Dobutamine is metabolised in the liver and other tissues by catechol-O-methyltransferase to an inactive compound, 3-O-methyldobutamine, and by conjugation with glucuronic acid. Conjugates of dobutamine and 3-O-methyldobutamine are excreted mainly in urine and to a minor extent in faeces.

Paediatric population

In most paediatric patients, there is a log-linear relationship between plasma dobutamine concentration and hemodynamic response that is consistent with a threshold model.

Dobutamine clearance is consistent with first-order kinetics over the dosage range of 0.5 to 20 micrograms/kg/minute. Plasma dobutamine concentration can vary as much as two-fold between paediatric patients at the same infusion rate and there is a wide variability in both the plasma dobutamine concentration necessary to initiate a hemodynamic response and the rate of hemodynamic response to increasing plasma concentrations. Therefore, in clinical situations dobutamine infusion rates must be individually titrated.

5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to those included in other sections.

6. Pharmaceutical particulars
6.1 List of excipients
Sodium metabisulphite

Water for injections

3M Hydrochloric acid

3M Sodium hydroxide

6.2 Incompatibilities
Because of potential physical incompatibilities, it is recommended that dobutamine not be mixed with other drugs in the same solution.

Do not add dobutamine to 5% sodium bicarbonate intravenous infusion or to any other strongly alkaline solutions.

Dobutamine hydrochloride should not be used in conjunction with other agents or diluents containing both sodium bisulphite and ethanol.

6.3 Shelf life
24 months

6.4 Special precautions for storage
Protect from light.

Store below 25°C.

If not required immediately, the diluted solution may be stored for up to 24 hours in a refrigerator. Solutions of dobutamine may turn pink over time due to slight oxidation. This does not affect the potency of the product.

6.5 Nature and contents of container
Neutral glass ampoules containing 5ml, 10ml or 20ml of solution. The ampoules are packed into cartons containing 1, 5 or 10 ampoules.

6.6 Special precautions for disposal and other handling
Refer to Section 4.2

7. Marketing authorisation holder
Wockhardt UK Ltd

Ash Road North

Wrexham

LL13 9UF

UK

8. Marketing authorisation number(s)
PL 29831/0075
9. Date of first authorisation/renewal of the authorisation
3 March 2008

10. Date of revision of the text
13/10/2014