Tabulated list of adverse reactions [Clinical Studies]: Not applicable. No adverse drug reactions were reported in a clinical study involving CYCLOMYDRIL Ophthalmic Solution.
Tabulated list of adverse reactions [Post-marketing surveillance]: The following adverse reactions have been identified from post-marketing surveillance following administration of CYCLOMYDRIL Ophthalmic Solution. Frequency cannot be estimated from the available data. (See table.)
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The ADRs listed previously have been reported in newborns and infants (especially in premature infants) with the use of the CYCLOMYDRIL Ophthalmic Solution.
Description of selected adverse reactions: Cyclopentolate produces reactions similar to those of other anticholinergic drugs. The central nervous system manifestations such as ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people are possible. Other toxic manifestations of anticholinergic drugs are skin rash, abdominal distention in infants, unusual drowsiness, tachycardia, hyperpyrexia, vasodilation, urinary retention, diminished gastrointestinal motility, and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages.
Severe reactions are manifested by hypotension with rapid progressive respiratory depression.
Systemic toxicity can result from topical application of sympathomimetic drugs: headache, blood pressure elevation, extrasystoles, tachycardia, syncope and cerebrovascular accidents have been reported.
CYCLOMYDRIL Ophthalmic Solution may increase intraocular pressure and provoke glaucoma attacks in patients predisposed to acute angle closure.
Paediatric population: Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances in pediatric patients. Increased susceptibility to cyclopentolate has been reported in infants, young children, and in children with spastic paralysis or brain damage (see Precautions). These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people. Infants may be at an increased risk for systemic adverse reactions from phenylephrine, including transient increases in blood pressure.
Feeding intolerance may follow ophthalmic use of this product in infants.