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HETASTARCH (6% hetastarch in 0.9% sodium chloride injection)
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HETASTARCH Quick Finder
WARNING: MORTALITY; KIDNEY INJURY; COAGULOPATHY
- Use of hydroxyethyl starch (HES) products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, increases risk of
- Mortality...
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...
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-dose container:
- •
- 30 g hetastarch in 500 mL of 0.9% sodium chloride injection.
4 CONTRAINDICATIONS
Do not use HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, unless adequate alternative treatment is unavailable.
5 WARNINGS AND PRECAUTIONS
5.1 Mortality and Renal Dysfunction
- Critically ill patients, including patients with sepsis, are at increased risk of mortality and...
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...
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.
- • ...
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
- 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-dose flexible plastic containers.
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