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  • CLASSES

    Preserved Human Serum

    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

    COMMON BRAND NAMES

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

    HOW SUPPLIED

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

    DOSAGE & INDICATIONS

    For the treatment of shock due to hypovolemia.
    NOTE: Dosage should be based on patient response as indicated by blood pressure, degree of pulmonary congestion, and hematocrit.
    Intravenous dosage
    Adults

    Initially, rapidly administer 5% solution IV. As the plasma volume approaches normal, infuse IV at a rate <= 2—4 mL/minute (rate of 25% solution <= 1 mL/minute). May repeat initial dose in 15—30 minutes. Continued protein loss may require administration of whole blood and/or other blood factors.

    Children

    0.5—1 g/kg/dose IV. May repeat as needed. Maximum dosage is 6 g/kg/day.

    Neonates

    The usual dose is 0.5 g/kg IV as a 5% solution; however, dosages may range from 0.25—0.5 g/kg IV. The 25% solution should be avoided in preterm neonates due to the risk of intraventricular hemorrhage.

    For adjunctive treatment of severe burns.
    Intravenous dosage
    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 (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
    Adults

    50 to 100 g IV initially.

    Intravenous dosage
    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 (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
    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
    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 (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 (25% solution)
    Adults

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

    MAXIMUM DOSAGE

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

    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.

    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]

    STORAGE

    Generic:
    - Store below 86 degrees F
    Albuked :
    - Avoid temperatures above 86 degrees F
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard unused portion. Do not store for later use.
    Albumarc:
    - Avoid temperatures above 86 degrees F
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard unused portion. Do not store for later use.
    Albuminar:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Albuminex:
    - Avoid temperatures above 86 degrees F
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Do not freeze
    - Protect from light
    - Store in carton
    AlbuRx :
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Store at room temperature not exceeding 86 degrees F
    Albutein:
    - Avoid temperatures above 86 degrees F
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard unused portion. Do not store for later use.
    Buminate:
    - Avoid temperatures above 86 degrees F
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard unused portion. Do not store for later use.
    Flexbumin:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard unused portion. Do not store for later use.
    - Protect from freezing
    - Store below 86 degrees F
    Kedbumin:
    - Avoid temperatures above 86 degrees F
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard unused portion. Do not store for later use.
    Macrotec:
    - Refrigerate (between 36 and 46 degrees F)
    Plasbumin:
    - Avoid temperatures above 86 degrees F
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard unused portion. Do not store for later use.

    CONTRAINDICATIONS / PRECAUTIONS

    Albumin hypersensitivity

    Use of albumin is contraindicated in patients with a history of albumin hypersensitivity or hypersensitivity to any of the excipients. Discontinue administration immediately and institute appropriate medical treatment if a hypersensitivity reaction is suspected.[33887] [63588]

    Anemia, coagulopathy, electrolyte imbalance, esophageal varices, heart failure, hypertension, pulmonary edema, renal failure, surgery, trauma

    Albumin is contraindicated in patients with severe anemia or heart failure with normal or increased intravascular volume. Under conditions where hypervolemia and/or hemodilution may occur, adjust the albumin dose and rate of infusion to the patient's volume status. Monitor coagulation and hematology parameters when large volumes are replaced. Ensure adequate substitution of other blood constituents (e.g., coagulation factors, platelets, erythrocytes). Monitor electrolyte status and take appropriate steps to address electrolyte imbalance. Discontinue albumin administration at the first sign of cardiovascular overload (e.g., headache, dyspnea, jugular venous distention, rales, hypertension). Albumin increases plasma volume and can cause vascular overload, especially after rapid infusion. Patients with preexisting heart failure, hypertension, esophageal varices, pulmonary edema, coagulopathy, severe anemia, or renal failure are at increased risk of hypervolemia and/or hemodilution. Monitor blood pressure in trauma and postoperative surgery patients in order to detect rebleeding secondary to clot disruption. Closely monitor hemodynamic parameters for evidence of increased intracranial pressure and cardiac, respiratory, or renal failure in all patients.[33887] [45325] [63588]

    Premature neonates, renal disease

    Aluminum toxicity is rare but may be seen with high doses and/or prolonged use of aluminum-containing albumin products. Accumulation at concentrations associated with central nervous system and bone toxicity is more likely to occur in patients with renal disease or in premature neonates with immature kidneys.[64642] [64643]

    Viral infection

    Albumin is a derivative of human blood. As with other products derived from or purified with human blood components, the remote possibility of contamination with Creutzfeldt-Jakob disease (CJD) or other viral infections exists in patients receiving albumin. The manufacturing processes are designed to reduce the risk of transmitting viral infection. No cases of transmission of viral illness or CJD have ever been identified for albumin. Report all infections thought to have been transmitted by albumin to the manufacturer.[33887] [63588]

    Dehydration

    Patients with marked dehydration require the administration of additional fluids when treated with concentrated albumin. The colloid-osmotic effect of 25% albumin is approximately 5-times that of blood plasma. Monitor patients carefully to guard against circulatory overload and hyperhydration.[45325]

    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]

    Breast-feeding

    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]

    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

    DRUG INTERACTIONS

    There are no drug interactions associated with Albumin products.

    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]

    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