PHENYLEPHRINE

Posology Adults Intravenous bolus injection:

Normal dose is 50 to 100 micrograms, which can be repeated until the desired effect is obtained. One bolus dose should not exceed 100 micrograms.

Continuous infusion:

Initial dose is 25 to 50 micrograms/min. Doses can be increased up to 100 micrograms/min or reduced in order to maintain systolic blood pressure close to the normal value. Doses between 25 and 100 micrograms/min have been considered effective.

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.

Elderly:

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:

Intravenous bolus injection or intravenous infusion. This medicine should only be administered by healthcare professionals with appropriate training and relevant experience.

Summary of the safety profile The most common adverse events of phenylephrine are bradycardia, hypertensive episodes, nausea and vomiting. Hypertension is more frequent with high doses. The most commonly reported cardiovascular adverse event appears to be bradycardia, likely due to baroreceptor-mediated vagal stimulation and consistent with the pharmacological effect of phenylephrine.

List of adverse reactions Frequency:

Not known (cannot be estimated from available data) 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:

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 peripheral 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); - aneurysm; - closed angle glaucoma.

Phenylephrine can induce a reduction in cardiac output. Consequently, it must be administered with extreme caution to patients with arteriosclerosis, to 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 when administering phenylephrine injection to avoid extravasation, since this may cause tissue necrosis.

This medicinal product contains sodium. 4 mmol (78 mg) sodium per vial, equivalent to 4 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

1. 5); - in patients with severe hypertension or peripheral vascular disease due to the risk of ischemic gangrene or vascular thrombosis; - in patients with severe hyperthyroidism.