Plasbumin (Albumin)

PLASBUMIN®-25

Bayer

Albumin (Human)

Plasma Substitute/Blood Derivative

Action And Clinical Pharmacology: Each 20 mL vial of albumin (human) 25% supplies the oncotic equivalent of approximately 100 mL citrated plasma; 50 mL supplies the oncotic equivalent of approximately 250 mL citrated plasma.

When administered i.v. to an adequately hydrated subject, the oncotic (colloid osmotic) effect of 20 mL albumin (human) 25% is such that it will draw approximately a further 70 mL of fluid from the extravascular tissues into the circulation within 15 minutes, thus increasing the total blood volume and reducing both hemoconcentration and whole blood viscosity. Accordingly, the main clinical indications are for hypoproteinemic states involving reduced oncotic pressure, with or without accompanying edema. Albumin (human) 25% can also be used as a plasma volume expander.

Albumin is a transport protein and it may be useful in severe hemolytic disease in the neonate who is awaiting exchange transfusion. The infused albumin may reduce the level of free bilirubin in the blood.

This could also be of importance in acute liver failure where albumin might serve the dual role of supporting plasma oncotic pressure, as well as binding excessive plasma bilirubin.

Indications And Clinical Uses: Emergency Treatment of Hypovolemic Shock: Albumin (human) 25% is hyperoncotic and on i.v. infusion will expand the plasma volume by an additional amount, 3 to 4 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, albumin (human) 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 albumin found in the normal individual, i.e., about 2 g/kg body weight in the absence of active bleeding. Although albumin (human) 5% is to be preferred for the usual volume deficits, albumin (human) 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 albumin 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 albumin (human) 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 albumin with the attendant complications of oncotic deficit. A similar situation can occur in sepsis or intensive care patients. Treatment with albumin (human) 25% may be of value in such cases.

Adult Respiratory Distress Syndrome (ARDS): 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, albumin (human) 25% together with a diuretic may play a role in therapy.

Cardiopulmonary Bypass: With the relatively small priming volume required with modern pumps, preoperative dilution of the blood using albumin 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 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.

Acute Liver Failure: In the uncommon situation of rapid loss of liver function with or without coma, administration of albumin may serve the double purpose of supporting the colloid osmotic pressure of the plasma as well as binding excess plasma bilirubin.

Neonatal Hemolytic Disease: The administration of albumin (human) 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 albumin.

Erythrocyte Resuspension: Albumin 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 albumin per litre of erythrocytes is commonly used, although the requirements in pre-existent hypoproteinemia or hepatic impairment can be greater. Albumin (human) 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 albumin (human) 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 albumin (human) 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 albumin administration is not warranted: In chronic nephrosis, infused albumin 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 albumin as a source of protein nutrition is not justified.

Contra-Indications: Certain patients, e.g., those with a history of congestive cardiac failure, renal insufficiency or stabilized chronic anemia, are at special risk of developing circulatory overload. A history of an allergic reaction to albumin is a specific contraindication to usage.

Manufacturers’ Warnings In Clinical States: Solutions which have been frozen should not be used. Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered. Partially used vials must be discarded. Vials which are cracked or which have been previously entered or damaged should not be used, as this may have allowed the entry of microorganisms. Albumin (human) 25% contains no preservative.

Precautions: General: Patients should always be monitored carefully in order to guard against the possibility of circulatory overload. Albumin (human) 25% is hyperoncotic, therefore, in the presence of dehydration, albumin must be given with or followed by addition of fluids.

In hemorrhage the administration of albumin should be supplemented by the transfusion of whole blood to treat the relative anemia associated with hemodilution. When circulating blood volume has been reduced, hemodilution following the administration of albumin persists for many hours. In patients with a normal blood volume, hemodilution lasts for a much shorter period.

The rapid rise in blood pressure which may follow the administration of a colloid with positive oncotic activity necessitates careful observation to detect and treat severed blood vessels which may not have bled at the lower blood pressure.

Drug Interactions: Albumin (human) 25%, USP is compatible with whole blood, packed red cells, as well as the standard carbohydrate and electrolyte solutions intended for i.v. use. It should, however, not be mixed with protein hydrolysates, amino acid solutions nor those containing alcohol.

Pregnancy: Animal reproduction studies have not been conducted with albumin (human) 25%. It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.

Children: Safety and effectiveness in the pediatric population have not been established.

Adverse Reactions: Adverse reactions to albumin are rare. Such reactions may be allergic in nature or due to high plasma protein levels from excessive albumin administration. Allergic manifestations include urticaria, chills, fever, and changes in respiration, pulse and blood pressure.

Dosage And Administration: Albumin (human) 25% should always be administered by i.v. infusion. If sodium restriction is required, it may be administered either undiluted or diluted in a sodium-free carbohydrate solution such as 5% dextrose in water.

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 albumin concentration in the region of 2.5±0.5 g/100 mL with a plasma oncotic pressure of 20 mm Hg (equivalent to a total plasma protein concentration of 5.2 g/100 mL). This is best achieved by the i.v. administration of albumin (human) 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 albumin 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 i.v. administration of albumin (human) 25% must be considered purely symptomatic or supportive (see Situations in which albumin administration is not warranted). The usual daily dose of albumin for adults is 50 to 75 g and for children 25 g. Patients with severe hypoproteinemia who continue to lose albumin may require larger quantities. Since hypoproteinemic patients usually have approximately normal blood volumes, the rate of administration of albumin (human) 25% should not exceed 2 mL/min, as more rapid injection may precipitate circulatory embarrassment and pulmonary edema.

Other dosage recommendations are given under Indications.

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.

Availability And Storage: Each vial of sterile, aqueous solution for i.v. administration contains albumin (human) 25%, USP: 5 g (in 20 mL), 12.5 g (in 50 mL), 25 g (in 100 mL). The solution also contains sodium caprylate 0.02 M and acetyltryptophan 0.02 M and is buffered with sodium carbonate. Preservative-free. Vials of 20, 50 and 100 mL.

Each vial is heat-treated at 60°C for 10 hours against the possibility of transmitting the hepatitis viruses.

Store at room temperature not exceeding 30°C. Do not use after expiration date. Do not freeze.

PLASBUMIN®-25 Bayer Albumin (Human) Plasma Substitute/Blood Derivative

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