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AZASITE- azithromycin monohydrate solution/ drops


  1. Patient Information
  2. Who Should Not Use Azasite?
  3. Before You Use Azasite, Tell Your Doctor If You:
  4. How Should I Use Azasite?
  5. What Should I Be Aware Of While Using Azasite?
  6. What Are The Possible Side Effects Of Azasite?
  7. Active Ingredient:
  8. Inactive Ingredients:
  9. Important:
  10. The Checklist Below Tells You When To Use Your Medicine For Each Eye That Has Bacterial Conjunctivitis:
  11. Before Using A New Bottle Of Azasite:
  12. To Use Azasite:
  13. Principal Display Panel Text For Container Label:
  14. Principal Display Panel Text For Carton Label:
  15. Revised: 11/2017document Id:

Patient Information 

AzaSite is a prescription sterile eye drop solution. AzaSite is used to treat bacterial conjunctivitis which is an infection of the eye caused by certain bacteria.

It is not known if AzaSite is safe and effective in children less than 1 year of age.

Information about bacterial conjunctivitis.

Bacterial conjunctivitis is a bacterial infection of the mucous membranes which line the inside of the eyelids. Symptoms may include redness of the eye and discharge. The infection can be spread to other people and to both eyes.

Who Should Not Use Azasite? 

Do notuse AzaSite if you are allergic to azithromycin or any of the ingredients in AzaSite.

Before You Use Azasite, Tell Your Doctor If You: 

  • wear contact lenses. Do not wear contact lenses if you have signs or symptoms of bacterial conjunctivitis.
  • are pregnant or plan to become pregnant. It is not known if AzaSite will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breast-feeding or plan to breast-feed. It is not known if AzaSite passes into your breast milk. Talk to your doctor about the best way to feed your baby if you are using AzaSite.

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

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

How Should I Use Azasite? 

  • Read the Instructions for Use at the end of this Patient Informationleaflet for the right way to use AzaSite.
  • Use AzaSite exactly as your doctor tells you to use it.
  • For the first 2 days place 1 drop of AzaSite in your eye (or eyes) each morning and 1 drop in your eye (or eyes) each evening. Wait 8 to 12 hours after placing your morning drops before you place evening drops in your eye (or eyes).
  • For the next 5 days place 1 drop of AzaSite in your eye (or eyes) 1 time each day.
  • Make sure you continue to use AzaSite as directed by your doctor even if you feel better after you start using it. Skipping drops can increase the chances that:
    • your medicine will not work well
    • Bacteria can develop resistance, which means in the future your bacterial conjunctivitis may not improve from AzaSite or other drugs that treat infections from bacteria.

What Should I Be Aware Of While Using Azasite? 

Do notwear contact lenses if you have signs or symptoms of bacterial conjunctivitis and until you have finished your prescribed course of treatment. The symptoms of bacterial conjunctivitis may include:

  • discharge coming from the eye
  • eye redness
  • eye irritation

Only your doctor can tell you if you have bacterial conjunctivitis.

Severe allergic reactions have been reported rarely when azithromycin has been taken by mouth.

  • Serious rash or serious allergic reactions may occur. Azithromycin, the active ingredient in AzaSite, may cause a serious rash or a serious allergic reaction. Both of these reactions may need to be treated in a hospital and may be life-threatening.
  • Stop taking AzaSite and call your doctor right away or get emergency help if you have any of these symptoms:
    • skin rash, hives, sores in your mouth, or your skin blisters and peels
    • swelling of your face, eyes, lips, tongue, or throat
    • trouble swallowing or breathing

Increased risk of other infections caused by bacteria or fungi.

  • Using AzaSite for a long time may cause other bacteria or fungi to grow. If this happens you may get a new infection. Tell your doctor right away if your symptoms do not get better.

What Are The Possible Side Effects Of Azasite? 

The most common side effect of AzaSite is eye irritation.

Other side effects

  • Before you open your AzaSite, store it in the refrigerator between 36 F to 46 F (2 C to 8 C).
  • After you open your AzaSite, store it at room temperature or the refrigerator between 36 F to 77 F (2 C to 25 C).
  • AzaSite should not be stored for more than 14 days after opening. After 14 days, throw the AzaSite bottle away.
  • Safely throw away medicine that is out of date or no longer needed.

Keep AzaSite and all medicines out of reach of children.

General information about the safe and effective use of AzaSite

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use AzaSite for a condition for which it was not prescribed. Do not give AzaSite to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information summarizes the most important information about AzaSite. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about AzaSite that is written for health professionals.

For more information, go towww.azasite.comor call 1-800-932-5676.

Active Ingredient: 

azithromycin

Inactive Ingredients: 

0.003% benzalkonium chloride, mannitol, citric acid, sodium citrate, poloxamer 407, polycarbophil, edetate disodium (EDTA), sodium chloride, water, and sodium hydroxide.

Instructions for Use

AzaSite(A-zuh-site)

(azithromycin ophthalmic solution) 1%

Read this Instructions for Use for AzaSite before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or treatment.

Important: 

  • AzaSite is for use as an eye drop only.

The Checklist Below Tells You When To Use Your Medicine For Each Eye That Has Bacterial Conjunctivitis: 

Checklist

This is a total of 9 drops of AzaSite for each infected eye.

  • Avoid letting the applicator tip touch your eye, your fingers, or other objects.
  • If a drop misses your eye, try again.
  • Follow the steps below to use AzaSite correctly.

Before Using A New Bottle Of Azasite: 

Figure A
  • Turn the white cap clockwise until it comes off. Throw away the white cap.SeeFigure AFigure B
  • Hold the bottle straight, turn the tan cap counterclockwise until it comes off. Put the tan cap back on the bottle and close tightly. (This lets out the air.)SeeFigure B

Wash your hands each time you use AzaSite.

To Use Azasite: 

Figure C

Step 1. Turn the closed bottle upside down.SeeFigure C

Figure D

Step 2.Shake your hand firmly. This helps move the medicine into the tip of the bottle.SeeFigure D

Figure E

Step 3. Hold the bottle upside down and take off the tan cap.SeeFigure E

Figure F

Step 4.Tilt your head back.Hold the bottle over your eye and gently squeeze the bottle to let 1 drop into each eye that has bacterial conjunctivitis. Put the tan cap back on the bottle and close tightly.SeeFigure F

If a drop does not come out of the bottle, repeat steps one to four.

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

AKORN
Distributed by:Akorn, Inc.
Lake Forest, IL 60045

U.S. Patent Nos.: 6,159,458; 6,239,113; 6,569,443; 6,861,411; 7,056,893; and Patents Pending

AzaSite is a registered trademark of InSite Vision Inc.

OPZTA0N Rev. 06/17

Principal Display Panel Text For Container Label: 

NDC 17478-307-03

AzaSITE

(azithromycin ophthalmic solution) 1%

Rx Only Sterile 2.5 mL

Principal Display Panel Text for Container Label

Principal Display Panel Text For Carton Label: 

NDC 17478-307-03

AzaSITE

(azithromycin ophthalmic solution) 1%

Sterile 2.5 mL

Rx Only

FOR OPHTHALMIC USE ONLY

Principal Display Panel Text for Carton Label
AZASITE
azithromycin monohydrate solution/ drops
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17478-307
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Azithromycin Monohydrate(UNII: JTE4MNN1MD) (Azithromycin Anhydrous - UNII:J2KLZ20U1M)Azithromycin Anhydrous10 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
Mannitol(UNII: 3OWL53L36A)
Citric Acid Monohydrate(UNII: 2968PHW8QP)
Sodium Citrate(UNII: 1Q73Q2JULR)
Poloxamer 407(UNII: TUF2IVW3M2)
Polycarbophil(UNII: W25LM17A4W)
Sodium Chloride(UNII: 451W47IQ8X)
Edetate Disodium(UNII: 7FLD91C86K)
Water(UNII: 059QF0KO0R)
Sodium Hydroxide(UNII: 55X04QC32I)
Benzalkonium Chloride(UNII: F5UM2KM3W7)0.03 mg in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17478-307-031 in 1 CARTON05/14/2014
12.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:17478-307-041 in 1 CARTON05/14/2014
22.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3NDC:17478-307-011 in 1 CARTON05/14/2014
31 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA05081005/14/2014
Labeler -Akorn, Inc. (062649876)

Revised: 11/2017document Id: 

e6fd3055-d577-47d0-8606-1363423c3dcaSet id: 14ae4c07-b042-452a-b069-2b41bc646e04Version: 3Effective Time: 20171120Akorn, Inc.



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