Summary of Product Characteristics Updated 09-Aug-2016 | Bausch & Lomb U.K Limited
Adults, including the elderly populationApply one drop topically to each eye. If necessary, this dose may be repeated once only, at least one hour after the first drop.
Paediatric populationApply one drop topically to the eye. It is not usually necessary to exceed this dose.Phenylephrine 2.5%w/v eye drops may be combined with other mydriatics/cycloplegics to produce adequate mydriasis/cycloplegia. Heavily pigmented irides may require larger doses and caution should be exercised to avoid overdosage. The use in preterm and newborn infants is not recommended unless clearly necessary and only with caution because of safety concerns associated with the risk of systemic adverse reactions including transient increases in blood pressure. If treatment is medically justified the lowest possible concentration and dose should be used and instillation of more than one drop per eye must be avoided (see section 4.4).
Method of administrationThe use of a drop of topical anaesthetic a few minutes before instillation of phenylephrine is recommended to prevent stinging.Especially in infants, children and the elderly, it is advised to minimise systemic absorption and the risk for systemic adverse reactions by compressing the lacrimal sac at the medial canthus or gently closing the eye for a few minutes after instillation. To minimise cutaneous absorption, excess fluid should be wiped away from the periocular area (see also section 4.4).
Paediatric populationUse with caution in children. The lowest dose necessary to produce the desired effect should always be used (see section 4.2). Parents should be warned not to get this preparation in their children's mouth or cheeks and to wash their hands and the child's hands or cheeks following administration. Both full-term, but especially low birth weight and premature infants may be at an increased risk for systemic adverse reactions including transient increases in blood pressure which potentially increases the risk of intraventricular haemorrhage. The infant should be monitored after instillation and routines to adequately deal with emergency situations should be in place.
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 AntidepressantsThe pressor response to adrenergic agents and the risk of cardiac arrythmia may be potentiated in patients receiving tricyclic antidepressants (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 arrythmias.
Immune System DisordersHypersensitivity
Eye DisordersEye pain, eye irritation, blurred vision, photophobia, conjunctivitis allergic.
Cardiac disordersPalpitations, tachycardia, extrasystoles, arrythmias.
Vascular disordersHypertensionSerious cardiovascular reactions including arteriospasm coronary, ventricular arrhythmia and myocardial infarction have occurred following topical use of 10% phenylephrine. These sometimes fatal reactions have usually occurred in patients with pre-existing cardiovascular disease.
Paediatric populationPeriorbital pallor in preterm patients 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 actionIt 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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