Pharmacokinetics in children

Phenylephrine administered in the eye can be absorbed through the nasal mucosa and the eye.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Infants: administration of eye drops with concentrations of 2.5%) may cause systemic effects such as severe headache, palpitations, severe hypertension, subarachnoid hemorrhage and uncommonly fatal myocardial infarction (especially in pre-existing cardiovascular disease). Pulmonary edema and peri-orbital pallor have been reported in preterm neonates.

Older children: Eye drops with concentration 10% may cause systemic effects such as severe headache, palpitations, severe hypertension, subarachnoid hemorrhage and uncommonly fatal myocardial infarction (especially in pre-existing cardiovascular disease). Furthermore, pulmonary edema has been reported in children.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

In infants, weigh the benefits against the risks.

Watch out for severe systemic side-effects: hypertension, subarachnoidal bleeding, arrhythmia, myocardial infarction. Minimize systemic effect by briefly pressing the tear duct during and immediately after administration. Prevent systemic and local skin absorption as much as possible e.g. wipe excessive fluid after drop instillation. 

Both tachycardia and bradycardia can occur during ROP screening. This should be taken into account considering the vulnerability and complex problems with premature children.

In combination with tropicamide, systemic effects may particularly be concerned with phenylephrine. Consider monitoring heart rate and blood pressure until 1-2 hours after administration in neonates. It's recommended to keep the light dimmed in the hours after dilation to prevent discomfort due to high light exposure, as pupils cannot react. 

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

• SENSORY ORGANS
• OPHTHALMOLOGICALS

MYDRIATICS AND CYCLOPLEGICS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

References

1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2008
2. Anderson HA, et al, Comparison of two drug combinations for dilating dark irides, Optom Vis Sci, 2010, Feb;87(2), 120-4
3. Bolt B, et al, A mydriatic eye-drop combination without systemic effects for premature infants: a prospective double-blind study, J Pediatr Ophthalmol Strabismus, 1992, May-Jun;29(3), 157-62
4. Caputo AR, et al, Systemic response to mydriatic eyedrops in neonates: mydriatics in neonates, J Pediatr Ophthalmol Strabismus, 1978, Mar-Apr;15(2), 109-22
5. Chew C, et al, Comparison of mydriatic regimens used in screening for retinopathy of prematurity in preterm infants with dark irides, J Pediatr Ophthalmol Strabismus, 2005, May-Jun;42(3), 166-73
6. Fan DS, et al, Comparative study on the safety and efficacy of different cycloplegic agents in children with darkly pigmented irides, Clin Experiment Ophthalmol, 2004, Oct;32(5), 462-7
7. Khoo BK, et al, Combination cyclopentolate and phenylephrine for mydriasis in premature infants with heavily pigmented irides, J Pediatr Ophthalmol Strabismus, 2000, Jan-Feb;37(1), 15-20
8. Borromeo-McGrail V et al, Systemic hypertension following ocular administration of 10 per cent phenylephrine in the neonate, Pediatrics, 1973, Jun;51(6), 1032-6
9. LAREB, Signal Fenylefrine oogdruppels en bradycardie bij neonaten
10. Nederlands Oogheelkunde Gezelschap in samenwerking met de Nederlandse Vereniging voor Kindergeneeskunde, Guideline Prematuren retinopathie 13-11-2023, https://richtlijnendatabase.nl/nieuws/herziene_richtlijn_prematurenretinopathie_rop.html
11. Editorial board Kinderformularium, Expert opinie
12. Bausch & Lomb Ireland Limited, SmPC Minims Phenylephrine 2.5mg/ml, eyedrops solution (RVG 14872). 24-03-2022, www.geneesmiddelinformatiebank.nl
13. Oğüt MS, et al., Effects and side effects of mydriatic eyedrops in neonates. , Eur J Ophthalmol., 1996, 6(2), 192-6
14. Alpay A, et al., Efficiency and safety of phenylephrine and tropicamide used in premature retinopathy: a prospective observational study., BMC Pediatr., 2019, 19(1), 415
15. Laboratoires Théa, Monofree Fenylefrine HCL 5%, eyedrops, solution (RVG 01728) 25-09-2017. , www.geneesmiddelinformatiebank.nl
16. Kremer LJ, et al., Systematic review of mydriatics used for screening of retinopathy in premature infants., BMJ Paediatr Open., 2019, 3(1), e000448
17. Dincer E, et al., Early Hemodynamic Effects of Mydriatic Eye Drops in Preterm Infants., Am J Perinatol, 2024, May;41(S 01):, e324-e330
18. Werkgroep Neonatale Farmacologie NVK sectie Neonatologie., Expert opinion NEODOSE, 05-03-2024
19. Laboratoires Théa, Monofree Fenylefrine HCL 5%, eyedrops, solution (RVG 01728) 25-09-2017., www.geneesmiddelinformatiebank.nl
20. Oğüt MS, et al., Effects and side effects of mydriatic eyedrops in neonates., Eur J Ophthalmol., 1996, 6(2), 192-6

Changes

Therapeutic Drug Monitoring

Overdose