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Cyclopentolate (Ophthalmic)


VA CLASSIFICATION
Primary: OP600

Commonly used brand name(s): AK-Pentolate; Ak-Pentolate; Cyclogyl; Cylate; Diopentolate; Minims Cyclopentolate; Ocu-Pentolate; Pentolair.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Cycloplegic—

mydriatic—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Refraction, cycloplegic{01}{28}{37}—Indicated for measurement of refractive errors; also indicated for cycloplegia in diagnostic procedures, {02} {08} such as ophthalmoscopy.

Mydriasis,{01}{28}{37} in diagnostic procedures—Indicated for mydriasis in diagnostic procedures, {02} {08} such as ophthalmoscopy.

[Synechiae, posterior (prophylaxis)]1—Cyclopentolate is used for prophylaxis of posterior synechiae. {07} {10}

[Uveitis (treatment)]1—Used in inflammatory conditions of the iris and uveal tract when a shorter-acting mydriatic and cycloplegic is required.

1 Not included in Canadian product labeling.



Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    327.85 {19}

Mechanism of action/Effect:

Cyclopentolate is an anticholinergic drug that blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to stimulation by acetylcholine. {01} Dilation of the pupil (mydriasis) and paralysis of accommodation (cycloplegia) result. {01}

Onset of action:

Rapid. {01}

Time to peak effect:

Cycloplegia—Within 25 to 75 minutes. {01}

Mydriasis—Within 30 to 60 minutes.

Duration of action:

Has a shorter duration of action than atropine. {01}

Complete recovery of accommodation usually takes 6 to 24 hours. {01}

Complete recovery from mydriasis in some persons may take several days. {01}


Precautions to Consider

Pregnancy/Reproduction

Pregnancy—
Cyclopentolate may be systemically absorbed. {17}

Studies have not been done in humans. {17}

Studies have not been done in animals. {17}

FDA Pregnancy Category C. {17}

Breast-feeding

It is not known whether cyclopentolate is distributed into breast milk; {17} however, cyclopentolate may be systemically absorbed.

Pediatrics

An increased susceptibility to cyclopentolate and similar drugs (such as atropine) has been reported in infants {01} {17} and young children {01} {17} and in children with blond hair, {13} blue eyes, {13} Down's syndrome, {01} spastic paralysis, {01} {17} or brain damage; {01} {17} therefore, cyclopentolate should be used with great caution in these patients. In addition, premature and small infants are especially prone to CNS and cardiopulmonary side effects from systemic absorption of cyclopentolate. {17} Infants should be closely observed for at least 30 minutes following administration of cyclopentolate. {28} {37} Also, feeding intolerance may follow ophthalmic use of cyclopentolate in neonates. {17} It is recommended that feeding be withheld for 4 hours following administration of this medication. {17}


Geriatrics


Geriatric patients are more susceptible to the effects of cyclopentolate and similar drugs (such as atropine), thus increasing the potential for systemic side effects. {01} {13}

Also, cyclopentolate should be used with caution in the elderly {01} because of possible undiagnosed predisposition to angle-closure glaucoma. {11}

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Antiglaucoma agents, cholinergic, long-acting, ophthalmic{06}    (cyclopentolate may antagonize the antiglaucoma and miotic actions of ophthalmic long-acting cholinergic antiglaucoma agents, such as demecarium, echothiophate, and isoflurophate)


Carbachol or
Pilocarpine    (cyclopentolate may interfere with the antiglaucoma action of carbachol or pilocarpine; {17} also, these medications counteract the mydriatic effect of cyclopentolate, the result of which may be used to therapeutic advantage)


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
Brain damage, in children or
Down's syndrome (mongolism), in children and adults or
Spastic paralysis, in children    (increased susceptibility to the effects of cyclopentolate)


» Glaucoma, angle-closure{14}{17} or predisposition to angle-closure{01}{13}{17}
Sensitivity to cyclopentolate


Side/Adverse Effects

Note: An increased susceptibility to cyclopentolate and similar drugs (such as atropine) has been reported in infants, {17} young children, {17} children with blond hair or blue eyes, adults and children with Down's syndrome, children with brain damage or spastic paralysis, {17} and the elderly. {01} {13} {15} This susceptibility increases the potential for systemic side effects. {01} {13}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Symptoms of systemic absorption
    
Ataxia{01}{17} (clumsiness or unsteadiness)
    
behavioral disturbances{01}{17}
psychotic reactions{01}{17} (unusual behavior, such as disorientation to time or place, failure to recognize people, hyperactivity, or restlessness,{28} especially in children using 2% cyclopentolate)
    
confusion{01}{17}
    
diminished gastrointestinal mobility{28} (constipation; full feeling or passing gas; stomach cramps or pain)
    
fast{01}{17} or irregular{13} heartbeat
    
fever{13}{17}
    
hallucinations{01}{17}
    
increased intraocular pressure{28}
    
seizures{28}
    
skin rash{01}{17}
    
slurred speech{01}{17}
    
swollen stomach{01}{17} —in infants
    
thirst or dryness of mouth{01}{17}
    
unusual drowsiness{01}{17}
    
tiredness or weakness{13}
    
urinary retention{28} (passing urine less often)
    
vasodilation{01}{17} (flushing or redness of face)



Those indicating need for medical attention only if they continue or are bothersome
    
Blepharoconjunctivitis{17}
conjunctivitis{17}
hyperemia{17}
punctate keratitis{17}
synechiae{17} (eye irritation not present before therapy{01}{13})
    
blurred vision{01}{13}{17}
    
burning of eye{01}{17}
    
photophobia{01}{17} (increased sensitivity of eyes to light)




Overdose
For specific information on the agents used in the management of ophthalmic cyclopentolate overdose, see:
   • Physostigmine (Systemic) monograph.
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).

Clinical effects of overdose

Note: Excessive dosage may result in exaggerated symptoms as noted in the Side/Adverse Effects section. {28}

The following effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Acute
    
Coma{28}
    
medullary paralysis{28}


Note: In some cases, overdose has resulted in death. {28}


Treatment of overdose
Cessation of ophthalmic cyclopentolate usually results in spontaneous recovery from adverse systemic effects; {17} for severe toxicity, physostigmine is the antidote of choice. {01} {17}

For children—A dose of 0.5 mg of physostigmine should be slowly administered intravenously. {01} {17} If toxic symptoms persist and no cholinergic symptoms are produced, the dose should be repeated at 5-minute intervals up to a maximum of 2 mg. {01} {17}

For adolescents and adults—A dose of 2 mg of physostigmine should be slowly administered intravenously. {01} {17} A second dose of 1 to 2 mg may be given after 20 minutes if no reversal of toxic manifestations has occurred. {01} {17} Physostigmine may also be administered subcutaneously.


Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Cyclopentolate (Ophthalmic).
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to cyclopentolate





Use in children—Infants and young children and children with blond hair or blue eyes may be especially sensitive to the effects of cyclopentolate and similar drugs (such as atropine); this may increase the chance of side effects during treatment; premature and small infants are especially prone to CNS and cardiopulmonary side effects from systemic absorption; feeding intolerance may occur following administration in neonates; it is recommended that feeding be withheld for 4 hours following administration






Use in the elderly—Geriatric patients are more susceptible to the effects of cyclopentolate and similar drugs (such as atropine), thus increasing the potential for systemic side effects
Other medical problems, especially angle-closure glaucoma or predisposition to angle-closure

Proper use of this medication
Proper administration technique

» Importance of nasolacrimal pressure, especially in infants

Washing hands immediately after application to remove any medicine that may be on them; if applying medication to infants or children, washing their hands also, and not letting any medication get into their mouths

Preventing contamination: Not touching applicator tip to any surface; keeping container tightly closed

» Importance of not using more medication than the amount prescribed

» Proper dosing
Missed dose: Applying as soon as possible; if almost time for next dose, skipping missed dose and going back to regular dosing schedule; not doubling doses

» Proper storage

Precautions while using this medication
» Medication causes blurred vision; checking with physician if effect continues for longer than 36 hours after discontinuation of medication

» Medication causes increased sensitivity of the eyes to light; wearing sunglasses that block ultraviolet light to protect eyes; checking with physician if effect continues for longer than 36 hours after discontinuation of medication


Side/adverse effects
Signs of potential side effects, especially symptoms of systemic absorption, such as ataxia, behavioral disturbances or psychotic reactions, confusion, diminished gastrointestinal mobility, fast or irregular heartbeat, fever, hallucinations, increased intraocular pressure, seizures, skin rash, slurred speech, swollen stomach (in infants), thirst or dryness of mouth, unusual drowsiness, tiredness or weakness, urinary retention, and vasodilation.


General Dosing Information
Although some manufacturers recommend a dose of 2 drops of an ophthalmic solution at appropriate intervals, the conjunctival sac will usually hold only 1 drop. {20}

More frequent instillation or use of a stronger solution may be required to produce adequate cycloplegia in eyes with brown or hazel irides than in eyes with blue irides. {17}

An estimation of the depth of the angle of the anterior chamber should be made to avoid inducing angle-closure glaucoma. {28}

To avoid excessive systemic absorption, patient should apply digital pressure to the lacrimal sac during and for 2 or 3 {01} {17} minutes following instillation of the solution. {17} This is especially important in infants. {17}


Ophthalmic Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

CYCLOPENTOLATE HYDROCHLORIDE OPHTHALMIC SOLUTION USP

Usual adult and adolescent dose
Cycloplegic refraction
Topical, to the conjunctiva, 1 drop of a 0.5 to 2% solution, {01} {17} {28} {37} repeated once in five to ten minutes if necessary, {01} {17} {28} {37} with refraction scheduled for forty to fifty minutes afterward.

For ophthalmoscopy
Topical, to the conjunctiva, 1 drop of a 0.5 to 2% solution, {01} {28} {37} repeated once in five to ten minutes if necessary. {01} {28} {37}

[Uveitis]1
Topical, to the conjunctiva, 1 drop of a 0.5 or 1% solution three or four times a day.


Usual pediatric dose
Cycloplegic refraction
Premature and small infants: Topical, to the conjunctiva, 1 drop of a 0.5% solution, as a single dose. {01} {17} {28} {37}

Children: Topical, to the conjunctiva, 1 drop of a 0.5 to 2% solution, {01} {17} {28} {37} followed by 1 drop of a 0.5 or 1% solution after five to ten minutes if necessary, {01} {17} {28} {37} with refraction scheduled for forty to fifty minutes afterward.

For ophthalmoscopy
Premature and small infants: Topical, to the conjunctiva, 1 drop of a 0.5% solution, as a single dose. {28} {37}

Children: Topical, to the conjunctiva, 1 drop of a 0.5 to 2% solution, {28} {37} followed by 1 drop of a 0.5 or 1% solution after five to ten minutes if necessary. {28} {37}

[Uveitis]1
Topical, to the conjunctiva, 1 drop of a 0.5 or 1% solution three or four times a day.


Note: In small infants, use of concentrations above 0.5% is not recommended. {01} {17} {28}
Infants should be closely observed for signs of adverse reactions for at least 30 minutes following administration. {01} {17} {28}
To minimize systemic absorption, application of nasolacrimal pressure for 2 or 3 minutes is recommended, {17} especially in infants. {17} {28}


Strength(s) usually available
U.S.—


0.5% (Rx) [Cyclogyl{35}{37} (benzalkonium chloride 0.01%)]


1% (Rx) [Ak-Pentolate{29} (benzalkonium chloride 0.01%)] [Cyclogyl{35}{37} (benzalkonium chloride 0.01%)] [Cylate{38}] [Ocu-Pentolate{31}] [Pentolair{05}{08}{32}][Generic]{22}{27}{30}


2% (Rx) [AK-Pentolate{29}] [Cyclogyl{35}{37} (benzalkonium chloride 0.01%)]

Canada—


0.5% (Rx) [Ak-Pentolate (benzalkonium chloride)] [Minims Cyclopentolate{03}{34}]


1% (Rx) [Ak-Pentolate (benzalkonium chloride)] [Cyclogyl{33} (benzalkonium chloride)] [Diopentolate{36} (benzalkonium chloride)] [Minims Cyclopentolate{34}]

Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F). {18} Store in a tight container. {18}

Auxiliary labeling:
   • For the eye.
   • Keep container tightly closed.



Revised: 08/14/1998



References
  1. PI US - Cyclogyl, Alcon: Rev 11/87, Rec 4/88.
  1. PI US - Ak-Pentolate, Akorn: Rev 2/84, Rec 4/88.
  1. PI Canada- Minims, Smith & Nephew: CPS-86, p. 456.
  1. Open.
  1. Pentolair - Per Red Book 1987, manufacturered by Balan and Pharmafair.
  1. Open.
  1. Per Indications Index review in 1986.
  1. PI US - Pentolair, Pharmafair: Rev 2/84, Rec 6/87.
  1. Open.
  1. Per Ophthalmic ballot of 9/86.
  1. Open.
  1. Open.
  1. Open.
  1. Panel Comments, sent 7/7/88, due back 7/28/88, processed 9/88.
  1. Open.
  1. Open.
  1. Open.
  1. USP/NF.
  1. USAN.
  1. F&C, p. 477a, 8/89.
  1. Open.
  1. Generic 1%, Steris Labs, as of 1/14/91.
  1. Open.
  1. Open.
  1. Open.
  1. Open.
  1. Red Book-91, p. 224.
  1. Generic 1% package insert (Bausch & Lomb—US), Rev 12/96, Rec 07/98.
  1. AK-Pentolate (Akorn). In: PDR Physicians' desk reference for ophthalmology. 26th ed. 1998. Montvale, NJ: Medical Economics Company; 1998. p. 201.
  1. Cyclopentolate 1% (Medical Ophthalmics). In: PDR Physicians' desk reference for ophthalmology. 26th ed. 1998. Montvale, NJ: Medical Economics Company; 1998. p. 260.
  1. Ocu-Pentolate (Ocumed). In: PDR Physicians' desk reference for ophthalmology. 26th ed. 1998. Montvale, NJ: Medical Economics Company; 1998. p. 280.
  1. Pentolair (Bausch & Lomb) In: PDR Physicians' desk reference for ophthalmology. 26th ed. 1998. Montvale, NJ: Medical Economics Company; 1998. p. 247.
  1. Cyclogyl (Alcon). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmaceutical Association; 1998. p. 404.
  1. Cyclopentolate (Minims). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmaceutical Association; 1998. p. 1000.
  1. Cyclogyl (Alcon). In: Drug Topics Red Book. 1998. Montvale, NJ: Medical Economics Company; 1998. p. 252.
  1. Diopentolate (Dioptic). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmaceutical Association; 1998. p. 503
  1. Cyclogyl package insert (Alcon—US), Rev 9/90, Rec 7/98.
  1. Cylate (Ocusoft). In: Drug Topics Red Book. 1998. Montvale, NJ: Medical Economics Company; 1998. p. 253.
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