Plasma volume expansion: IV infusion: May administer up to 50 mL/kg/day (or up to 3500 mL per day in a 70 kg patient); may administer repetitively over several days. Note: With severe dehydration, administer crystalloid first. Daily dose and rate of infusion dependent on amount of blood lost, on maintenance or restoration of hemodynamics, and on amount of hemodilution. Titrate to individual colloid needs, hemodynamics, and hydration status. Avoid use in the critically ill including patients with sepsis or septic shock, those with preexisting kidney dysfunction or receiving dialysis, those with preexisting bleeding disorders or those with intracranial bleeding (SSC [Evans 2021]; manufacturer's labeling).
Avoid use in patients with preexisting kidney dysfunction. Use is contraindicated in oliguric/anuric kidney failure unrelated to hypovolemia or patients receiving dialysis. Discontinue use at the first sign of kidney injury.
No dosage adjustment provided in manufacturer’s labeling; use is contraindicated in severe liver disease.
(For additional information see "Tetrastarch (Hydroxyethyl starch 130/0.4; Voluven): Pediatric drug information")
Note: With severe dehydration, administer crystalloid first. Dose and rate of infusion dependent on amount of blood lost, on maintenance or restoration of hemodynamics, and on amount of hemodilution. Titrate to individual colloid needs, hemodynamics, and hydration status. Do not use in critically ill patients, those undergoing open heart surgery with cardiopulmonary bypass, or those with preexisting kidney dysfunction. Critical Care Medicine societies (ACCM, SCCM) recommend against the use of hydroxyethyl starch (HES) solutions for fluid resuscitation of severe sepsis and septic shock in neonatal and pediatric patients (ACCM [Davis 2017]; SCCM [Dellinger 2013]).
Volume expansion:
Infants and Children <2 years: IV infusion: Usual range: 7 to 25 mL/kg/dose; mean reported dose: 16 ± 9 mL/kg/dose; maximum daily dose: 50 mL/kg/day; in clinical trials of intraoperative use, a dose of 10 mL/kg/dose has been reported (Chong Sung 2006; Osthaus 2009; Witt 2008).
Children 2 to 12 years: IV infusion: Usual range: 25 to 47 mL/kg/dose; mean reported dose: 36 ± 11 mL/kg/dose; maximum daily dose: 50 mL/kg/day; in clinical trials of intraoperative use, a dose of 10 mL/kg/dose has been reported (Chong Sung 2006; Osthaus 2009; Van der Linden 2013; Witt 2008).
Adolescents: IV Infusion: Administer up to 50 mL/kg/day (or up to 3,500 mL daily in a 70 kg patient); may administer repetitively over several days.
Avoid use in patients with pre-existing renal dysfunction; use is contraindicated in oliguric/anuric renal failure unrelated to hypovolemia or patients receiving dialysis. Discontinue use at the first sign of renal injury.
There are no dosage adjustments provided in manufacturer’s labeling; use is contraindicated in severe impairment.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Intravenous:
Voluven: 6% (500 mL [DSC]) [dehp free, latex free, pvc free]
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Volulyte: 6% (250 mL, 500 mL)
Voluven: 6% (250 mL, 500 mL)
IV: Administer IV only; may be administered via infusion pump or pressure infusion. Infuse the initial 10-20 mL slowly while observing for possible anaphylactoid reaction; have epinephrine and resuscitative equipment available. If administered by pressure infusion, air should be withdrawn or expelled from bag prior to infusion to prevent air embolus. Do not use if crystalline precipitate forms or is turbid deep brown. Change IV tubing at least every 24 hours.
IV: Administer IV only; may be administered via infusion pump or pressure infusion; if administered by pressure infusion, air should be withdrawn or expelled from bag prior to infusion to prevent air embolus. Infuse the first 10 to 20 mL slowly to observe for anaphylaxis; have epinephrine and resuscitative equipment available. Do not use if crystalline precipitate forms or is turbid deep brown. Change IV tubing at least once every 24 hours.
Blood volume expander used in treatment and prevention of hypovolemia
Voluven may be confused with VoLumen
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Dermatologic: Pruritus (dose dependent; may be delayed), skin rash
Gastrointestinal: Increased serum amylase
Hematologic & oncologic: Anemia, coagulation time increased, decreased clotting factors, decreased hematocrit, prolonged prothrombin time, wound hemorrhage
<1%, postmarketing, and/or case reports: Acute kidney injury, anaphylactoid reaction, anaphylaxis, bradycardia, bronchospasm, circulatory shock, flu-like symptoms, hemorrhage (perioperative) (Rasmussen 2014), hypersensitivity reaction, hypotension, non-cardiogenic pulmonary edema, shock, tachycardia
Hypersensitivity to hydroxyethyl starch or any component of the formulation; critically ill adult patients, including patients with sepsis, due to increased risk of mortality and renal replacement therapy; kidney failure with oliguria or anuria (not related to hypovolemia); dialysis; any fluid overload condition (eg, pulmonary edema, congestive heart failure); severe hypernatremia; severe hyperchloremia; patients with intracranial bleeding; severe liver disease; preexisting coagulation or bleeding disorders.
Canadian labeling: Additional contraindications (not in US labeling): Volulyte only: Severe hyperkalemia.
Concerns related to adverse effects:
• Anaphylactoid reactions: Anaphylactoid reactions (eg, mild influenza-like symptoms, bradycardia, tachycardia, bronchospasm, noncardiac pulmonary edema) have been reported with solutions containing hydroxyethyl starch; discontinue use immediately with signs of hypersensitivity and administer appropriate therapy.
• Bleeding: Monitor the coagulation status in patients undergoing open heart surgery in association with cardiopulmonary bypass. Hydroxyethyl starch (HES) solutions have been associated with excess bleeding in these patients. Discontinue use of HES at the first sign of coagulopathy. Use is contraindicated in patients with preexisting coagulation or bleeding disorders.
• Fluid overload: Administration may cause fluid overload; use with caution in patients at risk from overexpansion of blood volume (eg, very young patients, elderly patients); use is contraindicated in heart failure or any preexisting condition where volume overload is a potential concern. Adjust the dosage in patients with preexisting cardiac dysfunction. Avoid use in patients with preexisting kidney dysfunction.
• Hemodilution: Large volumes may cause a reduction in hematocrit, coagulation factors and other plasma proteins due to hemodilution; coagulation may be impaired (eg, prolonged PT, PTT, and clotting times) and a transient prolongation of bleeding time may be observed.
• Hepatic effects: Monitor liver function at baseline and periodically during treatment.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with hepatic impairment. Monitor liver function at baseline and periodically during treatment. Use is contraindicated in patients with severe liver disease; may result in further reduction of coagulation factors, increasing the risk of bleeding.
• Kidney impairment: Avoid use in patients with preexisting kidney impairment; fluid status including urine output should be monitored closely; discontinue use at the first sign of kidney injury. Use is contraindicated with oliguria or anuria unrelated to hypovolemia or patients receiving hemodialysis.
Special populations:
• Critically ill patients: [US Boxed Warning]: HES solutions have been associated with mortality and renal injury requiring renal replacement therapy in critically ill patients, including patients with sepsis; avoid use in critically ill adult patients, including those with sepsis. Avoid use in patients admitted to the ICU (Brunkhorst 2008; Perel 2012; Perner 2012; SSC [Evans 2021]). Crystalloids (eg, sodium chloride and balanced solutions) are recommended as the fluid of choice for initial resuscitation and ongoing resuscitation (SSC [Evans 2021]). If used in patients who are not critically ill, avoid use in patients with preexisting kidney dysfunction and discontinue use at the first sign of kidney injury. Since the need for renal replacement therapy has been reported up to 90 days after HES administration, continue to monitor kidney function in all patients for at least 90 days.
Other warnings/precautions:
• Appropriate use: Not a substitute for red blood cells or coagulation factors. Severely dehydrated patients should be infused with a sufficient volume of crystalloid solution initially, prior to consideration of tetrastarch administration.
• Laboratory test interference: May cause temporarily elevated serum amylase levels and interfere with pancreatitis diagnosis.
HES use has also been associated with acute kidney injury in pediatric patients (Reinhart 2012).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Arbekacin: Tetrastarch may enhance the nephrotoxic effect of Arbekacin. Risk X: Avoid combination
Adverse events have been observed in animal reproduction studies.
It is not known if tetrastarch is excreted in breast milk. The manufacturer recommends that caution be exercised when administering tetrastarch to nursing women.
BP, heart rate, capillary refill time, CVP, RAP, MAP; if pulmonary artery catheter in place, monitor cardiac index, PCWP, SVR, and PVR; hemoglobin, coagulation parameters, kidney function (continue to monitor for at least 90 days after administration), liver function, urine output, acid-base balance
Produces plasma volume expansion by virtue of its highly colloidal starch structure
Duration: ≥6 hours
Distribution: Vd: 5.9 L
Metabolism: Molecules >50,000 daltons are metabolized by plasma α-amylase
Half-life elimination: 12 hours
Excretion: Urine (smaller hydroxyethyl starch molecules [<50,000 daltons] unchanged, metabolites)
Clearance: 31.4 mL/minute
Solution (Voluven Intravenous)
6-0.9% (per mL): $0.12
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