cyclopentolate 1% eye drops generic cyclogyl

Uses

Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia for refraction (e.g., retinal and optic disc examination, measurement of refractive error). Cyclopentolate usually is preferred over atropine for such use because cyclopentolate has a more rapid onset and shorter duration of action relative to atropine.

The combination preparation containing cyclopentolate hydrochloride 0.2% and phenylephrine hydrochloride 1% is used to produce pronounced mydriasis with little accompanying cycloplegia for ophthalmologic examination; this combination may be particularly useful for providing maximal mydriasis during examination of patients with retinal detachment. The fixed combination also may be useful in dilation of pupils in young infants for ophthalmologic examinations (e.g., screening for retinopathy of prematurity).(See Cautions: Pediatric Precautions.)

Dosage and Administration

Administration

Cyclopentolate hydrochloride is applied topically to the eye in the form of a solution. To avoid excessive systemic absorption, finger pressure should be applied on the lacrimal sac during and for 2-3 minutes following topical instillation of the solution, particularly if the 2% solution is used and especially in children.

Dosage

To produce mydriasis and cycloplegia for refraction in adults, 1 or 2 drops of a 0.5, 1, or 2% cyclopentolate hydrochloride solution may be instilled onto the eye(s) approximately 40-50 minutes before the procedure; if necessary, a second dose may be instilled in 5-10 minutes. In adults with darkly pigmented irides, more doses or use of the 2% solution may be needed. Although recovery from mydriasis and cycloplegia usually occurs within 24 hours, 1 or 2 drops of a 1 or 2% pilocarpine solution instilled onto the eye(s) may reduce recovery time to 3-6 hours in most patients.

For cycloplegic refraction in children, 1 drop of a 0.5, 1, or 2% solution may be instilled onto the eye(s); if necessary, this dose may be followed by a second drop of a 0.5 or 1% solution 5-10 minutes later. The concentration of cyclopentolate hydrochloride used in pediatric patients should be selected based on the patient's weight, iris coloration, and dilation history. In small infants, 1 drop of the 0.5% solution may be instilled into the eye(s). Following instillation, infants should be observed closely for at least 30 minutes.(See Cautions: Pediatric Precautions.)

To produce mydriasis for funduscopic examination with the combination preparation (Cyclomydril), 1 drop of the solution containing 0.2% cyclopentolate hydrochloride and 1% phenylephrine hydrochloride instilled onto each eye will generally provide rapid mydriasis and permit ready visual access to the fundus. The dose may be repeated every 5-10 minutes if necessary. When used in infants to produce mydriasis for screening for retinopathy of prematurity, instillation 30 minutes before the examination is recommended.

Cautions

Adverse Effects

Cyclopentolate hydrochloride may increase intraocular pressure. A considerable burning sensation usually occurs following instillation of a 1 or 2% solution of the drug; the 0.5% solution is less irritating. This burning sensation is transient and patients should be advised of the likelihood of its occurrence; children may be particularly distressed by this local discomfort.

Topical application of cyclopentolate hydrochloride to the eye may cause adverse systemic antimuscarinic effects , especially with frequent or prolonged topical instillation of the drug and in children. Use of cyclopentolate hydrochloride has been associated with adverse CNS reactions (e.g., CNS disturbances, psychotic reactions). Younger patients are especially prone to develop CNS disturbances, but such effects may occur at any age, particularly with the more concentrated preparations. Psychotic reactions and behavioral disturbances have been reported in children, especially with the 2% solution. These reactions develop within about 30-45 minutes after instillation of the drug and have been manifested as ataxia, incoherent speech, restlessness, hyperactivity, seizures, aimless wandering, irrelevant talking, hallucinations, disorientation as to time and place, failure to recognize people, amnesia, and tachycardia. Rarely, adults may develop comparable reactions.

An allergic reaction may occur following repeated use of cyclopentolate hydrochloride. The reaction is characterized by persistent irritation that develops within minutes of instillation of the drug; while vision is blurred and the eyes are diffusely red, itching is not common. The corneal surface is uniformly covered with tiny, superficial punctate epithelial lesions; with repeated reactions, the lacrimal drainage system may become occluded.

Precautions and Contraindications

When cyclopentolate hydrochloride is used as a fixed-combination preparation that includes phenylephrine hydrochloride, the cautions, precautions, and contraindications associated with phenylephrine must be considered in addition to those associated with cyclopentolate.

Patients should be advised not to drive or engage in other hazardous activities while their pupils are dilated. Because sensitivity to light may occur, patients also should be advised to protect their eyes if exposed to bright illumination during dilation. Care should be taken to avoid contamination of the solution container.

Cyclopentolate hydrochloride is contraindicated in patients with angle-closure glaucoma. Cyclopentolate hydrochloride should be used with caution in patients who may be predisposed to increased intraocular pressure. Tonometric examinations are advisable prior to use of the drug. To avoid induction of angle-closure in susceptible patients, an estimation of the depth of the angle of the posterior chamber should be performed prior to initiation of therapy.

Pediatric Precautions

If cyclopentolate hydrochloride is used in children, the possibility of precipitating adverse systemic effects such as psychotic reactions and behavioral disturbances should be considered (see Cautions: Adverse Effects); the risk of these effects is greatest with a 2% solution of the drug. The concentration of cyclopentolate hydrochloride used in pediatric patients should be selected based on the patient's weight, iris coloration, and dilation history. Increased susceptibility to cyclopentolate has been reported in infants, young children, and in children with spastic paralysis or brain damage.

When cyclopentolate is used in children, the child's parents should be advised to prevent the child from getting the solution into his or her mouth and to wash their own hands and the child's hands following administration of the drug. Infants should be closely observed for at least 30 minutes after instillation of cyclopentolate hydrochloride (alone or in fixed combination with phenylephrine hydrochloride), Because feeding intolerance may follow ophthalmic use of cyclopentolate in infants, the manufacturer states that parents should be advised to withhold feeding for 4 hours after use of the drug in ophthalmic examination of an infant.

Geriatric Precautions

No overall differences in efficacy or safety of cyclopentolate have been observed between geriatric and younger patients.

Carcinogenicity

Studies have not been performed to date to evaluate the carcinogenic potential of cyclopentolate.

Pregnancy and Lactation

Pregnancy

Animal reproduction studies have not been performed with cyclopentolate, and it is also not known whether the drug can cause fetal harm when administered to pregnant women. Cyclopentolate should be used during pregnancy only when clearly needed.

Lactation

It is not known whether cyclopentolate is distributed into milk. Because many drugs are distributed into milk, caution should be exercised when cyclopentolate is used in nursing women.