Azithromycin (ophthalmic): Difference between revisions

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|aOrAn=a
|aOrAn=a
|indicationType=treatment
|indicationType=treatment
|hasBlackBoxWarning=Yes
|adverseReactions=<!--Black Box Warning-->
|adverseReactions=<!--Black Box Warning-->
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
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<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult===Indications==


* Dosing Information
* AzaSite® is indicated for the treatment of bacterial [[conjunctivitis]] caused by susceptible isolates of the following microorganisms:


:* Dosage
:*CDC coryneform group G1
:*[[Haemophilus influenzae]]
:*[[Staphylococcus aureus]]
:*Streptococcus mitis group
:*[[Streptococcus pneumoniae]]


=====Condition2=====
==Dosage==


* Dosing Information
* 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.


:* Dosage
==DOSAGE FORMS AND STRENGTHS==


=====Condition3=====
* 2.5 mL of a 1% sterile topical ophthalmic solution.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


* Dosing Information


:* Dosage
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


=====Condition4=====


* Dosing Information
:* Dosage
<!--Off-Label Use and Dosage (Adult)-->
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
* Developed by:
* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Pediatric Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Off-Label Use and Dosage (Pediatric)-->
 
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Contraindications-->
|contraindications=* Condition1
 
<!--Warnings-->
|warnings=* Description
 
====Precautions====
 
* Description
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
 
=====Body as a Whole=====






 
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
=====Cardiovascular=====




|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.




=====Digestive=====
|contraindications=* [[Hypersensitivity]] to any component of this product.
|warnings='''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.


'''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.


=====Endocrine=====
'''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.


'''Avoidance of Contact Lenses'''


* Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial [[conjunctivitis]].
|clinicalTrials=* 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.


=====Hematologic and Lymphatic=====
* 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).
 
 
 
 
=====Metabolic and Nutritional=====
 
 
 
 
=====Musculoskeletal=====
 
 
 
 
=====Neurologic=====
 
 
 
 
=====Respiratory=====
 
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
 
=====Special Senses=====
 
 
 
 
=====Urogenital=====
 
 
 
 
=====Miscellaneous=====
 
 
 
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.


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<!--Brand Names-->
<!--Brand Names-->
|brandNames=* AZASITE ®<ref>{{Cite web | title =azithromycin monohydrate solution| url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5dc0f75a-1e14-469f-af4f-c668a32f2328 }}</ref>
|brandNames=* AZASITE ®<ref>{{Cite web | title =azithromycin monohydrate solution| url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5dc0f75a-1e14-469f-af4f-c668a32f2328 }}</ref>
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
|drugShortage=
|drugShortage=
}}
}}

Revision as of 18:29, 6 May 2015

Azithromycin (ophthalmic)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

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Overview

Azithromycin (ophthalmic) is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • AzaSite® is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms:

Dosage

  • 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.

DOSAGE FORMS AND STRENGTHS

  • 2.5 mL of a 1% sterile topical ophthalmic solution.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Azithromycin (ophthalmic) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Azithromycin (ophthalmic) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Azithromycin (ophthalmic) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Azithromycin (ophthalmic) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Azithromycin (ophthalmic) in pediatric patients.

Contraindications

Warnings

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.

Anaphylaxis and Hypersensitivity with Systemic Use of Azithromycin

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.

Avoidance of Contact Lenses

  • Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.

Adverse Reactions

Clinical Trials Experience

  • 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).

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Azithromycin (ophthalmic) in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Azithromycin (ophthalmic) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Azithromycin (ophthalmic) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Azithromycin (ophthalmic) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Azithromycin (ophthalmic) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Azithromycin (ophthalmic) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Azithromycin (ophthalmic) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Azithromycin (ophthalmic) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Azithromycin (ophthalmic) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Azithromycin (ophthalmic) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Azithromycin (ophthalmic) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Azithromycin (ophthalmic) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Azithromycin (ophthalmic) in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Azithromycin (ophthalmic) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Azithromycin (ophthalmic) in the drug label.

Pharmacology

There is limited information regarding Azithromycin (ophthalmic) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Azithromycin (ophthalmic)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Azithromycin (ophthalmic) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Azithromycin (ophthalmic) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Azithromycin (ophthalmic) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Azithromycin (ophthalmic) in the drug label.

How Supplied

Storage

There is limited information regarding Azithromycin (ophthalmic) Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Azithromycin (ophthalmic) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Azithromycin (ophthalmic) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Azithromycin (ophthalmic) in the drug label.

Precautions with Alcohol

  • Alcohol-Azithromycin (ophthalmic) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ "azithromycin monohydrate solution".
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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