Azasite (azithromycin)

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Apply azithromycin 1% ophthalmic solution topically to the affected eye(s).

Azithromycin ophthalmic solution is available as 2.5 mL of a 1% sterile topical ophthalmic solution.

Store unopened bottles under refrigeration at 2-8oC. Once opened, store the bottle at 2-25oC for up to 14 days. Discard after 14 days.

Azithromycin 1% ophthalmic solution is for topical ophthalmic use only.

Wash hands prior to administration. Invert the closed bottle (upside down) and shake once before each use. Remove the cap with the 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).

Skipping doses or not completing the full course of therapy may decrease the effectiveness of the immediate treatment and increase the likelihood that bacteria will develop resistance and will not be treatable by azithromycin or other antibacterials in the future.

No dosing information is available for this tab.

Specific drug interaction studies have not been performed using azithromycin ophthalmic preparations. Systemic exposure following ocular administration is not known but is estimated to be minimal.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Hypersensitivity to any component of the product.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

Most common adverse reaction reported in patients was eye irritation (1 to 2% of patients).

Rare or Very Rare

• Contact dermatitis
• Corneal erosion
• Fungal infection of eye
• Punctate keratitis
• Urticaria

Less Frequent

• Ocular irritation

Rare or Very Rare

• Blurred vision
• Dry eye
• Dysgeusia
• Facial edema
• Nasal congestion
• Ocular discharge
• Sinusitis
• Skin rash

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Safety and efficacy of azithromycin 1% ophthalmic solution have not been established in pediatric patients <=1 year of age.

Data from published literature and postmarketing experience over several decades with azithromycin use in pregnant women have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Azithromycin is present in human milk. Non-serious adverse reactions have been reported in breastfed infants after maternal administration of oral azithromycin. There are no data on the effects of azithromycin on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for azithromycin and any potential adverse effects on the breastfed infant.

The manufacturer makes no specific recommendations for geriatric patients.

No differences in safety or efficacy have been observed between geriatric patients >=65 years of age and younger adults (<65 years of age). Patients >=65 years of age represented 11% of the population in the clinical trial comparing azithromycin 1% ophthalmic solution to vehicle.