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Azithromycin (Ophthalmic)

Medically reviewed by Drugs.com. Last updated on Jul 31, 2020.

Pronunciation

(az ith roe MYE sin)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Ophthalmic:

AzaSite: 1% (2.5 mL) [contains benzalkonium chloride, disodium edta]

Brand Names: U.S.

  • AzaSite

Pharmacologic Category

  • Antibiotic, Macrolide
  • Antibiotic, Ophthalmic

Pharmacology

Inhibits RNA-dependent protein synthesis at the chain elongation step; binds to the 50S ribosomal subunit resulting in blockage of transpeptidation

Absorption

Systemic absorption estimated to be negligible

Use: Labeled Indications

Bacterial conjunctivitis: For the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms: Centers for Disease Control and Prevention (CDC) coryneform group G (efficacy studied in fewer than 10 infections), Haemophilus influenzae, Staphylococcus aureus, Streptococcus mitis group, and Streptococcus pneumoniae.

Contraindications

Hypersensitivity to azithromycin or any component of the formulation

Dosing: Adult

Bacterial conjunctivitis: Ophthalmic: Instill 1 drop into affected eye(s) twice daily (8 to 12 hours apart) for 2 days, then 1 drop into affected eye(s) once daily for the next 5 days

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Bacterial conjunctivitis: Children and Adolescents: Ophthalmic: Instill 1 drop in the affected eye(s) twice daily (8 to 12 hours apart) for 2 days, then 1 drop once daily for 5 days

Administration

For ophthalmic use only; avoid touching tip of applicator to eye or other surfaces. Invert closed bottle and shake once before each use. With bottle inverted, remove cap, tilt head back and gently squeeze bottle to instill drop. Wash hands before and after instillation.

Storage

Prior to use, store unopened under refrigeration at 2°C to 8°C (36°F to 46°F). After opening, store at 2°C to 25°C (36°F to 77°F) for ≤14 days; discard any remaining solution after 14 days.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%: Ophthalmic: Eye irritation (1% to 2%)

<1%, postmarketing, and/or case reports: Blurred vision, contact dermatitis, corneal erosion, decreased visual acuity, dysgeusia, eye pain, facial edema, local ocular hypersensitivity reaction (includes burning sensation of eyes, eye discharge, eye irritation, eye pruritus, stinging of eyes), nasal congestion, punctate keratitis, sinusitis, skin rash, swelling of eye, urticaria, xerophthalmia

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Severe hypersensitivity reactions, including anaphylaxis, angioedema, and dermatologic reactions, have been reported with systemic use of azithromycin.

• Superinfection: Prolonged use may lead to overgrowth of nonsusceptible organisms, including fungi. Discontinue use and institute alternative therapy if superinfection is suspected.

Special populations:

• Contact lens wearers: Solution contains benzalkonium chloride which may be absorbed by contact lenses; contact lens should not be worn during treatment.

Other warnings/precautions:

• Appropriate use: For topical ophthalmic use only; do not inject subconjunctivally or introduce directly into the anterior chamber of the eye. Whenever clinical judgment dictates, examine the patient with the aid of magnification, such as slit-lamp biomicroscopy and, when appropriate, fluorescein staining.

Pregnancy Risk Factor

B

Pregnancy Considerations

The amount of azithromycin available systemically following topical application of the ophthalmic drops is estimated to be below quantifiable limits. Systemic absorption would be required in order for azithromycin to cross the placenta and reach the fetus. When administered orally or IV, azithromycin crosses the placenta. Refer to the Azithromycin (Systemic) monograph for details.

Patient Education

What is this drug used for?

• It is used to treat eye infections.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Vision changes

• Eye pain

• Severe eye irritation

• Eye discharge

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.