Last update Feb. 10, 2019

S01FA04

Likely Compatibility

Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.

A tertiary amine with a muscarinic effect similar to atropine, used in the form of eye drops for pupil dilation (Akorn 2017, Alcon 2017)

Since the last update we have not found published data on its excretion in breastmilk.

There have been reports of serious side effects after ophthalmic administration in children (seizure in a premature baby girl: Büyükcam 2012).
A recent publication reports fewer side effects than atropine (Wakayama 2018)

Because of its anticholinergic effect it can inhibit the secretion of prolactin (Bizzarro 1980, Evans 1985) and reduce the production of milk during the first weeks after childbirth. When breastfeeding is well established, milk production depends less on the levels of prolactin.

The small dose and the low plasma absorption of most topical ophthalmological preparations make it unlikely it will transfer to breastmilk in significant amounts.
After its ophthalmic administration, plasma concentrations of cyclopentolate are in the order of few nanograms per millilitre and are about 3,000 times lower than ophthalmic concentrations (Hale 2017 p 238, Alcon 2017).

Use the minimum dose and concentration possible and press a finger on the conjunctival sac for 2 minutes, removing the excess with a clean cloth, in order to avoid systemic absorption.

Alternatives

We do not have alternatives for S01FA04.

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Group

S01FA04 belongs to this group or family:

Tradenames

Main tradenames from several countries containing S01FA04 in its composition:

Pharmacokinetics

Variable Value Unit
Molecular weight 328 daltons
Tmax 1 hours
2 hours

References

  1. Wakayama A, Nishina S, Miki A, Utsumi T, Sugasawa J, Hayashi T, Sato M, Kimura A, Fujikado T. Incidence of side effects of topical atropine sulfate and cyclopentolate hydrochloride for cycloplegia in Japanese children: a multicenter study. Jpn J Ophthalmol. 2018 Abstract
  2. Hale TW, Rowe HE. Medications & Mothers' Milk. A Manual of Lactation Pharmacology. Springer Publishing Company. 2017
  3. Alcon Cusi. Ciclopentolato. Ficha técnica. 2017 Full text (in our servers)
  4. Akron. Cyclopentolate. Leaflet. 2017 Full text (in our servers)
  5. Büyükcam A, Celik HT, Korkmaz A, Yurdakök M. Myoclonic seizure due to cyclopentolate eye drop in a preterm infant. Turk J Pediatr. 2012 Abstract
  6. Evans PJ, Dieguez C, Foord S, Peters JR, Hall R, Scanlon MF. The effects of cholinergic blockade on the growth hormone and prolactin response to insulin hypoglycaemia. Clin Endocrinol (Oxf). 1985 Abstract
  7. Bizzarro A, Iannucci F, Tolino A, Soricelli A, Guarino G, Verdoliva A. Inhibiting effect of atropine on prolactin blood levels after stimulation with TRH. Clin Exp Obstet Gynecol. 1980 Abstract

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