Version July 2025
Dosage guidance:
Safety: With severe dehydration, administer crystalloid first. Do not use in critically ill patients (including those with sepsis or septic shock), or patients with preexisting kidney dysfunction, receiving renal replacement therapy, preexisting bleeding disorders, intracranial bleeding, or severe hepatic dysfunction (Ref).
Hypovolemia, plasma volume expansion: IV: 250 to 1,000 mL once; may repeat over several days as needed based on assessment of intravascular volume status. Initial, total volume, and rate of infusion based on clinical situation and individual patient needs; maximum total daily dose: up to 50 mL/kg/day (or up to 3,500 mL/day in a 70 kg patient) (Ref).
Altered kidney function prior to therapy: Avoid use.
Kidney injury during therapy: Discontinue tetrastarch use at the first sign of clinically significant kidney injury.
There are no dosage adjustments provided in the manufacturer’s labeling; use is contraindicated in severe hepatic disease.
Coagulopathy: Discontinue tetrastarch at the first sign of clinically significant coagulopathy.
Hypersensitivity reactions: Discontinue tetrastarch immediately and institute appropriate treatment and supportive measures.
Refer to adult dosing.
(For additional information see "Tetrastarch (Hydroxyethyl starch 130/0.4; Voluven): Pediatric drug information")
Dosage guidance:
Dosage form information: Product only available in Canada.
Volume expansion: Limited data available:
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 sepsis and septic shock in neonatal and pediatric patients (Ref).
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 (Ref).
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 (Ref).
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 (Ref).
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.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Dermatologic: Pruritus
Gastrointestinal: Increased serum amylase
Hematologic & oncologic: Decreased hematocrit, hypoproteinemia
<1%:
Hematologic & oncologic: Disorder of hemostatic components of blood
Hypersensitivity: Anaphylaxis, nonimmune anaphylaxis
Postmarketing: Hematologic & oncologic: Hemorrhage (perioperative) (Rasmussen 2014)
Hypersensitivity to hydroxyethyl starch or any component of the formulation; sepsis; critical illness (typically admitted to the ICU); kidney failure with oliguria or anuria (not related to hypovolemia); dialysis; fluid overload (eg, pulmonary edema, congestive heart failure); severe hypernatremia; severe hyperchloremia; severe hyperkalemia (Volulyte only); patients with intracranial bleeding; severe liver disease; preexisting coagulation or bleeding disorders.
Concerns related to adverse effects:
• Anaphylactoid reactions: Anaphylactoid reactions (eg, hypersensitivity, mild influenza-like symptoms, bradycardia, tachycardia, bronchospasm, noncardiac pulmonary edema) have been reported with solutions containing hydroxyethyl starch.
• Bleeding/coagulopathy: Hydroxyethyl starch (HES) solutions have been associated with excess bleeding in patients undergoing open heart surgery in association with cardiopulmonary bypass.
• Fluid overload: Administration may cause fluid overload; avoid use in patients at risk from overexpansion of blood volume (eg, very young patients, older adults).
• 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.
• Pruritus: HES may cause pruritus, especially with prolonged use or high doses; onset may be delayed (1 to 6 weeks after administration), severe, and prolonged (weeks to months). Pruritus is usually not responsive to treatment.
Special populations:
• Critically ill patients: [Canadian box warning]: In critically ill patients, including patients with sepsis, use of HES products increases risk of mortality and renal replacement therapy. Do not use HES products in critically ill patients, including patients with sepsis. 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. The need for renal replacement therapy has been reported up to 90 days after HES administration.
• Dehydrated patients: Administer a crystalloid prior to tetrastarch in patients with severe dehydration; ensure sufficient fluids to avoid dehydration.
• Electrolyte abnormalities: Use caution in patients with electrolyte abnormalities (eg, hyperchloremia, hyperkalemia, hypermagnesemia, hypernatremia).
• Metabolic alkalosis: Administer sodium chloride and balanced solutions over tetrastarch in patients with metabolic alkalosis or clinical situations where alkalization should be avoided.
Dosage form specific issues:
• Volulyte: Contains sodium, magnesium, acetate and potassium; use with caution in situations where electrolyte and/or acid-base disturbances may be exacerbated.
Other warnings/precautions:
• Appropriate use: Not a substitute for red blood cells or coagulation factors. Severely dehydrated patients should be resuscitated with a sufficient volume of crystalloid solution before consideration of tetrastarch administration.
HES use has also been associated with acute kidney injury in pediatric patients (Reinhart 2012).
Yes
Solution (Voluven Intravenous)
6-0.9% (per mL): $0.12
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
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 to 20 mL slowly while observing for possible anaphylactoid reaction; have epinephrine and resuscitative equipment available. Initial and total volume and rate of infusion is based on clinical situation and individual patient needs. 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.
Note: Not approved in the US.
Hypovolemia, plasma volume expansion: Treatment of hypovolemia due to acute blood loss when crystalloids alone are not considered sufficient.
Note: Not a substitute for red blood cells or coagulation factors in plasma.
Voluven may be confused with VoLumen
ALERT: Canadian Boxed Warning: Health Canada-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling.
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 drug interactions program by clicking on the “Launch drug interactions program” link above.
Arbekacin: Tetrastarch may increase nephrotoxic effects of Arbekacin. Risk X: Avoid
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 patients who are nursing.
BP, heart rate, electrolytes, fluid balance (especially in patients with cardiac insufficiency or kidney impairment), urine output, kidney function (continue to monitor hospitalized patients for at least 90 days after administration), urine output, hemodynamic parameters where appropriate, hemoglobin, hematocrit, coagulation parameters (with prolonged therapy and in patients undergoing open heart surgery with cardiopulmonary bypass), liver function (at baseline and periodically during treatment), 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.
