Approved indications: AzaSite is approved to treat bacterial conjunctivitis ("pink eye") caused by susceptible bacteria such as Haemophilus influenzae, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus mitis group, and CDC coryneform group G in adults and children 1 year and older.

Common off-label uses:

• Posterior blepharitis and meibomian gland dysfunction (MGD), often together with warm compresses and lid hygiene; multiple small clinical studies show meaningful improvement in lid signs, tear film stability, and symptoms.
• Chronic ocular surface disease related to eyelid inflammation (e.g., some forms of evaporative dry eye) where its antibacterial and anti-inflammatory effects can reduce symptoms; evidence is moderate and based on open-label and comparative trials.

Efficacy expectations for bacterial conjunctivitis:

• Many patients notice less redness, discharge, and irritation within 1 to 3 days, with high rates of clinical cure by the end of the 7-day course.
• In head-to-head trials, azithromycin 1% eye drops achieved similar clinical cure and bacterial eradication rates to commonly used antibiotic drops such as tobramycin, with far fewer total doses.
• Because the drop stays on the eye longer, the full course uses only 9 drops per infected eye, which can improve adherence compared with antibiotics that must be used several times a day throughout treatment.

Typical dosing (bacterial conjunctivitis): For adults and children 1 year and older, instill 1 drop in the affected eye or eyes twice daily (about 8 to 12 hours apart) on days 1 and 2, then 1 drop once daily on days 3 through 7, for a total of 9 drops per infected eye.

How to use the eye drops:

• Wash hands before and after using the drops.
• Keep the closed bottle upside down and shake it once before each use; with the bottle still inverted, remove the cap.
• Tilt your head back, gently pull the lower eyelid down to form a small pocket, and squeeze 1 drop into the pocket without touching the eye or eyelashes with the tip.
• Close the eye gently for 1 to 2 minutes; do not blink hard or rub the eye, and wipe away any excess liquid from the skin.
• If both eyes are infected, repeat in the other eye.
• If using other eye drops, separate them from AzaSite by at least 5 minutes to avoid washing either medicine out.

Special instructions:

• Use the drops for the full 7-day course, even if the eye feels better sooner, to reduce the risk of relapse and bacterial resistance.
• Do not wear contact lenses during treatment or while the eye is still red, painful, or producing discharge.
• Do not share the bottle with anyone else, even if they have similar symptoms, to avoid spreading infection.

Missed dose: If a dose is missed, apply it as soon as you remember unless it is almost time for the next dose; if it is close to the next scheduled dose, skip the missed dose and resume the regular schedule, and do not use extra drops to make up for a missed dose.

Overdose: Accidental use of extra drops in the eye may cause more irritation but is unlikely to cause serious harm; if a large amount is swallowed or if there is severe or persistent eye pain, vision changes, or systemic symptoms, contact a poison control center or healthcare provider right away.

Common side effects:

• Mild eye irritation, burning, or stinging right after the drop is placed (about 125 to 225 of people), usually brief and self-limited.
• Less commonly, blurred vision for a short time after instillation, dry eye, itching, watery eyes, a bad or metallic taste in the mouth, nasal congestion, or sinus discomfort.
• These effects are generally mild; if they persist or worsen, the prescriber should be contacted.

Serious or rare adverse effects (seek immediate medical care):

• Signs of an allergic reaction, such as severe eye redness or swelling, rash, hives, swelling of the face, lips, tongue, or throat, or trouble breathing.
• Severe eye pain, sudden vision changes, or marked worsening of redness or discharge, which may signal a more serious eye problem or a different type of infection.
• Very rare severe allergic skin reactions (like Stevensb7Johnson syndrome) have been reported with oral azithromycin; although systemic exposure from eye drops is very low, a history of such reactions to azithromycin or related antibiotics is a reason to avoid AzaSite.

Warnings and precautions:

• For topical ophthalmic use only; do not inject, swallow intentionally, or put directly inside the eye (anterior chamber).
• Do not wear contact lenses while you have signs or symptoms of bacterial conjunctivitis or while using AzaSite; the preservative (benzalkonium chloride) can absorb into soft lenses and further irritate the eye.
• Allergy/hypersensitivity: Do not use if you have a known allergy to azithromycin, other macrolide or ketolide antibiotics, or any component of the drop.
• Superinfection: Using any antibiotic for longer than directed can allow non-susceptible bacteria or fungi to overgrow; if symptoms persist or worsen, the eye should be re-evaluated.
• Pregnancy: Classified as pregnancy category B; animal studies show no fetal harm and systemic absorption from eye drops is very low, but use during pregnancy should be limited to situations where it is clearly needed.
• Breastfeeding: Only tiny amounts, if any, are expected in breast milk from eye-drop use; most experts consider it compatible with breastfeeding, but caution and consultation with a clinician are recommended.
• Pediatrics and older adults: Safety and effectiveness are established for children 1 year and older and adults of all ages; it is not established in infants under 1 year.
• Liver or kidney disease: No dosage adjustment is specified because systemic exposure from ophthalmic use is minimal, but people with severe liver disease should still use the drug under medical supervision.

Safety compared with other antibiotic eye drops: AzaSite has a side-effect profile similar to other topical ophthalmic antibiotics, with eye irritation as the main adverse effect, but offers a shorter, less frequent dosing schedule, which may lower the risk of dosing errors and improve adherence.

Reporting side effects and safety updates: Patients and caregivers can report suspected side effects to the FDA MedWatch program (online or at 1800a0FDAa01088) or to the producta0manufacturer using the phone number on the bottle or package insert; updated safety information is posted on the FDA and manufacturer websites as it becomes available.

Drug and other interactions:

• Because AzaSite is used only in the eye and very little medicine reaches the bloodstream, clinically important interactions with other oral or injected drugs are not expected.
• No specific interactions are known with common prescription medicines, over-the-counter drugs, supplements, foods, or alcohol when AzaSite is used as directed.
• When using more than one type of eye drop (for example, glaucoma drops or artificial tears), wait at least 5 minutes between products so they do not dilute or wash each other out.

Conditions and co-medications requiring caution:

• History of allergy or severe reaction to azithromycin, erythromycin, or other macrolide or ketolide antibiotics, or to any ingredient in the product 96 AzaSite should not be used.
• History of severe allergic skin reactions to azithromycin or similar drugs 96 discuss alternatives with an eye-care professional.
• Severe liver disease 96 although systemic exposure from eye drops is very low, the prescriber may wish to monitor more closely.
• Existing severe eye conditions (such as corneal ulcers, eye trauma, or recent eye surgery) 96 may need closer follow-up to be sure this is the right treatment.

Monitoring needs:

• Routine blood tests or ECGs are not required for typical short-term use because systemic absorption is minimal.
• The eye should be rechecked if symptoms worsen at any time, if there is no clear improvement within a few days, or if symptoms return soon after finishing the course.

Q: How long will it take for my eye to feel better with AzaSite?
A: Many people notice less redness and discharge within 1 to 3 days, but it is important to keep using the drops for the full 7-day course even if the eye seems back to normal.

Q: Can I wear my contact lenses while using AzaSite?
A: No, you should not wear contact lenses while your eye is red, painful, or has discharge, or while you are using AzaSite, and you should wait until treatment is finished and the eye is comfortable before wearing lenses again.

Q: What should I do if I miss a dose?
A: Put in the missed drop as soon as you remember unless it is almost time for your next scheduled dose, in which case you should skip the missed dose and continue with your regular schedule without doubling up.

Q: Is AzaSite safe to use during pregnancy or while breastfeeding?
A: AzaSite is pregnancy category B and only tiny amounts, if any, reach the bloodstream and breast milk from eye-drop use, so it is generally considered acceptable when clearly needed, but you should decide with your obstetric or eye-care provider.

Q: Does AzaSite work for viral or allergic pink eye?
A: No, AzaSite targets bacterial infections and will not treat viral or allergic conjunctivitis, so if your symptoms do not begin to improve within a few days, your eye-care provider may reassess the cause.

Q: Can AzaSite be used in very young children?
A: Safety and effectiveness have been established for children 1 year of age and older; in infants under 1 year, its use is not well studied and requires specialist guidance.

Storage: Keep unopened bottles in the refrigerator at 36b0F to 46b0F (2b0C to 8b0C) and do not freeze; after opening, store at room temperature or in the refrigerator (36b0F to 77b0F / 2b0C to 25b0C) and discard any remaining solution 14 days after first opening.

Handling: Keep the cap tightly closed when not in use, avoid touching the dropper tip to any surface (including the eye or fingers), and keep out of reach of children and pets.

Disposal: After 14 days from opening or when no longer needed, throw the bottle away in household trash unless your pharmacist or local waste program offers a medicine take-back option; do not flush the drops down the toilet or pour them into a drain unless specifically instructed.