ROMYCIN (Eye Drops)
AZITHROMYCIN DIHYDRATE USP
| NAME | STRENGTH | PACK SIZE | DOSAGE FORM |
|---|---|---|---|
| ROMYCIN 1% W/V | 1% W/V | 2.5 ML | EYE DROP |
| Each ml sterile Eye Drops contains Azithromycin Dihydrate USP equivalent to Azithromycin 10 mg. |
| Azithromycin is a macrolide antibiotic. It acts by binding to the 50 S ribosomal subunit of susceptible bacteria. |
| 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. |
| 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. |
| Hypersensitivity to any component of the preparation. |
| Romycin (Azithromycin) Eye Drops 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. |
| Eye irritation, contact dermatitis, corneal erosion, dry eye, punctate keratitis etc. |
| 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. |
| Sign and symptoms of overdose may be similar to side effects as described above |
| 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. |
| Romycin Eye Drops: Each Plastic Dropper bottle contains 2.5 ml sterile eye drops. |