1. Name of the medicinal product
Dobutamine 12.5mg/ml Concentrate for Solution for Infusion

2. Qualitative and quantitative composition
Dobutamine Hydrochloride 14.01 mg/ml equivalent to dobutamine 12.5mg/ml.

Each 12.5mg of dobutamine sterile concentrate contains 0.06 mg of sodium.

3. Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate).

4. Clinical particulars
4.1 Therapeutic indications
Dobutamine is indicated in adults as inotropic support in the short term treatment of conditions characterised by low output cardiac failure, e.g. myocardial infarction, open heart surgery, cardiomyopathies, septic shock and cardiogenic shock. It can also increase or maintain cardiac output during positive end expiratory pressure (PEEP) ventilation.

Paediatric population

Dobutamine is indicated in all paediatric age groups (from neonates to 18 years of age) as inotropic support in low cardiac output hypoperfusion states resulting from decompensated heart failure, following cardiac surgery, cardiomyopathies and in cardiogenic or septic shock.

4.2 Posology and method of administration
Dobutamine is administered by continuous intravenous infusion due to the short half life of dobutamine. The solution must first be diluted to at least 50ml in an iv container with one of the following intravenous solutions:

Sodium Chloride Intravenous Infusion BP

5% Glucose Intravenous Infusion BP

5% Glucose + 0.9% Sodium Chloride Intravenous Infusion BP

5% Glucose + 0.45% Sodium Chloride Intravenous Infusion BP

Sodium Lactate Intravenous Infusion BP

20ml Dobutamine Sterile Concentrate will yield the following concentrations when diluted:

In 250ml:
 1000 micrograms/ml of dobutamine
 
In 500ml:
 500 micrograms/ml of dobutamine
 
In 50ml:
 5,000 micrograms/ml (only appropriate in patients on restricted fluid intake, for administration by infusion pump for accuracy of dosing).
 

The prepared solution should be used within 24 hours.

After dilution, dobutamine should be administered intravenously through an intravenous needle or catheter. An iv drip chamber or other suitable metering device is essential for controlling the rate of flow in drops per minute.

Adults, including the elderly:

Cardiac failure:-

The usual infusion rate is 2.5 to 10 micrograms per kg body weight per minute, according to the patient's heart rate, blood pressure, urine output, and if available cardiac output. Doses ranging from 0.5 up to 40 micrograms per kg body weight per minute have been used.

It is recommended that treatment with dobutamine should be discontinued gradually.

Paediatric population

For all paediatric age groups (neonates to 18 years) an initial dose of 5 micrograms/kg/minute, adjusted according to clinical response to 2–20 micrograms/kg/minute is recommended. Occasionally, a dose as low as 0.5-1.0 micrograms/kg/minute will produce a response.

There is reason to believe that the minimum effective dosage for children is higher than for adults. Caution should be taken in applying high doses, because there is also a reason to believe that the maximum tolerated dosage for children is lower than the one for adults. Most adverse reactions (tachycardia in particular) are observed when dosage was higher than/equal to 7.5 micrograms/kg/