Azasite (azithromycin)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Azithromycin is a macrolide antimicrobial.
Azithromycin 1% ophthalmic solution is a macrolide antimicrobial that acts by binding to the 50S ribosomal subunit of susceptible microorganisms and interfering with microbial protein synthesis. In vitro and clinically in bacterial conjunctivitis, azithromycin 1% ophthalmic solution has demonstrated activity againstCDC coryneform group G (efficacy for this organism was studied in fewer than 10 infections), Haemophilus influenzae, Staphylococcus aureus, Streptococcus mitis group,and Streptococcus pneumoniae. In vitro, activity has been demonstrated against Chlamydia pneumoniae, Chlamydia trachomatis, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma hominis, Mycoplasma pneumoniae, Neisseria gonorrhoeae, Peptostreptococcus species, Streptococci (Groups C, F, G), Streptococcus pyogenes, Streptococcus agalactiae, Ureaplasma urealyticum, and Viridans group streptococci; however, clinical activity in ophthalmic infections has not been demonstrated.
Plasma concentrations of azithromycin following ocular administration of the 1% ophthalmic solution are unknown. However, systemic exposure is not likely following ocular administration, based on exposure estimates following systemic administration. Azithromycin plasma concentrations following ocular administration are estimated to be below quantifiable limits (<10 ng/mL) at steady-state.
USES: This medication is used to treat certain eye infections. It is a macrolide antibiotic that works by stopping the growth of bacteria. This medication treats only bacterial eye infections.
It will not work for other types of eye infections. Using any antibiotic when it is not needed can cause it to not work for future infections.
Generic name: azithromycin
Pronunciation: (ay-ZITH-roe-MYE-sin)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Azasite
Indications
The following indications are listed for Azasite:
- Bacterial Conjunctivitis
Also known as: Inflammation Of The Conjunctiva Due To Bacteria.
Dosing
No dosing information is available for this tab.
Apply azithromycin 1% ophthalmic solution topically to the affected eye(s).
Azithromycin ophthalmic solution is available as 2.5 mL of a 1% sterile topical ophthalmic solution.
Store unopened bottles under refrigeration at 2-8oC. Once opened, store the bottle at 2-25oC for up to 14 days. Discard after 14 days.
Azithromycin 1% ophthalmic solution is for topical ophthalmic use only.
Wash hands prior to administration. Invert the closed bottle (upside down) and shake once before each use. Remove the cap with the bottle still in the inverted position. Tilt head back, and with bottle inverted, gently squeeze bottle to instill one drop into the affected eye(s).
Skipping doses or not completing the full course of therapy may decrease the effectiveness of the immediate treatment and increase the likelihood that bacteria will develop resistance and will not be treatable by azithromycin or other antibacterials in the future.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
Specific drug interaction studies have not been performed using azithromycin ophthalmic preparations. Systemic exposure following ocular administration is not known but is estimated to be minimal.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Hypersensitivity to any component of the product.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Most common adverse reaction reported in patients was eye irritation (1 to 2% of patients).
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy of azithromycin 1% ophthalmic solution have not been established in pediatric patients <=1 year of age.
Data from published literature and postmarketing experience over several decades with azithromycin use in pregnant women have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Azithromycin is present in human milk. Non-serious adverse reactions have been reported in breastfed infants after maternal administration of oral azithromycin. There are no data on the effects of azithromycin on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for azithromycin and any potential adverse effects on the breastfed infant.
The manufacturer makes no specific recommendations for geriatric patients.
No differences in safety or efficacy have been observed between geriatric patients >=65 years of age and younger adults (<65 years of age). Patients >=65 years of age represented 11% of the population in the clinical trial comparing azithromycin 1% ophthalmic solution to vehicle.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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