Indication:
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
Hydroxyethyl starch 10% 18-07-2009
solution
For the treatment of imminent or manifest hypovalemia and shock
Hypovolemia
Adverse Reaction:
Vomiting, . mild temperature elevation, chills, itching,
submaxillary and parotid glandular enlargement, mild influenza -like symptoms,
headache, muscle pain, peripheral edema of the lower extremities,
allergic reactions
Contra-Indications:
Severe bleeding disorders, severe cardiac failure, renal failure, with oliguria or anuria
Special Precautions-
Blood/ plasma substitute - not a substitute for blood or plasma, as it does not have oxygen carrying
capacity or contain plasma proteins eg coagulation factors
Coagulation effects- large volumes may alter coagulation and result in transcient prolongation
of prothrombin time PT , partial thrombiplastin time, PTT , bleeding and clotting times, decreased
hemotocrit and excessive dilution of plasma proteins
Leukaphresis- slight decline in platelet count and hemoglobin levels have been observed in donors
undergoing repeated leukapheresis procedures due to volume expanding effects of hetastarch.
Hemoglobin levels normally return to normal within 24 hours.
Hypersensitivity reactions- anaphylactoid reactions ( periorbital edema, urticaria, wheezing)
have been reported . If these occur, discontinue the drug. If necessary give antihistamines
Special risks- the possibility of circulatory overload exists. Take special care in patients with
impaired renal clearance and when the risk of pulmonary edema or congestive heart failure is
increased. Use caution in liver disease.
Pregnancy- use only when clearly needed and when potential benefits outweigh the potential
hazards to the fetus.
Lactation- it is not known whether hetastarch is excreted in breast milk. Excercise caution
when adminstering to a breast- feeding woman.
Chidren- safety and efficacy have not been established
Monitoring- during leukapheresis monitor CBC, total leukocyte and platelet counts, leukocyte
differential count, hemoglobin, hemotocrit, PT and PTT
Dosages/ Overdosage Etc:
Indication-
Hypovolemia
Dosage-
Adult- the usual dosage is 500 to 1000ml. Total dosage does not usually exceed 1500ml/day
( 20ml/kg) . In acute hemorrhage shock rates approaching 20ml/kg/hr may be used
Pediatric dose- adequate well controlled clinical trials to establish the safety and effectiveness in
children have not been conducted.
In children including new borns to infants ( younger than 2 years ) a mean dose of 16+/- 9ml/kg
was administrered . The dosage should be adapted to the individual patient colloid needs,
taking into acount the disease state as well as the hemodynamic and hydration status
Pharmacology/ Pharmacokinetics:
Pharmacology-
Heatstarch (HES) is a complex mixture of ethoxylated anylopectin molecules of various sizes,
average molecular weight (MW) is 450,000 range ( 10,000 to more than 1 million)
Adding HES to whole blood increases the erythrocyte sedimentation rate and improves the
efficacy of granulocyte collection by centrifugal means.
Pregnancy and lactation:
Pregnancy-
Use only when clearly needed and when potential benefits outweigh the potential
hazards to the fetus.
Lactation-
It is not known whether hetastarch is excreted in breast milk. Excercise caution
when adminstering to a breast- feeding woman.
Chidren-
Safety and efficacy have not been established
Manufacturer Details