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ZIOPTAN- tafluprost solution/ drops


  1. Patient Information
  2. , Tell Your Doctor If You:
  3. May Cause Serious Side Effects Including:
  4. Additionally, The Following Side Effects Have Been Reported In General Use:
  5. Important Information For Mail-order Patients:
  6. Before Opening The Foil Pouches:
  7. After Opening The Foil Pouch:
  8. Active Ingredients:
  9. Inactive Ingredients:
  10. Important:
  11. Principal Display Panel Text For Container Label:
  12. Principal Display Panel Text For Pouch Label:
  13. Principal Display Panel Text For Carton Label:
  14. Contains:
  15. 30 Single-use Containers:
  16. Revised: 11/2018document Id:

Patient Information 

ZIOPTANis a prescription sterile eye drop solution. ZIOPTANis used to lower the pressure in the eye (intraocular pressure) in people with open-angle glaucoma or ocular hypertension when their eye pressure is too high. ZIOPTANbelongs to a group of medicines called prostaglandin analogs.

ZIOPTANis not for use in children.

What should I tell my doctor before using ZIOPTAN?

Before you use ZIOPTAN

, Tell Your Doctor If You: 

  • have or have had eye problems including any surgery on your eye or eyes
  • are using any other eye medicines
  • have any other medical problems
  • are pregnant or plan to become pregnant. It is not known if ZIOPTANwill harm your unborn baby. You should use an effective method of birth control while you use ZIOPTAN. If you become pregnant while using ZIOPTANtalk to your doctor right away.
  • are breastfeeding or plan to breastfeed. It is not known if ZIOPTANpasses into your breast milk. Talk to your doctor about the best way to feed your baby if you use ZIOPTAN.

Tell your doctor about all the medicines you take,including prescription and nonprescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take ZIOPTAN?

Read theInstructions for Useat the end of this Patient Information leaflet for additional instructions about the right way to use ZIOPTAN.

  • Use 1 drop of ZIOPTANin your eye (or eyes) each evening.Talk to your doctor or pharmacist if you are not sure how to use ZIOPTAN.
  • Your ZIOPTANmay not work as well if you use it more than 1 time each evening.
  • If you use other medicines in your eye, wait at least 5 minutes between using ZIOPTANand your other eye medicines.
  • Use your ZIOPTANright away after opening. Each ZIOPTANsingle-use container is sterile and is to be used 1 time then thrown away. Do not save any ZIOPTANthat may be left over after you use your medicine. Using ZIOPTANthat is not sterile may cause other eye problems.

What are the possible side effects of ZIOPTAN? ZIOPTAN

May Cause Serious Side Effects Including: 

  • changes in the color of your eye (iris).Your iris may become more brown in color while using ZIOPTAN. This color change may not go away when you stop using ZIOPTAN. If ZIOPTANis used in 1 eye only, the color of that eye may always be a different color from the color of your other eye.
  • darkening of the color of the skin around your eye (eyelid).These skin changes usually go away when you stop using ZIOPTAN.
  • increasing the length, thickness, color, or number of your eyelashes.These eyelash changes usually go away when you stop using ZIOPTAN.
  • hair growth on your eyelids.This hair growth usually goes away when you stop using ZIOPTAN.

The most common side effects of ZIOPTANinclude:

  • redness, stinging or itching of your eye
  • cataract formation
  • dry eye
  • eye pain
  • blurred vision
  • headache
  • common cold
  • cough
  • urinary tract infection

Tell your doctor if you have any new eye problems while using ZIOPTANincluding:

  • an eye injury
  • an eye infection
  • a sudden loss of vision
  • eye surgery
  • swelling and redness of and around your eye (conjunctivitis)
  • problems with your eyelids

Additionally, The Following Side Effects Have Been Reported In General Use: 

  • worsening of asthma
  • shortness of breath

Tell your doctor if you have any other side effects that bother you.

These are not all the possible side effects of ZIOPTAN. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ZIOPTAN?

Important Information For Mail-order Patients: 

Do not use if prescription is not received within two days of dispensing date.

Keep the foil pouches and ZIOPTANsingle-use containers dry.

Before Opening The Foil Pouches: 

  • Store the unopened foil pouches in a refrigerator between 36 F to 46 F (2 C to 8 C).
  • Do not open the pouch containing ZIOPTANuntil you are ready to use the eye drops.

After Opening The Foil Pouch: 

  • Store the opened foil pouch at room temperature, between 68 F to 77 F (20 C to 25 C), for up to 30 days.
  • Throw away all unused ZIOPTANsingle-use containers in the opened foil pouch after 30 days.
  • Keep the ZIOPTANsingle-use containers in their original foil pouch.
  • After opening the foil pouch, refrigeration is not required.

Keep ZIOPTANand all medicines out of the reach of children.

General information about the safe and effective use of ZIOPTAN.

Do not use ZIOPTANfor a condition for which it was not prescribed. Do not give ZIOPTANto other people, even if they have the same symptoms that you have. It may harm them. This Patient Information leaflet summarizes the most important information about ZIOPTAN. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about ZIOPTANthat is written for health professionals.

What are the ingredients in ZIOPTAN?

Active Ingredients: 

tafluprost

Inactive Ingredients: 

glycerol, sodium dihydrogen phosphate dihydrate, disodium edetate, and polysorbate 80, hydrochloric acid and/or sodium hydroxide, and water for injection.

Instructions for Use

Read these Instructions for Use before using your ZIOPTANand each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

Important: 

  • ZIOPTANis for the eye only. Do not swallow ZIOPTAN.
  • ZIOPTANsingle-use containers are packaged in a foil pouch.
  • Do notuse the ZIOPTANsingle-use containers if the foil pouch is opened.
  • Write down the date you open the foil pouch in the space provided on the pouch.

Every time you use ZIOPTAN:

Step 1.Wash your hands.
Step 2.Take the strip of single-use containers from the foil pouch.
Step 3.Pull off one single-use container from the strip.
Step 4.Put the remaining strip of single-use containers back in the foil pouch and fold the edge to close the pouch.
Step 5.Hold the single-use container upright. Make sure that your ZIOPTANmedicine is in the bottom part of the single-use container.
SeeFigure A.
Figure A Figure A
Step 6.Open the single-use container by twisting off the tab.
SeeFigure B.
Figure B Figure B
Step 7.Tilt your head backwards. If you are unable to
tilt your head, lie down.
Figure C Figure C
Step 8.Place the tip of the single-use container close to your eye. Be careful not to touch your eye with the tip of the single-use container.
SeeFigure C.
Step 9.Pull your
lower eyelid downwards and look up.
Figure D Figure D
Step 10.
Gently squeeze the container and let 1 drop of ZIOPTANfall into the space between your lower eyelid and your eye. If a drop misses your eye, try again.
SeeFigure D.
  • If your doctor has told you to use ZIOPTANdrops in both eyes, repeat Steps 7 to 10 for your other eye.
  • There is enough ZIOPTANin one single-use container for both of your eyes.
  • Throw away the opened single-use container with any remaining ZIOPTANright away.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Rx only

AKORN
Distributed by:Akorn, Inc.

Manufactured for:Oak Pharmaceuticals, Inc.

Made in France

The ZIOPTAN trademark is owned by Merck Sharp & Dohme Corp. and is used under license.
Revised: 11/2018

Principal Display Panel Text For Container Label: 

ZIOPTAN0.0015%

(tafluprost) ophthalmic solution

Rx only

Principal Display Panel Text for Container Label

Principal Display Panel Text For Pouch Label: 

NDC 17478-609-01

ZIOPTAN

(tafluprost ophthalmic

solution) 0.0015%

For Topical Application in the Eye

Single-use Containers

Preservative-Free, Sterile

Principal Display Panel Text for pouch Label

Principal Display Panel Text For Carton Label: 

NDC 17478-609-30

ZIOPTAN

(tafluprost ophthalmic

solution)

0.0015%

For Topical Application in the Eye

REFRIGERATE (2 to 8 C or 36 to 46 F)

Single-use Containers

Preservative-Free, Sterile

Contains: 

Active: Tafluprost 0.0015%

(4.5 mcg per single-use container).

Inactive ingredients: Glycerol, Sodium Dihydrogen

Phosphate Dihydrate, Disodium Edetate, Polysorbate 80,

Water for Injection, Hydrochloric Acid and/or Sodium

Hydroxide are added to adjust pH.

Rx only

30 Single-use Containers: 

3 pouches x 10 single-use containers

(0.3 mL each)

Principal Display Panel Text for Carton Label
ZIOPTAN
tafluprost solution/ drops
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17478-609
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tafluprost(UNII: 1O6WQ6T7G3) (Tafluprost - UNII:1O6WQ6T7G3)Tafluprost0.0045 mg in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin(UNII: PDC6A3C0OX)
Sodium Phosphate, Monobasic, Dihydrate(UNII: 5QWK665956)
Edetate Disodium(UNII: 7FLD91C86K)
Polysorbate 80(UNII: 6OZP39ZG8H)
Water(UNII: 059QF0KO0R)
Hydrochloric Acid(UNII: QTT17582CB)
Sodium Hydroxide(UNII: 55X04QC32I)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17478-609-909 in 1 CARTON11/26/2017
1NDC:17478-609-0110 in 1 POUCH
10.3 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2NDC:17478-609-303 in 1 CARTON11/26/2017
2NDC:17478-609-0110 in 1 POUCH
20.3 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
3NDC:17478-609-101 in 1 CARTON11/26/2017
3NDC:17478-609-0110 in 1 POUCH
30.3 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20251411/26/2014
Labeler -Akorn, Inc. (062649876)

Revised: 11/2018document Id: 

10802957-26fe-405e-9818-8f008c607415Set id: a3173c26-0e19-47af-a01c-3fc06b2700d1Version: 6Effective Time: 20181130Akorn, Inc.



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