Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Hameln pharma plus gmbh,Langes Feld 13,31789 Hameln, Germany
Dobutamine must not be used in the case of:
Dobutamine must not be used for detection of myocardial ischaemia and of viable myocardium in case of:
Note: If administering atropine, the respective contraindications have to be observed.
Dobutamine must not be used for the treatment of patients with bronchial asthma who are hypersensitive to sulfites.
A local increase or decrease of coronary blood flow, which may have an impact on the myocardial oxygen demand, has been observed with dobutamine therapy. The clinical characteristics of patients with severe coronary heart disease may deteriorate, in particular if dobutamine therapy is accompanied by a considerable increase in the heart rate and/or blood pressure. Therefore, as with all positive inotropes, the decision to use dobutamine to treat patients with cardiac ischaemia must be made for each case individually.
Due to the risk of arrhythmias and the uncertainty about long term effects on myocardial dysfunction, inotropic agents, such as dobutamine, should be used with caution in the treatment of Acute Heart Failure (AHF).
As alterations in serum potassium level may occur, the potassium level should be monitored.
If dobutamine is administered continuously for more than 72 hours, tolerance phenomena (tachyphylaxis) may occur, requiring dosage increase.
Precipitous decreases in blood pressure (hypotension) have occasionally been described in association with dobutamine therapy. Decreasing the dose or discontinuing the infusion, typically results in rapid return of blood pressure to baseline values, but rarely intervention may be required and reversibility may not be immediate.
Dobutamine may interfere with HPLC determination of chloramphenicol.
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 blood pressure appear to be more frequent and intense in children. Pulmonary wedge pressure may not decrease in children, as it does in adults, or it may actually increase, especially in infants less than one year old. The neonate cardiovascular system has been reported to be less sensitive to dobutamine and hypotensive effect seems to be more often observed in adult patients than in small children.
Accordingly, the use of dobutamine in children should be monitored closely, bearing in mind these pharmacodynamic characteristics.
Because of possible life-threatening complications, the administration of dobutamine for stress echocardiography should only be undertaken by a physician with sufficient personal experience of the use of dobutamine for this indication.
Dobutamine stress echocardiography must be discontinued if one of the following diagnostic endpoints occurs:
In the event of serious complications (see section 4.8) dobutamine stress echocardiography must be stopped immediately.
Dobutamine contains sodium metabisulfite (E223), which may rarely cause allergic reactions (hypersensitivity) and asthma-like symptoms (bronchospasm).
After termination of infusion, patients must be monitored until stabilised.
Via competitive receptor inhibition, the sympathomimetic effect of dobutamine can be reduced by simultaneous administration of a beta receptor blocker. In addition, the alpha agonistic effects may cause peripheral vasoconstriction with a consequent increase in blood pressure.
With simultaneous alpha-receptor blockade, the predominating beta-mimetic effects may cause tachycardia and peripheral vasodilatation.
Simultaneous administration of dobutamine and primarily venous acting vasodilators (e.g. nitrates, sodium nitroprusside) may cause a greater increase of cardiac output as well as a more pronounced decrease of peripheral resistance and ventricular filling pressure than administration of one of the individual substances alone.
Administering dobutamine to diabetic patients may cause increased insulin demand. In diabetic patients insulin levels should be checked when starting dobutamine therapy, changing the rate of infusion and discontinuing the infusion. If necessary the insulin dose must be adjusted as required.
Simultaneous administration of high doses of dobutamine with ACE inhibitors (e.g. captopril) may cause an increase in cardiac output, accompanied by increased myocardial oxygen consumption. Chest pain and rhythm disturbances have been reported in this context.
Dobutamine combined with dopamine causes – depending on the dopamine dosage and in contrast to its sole administration – a more distinct increase of blood pressure as well as a decrease or no change of ventricular filling pressure.
Sodium metabisulfite is a very reactive compound. It must therefore be assumed that thiamine (vitamin B1) co-administered with the preparation is catabolised.
Caution should be exercised when administering dobutamine with inhaled anaesthetics, since concomitant use may increase the excitability of the myocardium and the risk of ventricular extrasystoles.
In the case of anti-anginal therapy, in particular heart rate lowering agents like beta-blockers, the ischaemic reaction to stress is less pronounced or may be nonexistent.
Therefore anti-anginal therapy may need to be withheld for 12 hours prior to dobutamine stress echocardiography.
When adding atropine at the highest titration level of dobutamine:
Due to the prolonged duration of the stress echocardiography protocol, the higher total dose of dobutamine and the simultaneous administration of atropine, there is an increased risk of adverse reactions.
As there is no adequate data on the safety of dobutamine in human pregnancy and it is not known whether dobutamine crosses the placenta, dobutamine should not be used during pregnancy unless potential benefits outweigh the potential risks to the foetus and there are no safer therapeutic alternatives.
It is not known, whether dobutamine is excreted in breast milk, so caution should be exercised. If treatment with dobutamine is required for the mother during lactation, breast feeding should be discontinued for the duration of treatment.
Not relevant.
Evaluation of undesirable effects is based on the following frequency scale:
Very common: ≥ 1/10
Common: ≥ 1/100 to < 1/10
Uncommon: ≥ 1/1,000 to < 1/100
Rare: ≥ 1/10,000 to < 1/1,000
Very rare: < 1/10,000
Not known: cannot be estimated from the data available
Common: Eosinophilia, inhibition of thrombocyte aggregation (only when continuing infusion over a number of days).
Very rare: Hypokalaemia.
Common: Headache.
Very common: Increase of the heart rate by ≥ 30 beats/min.
Common: Blood pressure increase of ≥ 50 mmHg. Patients suffering from arterial hypertension are more likely to have a higher blood pressure increase. Blood pressure decrease, ventricular dysrhythmia, dose-dependent ventricular extrasystoles. Increased ventricular frequency in patients with atrial fibrillation. These patients should be digitalised prior to dobutamine infusion. Vasoconstriction in particular in patients who have previously been treated with beta blockers. Anginal pain, palpitations.
Uncommon: Ventricular tachycardia, ventricular fibrillation.
Very rare: Bradycardia, myocardial ischaemia, myocardial infarction, cardiac arrest.
Not known: Decrease in pulmonary capillary pressure.
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.
Dobutamine stress echocardiography:
Very common: Pectoral anginal discomfort, ventricular extra-systoles with a frequency of > 6/min.
Common: Supraventricular extrasystoles, ventricular tachycardia.
Uncommon: Ventricular fibrillation, myocardial infarction.
Very rare: Occurrence of second degree atrioventricular block, coronary vasospasms. Hypertensive/hypotensive blood pressure decompensation, occurrence of intracavitary pressure gradients, palpitations.
Not known: Stress cardiomyopathy.
Common: Bronchospasm, shortness of breath.
Common: Nausea.
Common: Exanthema.
Very rare: Petechial bleeding.
Common: Chest pain.
Common: Increased urgency at high dosages of infusion.
Common: Fever, phlebitis at the injection site. In case of accidental paravenous infiltration, local inflammation may develop.
Very rare: Cutaneous necrosis.
Restlessness, nausea, headache, paraesthesia, tremor, urinary urgency, feeling of heat and anxiety, myoclonic spasm.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
Dobutamine solutions have proven to be incompatible with:
Furthermore known incompatibilities for sodium metabisulfite are:
This medicinal product should not be mixed with other medicinal products except with those for which compatibility is proven.
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