Hetastarch in Sodium Chloride 6 g/100mL
HETASTARCH · INJECTION, SOLUTION · Hospira, Inc.
Hetastarch in Sodium Chloride is a injection, solution containing hetastarch at 6 g/100mL, taken intravenous. Manufactured by Hospira, Inc..
Key Facts
- Brand Name
- Hetastarch in Sodium Chloride
- Generic Name
- HETASTARCH
- NDC Code (Product)
0409-7248- Manufacturer
- Hospira, Inc.
- Strength
- 6 g/100mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BA740193
- Drug Class
- Plasma Volume Expander [EPC]
- Marketing Start
- 02/28/2005
Recall History
No Recall HistoryFull Prescribing Information
Indications & 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 is not a substitute for blood or plasma. The adjunctive use of 6% Hetastarch in 0.9% Sodium Chloride Injection in leukapheresis has also been shown to be safe and efficacious in improving the harvesting and increasing the yield of granulocytes by centrifugal means. • 6% Hetastarch in 0.9% Sodium Chloride Injection is a hetastarch indicated for treatment of hypovolemia when plasma volume expansion is desired in settings where adequate alternative treatment is unavailable. ( 1 ) • 6% Hetastarch in 0.9% Sodium Chloride Injection in leukapheresis has shown to be safe and efficacious in improving the harvesting and increasing the yield of granulocytes by centrifugal means. ( 1 )
Dosage & 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 infusion only. Total dosage and rate of infusion depend upon the amount of blood or plasma lost and the resultant hemoconcentration. For intravenous use only. Recommended Dosage Dose Adults ( 2.1 ) 500 to 1000 mL Leukapheresis ( 2.2 ) 250 to 700 mL of 6% Hetastarch in 0.9% Sodium Chloride Injection with citrate anticoagulant is added to the input line of the centrifugation apparatus. 2.1 Adults The 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 Leukapheresis 250 to 700 mL of 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 6% Hetastarch in 0.9% Sodium Chloride Injection and citrate should be…
Contraindications
4 CONTRAINDICATIONS Do not use HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, unless adequate alternative treatment is unavailable. • Do not use HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, unless adequate alternative treatment is unavailable.
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. • The safety and compatibility of other additives have not been established. • Use with caution with drugs that negatively influence the coagulation system. ( 7 ) • The safety and compatibility of other additives have not been established. ( 7 )
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 subjects. Clinical trials have also shown increased mortality and AKI in blunt trauma subjects. Increased coagulopathy was reported in surgical subjects. Most common adverse reactions are hypersensitivity, coagulopathy, hemodilution, circulatory overload and metabolic acidosis. • Most common adverse reactions are hypersensitivity, coagulopathy, hemodilution, circulatory overload and metabolic acidosis. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. (Note: All of the studies listed below used licensed HES products except for reference 4.) A randomized controlled trial (N=804) in severe sep…
Frequently Asked Questions
What is Hetastarch in Sodium Chloride used for?
Hetastarch in Sodium Chloride contains HETASTARCH. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Hetastarch in Sodium Chloride a controlled substance?
Hetastarch in Sodium Chloride is not classified as a controlled substance by the DEA.
What is the generic name for Hetastarch in Sodium Chloride?
The generic name for Hetastarch in Sodium Chloride is HETASTARCH. There are 1 other brand versions of HETASTARCH.
What is the NDC code for Hetastarch in Sodium Chloride 6 g/100mL?
The NDC (National Drug Code) for Hetastarch in Sodium Chloride 6 g/100mL is 0409-7248, listed by Hospira, Inc..