CICLOPLEGICEDOL

A parasympatholytic anticholinergic used solely to obtain mydriasis or cycloplegia.

Used mainly to produce mydriasis and cycloplegia for diagnostic purposes.

Cyclopentolate is an anti-muscarinic in the same class as atropine and scopolamine.

Cyclopentolate blocks the receptors in the muscles of the eye (muscarinic receptors).

These receptors are involved controlling the pupil size and the shape of the lens.

Cyclopentolate thus induces relaxation of the sphincter of the iris and the ciliary muscles.

When applied topically to the eyes, it causes a rapid, intense cycloplegic and mydriatic effect that is maximal in 15-60 minutes; recovery usually occurs within 24 hours.

The cycloplegic and mydriatic effects are slower in onset and longer in duration in patients who have dark pigmented irises.

Absorbed following ophthalmic administration.

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LD in the rat is 4000 mg/kg and 960 mg/kg in the mouse.

Symptoms of overdose include tachycardia, dizziness, dry mouth, behavioral disturbances, uncoordination and drowsiness.

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.

Therefore, patients with untreated narrow angle glaucoma or anatomically narrow angles may be susceptible to angle closure following administration.

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

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.

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.

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.

In multiple-dose plastic

DROP-TAINER® dispensers: 0.5% CYCLOGYL 1% CYCLOGYL 2% CYCLOGYL 15 mL NDC 0065-0395-15 2 mL NDC 0065-0396-02 2 mL NDC 0065-0397-02 5 mL NDC 0065-0396-05 5 mL NDC 0065-0397-05 15 mL NDC 0065-0396-15 15 mL NDC 0065-0397-15 Storage: Store at 8°C to 25°C (46°F to 77°F).

After opening, Cyclogyl can be used until the expiration date on the bottle.

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.

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.

Cases of

NEC have been reported in preterm infants following administration; however, causality has not been established.

It is recommended that feeding be withheld for four 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.