HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
Did you find an answer to your question?
Yes
No
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
HETASTARCH (6% hetastarch in 0.9% sodium chloride injection)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
HETASTARCH Quick Finder
Highlights
Boxed Warning
WARNING: MORTALITY; KIDNEY INJURY; COAGULOPATHY
- Use of hydroxyethyl starch (HES) products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, increases risk of
- Mortality...
Did you find an answer to your question?
Yes
No
Indications and Usage
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...
Did you find an answer to your question?
Yes
No
Dosage and Administration
2 DOSAGE AND ADMINISTRATION
Dosage for Acute Use in Plasma Volume Expansion
6% Hetastarch in 0.9% Sodium Chloride Injection is administered by intravenous...
Did you find an answer to your question?
Yes
No
Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Single-dose container:
- •
- 30 g hetastarch in 500 mL of 0.9% sodium chloride injection.
Did you find an answer to your question?
Yes
No
Contraindications
4 CONTRAINDICATIONS
Do not use HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, unless adequate alternative treatment is unavailable.
Did you find an answer to your question?
Yes
No
Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Mortality and Renal Dysfunction
- Critically ill patients, including patients with sepsis, are at increased risk of mortality and...
Did you find an answer to your question?
Yes
No
Adverse Reactions
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...
Did you find an answer to your question?
Yes
No
Drug 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.
- • ...
Did you find an answer to your question?
Yes
No
Use in Specific Populations
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...
Did you find an answer to your question?
Yes
No
Description
11 DESCRIPTION
6% Hetastarch in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic solution for intravenous administration.
Each 100 mL contains:
Hetastarch...
Did you find an answer to your question?
Yes
No
Clinical Pharmacology
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%...
Did you find an answer to your question?
Yes
No
Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies of animals have not been performed to evaluate the carcinogenic...
Did you find an answer to your question?
Yes
No
Clinical Studies
14 CLINICAL STUDIES
Surgical Patients Comparative Studies
In randomized, controlled, comparative studies of 6% Hetastarch in 0.9% Sodium Chloride Injection (n=92...
Did you find an answer to your question?
Yes
No
References
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....
Did you find an answer to your question?
Yes
No
How Supplied/Storage and Handling
...
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.
Did you find an answer to your question?
Yes
No
Did you find an answer to your question?
Yes
No
Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.