ISUPREL Solution for injection Ref.[8252] Active ingredients: Isoprenaline

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2019  Publisher: Pfizer New Zealand Limited, P O Box 3998, Auckland, New Zealand, 1140, Toll Free Number: 0800 736 363

Therapeutic indications

Isuprel is indicated for:

  1. Mild or transient episodes of heart block that do not require electric shock or pacemaker therapy.
  2. Serious episodes of heart block and Adams-Stokes attacks (except when caused by ventricular tachycardia of fibrillation). (see section 4.3).
  3. Use in cardiac arrest until electric shock or pacemaker therapy, the treatments of choice, are available. (see section 4.3).
  4. Bronchospasm occurring during anaesthesia.
  5. As an adjunct to fluid and electrolyte replacement therapy and the use of other medicines and procedures in the treatment of hypovolaemic and septic shock, low cardiac output (hypoperfusion) states, congestive heart failure, and cardiogenic shock. (see section 4.4).

Posology and method of administration

Isuprel can be administered by the intravenous, intramuscular, subcutaneous or intracardiac routes.

Isuprel should generally be started at the lowest recommended dose and the rate of administration gradually increased if necessary while carefully monitoring the patient. The usual route of administration is by intravenous infusion or bolus intravenous injection. In dire emergencies, the medicine may be administered by intracardiac injection. If time is not of the utmost importance, initial therapy by intramuscular or subcutaneous injection is preferred.

Elderly patients may be more sensitive to the effects of sympathomimetics and lower doses may be required.

Adults

Recommended Dosage for adults with shock and hypoperfusion states:

Route of AdministrationPreparation of Dilution+Infusion Rate++
Intravenous infusionDilute 5mL (1mg) in 500mL of 5% Glucose Injection, BP0.5 mcg to 5mcg per minute (0.25mL to 2.5mL) of diluted solution.

+ Concentrations up to 10 times greater have been used when limitation of volume is essential.
++ Rates over 30mcg per minute have been used in advanced stages of shock. The rate of infusion should be adjusted on the basis of heart rate, central venous pressure, systemic blood pressure, and urine flow. If the heart rate exceeds 110 beats per minute, it may be advisable to decrease or temporarily discontinue the infusion.

Recommended dosage for adults with heart block, Adams-Stokes attacks, and cardiac arrest:

Route of AdministrationPreparation of dilutionInitial doseSubsequent administration dose range*
Bolus intravenous injectionDilute 1mL of solution 1:5000 (0.2mg) to 10mL with Sodium Chloride Injection BP, or 5% Glucose, Injection, BP0.02mg to 0.06mg (1mL to 3mL of diluted solution 1:50,000)0.01mg to 0.2mg (0.5mL to 10mL of diluted solution)
Intravenous infusionDilute 10mL of solution 1:5000 (2mg) in 500mL of 5% Glucose Injection, BP5mcg/min (1.25mL of diluted solution 1:250,000 per minute) 
IntramuscularUse Solution 1:5000 undiluted0.2mg (1mL)0.02mg to 1mg (0.1mL to 5mL)
SubcutaneousUse Solution 1:5000 undiluted0.2mg (1mL)0.15mg to 0.2mg (0.75mL to 1mL)
IntracardiacUse Solution 1:5000 undiluted0.02mg (0.1mL) 

* Subsequent dosage and method of administration depend on the ventricular rate and the rapidity with which the cardiac pacemaker can take over when the medicine is gradually withdrawn.

Recommended dosage for adults with bronchospasm occurring during anaesthesia:

Route of administrationPreparation of DilutionInitial DoseSubsequent Dose Range*
Bolus intravenous injectionDilute 1mL (0.2mg) to 10mL with sodium chloride injection, BP, or 5% glucose Injection, BP0.01mg to 0.02mg (0.5mL to 1mL of dilute solution)The initial dose may be repeated when necessary

* Subsequent dosage and method of administration depend on the ventricular rate and the rapidity with which the cardiac pacemaker can take over when the medicine is gradually withdrawn.

Paediatric population

There are no well-controlled studies in children to establish appropriate dosing; however, the American Heart Association recommends an initial infusion rate of 0.1mcg/kg/min, with the usual range being 0.1mcg/kg/min to 1.0mcg/kg/min.

Adequacy and safety of intravenous isoprenaline in children are not established. Based on published literature, the initial dose of intravenous isoprenaline used in children is not established. Based on published literature, the initial dose of intravenous isoprenaline used in children (age 7 to 19 years of age) ranges between 0.05 to 0.17mcg/kg/min, which is increased gradually by 0.1 to 0.2mcg/kg/min at intervals of 15 to 20 minutes, titrated to clinical response; a maximum dose ranging between 1.3 to 2.7mcg/kg/min has been used. In children generally, post-operative cardiac patients with bradycardia require lower doses (0.029 ± 0.002mcg/kg/min) of intravenous isoprenaline than asthma patients (0.5 ± 0.21mcg/kg/min).

Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit. Such solution should not be used.

Do not administer unless solution is clear and container is undamaged. Discard unused portion.

Overdose

The acute toxicity of isoprenaline in animals is much less than that of adrenaline. Excessive doses in animals or man can cause a striking drop in blood pressure, and repeated large doses in animals may result in cardiac enlargement and focal myocarditis.

In case of accidental overdosage as evidenced mainly by the tachycardia or other arrhythmias, palpitations, angina, hypotension, or hypertension, reduce rate of administration or discontinue Isuprel until patients condition stabilises. Blood pressure, pulse, respiration and ECG should be monitored.

Very cautious use of a non-selective beta receptor antagonist should be considered if symptoms are very severe but close monitoring of airway function would be essential.

It is not known whether Isuprel is dialysable.

For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).

Shelf life

Shelf life: 18 months.

Special precautions for storage

Store below 25°C. Protect from Light.

Nature and contents of container

Injection, 200 microgram/1 mL ampoules: 25’s; 1 mg/5 mL ampoules: 10’s.

Special precautions for disposal and other handling

Any unused medicine or waste material should be disposed of in accordance with local requirements.

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