March 29, 2017
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Buminate

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Buminate 25%

Indications
Dosage
How Supplied

INDICATIONS

Hypovolemia

The effectiveness of in BUMINATE 25% reversing hypovolemia depends largely upon its ability to draw interstitial fluid into the circulation. It is most effective with patients who are well hydrated. When hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema,4,6 25% albumin is preferable to 5% protein solutions. Use 5% protein solutions or dilute 25% albumin with crystalloid solutions in the absence of adequate or excessive hydration. Administer compatible red blood cells or whole blood as quickly as possible when blood volume deficit is the result of hemorrhage.

Hypoalbuminemia

General

Hypoalbuminemia can result from one or more of the following:5

  1. Inadequate production (malnutrition, burns, major injury, infections, etc.)
  2. Excessive catabolism (burns, major injury, pancreatitis, etc.)
  3. Loss from the body (hemorrhage, excessive renal excretion, burn exudates, etc.)
  4. Redistribution within the body (major surgery, various inflammatory conditions, etc.)

When albumin deficit is the result of excessive protein loss, the effect of albumin administration will be temporary unless the underlying disorder is reversed.

There is no valid reason for use of albumin as an intravenous nutrient. In most cases, increased nutritional replacement of amino acids and/or protein with concurrent treatment of the underlying disorder will restore normal plasma albumin levels more effectively than albumin solutions.

Occasionally hypoalbuminemia accompanying severe injuries, infections or pancreatitis cannot be quickly reversed and nutritional supplements can fail to restore serum albumin levels. BUMINATE 25% is indicated in these cases.

Burns

An optimum regimen for the use of albumin, electrolytes and fluid in the early treatment of burns has not been established; however, in conjunction with appropriate crystalloid therapy, BUMINATE 25% is indicated for treatment of oncotic deficits after the initial 24 hour period following extensive burns and to replace the protein loss which accompanies any severe burn.4,6

Adult Respiratory Distress Syndrome (ARDS)

A characteristic of ARDS is interstitial pulmonary edema, which can be causally related to hypoproteinemia. 25% albumin solution is indicated for these cases when used with a diuretic.4

Nephrosis

BUMINATE 25% is indicated for treatment of edema in patients with severe nephrosis who are receiving steroids and/or diuretics.

Cardiopulmonary Bypass Surgery

BUMINATE 25% is indicated during cardiopulmonary bypass surgery as a component of the pump prime.4,6,12

Hemolytic Disease Of The Newborn (HDN)

BUMINATE 25% is indicated for infants with severe HDN to bind and detoxify unconjugated bilirubin.

DOSAGE AND ADMINISTRATION

BUMINATE 25% must be administered intravenously.

  • Do not use if turbid.
  • Do not begin administration more than 4 hours after the container has been entered.
  • Monitor hemodynamic parameters in patients receiving BUMINATE 25% and check for the risk of hypervolemia and cardiovascular overload. [see PRECAUTIONS] Hypervolemia can occur if the dosage and rate of infusion are not adjusted, giving consideration to the solution concentration and the patient's clinical status.
  • Do not dilute with Sterile Water for Injection as this can cause hemolysis in recipients [see CONTRAINDICATIONS].
  • Do not mix with other medicinal products including blood and blood components. BUMINATE 25% can be used concomitantly with other parenterals such as whole blood, plasma, saline, glucose or sodium lactate when deemed medically necessary. The addition of four volumes of normal saline or 5% glucose to 1 volume of BUMINATE 25% gives a solution, which is approximately isotonic and isosmotic with citrated plasma.
  • Do not mix with protein hydrolysates or solutions containing alcohol since these combinations can cause the proteins to precipitate.
  • Do not add supplementary medication.
  • Record the name and batch number of the product to maintain a link between the patient and the product.
  • Discard unused portion.

Recommended Dosages

Hypovolemic Shock

The dosage of BUMINATE 25% must be individualized. Initial dosage range for adults is 100 to 200 mL and for children 2.5 to 5 mL per kilogram body weight. Repeat after 15 to 30 minutes if the response is not adequate. Administer albumin replacement in the form of 5% Albumin (Human) in patients with significant plasma volume deficits.

Upon administration of additional albumin or if hemorrhage occurs, hemodilution and anemia can occur. Supplemental administration of compatible red blood cells or compatible whole blood may be required to treat this condition.

Burns

The optimal therapeutic regimen for administration of crystalloid and colloid solutions after extensive burns has not been established. Determine the appropriate dose according to the patient's condition and response to treatment when BUMINATE 25% is administered after the first 24 hours following burns.

Hypoalbuminemia

Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. Consider total body albumin deficit when determining the amount of albumin necessary to reverse the hypoalbuminemia. Calculate the body albumin compartment to be 80 to 100 mL per kg of body weight when using the patient's serum albumin concentration to estimate the deficit.5,6 Do not exceed a daily dose of 2 g of albumin per kilogram of body weight.

Hemolytic Disease Of The Newborn

Administer BUMINATE 25% prior to or during exchange transfusion at a dose of 1g per kilogram body weight.15

Preparation For Administration

Visually inspect parenteral drug products for particulate matter and discoloration prior to administration. BUMINATE 25% is a transparent or slightly opalescent solution, which may have a greenish tint or may vary from a pale straw to an amber color. Do not use unless solution is clear of particulate matter and seal is intact.

  1. Remove cap from bottle to expose center portion of rubber stopper.
  2. Clean stopper with germicidal solution.

Administration

Follow directions for use printed on the administration set container. Make certain that the administration set contains an adequate filter (15-micron or smaller).

HOW SUPPLIED

BUMINATE 25% is supplied in glass bottles:

20 mL NDC 0944-0490-01
50 mL NDC 0944-0490-02
100 mL NDC 0944-0490-03

Storage

Room temperature: Do not exceed 30°C (86°F). Avoid freezing.

Stability testing for BUMINATE 25% showed that aluminum concentration increased over time reaching levels that could exceed 1000 ppb over the shelf life of the product. [see CONTRAINDICATIONS].

REFERENCES

4.Tullis JL: Albumin, 1. Background and use, and 2. Guidelines for clinical use. JAMA 237:355- 360, 460-463, 1977

REFERENCES

5. Peters T Jr: Serum albumin, in The Plasma Proteins , 2nd ed, Vol 1. Putnam FW (ed). New York, Academic Press, 1975, pp 133-181

6. Finlayson JS: Albumin products. Semin Thromb Hemos tas . 6:85-120, 1980

12.Ott SM, Maloney NA, Klein GL, et al: Aluminum is associated with low bone formation in patients receiving chronic parenteral nutrition. Ann Intern Med 98:910-4,1983

15. Tsao YC, Yu VYH: Albumin in management of neonatal hyperbilirubinaemia. Arch Dis Childhood 47:250-256, 1972

Baxalta US Inc., Westlake Village, CA 91362 USA. Revised Oct 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 11/21/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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