Kedbumin

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Kedbumin

Classes

Preserved Human Serum

Administration
Injectable Administration

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
Albumin is a transparent or slightly opalescent solution which may have a greenish tint or may vary from pale straw to amber color.[33887] [63588]

Intravenous Administration

Albumin may be given undiluted. Acceptable diluents include 0.9% Sodium Chloride Injection or 5% Dextrose Injection; do NOT dilute with Sterile Water for Injection.
Do not mix or add with other medicinal products including blood and blood components, protein hydrolysates, or solutions containing alcohol. Do not add supplementary medication.
Storage: Administer within 4 hours of entering the container.[33887] [63588]
 
IV Infusion
Adjust infusion rate to the patient's individual requirements. Do not exceed 1 to 2 mL/minute for patients with normal blood volume. More rapid administration can cause circulatory overload and pulmonary edema.[33887] [58436] [58438] [63588]
Monitor hemodynamic parameters and for the risk of hypervolemia and cardiovascular overload.[63588]
For the treatment of acute respiratory distress syndrome (ARDS), administer each dose over 30 minutes.[45324] [45325]

Adverse Reactions
Severe

aluminum toxicity / Delayed / 0-1.0
myocardial infarction / Delayed / Incidence not known
heart failure / Delayed / Incidence not known
bradycardia / Rapid / Incidence not known
atrial fibrillation / Early / Incidence not known
bronchospasm / Rapid / Incidence not known
pulmonary edema / Early / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
anaphylactic shock / Rapid / Incidence not known
angioedema / Rapid / Incidence not known

Moderate

hypervolemia / Delayed / 1.0-10.0
hypotension / Rapid / Incidence not known
sinus tachycardia / Rapid / Incidence not known
hypertension / Early / Incidence not known
edema / Delayed / Incidence not known
dyspnea / Early / Incidence not known
confusion / Early / Incidence not known
loss of consciousness / Rapid / Incidence not known

Mild

nausea / Early / 1.0-2.0
abdominal pain / Early / 1.0-1.0
flushing / Rapid / Incidence not known
fever / Early / Incidence not known
chills / Rapid / Incidence not known
hyperhidrosis / Delayed / Incidence not known
urticaria / Rapid / Incidence not known
pruritus / Rapid / Incidence not known
rash / Early / Incidence not known
hypersalivation / Early / Incidence not known
vomiting / Early / Incidence not known
infection / Delayed / Incidence not known
headache / Early / Incidence not known

Common Brand Names

Albuked, Albumarc, Albuminar, Albuminex, AlbuRx, Albutein, Buminate, Flexbumin, Kedbumin, Macrotec, Plasbumin

Dea Class

Rx

Description

Parenteral colloid
Used for hypovolemia, hypoalbuminemia, prevention of central volume depletion after paracentesis due to cirrhotic ascites, ovarian hyperstimulation syndrome, adult respiratory distress syndrome, acute nephrosis, hemolytic disease of the newborn, burns, cardiopulmonary bypass surgery, and erythrocyte resuspension during exchange transfusion to prevent hypoproteinemia
Made from large pools of human venous plasma

Dosage And Indications
For the treatment of hypovolemia. Intravenous dosage (5%, 20%, or 25% solution) Adults

12.5 to 25 g IV. May repeat dose after 15 to 30 minutes if response is inadequate. [63588] Guidelines suggest using albumin in patients with sepsis or septic shock who received large volumes of crystalloids.

Adolescents

12.5 to 25 g IV. May repeat dose after 15 to 30 minutes if response is inadequate.  [63588]

Infants and Children

0.5 to 1 g/kg/dose (Max: 25 g) IV. May repeat dose after 15 to 30 minutes if response is inadequate. [45323]  [63588]

Neonates

0.5 to 1 g/kg/dose (Max: 25 g) IV. May repeat dose after 15 to 30 minutes if response is inadequate. [45323]  [63588]

For adjunctive treatment of severe burns. Intravenous dosage (5%, 20%, or 25% solution) Adults

25 g IV initially, beginning after 24 hours of crystalloid administration. Adjust dose to maintain plasma albumin concentration of 2.5 g/100 mL or serum protein concentration of 5.2 g/100 mL (equivalent to a plasma oncotic pressure of 20 mmHg). [45324] [58436]  [58438] Max: 2 g/kg/day.[33887] [63588] Duration of treatment is based on protein loss through renal excretion, denuded skin, and decreased albumin synthesis.[33888] [58436] [58438]

For the treatment of acute nephrosis in nephrotic syndrome. Intravenous dosage (20% or 25% solution) Adults

25 g IV once daily for 7 to 10 days. Administer with an appropriate diuretic.[45324] [45325]

For treatment of hypoproteinemia. For third space protein loss due to infection. Intravenous dosage (5%, 20%, or 25% solution) Adults

50 to 100 g IV initially. 

Intravenous dosage (5%, 20%, or 25% solution) Adults

50 to 75 g IV initially.[45324] [45325] [58436] Consider the total body albumin deficit when determining the amount of albumin necessary.[45324] Calculate the body albumin compartment to be 80 to 100 mL/kg. Do not exceed 2 g/kg/day.[33887] [63588]

Children and Adolescents

25 g IV initially.[58436] Consider the total body albumin deficit when determining the amount of albumin necessary.[45324] Calculate the body albumin compartment to be 80 to 100 mL/kg. Do not exceed a daily dose of 2 g/kg.[33887] [63588]

For adjunctive use with exchange transfusion in the treatment of hyperbilirubinemia and erythroblastosis fetalis (hemolytic disease of the newborn). Intravenous dosage (20% or 25% solution) Neonates

1 g/kg/dose IV given approximately 1 hour prior to or during exchange transfusion.[33887] [45325] [58438]

For use during cardiopulmonary bypass surgery, including pump priming. Intravenous dosage (5%, 20%, or 25% solution) Adults

25 g IV initially. May administer additional amounts as clinically indicated.[45325] [63588]

Infants, Children, and Adolescents

Preoperative dilution of blood using albumin and crystalloids can be used.[63588]

Extracorporeal dosage (5%, 20%, or 25% solution) Adults

Adjust the albumin and crystalloid pump prime to achieve a hematocrit of 20% and a plasma albumin concentration of 2.5 g/100 mL in the patient.[45323] [45325] [58438]  [63588]

Infants, Children, and Adolescents

Albumin may be used in the priming fluid.[63588]

For the treatment of acute respiratory distress syndrome (ARDS). Intravenous dosage (20% or 25% solution) Adults

25 g IV every 8 hours for up to 3 days, if necessary.[45324] [45325]

For the prevention of central volume depletion after paracentesis due to ascites in hepatic cirrhosis. Intravenous dosage (20% or 25% solution) Adults

6 to 8 g IV for every 1,000 mL of ascitic fluid removed.[45324] [45325]

Infants†, Children†, and Adolescents†

0.5 to 1 g/kg/dose IV or 6 to 8 g IV for every 1,000 mL of ascitic fluid removed.

For the treatment of hypotension during dialysis. Intravenous dosage (20% or 25% solution) Adults

20 or 25 g IV initially.

For the treatment of ovarian hyperstimulation syndrome. Intravenous dosage (20% or 25% solution) Adults

50 to 100 g IV over 4 hours. May repeat dose every 4 to 12 hours as needed. Use when normal saline infusion fails to achieve or maintain hemodynamic stability and urine output.

For exchange transfusion-induced hypoproteinemia prophylaxis. Intravenous dosage (25% solution) Adults

25 g/L of erythrocytes. Requirements in patients with pre-existing hypoproteinemia or hepatic impairment may be greater. 

For the treatment of hepatorenal syndrome† in combination with a vasoconstrictor. Intravenous dosage Adults

1 g/kg/dose IV on day 1, then 40 to 50 g/day IV for the duration of therapy. Response is defined by serum creatinine decreases to less than 1.5 mg/dL or return to within 0.3 mg/dL of baseline over a maximum of 14 days. In persons whose serum creatinine remains at or above the pretreatment level over 4 days with the maximum tolerated doses of the vasoconstrictor, therapy may be discontinued. The treatment of choice for hepatorenal syndrome is a vasoconstrictor in combination with albumin; terlipressin is the preferred vasoconstrictor.

For the treatment of spontaneous bacterial peritonitis†. Intravenous dosage Adults

1.5 g/kg/dose IV on day 1, then 1 g/kg/dose IV on day 3.

†Indicates off-label use

Dosing Considerations
Hepatic Impairment

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Renal Impairment

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Drug Interactions

There are no drug interactions associated with Albumin products.

How Supplied

Albuked/Albumarc/Albumin Human/Albuminar/Albuminex/AlbuRx/Albutein/Buminate/Flexbumin/Kedbumin/Macrotec/Plasbumin Intravenous Inj Sol: 5%, 5mL, 25%, 10-1.5mg

Maximum Dosage

Individualize dosage based on careful monitoring of clinical parameters in all patient populations. In general, do not exceed 2 g/kg/day.

Mechanism Of Action

Albumin is normally present in the blood and constitutes 50% to 60% of the plasma proteins and 80% to 85% of the oncotic pressure. Exogenously administered albumin increases the oncotic pressure of the intravascular system, pulling fluids from the interstitial space, thereby decreasing edema and increasing the circulating blood volume. This increase in volume reduces the concentration and viscosity of blood in patients with decreased circulating blood volume and also maintains cardiac output in shock. In dehydrated patients, albumin has little or no clinical effect on circulating blood volume. Albumin is also used to replace protein in patients with hypoproteinemia until the cause of the deficiency can be determined.

Pharmacokinetics

Albumin is administered intravenously as either a 5%, 20%, or 25% solution. It is distributed only in the intravascular space. Albumin solutions have a plasma half-life of 16 to 24 hours and a duration of volume expansion of 12 to 24 hours.[41931] Albumin 5% is osmotically equivalent to an equal volume of normal human plasma and will increase the circulating plasma volume by the amount equal to the volume infused.[63588] Albumin 25% solution will draw approximately 3.5 times the administered volume into the circulation within 15 minutes in adequately hydrated patients.[33887] The degree and duration of volume expansion depend on initial blood volume. When administered to patients with diminished blood volume, the effect of infused albumin may last for many hours; however, the duration is much shorter in patients with normal blood volume. In a 70-kg patient, total blood albumin is approximately 350 g. Albumin has a circulating life span of 15 to 20 days, with a turnover of approximately 15 g/day.[33887] [63588]
 
Affected cytochrome P450 isoenzymes and drug transporters: none

Pregnancy And Lactation
Pregnancy

It is not known whether albumin products can cause fetal harm or affect reproductive capacity when administered to a pregnant woman. No human or animal data are available to indicate the presence or absence of drug-associated risk with albumin use during pregnancy.[33887] [63588]

It is not known whether albumin is excreted in human milk. No human or animal data are available to indicate the presence or absence of drug-associated risk with albumin use while breast-feeding.[33887] [63588]