Dopamine Hcl Fresenius 200 Mg/5 Ml Solution

DOPAMINE HCl 200 mg/5 ml FRESENIUS is used in the treatment of:

• Shock unresponsive to replacement of fluid loss and especially where renal function is impaired.
• To correct haemodynamic imbalances associated with myocardial infarction, trauma, septic shock, and cardiac surgery.
• It is also used in the management of chronic refractory congestive heart failure.

Posology: Hypovolaemia should be fully corrected, if possible, before DOPAMINE HCl 200 mg/5 ml FRESENIUS is used. The initial rate is 2 to 5 u03bcg per kg body mass per minute, gradually increased by 5 to 10 u03bcg per kg per minute according to the patientu2019s blood pressure, cardiac output and urine output. Up to 20 to 50 u03bcg per kg per minute may be required in seriously ill patients. A reduction in urine flow, without hypotension, may indicate a need to reduce the dose. To avoid tissue necrosis DOPAMINE HCl 200 mg/5 ml FRESENIUS is best administered into a large lumen vein. Large veins of the antecubital fossa are preferred to veins in the dorsum of the hand or ankle. Less suitable infusion sites should be used only if the patientu2019s condition requires immediate attention. More suitable sites should be used as rapidly as possible.

Method of administration: For intravenous infusion only. DOPAMINE HCl 200 mg/5 ml FRESENIUS should be given via an infusion pump or another suitable metering device to control the rate of flow in drops per minute. DOPAMINE HCl 200 mg/5 ml FRESENIUS MUST be diluted before administration to the patient. Dilution should be made just prior to administration. For instructions on reconstitution of DOPAMINE HCl 200 mg/5 ml FRESENIUS before administration, see section 6.6.

• Patients with known hypersensitivity to dopamine hydrochloride or to any of the excipients listed in section 6.1.
• The safety of DOPAMINE HCl 200 mg/5 ml FRESENIUS in pregnancy and lactation has not been established.
• The safety and efficacy of DOPAMINE HCl 200 mg/5 ml FRESENIUS in children have not been established.
• DOPAMINE HCl 200 mg/5 ml FRESENIUS should not be given to patients receiving monoamine oxidase (MAO) inhibitors or within 14 days of discontinuing such treatment.
• DOPAMINE HCl 200 mg/5 ml FRESENIUS should not be used in patients suffering from phaeochromocytoma or in the presence of uncorrected tachydysrhythmias or ventricular fibrillation.

DOPAMINE HCl 200 mg/5 ml FRESENIUS should not be used in patients with hyperthyroidism. At high concentrations DOPAMINE HCl 200 mg/5 ml FRESENIUS activates vascular alfa 1 adrenergic receptors, leading to vasoconstriction. Therefore, when DOPAMINE HCl 200 mg/5 ml FRESENIUS is used in life-threatening states of shock, blood pressure and renal function must be monitored. Abrupt discontinuation of the infusion can lead to vascular collapse. DOPAMINE HCl 200 mg/5 ml FRESENIUS should be avoided or extreme caution must be exercised when using DOPAMINE HCl 200 mg/5 ml FRESENIUS together with anaesthetics like cyclopropane, halothane and other halogenated anaesthetics (see section 4.5 below). DOPAMINE HCl 200 mg/5 ml FRESENIUS should be infused into a large vein whenever possible to prevent the possibility of infiltration of perivascular tissue adjacent to the infusion site. Extravasation of dopamine hydrochloride may result in tissue necrosis and sloughing. Angina may be precipitated in patients with angina pectoris. Administer with care to patients with diabetes mellitus or closed angle glaucoma. Great care is also needed in patients with cardiovascular disease such as ischaemic heart disease, dysrhythmia or tachycardia, occlusive vascular disorders including arteriosclerosis, hypertension, or aneurysms. Regular clinical and biochemical assessment is necessary to monitor changes in fluid, electrolyte or acid-base status during prolonged treatment and whenever the patient condition demands it. The infusion site should be continuously monitored for free flow. Close monitoring of the following parameters u2013 urine flow, cardiac output and blood pressure u2013 during dopamine hydrochloride infusion is necessary.

It is recommended that on gradual discontinuation of dopamine hydrochloride, care should be taken to avoid undue hypotension associated with very low dosage levels where vasodilatation could predominate. DOPAMINE HCl 200 mg/5 ml FRESENIUS should be used with caution in patients with benign prostatic hyperplasia with urinary retention. Excess administration of potassium-free solutions may result in significant hypokalaemia. The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary oedema. DOPAMINE HCl 200 mg/5 ml FRESENIUS should not be added to sodium bicarbonate or other alkaline solution as medicine inactivation will occur. Conditions like hypoxia, hypercapnia and acidosis can reduce dopamine efficacy and/or increase the incidence of adverse events and should therefore be identified and corrected before or during administration of DOPAMINE HCl 200 mg/5 ml FRESENIUS. If tachydysrhythmias or increase in ectopic beats are observed, DOPAMINE HCl 200 mg/5 ml FRESENIUS should be reduced, if possible. Hypovolaemia should be corrected where necessary prior to DOPAMINE HCl 200 mg/5 ml FRESENIUS infusion. Low doses should be used in shock due to acute myocardial infarction. 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. Patients with a history of peripheral vascular disease 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 HCl 200 mg/5 ml FRESENIUS infusion should be weighed against the risk of possible necrosis. These changes may be reversed by decreasing the rate or discontinuing the infusion. Ischaemia can be reversed by infiltration of the affected area with 10 u2013 15 ml of saline containing 5 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. Dextrose solutions should be used with caution in patients with known subclinical or overt diabetes mellitus. As the effect of dopamine on impaired renal and hepatic function is not known, close monitoring is advised. DOPAMINE HCl 200 mg/5 ml FRESENIUS contains potassium metabisulphite, an excipient that may rarely cause severe hypersensitivity reactions and bronchospasm.

Anaesthetics: DOPAMINE HCl 200 mg/5 ml FRESENIUS should be used with extreme caution and reduced dosage in patients receiving hydrocarbon anaesthetics, as there is an increased risk of severe ventricular dysrhythmias. The results of animal studies indicate that ventricular dysrhythmias induced by DOPAMINE HCl 200 mg/5 ml FRESENIUS during anaesthesia can be reversed by propranolol.

Tricyclic antidepressants and guanethidine: Tricyclic antidepressant medicines and guanethidine may potentiate the cardiovascular effects of DOPAMINE HCl 200 mg/5 ml FRESENIUS.

Alpha and beta blockers: Beta adrenergic blocking medicines (e.g. propranolol) antagonise the cardiac effects of dopamine hydrochloride. The peripheral vasoconstriction caused by high doses of dopamine is antagonised by alpha adrenergic blocking medicines.

Monoamine oxidase inhibitors (MAOIs): MAOIs (or for 3 weeks after withdrawal) prolong and intensify the effects of DOPAMINE HCl 200 mg/5 ml FRESENIUS (see section 4.3).

Reserpine, glycoside, metoclopramide: The risk of dysrhythmias is greater in patients taking medicines that impact to the conduction in the heart, thyroid hormones and antidysrhythmics. If concurrent use of dopamine hydrochloride and digitalis glycosides is necessary, there may be an increased risk of cardiac dysrhythmias.

Ergotamine: DOPAMINE HCl 200 mg/5 ml FRESENIUS and ergot derivatives used concurrently may result in severe hypertension. The use of ergotamine with dopamine hydrochloride may produce peripheral vascular ischaemia and potentiate the possibility of gangrene.

Phenytoin: Administration of IV phenytoin to patients receiving dopamine hydrochloride may result in bradycardia and hypotension; administer with care. DOPAMINE HCl 200 mg/5 ml FRESENIUS may increase the effect of diuretic medicines. Dopaminergic medicines (entacapone) may enhance the effects of DOPAMINE HCl 200 mg/5 ml FRESENIUS when both medicines are given simultaneously. Doxapram may cause hypertension in patients receiving DOPAMINE HCl 200 mg/5 ml FRESENIUS.

The safety of DOPAMINE HCl 200 mg/5 ml FRESENIUS in pregnancy and lactation has not been established (see section 4.3). No information on fertility is available.

Patients should be advised to use caution when driving a car or operating machinery until they are reasonably certain that their performance is not affected by DOPAMINE HCl 200 mg/5 ml FRESENIUS.

Infections and infestations: Less frequent: Gangrene.

Nervous system disorders: Frequent: Headache, anxiety, tremor. Less frequent: Piloerection.

Eye disorders: Less frequent: Mydriasis.

Cardiac disorders: Frequent: Ectopic heartbeats, tachycardia, anginal pain, palpitations. Less frequent: Aberrant conduction, bradycardia, widened QRS complex, hypertension, fatal ventricular dysrhythmias.

Vascular disorders: Frequent: Hypotension, vasoconstriction.

Respiratory, thoracic and mediastinal disorders: Frequent: Dyspnoea.

Gastrointestinal disorders: Frequent: Nausea, vomiting.

Renal and urinary disorders: Frequent: Polyuria. Less frequent: Azotaemia.

Investigations: Frequent: Serum glucose level increased, blood urine nitrogen (BUN) level increased.

Description of selected adverse reactions: Gangrene of the extremities has occurred following higher doses and in lower doses in patients with pre-existing vascular disease.

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of DOPAMINE HCl 200 mg/5 ml FRESENIUS is important. It allows continued monitoring of the benefit/risk balance of DOPAMINE HCl 200 mg/5 ml FRESENIUS. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.

Health care providers are asked to report any suspected adverse drug reactions to the Holder of the Certificate of Registration at the following email address: [email protected] and to the relevant medicineu2019s regulatory authority in the country where the product is marketed.

See section 4.8. In case of accidental overdosage, as evidenced by excessive blood pressure elevation, reduce rate of administration or temporarily discontinue DOPAMINE HCl 200 mg/5 ml FRESENIUS until the patientu2019s condition stabilises. Further treatment is symptomatic and supportive. Management of peripheral ischaemia: To prevent sloughing and necrosis in ischaemic areas, the area should be infiltrated as soon as possible with 10 to 15 ml of saline solution containing from 5 to 10 mg of phentolamine (alpha adrenoreceptor blocker). A syringe with a fine hypodermic needle should be used, and the solution liberally infiltrated throughout the ischaemic areas. Sympathetic blockade with phentolamine causes local hyperaemic changes if the area is infiltrated within 12 hours.