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HETASTARCH (6% hetastarch in 0.9% sodium chloride injection)

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HETASTARCH Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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WARNING: MORTALITY; KIDNEY INJURY; COAGULOPATHY

  • Use of hydroxyethyl starch (HES) products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, increases risk of
    • Mortality...
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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 in settings where adequate alternative treatment is unavailable. It...

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2 DOSAGE AND ADMINISTRATION

Dosage for Acute Use in Plasma Volume Expansion

6% Hetastarch in 0.9% Sodium Chloride Injection is administered by intravenous...

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3 DOSAGE FORMS AND STRENGTHS

Single-dose container:

30 g hetastarch in 500 mL of 0.9% sodium chloride injection.
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4 CONTRAINDICATIONS

Do not use HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, unless adequate alternative treatment is unavailable.

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5 WARNINGS AND PRECAUTIONS

5.1 Mortality and Renal Dysfunction

  • Critically ill patients, including patients with sepsis, are at increased risk of mortality and...
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6 ADVERSE REACTIONS

Serious adverse reactions reported in postmarket clinical trials include increased mortality and AKI (including need for RRT) in critically ill subjects, including subjects with sepsis, and surgical...

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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.

...
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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Hetastarch has been shown to have an embryocidal effect on New Zealand rabbits when given intravenously over the entire...

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11 DESCRIPTION

6% Hetastarch in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic solution for intravenous administration.

Each 100 mL contains:
Hetastarch...

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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%...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies of animals have not been performed to evaluate the carcinogenic...

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14 CLINICAL STUDIES

Surgical Patients Comparative Studies

In randomized, controlled, comparative studies of 6% Hetastarch in 0.9% Sodium Chloride Injection (n=92...

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15 REFERENCES

  1. Knutson JE., et al., Does Intraoperative Hetastarch Administration Increase Blood Loss and Transfusion Requirements After Cardiac Surgery? Anesthesia Analg., 2000;90:801–7....
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16 HOW SUPPLIED/STORAGE AND HANDLING

6% Hetastarch in 0.9% Sodium Chloride Injection is supplied sterile and nonpyrogenic in 500 mL single-dose flexible plastic containers.

...
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