PHENYLEPHRINE

Intravenous bolus injection:

Normal dose is 50 to 100 micrograms, which can be repeated until desired effect is attained. One bolus dose should not exceed 100 micrograms. 2.

Continuous infusion:

Initial dose is 25 to 50 micrograms/min. The doses may be increased or decreased to maintain the systolic blood pressure close to the normal value. Doses between 25 and 100 micrograms/min have been assessed to be 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.

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, by intravenous infusion. Phenylephrine 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 The following adverse reactions have been reported during the use of phenylephrine, although their frequency has not been clearly established: Immune system disorders: Not Known: hypersensitivity Psychiatric disorders: Not Known: Anxiety, excitability, agitation, psychotic states, confusion.

Nervous system disorders:

Not Known: Headache, brain haemorrhage, vertigo, fainting, torpor, insomnia, paresthesia, tremor.

Eye disorders:

Not Known: Mydriasis, aggravation of pre-existing closed angle glaucoma.

Cardiac disorders:

Not Known: Reflex bradycardia, reflex tachycardia, cardiac arrhythmia, anginal pain, palpitations, cardiac arrest.

Vascular disorders:

Not Known: Hypertension, hypotension, flushing, hypertensive crisis Respiratory, thoracic and mediastinal disorders: Not Known: Dyspnea, pulmonary oedema.

Gastrointestinal disorders:

Not Known: Nausea, Vomiting, hypersalivation.

Skin and subcutaneous tissue disorders:

Not Known: Sweating, temporary tingling, coolness of the skin, pallor or skin blanching, piloerection Renal and urinary disorders: Not Known: Difficulty urinating, urinary retention.

Caution is required when administering phenylephrine in patients with: - pre-existing cardiovascular disease - diabetes mellitus - arterial hypertension - ischemic heart disease - arrhythmia - bradycardia - incomplete heart block - tachycardia - occlusive peripheral vascular disease including arteriosclerosis - aneurysm - in patients with angina pectoris, phenylephrine may precipitate or exacerbate angina.

- angle closure glaucoma Phenylephrine may induce a reduction in cardiac output. Therefore, caution is required when administering to patients with atherosclerosis, the elderly, and patients with compromised cerebral or coronary circulation.

In patients with severe heart failure or cardiogenic shock, phenylephrine may cause worsening of heart failure as a consequence of the induced vasoconstriction and increased afterload. 8). 3% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

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