Voluven

Starches

 
NOTE: Hetastarch may be administered as a 6% solution in 0.9% sodium chloride.

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer solution that is cloudy or contains a precipitate. Discard any unused portions.

Hetastarch is administered by intravenous infusion.
 
Continuous IV infusion
Administer undiluted. Rate of administration is determined by individual patient requirements (i.e., amount of fluid loss, indication, and patient response).

angioedema / Rapid / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
erythema multiforme / Delayed / Incidence not known
cardiac arrest / Early / Incidence not known
ventricular fibrillation / Early / Incidence not known
bradycardia / Rapid / Incidence not known
pulmonary edema / Early / Incidence not known
bronchospasm / Rapid / Incidence not known
renal failure (unspecified) / Delayed / Incidence not known
heart failure / Delayed / Incidence not known
clotting factor deficiency / Delayed / Incidence not known
disseminated intravascular coagulation (DIC) / Delayed / Incidence not known
coagulopathy / Delayed / Incidence not known
intracranial bleeding / Delayed / Incidence not known

dyspnea / Early / Incidence not known
hypotension / Rapid / Incidence not known
sinus tachycardia / Rapid / Incidence not known
chest pain (unspecified) / Early / Incidence not known
tachypnea / Early / Incidence not known
wheezing / Rapid / Incidence not known
anemia / Delayed / Incidence not known
prolonged bleeding time / Delayed / Incidence not known
hemolysis / Early / Incidence not known
bleeding / Early / Incidence not known
metabolic acidosis / Delayed / Incidence not known
peripheral edema / Delayed / Incidence not known

rash / Early / Incidence not known
pruritus / Rapid / Incidence not known
chills / Rapid / Incidence not known
sneezing / Early / Incidence not known
urticaria / Rapid / Incidence not known
cough / Delayed / Incidence not known
restlessness / Early / Incidence not known
fever / Early / Incidence not known
flushing / Rapid / Incidence not known
myalgia / Early / Incidence not known
vomiting / Early / Incidence not known
nausea / Early / Incidence not known
headache / Early / Incidence not known

Excess bleeding has occurred with hetastarch use in patients undergoing surgery. Do not use hetastarch unless adequate alternative treatment is unavailable. Hetastarch is contraindicated in patients with a pre-existing coagulopathy or bleeding disorder or intracranial bleeding.  Hetastarch is not recommended for use as a cardiac bypass pump prime, while the patient is on cardiopulmonary bypass, or in the immediate period after the pump has been discontinued because of the risk of increasing coagulation abnormalities and bleeding in patients whose coagulation status is already impaired. Monitor the coagulation status of patients undergoing coronary artery bypass graft surgery (CABG) as excess bleeding has been reported with hetastarch solutions in this population.  Discontinue use of hetastarch at first sign of coagulopathy. Repeated administration or large volumes of hetastarch over several days has been associated with coagulation abnormalities in conjunction with an acquired, reversible acquired von Willebrand's-like syndrome and/or factor VIII deficiency. Consider replacement therapy if a severe factor VIII deficiency is identified. If a coagulopathy develops, it may take several days to resolve. Certain conditions may affect the safe use of hetastarch on a chronic basis. For example, in patients with subarachnoid hemorrhage where hetastarch is used repeatedly over a period of days for the prevention of cerebral vasospasm, significant clinical bleeding may occur.

Hetastarch is contraindicated in adults with critical illness, including patients with sepsis, due to increased risk of mortality and renal replacement therapy (RRT) as well as in patients receiving dialysis or with clinical conditions where hypervolemia is a potential problem, including congestive heart failure or renal disease with anuria or oliguria not related to hypovolemia. Avoid excessive hemodilution and circulatory overload in patients at risk for developing congestive heart failure or pulmonary edema. Blunt trauma patients are also at increased risk of mortality and RRT. Do not use hetastarch unless adequate alternative treatment is unavailable.  Avoid hetastarch use in patients with pre-existing renal impairment or renal failure. Discontinue hetastarch use at the first sign of renal injury. Continue to monitor renal function in hospitalized patients for at least 90 days as use of RRT has been reported up to 90 days after administration of hetastarch. Avoid fluid overload; adjust hetastarch dosage in patients with cardiac disease or renal impairment. Assess fluid status and rate of infusion regularly during treatment, especially in patients with cardiac insufficiency or severe kidney dysfunction. 

Voluven

Rx

Hetastarch IV colloid plasma expander; used for shock states; produces plasma expansion similar to albumin, dextran or hetastarch with electrolytes; has fewer antigenic properties than dextran.

Initially, 30—60 g (500—1000 mL) IV infusion. Do not exceed 1.2 g/kg (20 mL/kg) or 90 g (1500 mL) per day. A rate up to 1.2 g/kg/hour (20 mL/kg/hour) may be used in acute hemorrhagic shock. A slower rate is used in septic shock or burns.

See adult dosage. No specific dosage recommendations are available; associated renal dysfunction in elderly patients may reduce hetastarch clearance.

Initially, 10 mL/kg IV infusion (do not exceed 20 mL/kg/hour for hemorrhagic shock). Maximum dosage 20 mL/kg/day.

250—700 mL with added citrate anticoagulant is administered by aseptic addition to the input line of the centrifugation apparatus at a ratio of 1:8 to 1:13 to venous whole blood. Up to 2 procedures a week, and a total number of between 7 and 10 procedures have been used safely. NOTE: When stored at room temperature, hetastarch admixtures of 500—560 mL with citrate concentrations up to 2.5% are compatible for 24 hours.

Specific dosage guidelines are not available.

CrCl < 10 mL/min: The usual initial dose may be given, but subsequent doses should be reduced by about 25—50% of the usual dosage.

Dichlorphenamide: (Moderate) Use dichlorphenamide and hetastarch together with caution as both drugs can cause metabolic acidosis. Concurrent use may increase the severity of metabolic acidosis. Measure sodium bicarbonate concentrations at baseline and periodically during dichlorphenamide treatment. If metabolic acidosis occurs or persists, consider reducing the dose or discontinuing dichlorphenamide therapy.
Lithium: (Moderate) Moderate to significant dietary sodium changes, or changes in sodium and fluid intake, may affect lithium excretion. Systemic sodium chloride administration may result in increased lithium excretion and therefore, decreased serum lithium concentrations. In addition, high fluid intake may increase lithium excretion. For patients receiving sodium-containing intravenous fluids, symptom control and lithium concentrations should be carefully monitored. It is recommended that patients taking lithium maintain consistent dietary sodium consumption and adequate fluid intake during the initial stabilization period and throughout lithium treatment. Supplemental oral sodium and fluid should be only be administered under careful medical supervision.
Tolvaptan: (Moderate) Coadministration of tolvaptan and hypertonic saline (e.g., 3% NaCl injection solution) is not recommended. The use of hypertonic sodium chloride in combination with tolvaptan may result in a too rapid correction of hyponatremia and increase the risk of osmotic demyelination (i.e., central pontine myelinolysis).

Hetastarch, Sodium Chloride/Voluven Intravenous Inj Sol: 6-0.9%

1500 mL/day IV (or approximately 20 mL/kg/day IV).

1500 mL/day IV (or approximately 20 mL/kg/day IV).

20 mL/kg/day IV.

20 mL/kg/day IV.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Hetastarch produces volume expansion by increasing the oncotic pressure within the intravascular space. This mechanism is similar to both albumin and dextran. Administration of the colloidal mixture of hetastarch causes water to move from interstitial spaces into the intravascular space, thereby increasing the circulating blood volume. Intravenous infusion of hetastarch 6% solution results in expansion of plasma volume that decreases over the succeeding 24 to 36 hours. The degree of plasma volume expansion and improvement in hemodynamic state depend upon the patient's intravascular and cardiovascular status. In patients who are hypovolemic, this results in an increase in cardiac index, stroke work index, arterial and venous pressures, and pulmonary wedge pressures. Large volumes of hetastarch solution may transiently alter the coagulation mechanism due to hemodilution in addition to a mild direct inhibitory action on Factor VIII.
 
Hetastarch causes an increase in the erythrocyte sedimentation rate (ESR) when added to whole blood. This facilitates the collection of granulocytes by centrifugation. Compared with dextran 75, hetastarch causes a greater increase in the ESR.

Hetastarch is administered by intravenous infusion. It produces a volume expansion that is slightly greater than the administered volume, with maximum expansion occurring within minutes following cessation of infusion. Increases in plasma volume last for 24 hours or longer. Hetastarch molecules below 50,000 molecular weight are rapidly eliminated by renal excretion, about 33% of the dose is excreted in the urine within 24 hours. The hydroxyethyl groups present in hetastarch are not metabolized but are excreted intact (attached to the glucose residues). About 2 weeks after administration, the intravascular hetastarch concentration accounts for less than 10% of the total dose injected. Hetastarch is not eliminated by hemodialysis.

Hetastarch solution (Hespan) is classified as FDA pregnancy category C. Hetastarch has been shown to be embryocidal in animal studies; however, there are no adequate and well controlled studies in pregnant women. Hetastarch solutions should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether hetastarch is excreted in human milk. According to the manufacturer, because many drugs are excreted in human milk, caution should be exercised when hetastarch is administered to breast-feeding women. However, the very large molecular weight of hetastarch most likely limits the amount of drug that is excreted into breast milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.