RX ITEM-Azasite Eye 1% Azithromycin drops 2.5ml by Thea Pharma

Clinical Information
Gen. Code and Des.
62828 azithromycin OPHTHALMIC DROPS 1 %
GCN and Des.
98599 azithromycin OPHTHALMIC DROPS 1 %
Strength
1%
Dose Form
DROPS
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
52040400 ANTIBACTERIALS (EENT)
Active Ingredients
3635 azithromycin 117772700
Inactive Ingredients
2272 mannitol 69658
2332 sodium citrate 68042
3141 benzalkonium chloride 8001545
3785 edetic acid 60004




These highlights do not include all the information needed to use AzaSite safely and effectively. See full prescribing information for AzaSite.



AzaSite ® (azithromycin ophthalmic solution) 1%

Sterile topical ophthalmic drops

Initial U.S. Approval: 2007
INDICATIONS AND USAGE

AzaSite is a macrolide antibiotic indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms: CDC coryneform group G, Haemophilus influenzae, Staphylococcus aureus, Streptococcus mitis group, and Streptococcus pneumoniae. ( 1)
DOSAGE AND ADMINISTRATION

Instill 1 drop in the affected eye(s) twice daily, eight to twelve hours apart for the first two days and then instill 1 drop in the affected eye(s) once daily for the next five days. ( 2)
DOSAGE FORMS AND STRENGTHS

2.5 mL of 1% sterile topical ophthalmic solution. ( 3)
CONTRAINDICATIONS

Hypersensitivity ( 4)
WARNINGS AND PRECAUTIONS

For topical ophthalmic use only. ( 5.1)
Anaphylaxis and hypersensitivity have been reported with systemic use of azithromycin. ( 5.2)
Growth of resistant organisms may occur with prolonged use. ( 5.3)
Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis. ( 5.4)

ADVERSE REACTIONS

Most common adverse reaction reported in patients was eye irritation (1-2% of patients). ( 6)

To report SUSPECTED ADVERSE REACTIONS, contact Thea Pharma Inc. at 1-833-838-4028 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 5/2022

Azasite Eye 1% drops 2.5ml
NDC No.17478-0307-03 UPC/GTIN No.3-17478-30703-7 MPN 30703 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapis

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