azasite
Pharmaranks rates Azasite 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Azasite (Azithromycin) is a macrolide antimicrobial used to treat Chlamydia Infections, Haemophilus Infections, Nontuberculous Mycobacterium Infections, Otitis Media.
Azithromycin · by Thea Pharma
Available as a generic: Azithromycin
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Azithromycin
- Drug class
- Macrolide Antimicrobial
- Form
- Drops
- Strength
- Azithromycin 1%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Thea Pharma
- Half-life
- about 68 hours (how long it stays in your system)
- What the pharmacy pays
- ~$9.48 for 30 — not your price
- FDA application
- NDA050810
What is Azasite?
From the FDA label: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-3-C-methyl-3-O-methyl-α-L-ribohexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-aza-cyclopentadecan-15-one, and the structural formula is: Azithromycin has a molecular weight of 749, and its empirical formula is C 38 H 72 N 2 O 12 . Chemical Structure
How to use
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. 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 ) 2.1 Recommended Dosage The recommended dosage 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. 2.2 Administration Instructions Wash hands prior to using AzaSite. Invert the closed bottle (upside down) and shake once before each use. Remove the tan 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 (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.
Side effects
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.
Warnings
Important safety information
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 ) 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 Stevens-Johnson 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 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 Contamination of the Applicator Tip Avoid contaminating the applicator tip by not allowing it to touch the eye, fingers or other sources. 5.5 Avoidance of Contact Lenses Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.
Who should not take Azasite
Azasite is contraindicated in patients with hypersensitivity to any component of this product. Hypersensitivity ( 4 )
Storing Azasite, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Discard after the 14 days.”
How long does Azithromycin stay in your body?
The elimination half-life of azithromycin is about 68 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The unusually long half-life reflects the parent drug's extensive uptake into and slow release from body tissues, not an active metabolite (azithromycin is largely eliminated unchanged); the value is from single 500 mg dosing in adults with normal organ function.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: ZITHROMAX (azithromycin) tablets and for oral suspension — FDA prescribing information (DailyMed).
Drug class
May treat (source: NIH RxClass)
- chlamydia infections
- haemophilus infections
- nontuberculous mycobacterium infections
- otitis media
- mycoplasma pneumonia
- infectious skin diseases
See how Azasite ranks — best-rated macrolide antimicrobial for:
Dosage forms
Drops
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Azasite treat?
- Azasite (Azithromycin) may be used to treat chlamydia infections, haemophilus infections, nontuberculous mycobacterium infections, otitis media, mycoplasma pneumonia, infectious skin diseases, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Azasite rated?
- pharmaranks gives Azasite a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Azasite cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $9.48 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Azasite?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Azasite. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Azasite?
- Azasite is marketed by Thea Pharma. You can see Thea Pharma's full profile, rating, and other products on pharmaranks.
- Is Azasite a brand-name or generic drug?
- Azasite is a brand-name product with the active ingredient Azithromycin. Lower-cost generic equivalents containing Azithromycin are available — ask your pharmacist.
- Is Azasite available over the counter?
- No. Azasite is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Azasite come in?
- Azasite is currently marketed as drops, per the FDA's National Drug Code Directory.
- What class of drug is Azasite?
- Azasite is classified as macrolide antimicrobial, per the FDA's Established Pharmacologic Class.
- Is Azasite FDA-registered?
- Azasite is on record with the U.S. FDA under application number NDA050810. You can verify this on its official FDA label.
- Has Azasite been recalled by the FDA?
- Azasite has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Azasite safe?
- There's no single safe-or-not verdict. pharmaranks gives Azasite a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Azasite?
- Azasite's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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azasite
70/100