See Supplemental Patient Information
- For topical ophthalmic use only. Avoid using as an injection
- This combination may cause CNS disturbances and may have an adverse effect on patients suffering from cardiovascular disease, hypertension and hyperthyroidism
- Infants are especially susceptible to CNS and cardiopulmonary side effects due to cyclopentolate; observe closely for at least 30 minutes
- May produce a transient elevation of intraocular pressure
- After instillation of eye drops compress lacrimal sac by digital pressure for 2-3 minutes to reduce excessive systemic absorption
- In pediatric patients cyclopentolate use has been associated with psychotic reactions and behavioral disturbances like ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people
- Increased susceptibility to cyclopentolate has been observed in infants, young children, and in children with spastic paralysis or brain damage
- In infants opthalmic use of this product may cause feeding intolerance, hence withheld feeding or four (4) hours after examination
- Restrict to short-term use
Cautions: Use cautiously in
- Infants/young children
- Cardiovascular diseases
- Down syndrome
- Angle-closure glaucoma
- Hypertension
- Hyperthyroidism
- Elderly patients
- Spastic paralysis (pediatrics)
- Brain damage (pediatrics)
Supplemental Patient Information
- Advise patients to avoid touching dropper tip to any surface as this may contaminate the solution
- Advise patients to avoid driving or engaging in other hazardous activities while pupils are dilated
- Instruct patients to protect eyes in bright illumination during dilation
- Warn parents to avoid getting this preparation in their child’s mouth and to wash their own hands and the child’s hands following instillation
- Advise patients to withhold feeding for 4 hours in infants due to the possibility of feeding intolerance following eye drops instillation
Pregnancy Category:C
Breastfeeding: Literature unavailable on the use of cyclopentolate during breastfeeding. Anticholinergic drugs might interfere with breastfeeding. A single dose is not likely to interfere with breastfeeding; during prolonged use, observe the infant for signs of decreased lactation (e.g., insatiety, poor weight gain). For substantially diminishing the amount of drug that reaches the breastmilk after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue. Phenylephrine ophthalmic drops are less likely to decrease lactation. Place pressure over the tear duct by the corner of the eye for 1 minute or more then remove the excess solution with an absorbent tissue. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 23 October 2013). Manufacturer advises caution.
US Trade Name(s)
US Availability
Cyclomydril (cyclopentolate/phenylephrine)
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
