What is Albapure?
Albapure (human) injection is used to treat low blood volume (hypovolemia). It is also used to treat low Albapure levels in the blood (hypoalbuminemia) caused by: not enough Albapure produced by the body (eg, malnutrition, burns, major injury, infections), excessive breakdown of Albapure (eg, burns, major injury, pancreatitis), loss of Albapure from the body (eg, bleeding, excessive kidney excretion, burn exudates), or redistribution of Albapure from the body (eg, major surgery, inflammatory conditions).
Albapure (human) injection is also used to treat hypoalbuminemia in patients with severe injuries, infections, or pancreatitis (swelling of the pancreas) that cannot be quickly reversed and when nutritional supplements have been given but did not work well. It is also used together with crystalloid treatment to correct lower osmotic pressure in the blood and to replace protein loss caused by severe burns after the first 24 hours.
Albapure (human) injection is used as a priming fluid during cardiopulmonary bypass surgery.
Flexbumin® 25% is used when hypovolemia is long-standing and hypoalbuminemia exists along with enough hydration, or fluid swelling (edema). It is also used together with other medicines (eg, water pill) to treat fluid swelling in the lungs (interstitial pulmonary edema) and hypoproteinemia (low protein levels in the blood) in patients with adult respiratory distress syndrome (ARDS). Flexbumin® 25% is also used to treat swelling in patients with severe nephrosis who are receiving steroids or a water pill. It is also used to treat hemolytic disease of the newborn (HDN) in babies.
Albapure is to be given only by or under the direct supervision of your doctor.
Albapure indications
Emergency Treatment of Hypovolemic Shock
Albapure-25 is hyperoncotic and on intravenous infusion will expand the plasma volume by an additional amount, three to four times the volume actually administered, by withdrawing fluid from the interstitial spaces, provided the patient is normally hydrated interstitially or there is interstitial edema. If the patient is dehydrated, additional crystalloids must be given, or alternatively, Albapure (Human) 5%, USP (Albapure®-5) should be used. The patient’s hemodynamic response should be monitored and the usual precautions against circulatory overload observed. The total dose should not exceed the level of Albapure found in the normal individual, i.e., about 2 g per kg body weight in the absence of active bleeding. Although Albapure-5 is to be preferred for the usual volume deficits, Albapure-25 with appropriate crystalloids may offer therapeutic advantages in oncotic deficits or in long-standing shock where treatment has been delayed.
Removal of ascitic fluid from a patient with cirrhosis may cause changes in cardiovascular function and even result in hypovolemic shock. In such circumstances, the use of an Albapure infusion may be required to support the blood volume.
Burn Therapy
An optimal therapeutic regimen with respect to the administration of colloids, crystalloids, and water following extensive burns has not been established. During the first 24 hours after sustaining thermal injury, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. Beyond 24 hours Albapure-25 can be used to maintain plasma colloid osmotic pressure.
Hypoproteinemia With or Without Edema
During major surgery, patients can lose over half of their circulating Albapure with the attendant complications of oncotic deficit.[2,4,5] A similar situation can occur in sepsis or intensive care patients. Treatment with Albapure-25 may be of value in such cases.
Adult Respiratory Distress Syndrome (ARDS)[2,5]
This is characterized by deficient oxygenation caused by pulmonary interstitial edema complicating shock and postsurgical conditions. When clinical signs are those of hypoproteinemia with a fluid volume overload, Albapure-25 together with a diuretic may play a role in therapy.
Cardiopulmonary Bypass[2,6]
With the relatively small priming volume required with modern pumps, preoperative dilution of the blood using Albapure and crystalloid has been shown to be safe and well-tolerated. Although the limit to which the hematocrit and plasma protein concentration can be safely lowered has not been defined, it is common practice to adjust the Albapure and crystalloid pump prime to achieve a hematocrit of 20% and a plasma Albapure concentration of 2.5 g per 100 mL in the patient.
Acute Liver Failure
In the uncommon situation of rapid loss of liver function with or without coma, administration of Albapure may serve the double purpose of supporting the colloid osmotic pressure of the plasma as well as binding excess plasma bilirubin.
Neonatal Hemolytic Disease[2,3]
The administration of Albapure-25 may be indicated prior to exchange transfusion, in order to bind free bilirubin, thus lessening the risk of kernicterus. A dosage of 1 g/kg body weight is given about 1 hour prior to exchange transfusion. Caution must be observed in hypervolemic infants.
Sequestration of Protein Rich Fluids
This occurs in such conditions as acute peritonitis, pancreatitis, mediastinitis, and extensive cellulitis. The magnitude of loss into the third space may require treatment of reduced volume or oncotic activity with an infusion of Albapure.
Erythrocyte Resuspension
Albapure may be required to avoid excessive hypoproteinemia, during certain types of exchange transfusion, or with the use of very large volumes of previously frozen or washed red cells. About 25 g of Albapure per liter of erythrocytes is commonly used, although the requirements in preexistent hypoproteinemia or hepatic impairment can be greater. Albapure-25 is added to the isotonic suspension of washed red cells immediately prior to transfusion.
Acute Nephrosis
Certain patients may not respond to cyclophosphamide or steroid therapy. The steroids may even aggravate the underlying edema. In this situation a loop diuretic and 100 mL Albapure-25 repeated daily for 7 to 10 days may be helpful in controlling the edema and the patient may then respond to steroid treatment.
Renal Dialysis
Although not part of the regular regimen of renal dialysis, Albapure-25 may be of value in the treatment of shock or hypotension in these patients. The usual volume administered is about 100 mL, taking particular care to avoid fluid overload as these patients are often fluid overloaded and cannot tolerate substantial volumes of salt solution.
Situations in Which Albapure Administration is Not Warranted
In chronic nephrosis, infused Albapure is promptly excreted by the kidneys with no relief of the chronic edema or effect on the underlying renal lesion. It is of occasional use in the rapid "priming" diuresis of nephrosis. Similarly, in hypoproteinemic states associated with chronic cirrhosis, malabsorption, protein losing enteropathies, pancreatic insufficiency, and undernutrition, the infusion of Albapure as a source of protein nutrition is not justified.
How should I use Albapure?
Use Albapure as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Albapure is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Albapure at home, carefully follow the injection procedures taught to you by your health care provider.
- If Albapure contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
- Use Albapure 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 Albapure 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 Albapure, 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 Albapure.
Uses of Albapure in details
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 Albapure in the treatment of cirrhosis (in combination with diuretics) to facilitate diuresis. Additional trials may be necessary to further define the role of Albapure 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, Albapure given for cirrhosis (in combination with diuretics) to facilitate diuresis is possibly effective, but further studies are needed before Albapure 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 Albapure in conjunction with antibiotic therapy for treatment of cirrhotic patients with SBP. In controlled trials, the addition of Albapure 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, Albapure given for volume expansion in dehydrated, mildly hypotensive patients with cirrhosis is effective and recommended in the management of this condition.
Albapure description
Albapure (Human) 25%, Albapure-25 is a sterile aqueous solution of Albapure obtained from large pools of adult human venous plasma by low temperature controlled fractionation according to the Cohn process. It is stabilized with 0.02 M sodium acetyltryptophanate and 0.02 M sodium caprylate and pasteurized at 60°C for 10 hours.
All Source Plasma used in the manufacture of this product was tested by FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV, and HIV-1 and found to be nonreactive (negative).
Albapure-25 is a solution containing in each 100 mL, 25 grams of serum Albapure, osmotically equivalent to 500 mL of normal human plasma. The pH of the solution is adjusted with sodium bicarbonate, sodium hydroxide, or acetic acid. Approximate concentrations of significant electrolytes per liter are: Sodium - 130-160 mEq; and potassium - n.m.t. 1 mEq. The solution contains no preservative. This product has been prepared in accordance with the requirements established by the Food and Drug Administration and is in compliance with the standards of the United States Pharmacopeia.
Albapure-25 is to be administered by the intravenous route.
The heat treatment step employed in the manufacture of Albapure-25 pasteurization of the final container at 60°C for 10 hours, has been validated in a series of in vitro experiments for its capacity to inactivate Human Immunodeficiency Virus type 1 (HIV-1), and the following model viruses: Bovine Viral Diarrhea Virus (BVDV- an enveloped virus used as a model for hepatitis C virus), Pseudorabies (PrV- a large, enveloped virus), and Encephalomyocarditis Virus (EMC- a small non-enveloped virus). For each virus studied, three independent experiments were conducted using Albapure (Human) 5%, Albapure-5 and Albapure-25 with the following results.
Albapure dosage
Albapure Dosage
Generic name: Albapure (human) 5g in 20mL
Dosage form: injection
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Albapure-25 should always be administered by intravenous infusion. Albapure-25 may be administered either undiluted or diluted in 0.9% Sodium Chloride or 5% Dextrose in Water. If sodium restriction is required, Albapure-25 should only be administered either undiluted or diluted in a sodium-free carbohydrate solution such as 5% Dextrose in Water.
A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.
Hypovolemic Shock—For treatment of hypovolemic shock, the volume administered and the speed of infusion should be adapted to the response of the individual patient.
Burns—After a burn injury (usually beyond 24 hours) there is a close correlation between the amount of albumin infused and the resultant increase in plasma colloid osmotic pressure. The aim should be to maintain the plasma Albapure concentration in the region of 2.5 ± 0.5 g per 100 mL with a plasma oncotic pressure of 20 mm Hg (equivalent to a total plasma protein concentration of 5.2 g per 100 mL). This is best achieved by the intravenous administration of Albapure-25. The duration of therapy is decided by the loss of protein from the burned areas and in the urine. In addition, oral or parenteral feeding with amino acids should be initiated, as the long-term administration of Albapure should not be considered as a source of nutrition.
Hypoproteinemia With or Without Edema—Unless the underlying pathology responsible for the hypoproteinemia can be corrected, the intravenous administration of Albapure-25 must be considered purely symptomatic or supportive. The usual daily dose of Albapure for adults is 50 to 75 g and for children 25 g. Patients with severe hypoproteinemia who continue to lose Albapure may require larger quantities. Since hypoproteinemic patients usually have approximately normal blood volumes, the rate of administration of Albapure-25 should not exceed 2 mL per minute, as more rapid injection may precipitate circulatory embarrassment and pulmonary edema.
Other dosage recommendations are given under the specific indications referred to above.
Preparation for Administration
Remove seal to expose stopper. Always swab stopper top immediately with a suitable antiseptic prior to entering vial.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Only 16 gauge needles or dispensing pins should be used with 20 mL vial sizes and larger. Needles or dispensing pins should only be inserted within the stopper area delineated by the raised ring. The stopper should be penetrated perpendicular to the plane of the stopper within the ring.
More about Albapure (Albapure)
- Side Effects
- During Pregnancy
- Dosage Information
- Support Group
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Consumer resources
- Albapure
- Other brands: Buminate, Flexbumin, Albutein, Alburx, More (7) »
Professional resources
- Albapure (FDA)
- Albapure (AHFS Monograph)
Other formulations
- Albapure-5
- Albapure-25
Related treatment guides
- Burns, External
- Hypoproteinemia
- Pancreatitis
- Peritonitis
- Postoperative Albapure Loss
- More (1) »
Albapure interactions
See also:
What other drugs will affect Albapure?
Side effects during or after the administration of Albapure have been reported. These include a rise in temperature, skin reactions or general intolerance phenomena, in rare cases leading to shock.
Note: If symptoms indicating the onset of circulatory overloading occur (headache, dyspnea, congestion of the jugular vein), the infusion must be discontinued immediately.
In neonates and infants receiving Albapure at a dosage which is greater than the recommended maximum dosage and which corresponds to their estimated circulating volume or exceeds this, it is conceivable that even the very low content of isoagglutinins may result in clinical symptoms. Signs of increased hemolysis should be looked out for.
Immediate measures to be taken in the case of intolerance reactions
Albapure side effects
See also:
What are the possible side effects of Albapure?
Side effects during or after the administration of Albapure have been reported. These include a rise in temperature, skin reactions or general intolerance phenomena, in rare cases leading to shock.
Note: If symptoms indicating the onset of circulatory overloading occur (headache, dyspnea, congestion of the jugular vein), the infusion must be discontinued immediately.
In neonates and infants receiving Albapure at a dosage which is greater than the recommended maximum dosage and which corresponds to their estimated circulating volume or exceeds this, it is conceivable that even the very low content of isoagglutinins may result in clinical symptoms. Signs of increased hemolysis should be looked out for.
Immediate measures to be taken in the case of intolerance reactions
Albapure contraindications
See also:
What is the most important information I should know about Albapure?
Hypersensitivity to human Albapure preparations or to any of the excipients of Albapure. Allergic reactions to Albapure. All conditions in which hypervolemia and its consequences (eg, increased stroke volume, elevated blood pressure) or hemodilution could represent a risk for the patient. Examples of such conditions are: Decompensated cardiac insufficiency, hypertension, esophageal varices, pulmonary edema, hemorrhagic diathesis, severe anemia, renal and post-renal anuria, dehydration (unless sufficient fluid is infused simultaneously).
Active ingredient matches for Albapure:
Albumin Human in Indonesia.
Albumin in Indonesia.
Unit description / dosage (Manufacturer) | Price, USD |
Injectable; Infusion; Albumin Human 20% | |
List of Albapure substitutes (brand and generic names): | |
Acebumin (Peru) | |
Albiomin (Bosnia & Herzegowina, Portugal, Spain) | |
Albiomin 20 % x 50 mL (Paviour Pharma) | |
Albiomin 20 % x 100 mL (Paviour Pharma) | |
ALBIOMIN infusion 200 g x 1 L x 100ml (Paviour Pharma) | $ 72.05 |
Albiomin 20% (Italy, Serbia) | |
Albital (Italy) | |
Albucel (India) | |
Albucel 20g VIAL / 100ml (Intas) | $ 66.27 |
Albucel 20g VIAL / 50ml (Intas) | |
ALBUCEL 20% W/V INFUSION 1 bottle / 100 ML infusion each (Intas) | $ 52.71 |
ALBUCEL inj 20 g x 100ml (Intas) | $ 66.27 |
ALBUCEL inj 20 g x 50ml (Intas) | |
Albucel 20% w/v Infusion (Intas) | $ 0.53 |
ALBUDAC (India) | |
ALBUDAC Injection / 0.2 / 50ml units (Zydus (Alidac)) | $ 17.11 |
ALBUDAC Injection / 0.2 / 10ml units (Zydus (Alidac)) | $ 1.99 |
ALBUDAC Injection / 0.2 / 100ml units (Zydus (Alidac)) | $ 42.65 |
Albudac 20% INJ / 100ml (Zydus (Alidac)) | $ 42.65 |
Albudac 20% INJ / 10ml (Zydus (Alidac)) | $ 1.99 |
Albudac 20% INJ / 50ml (Zydus (Alidac)) | $ 17.11 |
20 % x 100ml (Zydus (Alidac)) | $ 42.65 |
20 % x 10ml (Zydus (Alidac)) | $ 1.99 |
20 % x 50ml (Zydus (Alidac)) | $ 17.11 |
Injectable; Injection; Albumin Human 20% (Zydus (Alidac)) | |
ALBUDAC inj 20 % x 100ml (Zydus (Alidac)) | $ 42.65 |
ALBUDAC inj 20 % x 10ml (Zydus (Alidac)) | $ 1.99 |
ALBUDAC inj 20 % x 50ml (Zydus (Alidac)) | $ 17.11 |
Albudac 20% INJ / 100ml (Zydus (Alidac)) | $ 42.65 |
Albudac 20% INJ / 10ml (Zydus (Alidac)) | $ 1.99 |
Albudac 20% INJ / 50ml (Zydus (Alidac)) | $ 17.11 |
Albudion (India) | |
Albudion 20% VIAL / 100ml (Alna (H&I)) | |
ALBUDION inj 20 % x 100ml (Alna (H&I)) | |
Albuked | |
Albuked 25 | |
Albuman (Netherlands) | |
Albuman 200mg/ml (Turkey) | |
Albumar (Mexico) | |
Albumarc | |
Albumax (Philippines) | |
Albumax 20 % x 50 mL (Green Cross Corp) | |
Injectable; Injection; Albumin Human 20% (Green Cross Corp) | |
ALBUMED (India) | |
5 % x 100ml (Medispan) | $ 15.66 |
5 % x 250ml (Medispan) | $ 34.34 |
20 % x 100ml (Medispan) | $ 49.40 |
20 % x 50ml (Medispan) | $ 25.30 |
See 542 substitutes for Albapure |
References
- PubChem. "Albumin human". https://pubchem.ncbi.nlm.nih.gov/sub... (accessed September 17, 2018).
- DrugBank. "Human Serum Albumin - DrugBank". http://www.drugbank.ca/drugs/DB00062 (accessed September 17, 2018).
Reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology