Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: BrePco Biopharma Ltd., Suite One, The Avenue, Beacon Court, Sandyford, Dublin D18HX31, Ireland
Treatment of hypotension in haemodynamically unstable neonates, infants and children <18 years.
Consideration should be given to the haemodynamic state of the patient and the pharmacodynamic profile of dopamine hydrochloride (see section 5.1) before deciding whether dopamine hydrochloride is appropriate.
Administration of dopamine hydrochloride should always be indicated/prescribed by a paediatric specialist or paediatric intensive care specialists to whom facilities are available for monitoring cardiovascular and renal indices, including blood volume, cardiac output, blood pressure, electrocardiography and urine flow.
Pressor therapy is not a substitute for replacement of blood, plasma, fluids, and/or electrolytes. Blood volume depletion should be corrected as fully as possible before dopamine hydrochloride therapy is instituted (see section 4.4). Because of variable, age-dependent clearance, the dose should be titrated slowly and deliberately, particularly in neonates.
Infusion of dopamine hydrochloride solution should begin at a rate of 5 μg/kg/min and increase gradually in 5 μg/kg/min increments. The recommended dose range is 5–10 μg/kg/min. Doses above 10 μg/kg/min up to a maximum of 20 μg/kg/min may be administered if considered justified.
Dose of dopamine hydrochloride should be adjusted according to the patient’s response, with particular attention to diminution of established urine flow rate, increasing tachycardia or development of new dysrhythmias as indications for decreasing or temporarily suspending the dose (see section 4.4).
For ease of dosing there are two different strengths for patients of different weight categories. Pre-calculated dose tables per weight are shown below with the recommended strength and vial volume to be used.
Rates of infusion according to body weight for children from 2 kg to 9 kg, who should be provided the lower strength, Neoatricon 1.5 mg/mL solution for infusion 30 mL vial.
| Neoatricon 1.5 mg/mL | |||
| Body weight | Rates of infusion according to target dose | ||
| 5 μg/kg/min | 10 μg/kg/min | 20 μg/kg/min | |
| 2 kg | 0.40 mL/hour | 0.80 mL/hour | 1.60 mL/hour |
| 3 kg | 0.60 mL/hour | 1.20 mL/hour | 2.40 mL/hour |
| 4 kg | 0.80 mL/hour | 1.60 mL/hour | 3.20 mL/hour |
| 5 kg | 1.00 mL/hour | 2.00 mL/hour | 4.00 mL/hour |
| 6 kg | 1.20 mL/hour | 2.40 mL/hour | 4.80 mL/hour |
| 7 kg | 1.40 mL/hour | 2.80 mL/hour | 5.60 mL/hour |
| 8 kg | 1.60 mL/hour | 3.20 mL/hour | 6.40 mL/hour |
| 9 kg | 1.80 mL/hour | 3.60 mL/hour | 7.20 mL/hour |
Rates of infusion according to body weight for children from 10 kg to 66 kg, who should be provided the higher strength: Neoatricon 4.5 mg/mL solution for infusion 50 mL vial.
| Neoatricon 4.5 mg/mL | |||
| Bodyweight | Rates of infusion according to target dose | ||
| 5 μg/kg/min | 10 μg/kg/min | 20 μg /kg/min | |
| 10 kg | 0.67 mL/hour | 1.33 mL/ hour | 2.67 mL/hour |
| 20 kg | 1.34 mL/hour | 2.68 mL/hour | 5.36 mL/hour |
| 30 kg | 2.00 mL/hour | 4.00 mL/hour | 8.00 mL/hour |
| 66 kg | 4.40 mL/hour | 8.80 mL/hour | 17.60 mL/hour |
Dopamine hydrochloride should be discontinued gradually and should not be stopped abruptly. Haemodynamic status should be continually assessed during the weaning phase (see section 4.4).
Because of the low rate of clearance, especially in the neonate, low doses of dopamine hydrochloride and slow deliberate titration should be employed (see section 4.4).
Patients who have been treated with MAO inhibitors prior to dopamine hydrochloride should be given reduced doses; the starting dose should be 10% of the usual dose (see section 4.4 and 4.5).
For intravenous use. Dopamine hydrochloride should be administered via a central line [Umbilical venous catheter (UVC), Longline, or Surgical central venous line (CVL)]. If no central access is available, a cannula in large vein should be used. A suitable metering device is required in the infusion system to control the rate and flow.
Other infusions should not be co-infused into the dopamine hydrochloride line. Administration into a second injection site should be used to avoid mixing of potent medicinal products with dopamine hydrochloride (see sections 4.4 and 6.2).
Single use only. For instructions on handling of the medicinal product before administration see section 6.6.
Possible symptoms of overdose include: severe increase in blood pressure, tachycardia, tachycardic arrhythmias, increase in left ventricular end-diastolic pressure with consequent pulmonary congestion to pulmonary oedema, angina pectoris-attacks (especially in patients with known coronary artery disease), nonspecific chest pain, palpitations, nausea, vomiting, sensation of coldness in the extremities and cyanosis. These conditions can be rapidly reversed by dose reduction or discontinuing the infusion, since dopamine hydrochloride has a half-life of less than 2 minutes in the body.
Should these measures fail, an infusion of an alpha-adrenergic blocking agent, should be considered.
2 years.
After first opening, the medicinal product should be used immediately; any unused contents should be discarded after 24 hours.
This medicinal product does not require any special temperature storage conditions.
Keep the container in the outer carton in order to protect from light.
Type I clear glass vial with bromobutyl rubber stopper, sealed with flip-off aluminium seal.
Pack size:
Neoatricon 1.5 mg/mL solution for infusion: single carton containing 30 mL vial.
Neoatricon 4.5 mg/mL solution for infusion: single carton containing 50 mL vial.
Not all pack sizes may be marketed.
Do not use this medicinal product if you notice an opaque, cloudy or discoloured solution.
This medicinal product does not require dilution prior to administration.
This medicinal product is for single use only. Any unused solution should be discarded.
Discard vial and any unused contents after 24 hours (see section 6.3).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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