tetrastarch (Rx)

Brand and Other Names:Voluven
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

IV solution

  • 6% hydroxyethyl starch 130/0.4 in 0.9% NaCl

Hypovolemia

Plasma volume substitute indicated for treatment and prophylaxis of hypovolemia

Daily dose and rate of infusion depend on the patient’s blood loss, on the maintenance or restoration of hemodynamics, and on the hemodilution

Administer up to 50 mL/kg/day (equivalent to 3 g hydroxyethyl starch and 7.7 mEq Na per kg of body weight)

This dose is equivalent to 3500 mL for a 70 kg patient

Give initial 10-20 mL by slow IV infusion and monitor for anaphylactoid reaction

Dosage Forms & Strengths

IV solution

  • 6% hydroxyethyl starch 130/0.4 in 0.9% NaCl

Hypovolemia

Plasma volume substitute indicated for treatment and prophylaxis of hypovolemia

Dosage in children should be adapted to the individual patient colloid needs, taking into account the disease state, as well as the hemodynamic and hydration status

Newborns and infants

<2 yr: Mean dose of 16 mL/kg IV

2-12 years: Mean dose of 36 mL/kg IV

Give initial 10-20 mL by slow IV infusion and monitor for anaphylactoid reaction

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Adverse Effects

1-10%

Pruritus

Increased serum amylase

Decreased coagulation factors

Decreased hematocrit

<1%

Anaphylactoid reactions

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Warnings

Black Box Warnings

Do not use hydroxyethyl starch (HES) in critically ill adults (including sepsis)

Use of HES increases risk of mortality and renal replacement therapy in critically ill adults

Contraindications

Critically ill adults, including those with sepsis (see Black Box Warnings)

Severe liver disease

Hypersensitivity

Clinical conditions with volume overload

Pre-existing coagulation or bleeding disorders

Renal failure with oliguria or anuria not related to hypovolemia

Patients receiving dialysis treatment

Severe hypernatremia or hyperchloremia

Intracranial bleeding

Cautions

Anaphylactoid reactions (mild influenza-like symptoms, bradycardia, tachycardia, bronchospasm, noncardiac pulmonary edema) reported

Avoid use with pre-existing renal dysfunction; discontinue at the first sign of renal injury

Monitor renal function for at least 90 days following administration

Monitor coagulation status of patients undergoing open heart surgery in association with cardiopulmonary bypass as excess bleeding has been reported with HES solutions in this population; discontinue at the first sign of coagulopathy

Avoid fluid overload; adjust dosage with cardiac or renal dysfunction

In cases of severe dehydration, a crystalloid solution should be given first

Monitor fluid balance, serum electrolytes, renal and hepatic function, acid-base balance, and coagulation parameters during prolonged parenteral therapy or when warranted

Interference with laboratory tests

  • Elevated serum amylase levels may be observed and can interfere with the diagnosis of pancreatitis
  • High doses may result in dilutional effects (eg, decreased levels of coagulation factors and other plasma proteins, decreased hematocrit)
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Pregnancy & Lactation

Pregnancy Category: C

Lactation: Unknown if distributed in human breast milk

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Colloidal solution volume expander that contains hydroxyethyl starch 130/0.4

130 refers to the molecular weight (130,000 daltons)

0.4 refers to the low molar substitution by hydroxyethyl groups

Absorption

Peak plasma time: At end of infusion

Peak plasma time (75%): 30 min post-infusion

Peak plasma time (14%): 6 hr post-infusion

Distribution

Vd: 5.9 L

Elimination

Half-life: 12 hr

Plasma clearance: 31.4 mL/min

Excretion: 62-70% in urine over 72 hr

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Images

No images available for this drug.
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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.