HEXTEND- hetastarch injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HETASTARCH (UNII: 875Y4127EA) (HETASTARCH - UNII:875Y4127EA)

Available from:

Hospira, Inc.

INN (International Name):

HETASTARCH

Composition:

HETASTARCH 6 g in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

HEXTEND (6% Hetastarch in Lactated Electrolyte Injection) is indicated in the treatment of hypovolemia when plasma volume expansion is desired in settings where adequate alternative treatment is unavailable. It is not a substitute for blood or plasma. Do not use HES products, including HEXTEND, unless adequate alternative treatment is unavailable.

Product summary:

HEXTEND (6% Hetastarch in Lactated Electrolyte Injection) is supplied sterile and nonpyrogenic in 500 mL single-dose flexible plastic infusion containers. Unit of Sale Volume/Container Each NDC 0409-1555-54 Case containing 12 500 mL NDC 0409-1555-64 Single-dose Flexible Container Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C/77°F); however, brief exposure up to 40°C does not adversely affect the product. References: To Open Tear overwrap down at notch and remove solution container. Check for any leakage by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired. Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container that is suspect should not be used. Distributed by: Hospira, Inc., Lake Forest, IL 60045 USA LAB-1288-2.0 Revised: 10/2021

Authorization status:

New Drug Application

Summary of Product characteristics

HEXTEND- HETASTARCH INJECTION, SOLUTION
HOSPIRA, INC.
----------
HEXTEND RX
ONLY
6% HETASTARCH IN LACTATED ELECTROLYTE INJECTION
FLEXIBLE PLASTIC CONTAINER
WARNING: MORTALITY; KIDNEY INJURY; COAGULOPATHY
•
DO NOT USE HES PRODUCTS, INCLUDING HEXTEND, UNLESS ADEQUATE
ALTERNATIVE TREATMENT IS UNAVAILABLE.
HEXTEND (6% Hetastarch in Lactated Electrolyte Injection) is a
sterile, nonpyrogenic
solution for intravenous administration. The composition, pH, and
osmolarity are given in
Table 1 and the electrolyte composition in Table 2.
TABLE 1
Each 100 mL contains
Hetastarch
6 g
Sodium Chloride, USP
672 mg
Sodium Lactate Anhydrous, USP
317 mg
Dextrose Hydrous, USP
99 mg
Calcium Chloride Dihydrate, USP
37 mg
Potassium Chloride, USP
22 mg
Magnesium Chloride Hexahydrate, USP
9 mg
Water for Injection, USP
qs
pH: approximately 5.9 with negligible buffering capacity
Calculated Osmolarity: approximately 307 mOsM
TABLE 2
Concentration of Electrolytes (mEq/L)
Sodium
143
Chloride
124
Lactate
28
Calcium
5
Potassium
3
Magnesium
0.9
HEXTEND (6% Hetastarch in Lactated Electrolyte Injection) is an
artificial colloidal
solution, pharmacologically classified as a plasma volume expander,
and is intended to
support oncotic pressure as well as provide electrolytes.
HEXTEND contains high molecular weight hetastarch at a concentration
of 6% as an
oncotic agent to permit retention of intravascular fluid until the
hetastarch is replaced by
blood proteins. Hetastarch is an artificial colloid derived from a
waxy starch composed
almost entirely of amylopectin. Hydroxyethyl ether groups are
introduced into the
glucose units of the starch, and the resultant material is hydrolyzed
to yield a product
with a molecular weight suitable for use as a plasma volume expander.
Hetastarch is
characterized by its molar substitution and also by its molecular
weight. The molar
substitution is approximately 0.75 which means hetastarch has an
average of
approximately 75 hydroxyethyl groups for every 100 glucose units. The
weight average
®
USE OF HYDROXYETHYL STARCH