Action and Clinical Pharmacology

NIRHES contains Hydroxyethyl starch in a colloidal solution. which expands plasma volume when administered intravenously. The low molecular substitution (0.4) is the main pharmacological determinant for the beneficial effects of NIRHES on pharmacokinetics, intravascular volume and haemodilution. The pharmacokinetic profile of Hydroxyethyl Starch is complex and largely dependent on its molar substitution as well as its molecular weight. When administered intravenously molecules smaller than the renal threshold (60,000 – 70,000 Daltons) are readily and rapidly excreted in the urine, while molecules with higher weights are metabolized by plasma alpha-amylase prior to excretion via renal route following intravenous administration of 500ml Hydroxyethyl starch results in elimination in the urine of approximately 62% of the dose within 72 hrs.

Indications and Clinical Uses

When plasma volume expansion is desired as an adjunct in the treatment and prophylaxis of hypovolemia. It is not a substitute for red blood cells or coagulation factors in plasma.

Contraindications

In patients w/ known hypersensitivity to Hydroxyethyl starch,or with intracranial bleeding or with congestive heart failure where vol. overload is a potential problem.It shoud not be used in renal disease with oliguria or anuria not related to hypovolemia

Warning

Do not use HES solns in critically ill adult patients including those with sepsis and those admitted to the ICU. Avoid use in patients with pre-existing renal dysfunction .Discontinue use of HES at the first sign of renal injury.Need for renal replacement therapy has been reported up to 90 days after HES administration .Continue to monitor renal function for at least 90 days in all patients. Avoid use in patients undergoing open heart surgery in association with cardiopulmonary bypasss due to excess bleeding. Discontinue use of HES at the first sign of coagulopathy

Precautions

General : Anaphylactoid reactions (mild influenza symptoms bradycardia,tachycardia, brochospasm,non-cardiac pulmonary edema)have been reported with solutions. Containing Hydroxyethyl Starch. Fluid status rate o infusion should be assessed regularly during treatment especially in patients with cardiac insufficiency or severe kidney dysfunction.

Caution

Should be observed before administering NIRHES to patients with severe liver disease or severe bleeding disorders.

Pregnancy

It has been shown to cause embryocidal or other adverse effects in rats and rabbits when given in doses 1.7 times the human dose.There are no adequate and well controlled studies in pregnant women. Tetrastarch should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk,because many drugs are excreted in human milk,caution should be exercised when Tetrastarch is administered to a nursing woman.

Children

Hydroxyethyl starch may be given to premature infants and newborn only after a careful benefit evaluation .This safety and efficacy of Hydroxyethyl Starch have not been established in the age group of 2 to 12 yrs.

Renal Impairment

Hydroxyethyl starch is mainly excreted by the kidneys,and the risk of adverse reactions may be greater in patients w/ impaired renal function .Volume status infusion rate,and urine output should be closely monitored .Because elderly patients are more likely to have decreased renal function care should be taken in dose selection.

Adverse Reactions

Symptoms and Treatment of Overdose

Symptoms and Treatment of Overdose

As with all plasma volume substitutes overdosage can lead to overloading of the circulatory system (e.g. pulmonary edema).In this case the infusion should be stopped immediately and if necessary a diuretic should be administered

Dosage and Administration

The daily dose and rate of infusion depend on the patient’s blood loss on the maintenance of restoration of haemodynamics and on the haemodilution (dilution effect NIRHES can be administered repetitively over several days. The initial 10 to 20 ml should be infused slowly,keeping the patient under close observation due to possible anaphylactoid patient.

Adult dose: up to 50ml of NIRHES per kg of body weight per day.This dose is equivalent to 3500ml of NIRHES for a 70 kg patient.

Pediatric Dose

Limited critical data on the use of Hydroxyethyl starch in children are available in 41 children including newborns to infants(< 2years)a mean dose of 16+ 9ml /kg was administered. The dosage in children should be adapted to the individual patient colloid needs taking into account the disease state as well as the haemodynamic, and hydration status. The safety and efficacy have not been established in the age group of 2 to 12 years. Parenteral products shouldcbe inspected for particulate matter and discoloration prior to administration wherever solution and container permit.

Special Instructions

Caution Before administering to patient review these directions.

Visual Checking

1. Do not remove the plastic infusion container from its overwrap until immediately before use.
2. while the overwrap is intact,identify the solution,lot number and expiration date
3. Check that the solution is clear
4. Inspect the intact unit for signs of obvious damage,if present the unit should not be used

Removal of overwrap : To open overwrap Tear at any notch located at either end of unit.After removing overwrap,check for minte leaks b squeezing container firmly,if leaks are found,discard unit as sterility may be impaired.

Preparation for Administration (use aseptic technique)

Close flow control clamp of administration set.Insert spike of infusion set into port with twisting motion until the set is firmly sealed.Suspend container from hanger.Follow manufacturer’s recommended procedures for the administration set.

Discontinue administration and notify physician immediately if patient exhibits signs of adverse reactions.

Storage

Store below 30C Do not freeze.Protect from light.

Presentation

500ml Non -PVC Bag