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]
Pharmacology
Mechanism of Action
Inhibits RNA-dependent protein synthesis at the chain elongation step; binds to the 50S ribosomal subunit resulting in blockage of transpeptidation
Pharmacokinetics/Pharmacodynamics
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
Dosage and Administration
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
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
Pregnancy Risk Factor
B
Pregnancy Considerations
Adverse events were not observed in animal reproduction studies. 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
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Have patient report immediately to prescriber vision changes, eye pain, severe eye irritation, or eye discharge (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
