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

Interactions
PK
Renal impairment
References

Atropine, ocular application

Generic name
Atropine, ocular application
Brand name
ATC Code
S01FA01

Pharmacokinetics in children

No information

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

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Mydriatic, cycloplegic
  • Ocular
    • 0 years up to 1 year
      [1] [2] [3] [4] [6]
      • 0,25% -0.5% atropine solution: 1 drop(s)/dose twice daily.
      • Duration of treatment:

        For 3 days and in the morning before retinoscopy

      • Use lower strenght if side effects occur

    • 1 year up to 18 years
      • 0.5% atropine solution: 1 drop(s)/dose twice daily.
      • Duration of treatment:

        For 2-3 days and in the morning before retinoscopy

    • 1 month up to 1 year
      • 0,25% -0.5% atropine solution: 1 drop(s)/dose twice daily.
      • Duration of treatment:

        For 2-3 days and in the morning before retinoscopy

      • Use lower strenght if side effects occur

    • Term neonate
      • 0,25% -0.5% atropine solution: 1 drop(s)/dose twice daily.
      • Duration of treatment:

        For 2-3 days and in the morning before retinoscopy

      • Use lower strenght if side effects occur
Acute phase of uveitis
  • Ocular
    • 4 years up to 18 years
      • 0.5% atropine solution: 1 - 2 drop(s)/dose 2-3x daily.

      • For short-term use.
        No studies have been carried out into the use of atropine for this indication.
Severe myopia
  • Ocular
    • ≥ 4 years
      [5] [7] [8]

      • 0.05%: 1 drop in each eye once daily in the evening

    • ≥ 3 years

      • 0,01- 0.05%: 1 drop in each eye once daily in the evening

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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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

Photophobia, eye irritation, and blurred vision are the most common side effects (SmPC Ryjunea).

Systemic side effects rarely occur but include anticholinergic effects such as dry mouth and skin, flushing, increased body temperature, urinary symptoms, gastrointestinal symptoms and tachycardia. These effects are more likely to occur in infants and children.

Infants may very rarely experience life-threatening conditions such as drowsiness, cramps, high fever and coma.

(SmPC Atropine)

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

Contra-indications in children

Children over 3 months to 1.5 years of age should receive atropine eye drops at a concentration of 0.5%.

(SmPC Atropine)

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

Pressing the tear duct closed briefly during and immediately after administration reduces the risk of systemic reactions. Care should be taken to ensure that the drop solution does not flow quickly into the nose and throat. (SmPC Ryjunea)

As the ability to regulate temperature may be impaired by inhibition of sweat secretion, caution is required in feverish patients and especially in children.

Infants and toddlers up to the age of two are particularly sensitive to systemic effects, as are patients with Down syndrom and children with spastic paralysis. Particularly careful dosage is therefore necessary in these cases.

Be careful in children woth cardiac conditions

(SmPC Atropine)

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Interactions

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

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Anticholinergics
S01FA04
S01FA05
S01FA06
Sympathomimetics excl. antiglaucoma preparations
S01FB01

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References

  1. Zetterstrom C., The effect of phenylephrine on the accommodative process in man, Acta Ophthalmol (Copenh), 1984, Dec;62(6), 872-8
  2. Bausch&Lomb Pharma, SPC Atropine Minims (RVG 09357), www.cbg-meb.nl, Geraadpleegd 20 okt 2010, http://db.cbg-meb.nl/IB-teksten/h09357.pdf
  3. 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
  4. Ingram RM, et al, Refraction of 1-year-old children after cycloplegia with 1% cyclopentolate: comparison with findings after atropinisation., Br J Ophthalmol., 1979, May;63(5), 348-52
  5. World Society of Ophthalmology & Strabismus, Myopia Consensus Statement, http://wspos.org/wp-content/uploads/2016/04/WSPOS_Consensus-Statement_Myopia.pdf, Geraadpleegd 10 okt 2016
  6. Nederlands Oogheelkundig Gezelschap, Expert opinion, 2019
  7. Yam JC, et al, Two-Year Clinical Trial of the Low-Concentration Atropine for Myopia Progression (LAMP) Study, Ophthalmolog, 2020, 127, 910-919
  8. Yam JC, et al, Low-Concentration Atropine for Myopia Progression (LAMP) Study A Randomized, Double-Blinded, Placebo-Controlled Trial of 0.05%, 0.025%, and 0.01% Atropine Eye Drops in Myopia Control, Ophthalmology, 2019, 126, 113-1
  9. 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
  10. Santen Oy, SmPC Ryjunea (EU/1/25/1920/001-002 ) 02-06-2025, www.ema.europa.eu
  11. Werkgroep Neonatale Farmacologie NVK sectie Neonatologie., Expert opinion NEODOSE, May 2024

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Changes

Changes