Download DEMONSTRATED EFFICACY. SIMPLE DOSING REGIMEN.

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S IMP L E D O S
Helps resolve bacterial conjunctivitis
Recommended dosing
9 DROPS. 7 DAYS.
AzaSite® is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of
the following microorganisms: CDC coryneform
group G*, Haemophilus infl uenzae, Staphylococcus aureus, Streptococcus mitis group, Streptococcus pneumoniae.
One drop twice a day
Day 1
Day 2
One drop once a day
Day 3 Day 4 Day 5 Day 6 Day 7
8–12 hours apart
*Efficacy for this organism was studied in fewer
than 10 infections.
AzaSite is dosed as a viscous drop
in the affected eye.
The only azithromycin-based eyedrop available.1
Redesigned bottle
Unrestricted access to 90% of patients on managed care5, a
Fingertip Formulary, LLC, September 28, 2012, percentage based on current enrollment.
Bottle not shown
at actual size.
SELECT IMPORTANT SAFETY INFORMATION
AzaSite® is contraindicated in patients with hypersensitivity to any component of this product.
AzaSite® is NOT FOR INJECTION. AzaSite is for topical ophthalmic use only and should not be administered
systemically, injected subconjunctivally, or introduced directly into the anterior chamber of the eye. In patients
receiving systemically administered azithromycin, serious allergic reactions, including angioedema, anaphylaxis,
and dermatologic reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been
reported rarely. Although rare, fatalities have been reported. As with other anti-infectives, prolonged use may
result in overgrowth of nonsusceptible organisms, including fungi. If super-infection occurs, discontinue use and
institute alternative therapy.
The most frequently reported ocular adverse reaction reported in clinical trials was eye irritation, which occurred in
1% to 2% of patients.
Please refer to full Prescribing Information for complete safety information and the use of AzaSite®.
NOW AVAILABLE FROM
In the treatment of bacterial conjunctivitis caused by susceptible
isolates of certain microorganisms
DEMONSTRATED RESOLUTION
AND ERADICATION1
In a clinical study of 279 participants with bacterial conjunctivitis1
CLINICAL RESOLUTION
Primary endpoint
BACTERIAL ERADICATION
Secondary endpoint
Significant resolution
of clinical signs vs. vehicle
Significant eradication
of baseline pathogens
on visit 3 (day 6 or 7)1
on visit 3 (day 6 or 7)1
Microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.
Study Design: A prospective, randomized, vehicle-controlled, parallel-group, double-masked, multicenter clinical study in 279 participants aged 1 to 96 evaluated
the efficacy of azithromycin ophthalmic solution 1% compared to vehicle in a 5-day course of treatment for bacterial conjunctivitis. Subjects received study medication
(azithromycin or vehicle) in study eye twice daily on days 1 and 2 and once daily on days 3 through 5. Signs of bacterial conjunctivitis (palpebral conjunctival injection,
bulbar conjunctival injection, and ocular discharge) were measured at visit 1 (day 1 [study entry]), visit 2 (day 3 or 4), and visit 3 (day 6 or 7). Both follow-up visits
occurred at least 12 hours after the previous dose of study medication. The primary efficacy endpoint was resolution of clinical signs on visit 3 (day 6 or 7). The secondary efficacy endpoint was eradication of causative bacteria on visit 3 (day 6 or 7). Clinical resolution was defined as the absence of the 3 clinical signs (palpebral
conjunctival injection, bulbar conjunctival injection, and ocular discharge). Bacterial eradication was defined as the absence of bacterial growth.1
SELECT IMPORTANT SAFETY INFORMATION
AzaSite® is contraindicated in patients with hypersensitivity to any component of this product.
AzaSite® is NOT FOR INJECTION. AzaSite® is for topical ophthalmic use only and should not be administered
systemically, injected subconjunctivally, or introduced directly into the anterior chamber of the eye.
In patients receiving systemically administered azithromycin, serious allergic reactions, including angioedema,
anaphylaxis, and dermatologic reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have
been reported rarely. Although rare, fatalities have been reported.
As with other anti-infectives, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.
If super-infection occurs, discontinue use and institute alternative therapy.
Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.
The most frequently reported ocular adverse reaction reported in clinical trials was eye irritation, which occurred in
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
nonocular reactions (dysgeusia, facial swelling, hives, nasal congestion, periocular swelling, rash, sinusitis, urticaria).
Please refer to full Prescribing Information for complete safety information and the use of AzaSite®.
SIMPLE DOSING REGIMEN
AzaSite® helps simplify dosing with the fewest drops approved to treat
bacterial conjunctivitis2–4.
RECOMMENDED DOSING SCHEDULE
9 DROPS. 7 DAYS.
AzaSite is dosed as
a viscous drop in the
affected eye.
One drop twice a day
Day 1
Day 2
One drop once a day
Day 3
Day 4
Day 5
Day 6
Day 7
8–12 hours apart
Redesigned bottle
Bottle not shown at actual size.
AzaSite® is dosed as a viscous drop in the affected eye
• AzaSite® is a 1% sterile aqueous topical ophthalmic solution of azithromycin formulated in DuraSite® (polycarbophil,
edetate disodium, sodium chloride).
Storage and handling
• Store unopened bottle under refrigeration at 2°C to 8°C (36°F to 46°F).
• Once the bottle is opened, store at 2°C to 25°C (36°F to 77°F) for up to 14 days. Discard after the 14 days.
SELECT IMPORTANT SAFETY INFORMATION
There are no adequate and well-controlled studies in pregnant women. Azithromycin should be used during
pregnancy only if clearly needed.
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.
Safety and effectiveness of AzaSite® solution in pediatric patients below 1 year of age have not been established.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Please refer to full Prescribing Information for complete safety information and the use of AzaSite®.
HELPS TO RESOLVE
BACTERIAL CONJUNCTIVITIS1
DEMONSTRATED RESOLUTION AND ERADICATION
Significant clinical resolution and bacterial eradication of certain baseline pathogens1
63.1
%
88.5
%
Clinical resolution
Bacterial eradication
(vs. 49.7% for vehicle) P =0.030
(vs. 66.4% for vehicle) P <0.001
Helps resolve bacterial conjunctivitis
AzaSite® is 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.
*Efficacy for this organism was studied in fewer than 10 infections.
Significant clinical resolution and bacterial eradication of certain baseline pathogens1
Simple dosing regimen with the fewest drops approved to treat bacterial conjunctivitis2–4
AzaSite® is a 1% sterile aqueous topical ophthalmic solution of azithromycin formulated in DuraSite®
(polycarbophil, edetate disodium, sodium chloride).
Unrestricted access to 90% of patients on managed care5, a
Fingertip Formulary, LLC, September 28, 2012, percentage based on current enrollment.
SELECT IMPORTANT SAFETY INFORMATION
AzaSite® is contraindicated in patients with hypersensitivity to any component of this product.
AzaSite® is NOT FOR INJECTION. AzaSite is for topical ophthalmic use only and should not be administered
systemically, injected subconjunctivally, or introduced directly into the anterior chamber of the eye. In patients
receiving systemically administered azithromycin, serious allergic reactions, including angioedema, anaphylaxis,
and dermatologic reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been
reported rarely. Although rare, fatalities have been reported. As with other anti-infectives, prolonged use may
result in overgrowth of nonsusceptible organisms, including fungi. If super-infection occurs, discontinue use and
institute alternative therapy.
The most frequently reported ocular adverse reaction reported in clinical trials was eye irritation, which occurred in
1% to 2% of patients.
Please refer to full Prescribing Information for complete safety information and the use of AzaSite®.
a
Unrestricted access includes nationwide access for covered lives in a combination of commercial and Medicare plans. Coverage may vary per
segment. Formulary status is believed to be accurate at the time of printing but cannot be guaranteed. Formulary status for national plans may
not reflect plan variation at the local level.
References: 1. Abelson MB, Heller W, Shapiro AM, et al. Clinical cure of bacterial conjunctivitis with azithromycin 1%: vehicle-controlled,
double-masked clinical trial. Am J Ophthalmol. 2008;145:959–965. 2. Besivance [prescribing information]. Tampa, FL: Bausch & Lomb Inc; 2009.
3. Moxeza [prescribing information]. Fort Worth, TX: Alcon Laboratories, Inc; 2010. 4. Vigamox [prescribing information]. Fort Worth, TX: Alcon
Laboratories, Inc; 2011. 5. Fingertip Formulary, LLC, September 28, 2012, percentage based on current enrollment.
AZASITE is a registered trademark of Insite Vision Incorporated and is used under license. All other trademarks are the property of their respective owners.
VISIT AZASITE.COM TODAY
P376 REV 03/15
HIGHLIGHTS OF PRESCRIBING INFORMATION
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
————— RECENT MAJOR CHANGES
Contraindications (4)
—————
07/2012
————— 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)
FULL
1
2
3
4
5
PRESCRIBING INFORMATION: CONTENTS*
INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
5.1
Topical Ophthalmic Use Only
5.2
Anaphylaxis and Hypersensitivity
Systemic Use of Azithromycin
5.3
Growth of Resistant Organisms
Prolonged Use
5.4
Avoidance of Contact Lenses
6
ADVERSE REACTIONS
8
USE IN SPECIFIC POPULATIONS
8.1
Pregnancy
8.3
Nursing Mothers
—————— CONTRAINDICATIONS
Hypersensitivity (4)
with
——————
———— WARNINGS AND PRECAUTIONS ————
Á For topical ophthalmic use only. (5.1)
Á Anaphylaxis and hypersensitivity have been reported
with systemic use of azithromycin. (5.2)
Á Growth of resistant organisms may occur with prolonged use. (5.3)
Á 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
Akorn, Inc. at 1-800-932-5676 or FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and
FDA-approved patient labeling.
Revised: 11/2013
11
12
13
with
FULL PRESCRIBING INFORMATION
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*
Haemophilus influenzae
Staphylococcus aureus
Streptococcus mitis group
Streptococcus pneumoniae
* Efficacy for this organism was studied in fewer than 10
infections.
2
DOSAGE AND ADMINISTRATION
The recommended dosage regimen for the treatment of
bacterial conjunctivitis is:
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.
3
DOSAGE FORMS AND STRENGTHS
2.5 mL of a 1% sterile topical ophthalmic solution.
4
CONTRAINDICATIONS
Hypersensitivity to any component of this product.
5
WARNINGS AND PRECAUTIONS
5.1 Topical Ophthalmic Use Only
NOT FOR INJECTION. AzaSite 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.
5.2 Anaphylaxis and Hypersensitivity with Systemic
Use of Azithromycin
In patients receiving systemically administered azithromycin, serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including StevensJohnson syndrome and toxic epidermal necrolysis have
been reported rarely in patients on azithromycin therapy.
Although rare, fatalities have been reported. The potential
for anaphylaxis or other hypersensitivity reactions should
1501-184 AzaSite PI OPZT00N Rev 11-13_01-14-15a.indd 1
——— DOSAGE FORMS AND STRENGTHS ———
2.5 mL of 1% sterile topical ophthalmic solution. (3)
14
16
17
8.4
Pediatric Use
8.5
Geriatric Use
DESCRIPTION
CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
12.4 Microbiology
NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of
Fertility
13.2 Animal Toxicology and/or Pharmacology
CLINICAL STUDIES
HOW SUPPLIED/STORAGE AND HANDLING
PATIENT COUNSELING INFORMATION
toxicity. These doses are estimated to be approximately
5,000 times the maximum human ocular daily dose of 2 mg.
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.
8.3 Nursing Mothers
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.
8.4 Pediatric Use
The safety and effectiveness of AzaSite solution in pediatric
patients below 1 year of age have not been established.
The efficacy of AzaSite in treating bacterial conjunctivitis in
pediatric patients one year or older has been demonstrated
in controlled clinical trials [see Clinical Studies (14)].
8.5 Geriatric Use
No overall differences in safety or effectiveness have been
observed between elderly and younger patients.
11 DESCRIPTION
AzaSite (azithromycin ophthalmic solution) is a 1% sterile
aqueous topical ophthalmic solution of azithromycin formulated in DuraSite® (polycarbophil, edetate disodium, sodium
chloride). AzaSite is an off-white, viscous liquid with an
osmolality of approximately 290 mOsm/kg.
Preservative: 0.003% benzalkonium chloride. Inactives:
mannitol, citric acid, sodium citrate, poloxamer 407, polycarbophil, edetate disodium (EDTA), sodium chloride, water for
injection, and sodium hydroxide to adjust pH to 6.3.
Azithromycin is a macrolide antibiotic with a 15-membered
ring. Its chemical name is
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3C-methyl-3-O-methyl-α-L-ribohexopyranosyl)oxy]-2-ethyl3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]1oxa-6-aza-cyclopentadecan-15-one, and the structural
formula is:
* Sections or subsections omitted from the full
prescribing information are not listed.
be considered based on known hypersensitivity to azithromycin when administered systemically.
5.3 Growth of Resistant Organisms with Prolonged
Use
As with other anti-infectives, prolonged use may result in
overgrowth of non-susceptible organisms, including fungi. If
super-infection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the
patient should be examined with the aid of magnification,
such as slit-lamp biomicroscopy, and where appropriate,
fluorescein staining.
5.4 Avoidance of Contact Lenses
Patients should be advised not to wear contact lenses if
they have signs or symptoms of bacterial conjunctivitis.
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 1-2% 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).
8
USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category B. Reproduction studies have been
performed in rats and mice at doses up to 200 mg/kg/day.
The highest dose was associated with moderate maternal
Azithromycin has a molecular weight of 749, and its empirical
formula is C38H72N2O12.
12
CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Azithromycin is a macrolide antibiotic [see Clinical Pharmacology (12.4)].
12.3 Pharmacokinetics
The plasma concentration of azithromycin following ocular
administration of AzaSite (azithromycin ophthalmic solution) in humans is unknown. Based on the proposed dose
of one drop to each eye (total dose of 100 mcL or 1 mg)
and exposure information from systemic administration, the
systemic concentration of azithromycin following ocular
administration is estimated to be below quantifiable limits
(≤10 ng/mL) at steady-state in humans, assuming 100%
systemic availability.
12.4 Microbiology
Azithromycin acts by binding to the 50S ribosomal subunit
of susceptible microorganisms and interfering with microbial protein synthesis.
Azithromycin has been shown to be active against most
isolates of the following microorganisms, both in vitro and
clinically in conjunctival infections [see Indications and
Usage (1)].
CDC coryneform group G*
Haemophilus influenzae
Staphylococcus aureus
Streptococcus mitis group
Streptococcus pneumoniae
* Efficacy for this organism was studied in fewer than 10
infections.
3/20/15 11:20 AM
The following in vitro data are also available, but their
clinical significance in ophthalmic infections is unknown. The safety and effectiveness of AzaSite in treating
ophthalmological infections due to these microorganisms
have not been established.
The following microorganisms are considered susceptible
when evaluated using systemic break points. However, a
correlation between the in vitro systemic breakpoint and
ophthalmological efficacy has not been established. This list
of microorganisms is provided as an aid only in assessing
the potential treatment of conjunctival infections. Azithromycin exhibits in vitro minimal inhibitory concentrations
(MICs) of equal or less (systemic susceptible breakpoint)
against most (≥90%) of isolates of the following ocular
pathogens:
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
Viridans group streptococci
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of
Fertility
Long-term studies in animals have not been performed to
evaluate carcinogenic potential. Azithromycin has shown no
mutagenic potential in standard laboratory tests: mouse
lymphoma assay, human lymphocyte clastogenic assay,
and mouse bone marrow clastogenic assay. No evidence of
impaired fertility due to azithromycin was found in mice or
rats that received oral doses of up to 200 mg/kg/day.
13.2 Animal Toxicology and/or Pharmacology
Phospholipidosis (intracellular phospholipid accumulation)
has been observed in some tissues of mice, rats, and dogs
given multiple systemic doses of azithromycin. Cytoplasmic
microvacuolation, which is likely a manifestation of phospholipidosis, has been observed in the corneas of rabbits
given multiple ocular doses of AzaSite. This effect was
reversible upon cessation of AzaSite treatment. The significance of this toxicological finding for animals and for
humans is unknown.
14 CLINICAL STUDIES
In a randomized, vehicle-controlled, double-blind, multicenter
clinical study in which patients were dosed twice daily for the
first two days, then once daily on days 3, 4, and 5, AzaSite
solution was superior to vehicle on days 6-7 in patients who
had a confirmed clinical diagnosis of bacterial conjunctivitis.
Clinical resolution was achieved in 63% (82/130) of patients
treated with AzaSite versus 50% (74/149) of patients treated
with vehicle. The p-value for the comparison was 0.03 and the
95% confidence interval around the 13% (63%-50%) difference was 2% to 25%. The microbiological success rate for the
eradication of the baseline pathogens was approximately 88%
compared to 66% of patients treated with vehicle (p<0.001,
confidence interval around the 22% difference was 13% to
31%). Microbiologic eradication does not always correlate with
clinical outcome in anti-infective trials.
16 HOW SUPPLIED/STORAGE AND HANDLING
AzaSite is a sterile aqueous topical ophthalmic formulation of
1% azithromycin.
NDC 17478-307-03: 2.5 mL in 5 mL bottle containing a total
of 25 mg of azithromycin in a white, round, low-density
polyethylene (LDPE) bottle, with a clear LDPE dropper tip, and
a tan colored high density polyethylene (HDPE) eyedropper
cap. A white tamper evident over-cap is provided.
NDC 17478-307-04: 2.5 mL in 4 mL bottle containing a total
of 25 mg of azithromycin in a white, round, low-density
polyethylene (LDPE) bottle, with a clear LDPE dropper tip, and
a tan colored high density polyethylene (HDPE) eyedropper
cap. A white tamper evident over-cap is provided.
Storage and Handling:
Store unopened bottle under refrigeration at 2°C to 8°C (36°F
to 46°F). Once the bottle is opened, store at 2°C to 25°C (36°F
to 77°F) for up to 14 days. Discard after the 14 days.
17 PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling (Patient Information).
Patients should be advised to avoid contaminating the applicator tip by allowing it to touch the eye, fingers or other
sources.
1501-184 AzaSite PI OPZT00N Rev 11-13_01-14-15a.indd 2
Patients should be directed to discontinue use and contact a
physician if any signs of an allergic reaction occur.
Patients should be told that although it is common to feel
better early in the course of the therapy, the medication should
be taken exactly as directed. Skipping doses or not completing
the full course of therapy may (1) decrease the effectiveness
of the immediate treatment and (2) increase the likelihood that
bacteria will develop resistance and will not be treatable by
AzaSite (azithromycin ophthalmic solution) or other antibacterial drugs in the future.
Patients should be advised not to wear contact lenses if they
have signs or symptoms of bacterial conjunctivitis.
Patients should be advised to thoroughly wash hands prior to
using AzaSite.
Patients should be advised to invert the closed bottle (upside
down) and shake once before each use. Remove cap with
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).
Distributed by: Akorn, Inc.
Lake Forest, IL 60045
U.S. Patent Nos.: 6,159,458; 6,239,113; 6,569,443; 6,861,411;
7,056,893; and Patents Pending
AzaSite is a registered trademark of InSite Vision Inc.
OPZT00N
Rev. 11/13
PATIENT INFORMATION
AzaSite® (A-zuh-site)
(azithromycin ophthalmic solution) 1%
Read this Patient Information before you start
using AzaSite® and each time you get a refill.
There may be new information. This information
does not take the place of talking to your doctor
about your medical condition or treatment.
What is AzaSite?
AzaSite is a prescription sterile eye drop solution.
AzaSite is used to treat bacterial conjunctivitis
which is an infection of the eye caused by certain
bacteria.
It is not known if AzaSite is safe and effective in
children less than 1 year of age.
Information about bacterial conjunctivitis.
Bacterial conjunctivitis is a bacterial infection of
the mucous membranes which line the inside of
the eyelids. Symptoms may include redness of
the eye and discharge. The infection can be
spread to other people and to both eyes.
Who should not use AzaSite?
Do not use AzaSite if you are allergic to azithromycin or any of the ingredients in AzaSite. See
the end of this Patient Information leaflet for a
complete list of the ingredients in AzaSite.
What should I tell my doctor before using
AzaSite?
Before you use AzaSite, tell your doctor if you:
• wear contact lenses. Do not wear contact
lenses if you have signs or symptoms of
bacterial conjunctivitis.
• are pregnant or plan to become pregnant. It
is not known if AzaSite will harm your unborn
baby. Talk to your doctor if you are pregnant
or plan to become pregnant.
• are breast-feeding or plan to breast-feed. It
is not known if AzaSite passes into your
breast milk. Talk to your doctor about the
best way to feed your baby if you are using
AzaSite.
Tell your doctor about all the medicines you
take, including prescription and non-prescription
medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them
to show your doctors and pharmacist when you
get a new medicine.
How should I use AzaSite?
• Read the Instructions for Use at the end
of this Patient Information leaflet for the
right way to use AzaSite.
• Use AzaSite exactly as your doctor tells you
to use it.
• For the first 2 days place 1 drop of AzaSite
in your eye (or eyes) each morning and 1
drop in your eye (or eyes) each evening.
Wait 8 to 12 hours after placing your morning
drops before you place evening drops in
your eye (or eyes).
• For the next 5 days place 1 drop of AzaSite
in your eye (or eyes) 1 time each day.
• Make sure you continue to use AzaSite as
directed by your doctor even if you feel better
after you start using it. Skipping drops can
increase the chances that:
„ your medicine will not work well
„ Bacteria can develop resistance, which
means in the future your bacterial conjunctivitis may not improve from AzaSite
or other drugs that treat infections from
bacteria.
What should I be aware of while using
AzaSite?
Do not wear contact lenses if you have signs or
symptoms of bacterial conjunctivitis and until you
have finished your prescribed course of treatment. The symptoms of bacterial conjunctivitis
may include:
• discharge coming from the eye
• eye redness
• eye irritation
Only your doctor can tell you if you have bacterial
conjunctivitis.
Severe allergic reactions have been reported
rarely when azithromycin has been taken by
mouth.
• Serious rash or serious allergic reactions
may occur. Azithromycin, the active ingredient in AzaSite, may cause a serious rash or
a serious allergic reaction. Both of these
reactions may need to be treated in a hospital and may be life-threatening.
• Stop taking AzaSite and call your doctor right
away or get emergency help if you have any
of these symptoms:
„ skin rash, hives, sores in your mouth, or
your skin blisters and peels
„ swelling of your face, eyes, lips, tongue,
or throat
„ trouble swallowing or breathing
Increased risk of other infections caused by
bacteria or fungi.
• Using AzaSite for a long time may cause
other bacteria or fungi to grow. If this happens you may get a new infection. Tell your
doctor right away if your symptoms do not
get better.
What are the possible side effects of AzaSite?
The most common side effect of AzaSite is eye
irritation.
Other side effects seen with AzaSite include:
• eye burning, stinging and irritation when the
drop hits your eye
3/20/15 11:20 AM
white cap. See Figure A
comes off. Put the tan cap
back on the bottle and
close tightly. (This lets out
the air.) See Figure B
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