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|Diopentolate Ophthalmic

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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.

Description

Cyclopentolate (sye-kloe-PEN-toe-late) 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, in the following 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, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to cyclopentolate. Also tell your health care professional if 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"s body. It is not known whether cyclopentolate passes into the breast milk. However, cyclopentolate has not been reported to cause problems in nursing babies.

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.

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. Tell your health care professional if you are using any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of cyclopentolate. Make sure you tell your doctor if 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 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 cyclopentolate 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 cyclopentolate. If your dose is different, do not change it unless your doctor tells you to do so .

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. Do not double doses.

Storage—To store this medicine:

Keep out of the reach of children. Overdose of this medicine is very dangerous 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 sure that any discarded medicine is out of the reach of children.

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

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

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 you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for 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 relating to proper use, precautions, or side effects for these uses.

Revised: 08/13/1998

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