1. Name Of The Medicinal Product
Sterile Dopamine Concentrate BP Selectajet
2. Qualitative And Quantitative Composition
Dopamine Hydrochloride 40 mg/ml
For full list of excipients, see section 6.1.
3. Pharmaceutical Form
Solution for injection.
4. Clinical Particulars
4.1 Therapeutic Indications
For the correction of haemodynamic imbalances present in the shock syndrome due to myocardial infarction, trauma, endotoxic septicaemia, cardiac surgery, renal failure and chronic cardiac decompensation as in congestive failure.
4.2 Posology And Method Of Administration
Adults, elderly and children over 12 years old:
Begin infusion at between 1 - 5 mcg/kg/min. Increase dose by 1 - 5 mcg/kg/min, as required every 10 - 30 minutes, up to 20 - 50 mcg/kg/min. Most patients can be maintained at 20mcg/kg/min or less. Doses in excess of 50mcg/kg/min have been used in advanced states of circulatory decompensation.
Patients with severe refractory chronic congestive heart failure should be started on 0.5 - 2mcg/kg/min and the dose increased by 1 - 3 mcg/kg/min as urinary output increases.
ECG, blood pressure and urine output should be monitored. Cardiac output and pulmonary wedge pressure should be monitored if possible.
Children under 12 years:
The safety and efficacy of dopamine in children has not been established.
4.3 Contraindications
Dopamine should not be used in patients with phaeochromocytoma, uncorrected tachyarrhythmias, or ventricular fibrillation.
4.4 Special Warnings And Precautions For Use
Correct hypovolaemia, before administering dopamine if possible.
Administer dilute solution through as large a vein as possible, to minimise the risk of extravasation. A metering chamber or device should be used to accurately control dosage in drops/minute.
Dopamine infusion should be withdrawn gradually, to avoid unnecessary hypotension.
Patients with a history of occlusive vascular disease (e.g. atherosclerosis, arterial embolism, Raynaud's disease, cold injury, diabetic endarteritis and Buerger's disease) should be closely monitored for any changes in colour or temperature of the skin in the extremities. If ischaemia occurs and is thought to be the result of vasoconstriction, the benefits of continued dopamine infusion should be weighed against the risk of possible necrosis. This condition may be reversed by either decreasing the rate or discontinuing the infusion. IV administration of phentolamine mesylate 5-10 mg may reverse the ischaemia.
If excessive vasoconstriction (as indicated by a disproportionate rise in diastolic pressure and a marked decrease in pulse pressure) is observed, the infusion rate should be decreased or suspended and the patient observed closely.
As the effect of dopamine on impaired renal and hepatic function is not known, close monitoring is advised.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
The action of dopamine is potentiated by monoamine oxidase inhibitors (MAOI's). In patients who have received MAOI's within the previous 2-3 weeks, the initial dopamine dose should be no greater than 10% of the usual dose.
The concurrent administration of dopamine in patients with a chronic use of selegiline (given for Parkinson disease) should be avoided.
The concurrent administration of cyclopropane or halogenated hydrocarbon anaesthetics may cause ventricular arrhythmias.
The cardiac effects of dopamine are antagonised by beta-adrenergic blocking agents such as propranolol and metoprolol.
The ergot alkaloids should be avoided because of the possibility of excessive vasoconstriction. Tricyclic antidepressants and guanethidine may potentiate the pressor response to dopamine.
Hypotension and bradycardia have been observed in patients receiving phenytoin.
Dopamine may increase the effect of diuretic agents.
Peripheral vasoconstriction may be antagonised by alpha-adrenergic blocking agents, such as phentolamine. Other vasodilators may also be useful in patients with heart failure, allowing greater inotropic and renal effects without the associated vasoconstriction. Care must be taken to avoid hypotension.
4.6 Pregnancy And Lactation
The use of any drug in pregnant women or women of child-bearing potential requires that the expected benefit be carefully weighed against the possible risk to mother and child. Animal studies have shown no evidence of teratogenic effect. It is not known whether dopamine crosses the placenta or enters breast milk.
4.7 Effects On Ability To Drive And Use Machines
This drug is intended for use in life threatening situations.
4.8 Undesirable Effects
Extravasation of dopamine into the tissues may cause local necrosis. The area should be infiltrated with 5-10mg phentolamine in 10-15mL saline.
The most frequent adverse reactions include ectopic beats, nausea, vomiting, tachycardia, anginal pain, palpitations, dyspnoea, headache, hypotension, hypertension and vasoconstriction. Other less frequent adverse reactions are aberrant ventricular conduction, bradycardia, piloerection, mydriasis, widened QRS complex, azotaemia, elevated blood pressure and diabetes insipidus. Peripheral ischaemic gangrene in patients with pre-existing vascular disease. Fatal ventricular arrhythmias have been reported on rare occasions.
4.9 Overdose
In case of accidental overdosage, as evidenced by excessive blood pressure elevation, reduce the rate of administration or temporarily discontinue dopamine until the patients condition stabilises. Since the duration of action of dopamine is quite short, no additional measures are usually necessary. If these measures fail to stabilise the patient's condition, use of the short-acting alpha- adrenergic blocking agent such as phentolamine should be considered.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
ATC code: C01CA 04; adrenergic and dopaminergic agents
Dopamine is a catecholamine. It is an agonist for specific dopamine receptors in the CNS, renal and other vascular beds (vasodilation) and for b1 adrenoceptors in the heart (positive inotrope). At high doses it activates a-adrenoceptors (vasoconstriction).
5.2 Pharmacokinetic Properties
The half life of an iv bolus of dopamine is about 2 minutes, thus it is given by continuous infusion. Steady state is reached within 5 - 10 minutes. On termination of the infusion, dopamine is cleared from the plasma with a half life of about 9 minutes.
Dopamine is widely distributed throughout the body, but does not cross the blood/brain barrier. Dopamine like all catecholamines is metabolised by monoamine oxidase (MAO) and catechol-O-methyl transerase (COMT), in the liver, kidney and plasma. A small amount of unchanged drug plus its main metabolites, homovanillic acid (HVA) and 3,4-dihydroxyphenyl acetic acid (DOPAC) are excreted in the urine.
5.3 Preclinical Safety Data
The LD50 values for IV dopamine hydrochloride have been determined as 290 mg/kg in mice and 38.8 mg/kg in rats; the animals suffered massive internal bleeding and pulmonary congestion.
Subacute toxicity tests in rats revealed prostatic hypertrophy with associated bladder distension and hydronephrosis. In animals given higher doses (570 mg/kg daily) weights of heart, kidneys and lung were significantly higher than in controls, the weight of the spleen was significantly lower. Dogs given dopamine continuously for two weeks suffered intractable vomiting. Subsequent examination showed an increase in weight of the adrenal glands in all animals and an increase in weight of the prostate gland in dogs given the higher doses, some of which also had small areas of myocardial necrosis.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sodium bisulphite
Water for Injection
6.2 Incompatibilities
Do not add dopamine to any alkaline diluent solution e.g. sodium bicarbonate, since the drug is inactivated by these solutions.
6.3 Shelf Life
36 months
6.4 Special Precautions For Storage
Do not store above 25°C. Keep vial in the outer carton.
6.5 Nature And Contents Of Container
The solution is contained in a USP type I glass vial with an elastomeric closure which meets all the relevant USP specifications. The product is available as 5 ml, 10 ml and 20ml.
6.6 Special Precautions For Disposal And Other Handling
Dopamine must be diluted before use. Appropriate diluents include 5% dextrose, sodium chloride 0.9% or compound sodium lactate. Incompatible with sodium bicarbonate or any other alkali solution.
Dopamine is stable for about 24 hours in sodium chloride or dextrose. It should be used as soon as possible after mixing.
The container is specially designed for use with the IMS Select-A-Jet injector.
Any unused product should be disposed of in accordance with local requirements.
7. Marketing Authorisation Holder
International Medication Systems (UK) Ltd.
208 Bath Road
Slough
Berkshire
SL1 3WE
UK
8. Marketing Authorisation Number(S)
PL 03265/0027
9. Date Of First Authorisation/Renewal Of The Authorisation
16th July 1979 / 24th August 2001
10. Date Of Revision Of The Text
Approved: March 2009
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