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Hetastarch in Sodium Chloride
Overview
What is HESPAN?
HESPAN® (6% hetastarch in 0.9% sodium chloride injection) is a sterile, nonpyrogenic solution for intravenous administration.
Each 100 mL contains:
Hetastarch.................................................. 6 g
Sodium Chloride, USP............................... 0.9 g
Water for Injection, USP............................. qs
pH adjusted with Sodium Hydroxide, NF if necessary
Concentration of Electrolytes (mEq/L): Sodium 154, Chloride 154
pH: approximately 5.9 with negligible buffering capacity
Calc. Osmolarity: approximately 309 mOsM
Hetastarch is a synthetic 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 and erythrocyte sedimenting agent. 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 molecular weight is approximately 600,000 with a range of 450,000 to 800,000 and with at least 80% of the polymers falling within the range of 20,000 to 2,600,000. Hydroxyethyl groups are attached by ether linkage primarily at C-2 of the glucose unit and to a lesser extent at C-3 and C-6. The polymer resembles glycogen, and the polymerized D-glucose units are joined primarily by α-1,4 linkages with occasional α-1,6 branching linkages.
The chemical name for hetastarch is hydroxyethyl starch.
The structural formula is as follows:
Amylopectin derivative in which R and Rare H or CHCHOH and R is H, CHCHOH, or a branching point in the starch polymer connected through an α-1,6 link to additional D-glucopyranosyl units.
HESPAN® is a clear, pale yellow to amber solution. Exposure to prolonged adverse storage conditions may result in a change to a turbid deep brown or the formation of a crystalline precipitate. Do not use the solution if these conditions are evident.
Not made with natural rubber latex, PVC or DEHP.
The plastic container is made from a multi-layered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.
The closure system has two ports; the one for the administration set has a tamper evident plastic protector.
What does HESPAN look like?
What are the available doses of HESPAN?
Single-use container:
What should I talk to my health care provider before I take HESPAN?
How should I use HESPAN?
HESPAN® is indicated in the treatment of hypovolemia when plasma volume expansion is desired. It is not a substitute for blood or plasma.
The adjunctive use of HESPAN® in leukapheresis has also been shown to be safe and efficacious in improving the harvesting and increasing the yield of granulocytes by centrifugal means.
Dosage for Acute Use in Plasma Volume Expansion
HESPAN® is administered by intravenous infusion only. Total dosage and rate of infusion depend upon the amount of blood or plasma lost and the resultant hemoconcentration.
What interacts with HESPAN?
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What are the warnings of HESPAN?
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What are the precautions of HESPAN?
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What are the side effects of HESPAN?
Sorry No records found
What should I look out for while using HESPAN?
Do not use hydroxyethyl starch (HES) products, including HESPAN®, in critically ill adult patients, including patients with sepsis, due to increased risk of mortality and renal replacement therapy (RRT). ()
Do not use HES products, including HESPAN®, in patients with severe liver disease ()
Do not use HES products, including HESPAN®, in patients with known hypersensitivity to hydroxyethyl starch ()
Do not use HES products, including HESPAN®, in clinical conditions where volume overload is a potential problem. ()
Do not use HES products, including HESPAN®, in patients with pre-existing coagulation or bleeding disorders ()
WARNING: MORTALITY RENAL REPLACEMENT THERAPY
What might happen if I take too much HESPAN?
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How should I store and handle HESPAN?
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).HESPAN® (6% hetastarch in 0.9% sodium chloride injection) is supplied sterile and nonpyrogenic in 500 mL EXCEL® Containers packaged 12 per case.NDC REF Volume Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.HESPAN® (6% hetastarch in 0.9% sodium chloride injection) is supplied sterile and nonpyrogenic in 500 mL EXCEL® Containers packaged 12 per case.NDC REF Volume Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.HESPAN® (6% hetastarch in 0.9% sodium chloride injection) is supplied sterile and nonpyrogenic in 500 mL EXCEL® Containers packaged 12 per case.NDC REF Volume Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.HESPAN® (6% hetastarch in 0.9% sodium chloride injection) is supplied sterile and nonpyrogenic in 500 mL EXCEL® Containers packaged 12 per case.NDC REF Volume Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.HESPAN® (6% hetastarch in 0.9% sodium chloride injection) is supplied sterile and nonpyrogenic in 500 mL EXCEL® Containers packaged 12 per case.NDC REF Volume Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.HESPAN® (6% hetastarch in 0.9% sodium chloride injection) is supplied sterile and nonpyrogenic in 500 mL EXCEL® Containers packaged 12 per case.NDC REF Volume Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.HESPAN® (6% hetastarch in 0.9% sodium chloride injection) is supplied sterile and nonpyrogenic in 500 mL EXCEL® Containers packaged 12 per case.NDC REF Volume Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.HESPAN® (6% hetastarch in 0.9% sodium chloride injection) is supplied sterile and nonpyrogenic in 500 mL EXCEL® Containers packaged 12 per case.NDC REF Volume Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.HESPAN® (6% hetastarch in 0.9% sodium chloride injection) is supplied sterile and nonpyrogenic in 500 mL EXCEL® Containers packaged 12 per case.NDC REF Volume Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The plasma volume expansion produced by HESPAN® approximates that of 5% Albumin (Human). Intravenous infusion of HESPAN® results in expansion of plasma volume.
Non-Clinical Toxicology
Do not use hydroxyethyl starch (HES) products, including HESPAN®, in critically ill adult patients, including patients with sepsis, due to increased risk of mortality and renal replacement therapy (RRT). ()Do not use HES products, including HESPAN®, in patients with severe liver disease ()
Do not use HES products, including HESPAN®, in patients with known hypersensitivity to hydroxyethyl starch ()
Do not use HES products, including HESPAN®, in clinical conditions where volume overload is a potential problem. ()
Do not use HES products, including HESPAN®, in patients with pre-existing coagulation or bleeding disorders ()
WARNING: MORTALITY RENAL REPLACEMENT THERAPY
Many drugs affect thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to Levothyroxine sodium tablets, USP. In addition, thyroid hormones and thyroid status have varied effects on the pharmacokinetics and actions of other drugs. A listing of drug-thyroidal axis interactions is contained in Table 2.
The list of drug-thyroidal axis interactions in Table 2 may not be comprehensive due to the introduction of new drugs that interact with the thyroidal axis or the discovery of previously unknown interactions. The prescriber should be aware of this fact and should consult appropriate reference sources (e.g., package inserts of newly approved drugs, medical literature) for additional information if a drug-drug interaction with levothyroxine is suspected.
Drug-Food Interactions
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Pregnancy - Category A
Hypothyroidism during pregnancy is associated with a higher rate of complications, including spontaneous abortion, pre-eclampsia, stillbirth and premature delivery. Maternal hypothyroidism may have an adverse effect on fetal and childhood growth and development. During pregnancy, serum T levels may decrease and serum TSH levels increase to values outside the normal range. Since elevations in serum TSH may occur as early as 4 weeks gestation, pregnant women taking Levothyroxine sodium tablets, USP should have their TSH measured during each trimester. An elevated serum TSH level should be corrected by an increase in the dose of Levothyroxine sodium tablets, USP. Since postpartum TSH levels are similar to preconception values, the Levothyroxine sodium tablets, USP dosage should return to the pre-pregnancy dose immediately after delivery. A serum TSH level should be obtained 6-8 weeks postpartum.
Thyroid hormones cross the placental barrier to some extent as evidenced by levels in cord blood of athyreotic fetuses being approximately one-third maternal levels. Transfer of thyroid hormone from the mother to the fetus, however, may not be adequate to prevent hypothyroidism.
Nursing Mothers
Avoid use in patients with pre-existing renal dysfunction ()
Discontinue use of HESPAN® at the first sign of renal injury ()
Continue to monitor renal function in hospitalized patients for at least 90 days as use of RRT has been reported up to 90 days after administration of HES products, including HESPAN® ()
HESPAN® is not recommended for use as a cardiac bypass pump prime, while the patient is on cardiopulmonary bypass, or in the immediate period after the pump has been discontinued because of the risk of increasing coagulation abnormalities and bleeding in patients whose coagulation status is already impaired. Discontinue use of HESPAN® at first sign of coagulopathy ()
Monitor liver function in patients receiving HES products, including HESPAN® ()
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, coagulopathy, hemodilution, circulatory overload and metabolic acidosis.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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