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
Indications-
Shock - Adjunct for plasma volume expansion in shock due to hemorrhage ,
burns, sepsis, or other trauma
Leukapheresis- Adjunct to improve harvesting and increase yield of granulocytes
Adverse Reaction:
Vomiting- mild temperature elevation , chills, itching,
submaxillary and paratiodglandular enlargement,
mild influenza -like sympoms, headache,
muscle pain, peripheral edema of lower extremities,
allergic reactions
Contra-Indications:
Warnings-
Blood plasma substitutes- Not a substitute for blood plasma as it does not
have oxygen-carrying capacity or contains proteins ( eg coagulation factors)
Coagulation effects-Large volumes may alter coagulation and may result in
transcient prolongation of prothrombin (PTI) partial thromboplastin time(PTT)
bleeding and clotting times, decreased hematocrit and excessive dilution
of plasma proteins.
Leukapheresis- slight decline in platelet count and hemoglobin levels have
been observed in donors undergoing repeated leukapheresis procedures
due to to volume expanding effect of hetastach. Hemoglobin levels usually
returns to normal within 24 hours. Hemodilution by hetastach and saline may
also resilt in 24 hour declines of total protein.albumin, and fibronogen values
Hypersensitivity- Anaphyloid reactions (periorbital edema, urticaria, wheezing)
have been reported. If these occur, discontinue the drug. If necessary , give
antihistamines .Also use caution when administering HES to a person allergic to corn.
Precautions-
Monitoring- During leukapheresis, monitor CBC, total leukocyte and platelet counts,
leukocyte diiferential count, hemoglobin, hemotocrit, PT and PTT
Special Risk patients- The possibility of circulatory overloada, exists. Take special
care in patients with impaired renal clearance and when the risk of pulmnary edema or
congestive heart failure is increased. Indirect bilirubin levels increased in two subjects
receiving multiple infusions: levels returened to normal by 96 hours after infusion. Total
bilirubin remained normal.
Obseve caution in liver disease.
Dosages/ Overdosage Etc:
Indications-
Shock - Adjunct for plasma volume expansion in shock due to hemorrhage ,
burns, sepsis, or other trauma
Leukapheresis- Adjunct to improve harvesting and increase yield of granulocytes
Administration and dosage-
Administer IV infusion only. Total dosage and rate of infusion depend upon the
amount of blood lost andthr resultant hemoconcentration
Plasma volume expansion - The usual amonut of 500 to 1000ml. The total dosage
does not usually exceed 1500ml/day (20ml/kg). In acute hemorrhage shock, rates
approaching 20ml/kg/hour may be used.
Leukapheresis- In continuous flow centrifugation (CFC) procedures , 250 to 700ml
is typically infused at a constant fixed ration of 1:8 to 1:3 to venous to whole blood
Storage and stabilty - Store at room temperature not exceedding 40C (104F).
Do not freeze . Do not freeze . Do not use if solution is turbid deep brown or if
crystalline precipitate forms
Pregnancy and lactation:
Pregnancy-
Catogery C- Safety for use has not been established. Use only when clearly needed
and when potential benefits outweigh potential hazard to the fetus.
Lactation-
It is not know whether hetastach is excreted in breast milk. Excercise caution when
administering to a nursing woman.
Children-
Sfety and efficacy have not been established
