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Drug overview for AZASITE (azithromycin):
Generic name: azithromycin (ay-ZITH-roe-MYE-sin)
Drug class: Ophthalmic Antibacterials
Therapeutic class: Ophthalmic Agents
Azithromycin is a macrolide antimicrobial.
No enhanced Uses information available for this drug.
Generic name: azithromycin (ay-ZITH-roe-MYE-sin)
Drug class: Ophthalmic Antibacterials
Therapeutic class: Ophthalmic Agents
Azithromycin is a macrolide antimicrobial.
No enhanced Uses information available for this drug.
DRUG IMAGES
AZASITE 1% EYE DROPS
The following indications for AZASITE (azithromycin) have been approved by the FDA:
Indications:
Bacterial conjunctivitis
Professional Synonyms:
Inflammation of the conjunctiva due to bacteria
Indications:
Bacterial conjunctivitis
Professional Synonyms:
Inflammation of the conjunctiva due to bacteria
The following dosing information is available for AZASITE (azithromycin):
No enhanced Dosing information available for this drug.
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.
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.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| AZASITE 1% EYE DROPS | Maintenance | Adults instill 1 drop into affected eye(s) by ophthalmic route once daily |
No generic dosing information available.
The following drug interaction information is available for AZASITE (azithromycin):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for AZASITE (azithromycin):
Drug contraindication overview.
*Hypersensitivity to any component of the product.
*Hypersensitivity to any component of the product.
There are 0 contraindications.
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| No disease contraindications |
The following adverse reaction information is available for AZASITE (azithromycin):
Adverse reaction overview.
Most common adverse reaction reported in patients was eye irritation (1 to 2% of patients).
Most common adverse reaction reported in patients was eye irritation (1 to 2% of patients).
There are 5 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Contact dermatitis Corneal erosion Fungal infection of eye Punctate keratitis Urticaria |
There are 9 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Ocular irritation |
| Rare/Very Rare |
|---|
|
Blurred vision Dry eye Dysgeusia Facial edema Nasal congestion Ocular discharge Sinusitis Skin rash |
The following precautions are available for AZASITE (azithromycin):
Safety and efficacy of azithromycin 1% ophthalmic solution have not been established in pediatric patients <=1 year of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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.
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.
The following prioritized warning is available for AZASITE (azithromycin):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for AZASITE (azithromycin)'s list of indications:
| Bacterial conjunctivitis | |
| H10.02 | Other mucopurulent conjunctivitis |
| H10.021 | Other mucopurulent conjunctivitis, right eye |
| H10.022 | Other mucopurulent conjunctivitis, left eye |
| H10.023 | Other mucopurulent conjunctivitis, bilateral |
| H10.029 | Other mucopurulent conjunctivitis, unspecified eye |
| H10.3 | Unspecified acute conjunctivitis |
| H10.30 | Unspecified acute conjunctivitis, unspecified eye |
| H10.31 | Unspecified acute conjunctivitis, right eye |
| H10.32 | Unspecified acute conjunctivitis, left eye |
| H10.33 | Unspecified acute conjunctivitis, bilateral |
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