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HETASTARCH (6% hetastarch in 0.9% sodium chloride injection)
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HETASTARCH Quick Finder
WARNING: MORTALITY
RENAL REPLACEMENT THERAPY
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- In critically ill adult patients, including patients with sepsis, use of hydroxyethyl starch (HES) products, including 6% Hetastarch in 0.9% Sodium Chloride...
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...
2 DOSAGE AND ADMINISTRATION
Dosage for Acute Use in Plasma Volume Expansion
6% Hetastarch in 0.9% Sodium Chloride Injection is administered by intravenous...
3 DOSAGE FORMS AND STRENGTHS
Single-use container:
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- 30 g hetastarch in 500 mL of 0.9% sodium chloride injection.
4 CONTRAINDICATIONS
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- 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...
5 WARNINGS AND PRECAUTIONS
5.1 Renal Dysfunction
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- Avoid use in patients with pre-existing renal dysfunction
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- Discontinue use of 6% Hetastarch in 0.9...
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,...
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...
11 DESCRIPTION
6% Hetastarch in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic solution for intravenous administration.
Each 100 mL contains:
Hetastarch...
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%...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies of animals have not been performed to evaluate the carcinogenic...
14 CLINICAL STUDIES
Surgical Patients Comparative Studies
In randomized, controlled, comparative studies of 6% Hetastarch in 0.9% Sodium Chloride Injection (n=92...
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. ...
16 HOW SUPPLIED/STORAGE AND HANDLING
6% Hetastarch in 0.9% Sodium Chloride Injection is supplied sterile and nonpyrogenic in 500 mL single-use flexible plastic containers.
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