Hydroxyethyl starch 200 (Solution) Instructions for Use
ATC Code
B05AA07 (Hydroxyethyl starch)
Active Substance
Pentastarch
Pentastarch (USAN)
Clinical-Pharmacological Group
Plasma substitute
Pharmacotherapeutic Group
Blood substitutes and perfusion solutions; blood products and related agents; blood substitutes and plasma protein fractions
Pharmacological Action
A plasma-substituting agent, hydroxyethyl starch (HES). HES is a high-molecular-weight compound consisting of polymerized glucose residues, obtained by hydroxyethylation of amylopectin – a natural polysaccharide contained in potato starch and waxy corn starch. Amylopectin is rapidly hydrolyzed in the blood; its presence in the bloodstream is about 20 min. To increase stability and duration of action, amylopectin is subjected to hydroxyethylation. The depth of this process is characterized by the degree of substitution.
The intensity and duration of the volume-substituting effect of HES preparations are determined by the molecular weight and degree of substitution of the HES substance. The higher the degree of substitution, the longer HES remains in the circulating blood. With a C2/C6 ratio greater than 8, HES is metabolized in the body significantly slower than with a ratio of less than 8.
Pentastarch has a molecular weight of about 200,000 daltons and a degree of substitution of about 0.5; the C2/C6 ratio, which determines the substitution features, is 6.
It improves the rheological properties of blood by reducing hematocrit, decreases plasma viscosity, reduces erythrocyte aggregation, and promotes the restoration of impaired microcirculation.
It is deposited in the cells of the reticuloendothelial system (RES), which has no clinical significance.
Pharmacokinetics
After IV infusion, pentastarch undergoes intensive metabolism, breaking down (under the action of serum amylase) into low-molecular-weight fragments. Metabolites with a molecular weight of less than 50,000 daltons are rapidly excreted by the kidneys. About 70% of the dose is excreted in the urine within 24 hours and about 80% within a week.
Indications
As a plasma-substituting agent for hypovolemia and shock associated with surgical interventions, injuries, infectious diseases, and burns; microcirculation disorders; therapeutic hemodilution.
ICD codes
| ICD-10 code | Indication |
| I98.8 | Other specified disorders of circulatory system in diseases classified elsewhere |
| R57.0 | Cardiogenic shock |
| R57.1 | Hypovolemic shock |
| R57.2 | Septic shock |
| R57.8 | Other types of shock |
| T78.2 | Anaphylactic shock, unspecified |
| T79.4 | Traumatic shock |
| ICD-11 code | Indication |
| 1G41 | Sepsis with septic shock |
| 4A84.30 | Exercise-induced anaphylaxis |
| 4A84.31 | Cold-induced anaphylaxis |
| 4A84.3Z | Anaphylaxis caused by unspecified physical factors |
| 4A84.4 | Anaphylaxis caused by inhalation of allergens |
| 4A84.5 | Anaphylaxis caused by contact with allergens |
| 4A84.6 | Secondary anaphylaxis in mast cell disease |
| 4A84.Z | Anaphylaxis, unspecified |
| BE2Y | Other specified diseases of the circulatory system |
| MG40.0 | Cardiogenic shock |
| MG40.1 | Hypovolemic shock |
| MG40.Z | Shock, unspecified |
| NF0A.4 | Traumatic shock, not elsewhere classified |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Solution
It is established individually, depending on the severity of hemodynamic disorders and the clinical situation. The daily dose and infusion rate are calculated based on the amount of blood loss, hemoglobin, and hematocrit levels. Administered IV, by drip.
The minimum effective dose should be used. Treatment should be carried out with constant hemodynamic monitoring; upon reaching the target hemodynamic parameters, the infusion should be stopped.
Adverse Reactions
From the blood coagulation system: very common – decreased hematocrit and development of dilutional hypoproteinemia; common (frequency depends on the administered dose) – increased bleeding time and aPTT, decreased levels of coagulation factor VIII complex and von Willebrand factor.
From the immune system: very rare – anaphylactic reactions of varying severity.
From the skin and subcutaneous tissues: rare – persistent but reversible skin itching.
From the liver and biliary tract: frequency not established – liver damage.
From the urinary system: rare – pain in the kidney area; frequency not established – impaired renal function.
From laboratory parameters: common – increased activity of plasma alpha-amylase, not associated with impaired pancreatic function; possible – changes in the concentration of glucose, protein, fatty acids, cholesterol, sorbitol dehydrogenase in plasma, ESR, biuret test, specific gravity of urine.
Contraindications
Hypersensitivity to HES; burns, sepsis, intracranial hypertension, arterial hypertension, ongoing intracranial or intracerebral bleeding, chronic heart failure, renal failure or renal replacement therapy, severe hepatic failure, pulmonary edema, condition after organ transplantation, overhydration, hypervolemia, dehydration, severe coagulopathy, severe hyperchloremia or severe hypernatremia, hypokalemia, hemodialysis; children and adolescents under 18 years of age; first trimester of pregnancy.
Do not use in open-heart surgery under cardiopulmonary bypass.
Contraindicated for use in intensive care patients (usually in the intensive care unit).
With caution compensated chronic heart failure, chronic liver diseases, coagulation disorders, von Willebrand disease, hemorrhagic diathesis, hypofibrinogenemia, patients who have undergone surgery and/or have trauma, elderly age, second and third trimesters of pregnancy; breastfeeding period.
Use in Pregnancy and Lactation
Contraindicated in the first trimester of pregnancy. In the second and third trimesters of pregnancy, use is possible only for vital indications, in cases where the potential benefit to the mother outweighs the potential risk to the fetus. When using pentastarch during pregnancy, it is necessary to consider the risk of anaphylactic reactions and the possible risk of fetal brain damage. If it is necessary to use during lactation, the issue of discontinuing breastfeeding should be decided.
Use in Hepatic Impairment
Contraindicated in severe hepatic failure. Should be used with caution in chronic liver diseases.
Use in Renal Impairment
Contraindicated in renal failure or during renal replacement therapy.
Pediatric Use
Contraindicated for use in children and adolescents under 18 years of age.
Geriatric Use
Should be used with caution in elderly patients (over 65 years of age). To prevent complications from the cardiovascular system and kidneys caused by hypervolemia, elderly patients require careful dose selection and monitoring during treatment.
Special Precautions
To prevent complications from the cardiovascular system and kidneys caused by hypervolemia, elderly patients, who are more likely to have heart and/or renal failure, require careful dose selection and monitoring during treatment.
Particular caution should be exercised when using HES solutions in patients with coagulation disorders, with impaired liver function. The appropriateness of using HES for the treatment of hypovolemia should be carefully assessed and hemodynamic parameters should be monitored to control the achievement of the necessary effect and determine the HES dose. Volume overload associated with overdose of the agent or high infusion rate should be avoided. The dose must be selected with caution, especially in patients with lung and cardiovascular diseases.
High doses of pentastarch should be avoided in patients with hypovolemia due to possible marked hemodilution. In case of repeated use of pentastarch, blood coagulation parameters should be carefully monitored.
If hypersensitivity reactions develop, the administration of pentastarch should be stopped immediately and necessary emergency measures should be taken. Patients should be under continuous medical supervision; additional therapeutic measures should be taken depending on the patients’ condition.
When using pentastarch, blood volume, electrolyte concentration, leukocytes, platelets, hemoglobin, and blood coagulation parameters should be monitored. At the first signs of coagulopathy, the use of the agent should be discontinued.
In open-heart surgery associated with cardiopulmonary bypass, there is an increased risk of bleeding, so the use of HES is contraindicated.
Before starting and during the use of HES, it is necessary to check renal function, constantly monitor serum creatinine levels, water-electrolyte balance, as well as urine retention indicators. At the first signs of kidney damage during treatment, the use of pentastarch should be discontinued. Monitoring of renal function should be carried out for 90 days after the use of pentastarch (risk of kidney damage in the long term).
Impaired renal function during therapy with HES solution may worsen the initial hepatic failure (with portal hypertension) and may lead to mechanical obstruction of the bile ducts.
During treatment, it is necessary to ensure sufficient fluid intake (at least 2-3 liters of fluid per day).
When treating patients whose blood type is not established, it should be borne in mind that the administration of large volumes of HES may complicate the interpretation of agglutination reaction results.
Pentastarch may give a positive result in doping control.
Drug Interactions
With simultaneous use with aminoglycosides, the risk of nephrotoxicity increases, so it is recommended to avoid simultaneous long-term use of pentastarch and aminoglycosides.
With simultaneous use with anticoagulants, an increase in bleeding time is possible.
Pentastarch is incompatible with solutions of other medicinal products.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Infusion solution 6%: bottle 200, 400, or 500 ml.
Marketing Authorization Holder
Kraspharma, PJSC (Russia)
Dosage Form
 |
Hydroxyethyl starch 200 | Infusion solution 6%: bottle 200, 400, or 500 ml. |
Dosage Form, Packaging, and Composition
| Infusion solution 6% | 100 ml |
| Pentastarch | 6 g |
200 ml – glass bottles (10) – cardboard boxes.
400 ml – glass bottles (10) – cardboard boxes.
500 ml – glass bottles (10) – cardboard boxes.
200 ml – glass bottles.
200 ml – glass bottles (24) – cardboard boxes.
400 ml – glass bottles.
400 ml – glass bottles (12) – cardboard boxes.
500 ml – glass bottles.
500 ml – glass bottles (1) – cardboard packs.
500 ml – glass bottles (12) – cardboard boxes.
Infusion solution 6%: bottle 200 ml, 250 ml, or 400 ml
Marketing Authorization Holder
Kursk Biofactory – Firm "BIOK", FKP (Russia)
Dosage Form
|
Hydroxyethyl starch 200 | Infusion solution 6%: bottle 200 ml, 250 ml, or 400 ml |
Dosage Form, Packaging, and Composition
Infusion solution colorless or light yellow, colorless, transparent or slightly opalescent.
| 1 L | |
| Hydroxyethyl starch 200/0.5 (pentastarch 200) | 60 g |
Excipients : sodium chloride – 9 g, water for injections – up to 1 L.
Theoretical osmolarity – 308 mOsm/L.
200 ml – blood bottles with a capacity of 250 ml (1) – cardboard packs.
200 ml – blood bottles with a capacity of 250 ml (1) – cardboard packs.
400 ml – blood bottles with a capacity of 450 ml (1) – cardboard packs.
Infusion solution 6%: 200 ml, 250 ml, 400 ml, 500 ml, or 1000 ml containers
Infusion solution 10%: 200 ml, 250 ml, 400 ml, 500 ml, or 1000 ml containers
Marketing Authorization Holder
Avexima Siberia LLC (Russia)
Dosage Forms
|
Hydroxyethyl starch 200/0.5 | Infusion solution 6%: 200 ml, 250 ml, 400 ml, 500 ml, or 1000 ml containers |
| Infusion solution 10%: 200 ml, 250 ml, 400 ml, 500 ml, or 1000 ml containers |
Dosage Form, Packaging, and Composition
Infusion solution transparent or slightly opalescent, colorless or light yellow in color.
| 1 L | |
| Hydroxyethyl starch 200/0.5 | 60 g |
Excipients : sodium chloride – 9 g, water for injections – up to 1 L.
Theoretical osmolarity 308.0 mOsmol/L.
200 ml – containers (1) – bags (1) – cardboard boxes.
250 ml – containers (1) – bags (1) – cardboard boxes.
400 ml – containers (1) – bags (1) – cardboard boxes.
500 ml – containers (1) – bags (1) – cardboard boxes.
1000 ml – containers (1) – bags (1) – cardboard boxes.
Infusion solution transparent or slightly opalescent, colorless or light yellow in color.
| 1 L | |
| Hydroxyethyl starch 200/0.5 | 100 g |
Excipients : sodium chloride – 9 g, water for injections – up to 1 L.
Theoretical osmolarity 308.2 mOsmol/L.
200 ml – containers (1) – bags (1) – cardboard boxes.
250 ml – containers (1) – bags (1) – cardboard boxes.
400 ml – containers (1) – bags (1) – cardboard boxes.
500 ml – containers (1) – bags (1) – cardboard boxes.
1000 ml – containers (1) – bags (1) – cardboard boxes.
Infusion solution 6%: bottle 100 ml, 200 ml, 250 ml, 400 ml, or 500 ml
Infusion solution 10%: bottle 100 mL, 200 mL, 250 mL, 400 mL, or 500 mL
Marketing Authorization Holder
IST-Pharm, LLC (Russia)
Dosage Forms
|
Hydroxyethyl starch 200/0.5 | Infusion solution 6%: bottle 100 ml, 200 ml, 250 ml, 400 ml, or 500 ml |
| Infusion solution 10%: bottle 100 mL, 200 mL, 250 mL, 400 mL, or 500 mL |
Dosage Form, Packaging, and Composition
Infusion solution colorless or light yellow, transparent or slightly opalescent.
| 1 L | |
| Hydroxyethyl starch 200/0.5 (with an average molecular weight of 200000 Da and a degree of substitution of 0.5) | 60 g |
Excipients : sodium chloride – 9 g, water for injections – up to 1 L.
Theoretical osmolarity – 308 mOsm/L.
100 ml – polyethylene bottles (1) – bags (1) – cardboard packs.
200 ml – polyethylene bottles (1) – bags (1) – cardboard packs.
250 ml – polyethylene bottles (1) – bags (1) – cardboard packs.
400 ml – polyethylene bottles (1) – bags (1) – cardboard packs.
500 ml – polyethylene bottles (1) – bags (1) – cardboard packs.
100 ml – polyethylene bottles (1) – bags (1) (for hospitals).
200 ml – polyethylene bottles (1) – bags (1) (for hospitals).
250 ml – polyethylene bottles (1) – bags (1) (for hospitals).
400 ml – polyethylene bottles (1) – bags (1) (for hospitals).
500 ml – polyethylene bottles (1) – bags (1) (for hospitals).
100 ml – polyethylene bottles (1) (1-96 pcs.) – bags (1) – cardboard boxes (for hospitals).
200 ml – polyethylene bottles (1) (1-96 pcs.) – bags (1) – cardboard boxes (for hospitals).
250 ml – polyethylene bottles (1) (1-96 pcs.) – bags (1) – cardboard boxes (for hospitals).
400 ml – polyethylene bottles (1) (1-96 pcs.) – bags (1) – cardboard boxes (for hospitals).
500 ml – polyethylene bottles (1) (1-96 pcs.) – bags (1) – cardboard boxes (for hospitals).
Infusion solution colorless or light yellow, transparent or slightly opalescent.
| 1 L | |
| Hydroxyethyl starch 200/0.5 (with an average molecular weight of 200,000 Da and a degree of substitution of 0.5) | 100 g |
Excipients: sodium chloride – 9 g, water for injections – up to 1 L.
Theoretical osmolarity – 308 mOsm/L.
100 ml – polyethylene bottles (1) – bags (1) – cardboard packs.
200 ml – polyethylene bottles (1) – bags (1) – cardboard packs.
250 ml – polyethylene bottles (1) – bags (1) – cardboard packs.
400 ml – polyethylene bottles (1) – bags (1) – cardboard packs.
500 ml – polyethylene bottles (1) – bags (1) – cardboard packs.
100 ml – polyethylene bottles (1) – bags (1) (for hospitals).
200 ml – polyethylene bottles (1) – bags (1) (for hospitals).
250 ml – polyethylene bottles (1) – bags (1) (for hospitals).
400 ml – polyethylene bottles (1) – bags (1) (for hospitals).
500 ml – polyethylene bottles (1) – bags (1) (for hospitals).
100 ml – polyethylene bottles (1) (1-96 pcs.) – bags (1) – cardboard boxes (for hospitals).
200 ml – polyethylene bottles (1) (1-96 pcs.) – bags (1) – cardboard boxes (for hospitals).
250 ml – polyethylene bottles (1) (1-96 pcs.) – bags (1) – cardboard boxes (for hospitals).
400 ml – polyethylene bottles (1) (1-96 pcs.) – bags (1) – cardboard boxes (for hospitals).
500 ml – polyethylene bottles (1) (1-96 pcs.) – bags (1) – cardboard boxes (for hospitals).
Infusion solution 6% bottle 250 ml or 500 ml.
Infusion solution 10% bottle 250 ml or 500 ml.
Marketing Authorization Holder
PFC Alium, LLC (Russia)
Dosage Forms
|
Hydroxyethyl starch 200-Alium | Infusion solution 6% bottle 250 ml or 500 ml. |
| Infusion solution 10% bottle 250 ml or 500 ml. |
Dosage Form, Packaging, and Composition
Infusion solution colorless or light yellow, transparent or slightly opalescent.
| 1 L | |
| Hydroxyethyl starch 200/0.5 | 60 g |
Excipients: sodium chloride – 9 g, water for injections up to 1 L.
Theoretical osmolarity value 308 mOsm/L.
250 ml – plastic bottles (1) – cardboard packs.
500 ml – plastic bottles (1) – cardboard packs.
250 ml – plastic bottles (1) (1/40) – cardboard boxes (for hospitals).
500 ml – plastic bottles (1) (1/40) – cardboard boxes (for hospitals).
Infusion solution colorless or light yellow, transparent or slightly opalescent.
| 1 L | |
| Hydroxyethyl starch 200/0.5 | 100 g |
Excipients: sodium chloride – 9 g, water for injections up to 1 L.
Theoretical osmolarity value 309 mOsm/L.
250 ml – plastic bottles (1) – cardboard packs.
500 ml – plastic bottles (1) – cardboard packs.
250 ml – plastic bottles (1) (1/40) – cardboard boxes (for hospitals).
500 ml – plastic bottles (1) (1/40) – cardboard boxes (for hospitals).
![Hydroxyethyl starch 200 [Solution] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Hydroxyethyl starch 200 [Solution] 2")