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Azithromycin Dihydrate USP
|NAME||STRENGTH||PACK SIZE||DOSAGE FORM|
|Romycin ED||0.1% w/v||2.5 ml||Eye drops|
Azithromycin is a macrolide antibiotic. It acts by binding to the 50 S ribosomal subunit of susceptible bacteria.
Each ml sterile Eye Drops contains Azithromycin Dihydrate USP equivalent to Azithromycin 10 mg.
Indications And Uses
Romycin (Azithromycin) Eye Drops is indicated for the treatment of bacterial conjunctivitis caused by CDC coryneform group G, Haemophilus influenzae, Staphylococcus aureus, Streptococcus mitis group, and Streptococcus pneumoniae.
Dosage And Administration
Children less than one year of age: Not recommended. Children of one year of age and adults: Instill 1 drop in affected eye(s) twice daily for the first 2 days then once daily for the next 5 days.
Eye irritation, contact dermatitis, corneal erosion, dry eye, punctate keratitis etc.
Use In Pregnancy Lactation
Pregnancy: Pregnancy Category B. In the animal studies, no evidence of harm to the fetus due to Azithromycin was found. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if clearly needed. Lactation: It is not known whether Azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Azithromycin is administered to a nursing woman.
Drug interaction studies have not been conducted with Romycin (Azithromycin) Eye Drops.
Store unopened bottle under refrigeration at 2°C to 8°C. Once the bottle is opened, store at 'C° to 25°C for up to 14 days. Discard after the 14 days of opening.
Hypersensitivity to any component of the preparation.
Each Plastic Dropper bottle contains 2.5 ml sterile eye drops.