PHENYLEPHRINE UNIMEDIC

Posology To be administered by intravenous injection or infusion. Whenever solution and container permit, parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration. This product should be administered after appropriate dilution.

6 for Instructions on dilution.

Adults Intravenous bolus injections:

Initially repeated bolus doses of 50 to 100 micrograms (1-2 ml of the 50 micrograms/ml diluted solution or 0,5-1 ml of the 100 micrograms/ml diluted solution) are given until the desired effect is attained and before the continuous infusion is started.

6) Continuous infusion: Large dose variations occur. Initial dose is commonly in the range of 25 to 50 micrograms/min. The doses may subsequently be increased or decreased to maintain the systolic blood pressure close to the normal (target) value.

Doses between 25 to 100 micrograms/min have been assessed to be effective. If doses higher than 50 micrograms/min are required or there is a tendency to reflex bradycardia a switch to another vasopressor drug should be done. The blood pressure must be monitored regularly.

Renal impairment:

Lower doses of phenylephrine may be needed in patients with impaired renal function.

Hepatic impairment:

Higher doses of phenylephrine may be needed in patients with cirrhosis of the liver.

Older people:

Treatment of the elderly should be carried out with care.

Paediatric population:

The safety and efficacy of phenylephrine in children have not been established. No data are available.

Method of administration:

Parenteral administration. 10 mg/ml: concentrate for dilution to injections or infusion. Phenylephrine, 10 mg/ml, should only be administered by health care professionals with appropriate training and relevant experience. Ensure that the needle is correctly inserted and avoid extravasation because of the risk of tissue damage/ ischemia.

Summary of the safety profile The most common adverse events of phenylephrine reported in literature are bradycardia, hypertensive episodes, nausea and vomiting. Most undesired effects of phenylephrine are dose dependent. Tabulated summary of adverse reactions The adverse reactions listed by system organ class and frequency.

Frequencies: not known (cannot be estimated from the available data) Table 1 Tabulated list of Adverse reactions Immune system disorders Not known Hypersensitivity Psychiatric disorders Not Known Anxiety, excitability, agitation, psychotic states, confusion Nervous system disorders Not Known Headache, nervousness, insomnia, paresthesia, tremor Eye disorders Not Known Mydriasis, aggravation of pre-existing angle-closure glaucoma Cardiac disorders Not Known Reflex bradycardia, tachycardia, palpitations, hypertension, arrhythmia, angina pectoris, myocardial ischemia Vascular disorders Not Known Cerebral haemorrhage, hypertensive crisis Respiratory, thoracic and mediastinal disorders Not Known Dyspnoea, pulmonary oedema Gastrointestinal disorders Not known: Nausea, vomiting Skin and subcutaneous tissue disorders Not known Sweating, pallor or skin blanching, piloerection, skin necrosis with extravasation Musculoskeletal and connective tissue disorders Not known Muscular weakness Renal and urinary disorders Renal and urinary disorders: Not Known Difficulty in micturition and urinary retention Description of selected adverse reactions As phenylephrine has been frequently used in the critical care setting in patients with hypotension and shock, some of the reported serious adverse events and deaths are probably related to the underlying disease and not related to the use of phenylephrine.

4). 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

The arterial blood pressure should be monitored during treatment. Phenylephrine should be administered with care to patients with: • diabetes mellitus; • arterial hypertension; • uncontrolled hyperthyroidism; • coronary heart disease and chronic heart conditions; • non-severe pheripheral vascular insufficiency; • bradycardia; • partial heart block; • tachycardia; • arrhythmias; • angina pectoris (phenylephrine can precipitate or exacerbate angina in patients with coronary artery disease and history of angina); • aneurysma; • closed angle glaucoma; Phenylephrine can induce a reduction in cardiac output.

Therefore, care should be exercised in administering to patients with arteriosclerosis, the elderly and to patients with impaired cerebral or coronary circulation. In patients with reduced cardiac output or coronary vascular disease, vital organ functions should be closely monitored and dose reduction should be considered when systemic blood pressure is near the lower end of the target range.

In patients with serious heart failure or cardiogenic shock, phenylephrine may cause deterioration in the heart failure as a consequence of the induced vasoconstriction (increase in afterload). Particular attention should be paid to phenylephrine injection to avoid extravasation, since this may cause tissue necrosis.

e. is essentially sodium-free.

5); - in patients with severe hyperthyroidism.