DOPAMINE HYDROCHLORIDE Concentrate for solution for infusion Ref.[7833] Active ingredients: Dopamine

Posology

Adults

Use as large a vein as possible for infusion. The initial rate of infusion is 2 to 5 micrograms per kilogram bodyweight per minute and this may be increased gradually by increments of 5 to 10 micrograms/kg/minute until the optimum dose for the individual is achieved. Up to 50 micrograms/kg/minute may be required, and even higher doses have been used.

Paediatric population

The safety and efficacy of dopamine hydrochloride therapy in children have not been established.

Method of administration

For intravenous use.

The solution must be diluted before administration.

For instructions on dilution of the medicinal product before administration, see section 6.6.

A suitable metering device is required in the infusion system to control the rate of flow, and this should be adjusted to the optimum patient response and monitored constantly in the light of the individual patient’s response.

Excessive elevation of blood pressure and vasoconstriction can occur due to the alpha adrenergic actions of dopamine, especially in patients with a history of occlusive vascular disease. If desired, this condition can be rapidly reversed by dose reduction or discontinuing the infusion, since dopamine has a half-life of less than 2 minutes in the body.

Should these measures fail, an infusion of an alpha adrenergic blocking agent, e.g. phentolamine mesylate, should be considered.

Dopamine at the infusion site can cause local vasoconstriction hence the desirability of infusing into a large vein. The resulting ischaemia can be reversed by infiltration of the affected area with 10-15 ml of saline containing 5 mg 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.

Accidental Overdosage

Accidental overdosage as evidenced by excessive blood pressure elevation can be controlled by dose reduction or discontinuing the dopamine infusion for a short period, since the duration of action of dopamine is short.

Should these measures fail, an infusion of phentolamine mesylate should be considered.

36 months.

For single use only If only part of an ampoule is used, discard the remaining solution.

Diluted solutions should be used immediately. Discard any remaining solution

Do not store above 25°C.

Keep the container in the outer carton in order to protect from light.

5 ml clear glass one point-cut (OPC) ampoules, glass Type I Ph Eur. borosilicate glass ampoules packed in cardboard cartons to contain 10 × 5ml ampoules.

This solution must be diluted before use.

Do not dilute with alkaline solution.

Inspect the solution before use. Do not use the injection if it is darker than slightly yellow or discoloured in any other way or if it contains particulate matter.

Alkaline solutions such as 5% sodium bicarbonate should NOT be added to dopamine hydrochloride because the drug will be inactivated. The usual dilution is 1,600 micrograms per ml and this may be achieved by transfer, aseptically of 800mg of dopamine hydrochloride (20 ml of the Dopamine Hydrochloride 40mg/ml Concentrate for Solution for Infusion) to 480 ml one of the following sterile I.V. solutions to achieve 1,600 microgram per ml concentration:

Sodium Chloride Injection
5% Glucose Injection
5% Glucose and 0.9% Sodium Chloride Injection
5% Glucose and 0.45% Sodium Chloride Solution
5% Glucose in Ringer Lactate Solution
Sodium Lactate 1/6 Molar Injection
Lactated Ringer’s Injection