NEOATRICON

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.

Posology Pressor therapy is not a substitute for replacement of blood, plasma, fluids, and/or electrolytes. 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.

4). For ease of dosing there are two different strengths for patients of different weight categories. Weaning and discontinuation Dopamine hydrochloride should be discontinued gradually and should not be stopped abruptly. 4). 4). 5). Method of administration 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. 2). Single use only. 6.

Summary of the safety profile Except for vasoconstrictive effects caused by inadvertent infusion of dopamine hydrochloride into the umbilical artery, adverse reactions unique to the paediatric population have not been identified. Tabulated list of adverse reactions The data in the following table is extracted from clinical studies and post-marketing experience pertaining to the adult population.

The frequency of adverse events cannot be estimated in the paediatric population. The adverse reactions are listed below by SOC (System Organ Class) and by frequency, most frequent reactions first, with the following guidelines: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000) and not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. 4). Description of selected adverse reactions Suppression of pituitary function Due to activation of D2 receptors in the pituitary gland, dopamine suppresses the release of prolactin and thyroid-stimulating hormone (TSH), the latter resulting in a decrease of T4 release from the thyroid gland.

Conversely, dopamine discontinuation may lead to a rebound effect with overshooting release of prolactin, TSH and T4. g. , increased blood flow even to hypoventilated alveolar areas (pulmonary "shunt" formation), specifically in ventilator-dependent patients.

Moreover, dopamine may increase systemic oxygen consumption (VO2). Reporting of suspected adverse reactions 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.

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Avoid co-infusion with other medicinal products. 2). Monitoring of volume, electrolyte and diastolic blood pressure Vasopressors, including dopamine, are generally not indicated in hypovolaemic shock. Once adequate fluid resuscitation has been initiated, vasopressor therapy may be considered in specific cases where blood pressure remains severely low despite adequate fluid resuscitation.

Dopamine hydrochloride should be chosen if inotropic, chronotropic, vasoconstrictive effects and an increase in peripheral venous resistance is required. However, the use of vasopressors in haemorrhagic or hypovolemic shock should be approached cautiously and under close monitoring.

Excess administration of potassium-free solutions may result in significant hypokalaemia. 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.

Constant evaluation of therapy in terms of blood volume, augmentation of cardiac contractility, and distribution of peripheral perfusion and urinary output is required for patients of any age. Monitoring of potential cardiac adverse reactions Careful monitoring should be performed for dysrhythmia and tachycardia and if present consideration should be given to reducing the infusion rate or discontinuing dopamine hydrochloride if clinically appropriate.

Any reversible causes of tachycardia such as volume depletion, hypoxia or pain should be corrected and tachycardia should be controlled. Peripheral vascular disease Patients 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.

1. - Patients with phaeochromocytoma or hyperthyroidism. - Presence of uncorrected atrial or ventricular tachyarrhythmias or ventricular fibrillation. 5).