AzaSite

Name: AzaSite

Azasite Interactions

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • drugs that can cause QT prolongation such as selegiline (Emsam, Eldepryl), amitriptyline (Elavil), and nortriptyline (Aventyl)
  • antacids containing aluminum or magnesium (Maalox, Mylanta, Rolaids, others)
  • anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)
  • carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Tegretol XR)
  • cyclosporine (Gengraf, Neoral, Sandimmune)
  • digoxin (Lanoxin)
  • dihydroergotamine (D.H.E. 45, Migranal)
  • ergotamine (Ergostat, Ergomar)
  • corticosteroids such as hydrocortisone (Cortef, Cortril, Hydrocortone), methylprednisolone (Medrol), and prednisone (Cortan, Prednisone Intensol)
  • nelfinavir (Viracept)
  • phenytoin (Dilantin)
  • tacrolimus (Prograf, Protopic)
  • triazolam (Halcion)

This is not a complete list of azithromycin drug interactions. Ask your doctor or pharmacist for more information.

Azasite Food Interactions

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of azithromycin, there are no specific foods that you must exclude from your diet when receiving azithromycin.

 

Azasite Usage

The injectable form of azithromycin is given directly into the vein (IV) by a healthcare professional.

Take all other forms of azithromycin exactly as prescribed.

For the tablets and regular suspensions (liquid):

  • Take once a day, with a glass of water and with or without food.
  • Take with food if azithromycin upsets your stomach.

For the extended release suspension (liquid):

  • Take one dose only on an empty stomach (at least 1 hour before or 2 hours following a meal).

For the eye drops:

  • One drop is instilled in the affected eye twice a day for the first 2 days.
  • One drop is instilled in the affected eye once a day for the next 5 days.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of azithromycin at the same time.

Adverse Effects

1-10%

Eye irritation (1-2%)

<1%

Anaphylaxis

Contact dermatitis

Corneal erosion

Dry eye

Rash

Urticaria

Dygeusia

Nasal congestion

Ocular discharge

Punctate keratitis

Sinusitis

What is the most important information I should know about azithromycin ophthalmic?

Stop using this medicine and get emergency medical help if you have any signs of a rare but serious reaction: fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Azithromycin ophthalmic side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing or swallowing; swelling of your face, lips, tongue, or throat.

Stop using azithromycin ophthalmic and call your doctor at once if you have:

  • drainage or crusting of your eye;

  • severe burning, stinging, itching, or other irritation after using the eye drops;

  • feeling like something is in your eye;

  • watery eyes, increased light sensitivity;

  • eye pain, redness, or swelling;

  • any signs of a new infection; or

  • signs of a rare but serious reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • dry or itchy eyes;

  • blurred vision;

  • changes in your sense of taste;

  • stuffy nose; or

  • mild stinging, burning, or irritation of your eyes.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What are some things I need to know or do while I take AzaSite?

  • Tell all of your health care providers that you take AzaSite. 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 medicine 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 AzaSite while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (AzaSite) best taken?

Use this medicine 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.

If OVERDOSE is suspected

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.

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).

AzaSite 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-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 C38H72N2O12.

For the Consumer

Applies to azithromycin ophthalmic: ophthalmic solution

Along with its needed effects, azithromycin ophthalmic (the active ingredient contained in Azasite) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking azithromycin ophthalmic:

Less common
  • Burning, redness, stinging, or other eye irritation
Rare
  • Blistering, burning, crusting, dryness, or flaking of the skin
  • blurred vision
  • cough
  • decreased vision
  • discharge from the eye
  • fever
  • headache
  • hives or welts
  • itching, scaling, severe redness, soreness, or swelling of the skin
  • pain or tenderness around the eyes and cheekbones
  • painful irritation of the clear front part of the eye
  • shortness of breath or troubled breathing
  • skin rash
  • stuffy or runny nose
  • swelling of the face
  • swelling or puffiness of the eyes
  • tightness of the chest or wheezing

Some side effects of azithromycin ophthalmic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare
  • Change in taste
  • dry eyes
  • loss of taste

For Healthcare Professionals

Applies to azithromycin ophthalmic: ophthalmic solution

Ocular

Very common (10% or more): Ocular discomfort (pruritus, burning, stinging) upon instillation
Common (1% to 10%): Eye irritation, blurred vision, sticky eye sensation, foreign body sensation upon instillation
Uncommon (0.1% to 1%): Conjunctival hyperemia, lacrimation increased upon instillation, erythema of the eyelid
Frequency not reported: Ocular reactions (burning, irritation upon instillation, contact dermatitis, corneal erosion, dry eye, eye pain, itching, ocular discharge, punctate keratitis, reduced visual acuity)
Postmarketing reports: Conjunctivitis, allergic conjunctivitis, keratitis, eyelid eczema, eyelid edema, eye allergy[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity[Ref]

Dermatologic

Frequency not reported: Hives/urticaria, rash, facial swelling, periocular swelling
Postmarketing reports: Angioedema[Ref]

Nervous system

Frequency not reported: Dysgeusia[Ref]

Respiratory

Frequency not reported: Nasal congestion, sinusitis[Ref]

Some side effects of Azasite may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Azithromycin ophthalmic Breastfeeding Warnings

Use is considered acceptable; caution is recommended. Excreted into human milk: Yes Comments: The effects in the nursing infant are unknown; however, harmful effects would not be expected.

Limited data indicate azithromycin is excreted into breast milk. Due to the low dose and low systemic availability, doses taken by neonates are considered negligible; therefore, breastfeeding is possible during therapy.

Administrative Information

LactMed Record Number

336

Last Revision Date

20170411

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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