Wednesday, January 23, 2008

Albumin

U.S. BRAND NAMES — Albumarc®; Albuminar®; AlbuRx™; Albutein®; Buminate®; Flexbumin; Plasbumin®
PHARMACOLOGIC CATEGORY Blood Product DerivativePlasma Volume Expander, Colloid
DOSING: ADULTS Note: Use 5% solution in hypovolemic patients or intravascularly-depleted patients. Use 25% solution in patients in whom fluid and sodium intake is restricted.
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: I.V.: 0.5-1 g/kg/dose; repeat every 1-2 days as calculated to replace ongoing losses.
Hypovolemia: 5% albumin: 0.5-1 g/kg/dose; repeat as needed. Note: May be considered after inadequate response to crystalloid therapy and when nonprotein colloids are contraindicated. The volume administered and the speed of infusion should be adapted to individual response.
DOSING: PEDIATRIC
(For additional information see "Albumin: Pediatric drug information")Note: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: Hypovolemia: I.V.: 0.5-1 g/kg/dose (10-20 mL/kg/dose of albumin 5%); maximum dose: 6 g/kg/day
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution [preservative free; human]: Albuminar®: 5% [50 mg/mL] (50 mL, 250 mL, 500 mL) [contains sodium 130-160 mEq/L and potassium 1 mEq/L; packaging contains dry natural rubber]; 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 1 mEq/L; packaging contains dry natural rubber] AlbuRx™: 5% [50 mg/mL] (250 mL, 500 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L]; 25% [250 mg/mL] (50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L] Albutein®: 5% [50 mg/mL] (250 mL, 500 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L]; 25% [250 mg/mL] (50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L] Buminate®: 5% [50 mg/mL] (250 mL, 500 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L; packaging contains dry natural rubber]; 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L; packaging contains dry natural rubber] Flexbumin: 25% [250 mg/mL] (50 mL, 100 mL) [contains sodium 130-160 and potassium 2 mEq/L] Human Albumin Grifols®: 25% [250 mg/mL] (50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L] Plasbumin®: 5% [50 mg/mL] (50 mL, 250 mL) [contains sodium ~145 mEq/L and potassium 2 mEq/L]; 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) [contains sodium ~145 mEq/L and potassium 2 mEq/L]
DOSAGE FORMS: CONCISE Injection, solution [preservative free; human]: Albuminar®: 5% [50 mg/mL] (50 mL, 250 mL, 500 mL); 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) AlbuRx™: 5% [50 mg/mL] (250 mL, 500 mL); 25% [250 mg/mL] (50 mL, 100 mL) Albutein®: 5% [50 mg/mL] (250 mL, 500 mL); 25% [250 mg/mL] (50 mL, 100 mL) Buminate®: 5% [50 mg/mL] (250 mL, 500 mL); 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) Flexbumin: 25% [250 mg/mL] (50 mL, 100 mL) Human Albumin Grifols®: 25% [250 mg/mL] (50 mL, 100 mL) Plasbumin®: 5% [50 mg/mL] (50 mL, 250 mL); 25% [250 mg/mL] (20 mL, 50 mL, 100 mL)
GENERIC EQUIVALENT AVAILABLE — Yes
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.
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.
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
ADVERSE REACTIONS SIGNIFICANT — 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
CONTRAINDICATIONS — Hypersensitivity to albumin or any component of the formulation; patients with severe anemia or cardiac failure
WARNINGS / PRECAUTIONS Concerns related to adverse effects: Hypervolemia: All patients should be observed for signs of hypervolemia such as pulmonary edema; monitor closely with rapid infusions.
Disease-related concerns: Hepatic impairment: Use with caution in patients with hepatic impairment; protein load may exacerbate or precipitate encephalopathy. Renal impairment: Use with caution in patients with renal impairment; protein load may precipitate azotemia.
Special populations: Preterm infants: Avoid 25% concentration in preterm infants due to risk of intraventricular hemorrhage. Sodium restricted patients: Use with caution in those patients for whom sodium restriction is necessary.
Other warnings/precautions: Nutritional supplementation: Is not an appropriate indication for albumin.
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
PREGNANCY RISK FACTOR — C (show table)
LACTATION — Excretion in breast milk unknown/compatible
DIETARY CONSIDERATIONS Albumarc®, Albuminar®, Albutein®, Buminate®, Flexbumin: 5% [50 mg/mL] and 25% [250 mg/mL] contain sodium 130-160 mEq/L
Plasbumin®: 5% [50 mg/mL] and 25% [250 mg/mL] contain sodium ~145 mEq/L
MONITORING PARAMETERS — Blood pressure, pulmonary edema, hematocrit
TOXICOLOGY / OVERDOSE COMPREHENSIVE — Symptoms include hypervolemia, congestive heart failure, and pulmonary edema.
CANADIAN BRAND NAMES — Plasbumin®-25; Plasbumin®-5
INTERNATIONAL BRAND NAMES — Albapure (ID, TW); Albital (EC); Albotein (IT); Albuman (PE); Albumer (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, PH, SC, SD, SL, SN, TH, TZ, UG, ZM, ZW); Albumex (AU, NZ); Albumin 5% (CH); Albumin 5% Human (DE); Albumin Human Salzarm 25% (DE); Albumina Humana (BR); Albuminar (BR, IL); Albuminar-25 (TW); Albuminar-5 (TW); Albuminate (ID); Alburaas (TH); Albutein 25% (BR, HK); Biseko 5% (CH); Buminate 25% (HK); Human Albumin "SSI" (DK); Human Albumin (AT, PL); Human Albumin 25% (DE); Human Albumin 5% (CZ, DE); Humanalbumin 5% (AT); Makroalbumina (PL); Octalbin (FI, ID); Plasbumin (ID); Plasbumin-25 (CA); Plasbumin-5 (CA); Probialbumin (MX); Seralbumin (CO, CR, DO, GT, HN, NI, PA, SV); SRK (CH); Taninal (PL); Tanninum albuminatum (PL); Vialebex (FR)
MECHANISM OF ACTION — Provides increase in intravascular oncotic pressure and causes mobilization of fluids from interstitial into intravascular space

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