Neoatricon · 4.8 Undesirable effects · 1

HOS-288954 · has-adverse-reaction-information · PDF-Seite 8

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. Table 1: Adverse reactions identified in clinical studies and post-marketing System organ class Frequency Adverse reaction Infections and infestations Uncommon Gangrene Not known Infection Immune system disorders Unknown Anaphylactic reactions* Endocrine disorders Not known Suppression of pituitary function Nervous system disorders Common Headache Eye disorders Uncommon Mydriasis Cardiac disorders Common Ectopic heart beats Sinus tachycardia Anginal pain Palpitation 8  Uncommon Aberrant conduction Bradycardia Widened QRS complex Supraventricular tachycardia Ventricular tachycardia up to ventricular fibrillation Not known Severe palpitations Vascular disorders Common Hypotension

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HOS-288950 · has-contraindication-information · PDF-Seite 4

- Patients with hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Patients with phaeochromocytoma or hyperthyroidism. - Presence of uncorrected atrial or ventricular tachyarrhythmias or ventricular fibrillation. - Combination with cyclopropane and halogenated hydrocarbon anaesthetics (see section 4.5).

HOS-288949 · has-indication-information · PDF-Seite 2

Treatment of hypotension in haemodynamically unstable neonates, infants and children < 18 years.

HOS-288952 · has-interaction-information · PDF-Seite 6

6 Anaesthetics The myocardium is sensitised by cyclopropane or halogenated hydrocarbon anaesthetics, and these medicinal products are contraindicated with dopamine hydrochloride (see section 4.3). This interaction applies both to pressor activity and cardiac beta adrenergic stimulation. Alpha and beta blockers It is not recommended to use dopamine with alpha and beta blockers. The cardiac effects of dopamine hydrochloride are antagonised by β-adrenergic blocking agents such as propranolol acebutolol, atenolol, bisoprolol, nadolol, nebivolol, and metoprolol, and the peripheral vasoconstriction caused by high doses of dopamine hydrochloride is antagonised by α adrenergic blocking agents (e.g. doxazosin, prazosin, terazosin). MAO inhibitors It is not recommended to use dopamine with MAO inhibitors. MAO inhibitors (e.g. isocarboxazid, phenelzine, tranylcypromine, rasagiline, selegiline, linezolid) potentiate the effect of dopamine hydrochloride and its duration of action. Patients who have been treated with MAO inhibitors prior to administration of dopamine hydrochloride will therefore require a substantially reduced dose (see sections 4.2, 4.4 and 5.2). Phenytoin Administration of IV phenytoin to patients receiving dopamine hydrochloride has resulted in hypotension, bradycardia and cardiac arrest; it is recommended that phenytoin should be used with extreme caution, if at all, in patients receiving dopamine hydrochloride. Diuretic agents It is not recommended to use dopamine with diuretic agents (e.g. bumetanide, torsemide, and furosemide). Dopamine hydrochloride may increase the effect of diuretic agents. Ergot alkaloids The combination of dopamine hydrochloride with ergot alkaloids (e.g., ergotamine) should be avoided because of the possibility of excessive peripheral vasoconstriction, increasing the risk of gangrene. Tricyclic antidepressants and guanethidine Tricyclic antidepressants (e.g. amitriptyline, desipramine, doxepin, imipramine, nortriptyline) and guanethidine may potentiate the pressor response to dopamine hydrochloride. Inactivation of dopamine hydrochloride by addition of alkalizing substances Dopamine hydrochloride is inactivated in alkaline solution please refer to section 4.4 and section 6.2. Metoclopramide It is not recommended to use dopamine with metoclopramide as metoclopramide can impair the dopamine hydrochloride effect. Blood glucose levels Dopamine hydrochloride may increase the blood glucose level and may theref

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HOS-288953 · has-pregnancy-information · PDF-Seite 8

Pregnancy There are limited amount of data from the use of dopamine hydrochloride in pregnant woman. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Neoatricon is not recommended during pregnancy and in women of childbearing potential not using contraception. Breast-feeding It is not known if dopamine hydrochloride is excreted in human milk. However, because of the short plasma half-life of dopamine hydrochloride at therapeutic doses no effects on the breastfed infants are anticipated. Therefore, Neoatricon can be used during breast-feeding. See section 4.4 for information on prolactin. Fertility No data available.

HOS-288951 · has-warning-information · PDF-Seite 4

Avoid co-infusion with other medicinal products. Mono-amine oxidase (MAO) inhibitors To avoid potentiation patients who have been treated with MAO inhibitors prior to dopamine hydrochloride should be given reduced doses of dopamine hydrochloride (see sections 4.2, 4.5 and 5.2). Monitoring of volume, electrolyte and diastolic blood pressure Vasopressors, including dopamine hydrochloride, are generally not indicated in hypovolemic 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. If a disproportionate rise in diastolic pressure (i.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. 4 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 hydrochloride infusion should be weighed against the risk of possible necrosis. These changes may be reversed by decreasing the rate or discontinuing the infusion. Even

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