For topical ophthalmic use only. Not for injection. This preparation may cause CNS disturbances. This
is especially true in younger age groups, but may occur at any age, especially with the stronger
solutions. Infants are especially prone to CNS and cardiopulmonary side effects from cyclopentolate.
To minimize absorption, use only 1 drop of 0.5% cyclopentolate hydrochloride ophthalmic solution per
eye, followed by pressure applied over the nasolacrimal sac for two to three minutes. Observe infants
closely for at least 30 minutes.
Mydriatics may produce a transient elevation of intraocular pressure.
The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to
reduce excessive systemic absorption. Caution should be observed when considering use of this
medication in the presence of Down's syndrome and in those predisposed to angle-closure glaucoma.
Carcinogenesis, Mutagenesis, And Impairment Of Fertility
Studies in animals or humans have not been conducted to evaluate the carcinogenic potential of
Pregnancy Category C
Animal reproduction studies have not been conducted with cyclopentolate. It is also not known whether
cyclopentolate can cause fetal harm when administered to a pregnant woman or can affect reproduction
capacity. Cyclopentolate should be administered to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human
milk, caution should be exercised when cyclopentolate hydrochloride is administered to a nursing
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. These disturbances include ataxia,
incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and
place, and failure to recognize people. Feeding intolerance may follow ophthalmic use of this product
in infants. It is recommended that feeding be withheld for four (4) hours after examination. Observe
infants closely for at least 30 minutes (see WARNINGS).