Cyclopentolate

Generic name
Cyclopentolate
Brand name
ATC Code
S01FA04
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Cyclopentolate

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

A study (n=6) with 1% cyclopentolate drops (35 µl) in the eye gave peak plasma concentrations ranging from undetectable to 5.8 ng/ml. Large inter-individual variability. Detectable levels from 3 minutes after administration in 5 children.

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

Diagnostic agent (cycloplegic)
  • Ocular
    • 1 year up to 18 years
      • 1% 1 drop(s)/dose, as required repeat after 5-10 minutes.

      • The maximum effect is only achieved later (30-40 min). Darker irises often need relatively higher doses

    • Full-term neonate to < 1 year
      • 0.5% 1 drop(s)/dose, as required repeat after 5-10 minutes.

      • The maximum effect is only achieved later (30-40 min). Darker irises often need relatively higher doses

    • 1 year up to 18 years
      [2] [3] [4] [5] [6] [7] [8] [9]
      • 1% 1 drop(s)/dose, as required repeat after 5-10 minutes.

      • The maximum effect is only achieved later (30-40 min). Darker irises often need relatively higher doses

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.

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

Rare (0.1-0.01%): Psychotic reactions and behavioral changes have been reported, particularly in children. Children are highly sensitive to systemic side effects such as restlessness, confusion, disorientation, hallucinations, psychotic reactions, convulsions, ataxia, agitation, dizziness, memory loss, and speech disorders.

Sleepiness or drowsiness (especially in young children (< 6 years) and in children with a low BMI), hyperactivity, red cheeks and dizziness.

Also reported: epilepsy; necrotizing enterocolitis in premature neonates; Food intolerance 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

Children, particularly premature babies and infants, are particularly sensitive to side effects on the central nervous system (CNS) and cardiovascular side effects. Side effects begin between 20 and 30 minutes after administration and, although it is usually transient (subsiding within 4 to 6 hours), symptoms may persist for 12 to 24 hours. Be alert to psychotic reactions and other CNS disorders caused by cyclopentolate. Try to limit systemic absorption as much as possible by pressing the tear duct closed. Monitor children for signs of side effects for at least 30 minutes after administration. [SmPC Cyclogyl] In young children and children with a low BMI, use only 1 drop of cyclopentolate if possible.


Particularly in (premature) neonates, food intolerance is reported after use of cyclopentolate drops. [Hermansen 1985; Chew 2005] In view of the pharmacodynamic effect on the motility of the gastrointestinal system and the occurrence of necrotising enterocolitis (NEC) in premature neonates in general, it is recommended that neonates be given no food for 4 hours after the examination.

Use with caution in children due to increased susceptibility to systemic anticholinergic side effects. Use caution if a severe systemic reaction has occurred in the past following atropine administration. Young children and children with Down's syndrome, spastic paralysis or brain damage are particularly susceptible to CNS disorders and to cardiopulmonary or gastrointestinal side effects. Also use caution in children with epilepsy. Children with fair skin and blue eyes may show an enhanced reaction and/or an increased sensitivity to side effects.

Hyperthermia: Use caution in patients, especially children, who have been exposed to elevated ambient temperatures or are febrile due to the potential for hyperthermia.

 

Interactions

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

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.

Anticholinergics
S01FA01
S01FA05
S01FA06
Sympathomimetics excl. antiglaucoma preparations
S01FB01

References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2008
  2. Lahdes K, et al, Systemic absorption of ocular cyclopentolate in children, Ger J Ophthalmol, 1992, 1(1), 16-8
  3. Anderson HA, et al, Comparison of two drug combinations for dilating dark irides, Optom Vis Sci, 2010, Feb;87(2), 120-4
  4. Bagheri A, et al, Optimal dosage of cyclopentolate 1% for complete cycloplegia: a randomized clinical trial, Eur J Ophthalmol, 2007, May-Jun;17(3), 294-300
  5. Gadioux-Madern F, et al, [Influence of the instillation of two versus three eyedrops of cyclopentolate 0.5% on refraction of Caucasian nonstrabismic children Influence de l'instillation de 2 ou 3 gouttes de cyclopentolate a 0,5% sur la refraction de l'enfant caucasien non st, J Fr Ophtalmol, 2008, Jan;31(1), 51-5
  6. Ebri A, et al, Cost-effectiveness of cycloplegic agents: results of a randomized controlled trial in nigerian children, Invest Ophthalmol Vis Sci, 2007, Mar;48(3), 1025-31
  7. 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
  8. Twelker JD, et al, Retinoscopy in infants using a near noncycloplegic technique, cycloplegia with tropicamide 1%, and cycloplegia with cyclopentolate 1%, Optom Vis Sci, 2001, Apr;78(4), 215-22
  9. Bartlett JD, et al, Efficacy of a pediatric cycloplegic administered as a spray, J Am Optom Assoc, 1993, Sep;64(9), 617-21
  10. Isenberg SJ, et al, Effects of cyclopentolate eyedrops on gastric secretory function in pre-term infants, Ophthalmology, 1985, May;92(5), 698-700
  11. Naseri A, et al, Herpes zoster virus sclerokeratitis and anterior uveitis in a child following varicella vaccination, Am J Ophthalmol, 2003, Mar;135(3), 415-7
  12. Minderhout van H et al., Adverse reactions following routine anticholinergic eye drops in a paediatric population: an observational cohort study, BMJ Open, 2015, 12 (5), 008798
  13. Hermansen MC, et al, Feeding intolerance following ophthalmologic examination. , Am J Dis Child. , 1985, Apr;139(4), 367-8
  14. Ozgun U, et al, Fatal necrotising enterocolitis due to mydriatic eye drops. , J Coll Physicians Surg Pak, 2014, May;24 , Suppl 2:S147-9.
  15. Hermansen MC, et al, Abolition of feeding intolerance following ophthalmologic examination of neonates. , J Pediatr Ophthalmol Strabismus, 1985 , 22(6), 256-7
  16. 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, 42(3), 166-73
  17. Dr. Gerhard Mann chem.-pharm. Fabrik GmbH, SmPC Zyklolat EDO 10 mg/mL Augentropfen (6253221.00.00), 04/2022
  18. Hermansen MC, et al, Abolition of feeding intolerance following ophthalmologic examination of neonates., J Pediatr Ophthalmol Strabismus, 1985, 22(6), 256-7
  19. BAUSCH + LOMB IRELAND LIMITED, SmPC Minims Cyclopentolaat (RVG 09359) 06-04-2022, www.geneesmiddeleninformatiebank.nl
  20. Hermansen MC, et al, Feeding intolerance following ophthalmologic examination., Am J Dis Child., 1985, Apr;139(4), 367-8
  21. Ozgun U, et al, Fatal necrotising enterocolitis due to mydriatic eye drops., J Coll Physicians Surg Pak, 2014, May;24, Suppl 2:S147-9.

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