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DOBUTAMINE is a brand name for Dobutamine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults Dobutamine is indicated for patients who require a positive inotropic support in the treatment of cardiac decompensation due to depressed contractility. In cardiogenic shock characterised by heart failure with severe hypotension and in case of septic shock Dobutamine may be useful if added to dopamine in case…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Dobutamine doses must be individually adjusted. The required rate of infusion depends on the patient’s response to therapy and the adverse reactions experienced. 5-10 μg dobutamine/kg/min. In individual cases, doses up to 40 μg dobutamine/kg/min have been administered.
Dosage in paediatric patients:
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. 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 reason to believe that the maximum tolerated dosage for children is lower than the one for adults. 5 micrograms/kg/minute but reducing or termination of the rate of dobutamine infusion is all that is required for rapid reversal of undesirable effects.
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.
e. 500 mg dobutamine added to 500 ml, or 250 mg added to 250 ml solution volume, infusion rates must be halved. 18) The chosen syringe pump must be suitable for the volume and rate of administration. 6. Dobutamine stress echocardiography (Adult population only) Administration in stress echocardiography is undertaken by gradually increasing dobutamine infusion.
The most frequently applied dosage scheme starts with 5 μg/kg/min Dobutamine increased every 3 minutes to 10, 20, 30, 40 μg/kg/min until a diagnostic endpoint (see method and duration of application) is reached. 5 mg at 1 minute intervals to increase the heart rate.
Alternatively the infusion rate of dobutamine may be increased to 50 μg/kg/min. The experience in children and adolescents is limited to the treatment of patients requiring positive inotropic support. Method of administration Dobutamine 5 mg/ml (250 mg in 50 ml) ampoule or vial Only for intravenous infusion (syringe pump).
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 available data Blood and lymphatic system disorders Common: Eosinophilia, inhibition of thrombocyte aggregation (only when continuing infusion over a number of days).
Immune system disorders Common:
Hypersensitivity reactions including rash and eosinophilic myocarditis have been reported. 4).
Metabolism and nutrition disorders Very rare:
Hypokalaemia.
Nervous system disorders Common:
Headache.
Very rare:
Myoclonus has been reported in patients with severe renal failure receiving dobutamine.
Cardiac disorders / Vascular disorders 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.
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.
Hypovolaemia should be corrected before administering dobutamine. Dobutamine may interfere with HPLC determination of chloramphenicol. 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 blood pressure appear to be more frequent and intense in children.
1, including in patients with bronchial asthma with hypersensitivity to sulfites, - mechanical obstruction of ventricular filling and/or of outflow, such as pericardial tamponade, constrictive pericarditis, hypertrophic obstructive cardiomyopathy, severe aortic stenosis, - hypovolaemic conditions, - phaeochromocytoma.
Dobutamine stress echocardiography Dobutamine must not be used for detection of myocardial ischaemia and of viable myocardium in case of: - recent myocardial infarction (within the last 30 days), - unstable angina pectoris, - stenosis of the main left coronary artery, - haemodynamically significant outflow obstruction of the left ventricle including hypertrophic obstructive cardiomyopathy, - haemodynamically significant cardiac valvular defect, - severe heart failure (NYHA III or IV), - predisposition for or documented medical history of clinically significant or chronic arrhythmia, particularly recurrent persistent ventricular tachycardia, - significant disturbance in conduction, - acute pericarditis, myocarditis or endocarditis, - aortic dissection, - aortic aneurysm, - poor sonographic imaging conditions, - inadequately treated / controlled arterial hypertension, - obstruction of ventricular filling (constrictive pericarditis, pericardial tamponade), - hypovolaemia, - previous experience of hypersensitivity to dobutamine and in patients with bronchial asthma who are hypersensitive to sulfites, - phaeochromocytoma.
Note:
If administering atropine, the respective contraindications have to be observed.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Dilution is not required. 45% sodium chloride in 5% glucose solution. ) Infusion solutions should be prepared immediately before use. ) Due to its short half-life, dobutamine must be administered as a continuous intravenous infusion. The dose of dobutamine should be gradually reduced when discontinuing therapy.
The duration of treatment depends on the clinical requirements and is to be determined by the physician and should be as short as possible. If dobutamine is administered continuously for more than 72 hours, tolerance may occur, requiring an increase in the dose.
During the course of dobutamine administration, heart rate, heart rhythm, blood pressure, diuresis and infusion rate should be closely monitored. Cardiac output, central venous pressure (CVP) and pulmonary capillary pressure (PCP) should be monitored if possible.
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 30 mg/kg body weight to a final volume of 50 mL of infusion fluid. 5 mL/hour provides a dose of 5 micrograms/kg/minute. Dobutamine stress echocardiography (Adult population only) For detection of myocardial ischaemia and of viable myocardium dobutamine may only be administered by a physician with sufficient experience in conducting cardiology stress tests.
Continuous monitoring of all wall areas via echocardiography, and ECG as well as control of blood pressure is necessary. g. V. ) and staff trained in the resuscitation procedure must be present. For instructions on dilution of the medicinal product before […]
Uncommon:
Ventricular tachycardia, ventricular fibrillation, atrial fibrillation.
Very rare:
Bradycardia, myocardial ischaemia, myocardial infarction, cardiac arrest.
Not known:
Decrease in pulmonary capillary pressure. 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.
Dobutamine stress echocardiography Cardiac disorders / Vascular disorders Very common: Pectoral anginal discomfort, ventricular extra-systoles with a frequency of > 6/min, electrocardiogram ST segment elevation.
Common:
Supraventricular extrasystoles, ventricular tachycardia.
Uncommon:
Ventricular fibrillation, myocardial infarction, atrial fibrillation, left ventricular outflow tract obstruction.
Very rare:
Occurrence of second degree atrioventricular block, coronary vasospasms. 4). Hypertensive/hypotensive blood pressure decompensation, occurrence of intracavitary pressure gradients, palpitations. 4).
Respiratory, thoracic and mediastinal disorders Common:
Bronchospasm, shortness of breath.
Gastrointestinal disorders Common:
Nausea.
Skin and subcutaneous tissue disorders Common:
Exanthema.
Very rare:
Petechial bleeding.
Musculoskeletal and connective tissue disorders Common:
Chest pain.
Renal and urinary disorders Common:
Increased urgency at high dosages of infusion.
General disorders and administration site conditions Common:
Fever, phlebitis at the injection site. In case of accidental paravenous infiltration, local inflammation may develop.
Very rare:
Cutaneous necrosis. Further undesirable effects Restlessness, nausea, headache, paraesthesia, tremor, urinary urgency, feeling of heat and anxiety, myoclonic spasm. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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. Dobutamine stress echocardiography (Adult population only) 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.
Cardiac rupture is a potential complication of myocardial infarction. The risk of cardiac rupture (septal and free wall) may be influenced by a variety of factors including site of, and time since, infarct. There have been very rare, fatal reports of acute cardiac rupture during dobutamine stress testing.
These events have occurred during pre-discharge examination in patients hospitalised with recent (within 4-12 days) myocardial infarction. In the reported cases of free wall rupture, resting echocardiogram showed a dyskinetic and thinned inferior wall.
Patients considered at risk of cardiac rupture during dobutamine testing should therefore be carefully evaluated prior to testing. g. 1 mV in patients without a previous myocardial infarction, - reaching peak dose. 8). The administration of dobutamine for stress echocardiography should be only undertaken by a physician experienced with the procedure.
The physician should be vigilant during the test and the recovery period and be prepared for appropriate therapeutic intervention during the test. In the event of stress cardiomyopathy (Takotsubo syndrome) dobutamine should be stopped immediately.
8) dobutamine stress echocardiography must be stopped immediately. 06 mg sodium per 1 ml solution. Each 50 ml ampoule/vial contains 153 mg sodium. 7% of the WHO recommended maximum daily intake of 2 g sodium for an adult. 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.