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|Phospholine Iodide Ophthalmic

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ANTIGLAUCOMA AGENTS, CHOLINERGIC, LONG-ACTING (Ophthalmic)

Some commonly used brand names are:

In the U.S.—

Humorsol ¹
Phospholine Iodide ²

In Canada—

Phospholine Iodide ²

Diflupyl ³

Other commonly used names are: DFP , difluorophate , dyflos , and ecothiopate

Note:

For quick reference, the following medicines are numbered to match the corresponding brand names.

This information applies to the following medicines:
1.	Demecarium (dem-e-KARE-ee-um)†
2.	Echothiophate (ek-oh-THYE-oh-fate)
3.	Isoflurophate (eye-soe-FLURE-oh-fate)*†
* Not commercially available in the U.S.
† Not commercially available in Canada

Description

Demecarium, echothiophate, and isoflurophate are used in the eye to treat certain types of glaucoma and other eye conditions, such as accommodative esotropia. They may also be used in the diagnosis of certain eye conditions, such as accommodative esotropia.

These medicines are available only with your doctor"s prescription, in the following dosage forms:

Ophthalmic
Demecarium
- Ophthalmic solution (eye drops) (U.S.)
Echothiophate
- Ophthalmic solution (eye drops) (U.S. and Canada)
Isoflurophate
- Ophthalmic ointment (eye ointment) (France)

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 demecarium, echothiophate, or isoflurophate, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to demecarium, echothiophate, or isoflurophate. Also tell your health care professional if you are allergic to any other substances, such as preservatives.

Pregnancy—Because of the toxicity of these medicines in general, demecarium, echothiophate, and isoflurophate are not recommended during pregnancy.

Breast-feeding—Demecarium, echothiophate, and isoflurophate may be absorbed into the body. These medicines are not recommended during breast-feeding, because they may cause unwanted effects in nursing babies. It may be necessary for you to use another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—Demecarium, echothiophate, or isoflurophate can cause serious side effects in any patient. When this medicine is used for a long time, eye cysts may occur. These eye cysts occur more often in children than in adults. Therefore, it is especially important that you discuss with the child"s doctor the good that this medicine may do as well as the risks of using it.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of these medicines in the elderly with use in other age groups. However, demecarium, echothiophate, or isoflurophate can cause serious side effects in any patient.

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 demecarium, echothiophate, or isoflurophate, it is especially important that your health care professional know if you are taking any of the following:

Amantadine (e.g., Symmetrel) or
Anticholinergics (medicine for abdominal or stomach spasms or cramps) or
Antidepressants (medicine for depression) or
Antidyskinetics (medicine for Parkinson"s disease or other conditions affecting control of muscles) or
Antihistamines or
Antimyasthenics (ambenonium [e.g., Mytelase], neostigmine [e.g., Prostigmin], pyridostigmine [e.g., Mestinon]) or
Antipsychotics (medicine for mental illness) or
Buclizine (e.g., Bucladin) or
Carbamazepine (e.g., Tegretol) or
Cyclizine (e.g., Marezine) or
Cyclobenzaprine (e.g., Flexeril) or
Disopyramide (e.g., Norpace) or
Flavoxate (e.g., Urispas) or
Ipratropium (e.g., Atrovent) or
Meclizine (e.g., Antivert) or
Methylphenidate (e.g., Ritalin) or
Orphenadrine (e.g., Norflex) or
Oxybutynin (e.g., Ditropen) or
Procainamide (e.g., Pronestyl) or
Promethazine (e.g., Phenergan) or
Quinidine (e.g., Quinidex) or
Trimeprazine (e.g., Temaril)—May increase the possibility of side effects or toxic effects; use of these medicines with demecarium, echothiophate, or isoflurophate is not recommended except under close supervision by your doctor

Malathion (topical) (e.g., Prioderm)—May increase the possibility of side effects or toxic effects, especially if large amounts of malathion are used

Pesticides or insecticides—Make sure you tell your doctor if you have been exposed recently to pesticides or insecticides.

Other medical problems—The presence of other medical problems may affect the use of demecarium, echothiophate, or isoflurophate. Make sure you tell your doctor if you have any other medical problems, especially:

Asthma or
Epilepsy or
Heart disease or
High or low blood pressure (severe) or
Myasthenia gravis or
Overactive thyroid or
Parkinsonism or
Stomach ulcer or other stomach problems or
Urinary tract blockage—If this medicine is absorbed into the body, it may make the condition worse

Down"s syndrome (mongolism)—This medicine may cause these children to become hyperactive

Eye disease or problems (other)—May increase absorption of this medicine into the body or this medicine may make the condition worse

Proper Use of This Medicine

To use the ophthalmic solution (eye drops) form of this medicine:

First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, 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 1 or 2 minutes to allow the medicine to be absorbed by the eye.
Remove any excess solution around the eye with a clean tissue, being careful not to touch the eye.
Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
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.
The preservative in the eye drops containing the medicine, demecarium, may be absorbed by soft contact lenses. If you wear soft contact lenses, and your doctor has informed you that you can wear them while taking this medication, you should wait at least 15 minutes after applying the eye drops before inserting your lenses.

To use the ophthalmic ointment (eye ointment) form of this medicine:

First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Squeeze a thin strip of ointment into this space. A 1/2-cm (approximately 1/4-inch) strip of ointment is usually enough, unless you have been told by your doctor to use a different amount. Let go of the eyelid and gently close the eyes. Keep the eyes closed for 1 to 2 minutes to allow the medicine to be absorbed by the eye.
Immediately after using the eye ointment, wash your hands to remove any medicine that may be on them.
Since isoflurophate loses its effectiveness when exposed to moisture, do not wash the tip of the ointment tube or allow it to touch any moist surface (including the eye).
To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using this eye ointment, wipe the tip of the ointment tube with a clean tissue and keep the tube tightly closed.

It is very important that you 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.

If the applicator tip touches any surface (including the eye), it may become contaminated with bacteria, which may increase the chance of developing an eye infection. If you think the applicator has become contaminated, notify your doctor immediately.

Eye ointment usually causes blurred vision for a short time after you use it, and eye drops containing these medicines may affect your vision for several hours after you use them. Therefore, ask your doctor if the dose (or one of the doses if you use more than 1 dose a day) can be used at bedtime.

Dosing—The doses of these medicines 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 these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

For demecarium
For ophthalmic solution (eye drops) dosage form:
- For glaucoma:
  - Adults and older children—Use one drop in the eye one or two times a day.
  - Infants and young children—Use and dose must be determined by your doctor.
- For treatment of accommodative esotropia:
  - Adults and older children—Use one drop in the eye once a day for two to three weeks, then one drop in the eye once every two days for three to four weeks, then use as determined by the doctor.
  - Infants and young children—Use and dose must be determined by your doctor.
- For diagnosis of accommodative esotropia:
  - Adults and older children—Use one drop in the eye once a day for two weeks, then one drop in the eye once every two days for two to three weeks.
  - Infants and young children—Use and dose must be determined by your doctor.

For echothiophate
For ophthalmic solution (eye drops) dosage form:
- For glaucoma:
  - Adults and older children—Use one drop in the eye one or two times a day.
  - Infants and younger children—Use and dose must be determined by your doctor.
- For treatment of accommodative esotropia:
  - Adults and older children—Use one drop in the eye once a day or one drop in the eye once every two days.
  - Infants and young children—Use and dose must be determined by your doctor.
- For diagnosis of accommodative esotropia:
  - Adults and older children—Use one drop in the eye once a day at bedtime for two to three weeks.
  - Infants and young children—Use and dose must be determined by your doctor.

For isoflurophate
For ophthalmic ointment dosage form:
- For glaucoma:
  - Adults and older children—Use the ointment in the eyes once every three days or as often as three times a day as directed by the doctor.
  - Infants and young children—Use and dose must be determined by your doctor.
- For treatment of accommodative esotropia:
  - Adults and older children—Use the ointment in the eyes once a day at bedtime for two weeks, then once a week or as often as once every two days as directed by the doctor.
  - Infants and young children—Use and dose must be determined by your doctor.
- For diagnosis of accommodative esotropia:
  - Adults and older children—Use the ointment in the eyes once a day at bedtime for two weeks.
  - Infants and young children—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine and your dosing schedule is:

One dose every other day—Use the missed dose as soon as possible if you remember it on the day it should be used. However, if you do not remember the missed dose until the next day, use it at that time. Then skip a day and start your dosing schedule again. Do not double doses.
One dose a day—Use the missed dose as soon as possible. However, if you do not remember the missed dose until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
More than one dose a day—Use the missed dose 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.

If your dosing schedule is different from all of the above and you miss a dose of this medicine, or if you have any questions about this, check with your doctor.

Storage—To store this medicine:

Keep out of the reach of children. Overdose of demecarium, echothiophate, or isoflurophate is very dangerous in young children.
Store away from heat and direct light.
Keep this 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

If you are using this medicine for glaucoma, your doctor should check your eye pressure at regular visits to make sure the medicine is working.

If you will be using this medicine for a long time, your doctor should examine your eyes at regular visits to make sure this medicine does not cause unwanted effects.

Before you have any kind of surgery (including eye surgery), dental treatment, or emergency treatment , tell the medical doctor or dentist in charge and the anesthesiologist or anesthetist (the person who puts you to sleep) that you are using this medicine or have used it within the past month.

These medicines should not be used if an eye infection is present, or if the eye is wounded or injured. If redness, pain, or discharge develops, or if a foreign object becomes lodged in one or both eyes, or if you suffer a blow to the eye or eye area, notify your doctor immediately.

Avoid breathing in even small amounts of carbamate- or organophosphate-type insecticides or pesticides (for example, carbaryl [Sevin], demeton [Systox], diazinon, malathion, parathion, ronnel [Trolene], or TEPP). They may add to the effects of this medicine. Farmers, gardeners, residents of communities undergoing insecticide or pesticide spraying or dusting, workers in plants manufacturing such products, or other persons exposed to such poisons should protect themselves by wearing a mask over the nose and mouth, changing clothes frequently, and washing hands often.

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 . This is because:

After you apply this medicine to your eyes, your pupils may become unusually small. This may cause you to see less well at night or in dim light.
After you begin using this medicine, your vision may be blurred or there may be a change in your near or distance vision.
The eye ointment form of this medicine usually causes blurred vision for a short time after you apply it.

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 immediately if any of the following side effects occur:

Rare

Burning, redness, stinging, or other eye irritation; eye pain; veil or curtain appearing across part of vision

Symptoms of too much medicine being absorbed into the body

Increased sweating; loss of bladder control; muscle weakness; nausea, vomiting, diarrhea, or stomach cramps or pain; shortness of breath, tightness in chest, or wheezing; slow or irregular heartbeat; unusual tiredness or weakness; watering of mouth

Note:

The most common of these symptoms, especially in children, are nausea, vomiting, diarrhea, and stomach cramps or pain . Your doctor may tell you to stop taking the medicine if any of these side effects occur.

Too much medicine being absorbed is rare with the eye ointment form of this medicine.

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 or change in near or distance vision; difficulty in seeing at night or in dim light; headache or browache; twitching of eyelids; watering of eyes

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

Revised: 06/15/99

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