Albutein

Name: Albutein

Albutein Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; cough, difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregiver right away if you have:

  • a light-headed feeling, like you might pass out;
  • weak or shallow breathing;
  • throbbing headache, blurred vision, buzzing in your ears;
  • anxiety, confusion, sweating, pale skin; or
  • severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus, chest pain, and fast or uneven heart rate.

Common side effects may include:

  • nausea, vomiting;
  • fever, chills;
  • fast heart rate;
  • mild rash; or
  • flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Why is human albumin prescribed to patients?

Albumin is used for hypovolemia (low blood volume), hypoalbuminemia (low albumin), burns, acute respiratory distress syndrome (ARDS), nephrosis, renal dialysis, cardiopulmonary bypass surgery, acute liver failure, and hemolytic disease of the newborn.

What are the side effects of human albumin?

Side effects of albumin are

  • edema,
  • increased heart rate,
  • headache,
  • nausea,
  • vomiting,
  • flushing,
  • itching,
  • fever, and
  • chills.

Allergic reactions may occur. Albumin is a blood product and therefore has a small risk of transmission of viral diseases.

What else should I know about human albumin?

What preparations of human albumin are available?

Albumin intravenous solution is available in 5% and 25% concentrations. Albumin 5% is available in 50 ml (2.5 grams of albumin), 250 ml (12.5 grams of albumin), and 500 ml (25 grams of albumin) bottles or vials. Albumin 25% is available in 20 ml (5 grams of albumin), 50 ml (12.5 grams of albumin), and 100 ml (25 grams of albumin) bottles or vials.

How should I keep human albumin stored?

Albumin is stored at room temperature not exceeding 30 C (86 F). Do not freeze the solution.

How does human albumin work?

Albumin is a naturally occurring transport protein found in the body. Albumin binds to many substances including bilirubin, fatty acids, hormones, enzymes, drugs, dyes, and trace elements. Albumin is responsible for 70% to 80% of the osmotic pressure of normal plasma, regulating the volume of circulating blood. Albumin temporarily increases blood volume. Commercially available albumin is fractionated from blood or plasma from donors.

Reviewed on 2/6/2017 References REFERENCES:

FDA Prescribing Information.

Medscape. Albumin.

What do I need to tell my doctor BEFORE I take Albutein?

  • If you have an allergy to albumin, blood products, or any other part of Albutein (albumin).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have anemia or a weak heart.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Albutein with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Albutein or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Albutein. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Indications and usage

Albumin (Human) U.S.P., Albutein® 20% Solution is indicated:

  1. For treatment of hypovolemic shock.1,2
  2. As an adjunct in hemodialysis for patients undergoing long-term dialysis or for those patients who are fluid-overloaded and cannot tolerate substantial volumes of salt solution for therapy of shock or hypotension.3
  3. In cardiopulmonary bypass procedures; however, the optimum regimen of fluids has not been established.

Conditions in which Albutein® 20% MAY BE indicated:

  • Adult respiratory distress syndrome (ARDS).3,4
  • Major injury or surgery resulting in increased albumin loss or inadequate synthesis.3,5
  • Acute nephrosis not responding to cyclophosphamide or steroid therapy. Steroid therapy may increase edema which may respond to combined therapy of albumin with a diuretic.3
  • Acute liver failure or ascites where the therapeutic use is regulated by the individual circumstances.3

Unless the pathologic condition responsible for hypoalbuminemia can be corrected, administration of albumin can afford only symptomatic relief. There is NO valid reason for the use of albumin as an intravenous nutrient.

How supplied/storage and handling

Albutein® 20% is supplied as a sterile, aqueous solution for single dose intravenous administration containing 20% human albumin (weight/volume). It is available in the following vial sizes:

  • 50 mL vial Albutein® 20% (NDC 68516-5215-1).
  • 100 mL vial Albutein® 20% (NDC 68516-5215-2).

Storage

Albutein® 20% is stable for three years provided that storage temperature does not exceed 30 °C. Protect from freezing.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 ML VIAL

GRIFOLS

NDC 68516-5215-1

Albumin (Human) U.S.P.

Albutein® 20%

20% 10.0 g 50 mL

Store at temperatures not exceeding 30 °C.

DO NOT USE IF TURBID. DO NOT BEGIN ADMINISTRATION MORE THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 100 ML CARTON

GRIFOLS

NDC 68516-5215-2

Albumin (Human) U.S.P.

Albutein® 20%

Solution 20.0 g 100 mL

20%

Store at temperatures not exceeding 30 °C.

Albutein 
albumin (human) injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68516-5215
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Albumin Human (Albumin Human) Albumin Human 10.0 g  in 50 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride  
Sodium Caprylate  
Sodium Acetyltryptophanate  
Water  
Packaging
# Item Code Package Description
1 NDC:68516-5215-1 1 VIAL (1 VIAL) in 1 CARTON
1 50 mL in 1 VIAL
2 NDC:68516-5215-2 1 VIAL (1 VIAL) in 1 CARTON
2 100 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102478 08/15/1978
Labeler - Grifols Biologicals Inc. (096019096)
Establishment
Name Address ID/FEI Operations
Grifols Biologicals Inc. 092694538 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Grifols Biologicals Inc. 121076871 MANUFACTURE
Revised: 07/2008   Grifols Biologicals Inc.
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