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Pronunciation:

(al BYOO min)

U.S. Brand Names:

Albumarc®; Albuminar®; Albutein®; Buminate®; Plasbumin®

Synonyms:

Albumin (Human); Normal Human Serum Albumin; Normal Serum Albumin (Human); Salt Poor Albumin; SPA

Generic Available:

Yes

Canadian Brand Names:

Plasbumin®-5; Plasbumin®-25

Use:

Plasma volume expansion and maintenance of cardiac output in the treatment of certain types of shock or impending shock; may be useful for burn patients, ARDS, and cardiopulmonary bypass; other uses considered by some investigators (but not proven) are retroperitoneal surgery, peritonitis, and ascites; unless the condition responsible for hypoproteinemia can be corrected, albumin can provide only symptomatic relief or supportive treatment

Use - Unlabeled/Investigational:

In cirrhotics, administered with diuretics to help facilitate diuresis; large volume paracentesis; volume expansion in dehydrated, mildly-hypotensive cirrhotics

Pregnancy Risk Factor:

Lactation:

Excretion in breast milk unknown/compatible

Contraindications:

Hypersensitivity to albumin or any component of the formulation; patients with severe anemia or cardiac failure

Warnings/Precautions:

Use with caution in patients with hepatic or renal failure because of added protein load; rapid infusion of albumin solutions may cause vascular overload. All patients should be observed for signs of hypervolemia such as pulmonary edema. Use with caution in those patients for whom sodium restriction is necessary. Avoid 25% concentration in preterm infants due to risk of intraventricular hemorrhage. Nutritional supplementation is not an appropriate indication for albumin.

Adverse Reactions:

Frequency not defined.

Cardiovascular: CHF precipitation, edema, hyper-/hypotension, hypervolemia, tachycardia

Central nervous system: Chills, fever, headache

Dermatologic: Pruritus, rash, urticaria

Gastrointestinal: Nausea, vomiting

Respiratory: Bronchospasm, pulmonary edema

Miscellaneous: Anaphylaxis

Overdosage/Toxicology:

Symptoms of overdose include hypervolemia, congestive heart failure, and pulmonary edema.

Drug Interactions:

ACE inhibitors: May have increased risk of atypical reactions; withhold ACEIs for at least 24 hours prior to plasma exchanges using large volumes of albumin

Stability:

Store at a temperature 30°C (86°F); do not freeze. Do not use solution if it is turbid or contains a deposit; use within 4 hours after opening vial; discard unused portion.

If 5% human albumin is unavailable, it may be prepared by diluting 25% human albumin with 0.9% sodium chloride or 5% dextrose in water. Do not use sterile water to dilute albumin solutions, as this has been associated with hypotonic-associated hemolysis.

Compatibility:

Stable in dextran 6% in D5W, dextran 6% in NS, D5LR, D5NS, D5¹/2NS, D5¹/4NS, D5W, D10W, LR, NS, ¹/2NS; incompatible with sterile water

Y-site administration: Compatible: Diltiazem, lorazepam. Incompatible: Midazolam, vancomycin, verapamil

Compatibility when admixed: Compatible: TPN. Incompatible: Verapamil

Mechanism of Action:

Provides increase in intravascular oncotic pressure and causes mobilization of fluids from interstitial into intravascular space

Dosage:

I.V.:

5% should be used in hypovolemic patients or intravascularly-depleted patients

25% should be used in patients in whom fluid and sodium intake must be minimized

Dose depends on condition of patient:

Children: Hypovolemia: 0.5-1 g/kg/dose (10-20 mL/kg/dose of albumin 5%); maximum dose: 6 g/kg/day

Adults: Usual dose: 25 g; initial dose may be repeated in 15-30 minutes if response is inadequate; no more than 250 g should be administered within 48 hours

Hypoproteinemia: 0.5-1 g/kg/dose; repeat every 1-2 days as calculated to replace ongoing losses

Hypovolemia: 0.5-1 g/kg/dose; repeat as needed; maximum dose: 6 g/kg/day

Administration:

For I.V. administration only. Use within 4 hours after opening vial; discard unused portion. In emergencies, may administer as rapidly as necessary to improve clinical condition. After initial volume replacement:

5%: Do not exceed 2-4 mL/minute in patients with normal plasma volume; 5-10 mL/minute in patients with hypoproteinemia

25%: Do not exceed 1 mL/minute in patients with normal plasma volume; 2-3 mL/minute in patients with hypoproteinemia

Do not dilute 5% solution. Rapid infusion may cause vascular overload. Albumin 25% may be given undiluted or diluted in normal saline. May give in combination or through the same administration set as saline or carbohydrates. Do not use with ethanol or protein hydrolysates, precipitation may form.

Monitoring Parameters:

Blood pressure, pulmonary edema, hematocrit

Patient Education:

Education is provided as appropriate for patient condition. This medication can only be administered intravenously. You will be monitored closely during the infusion. Pregnancy precaution: Inform prescriber if you are pregnant.

Nursing Implications:

Observe for signs of hypervolemia, pulmonary edema, and cardiac failure.

Additional Information:

Albumin 5% and 25% solutions contain 130-160 mEq/L sodium and are considered isotonic with plasma. Dilution of albumin 25% solution with sterile water produces a hypotonic solution; administration of such can cause hemolysis and/or renal failure. An albumin 5% solution is osmotically equivalent to an equal volume of plasma, whereas a 25% solution is osmotically equivalent to 5 times its volume of plasma. Albumin solutions are heated to 60°C for 10 hours, decreasing any possible risk of viral hepatitis transmission. To date, there have been no reports of viral transmission using these products.

Anesthesia and Critical Care Concerns/Other Considerations:

An Australian/New Zealand group recently published results from their evaluation of resuscitation fluid (4% albumin versus normal saline) in a heterogeneous intensive care population (Finfer, 2004). They conducted this multicenter, randomized, double-blind trial to compare the effects of resuscitation fluid on mortality from any cause during the 28-day period after randomization. Patients were eligible for inclusion if the treating clinician judged that fluid resuscitation was required for intravascular fluid depletion as supported by one of the following criteria:

Heart rate >90 bpm,

Systolic BP <100 mm Hg,

Mean arterial BP <75 mm Hg,

Decrease of 40 mm Hg in systolic or mean arterial BP (as compared with baseline),

CVP <10 mm Hg,

PCWP <12 mm Hg,

Respiratory variation in systolic or mean BP of >5 mm Hg,

Capillary refill time >1 second, or

Urine output <0.5 mL/kg for 1 hour

Patients were excluded for a variety of reasons, including ICU transfer following cardiac or liver transplantation surgery, or burn treatment. Almost 7000 patients were randomized; 3497 to albumin and 3500 to saline. Baseline characteristics were similar between the groups, except CVP pressure was slightly higher in the albumin group (9.0 in albumin versus 8.6 in saline). There was no significant mortality difference between groups (726 deaths in albumin group; 729 deaths in saline group). There were no significant differences in secondary endpoints (length of stay in the ICU or hospital, days of mechanical ventilation, and days of renal replacement therapy). Similar outcomes resulted from use of either fluid for resuscitation in this patient population.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

None reported

Mental Health: Effects on Psychiatric Treatment:

None reported

Dosage Forms:

Injection, solution, human: 5% [50 mg/mL] (50 mL, 250 mL, 500 mL); 25% [250 mg/mL] (50 mL, 100 mL)

Albumarc®: 5% [50 mg/mL] (250 mL, 500 mL); 25% [250 mg/mL] (50 mL, 100 mL)

Albuminar®: 5% [50 mg/mL] (50 mL, 250 mL, 500 mL, 1000 mL); 25% [250 mg/mL] (20 mL, 50 mL, 100 mL)

Albutein®, Buminate®: 5% [50 mg/mL]: (250 mL, 500 mL); 25% [250 mg/mL] (20 mL, 50 mL, 100 mL)

Plasbumin®: 5% [50 mg/mL] (50 mL, 250 mL, 500 mL); 25% [250 mg/mL] (20 mL, 50 mL, 100 mL)

International Brand Names:

Plasbumin®-5 (CA); Plasbumin®-25 (CA)

References

Centers for Disease Control and Prevention, "Hemolysis Associated with 25% Human Albumin Diluted with Sterile Water - United States, 1994-1998,"MMWR Morb Mortal Wkly Rep, March 5, 1999, 48(8):157-9. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/00056596.htm. Accessed February 26, 2004.

Finfer S, Bellomo R, Boyce N, et al, "A Comparison of Albumin and Saline for Fluid Resuscitation in the Intensive Care Unit. SAFE Study Investigators,"N Engl J Med, 2004, 350(22):2247-56.

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