A great variability has been noted between paediatric patients in regard to both the plasma concentration necessary to initiate a hemodynamic response (threshold) and the rate of hemodynamic response to increasing plasma concentrations, which demonstrates that the required dose for children cannot be determined a priori and should be titrated in order to allow for the supposedly smaller “therapeutic width” in children.

Method of administration

For continuous intravenous infusion using an infusion pump, dilute to a concentration of 0.5 to 1mg/mL (max 5mg/mL if fluid restricted) with Glucose 5% or Sodium Chloride 0.9%. Infuse higher concentration solutions through central venous catheter only. Dobutamine intravenous infusion is incompatible with bicarbonate and other strong alkaline solutions.

Neonatal intensive care: Dilute 30mg/kg body weight to a final volume of 50mL of infusion fluid. An intravenous infusion rate of 0.5mL/hour provides a dose of 5 micrograms/kg/minute.

4.3 Contraindications
Previous hypersensitivity to dobutamine, sodium metabisulphite or other ingredients.

Sulphites may cause hypersensitivity reactions including anaphylactic symptoms and life-threatening or serious asthmatic attacks in those affected. Hypersensitivity is observed more frequently in asthmatic or atopic patients.

Avoid the use of sympathomimetic agents in patients with phaeochromocytoma.

4.4 Special warnings and precautions for use
In general, sympathomimetic agents should be used with caution in patients who may be particularly susceptible to their effects, particularly those with hyperthyroidism. Great care is also needed in patients with cardiovascular disease such as ischaemic heart disease, acute heart failure, arrhythmia or tachycardia, occlusive vascular disorders including arteriosclerosis, hypertension or aneurysms. Anginal pain may be precipitated in patients with ischaemic heart disease, particularly after myocardial infarction. Care is also required when sympathomimetic agents are given to patients with diabetes mellitus or closed angle glaucoma.

In particular, dobutamine should be avoided or used only with great caution in patients with marked obstruction of cardiac ejection, such as idiopathic hypertrophic subaortic stenosis. It may exacerbate pre-existing tachycardia and hypertension. Metabolic acidosis, hypoxia, hypercapnia and hypovolaemia should be corrected before and during dobutamine treatment. Use with caution in cardiogenic shock complicated by severe hypotension.

If an undue increase in heart rate or systolic blood pressure occurs during administration of dobutamine, or an arrhythmia is precipitated, the dose should be reduced or interrupted.

Special care should be taken with the use of dobutamine in the elderly.

Tolerance may occur with continuous infusions of dobutamine over more than 72 hours.

Paediatric population

Dobutamine has been administered to children with low-output hypoperfusion states resulting from decompensated heart failure, cardiac surgery, and cardiogenic and septic shock. Some of the haemodynamic effects of dobutamine hydrochloride may be quantitatively or qualitatively different in children as compared to adults. Increments in heart rate and blo