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  • CLASSES

    Preserved Human Serum

    DEA CLASS

    Rx

    DESCRIPTION

    A low-molecular-weight protein; maintains intravascular oncotic pressure; responsible for transport of bilirubin, calcium, and many drugs; indicated for urgent restoration of blood volume; preparations are derived from pooled human blood, plasma, serum, or placentas, and contain no blood-clotting factors, Rh factor, or other antibodies.

    COMMON BRAND NAMES

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

    HOW SUPPLIED

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

    Individualize dosage to clinical goals. Initial recommended therapy includes administration of a large volume of crystalloid solution for the first 24 hours, followed by more albumin and less crystalloid to maintain electrolyte balance and prevent marked hemoconcentration. Albumin should not be administered to patients with severe burns in the first 24 hours following the burn because of capillary exudation of albumin. Goal of therapy is to maintain plasma albumin level of 3—4 mg/dL. Duration of treatment is based on protein loss through renal excretion, denuded skin, and decreased albumin synthesis.

    For the treatment of nephrosis in nephrotic syndrome.
    Intravenous dosage
    Adults

    100—200 mL of 25% albumin IV administered with a loop diuretic for 7—10 days has been successful in controlling edema.

    For treatment of hypoproteinemia.
    Intravenous dosage
    Adults

    25 g IV. May repeat in 15—30 minutes. Alternatively, 200—300 mL (50—75 g) of 25% albumin IV infused at a rate <= 2 mL/minute to avoid an excessive increase in plasma volume. Maximum dosage is 250 g per 48 hours (5 L of a 5% solution or 1 L of a 25% solution).

    Neonates, Infants, and Children

    0.5—1 g/kg/dose IV infused over 2—4 hours. May repeat every 1—2 days. Alternatively, 100 mL (25 g albumin) of 25% albumin IV infused at rate <= 2 mL/minute to avoid too large an increase in plasma volume. For neonates, the dose may be added to hyperalimentation and infused over 24 hours.

    For adjunctive use with exchange transfusion in the treatment of hyperbilirubinemia and erythroblastosis fetalis.
    Intravenous dosage
    Children

    1 g/kg IV administered 1—2 hours prior to transfusion.

    MAXIMUM DOSAGE

    Specific maximum dosage information is not available. Individualize dosage based on careful monitoring of clinical parameters in all patient populations.

    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

    For storage information, see the specific product information within th How Supplied section.

    Injectable Administration

    Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
    Solution is a clear amber color; discard if turbid or a sediment is present. Since albumin human solution contains no antimicrobial preservative, do not begin administration more than 4 hours after the container has been entered.

    Intravenous Administration

    Albumin human 5% or 25% may be given undiluted. The 25% solution may be diluted with 0.9% Sodium Chloride Injection or 5% Dextrose Injection before administration to give a 20% (200 mL/L) albumin human solution. The 5% Dextrose solution is oncotically equivalent volume for volume to human plasma. 50 mL of 25% albumin supplies the oncotic equivalent of 250 mL citrated plasma.
    Intravenous (IV) infusion:
    Use administration set provided by the manufacturer. Administer using a large needle or catheter of at least 20 gauge.
    For hypovolemic shock: The initial dose should be administered as rapidly as tolerated. After the initial dose is administered, the rate of administration should be adapted to the response of the patient. As blood volume approaches normal, the infusion rate should be slow enough (1 mL/minute) to prevent too rapid expansion of plasma volume.
    For hypoproteinemic patients: Administration rates for the 25% solution vary by manufacturer. Maximum rates of 2 mL/minute and 3 mL/minute are recommended.
    Too rapid infusion may cause circulatory compromise, including pulmonary edema. Premature neonates are more prone to intraventricular hemorrhage due to rapid intravascular volume expansion.

    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
    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 in patients with known or suspected albumin hypersensitivity or hypersensitivity to blood or blood products is contraindicated.

    Anemia, heart failure, hypertension

    Albumin human increases plasma volume and can cause vascular overload, especially following rapid infusion,and is contraindicated in patients with heart failure. The increase in blood volume does not compensate for loss of red blood cells and is, therefore, contraindicated in patients with severe anemia. A rapid increase in plasma volume can result in hypertension and can expose undetected bleeding points following injury or surgery.

    Renal disease

    Albumin should be used with caution in patients with renal disease or dysfunction because of possible accumulation of aluminum, which is present in some products as a contaminant.

    Hypernatremia

    All commercially available products contain sodium and should be used with caution in patients with hypernatremia or who are required to restrict salt intake. Although older preparations of albumin contained significant amounts of sodium, all current commercial preparations of albumin contain reduced amounts of sodium.

    Burns

    Albumin should not be administered to patients with severe burns in the first 24 hours following the burn because of capillary exudation of albumin.

    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. All infections thought to have been transmitted by albumin should be reported to the manufacturer.

    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.

    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.

    ADVERSE REACTIONS

    Severe

    heart failure / Delayed / Incidence not known
    bradycardia / Rapid / Incidence not known
    aluminum toxicity / Delayed / Incidence not known
    pulmonary edema / Early / Incidence not known
    bronchospasm / Rapid / Incidence not known
    anaphylactoid reactions / Rapid / Incidence not known
    angioedema / Rapid / Incidence not known
    anaphylactic shock / Rapid / Incidence not known

    Moderate

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

    Mild

    nausea / Early / 1.0-2.0
    flushing / Rapid / Incidence not known
    chills / Rapid / Incidence not known
    fever / Early / Incidence not known
    rash (unspecified) / Early / Incidence not known
    urticaria / Rapid / Incidence not known
    pruritus / Rapid / Incidence not known
    hypersalivation / Early / Incidence not known
    dysgeusia / 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.

    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.

    MECHANISM OF ACTION

    Albumin is normally present in the blood and constitutes 50—60% of the plasma proteins and 80—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—24 hours and a duration of volume expansion of 12—24 hours. In adequately hydrated patients, administration of 25% albumin solution causes 3.5 times the administered volume to be drawn into the circulation within 15 minutes. The degree and duration of volume expansion depends on initial blood volume. When administered to patients with diminished blood volume, the effect of infused albumin may last for many hours compared to a much shorter time when administered to patients with normal blood volume. In a 70-kg male, total blood albumin is approximately 350 grams. Albumin has a circulating life span of 15—20 days, with a turnover of approximately 15 grams per day.