Tetrastarch

Tetrastarch is used for treatment and prophylaxis of low blood volume (hypovolemia).

Tetrastarch is available under the following different brand names: Voluven.

Dosages of Tetrastarch:

Dosage Forms and Strengths

Intravenous (IV) Solution

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

Dosage Considerations – Should be Given as Follows:

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 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 intravenous (IV) infusion and monitor for anaphylactoid reaction
• 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
• Children under 2 years: The mean dose of 16 mL/kg IV
• Children 2-12 years: Mean dose of 36 mL/kg IV
• Give initial 10-20 mL by slow IV infusion and monitor for anaphylactoid reaction

Common side effects of tetrastarch include:

• Itching
• Increased serum amylase
• Decreased coagulation factors
• Decreased hematocrit

Less common side effects of tetrastarch include:

• Anaphylactoid reactions

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Tetrastarch has no listed severe interactions with other drugs.
• Tetrastarch has no listed serious interactions with other drugs.
• Tetrastarch has no listed moderate interactions with other drugs.
• Tetrastarch has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains tetrastarch. Do not take Voluven if you are allergic to tetrastarch or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Black Box Warnings

• Do not use hydroxyethyl starch (HES) in critically ill adults (including sepsis)
• Use of HES increases the risk of mortality and renal replacement therapy in critically ill adults

Contraindications

• Critically ill adults, including those with sepsis
• 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

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Tetrastarch?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Tetrastarch?”

Cautions

• Anaphylactoid reactions (mild influenza-like symptoms, slow heart rate, fast heart rate, 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 (e.g., decreased levels of coagulation factors and other plasma proteins, decreased hematocrit)

Pregnancy and Lactation

• Use tetrastarch with caution during pregnancy if the benefits outweigh the risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.
• It is unknown if tetrastarch is distributed in human breast milk. Consult your doctor before breastfeeding.