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Cyclopentolate

Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.

Prescription medicine Ophthalmic Safety alerts on record

How to use Cyclopentolate

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Who it is for

Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.

How to take it and how often
  • Adults: Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated in five to ten minutes if necessary
  • Complete recovery usually occurs in 24 hours
  • Complete recovery from mydriasis in some individuals may require several days
  • Children: Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated five to ten minutes later by a second application of 0.5% or 1% solution if necessary
  • Small
  • Infants: A single instillation of one drop of 0.5% in the eye
  • To minimize absorption, apply pressure over the nasolacrimal sac for two to three minutes
  • Observe infant closely for at least 30 minutes following instillation
  • Individuals with heavily pigmented irides may require higher strengths
Children
  • 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 and necrotizing enterocolitis (NEC) in preterm
  • Infants may follow ophthalmic use of this product. …
Older adults

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

While you are taking it
  • Do not touch dropper tip to any surface, as this may contaminate the solution
  • A transient burning sensation may occur upon instillation
  • Patients should be advised not to drive or engage in other hazardous activities while pupils are dilated
  • Patients may experience sensitivity to light and should protect eyes in bright illumination during dilation
  • Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration
  • Feeding intolerance may follow ophthalmic use of this product in infants
  • It is recommended that feeding be withheld for 4 hours after examination
Talk to a doctor first if

Should not be used if the patient is hypersensitive to any component of this preparation.

Medicines it may not mix with

Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

Warnings

FOR TOPICAL OPHTHALMIC USE ONLY . NOT FOR INJECTION. This preparation may cause Central Nervous System (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% CYCLOGYL solution per eye, followed by pressure applied over the nasolacrimal sac for two to three minutes. Observe infants closely for at least 30 minutes following instillation. Mydriatics may produce a transient elevation of intraocular pressure. …

Possible side effects

Ocular: Increased intraocular pressure, burning, photophobia, blurred vision, irritation, hyperemia, conjunctivitis, blepharoconjunctivitis, punctate keratitis, synechiae have been reported. Non-ocular: Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances, usually in children, especially with 2% concentration. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people. This drug produces reactions similar to those of other anticholinergic drugs, but the central nervous system manifestations as noted above are more common. …

Pregnancy and breastfeeding

Pregnancy: 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.

If you take too much

Excessive dosage may produce behavioral disturbances, tachycardia, hyperpyrexia, hypertension, elevated intraocular pressure, vasodilation, urinary retention, diminished gastrointestinal motility and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Patients exhibiting signs of overdosage should receive supportive care and monitoring.

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2024-06-25.

Brands around the world

Products with Cyclopentolate as the active ingredient. Names differ between countries.

Registered products

United States (FDA)

Cyclopentolate HydrochlorideCYCLOPENTOLATE HYDROCHLORIDE 1 kg/kg · Powder · Bioxera Pharma Private Limited
NDC 53211-214Label
Cyclopentolate HydrochlorideCYCLOPENTOLATE HYDROCHLORIDE 10 mg/mL · Solution · Sandoz Inc.
NDC 61314-396Label
Cyclopentolate HclCYCLOPENTOLATE HYDROCHLORIDE 1 kg/kg · Powder · Esteve Quimica SA
NDC 57572-0721Label
CyclogylCYCLOPENTOLATE HYDROCHLORIDE 20 mg/mL · Solution/ Drops · Alcon Laboratories, Inc.
NDC 0065-0397Label
Cyclopentolate HydrochlorideCYCLOPENTOLATE HYDROCHLORIDE 1 kg/kg · Powder · Laurus Labs Limited
NDC 42385-105Label

Nigeria (NAFDAC)

NAFDACOpenna Eye Drops B4-3702

Other countries: check your pack's registration number and we point you to your regulator.

Safety alerts and recalls

Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL Bottles (NDC: 24208-735-05), Rx Only. Bausch and Lomb IncorpoU.S. FDA Class III
18 Jan 2016 · Bausch & Lomb, Inc. · TerminatedLabeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.

A recall usually affects certain batches only. Compare the lot number on your pack.

Check your pack of Cyclopentolate

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3 free checks left today Official sources: U.S. FDA · EMA (EU) · NAFDAC · WHO alerts

Questions about Cyclopentolate

What is Cyclopentolate used for?

Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia. (From the official U.S. FDA label.)

How do I take Cyclopentolate?

Follow your prescription or the leaflet in your pack. The official label says: Adults: Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated in five to ten minutes if necessary. Complete recovery usually occurs in 24 hours. Complete recovery from mydriasis in some individuals may require several days. Children: Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated five to ten minutes later by a…

Do I need a prescription for Cyclopentolate?

Usually yes. Cyclopentolate is a prescription medicine in most countries. Rules differ by country.

What brands contain Cyclopentolate?

Cyclopentolate is sold under names such as Cylate, Cyclogyl, Cyclomydril. Brand names differ between countries.

How can I check that my Cyclopentolate is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.