- phenylephrine hydrochloride
This information is intended for use by health professionals
AdultsApply one drop to each eye. If necessary, this dose may be repeated once only, at least one hour after the first drop.
Paediatric and elderly populationThe use of phenylephrine 10% solution is contraindicated in these groups because of the increased risks of systemic toxicity.(see section 4.3)Method of administrationThe use of a drop of topical anaesthetic a few minutes before instillation of phenylephrine is recommended to prevent stinging.
Anti-hypertensive AgentsTopical phenylephrine should not be used as it may reverse the action of many anti-hypertensive agents with possibly fatal consequences.
Monoamine Oxidase InhibitorsThere is an increased risk of adrenergic reactions when used simultaneously with, or up to three weeks after, the administration of MAOIs.
Tricyclic Anti-depressantsThe pressor response to adrenergic agents and the risk of cardiac arrhythmia may be potentiated in patients receiving tricyclic anti-depressants (or within several days of their discontinuation).
HalothaneBecause of the increased risk of ventricular fibrillation, phenylephrine should be used with caution during general anaesthesia with anaesthetic agents which sensitise the myocardium to sympathomimetics.
Cardiac Glycosides or QuinidineThere is an increased risk of arrhythmias.
The frequency of the undesirable effects are not known (cannot be estimated from the available data).
Immune System DisordersHypersensitivity
Eye DisordersEye pain, eye irritation, vision blurred, photophobia, allergic conjunctivitis.
Cardiac disordersPalpitations, tachycardia, extrasystoles, arrhythmias.Arteriospasm coronary, ventricular arrhythmia and myocardial infarction. These sometimes fatal reactions have usually occurred in patients with pre-existing cardiovascular disease.
Paediatric populationRespiratory, thoracic and mediastinal disordersPulmonary oedema 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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard
Mechanism of actionPhenylephrine is a direct acting sympathomimetic agent. It causes mydriasis via the stimulation of alpha receptors. There is almost no cycloplegic effect.
Pharmacodynamic effectsMaximal mydriasis occurs in 60- 90 minutes with recovery after 5 - 7 hours. The mydriatic effects of phenylephrine can be reversed with thymoxamine.
AbsorptionPhenylephrine is a weak base at physiological pH. The extent of ocular penetration is determined by the condition of the cornea. A healthy cornea presents a physical barrier, in addition to which, some metabolic activity may occur. Where the corneal epithelium is damaged, the effect of the barrier and the extent of metabolism are reduced, leading to greater absorption
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