Phospholine Iodide

Echothiophate iodide reduces pressure in the eye by increasing the amount of fluid that drains from the eye. This also causes the pupil to become smaller, reducing its response to light or dark conditions.

Echothiophate iodide ophthalmic (for the eyes) is used to treat glaucoma, especially after cataract surgery. This medicine is also used to treat certain eye-focusing disorders.

Echothiophate iodide ophthalmic may also be used for purposes not listed in this medication guide.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

It is not likely that other drugs you take orally or inject will have an effect on echothiophate iodide used in the eyes. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Use care when driving or doing other tasks that call for clear eyesight.
• Have your eye pressure checked. Talk with your doctor.
• Have an eye exam.
• If you are around certain insecticides and pesticides, you may have more side effects. If you are around insecticides and pesticides, be sure to wear a breathing mask, and wash and change your clothes often. Talk with your doctor.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Phospholine Iodide while you are pregnant.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• For the eye only.
• Wash your hands before and after use.
• Do not touch the container tip to the eye, lid, or other skin.
• Tilt your head back and drop drug into the eye.
• After use, keep your eyes closed. Put pressure on the inside corner of the eye. Do this for 1 to 2 minutes. This keeps the drug in your eye.
• Blot extra solution from the eyelid.
• To gain the most benefit, do not miss doses.
• Keep using Phospholine Iodide as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses or extra doses.

1. Although the relationship, if any, of retinal detachment to the administration of echothiophate iodide for ophthalmic solution has not been established, retinal detachment has been reported in a few cases during the use of echothiophate iodide for ophthalmic solution in adult patients without a previous history of this disorder.

2. Stinging, burning, lacrimation, lid muscle twitching, conjunctival and ciliary redness, browache, induced myopia with visual blurring may occur.

3. Activation of latent iritis or uveitis may occur.

4. Iris cysts may form, and if treatment is continued, may enlarge and obscure vision. This occurrence is more frequent in children. The cysts usually shrink upon discontinuance of the medication, reduction in strength of the drops or frequency of instillation. Rarely, they may rupture or break free into the aqueous. Regular examinations are advisable when the drug is being prescribed for the treatment of accommodative esotropia.

5. Prolonged use may cause conjunctival thickening, obstruction of nasolacrimal canals.

6. Lens opacities occurring in patients under treatment for glaucoma with echothiophate iodide for ophthalmic solution have been reported and similar changes have been produced experimentally in normal monkeys. Routine examinations should accompany clinical use of the drug.

7. Paradoxical increase in intraocular pressure may follow anticholinesterase instillation. This may be alleviated by prescribing a sympathomimetic mydriatic such as phenylephrine.

8. Cardiac irregularities.

Each package contains sterile echothiophate iodide for ophthalmic solution, sterile diluent, and dropper for dispensing 5 mL eyedrops of the strength indicated on the label. Four potencies are available:

NDC 0046-1062-05 . . . . . . . . . . . . . . . . . 1.5 mg package for 0.03%

White amorphous deposit on bottle walls. Aluminum crimp seal is blue.

NDC 0046-1064-05 . . . . . . . . . . . . . . . . . 3 mg package for 0.06%

White amorphous deposit on bottle walls. Aluminum crimp seal is red.

NDC 0046-1065-05 . . . . . . . . . . . . . . . . . 6.25 mg package for 0.125%

White amorphous deposit on bottle walls. Aluminum crimp seal is green.

NDC 0046-1066-05 . . . . . . . . . . . . . . . . . 12.5 mg package for 0.25%

White amorphous deposit on bottle walls. Aluminum crimp seal is yellow.

Prior to reconstitution: Store under refrigeration (2° to 8° C).

After reconstitution: Store at room temperature (approximately 25° C). Do not refrigerate. Discard any unused solution after 4 weeks.

Wyeth®

Manufactured for

Wyeth Pharmaceuticals Inc.

Philadelphia, PA 19101

by CANGENE bioPharma

Baltimore, MD 21230

W10441C006

ET01

Rev 04/10

PACKAGE LABEL - PACKAGE LABEL - PRINCIPAL DISPLAY - 5 mL - Bottle Label

NDC 0046-1162-05
STERILE DILUENT
FOR PREPARING
Phospholine Iodide®
(echothiophate iodide
for ophthalmic solution)

5 mL (1/6 fl oz)

EYEDROPS

PACKAGE LABEL - PRINCIPAL DISPLAY - 6.25 mg/5 mL - Bottle Label

NDC 0046-1465-05

Rx only

Phospholine Iodide®
(echothiophate iodide
for ophthalmic solution)

0.125% (1/8%) 6.25 mg/5 mL

Each 5 mL contains 6.25 mg of echothiophate iodide
With 40 mg Potassium Acetate for preparing 5 mL eyedrops.
See accompanying descriptive literature.

PACKAGE LABEL - PRINCIPAL DISPLAY - Kit Carton

Pfizer
NDC 0046-1065-05

Phospholine Iodide®
(echothiophate iodide
for ophthalmic solution)

0.125% (1/8%) 6.25 mg/5 mL

This package contains sterile
echothiophate iodide with 40 mg
potassium acetate (sodium
hydroxide or acetic acid may have
been incorporated to adjust pH
during manufacturing) and 5 mL
(1/6 fl oz) sterile aqueous diluent,
in individual bottles for dispensing
5 mL of eyedrops of strength
shown when reconstituted.

Rx only