| Summary: | Homero Contreras-Salinas, Vanessa Orozco-Ceja, María Soledad Romero-López, Mayra Yolanda Barajas-Virgen, Leopoldo Martín Baiza-Durán, Lourdes Yolotzin Rodríguez-Herrera Pharmacovigilance Department, Laboratorios Sophia, S.A. de C.V, Zapopan, Jalisco, MéxicoCorrespondence: Lourdes Yolotzin Rodríguez-Herrera, Tel +52 3001 4200 ext 1188, Email lourdes.rodriguez@sophia.com.mxAbstract: Cycloplegic and mydriatic agents are essential in ophthalmological clinical practice since they provide the means for diagnosing and treating certain eye conditions. In addition, cyclopentolate has proven to possess certain benefits compared to other available cycloplegics and mydriatics. Still, the incidence of some adverse drug reactions related to this drug, especially in susceptible patients, has created interest in reviewing the literature about the benefits and risks of using cyclopentolate. A literature search was conducted in Medline/PubMed and Google Scholar, focusing on identifying cyclopentolate’s benefits and risks; the most important benefit was its usefulness for evaluating refractive errors, especially for hyperopic children, pseudomyopia, anterior uveitis, treatment of childhood myopia, idiopathic vision loss, and during examinations before refractive surgery, with particular advantages compared to other cycloplegics. While the risks were divided into local adverse drug reactions such as burning sensation, photophobia, hyperemia, punctate keratitis, synechiae, and blurred vision, which are relatively frequent but mild and temporary; and systemic adverse drug reactions such as language problems, visual or tactile hallucinations and ataxia, but unlike ocular, systemic adverse drug reactions are rare and occur mainly in patients with risk factors. In addition, six cases of abuse were found. The treatment with cyclopentolate is effective and safe in most cases; nevertheless, special care must be taken due to the potential severe ADRs that may occur, especially in susceptible patients like children, geriatrics, patients with neurological disorders or Down’s syndrome, patients with a low blood level of pseudocholinesterase, users of substances with CNS effects, and patients with a history of drug addiction. The recommendations are avoiding the use of 2% cyclopentolate and instead employing solutions with lower concentrations, preferably with another mydriatic such as phenylephrine. Likewise, the occlusion of the nasolacrimal duct after instillation limits the drug’s absorption, reducing the risk of systemic adverse events.Keywords: cycloplegic, cyclopentolate, benefits, risks, adverse drug reactions, abuse
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