6% Hetastarch In 0.9% Sodium Chloride

Brand Names: 6% Hetastarch In 0.9% Sodium Chloride

Drug Class: Plasma Volume Expander

Overview

11 DESCRIPTION 6% Hetastarch in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic solution for intravenous administration. Each 100 mL contains: Hetastarch............................................................................ 6 g Sodium Chloride, USP........................................................ 0.9 g Water for Injection, USP.................................................

Mechanism of Action

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The plasma volume expansion produced by 6% Hetastarch in 0.9% Sodium Chloride Injection approximates that of 5% Albumin (Human). Intravenous infusion of 6% Hetastarch in 0.9% Sodium Chloride Injection results in expansion of plasma volume. 12.2 Pharmacodynamics 6% Hetastarch in 0.9% Sodium Chloride Injection 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 status. 12.3 Pharmacokinetics Hetastarch molecules below 50,000 molecular weight are rapidly eliminated by renal excretion. A single dose of approximately 500 mL of 6% Hetastarch in 0.

Indications

  • 1 INDICATIONS AND USAGE 6% Hetastarch in 0.9% Sodium Chloride Injection is indicated in the treatment of hypovolemia when plasma volume expansion is desired. It is not a substitute for blood or plasma. The adjunctive use of 6% Hetastarch in 0.9% Sodium Chloride Injection in leukapheresis has also been shown to be safe and efficacious in improving the harvesting and increasing the yield of granulocytes by centrifugal means.

Common Doses

  • 1000 mL
  • 1500 mL
  • 20 mL
  • 700 mL

Dosage

2 DOSAGE & ADMINISTRATION Dosage for Acute Use in Plasma Volume Expansion 6% Hetastarch in 0.9% Sodium Chloride Injection is administered by intravenous infusion only. Total dosage and rate of infusion depend upon the amount of blood or plasma lost and the resultant hemoconcentration. 2.1 Adults The amount usually administered is 500 to 1000 mL. Doses of more than 1500 mL per day for the typical 70 kg patient (approximately 20 mL per kg of body weight) are usually not required.

Black Box Warning

BOXED WARNING BOXED WARNING

Contraindications

  • 4 CONTRAINDICATIONS Do not use hydroxyethyl starch (HES) products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, in critically ill adult patients, including patients with sepsis, due to increased risk of mortality and renal replacement therapy (RRT). • Do not use HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, in patients with severe liver disease • Do not use HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, in patients with known hypersensitivity to hydroxyethyl starch • Do not use HES products, including 6% Hetastarch in 0.

Side Effects

  • 6 ADVERSE REACTIONS The serious adverse events reported in clinical trials are increased mortality and renal replacement therapy renal in critically ill patients. Most common adverse reactions are hypersensitivity, coagulopathy, hemodilution, circulatory overload and metabolic acidosis. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Interactions

  • 7 DRUG INTERACTIONS 6% Hetastarch in 0.9% Sodium Chloride Injection should be used with caution in patients who have been anticoagulated with other drugs that negatively influence the coagulation system. • The safety and compatibility of other additives have not been established.