Cyclopentolate

What is Cyclopentolate?

• Cyclopentolate (Akpentolate; Pentolair; Cyclogyl) is an anticholinergic used as an eye drop during pediatric eye examinations to dilate the eye (mydriatic) and prevent the eye from focusing/accommodating (cycloplegic).

Cyclopentolate Structure

Cyclopentolate

What are the uses of this medicine?

• Cyclopentolate (Akpentolate; Pentolair; Cyclogyl) is used to cause mydriasis (pupil dilation) and cycloplegia (paralysis of the ciliary muscle of the eye) before an eye examination.

How does this medicine work?

• The hydrochloride salt form of cyclopentolate, an anticholinergic drug.
• Administered in the eye, cyclopentolate hydrochloride blocks the acetylcholine receptor in the sphincter muscle of the iris and the ciliary muscle, thereby preventing contraction.
• This dilates the pupil, producing mydriasis, and prevents the eye from accommodating.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• untreated narrow-angle glaucoma
• untreated anatomically narrow angles
• hypersensitivity to any component of this preparation

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• carbachol (Miostat) or pilocarpine (Isopto Carpine, Salagen)
• ophthalmic cholinesterase inhibitors

Is this medicine FDA approved?

• Yes,it was FDA approved.
• Cyclopentolate was first synthesized in 1952 as a chemical analogue of atropine.
• It is on the World Health Organization's List of Essential Medicines.

How should this medicine be used?

Recommended dosage: Adults:

• Instill one or two drops of 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.

Children:

• Instill one or two drops of 1% or 2% solution in the eye which may be repeated five to ten minutes later by a second application of 1% solution if necessary.

Administration:

• Cyclopentolate comes as a solution (liquid) to instill in the eye.
• Your healthcare provider will instill the solution into the eye(s) prior to an eye examination.
• Cyclopentolate ophthalmic may take about a half an hour or more to fully work after instillation.
• Effects generally may last for up to 24 hours, but may last several days in some people.
• People with dark eye colors may require increased cyclopentolate doses.
• If cyclopentolate is given to a child, watch them closely for at least 30 minutes after instillation.
• Infants should not be fed for 4 hours after cyclopentolate instillation.
• Cyclopentolate ophthalmic is for use only in the eye(s).
• Do not swallow cyclopentolate solution.
• Be careful not to let the tip of the bottle touch your eye, fingers, face, or any surface

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1% & 2%

This medicine is available in fallowing brand namesː

• Akpentolate
• Cyclogyl
• Pentolair
• Cyclomydril (as a combination product containing Cyclopentolate, Phenylephrine)

What side effects can this medication cause?

The most common side effects of this medicine include:

• Increased intraocular pressure
• burning
• photophobia
• blurred vision
• irritation
• hyperemia
• conjunctivitis
• blepharoconjunctivitis
• punctate keratitis
• synechiae
• ataxia
• incoherent speech
• restlessness
• hallucinations
• hyperactivity
• seizures
• disorientation as to time and place
• failure to recognize people

• Other manifestations of anticholinergic drugs are skin rash, abdominal distention in infants, unusual drowsiness, tachycardia, hyperpyrexia, vasodilation, urinary retention, diminished gastrointestinal motility and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages.

Some serious side effects may include:

• coma
• medullary paralysis
• death

What special precautions should I follow?

• For topical ophthalmic use only. Not for injection.
• This preparation may cause CNS disturbances. This is especially true in younger age groups, but may occur at any age, especially with the stronger solutions. Observe infants closely for at least 30 minutes.
• Caution should be observed when considering use of this medication in the presence of Down's syndrome and in those predisposed to angle-closure glaucoma.
• The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption.
• Caution should be observed when considering use of this medication in the presence of Down's syndrome and in those predisposed to angle-closure glaucoma.
• Do not touch dropper tip to any surface, as this may contaminate the solution.
• Patients should be advised not to drive or engage in other hazardous activities while pupils are dilated.
• Patients may experience sensitivity to light and should protect eyes in bright illumination during dilation.
• Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration.
• Feeding intolerance may follow ophthalmic use of this product in infants.
• It is recommended that feeding be withheld for four (4) hours after examination.
• t is not known whether this drug is excreted in human milk.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• behavioral disturbances
• tachycardia
• hyperpyrexia
• hypertension
• elevated intraocular pressure
• vasodilation
• urinary retention
• diminished gastrointestinal motility
• decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages

Management of overdosage:

• Patients exhibiting signs of overdosage should receive supportive care and monitoring.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• 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.

Can this medicine be used in children?

• Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances in pediatric patients.
• Feeding intolerance may follow ophthalmic use of this product in infants.
• It is recommended that feeding be withheld for four (4) hours after examination.
• Observe infants closely for at least 30 minutes.

What are the active and inactive ingredients in this medicine?

Each mL contains:

• Active: Cyclopentolate Hydrochloride 10 mg (1%) or 20 mg (2%).

Inactives:

• Boric Acid, Edetate Disodium, Potassium Chloride (except 2% strength), Sodium Carbonate and/or Hydrochloric Acid may be added to adjust pH (3.0 to 5.5) and Water for Injection.

Preservative:

• Benzalkonium Chloride 0.1 mg (0.01%).

Who manufactures and distributes this medicine?

Distributed by:

• Akorn Operating Company LLC
• Gurnee, IL

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F).
• Keep tightly closed.

• Dailymed label info on Cyclopentolate
• FDA Cyclopentolate