Phospholine Iodide

Name: Phospholine Iodide

Patient Handout

Print without Office InfoPrint with Office Info

Phospholine Iodide Overview

Phospholine Iodide is a brand name medication. For more information about Phospholine Iodide see its generic Ecothiopate

What is Phospholine Iodide (echothiophate iodide ophthalmic)?

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.

What happens if I miss a dose?

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.

What other drugs will affect Phospholine Iodide (echothiophate iodide ophthalmic)?

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.

What are some things I need to know or do while I take Phospholine Iodide?

  • 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.

How is this medicine (Phospholine Iodide) best taken?

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.

Adverse Reactions

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.

How supplied

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.

Handling and storage

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.




This product's label may have been updated. For current package insert and further product information, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556.

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

Phospholine Iodide   OPHTHALMIC
echothiophate iodide kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0046-1065
Packaging
# Item Code Package Description
1 NDC:0046-1065-05 1 KIT in 1 KIT
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 6.25 mL
Part 2 1 BOTTLE 5 mL
Part 1 of 2
Phospholine Iodide   OPHTHALMIC
echothiophate iodide powder, for solution
Product Information
Item Code (Source) NDC:0046-1465
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ECHOTHIOPHATE IODIDE (ECHOTHIOPHATE) ECHOTHIOPHATE IODIDE 6.25 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ACETATE 40 mg  in 5 mL
Packaging
# Item Code Package Description
1 NDC:0046-1465-05 6.25 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA011963 12/04/1959
Part 2 of 2
STERILE DILUENT FOR PREPARING Phospholine Iodide 
diluent solution
Product Information
Item Code (Source) NDC:0046-1162
Route of Administration OPHTHALMIC DEA Schedule     
Inactive Ingredients
Ingredient Name Strength
CHLOROBUTANOL 27.5 mg  in 5 mL
MANNITOL 60 mg  in 5 mL
BORIC ACID 3 mg  in 5 mL
SODIUM PHOSPHATE 1.3 mg  in 5 mL
WATER 5 mL  in 5 mL
Packaging
# Item Code Package Description
1 NDC:0046-1162-05 5 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA011963 12/04/1959
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA011963 12/04/1959
Labeler - Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. (828831441)
Revised: 12/2013   Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.
(web3)