CYCLOPENTOLATE (Ophthalmic)

Some commonly used brand names are:

In the U.S.?

• Ak-Pentolate
• Cyclogyl
• Cylate
• Ocu-Pentolate
• Pentolair

In Canada?

• Ak-Pentolate
• Diopentolate
• Cyclogyl
• Minims Cyclopentolate

Generic name product may be available in the U.S.

Category

• Cycloplegic
• Mydriatic

Description

Cyclopentolate (sye-kloe-PEN-toe-late) is used to dilate (enlarge) the pupil. It is used beforeeye examinations (such as cycloplegic refraction or ophthalmoscopy).

This medicine is available only with your doctor's prescription, in thefollowing dosage form:

Ophthalmic
• Ophthalmic solution (eye drops) (U.S. and Canada)

Before Using This Medicine

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

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to cyclopentolate. Also tell your health care professionalif you are allergic to any other substances, such as preservatives.

Pregnancy?Cyclopentolate may be absorbed into the body. However,studies on effects in pregnancy have not been done in either humans or animals.

Breast-feeding?Cyclopentolate may be absorbed into the mother'sbody. It is not known whether cyclopentolate passes into the breast milk.However, cyclopentolate has not been reported to cause problems in nursingbabies.

Children?Infants and young children and children with blondhair 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 effectsof cyclopentolate. This may increase the chance of side effects during treatment.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are using any other prescription or nonprescription (over-the-counter[OTC]) medicine.

Other medical problems?The presence of other medicalproblems may affect the use of cyclopentolate. Make sure you tell your doctorif you have any other medical problems, especially:

• Brain damage (in children) or
• Down's syndrome (mongolism) (in children and adults) or
• Glaucoma or
• Spastic paralysis (in children)?Cyclopentolate may make thecondition worse

Proper Use of This Medicine

To use:

• First, wash your hands. Tilt the head back and with the index fingerof one hand, press gently on the skin just beneath the lower eyelid and pullthe lower eyelid away from the eye to make a space. Drop the medicine intothis 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 withyour 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 removeany medicine that may be on them. If you are using the eye drops for an infantor child, be sure to wash the infant's or child's hands also, and do not letany 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 applicatortip to any surface (including the eye). Also, keep the container tightly closed.

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

Dosing?The dose of cyclopentolate will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of cyclopentolate. If your dose isdifferent, do not change it unless your doctor tells you to do so.

• For ophthalmic solution (eye drops) dosageform:
  • For eye examinations:
    • Adults?One drop 40 to 50 minutes before the exam. Dose maybe repeated in five to ten minutes.
    • Children?One drop 40 to 50 minutes before the exam. After fiveto 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 assoon as possible. However, if it is almost time for your next dose, skip themissed dose and go back to your regular dosing schedule. Do not double doses.

Storage?To store this medicine:

• Keep out of the reach of children. Overdose of this medicine is verydangerous for infants and children.
• Store away from heat and direct light.
• Keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Afteryou apply this medicine to your eyes:

• Your pupils will become unusually large and you will have blurringof vision, especially for close objects. Make sure yourvision is clear before you drive, use machines, or do anything else that couldbe 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 fromsunlight and other bright lights. Ordinary sunglasses may not protectyour 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 havestopped 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 mayneed medical attention.

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

Symptoms of too much medicine being absorbed into the body

Clumsiness or unsteadiness; confusion; constipation, full feeling, passing gas, or stomachcramps 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 (ininfants); thirst or dryness of mouth; unusual behavior, such as disorientation to time or place, failureto recognize people, hyperactivity, or restlessness, especially in children; unusual drowsiness, tiredness, or weakness

Other sideeffects may occur that usually do not need medical attention. These side effectsmay go away during treatment as your body adjusts to the medicine. However,check with your doctor if any of the following side effects continue or arebothersome:

Blurred vision; burning of eye; eye irritation not present before therapy; increased sensitivity of eyes to light

Other side effects not listed above may also occur in some patients. If younotice any other effects, check with your doctor.

Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although this use is not included in product labeling,cyclopentolate is used in certain patients with the following medical conditions:

• Posterior synechiae
• Uveitis

Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for these uses.