Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Mercury Pharma International Ltd, 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland
Dopamine should not be used in patients with –
Dopamine should not be used in the presence of uncorrected atrial or ventricular tachyarrhythmias or ventricular fibrillation.
Cyclopropane and halogenated hydrocarbon anaesthetics should be avoided.
Patients who have been treated with MAO inhibitors prior to dopamine should be given reduced doses; the starting dose should be one tenth (1/10th) of the usual dose.
Excess administration of potassium-free solutions may result in significant hypokalaemia.
The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary oedema.
Hypovolaemia should be corrected where necessary prior to dopamine infusion. Low doses should be used in shock due to acute myocardial infarction.
If a disproportionate rise in diastolic pressure (i.e. a marked decrease in pulse pressure) is observed, the infusion rate should be decreased and the patients observed carefully for further evidence of predominant vasoconstriction activity, unless such an effect is desired.
Patients with a history of peripheral vascular disease should be closely monitored for any changes in colour or temperature of the skin of the extremities. If change of skin colour or temperature occurs and is thought to be the result of compromised circulation to the extremities, the benefits of continued dopamine infusion should be weighed against the risk of possible necrosis. These changes may be reversed by decreasing the rate or discontinuing the infusion. IV administration of phentolamine mesylate 5-10 mg may reverse the ischaemia.
Dopamine hydrochloride in 5% Glucose injection should be infused into a large vein whenever possible to prevent the possibility of infiltration of perivascular tissue adjacent to the infusion site. Extravasation of dopamine hydrochloride during infusion may cause ischaemic necrosis and sloughing of surrounding tissue. Ischaemia can be reversed by infiltration of the affected area with 10-15 ml of saline containing 5 to 10 mg phentolamine mesylate. A syringe with a fine hypodermic needle should be used to liberally infiltrate the ischaemic area as soon as extravasation is noted.
Administration of dopamine hydrochloride should always be under the direct supervision of a physician to whom facilities are available for monitoring cardiovascular and renal indices, including blood volume, cardiac output, blood pressure, electrocardiography and urine flow.
Glucose solutions should be used with caution in patients with known subclinical or overt diabetes mellitus.
When dopamine is used in patients with a history of occlusive vascular disease, particular attention should be paid to the status of blood circulation in the extremities.
The occurrence of undesirable increases in blood pressure or vasoconstriction or decrease in urinary output requires a reduction in dosage of dopamine hydrochloride.
The routine use of low-dose dopamine hydrochloride in critically ill patients to prevent or treat acute renal failure is not recommended because this may cause adverse effects which could further compromise such patients.
As the effect of dopamine on impaired renal and hepatic function is not known, close monitoring is advised.
Dopamine infusion should be withdrawn gradually, to avoid unnecessary hypotension.
Dopamine Hydrochloride 40mg/ml Concentrate for Solution for Infusion contains an antioxidant, sodium metabisulfite, a sulphite that may cause allergic-type reactions including bronchospasm, anaphylaxis and life- threatening episodes in certain susceptible individuals. The prevalence of sulphite-sensitivity in the general population is unknown and is probably low.
Sulphite-sensitivity is seen more frequently in persons with a history of asthma or atopic allergy.
This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially “sodium-free”.
The myocardium is sensitised by the effect of dopamine, cyclopropane or halogenated hydrocarbon anaesthetics, and these should be avoided. This interaction applies both to pressor activity and cardiac beta adrenergic stimulation.
The cardiac effects of dopamine are antagonised by β-adrenergic blocking agents such as propanolol and metoprolol, and the peripheral vasoconstriction caused by high doses of dopamine is antagonised by α adrenergic blocking agents. Dopamine induced renal and mesenteric vasodilation is not antagonised by either α or β- adrenergic blocking agents, but, in animals, is antagonised by haloperidol or other butrophenones, phenothiazines and opiates.
MAO inhibitors potentiate the effect of dopamine and its duration of action. Patients who have been treated with MAO inhibitors prior to administration of dopamine will therefore require a substantially reduced dosage. (The starting dose should be reduced to at least 1/10th of the usual dose).
Administration of IV phenytoin to patients receiving dopamine has resulted in hypotension and bradycardia; some clinicians recommend that phenytoin be used with extreme caution, if at all, in patients receiving dopamine.
Dopamine may increase the effect of diuretic agents.
The ergot alkaloids should be avoided because of the possibility of excessive vasoconstriction. Tricyclic antidepressants and guanethidine may potentiate the pressor response to dopamine.
Animal studies have shown no evidence of teratogenic effects with dopamine.
However, the effect of dopamine on the human foetus is unknown. Therefore the drug should be used in pregnant women only when the expected benefits outweigh the potential risk to the foetus.
It is not known if dopamine is excreted in breast milk, nor is the effect on the infant known.
No data available.
Not applicable in view of the indications for use and the short half-life of the drug.
Adverse reactions to dopamine are related to its pharmacological action.
The following adverse reactions are classified by system organ class and ranked under heading of frequency: Common (>1/100 to <1/10; Uncommon (≥1/1,000 to <1/100).
Common: Headache
Uncommon: Piloerection
Uncommon: Mydriasis
Common: Ectopic heart beats, tachycardia, anginal pain, palpitation, hypotension, vasoconstriction.
Uncommon: Aberrant conduction, bradycardia, widened QRS complex, hypertension, gangrene, fatal ventricular arrhythmias have been reported on rare occasions.
Common: Dyspnoea
Common: Nausea, vomiting
Uncommon: Azotaemia
Gangrene of the feet has occurred following doses of 10-14 microgram/kg/min and higher in a few patients with pre-existing vascular disease.
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.
Iron salts, alkalis or oxidising agents.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
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