Cyclogyl

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Cyclogyl

Classes

Mydriatics and Cycloplegics

Administration
Ophthalmic Administration

Wash hands before and after use. Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Squeeze the prescribed number of drops into the pouch. To avoid excessive systemic absorption, apply finger pressure on the lacrimal sac for 1—2 minutes (in adults or children) and 2—3 minutes (infants) following topical application to the eye.
Do not touch dropper tip to any surface to prevent contamination.
If more than one topical ophthalmic drug product is being used, the drugs should be administered at least 5 minutes apart.
To avoid contamination or the spread of infection, do not use dropper for more than one person.

Adverse Reactions
Severe

ocular hypertension / Delayed / Incidence not known
keratitis / Delayed / Incidence not known
seizures / Delayed / Incidence not known

Moderate

conjunctivitis / Delayed / Incidence not known
photophobia / Early / Incidence not known
blurred vision / Early / Incidence not known
hyperemia / Delayed / Incidence not known
urinary retention / Early / Incidence not known
sinus tachycardia / Rapid / Incidence not known
hypotension / Rapid / Incidence not known
impaired cognition / Early / Incidence not known
ataxia / Delayed / Incidence not known
psychosis / Early / Incidence not known
dysarthria / Delayed / Incidence not known
hallucinations / Early / Incidence not known

Mild

ocular irritation / Rapid / Incidence not known
ocular pain / Early / Incidence not known
fever / Early / Incidence not known
drowsiness / Early / Incidence not known
xerostomia / Early / Incidence not known
flushing / Rapid / Incidence not known
rash / Early / Incidence not known
hyperkinesis / Delayed / Incidence not known
urticaria / Rapid / Incidence not known

Common Brand Names

AK-Pentolate, Cyclogyl, Cylate, Ocu-Pentolate

Dea Class

Rx

Description

Cycloplegic, mydriatic ophthalmic agent; ocular anticholinergic effects similar to atropine; used for cycloplegic refraction and diagnostic pupil dilation.

Dosage And Indications
For mydriasis induction and cycloplegia induction. Ophthalmic dosage (0.5% ophthalmic solution) Adults

1 or 2 drops in the affected eye(s); may repeat dose in 5 to 10 minutes if necessary.

Children and Adolescents

1 or 2 drops in the affected eye(s); may repeat dose in 5 to 10 minutes if necessary.

Infants

1 drop in the affected eye(s) as a single dose.

Neonates

1 drop in the affected eye(s) as a single dose.

Ophthalmic dosage (1% ophthalmic solution) Adults

1 or 2 drops in the affected eye(s); may repeat dose in 5 to 10 minutes if necessary.

Children and Adolescents

1 or 2 drops in the affected eye(s); may repeat dose in 5 to 10 minutes if necessary.

Ophthalmic dosage (2% ophthalmic solution) Adults

1 or 2 drops in the affected eye(s); may repeat dose in 5 to 10 minutes if necessary.

Children and Adolescents

1 or 2 drops in the affected eye(s); may repeat dose with 0.5% or 1% solution in 5 to 10 minutes if necessary.

Dosing Considerations
Hepatic Impairment

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Renal Impairment

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Drug Interactions

There are no drug interactions associated with Cyclopentolate products.

How Supplied

AK-Pentolate/Cyclogyl/Cyclopentolate/Cyclopentolate Hydrochloride/Cylate/Ocu-Pentolate Ophthalmic Sol: 0.5%, 1%, 2%

Maximum Dosage
Adults

4 drops/eye/day.

Geriatric

4 drops/eye/day.

Adolescents

4 drops/eye/day 0.5% or 1% solution; 2 of the 4 drops may be with a 2% solution.

Children

4 drops/eye/day 0.5% or 1% solution; 2 of the 4 drops may be with a 2% solution.

Infants

1 drop/eye/day 0.5% solution.

Neonates

1 drop/eye/day 0.5% solution.

Mechanism Of Action

Cyclopentolate blocks the action of acetylcholine to produce relaxation of the sphincter muscle of the iris resulting in dilation of the pupil (mydriasis). This agent has an anticholinergic effect similar to atropine. Paralysis of accommodation (cycloplegia) is produced by blocking cholinergic stimulation of the ciliary muscle of the lens.

Pharmacokinetics

Cyclopentolate is administered as a topical ophthalmic solution.

Other Route(s)

Ophthalmic route
Cyclopentolate has a rapid onset of action producing the maximum mydriatic and cycloplegic effects within 15—60 minutes following topical application to the eye. The duration of both effects is normally 24 hours. However, mydriasis may persist for several days in selected patients.

Pregnancy And Lactation
Pregnancy

No adequate human or animal studies have examined the effects of cyclopentolate on the fetus or maternal reproduction. Therefore, in making the decision to administer this drug during pregnancy, the potential risks to the fetus must be weighed against the potential benefits to the mother.

Data are limited regarding the use of cyclopentolate during breast feeding and its' excretion in breast milk is unknown. Because of the potential risk for adverse reactions in nursing infants and because anticholinergic medications may interfere with breast-feeding, the manufacturer recommends caution when administering to nursing mothers. However, since cyclopentolate is typically a single dose ophthalmic agent, it is considered unlikely to cause harm to a nursing infant or interfere with lactation. To minimize the amount of drug that reaches systemic circulation and breast milk, apply pressure over the tear duct by the corner of the eye for 1 minute after each administration. If prolonged use is required, health care providers are advised to monitor for signs of decreased lactation. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.[51999]