Dobutamine hydrochloride parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
All formulations of dobutamine hydrochloride
Drugs List
Therapeutic Indications
Uses
Cardiac output support in positive end expiratory pressure ventilation
Cardiac stress testing
Inotropic support in low output cardiac failure
Inotropic support in low output cardiac failure
Indicated for patients who require inotropic support in the treatment of low output cardiac failure associated with myocardial infarction, open heart surgery, cardiomyopathies, septic shock and cardiogenic shock.
Cardiac output support in positive end expiratory pressure ventilation
Indicated to increase or maintain cardiac output during positive end expiratory pressure (PEEP) ventilation.
Stress echocardiography
Indicated for cardiac stress testing as an alternative to exercise in patients for whom routine exercise cannot be satisfactory performed. This use of dobutamine should only be undertaken in units which already perform exercise stress testing and all normal care and precautions required for such testing are also required when using dobutamine for this purpose.
Dosage
The rate of administration and duration of therapy should be adjusted according to patient response as determined by heart rate, blood pressure, urine flow and if possible, cardiac output.
Therapy should not be abruptly discontinued. Instead, the dose should be reduced gradually.
The duration of treatment should be as short as possible.
Adults
For inotropic support in the treatment of low output cardiac failure, to increase or maintain cardiac output during positive end expiratory pressure (PEEP) ventilation
Usual dose: 2.5 to 10micrograms/kg/minute.
Occasionally, 0.5micrograms/kg/minute will produce a response. Rarely doses up to 40micrograms/kg/minute are required.
The final volume administered should be determined by the fluid requirements of the patient. Concentrations up to 5000micrograms/ml (5mg/ml) have been used in patients with restricted fluid intake.
Cardiac stress testing
5micrograms/kg/minute, increasing in 5micrograms/kg/minute increments up to 20micrograms/kg/minute. Each dose should be infused over 8 minutes.
The following alternative dosing schedule may be suitable:
5micrograms/kg/minute, increased every 3 minutes to 10, 20, 30, 40micrograms/kg/minute until a diagnostic endpoint is reached.
Continuous ECG monitoring is essential and the infusion terminated in the event of greater than 3mm ST segment depression or any ventricular arrhythmia. The infusion should be terminated if heart rate reaches the age/sex maximum, systolic blood pressure rises above 220mmHg or any side effects occur.
If no endpoint is reached atropine sulfate may be administered at 0.5mg to 2mg in divided doses of 0.25mg to 0.5mg at 1 minute intervals to increase the heart rate. Alternatively the infusion rate of dobutamine may be increased to 50micrograms/kg/minute.
Children
5micrograms/kg/minute, adjusted according to clinical response to between 2 to 20micrograms/kg/minute. A dose as low as 0.5 to 1microgram/kg/minute may be adequate.
The minimum effective dose for children may be higher than that for adults. However, maximum tolerated dose for children is lower than that for adults. Therefore, administer high doses with caution. Titrate cautiously to allow for the supposedly 'narrow window'.
Adverse reactions are mostly seen at doses of 7.5micrograms/kg/minute and above.
Neonates
Neonatal intensive care
Dilute 30mg/kg to a final volume of 50ml with infusion fluid; an intravenous infusion rate of 0.5ml/hour provides a dose of 5micrograms/kg/minute.
The following alternative dosing schedule may be suitable:
5micrograms/kg/minute, this may be adjusted to between 2 to 20micrograms/kg/minute. A dose as low as 0.5 to 1microgram/kg/minute may be adequate.
Additional Dosage Information
If dobutamine is administered for more than 72 hours continuously, tolerance may occur. This may require an dose increase.
Administration
For intravenous infusion.
Dobutamine must be administered as a continuous intravenous infusion through an intravenous needle or catheter (higher concentrations should be given through a central venous catheter only). An IV drip chamber or other suitable measuring device is essential in order to control the rate of flow in drops per minute.
The concentrate for solution must be diluted to at least 50 ml before administration.
The unconcentrated solution can be administered undiluted, or may be diluted first.
High concentrations should only be given with an infusion pump, to ensure accurate dosage.
Contraindications
Predisposition to cardiac arrhythmia - if used in stress echocardiography
Acute pericarditis - if used in stress echocardiography
Aortic aneurysm - if used in stress echocardiography
Aortic dissection - if used in stress echocardiography
Breastfeeding
Cardiac tamponade - if used in stress echocardiography
Constrictive pericarditis - if used in stress echocardiography
Endocarditis - if used in stress echocardiography
History of cardiac arrhythmia - if used in stress echocardiography
Hypovolaemia
Left main coronary artery stenosis - if used in stress echocardiography
Left ventricular outflow obstruction
Myocarditis - if used in stress echocardiography
NYHA class III failure - if used in stress echocardiography
NYHA class IV failure - if used in stress echocardiography
Phaeochromocytoma
Pregnancy
Recent myocardial infarction - if used in stress echocardiography
Severe cardiac conduction defects - if used in stress echocardiography
Significant valvular heart disease - if used in stress echocardiography
Uncontrolled hypertension - if used in stress echocardiography
Unstable angina pectoris - if used in stress echocardiography
Precautions and Warnings
Predisposition to narrow angle glaucoma
Acute cardiac failure
Aortic stenosis
Asthma
Atrial fibrillation
Atrial flutter
Cardiac arrhythmias
Cardiac tamponade
Diabetes mellitus
Hyperthyroidism
Idiopathic hypertrophic subaortic stenosis
Ischaemic heart disease
Myocardial infarction
Occlusive peripheral vascular disorder
Severe hypotension
Tachycardia
Inotropic response inadequate where filling or outflow obstruction exists
Correct hypovolaemia prior to administration
Not all available brands are licensed for all indications
Treatment to be initiated and supervised by a specialist
After infusion has finished, monitor patients until stabilised
Diabetic control may need adjustment
Monitor ECG
Monitor heart rate, rhythm, arterial blood pressure, infusion rate
Monitor serum potassium periodically
Monitor urine output
Reduce dose or discontinue if excessive hypotension occurs
Consider use of vasoconstrictor if arterial BP remains low or decreases
Discontinue temporarily/reduce dose if heart rate or systolic BP increases
Tolerance may occur with prolonged use of large doses
May affect results of some laboratory tests
Avoid abrupt withdrawal
Discontinue treatment if arrhythmias occur
Cardiac stress testing should only be carried out by an physician experienced in this procedure. Monitoring and emergency device must be available (e.g. defibrillator, intravenously used beta-blocker, nitrates etc). Staff trained in the resuscitation procedure must also be present. During administration for cardiac stress testing, continuous ECG monitoring is essential. The infusion should be discontinued immediately any of the following occur:
More than 3 mm ST segment depression or ventricular arrhythmias
Heart rate reaches the maximum recommended based on age and gender
Blood pressure rises above 220/120 mmHg
Increase in end systolic volume
Systolic blood pressure decreases more than 20 mmHg
Progressive symptoms (e.g. angina, dyspnoea, dizziness)
Progressive arrhythmia
Progressive conduction disturbance
Recently developed wall motility disorders in more than 1 wall segment
Development of repolarisation abnormality (due to ischaemia horizontal or down sloping ST segment depression) greater than 0.2 mV at an interval of 80 (60) ms after the J point compared to baseline, progressive or monophasic ST segment elevation greater than 0.1 mV in patients without a previous myocardial infarction.
Reaching peak dose
If arterial blood pressure remains low or progressively decreases during treatment despite adequate ventricular filling pressure and cardiac output, concurrent peripheral vasoconstrictors may be required.
If tachycardia, arrhythmia, or an undue increase in systolic blood pressure occur, the dosage should be reduced or treatment temporarily discontinued.
There have rarely been reports of fatal acute cardiac rupture during cardiac stress testing with dobutamine. These events have occurred during pre-discharge examination of patients in hospital following recent (within 4 to 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 should be carefully evaluated before and during testing.
Patients undergoing dobutamine therapy have exhibited local changes in coronary blood flow, which may have an impact on the myocardial oxygen demand. Patients with severe coronary heart disease may deteriorate , particularly if dobutamine therapy is accompanied by a considerable increase in the heart rate, and/or blood pressure. Therefore, use with caution in patients with cardiac ischaemia.
Contains sodium metabisulfite which may cause allergic type reactions. Sulfite sensitivity is seen more frequently in asthmatic patients than non-asthmatic patients. Use in caution in asthmatic patients.
Pregnancy and Lactation
Pregnancy
Dobutamine is contraindicated in pregnancy.
At the time of writing there are no adequate or well controlled studies in human pregnancy.
Animal studies have revealed no evidence of foetal harm or teratogenic effects. Animal studies to determine effects on fertility have not been carried out.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Dobutamine is contraindicated in breastfeeding.
It is not known whether dobutamine is excreted in human breast milk. The relatively low molecular weight (about 301) suggests that the drug will be excreted into breast milk.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Side Effects
Anaphylactic reaction
Anginal pain
Anxiety
Arrhythmias
Asthma
Atrial fibrillation
Bradycardia
Bronchospasm
Cardiac arrest
Chest pain
Conduction disturbances
Coronary vasospasm
ECG changes
Ectopic beats
Eosinophilia
Exanthema
Fever
Headache
Heat sensation
Hypersensitivity reactions
Hypertension
Hypokalaemia
Hypotension
Inflammation (injection site)
Inhibition of platelet aggregation
Myocardial infarction
Myocardial ischaemia
Myocardial rupture
Myocarditis
Myoclonic movements
Nausea
Necrosis (injection site)
Palpitations
Paraesthesia
Petechial haemorrhage
Phlebitis (injection site)
Rash
Restlessness
Shortness of breath
Tachycardia
Thrombocytopenia
Tolerance
Tremor
Urinary urgency
Vasoconstriction
Ventricular extrasystoles
Ventricular fibrillation
Effects on Laboratory Tests
Dobutamine may interfere with the HPLC determination of chloramphenicol.
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: July 2014
Reference Sources
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.
Summary of Product Characteristics: Dobutamine 5mg/ml, solution for infusion. Hameln Pharmaceuticals Ltd. Revised September 2013.
Summary of Product Characteristics: Dobutamine Concentrate 250mg/20ml. Hameln Pharmaceuticals Ltd. Revised July 2013.
Summary of Product Characteristics: Dobutamine 12.5mg/ml concentrate for solution for infusion. Wockhardt UK Ltd. Revised July 2013.
NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed: 28 June 2017.
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