Azasite (Inspire Pharmaceuticals): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

AzaSite™ (azithromycin ophthalmic solution) 1% w/w is an antibiotic that is used to kill or prevent growth of certain types of bacteria in the eye that cause bacterial conjunctivitis, also known as pink eye (bacterial infection of the inside of the eyelid [conjunctiva]), in adults and children 1 year of age or older.

Your doctor has prescribed AzaSite™ to treat bacterial conjunctivitis (pink eye).

What it does:

Azithromycin is an antibiotic which binds to a part of the bacteria to prevent the production of bacterial protein. This prevents the growth of bacteria which causes conjunctivitis or pink eye, thereby reducing the infection.

When it should not be used:

Do not use AzaSite™ if:

• You are allergic (hypersensitive) to azithromycin

  or any of the components of the formulation (see what the nonmedicinal ingredients are).

Speak to your doctor prior to using AzaSite™ if you are pregnant or nursing.

What the medicinal ingredient is:

Azithromycin

What the important nonmedicinal ingredients are:

Citric acid, edetate disodium (EDTA), mannitol, benzalkonium chloride, poloxamer 407, polycarbophil, sodium chloride, sodium citrate, sodium hydroxide, and water for injection.

What dosage form it comes in:

4 mL size bottle containing 2.5 mL of 1% sterile topical ophthalmic solution.

WARNINGS AND PRECAUTIONS

Before using AzaSite™ talk to your doctor or pharmacist if:

•

There is no experience of using AzaSite™ in pregnant or nursing women.

• You wear contact lenses. Contact lenses should not be worn during treatment of conjunctivitis.
• You have had recent eye surgery.

Do not use AzaSite™ and contact your doctor if:

• Your condition does not improve or you develop worsening eye infection, blurring, eyelid swelling, itching, pain, reduction in vision, suffer eye injury or you develop an allergic reaction with symptoms such as swelling of the eye or face, hives, rash, or difficulty in breathing.

INTERACTIONS WITH THIS MEDICATION

No studies have been conducted to determine if AzaSite™ may interact with other drugs.

PROPER USE OF THIS MEDICATION

Usual dose:

You should instill 1 drop in the affected eye(s) twice a day, 8 to 12 hours apart for the first 2 days. Then instill 1 drop in the affected eye(s) once a day for the next 5 days.

Directions for Use:

1. 1. Wash your hands before use.
2. 2. Be careful to avoid contaminating the applicator tip by touching it to your eye, fingers or other sources.
3. 3.

   Holding the bottle upright, remove the tan cap.

   This will allow any excess pressure in the bottle to be released. Replace the tan cap on the bottle and close securely.

4. 4. Invert the closed bottle (upside down) and shake once before each use.
5. 5.

   Remove the cap with the bottle still in the

   inverted position. Tilt your head back, and with the bottle inverted, gently squeeze the bottle to instill one drop into the affected eye(s).

6. 6. If the drop misses your eye, try again.

Overdose:

In case of drug overdose, including oral ingestion, contact your healthcare professional, hospital emergency department or regional poison control centre, even if there are no symptoms.

There are 2.5 mL of 1% w/w sterile ophthalmic solution per bottle. Currently approved oral systemic formulations of azithromycin have doses as high as 600 mg/dose, which is 24 times higher than that which is found in the entire bottle of AzaSite™. Therefore, overdose with AzaSite™ is not expected to occur ophthalmically or systemically.

In case of accidental oral ingestion, contact your regional Poison Control Centre.

Missed dose:

You should only take AzaSite™ as prescribed. However, if you miss a dose, do not administer an extra dose. Just remember to administer your usual dose the following day.

Although it is common to feel better early in the course of the therapy, AzaSite™ 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™ or other antibacterial drugs in the future.

The safety and effectiveness of AzaSite™ in children <1 year of age have not been established.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The most commonly reported side effect in the eyes of patients receiving AzaSite™ was eye irritation. This occurred in 1-2% of patients. Other less common side effects that occurred in less than 1% of patients include the following:

• Burning, stinging and irritation of the eye upon

  instillation, corneal erosion, dry eye, eye discharge, and inflammation of the cornea.

• Skin irritation or rash;
• Altered taste;

• Nasal congestion and sinus inflammation; and

  • Temporary blurred vision. Use caution if driving or operating machinery.

This is not a complete list of side effects. For any unexpected effects while taking AzaSite™, contact your doctor or pharmacist immediately.

There were no serious sides effects observed in the clinical studies of AzaSite™.

HOW TO STORE IT

Store unopened bottle under refrigeration at 2°C to 8°C (36°F to 46°F). Once the bottle is opened, store at 2°C to 25°C (36°F to 77°F) for up to 14 days. Discard after the 14 days.

Keep out of reach of children.

REPORTING SUSPECTED ADVERSE EVENTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

• Report online at

  www.healthcanada.gc.ca/medeffect

• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form

  and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program

    Health Canada

    Postal Locator 0701E

    Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™

Canada Web site at

www.healthcanada.gc.ca/medeffect

or at Merck Canada Inc. by one of the following 2 ways:

• Call toll-free at 1-800-567-2594

• Complete a Canada Vigilance Reporting

  Form and:

  • Fax toll-free to 1-800-369-3090, or

  • Mail to: Merck Canada Inc.

    Pharmacovigilance P.O. Box 1005

    Pointe - Claire - Dorval, QC H9R 4P8

NOTE: Should you require information related to the management of the side effect, contact your health professional. . The Canada Vigilance Program or Merck do not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals, can be found at http://www.merck.ca

or by contacting Merck Canada Inc.,

at: 1-800-567-2594.

Last revised: November 19, 2013

^TM Trademark of InSite Vision Incorporated. Used by permission.

©2012, 2013 Inspire Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. All rights reserved.