Tetrastarch

Registered South African indications:

• Acute hypovolaemia associated with trauma and/or surgery

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to hydroxyethyl starches
• Renal impairment (eGFR <10ml/min/1.73m²)
  - Patients receiving dialysis treatment
• Renal failure with oliguria or anuria not due to hypovolaemia
• Critically ill patients with or without sepsis/ septicaemia
• Severe burns
• Moderate to severe dehydration
• Overhydration, with or without pulmonary oedema
• Congestive cardiac failure
• Intracranial bleeding
• Severe hypernatraemia, hyperkalaemia or hyperchloraemia
• Pre-existing bleeding or coagulation disorders

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment (eGFR ≥11-89mlml/min/1.73m²)
• Severe hepatic impairment (Child-Pugh Class C)
• Elderly
• Clinically relevant renal injury
• Organ transplant patients
• Cardiac dysfunction
• Cardiac insufficiency
• Treatment duration >24hrs
• Severe electrolyte imbalances, such as hypermagnesaemia
• Metabolic alkalosis and clinical situations where alkalisation should be avoided
• Patients undergoing open-heart surgery in association with cardiopulmonary bypass

Forms avail. in SA and covered in this monograph: inf

Acute hypovolaemia associated with trauma and/or surgery (additional agent required)

• IV: Infusion amount and rate to be determined by severity of hypovolaemia; Max: 30ml/kg/24hrs; Max duration: 24hrs

To be used in conjunction with crystalloids to restore haemodynamic stability

Tetrastarch is administered by IV infusion only

The dose and rate of infusion depend on the patient’s blood loss, on the maintenance or restoration of haemodynamics and on the haemodilution (dilution effect)

The initial 10–20 ml should be infused slowly. Keep the patient under close observation for the possibility of anaphylactic/ anaphylactoid reactions

The underlying cause of the hypovolaemia should be corrected and the patient should be continuously monitored

Forms avail. in SA and covered in this monograph: inf

Acute hypovolaemia associated with trauma and/or surgery (additional agent required)

Younger than 1 month

• Not recommended for use

Between 1 month-12 years

• IV: Infusion amount and rate to be determined by severity of hypovolaemia; Max: 15ml/kg/24hrs; Max duration: 24hrs

Older than 12 years

• See adult dosage

To be used in conjunction with crystalloids to restore haemodynamic stability

Tetrastarch is administered by IV infusion only

The dose and rate of infusion depend on the patient’s blood loss, on the maintenance or restoration of haemodynamics and on the haemodilution (dilution effect)

The initial 10–20 ml should be infused slowly. Keep the patient under close observation for the possibility of anaphylactic/ anaphylactoid reactions

The underlying cause of the hypovolaemia should be corrected and the patient should be continuously monitored

Pregnancy

• Caution
• Safety in pregnancy has not been established
• Information on the use of tetrastarch during labour or delivery is unknown with the exception of caesarean section

Breastfeeding

• Caution
• It is not known whether tetrastarch is excreted in human breastmilk
• Caution should be exercised when tetrastarch is administered to a woman who is breastfeeding her baby

Renal Impairment

• eGFR ≥30-89ml/min/1.73m²: Caution; no dose adjustment recommended
• eGFR ≥11-29ml/min/1.73m²: Caution; dose adjustment recommended 
  Reduce the recommended dose by 50%
  Close monitoring for renal function and urinary output. If oliguria or anuria reported, then discontinue
• eGFR <10ml/min/1.73m²: Contraindicated

Hepatic Impairment

• Mild to moderate (Child-Pugh Classes A & B): No dose adjustment recommended
  Closely monitor signs of fluid overload like oedema and ascites
• Severe (Child-Pugh Class C): Caution; no dose adjustment recommended
  Use with high caution. Discontinue in patients with ascites, sacral or pedal oedema, and dyspnoea (pulmonary effusion)

Elderly

• Caution; no information available
  Not recommended for use in patients >65 years due to insufficient data on safety and efficacy in this age group

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Prohibited - At all times

Gastrointestinal Disorders

• Increased serum amylase

Skin and Subcutaneous Tissue Disorders

• Pruritus

Immune, Blood and Lymphatic System Disorders

• Disturbances of blood coagulation
  - Increased haemorrhage
• Anaphylactic/ anaphylactoid reactions
  - Hypersensitivity
  - Influenza-like symptoms
  - Bradycardia
  - Tachycardia
  - Bronchospasm
  - Non-cardiac pulmonary oedema
• Dilution of blood components, such as coagulation factors and other plasma proteins
• Decreased haematocrit

• Agents causing potassium or sodium retention

• Blood pressure
• Heart rate
• Capillary refill time
• Central venous pressure
• Right arterial pressure
• Mean arterial pressure
• Pulmonary capillary wedge pressure
• Systemic vascular resistance
• Pulmonary vascular resistance
• Urine output
• Fluid balance
• Serum electrolytes
• Renal function
• Hepatic function
• Acid-base balance
• Haemoglobin
• Haematocrit
• Coagulation parameters
• Plasma proteins

Some cases may require

• Cardiac index

Interference with laboratory tests

• Elevated serum amylase levels may be observed following administration of the product and can interfere with the diagnosis of pancreatitis
• At high dosages the dilutional effects may result in decreased levels of coagulation factors and other plasma proteins and a decrease in haematocrit

Incompatibilities

• The mixing with other medicines should be avoided
• If, in exceptional cases, a mixture with other medicines is required, care should be taken with the compatibility (clouding or precipitation), hygienic injection and good admixture

Tetrastarch, a hydroxyethyl starch, is an artificial colloid for volume replacement. Its pharmacological properties depend on the molar substitution by hydroxyethyl groups (0,4), the mean molecular weight (130 000 Da), the concentration (6 %), the substitution ratio (C2/C6 ratio) of approximately 9:1 as well as the dosage and infusion rate.

COMBINATION PREPARATIONS

Poly (O-2-hydroxyethyl) starch / Sodium chloride

Infusion (per 1000ml)  60g/9g

• Voluven (Fresenius Kabi) originator

Infusion (per 1000ml) 60g/6.02g

• Volulyte (Fresenius Kabi) originator