It is not known whether this drug is excreted in human milk, so caution should be exercised. If a mother requires dobutamine treatment, breast feeding should be discontinued for the duration of treatment.

4.7 Effects on ability to drive and use machines
Patients should not drive or operate machinery if experiencing any ill effects.

4.8 Undesirable effects
Effects on the cardiovascular system are complex. Stimulation of alpha-adrenergic receptors produces vasoconstriction with resultant hypertension. Dobutamine may cause a marked increase in heart rate or blood pressure. Hypertensive patients can develop marked systolic hypertension. The rise in blood pressure may produce cerebral haemorrhage and pulmonary oedema. There may also be a reflex bradycardia but stimulation of β1-adrenergic receptors of the heart may cause tachycardia, palpitations, ectopic heart beats and cardiac arrhythmias, anginal pain and cardiac arrest.

Because dobutamine facilitates atrioventricular conduction, patients with atrial fibrillation may be at risk of developing a rapid ventricular response. If rapid ventricular rates occur in the presence of obstructive coronary artery disease, myocardial ischaemia may be induced or exacerbated.

Occasionally hypotension with dizziness and fainting and flushing may occur due to vasodilation, and, as with other catecholamines, serum potassium could be reduced.

Other side effects include nausea, vomiting, headache, anxiety, paraesthesias, non-specific chest pain, eosinophilic myocarditis, shortness of breath, myocardial infarction, coronary artery spasm and reactions suggestive of hypersensitivity including rash, fever, eosinophilia, bronchospasm and local cellulitis at the site of infusion. Pruritus of the scalp has been reported. Extravasation of parenterally administered catecholamines may result in tissue necrosis and sloughing. Phlebitis has occasionally been reported at the site of infusion. Partial tolerance may develop with infusions over more than 72 hours, requiring dosage increase. There is the potential for psychosis to occur as a rare side effect of dobutamine. There is also the potential for urinary urgency to occur during infusion of relatively high doses (15 micrograms/kg/minute) of dobutamine.

Paediatric population

The undesirable effects include elevation of systolic blood pressure, systemic hypertension or hypotension, tachycardia, headache, and elevation of pulmonary wedge pressure leading to pulmonary congestion and edema and symptomatic complaints.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
4.9 Overdose
a) Symptoms

Nausea, vomiting, anxiety, palpitations, headache, shortness of breath and anginal and non-specific chest pain. Urinary incontinence has been reported.

Hypertension (which may be systolic and severe), tachyarrhythmias, myocardial ischaemia and ventricular fibrillation due to positive inotropic and chronotropic effects and hypotension resulting from vasodilation.

b) Treatment

Since the half-life of dobutamine is only a