Pronunciation:

sye-kloe-PEN-toe-late

Brand Names:

• AK-Pentolate
• Cyclogyl
• Cylate
• Ocu-Pentolate
• Minims Cyclopentolate 0.5%
• Minims Cyclopentolate 1%

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Mydriatic-Cycloplegic

Pharmacologic—

Antimuscarinic

Uses of This Medicine:

Cyclopentolate is used to dilate (enlarge) the pupil. It is used before eye examinations (such as cycloplegic refraction or ophthalmoscopy).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Infants and young children and children with blond hair or blue eyes may be especially sensitive to the effects of cyclopentolate. This may increase the chance of side effects during treatment.

Older adults—

Elderly people are especially sensitive to the effects of cyclopentolate. This may increase the chance of side effects during treatment.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Potassium Citrate

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amantadine
• Amifampridine
• Buprenorphine
• Bupropion
• Clozapine
• Codeine
• Donepezil
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Methacholine
• Oxycodone
• Quetiapine
• Revefenacin
• Scopolamine
• Secretin Human
• Tapentadol
• Tiotropium

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Brain damage (in children) or
• Down's syndrome (Trisomy21) (in children and adults) or
• Glaucoma or
• Spastic paralysis (in children)—Cyclopentolate may make the condition worse

Proper Use of This Medicine:

To use:

• First, wash your hands. Tilt the head back and with the index finger of one hand, press gently on the skin just beneath the lower eyelid and pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 2 or 3 minutes, to allow the medicine to be absorbed. This is especially important in infants.
• Immediately after using the eye drops, wash your hands to remove any medicine that may be on them. If you are using the eye drops for an infant or child, be sure to wash the infant's or child's hands also, and do not let any of the medicine get in the infant's or child's mouth.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic solution (eye drops) dosage form:
  • For eye examinations:
    • Adults—One drop 40 to 50 minutes before the exam. Dose may be repeated in five to ten minutes.
    • Children—One drop 40 to 50 minutes before the exam. After five to ten minutes, another drop may be used.
    • Babies—One drop of 0.5% solution.

Missed dose—

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

After you apply this medicine to your eyes:

• Your pupils will become unusually large and you will have blurring of vision, especially for close objects. Make sure your vision is clear before you drive, use machines, or do anything else that could be dangerous if you are not able to see well.
• Your eyes will become more sensitive to light than they are normally. When you go out during the daylight hours, even on cloudy days, wear sunglasses that block ultraviolet (UV) light to protect your eyes from sunlight and other bright lights. Ordinary sunglasses may not protect your eyes. If you have any questions about the kind of sunglasses to wear, check with your doctor.

If these side effects continue for longer than 36 hours after you have stopped using this medicine, check with your doctor.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Symptoms of too much medicine being absorbed into the body

Clumsiness or unsteadiness

confusion

constipation, full feeling, passing gas, or stomach cramps or pain

fast or irregular heartbeat

convulsions (seizures)

fever

flushing or redness of face

hallucinations (seeing, hearing, or feeling things that are not there)

passing urine less often

skin rash

slurred speech

swollen stomach (in infants)

thirst or dryness of mouth

unusual behavior, such as disorientation to time or place, failure to recognize people, hyperactivity, or restlessness, especially in children

unusual drowsiness, tiredness, or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Blurred vision

burning of eye

eye irritation not present before therapy

increased sensitivity of eyes to light

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.