Cyclomydril Special Precautions




Full Prescribing Info
Special Precautions
The use of this combination may have an adverse effect on individuals suffering from cardiovascular disease, hypertension, and hyperthyroidism; and it may cause central nervous system disturbances.
Mydriatics may produce a transient elevation of intraocular pressure. Determine the intraocular pressure and an estimation of the depth of the angle of the anterior chamber prior to initiation of therapy to avoid glaucoma attacks.
Caution should be observed when considering use of this medication in the presence of Down's syndrome.
Because of risk of provoking hyperthermia, use with caution in patients, especially children, who may be exposed to elevated environmental temperatures or who are febrile.
Due to a strong action of the drug on the dilator muscle, the use of phenylephrine in the eye may liberate pigment granules from the iris, especially when given in high doses to elderly patients.
Patients may experience sensitivity to light and should protect eye in bright illumination during dilation.
CYCLOMYDRIL Ophthalmic Solution contains benzalkonium chloride which may cause eye irritation and is known to discolor soft contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to application of CYCLOMYDRIL Ophthalmic Solution and wait at least 15 minutes before reinsertion.
Effects on Ability to Drive and Use Machines:
Patients should be advised not to drive or engage in hazardous activities while pupils are dilated.
Use in Children: Newborns and infants (especially premature and low birth weight infants) are especially prone to central nervous system, cardiopulmonary and gastrointestinal side effects from cyclopentolate and to experience transient increases in blood pressure due to the phenylephrine component. The lowest dose necessary to produce the desired effect should always be used. The infant should be monitored for at least 30 minutes after instillation and routines to adequately deal with emergency situations should be in place.
Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances, especially in pediatric patients. Increased susceptibility to cyclopentolate has been reported in infants, young children, and in children with spastic paralysis or brain damage.
Seizures and acute psychosis induced by cyclopentolate are especially prominent in children. CYCLOMYDRIL Ophthalmic Solution should be used with caution in children with known epilepsy. Feeding intolerance may follow ophthalmic use of this product in infants. It is recommended that feeding be withheld for 4 hours after examination.
Parents should be warned not to get this preparation in their child's mouth and to wash their own and the child's hands following administration.
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