AzaSite® is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms:

 

CDC coryneform group G*

 

Haemophilus influenzae

 

Staphylococcus aureus

 

Streptococcus mitis group

 

Streptococcus pneumoniae

 

* Efficacy for this organism was studied in fewer than 10 infections.

The recommended dosage regimen for the treatment of bacterial conjunctivitis is:

Instill 1 drop in the affected eye(s) twice daily, eight to twelve hours apart for the first two days and then instill 1 drop in the affected eye(s) once daily for the next five days.

2.5 mL of a 1% sterile topical ophthalmic solution.

Hypersensitivity to any component of this product.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in one clinical trial of a drug cannot be directly compared with the rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to AzaSite in 698 patients. The population was between 1 and 87 years old with clinical signs and symptoms of bacterial conjunctivitis. The most frequently reported ocular adverse reaction reported in patients receiving AzaSite was eye irritation. This reaction occurred in approximately 1-2% of patients. Other adverse reactions associated with the use of AzaSite were reported in less than 1% of patients and included ocular reactions (blurred vision, burning, stinging and irritation upon instillation, contact dermatitis, corneal erosion, dry eye, eye pain, itching, ocular discharge, punctate keratitis, visual acuity reduction) and non-ocular reactions (dysgeusia, facial swelling, hives, nasal congestion, periocular swelling, rash, sinusitis, urticaria).

AzaSite (azithromycin ophthalmic solution) is a 1% sterile aqueous topical ophthalmic solution of azithromycin formulated in DuraSite® (polycarbophil, edetate disodium, sodium chloride). AzaSite is an off-white, viscous liquid with an osmolality of approximately 290 mOsm/kg.

Preservative: 0.003% benzalkonium chloride. Inactives: mannitol, citric acid, sodium citrate, poloxamer 407, polycarbophil, edetate disodium (EDTA), sodium chloride, water for injection, and sodium hydroxide to adjust pH to 6.3.

Azithromycin is a macrolide antibiotic with a 15-membered ring. Its chemical name is (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribohexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]1-oxa-6-aza-cyclopentadecan-15-one, and the structural formula is:

Azithromycin has a molecular weight of 749, and its empirical formula is C38H72N2O12.

In a randomized, vehicle-controlled, double-blind, multicenter clinical study in which patients were dosed twice daily for the first two days, then once daily on days 3, 4, and 5, AzaSite solution was superior to vehicle on days 6-7 in patients who had a confirmed clinical diagnosis of bacterial conjunctivitis. Clinical resolution was achieved in 63% (82/130) of patients treated with AzaSite versus 50% (74/149) of patients treated with vehicle. The p-value for the comparison was 0.03 and the 95% confidence interval around the 13% (63%-50%) difference was 2% to 25%. The microbiological success rate for the eradication of the baseline pathogens was approximately 88% compared to 66% of patients treated with vehicle (p<0.001, confidence interval around the 22% difference was 13% to 31%). Microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.

AzaSite is a sterile aqueous topical ophthalmic formulation of 1% azithromycin.

NDC 17478-307-03: 2.5 mL in 5 mL bottle containing a total of 25 mg of azithromycin in a white, round, low-density polyethylene (LDPE) bottle, with a clear LDPE dropper tip, and a tan colored high density polyethylene (HDPE) eyedropper cap. A white tamper evident over-cap is provided.

NDC 17478-307-04: 2.5 mL in 4 mL bottle containing a total of 25 mg of azithromycin in a white, round, low-density polyethylene (LDPE) bottle, with a clear LDPE dropper tip, and a tan colored high density polyethylene (HDPE) eyedropper cap. A white tamper evident over-cap is provided.

See FDA-Approved Patient Labeling (Patient Information).

Patients should be advised to avoid contaminating the applicator tip by allowing it to touch the eye, fingers or other sources.

Patients should be directed to discontinue use and contact a physician if any signs of an allergic reaction occur.

Patients should be told that although it is common to feel better early in the course of the therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by AzaSite (azithromycin ophthalmic solution) or other antibacterial drugs in the future.

Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.

Patients should be advised to thoroughly wash hands prior to using AzaSite.

Patients should be advised to invert the closed bottle (upside down) and shake once before each use. Remove cap with bottle still in the inverted position. Tilt head back, and with bottle inverted, gently squeeze bottle to instill one drop into the affected eye(s).

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.

OPZT00N      Rev. 06/17

PATIENT INFORMATION

AzaSite® (A-zuh-site)

(azithromycin ophthalmic solution) 1%

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

What is AzaSite?

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 not use AzaSite if you are allergic to azithromycin or any of the ingredients in AzaSite. See the end of this Patient Information leaflet for a complete list of the ingredients in AzaSite.

What should I tell my doctor before using 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 Information leaflet 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 not wear 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 seen with AzaSite include:

• eye burning, stinging and irritation when the drop hits your eye
• irritation on your eyelid and the skin around your eye
• a feeling of discomfort and irritation or that something is in your eye
• dry eye
• eye pain
• eye itching
• discharge coming from your eye
• changes to the surface of your eye
• blurred vision
• changes in your taste
• hives and rash on your skin
• stuffy nose and sinus infection
• swelling around your eye or of your face

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all of the possible side effects of AzaSite. 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 AzaSite?

• 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 to www.azasite.com or call 1-800-932-5676.

What are the ingredients in AzaSite?

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:

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:

• Turn the white cap clockwise until it comes off. Throw away the white cap. See Figure A
  
• 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.) See Figure B

Wash your hands each time you use AzaSite.

To use AzaSite:

Step 1. Turn the closed bottle upside down. See Figure C

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

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

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. See Figure 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 Carton Label:

NDC 17478-307-03

AzaSITE®

(azithromycin ophthalmic solution) 1%

Sterile 2.5 mL

Rx Only

FOR OPHTHALMIC USE ONLY