Hespan
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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 R2 and R3 are H or CH2CH2OH and R6 is H, CH2CH2OH, 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.
Sources
Hespan Manufacturers
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B. Braun Medical Inc.
![Hespan (Hetastarch In Sodium Chloride) Injection, Solution [B. Braun Medical Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Hespan | B. Braun Medical Inc.
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.
2.1 AdultsThe amount usually administered is 500 to 1000 mL. Doses of more than 1500 mL per day for the typical 70 kg patient (approximately 20 mL per kg of body weight) are usually not required. Higher doses have been reported in postoperative and trauma patients where severe blood loss has occurred [see Warnings and Precautions (5)].
2.2 Leukapheresis250 to 700 mL of HESPAN® (6% hetastarch in 0.9% sodium chloride injection) with citrate anticoagulant is administered by aseptic addition to the input line of the centrifugation apparatus at a ratio of 1:8 to 1:13 to venous whole blood. The HESPAN® and citrate should be thoroughly mixed to assure effective anticoagulation of blood as it flows through the leukapheresis machine.
2.3 Direction for use for HESPAN® Do not use plastic container in series connection. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use only if solution is clear and container and seals are intact. Intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Withdraw or expel all air from the bag through the medication port prior to infusion if administration is by pressure infusion.For single use only. Discard unused portion.
CAUTION: Before administering to the patient, review these directions:
Visual Inspection Do not remove the plastic infusion container from its overwrap until immediately before use. Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date. Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used. To Open Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If any leaks are found, discard solution as sterility may be impaired. Preparation for Administration Remove plastic protector from sterile set port at bottom of container. Attach administration set. Refer to complete directions accompanying set.When stored at room temperature, HESPAN® admixtures of 500-560 mL with citrate concentrations up to 2.5% were compatible for 24 hours. The safety and compatibility of additives other than citrate have not been established.
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Cardinal Health
Hespan | Cardinal Health
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.
2.1 AdultsThe amount usually administered is 500 to 1000 mL. Doses of more than 1500 mL per day for the typical 70 kg patient (approximately 20 mL per kg of body weight) are usually not required. Higher doses have been reported in postoperative and trauma patients where severe blood loss has occurred [see Warnings and Precautions (5)].
2.2 Leukapheresis250 to 700 mL of HESPAN® (6% hetastarch in 0.9% sodium chloride injection) with citrate anticoagulant is administered by aseptic addition to the input line of the centrifugation apparatus at a ratio of 1:8 to 1:13 to venous whole blood. The HESPAN® and citrate should be thoroughly mixed to assure effective anticoagulation of blood as it flows through the leukapheresis machine.
2.3 Direction for use for HESPAN® Do not use plastic container in series connection. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use only if solution is clear and container and seals are intact. Intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Withdraw or expel all air from the bag through the medication port prior to infusion if administration is by pressure infusion.For single use only. Discard unused portion.
CAUTION: Before administering to the patient, review these directions:
Visual Inspection Do not remove the plastic infusion container from its overwrap until immediately before use. Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date. Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used. To Open Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If any leaks are found, discard solution as sterility may be impaired. Preparation for Administration Remove plastic protector from sterile set port at bottom of container. Attach administration set. Refer to complete directions accompanying set.When stored at room temperature, HESPAN® admixtures of 500-560 mL with citrate concentrations up to 2.5% were compatible for 24 hours. The safety and compatibility of additives other than citrate have not been established.
![Hespan (Hetastarch In Sodium Chloride) Injection, Solution [Cardinal Health]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6d1c2560-f289-49a9-9471-71199492fd8e&name=6d1c2560-f289-49a9-9471-71199492fd8e-03.jpg)
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