same manner as adults.

Dialysis

Data not available

Other Comments

The manufacturer does not recommend diluting Albusol 5% solution.

Albusol 25% may be given intravenously without dilution or it may be diluted with normal saline or 5% dextrose before administration (200 mL per liter gives a solution which is approximately isotonic and iso-osmotic with citrated plasma).

Albusol, unlike whole blood or plasma, is considered free of the danger of homologous serum hepatitis. Albusol may be given in conjunction with other parenteral fluids such as saline, dextrose, or sodium lactate. It is convenient to use since no cross-matching is required and the absence of cellular elements removes the danger of sensitization with repeated infusions.

Albusol human solution is compatible with whole blood or packed red blood cells as well as the usual electrolyte and carbohydrate solutions intended for intravenous use. Albusol should not be mixed with protein hydrolysates, amino acid mixtures, or solutions containing alcohol. It is ready for use as contained in the bottle and may be given without regard to the blood group of the patient.

See also:
What is the most important information I should know about Albusol?

Hypersensitivity to Albusol or any component of the formulation; severe anemia, heart failure; patients at risk of volume overload (eg, patients with renal insufficiency, severe anemia, stabilized chronic anemia, or heart failure); dilution with sterile water for injection (may cause hemolysis or acute renal failure)

Use Albusol (human) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Albusol (human) is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Albusol (human) at home, carefully follow the injection procedures taught to you by your health care provider.
• If Albusol (human) contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Use Albusol (human) with the administration set that came with it. Be sure the filter is used. After opening, administration must be started within 4 hours. Discard any bottles that have been open for more than 4 hours. Do not save partially used bottles for later use.
• Do not infuse Albusol (human) faster than the rate specified by your doctor.
• Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Albusol (human), use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once. If more than one dose is missed, contact your doctor or pharmacist.

Ask your health care provider any questions you may have about how to use Albusol (human).

Use: Labeled Indications

Acute respiratory distress syndrome (25% solution only): To correct interstitial pulmonary edema and hypoproteinemia associated with acute respiratory distress syndrome in conjunction with diuretics.

Cirrhotic ascites, adjunct treatment: To maintain intravascular volume following removal of large-volume paracentesis in cirrhotic patients.

Erythrocyte resuspension: To avoid excessive hypoproteinemia, during certain types of exchange transfusion, or with the use of very large volumes or previously frozen or washed red cells.

Hypovolemia: Plasma volume expansion and maintenance of intravascular volume in the emergency treatment of hypovolemia (with or without shock).

Neonatal hemolytic disease: Binds and detoxifies unconjugated bilirubin in severe hemolytic disease of the newborn during exchange transfusion.

Nephrosis (acute), adjunct: Treatment of edema in patients with acute nephrosis in combination with diuretics.

Ovarian hyperstimulation syndrome, treatment (25% solution only): As a plasma volume expander in fluid management for the treatment of severe ovarian hyperstimulation syndrome.

Off Label Uses

Cirrhosis (in combination with diuretics to facilitate diuresis)

Data from an unblinded, randomized, controlled study supports the use of Albusol in the treatment of cirrhosis (in combination with diuretics) to facilitate diuresis. Additional trials may be necessary to further define the role of Albusol in this condition.

Based on the American Association for the Study of Liver Diseases (AASLD) guidelines for the management of adult patients with ascites due to cirrhosis, Albusol given for cirrhosis (in combination with diuretics) to facilitate diuresis is possibly effective, but further studies are needed before Albusol can be recommended for the management of this condition.

Spontaneous bacterial peritonitis (treatment)

American Association for the Study of Liver Diseases and European Association for the Study of the Liver clinical practice guidelines recommend Albusol in conjunction with antibiotic therapy for treatment of cirrhotic patients with SBP. In controlled trials, the addition of Albusol to antibiotic therapy was associated with significant reductions in incidences of renal impairment and mortality.

Volume expansion in dehydrated, mildly hypotensive patients with cirrhosis

Based on the American Association for the Study of Liver Diseases (AASLD) guidelines for the management of adult patients with ascites due to cirrhosis, Albusol given for volume expansion in dehydrated, mildly hypotensive patients with cirrhosis is effective and recommended in the management of this condition.

See also:
What other drugs will affect Albusol?

There are no known significant interactions.

See also:
What are the possible side effects of Albusol?

General

The most serious events are anaphylactic shock, circulatory failure, cardiac failure, and pulmonary edema.

The most common adverse events are anaphylactoid type of reactions.

Adverse reactions for Albusol (Human) 20% normally resolve when the infusion rate is slowed down or the infusion is stopped. In case of severe reactions, the infusion should be stopped and appropriate treatment should be initiated.

Clinical Studies Experience

No clinical studies were done using Albusol (Human) 20%

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Albusol (Human) (any strength). Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency.

Table 1 Adverse reactions observed for Albusol HUMAN (any strength) during post-marketing phase (in decreasing order of severity)

No drug interaction studies have been conducted.