Azithromycin (Ophthalmic) (Lexi-Drugs)

Drug Shortages

One or more forms of this drug may be in short supply or unavailable. Refer to the following for additional information:

FDA: https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Azithromycin%20(Azasite)%20Ophthalmic%20Solution%201per&st=c

Pronunciation

(az ith roe MYE sin)

Brand Names: US

AzaSite

Dosing: Adult

Bacterial conjunctivitis: Ophthalmic: Instill 1 drop into affected eye(s) twice daily (8 to 12 hours apart) for 2 days, then 1 drop into affected eye(s) once daily for the next 5 days

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Pediatric

Bacterial conjunctivitis: Children and Adolescents: Ophthalmic: Instill 1 drop in the affected eye(s) twice daily (8 to 12 hours apart) for 2 days, then 1 drop once daily for 5 days

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Use: Labeled Indications

Bacterial conjunctivitis: For the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms: Centers for Disease Control and Prevention (CDC) coryneform group G (efficacy studied in fewer than 10 infections), Haemophilus influenzaeStaphylococcus aureusStreptococcus mitis group, andStreptococcus pneumoniae.

Administration: Ophthalmic

For ophthalmic use only; avoid touching tip of applicator to eye or other surfaces. Invert closed bottle and shake once before each use. With bottle inverted, remove cap, tilt head back and gently squeeze bottle to instill drop. Wash hands before and after instillation.

Administration: Pediatric

For topical ophthalmic use only; not for injection into the eye. Wash hands before and after instillation. Contact lenses should not be worn during treatment of ophthalmic infections. Avoid touching tip of applicator to eye or other surfaces. Invert closed bottle and shake once before each use. Remove cap with bottle inverted. Tilt head back and gently squeeze inverted bottle to instill drop.

Storage/Stability

Prior to use, store unopened under refrigeration at 2°C to 8°C (36°F to 46°F). After opening, store at 2°C to 25°C (36°F to 77°F) for ≤14 days; discard any remaining solution after 14 days.

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber vision changes, eye pain, severe eye irritation, or eye discharge (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
Contraindications

Hypersensitivity to azithromycin or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Severe hypersensitivity reactions, including anaphylaxis, angioedema, and dermatologic reactions, have been reported with systemic use of azithromycin.

• Superinfection: Prolonged use may lead to overgrowth of nonsusceptible organisms, including fungi. Discontinue use and institute alternative therapy if superinfection is suspected.

Special populations:

• Contact lens wearers: Solution contains benzalkonium chloride which may be absorbed by contact lenses; contact lens should not be worn during treatment.

Other warnings/precautions:

• Appropriate use: For topical ophthalmic use only; do not inject subconjunctivally or introduce directly into the anterior chamber of the eye. Whenever clinical judgment dictates, examine the patient with the aid of magnification, such as slit-lamp biomicroscopy and, when appropriate, fluorescein staining.

Geriatric Considerations

Evaluate the patient’s or caregiver’s ability to safely administer the correct dose of ophthalmic medication.

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. The amount of azithromycin available systemically following topical application of the ophthalmic drops is estimated to be below quantifiable limits. Systemic absorption would be required in order for azithromycin to cross the placenta and reach the fetus. When administered orally or IV, azithromycin crosses the placenta. Refer to the Azithromycin (Systemic) monograph for details.

Breast-Feeding Considerations

It is not known if azithromycin is excreted into breast milk following ophthalmic administration. The amount of azithromycin available systemically following topical application of the ophthalmic drops is estimated to be below quantifiable limits. Systemic absorption would be required in order for azithromycin to enter breast milk. The manufacturer recommends that caution be exercised when administering azithromycin eye drops to nursing women. When administered orally or IV, azithromycin enters breast milk. Refer to the Azithromycin (Systemic) monograph for details.

Lexicomp Pregnancy & Lactation, In-Depth
Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

1% to 10%: Ophthalmic: Eye irritation (1% to 2%)

<1%, postmarketing, and/or case reports: Blurred vision, contact dermatitis, corneal erosion, decreased visual acuity, dysgeusia, eye pain, facial edema, local ocular hypersensitivity reaction (includes burning sensation of eyes, eye discharge, eye irritation, eye pruritus, stinging of eyes), nasal congestion, punctate keratitis, sinusitis, skin rash, swelling of eye, urticaria, xerophthalmia

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

None known.

Drug Interactions 

There are no known significant interactions.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Ophthalmic:

AzaSite: 1% (2.5 mL) [contains benzalkonium chloride, disodium edta]

Anatomic Therapeutic Chemical (ATC) Classification
  • S01AA26
Generic Available (US)

No

Pricing: US

Solution (AzaSite Ophthalmic)

1% (per mL): $98.98

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Inhibits RNA-dependent protein synthesis at the chain elongation step; binds to the 50S ribosomal subunit resulting in blockage of transpeptidation

Pharmacodynamics/Kinetics

Absorption: Systemic absorption estimated to be negligible

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

FDA Approval Date
November 01, 1991
References

Azasite (azithromycin) [prescribing information]. Lake Forest, IL: Akorn, Inc; March 2015.

Brand Names: International

Azydrop (ES); Azyter (DE, FR, GB, HK, HR, IE, PT, RO, TH)

Azithromycin (Ophthalmic) (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(az ith roe MYE sin)

Brand Names: US

AzaSite

What is this drug used for?
  • It is used to treat eye infections.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to azithromycin or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • This drug may interact with other drugs or health problems.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Use care when driving or doing other tasks that call for clear eyesight.
  • Do not use longer than you have been told. A second infection may happen.
  • Very bad and sometimes deadly allergic reactions have rarely happened with other forms of this drug as well as drugs like this one. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Change in eyesight, eye pain, or very bad eye irritation.
  • Eye discharge.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Eye irritation.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • To gain the most benefit, do not miss doses.
  • Use as you have been told, even if your signs get better.
  • For the eye only.
  • Wash your hands before and after use.
  • Avoid wearing contacts unless told to wear them by your doctor.
  • Do not touch the container tip to the eye, lid, or other skin.
  • Turn bottle with lid on upside down and shake 1 time before each use.
  • Tilt your head back and drop drug into the eye.
  • After use, keep your eyes closed. Put pressure on the inside corner of the eye. Do this for 1 to 2 minutes. This keeps the drug in your eye.
What do I do if I miss a dose?
  • Use a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not use 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store unopened containers in a refrigerator. Do not freeze.
  • After opening, store at room temperature or in a refrigerator. Throw away after 14 days.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Azithromycin (Ophthalmic) (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(az ith roe MYE sin)

Brand Names: US

AzaSite

What is this drug used for?
  • It is used to treat eye infections.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • This drug may interact with other drugs or health problems.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child avoid tasks or actions that call for clear eyesight until you see how this drug affects your child.
  • Do not give to your child longer than you have been told. A second infection may happen.
  • Very bad and sometimes deadly allergic reactions have rarely happened with other forms of this drug as well as drugs like this one. Talk with the doctor.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Change in eyesight, eye pain, or very bad eye irritation.
  • Eye discharge.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Eye irritation.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • To gain the most benefit, do not miss giving your child doses.
  • Keep using this drug as you have been told by your child’s doctor or other health care provider, even if your child’s signs get better.
  • For the eye only.
  • Wash your hands before and after use.
  • Have your child stop wearing his/her contact lenses unless the doctor tells them to keep wearing them.
  • Do not touch the container tip to your child’s eye, lid, or other skin.
  • Turn bottle with lid on upside down and shake 1 time before each use.
  • Tilt your child’s head back and drop drug into the eye.
  • After giving this drug, ask your child to keep eyes closed. Put light pressure on the inside corner of the eye. Do this for 1 to 2 minutes. This keeps the drug in your child’s eye.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store unopened containers in a refrigerator. Do not freeze.
  • After opening, store at room temperature or in a refrigerator. Throw away after 14 days.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.