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. The effect of long-term use of this preparation has not been
established, therefore, it should be restricted to short-term use.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
There have been no long-term studies done using
cyclopentolate hydrochloride and/or phenylephrine hydrochloride in animals to
evaluate carcinogenic potential.
Pregnancy Category C
Animal reproduction studies have not been conducted with
cyclopentolate hydrochloride and/or phenylephrine hydrochloride. It is also not
known whether cyclopentolate hydrochloride and/or phenylephrine hydrochloride
can cause fetal harm when administered to a pregnant woman or can affect reproduction
capacity. CYCLOMYDRIL® Ophthalmic Solution should be given to a pregnant woman
only if clearly needed.
It is not known whether these drugs are excreted in human
milk. Because many drugs are excreted in human milk, caution should be exercised
when CYCLOMYDRIL Ophthalmic Solution is administered to a nursing woman.
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).
No overall differences in safety or effectiveness have
been observed between elderly and younger patients.