Composition:

AZ sterile ophthalmic solution: Each ml contains Azithromycin Dihydrate USP equivalent to Azithromycin 10 mg.

Pharmacology:

Azithromycin is a macrolide antibiotic. It acts by binding to the 50S ribosomal subunit of susceptible microorganisms and interfering with microbial protein synthesis. It is effective against most of the pathogens like Haemophilus influenzae, Staphylococcus aureus, Streptococcus mitis group, Streptococcus pneumoniae, CDC coryneform group G. It is also effective against most isolates of ocular pathogens like Chlamydia pneumoniae, Chlamydia trachomatis, Moraxella catarrhalis, Mycoplasma hominis, Mycoplasma pneumoniae & Neisseria gonorrhoeae.

Indications:

AZ sterile ophthalmic solution is indicated for the treatment of infection in the anterior segment of the eye.

Dosage & administration:

Instill 1 drop in the affected eye(s) twice daily for the first two days and then instill 1 drop in the affected eye(s) once daily for the next five days.

Contraindications:

Hypersensitivity to any component of the preparation.

Side-effects:

Eye irritation, contact dermatitis, corneal erosion, dry eye, punctate keratitis etc.

Warning & precaution:

AZ sterile ophthalmic solution is indicated for topical ophthalmic use only and should not be administered systemically, injected subconjunctivally or introduced directly into the anterior chamber of the eye.

Use in pregnancy:

There are no adequate and well-controlled studies in pregnant women. Thus it should be used during pregnancy only if clearly needed.

Use in lactation:

It is not known whether Azithromycin is excreted in human milk. Caution should be exercised when Azithromycin ophthalmic solution is administered during lactation.

Pediatric use:

The safety and effectiveness of Azithromycin ophthalmic solution in pediatric patients below 1 year of age have not been established.

Geriatric use:

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

Storage:

Store unopened bottle at 20° C to 80° C. Once the bottle is opened, store at 20° C to 25° C. Do not use longer than 14 days after first opening. Keep out of the reach of the children.

Packing:

AZ sterile ophthalmic solution: Each plastic dropper bottle contains 2.5 ml sterile ophthalmic solution.