Dopamine Fresenius 200 mg/5 ml is a medicinal product of the therapeutic group of the so called catecholamines. Dopamine is an antihypotensive.

Dopamine Fresenius 200 mg/5 ml is used for: Shock or imminent shock, e. g. in cases of:

- heart failure, including heart failure caused by myocardial infarction (cardiogenic shock)

- postoperative shock - severe infections (infectious-toxic shock)

- hypersensitivity reactions (anaphylactic shock)

- severe fall in blood pressure (severe hypotension)

- incipient or manifest acute renal failure.

Do not use Dopamine Fresenius 200 mg/5 ml

- Known hypersensitivity to dopamine or one of the other ingredients

- Adrenal tumour (Phaeochromocytoma) - Particular form of glaucoma (Narrow angle glaucoma)

- Over-function of the thyroid (Hyperthyroidism)

- Enlargement of the prostate gland with residual urine (Prostate adenoma)

- Atrial fibrillation with rapid conduction (Tachyarrhythmia)

- Ventricular fibrillation

- Hypovolaemia (volume deficiency should be replaced before treatment with Dopamine Fresenius 200 mg/5 ml is commenced)

Warnings and precautions

Talk to your doctor healthcare professional before using Dopamine Fresenius 200 mg/5 ml, if you are suffering from organic cardiovascular alterations, e. g.: - certain heart diseases such as coronary heart disease and angina pectoris  - occlusive arterial diseases (e. g. arteriosclerosis, arterial embolism, Morbus Raynaud, damage due to cold temperatures such as frostbite, diabetic microangiopathy, Morbus Winiwarter-Buerger) - cardiac arrhytmia. Dopamine should only be administered with extreme caution in association with inhalation anaesthesia induced using halogenated hydrocarbon anaesthetics. Care must be taken to keep the airways clear in drowsy patients, because of the risk of aspiration. Do not inject i.v. as an undiluted bolus! Accidental paravenous infusion can result in local necrosis. Thus, the infusion should preferably be administered by a central venous catheter. For the same reason (tissue injury) Dopamin Fresenius must not be administered subcutaneously or intramuscularly. An intra-arterial administration has absolutely to be avoided as well as the risk of a vasoconstrictive effect exists. As an emergency countermeasure, immediate local infiltration of a vasodilator in the extravasate is advisable. In individual cases glyceryl trinitrate ointment was topically applied in addition. Evidence based data from clinical studies about the mode and the extent of the effectiveness of this emergency measure does not exist (see also section 4 "Possible side effects").

Children

There are insufficient data available in children to date to permit definite recommendations to be given for suitable doses in this patient group.

Other medicines and Dopamine Fresenius 200 mg/5 ml

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines. Alkalizing substances should not be added to Dopamine Fresenius 200 mg/5 ml as this leads to inactivation of dopamine. Metoclopramide (a medicinal product for speeding up the gastrointestinal activity) can impair the desired effects of dopamine. On concomitant administration of dopamine and guanethidine (a medicinal product for treatment of high blood pressure) the sympathomimetic effects of dopamine are increased. Concomitant administration of monoamine oxidase (MAO) inhibitors and medicinal products, being like Dopamine Fresenius 200 mg/5 ml among the group of sympathomimetics, can lead to life-threatening side effects (e. g. sudden high blood pressure (hypertensive crisis), circulatory failure, bleeding in your brain (intracranial bleeding) and cardiac arrhythmia). MAO inhibitors enhance and prolong the effects of dopamine. Patients treated with MAO inhibitors require a considerably reduced dose of dopamine (commence treatment with 1/10th of the normal dose at the most). Concomitant administration of dopamine and diuretics can have additive and potentiating effects. Further interactions are known between dopamine and tricyclic antidepressants, anaesthetics (increase tendency to cardiac arrhythmia) or phenytoin (fall in blood pressure, bradycardia, cardiac arrest). The combination of dopamine with ergot alkaloids can lead to maximal peripheral vasoconstriction with a risk of gangrene. Halogenated hydrocarbon anaesthetics may sensitize the autonomous cardiac centres and the myocardium to certain intravenously administered catecholamines, which may possibly increase the risk of cardiac arrhythmia caused by dopamine. Serum glucose levels may be elevated during treatment with dopamine.  Determination of excretion of catecholamines in urine may lead to false-positive results.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. As there is insufficient experience of the use of dopamine hydrochloride during pregnancy in humans, it should only be used in life-threatening situations. There are no data available on whether dopamine hydrochloride passes into mother’s milk. On account of the short plasma half-life of dopamine hydrochloride, breast feeding an infant after intravenous administration would appear to be safe.

Driving and using machines

No special precautions are necessary. This medicinal product is only applied to patients in life-threatening conditions.

Always use Dopamine Fresenius 200 mg/5 ml exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The dose of dopamine must be adjusted for the individual! The required rate of infusion depends on the severity of the shock, individual response to the treatment and the side effects. For each patient the desired effect of dopamine on haemodynamics or kidney function must be individually and gradually adjusted. In the course of gradual adjustment of the dose to obtain the desired increase in systolic blood pressure, the optimal dose for kidney function response may be exceeded. For this reason, after the haemodynamic status of the patient has stabilised, the rate of infusion may need to be reduced. Additional measures such as adequate circulatory volume replacement and exact monitoring of the electrolyte balance etc. should not be overlooked. Unless prescribed otherwise by the doctor:

Adults

Experience has shown that in patients who respond adequately to moderate supportive treatment of the cardiovascular function or blood perfusion of the kidneys, the infusion of dopamine can be started with a dose of 2 - 5 μg/kg bodyweight/minute. In severely ill patients the administration should be commenced with a dose of 5 μg/kg bodyweight/minute and, if necessary, the dose gradually increased stepwise (e. g. every 15 - 30 minutes) by 5 - 10 μg/kg bodyweight/minute to a maximum of 20 - 50 μg/kg bodyweight/minute. The majority of patients respond to doses of up to 20 μg/kg bodyweight/minute. Doses exceeding 20 μg/kg bodyweight/minute can be associated with reduced blood perfusion of the kidneys. In cases of advanced circulatory decompensation dopamine had been administered at a rate of infusion exceeding 50 μg/kg bodyweight/minute. If doses exceeding 50 μg/kg bodyweight/minute are required, it is essential that urine excretion be monitored. If the excretion of urine declines the rate of infusion should be reduced. If there are misgivings concerning administration of larger volumes of fluids, use of higher concentrations of dopamine is preferable to increasing the rate of infusion of solutions with lower dopamine concentrations.

Use in children

There are insufficient data available in children to date to permit definite recommendations to be given for suitable doses in this patient group.

Notes on the preparation of the solution for infusion

For infusion into a vein only (intravenous infusion).

Do not inject intravenously as an undiluted bolus! Dopamine Fresenius 200 mg/5 ml is administered intravenously after dilution with a suitable solution for infusion.

Recommended solutions for infusion: 1. 0.9% Sodium chloride solution for infusion 2. 5% Glucose solution for infusion. The solution for infusion should be freshly prepared immediately prior to each administration. Only clear solutions, without discoloration after addition of Dopamine Fresenius 200 mg/5 ml, should be used for infusion. Ready-to-use solutions for infusion with Dopamine Fresenius 200 mg/5 ml are stable over the usual duration of infusion (maximum 24 hours).

Duration of treatment: Dopamine should be administered by continuous intravenous infusion via a central venous catheter. The duration of the infusion therapy is determined by the clinical requirements and is to be decided by the doctor.

If you use more Dopamine Fresenius 200 mg/5 ml than you should

a) Symptoms of overdose The symptoms are generally caused by the sympathomimetic effects of dopamine. With increasing doses, in addition to the agonistic effects on betareceptors, increased stimulation of alpha-receptors occurs, the vasoconstrictive effects of which can finally become predominant. The following symptoms of overdose can occur: large increase in blood pressure, tachycardia, tachyarrhythmia, increase of the left ventricular end-diastolic pressure with consecutive pulmonary congestion with pulmonary oedema in extreme cases, angina pectoris episodes (particularly in patients with known coronary heart disease), unspecific chest pain, palpitations, nausea, vomiting, sensation of cold in the extremities and cyanosis.

b) Treatment measures in case of overdose As the half-life of dopamine is relatively short, the rate of infusions should be reduced or the infusion interrupted, until the status of the patient has stabilized. If these measures are unsuccessful, administration of phentolamine (short-acting alpha-blocker), beta receptor blockers or nitroglycerin should be considered. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Dopamine Fresenius 200 mg/5 ml can cause side effects, although not everybody gets them.

For the evaluation of side effects the following information on frequency are taken as a basis:

Very common: more than 1 in 10 patients

Common: 1-10 in 100 patients

Uncommon: 1-10 in 1000 patients

Rare: 1-10 in 10000 patients

Very rare: less than 1 in 10000 patients

Not known: frequency cannot be estimated from the available data

Common:

Cardiac arrhythmia (mainly extrasystoles), sinus tachycardia, palpitations, respiratory distress, angina pectoris symptoms, nausea, vomiting, headache, agitation, finger tremor, fall in blood pressure and constriction of blood vessels (vasoconstriction).

Rare:

Supraventricular tachycardia or ventricular tachycardia up to ventricular fibrillation, conduction defects, slowing of the heart rate (bradycardia), prolonged QRS complex, high blood pressure, “standing on end” of body-hair (piloerection), elevated blood urea value.

Not known:

With increasing doses the risk for an increase of the left-ventricular enddiastolic pressure rises. At higher doses (≥ 20 μg/kg bodyweight/minute) the dopaminergic vasodilatation (expansion of blood vessels) in the splanchnicus region (region of supply to the splanchnicus nerve in the abdomen) and renal vascular bed due to stimulation of the alpha-receptors, can reverse and lead to vasoconstriction (constriction of the blood vessels) and reduced blood perfusion of the kidneys.

Necrosis of the skin (decay of skin tissue) and gangrene of the distal part of the extremities can occur, even at low doses. The risk is particularly high in patients with impaired blood perfusion of the distal part of the extremities and after administration of higher doses (≥10 μg/kg bodyweight/minute).

Patients with a history of an arterial occlusive disease (e. g. arteriosclerosis, arterial embolism, Raynaud’s disease, damage due to cold temperatures such as frostbite, diabetic microangiopathy and Buerger’s disease) should be carefully monitored for the slightest changes in skin colour or temperature of the extremities. If a change in skin colour or temperature occurs, this may indicate further deterioration of blood perfusion of the skin.

If an unusually large increase in diastolic blood pressure is observed in patients receiving dopamine (i.e. a marked reduction of blood pressure amplitude), the rate of infusion should be reduced and the patient carefully monitored for further signs of unusual vasoconstrictive activity, unless this effect is intentional.

After surgery in the splanchnicus region or in patients with a tendency to bleeding in the gastrointestinal tract, there is a risk of haemorrhage on account of redistribution of blood flow.

In patients on assisted ventilation, an increase in hypoxemia (reduced concentration of oxygen in arterial blood) was observed, which was attributed to increased blood perfusion of the hypoventilated alveolar regions (pulmonary shunt formation).

Accidental paravenous infusion can lead to local necrosis. For this reason, the infusion should be given via a venous catheter whenever possible (see section 3 “ How to use Dopamine Fresenius 200 mg/5 ml”).

If you get any side effects, talk to your doctor, pharmacist or healthcare professional.

Keep this medicine out of the sight and reach of children. Do not store above 25°C. Store in the outer box to protect the content from light. Do not use this medicine after the expiry date which is stated on the container and the outer carton after EXP/Expiry date. The expiry date refers to the last day of that month.

Shelf life after opening the container or preparation of the ready-to use solution: The shelf life after dilution of the concentrate for solution for infusion is 24 hours at the most.

Only clear solutions, without discoloration after addition of Dopamine Fresenius 200 mg/5 ml, should be used for infusion!