Cyclopentolate Hcl

Drug overview for CYCLOPENTOLATE HCL (cyclopentolate hcl):

Generic name: CYCLOPENTOLATE HCL (SYE-kloe-PEN-toe-late)
Drug class: Ophthalmic Cycloplegics/Mydriatics
Therapeutic class: Ophthalmic Agents

Cyclopentolate hydrochloride, a tertiary amine antimuscarinic, is a mydriatic and cycloplegic.

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.)

DRUG IMAGES

CYCLOPENTOLATE 1% EYE DROP
CYCLOPENTOLATE 1% EYE DROPS

The following indications for CYCLOPENTOLATE HCL (cyclopentolate hcl) have been approved by the FDA:

Indications:
Cycloplegia
Mydriasis

Professional Synonyms:
None.

The following dosing information is available for CYCLOPENTOLATE HCL (cyclopentolate hcl):

Dosing
Administration
CYCLOPENTOLATE HCL
CYCLOPENTOLATE HCL

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(R)), 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.

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.

Dosing information for CYCLOPENTOLATE HCL
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
CYCLOPENTOLATE 1% EYE DROPS	Maintenance	Adults instill 1 drop into affected eye(s) by ophthalmic route 3 times per day
CYCLOPENTOLATE 1% EYE DROP	Maintenance	Adults instill 1 drop into affected eye(s) by ophthalmic route 3 times per day

Generic dosing information for CYCLOPENTOLATE HCL
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
CYCLOPENTOLATE 1% EYE DROPS	Maintenance	Adults instill 1 drop into affected eye(s) by ophthalmic route 3 times per day
CYCLOPENTOLATE 1% EYE DROP	Maintenance	Adults instill 1 drop into affected eye(s) by ophthalmic route 3 times per day

Severe List
Angle-closure glaucoma
Predisposition to glaucoma

Moderate List
Down's syndrome

The following adverse reaction information is available for CYCLOPENTOLATE HCL (cyclopentolate hcl):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 13 severe adverse reactions.

More Frequent	Less Frequent
None.	Blepharoconjunctivitis Conjunctivitis Punctate keratitis

Rare/Very Rare
Acute cognitive impairment Ataxia Behavioral disorders Cardiac arrhythmia Drug-induced psychosis Hallucinations Ocular hypertension Seizure disorder Slurred speech Urinary retention

There are 12 less severe adverse reactions.

More Frequent	Less Frequent
None.	Blurred vision Ocular irritation Photophobia

Rare/Very Rare
Disorder of the digestive system Drowsy Fatigue Fever General weakness Skin rash Tachycardia Vasodilation of blood vessels Xerostomia

The following precautions are available for CYCLOPENTOLATE HCL (cyclopentolate hcl):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

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.

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.

No enhanced Geriatric Use information available for this drug.

Mydriasis
Z01.0	Encounter for examination of eyes and vision
Z01.00	Encounter for examination of eyes and vision without abnormal findings
Z01.01	Encounter for examination of eyes and vision with abnormal findings