AZASITE
Generic: AZITHROMYCIN MONOHYDRATE
Basic Information
Manufacturer
Thea Pharma Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
0c5d6f5e-18ea-436f-8c62-bbaf66effe3d
Indications & Usage
1 INDICATIONS AND USAGE AzaSite ® is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms: CDC coryneform group G Efficacy for this organism was studied in fewer than 10 infections.
Haemophilus influenzae Staphylococcus aureus Streptococcus mitis group Streptococcus pneumoniae AzaSite is a macrolide antimicrobial 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 )
Haemophilus influenzae Staphylococcus aureus Streptococcus mitis group Streptococcus pneumoniae AzaSite is a macrolide antimicrobial 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 )
Adverse Reactions
6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in one clinical trial of a drug cannot be directly compared with the rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to AzaSite in 698 patients.
The population was between 1 and 87 years old with clinical signs and symptoms of bacterial conjunctivitis.
The most frequently reported ocular adverse reaction reported in patients receiving AzaSite was eye irritation.
This reaction occurred in approximately 1 to 2% of patients.
Other adverse reactions associated with the use of AzaSite were reported in less than 1% of patients and included ocular reactions (blurred vision, burning, stinging and irritation upon instillation, contact dermatitis, corneal erosion, dry eye, eye pain, itching, ocular discharge, punctate keratitis, visual acuity reduction) and non-ocular reactions (dysgeusia, facial swelling, hives, nasal congestion, periocular swelling, rash, sinusitis, urticaria).
Most common adverse reaction reported in patients was eye irritation (1 to 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.
The data described below reflect exposure to AzaSite in 698 patients.
The population was between 1 and 87 years old with clinical signs and symptoms of bacterial conjunctivitis.
The most frequently reported ocular adverse reaction reported in patients receiving AzaSite was eye irritation.
This reaction occurred in approximately 1 to 2% of patients.
Other adverse reactions associated with the use of AzaSite were reported in less than 1% of patients and included ocular reactions (blurred vision, burning, stinging and irritation upon instillation, contact dermatitis, corneal erosion, dry eye, eye pain, itching, ocular discharge, punctate keratitis, visual acuity reduction) and non-ocular reactions (dysgeusia, facial swelling, hives, nasal congestion, periocular swelling, rash, sinusitis, urticaria).
Most common adverse reaction reported in patients was eye irritation (1 to 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.