Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Tropicamide

Generic name
Tropicamide
Brand name
ATC Code
S01FA06

Pharmacokinetics in children

No information

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

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

No information is present at this moment.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Available formulations

No information is present at this moment.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Dosages

Mydriasis in eye fundus examination
  • Ocular
    • 1 month up to 18 years
      [2]

      • 0.5 %: at least 15 minutes prior to the procedure: 2 drops at a 5-minute interval. Further if necessary 1-2 drops after 30 minutes.

    • Term neonate
      [2] [4] [8]

      • 0,5 %: 30-60 minutes prior to the examination: 1 drop per dose, repeat 1-2 times with an interval of 5-15 minutes .

    • Gestational age < 37 weeks
      [8] [9] [10] [11] [12]

      • 0,5 %: 30-60 minutes prior to the examination: 1 drop per dose, repeat 1-2 times with an interval of 5-15 minutes .
Uveitis
  • Ocular
    • 1 month up to 18 years
      [1] [2]
      • 0,5 %: 1 drop(s)/dose twice daily.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

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

Central nervous system reactions occur particularly in children, including hallucinations, speech and orientation disorders, behavioral disorders, restlessness, ataxia and convulsions

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

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

Minimize systemic effects, by briefly pressing the tear duct closed during and immediately after administration. Prevent the systemic and local skin absorption as much as possible, e.g. wipe excessive fluid after drop instillation.

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

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Interactions

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

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Anticholinergics
S01FA01
S01FA04
S01FA05

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Bausch & Lomb Pharma, SPC Minims tropicamide (RVG 10166) 05-04-2022, www.geneesmiddeleninformatiebank.nl
  3. LAREB, Convulsies in bijsluiter tropicamide oogdruppels, https://www.lareb.nl/nl/nieuwsoverzicht/convulsies-in-bijsluiter-tropicamide-oogdruppels/, Accessed Jan 23, 2020
  4. Oğüt MS, et al., Effects and side effects of mydriatic eyedrops in neonates., Eur J Ophthalmol. , 1996, 6(2), 192-6
  5. Elibol O,et al., The influence of drop size of cyclopentolate, phenylephrine and tropicamide on pupil dilatation and systemic side effects in infants. , Acta Ophthalmol Scand, 1997, 75(2), 178-80
  6. Obata S, et al., Systemic adverse events after screening of retinopathy of prematurity with mydriatic., PLoS One, 2021, 16(9), e0256878
  7. Lux AL, et al., Combination of 5% phenylephrine and 0.5% tropicamide eyedrops for pupil dilation in neonates is twice as effective as 0.5% tropicamide eyedrops alone., Acta Ophthalmol., 2017, 95(2), 165-9
  8. Federatie Medisch Specialisten, Richtlijn Prematurenretinopathie (ROP), 13-11-2023
  9. Kremer LJ, et al., Systematic review of mydriatics used for screening of retinopathy in premature infants. , BMJ Paediatr Open, 2019, 3(1), e000448
  10. 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
  11. Seliniotaki AK, et al., Efficacy and safety of mydriatic microdrops for retinopathy of prematurity screening: an external pilot crossover randomized controlled trial., J Perinatol., 2022, 42(3), 371-7
  12. Dincer E, et al. , Early Hemodynamic Effects of Mydriatic Eye Drops in Preterm Infants., Am J Perinatol., 2022, May;41(S 01), e324-e330
  13. Baldo F, Travan L., Acute drug reaction to phenylephrine and tropicamide collyrium in a late-preterm newborn: a case report, BMC Pediatr., 2022, 22(1), 398
  14. Phamonvaechavan P, et al., Comparison of the effectiveness of mydriasis by two instillation methods of combined 0.75% tropicamide and 2.5% phenylephrine eye drop in preterm infants., J Med Assoc Thai, 2012, 95 Suppl 4, S1-7
  15. Lees BJ, et al, Increased blood pressure following pupillary dilation with 2.5% phenylephrine hydrochloride in preterm infants., Pediatrics, 1981, 68(2), 231-4
  16. Luo S, et al, Comparison of the mydriatic effects of mydrin-P and compound tropicamide in the screening of retinopathy of prematurity., Eye Sci., 2014, 29(4), 219-22
  17. Mimori K, et al. , Necrotizing enterocolitis after an eye examination with mydriatics. , Pediatr Int., 2020, 62(2), 248-50
  18. Rush R,et al, Systemic manifestations in response to mydriasis and physical examination during screening for retinopathy of prematurity. , Retina, 2004, 24(2), 242-5

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Changes

Changes