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Azithromycin (Ophthalmic)

Pronunciation

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

Treatment of bacterial conjunctivitis caused by susceptible microorganisms

Contraindications

Hypersensitivity to azithromycin or any component of the formulation

Dosing: Adult

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

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Bacterial conjunctivitis: Children ≥1 year: Refer to adult dosing.

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% (Limited to important or life-threatening): 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.

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.

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