Azithromycin (ophthalmic): Difference between revisions

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

VisualWikitext

Revision as of 18:38, 6 May 2015

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:

CDC coryneform group G1
Haemophilus influenzae
Staphylococcus aureus
Streptococcus mitis group
Streptococcus pneumoniae

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

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.

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.

Drug Interactions

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

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

Pregnancy Category B. Reproduction studies have been performed in rats and mice at doses up to 200 mg/kg/day. The highest dose was associated with moderate maternal toxicity. These doses are estimated to be approximately 5,000 times the maximum human ocular daily dose of 2 mg. In the animal studies, no evidence of harm to the fetus due to azithromycin was found. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, azithromycin should be used during pregnancy only if clearly needed.

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

It is not known whether azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when azithromycin is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of AzaSite solution in pediatric patients below 1 year of age have not been established. The efficacy of AzaSite in treating bacterial conjunctivitis in pediatric patients one year or older has been demonstrated in controlled clinical trials

Geriatic Use

No overall differences in safety or effectiveness have been observed between elderly and younger 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

Ophthalmic

Monitoring

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

IV Compatibility

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

Overdosage

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

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

Structure

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

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

AZASITE ®^[1]

Look-Alike Drug Names

A® — B®^[2]

Drug Shortage Status

Price

References

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

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

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[1] "azithromycin monohydrate solution".

[www.ismp.org-2] "http://www.ismp.org". External link in |title= (help)

[1]

[2]

@@ Line 31: / Line 31: @@
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@@ Line 39: / Line 37: @@
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 |contraindications=* [[Hypersensitivity]] to any component of this product.
 |warnings='''Topical Ophthalmic Use Only'''
@@ Line 66: / Line 57: @@
 |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.
-* 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).
+* 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]]).
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-=====Metabolic and Nutritional=====
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-|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
+|useInNursing=* It is not known whether azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when azithromycin is administered to a nursing woman.
-|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
+|useInPed=* The safety and effectiveness of AzaSite solution in pediatric patients below 1 year of age have not been established. The efficacy of AzaSite in treating bacterial conjunctivitis in pediatric patients one year or older has been demonstrated in controlled clinical trials
-|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
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 |useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
 |useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
@@ Line 141: / Line 76: @@
 |useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
-<!--Administration and Monitoring-->
-|administration=* Oral
-* Intravenous
+|administration=* Ophthalmic
 |monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
-* Description
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 |IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
-<!--Overdosage-->
-|overdose====Acute Overdose===
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Azithromycin (ophthalmic): Difference between revisions

Revision as of 18:38, 6 May 2015

Disclaimer

Overview

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Dosage

DOSAGE FORMS AND STRENGTHS

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Non–Guideline-Supported Use

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Non–Guideline-Supported Use

Contraindications

Warnings

Adverse Reactions

Clinical Trials Experience

Postmarketing Experience

Drug Interactions

Use in Specific Populations

Pregnancy

Labor and Delivery

Nursing Mothers

Pediatric Use

Geriatic Use

Gender

Race

Renal Impairment

Hepatic Impairment

Females of Reproductive Potential and Males

Immunocompromised Patients

Administration and Monitoring

Administration

Monitoring

IV Compatibility

Overdosage

Pharmacology

Mechanism of Action

Structure

Pharmacodynamics

Pharmacokinetics

Nonclinical Toxicology

Clinical Studies

How Supplied

Storage

Images

Drug Images

Package and Label Display Panel

Patient Counseling Information

Precautions with Alcohol

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

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