"To address "continuing safety concerns" about severe neutropenia associated with the atypical antipsychotic clozapine (multiple brands), the US Food and Drug Administration (FDA) is making changes to requirements for monitoring, prescribing, disp"...
Hypovolemia is a possible indication for use of BUMINATE 5%, Albumin (Human), 5% Solution. Its effectiveness in reversing hypovolemia depends largely upon its colloid osmotic pressure. Although crystalloid solutions and colloid-containing plasma substitutes can be used in emergency treatment of shock, Albumin (Human) has a longer intravascular half-life than crystalloid solutions.9
When the hypovolemia is long-standing and hypoalbuminemia exists accompanied by adequate hydration or edema, treatment with BUMINATE 25%, Albumin (Human), 25% Solution is preferable.4,6
When blood volume deficit is the result of hemorrhage, compatible red blood cells or whole blood should be administered as quickly as possible.
Hypoalbuminemia is another possible indication for use of BUMINATE 5%, Albumin (Human), 5% Solution. Hypoalbuminemia can result from one or more of the following:5
- Inadequate production (malnutrition, burns, major injury infections, etc.)
- Excessive catabolism (burns, major injury, pancreatitis, etc.)
- Loss from the body (hemorrhage, excessive renal excretion, burn exudates, etc.)
- Redistribution within the body (major surgery, various inflammatory conditions, etc.)
When albumin deficit is the result of excessive protein loss, the effect of administration of albumin will be temporary unless the underlying disorder is reversed. 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 administration of albumin solutions. Occasionally hypoalbuminemia accompanying severe injuries, infections or severe pancreatitis cannot be quickly reversed and nutritional supplements may fail to restore adequate plasma albumin levels. In these cases, BUMINATE 5%, Albumin (Human), 5% Solution may be useful.
In conjunction with appropriate crystalloid therapy, BUMINATE 5%, Albumin (Human), 5% Solution may be useful for treatment of protein deficits after the initial 24-hour period following extensive burns.4
BUMINATE 5%, Albumin (Human), 5% Solution may be indicated prior to or during cardiopulmonary bypass surgery, though the data do not indicate a clear-cut advantage over crystalloid solutions.4,6,10
There is no valid reason for use of albumin as an intravenous nutrient.
DOSAGE AND ADMINISTRATION
BUMINATE 5%, Albumin (Human), 5% Solution must be administered intravenously. It may be administered either in conjunction with or combined with other parenterals such as whole blood, plasma, saline, glucose or sodium lactate. The volume of the total dose and the rate of infusion depends on the patient's condition and response.
Although the volume of BUMINATE 5%, Albumin (Human), 5% Solution administered must be individualized, the initial dose should be 250 to 500 mL for older children and adults and 12 to 20 mL per kilogram of body weight for infants and young children. It may be repeated after 30 minute intervals if the response is not adequate.
Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. This total body albumin deficit must be considered when determining the amount of albumin necessary to reverse the hypoalbuminemia. When using the patient's serum albumin concentration to estimate the deficit, the body albumin compartment should be calculated to be 80 to 100 mL per kilogram of body weight.5,6 Daily dose should not exceed 2 g of albumin per kilogram of body weight.
When BUMINATE 5%, Albumin (Human), 5% Solution is administered after the first 24 hours following burns, an initial dose of 500 mL is recommended. Preparation for Administration
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
- Remove cap from bottle to expose center portion of rubber stopper.
- Clean stopper with germicidal solution.
Follow directions for use printed on the administration set container. Make certain that the administration set contains an adequate filter.
BUMINATE 5%, Albumin (Human), 5% Solution is supplied in 250 mL and 500 mL bottles.
Store BUMINATE 5%, Albumin (Human), 5% Solution at room temperature, not to exceed 30°C (86°F). Avoid freezing to prevent damage to the bottle.
4. Tullis JL: Albumin, 1. Background and use, and 2. Guidelines for clinical use. JAMA 237:355-360,460-463, 1977
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. Sem Thromb Hemostas 6:85-120, 1980
9. Shoemaker WC, Schluchter M, Hopkins JA, et al: Comparison of the relative effectiveness of colloids and crystalloids in emergency resuscitation. Am J Surg 142:73-83, 1981
10. Lowenstein E, Hallowell P, Bland JHL: Use of colloid and crystalloid solutions in open heart surgery: Physiological basis and clinical results, in Proceedings of the Workshop on Albumin. Sgouris JT, Rene A (eds.) DHEW Publication No. (NIH) 76-925, Washington DC, U.S. Government Printing Office, 1976, pp 195-210
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Baxter Healthcare Corporation, Westlake Village, CA 91362 USA. Revised September 2002. FDA rev date: n/aThis monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/28/2016
Additional Buminate 5% Information
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