Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
Excessive administration of potassium-free solutions may cause significant hypokalemia. Intravenous administration of these solutions may cause fluid and/or solute overload, resulting in dilution of serum electrolyte concentrations, hyperhydration, congestive states or pulmonary edema.

Before treatment with dopamine hydrochloride, hypovolemia should be corrected with appropriate amounts of blood or plasma according to the indications.
During therapy with dopamine hydrochloride it is necessary to control urine flow, cardiac output, blood pressure.
Should a disproportionate increase in diastolic blood pressure (i.e. a significant wrist pulse decrease) occur, the infusion should be reduced and the patient should be observed carefully in order to prevent a predominant undesired vasoconstrictor activity.
Dopamine hydrochloride should be infused into the largest veins, if possible, to avoid extravasation into adjacent tissues. Extravasation may cause necrosis and sores. Therefore, infusion rate should be checked.
Ischemia is reversible by infiltration of the affected area with 10 ml - 15 ml of saline solution containing 5 mg to 10 mg of phentolamine mesylate. When an extravasation occurs, a syringe with a small diameter hypodermic needle should be used to allow free infiltration of phentolamine in the ischemic zone.
Patients with previous occlusive vascular disease (atherosclerosis, arterial embolism, Raynaud's disease, cold sores, diabetic endarteritis and Buerger's disease) should be carefully observed for any change in color or temperature of the skin at the extremities. If you observe some variation in this regard and you believe that this may be the result of impaired circulation in extremities, it is necessary to evaluate the benefits of continuing the infusion with dopamine hydrochloride and the risks of a possible necrosis.
This condition can be reversed, by decreasing or stopping the infusion.
As an antidote for peripheral ischemia, in order to prevent sores and necrosis, it is advisable to infiltrate 10 or 15 ml of saline solution containing 5 or 10 mg of phentolamine as quickly as possible.
Patients treated with monoamine oxidase inhibitors (MAOIs) require a substantial reduction in the dosage (at least 1/10 of the normal dosage).

The solution should be clear and slightly yellow (Y6, color scale of Eur. Ph. current edition) or slightly brown (B6, color scale of Eur. Ph. current edition).

Do not add alkaline solutions to Dopamine Hydrochloride S.A.L.F. 40 mg/1 ml.
Dextrose solutions should be used with caution in patients with a history of subclinical or manifested diabetes mellitus.
Not being known the effect of dopamine in case of reduced renal and hepatic function, in these patients careful monitoring is needed.
To avoid an inappropriate state of hypotension, dopamine infusion should be stopped gradually.
Keep the medicine out of the sight and reach of children.

Warning to athletes: the use of this drug without therapeutic necessity constitutes doping: it may cause doping effects and positivity to anti-doping tests even with therapeutic doses.

Important information about some of the ingredients:
Dopamine Hydrochloride S.A.L.F. 40 mg/1 ml contains potassium metabisulfite; in rare cases, it may cause allergic-type reactions and bronchospasm.

Each ampoule contains less than 1 mmol (23 mg) of sodium, i.e. it is essentially sodium-free.

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