Azelastine (ophthalmic): Difference between revisions

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<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult===Indications==
For the treatment of [[itch|itching]] of the eye associated with allergic [[conjunctivitis]].


* Dosing Information
==Dosage==


:* Dosage
* The recommended dose is one drop instilled into each affected eye twice a day.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


=====Condition2=====


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


:* Dosage


=====Condition3=====
* Dosing Information
:* Dosage
=====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
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


:* Dosage


=====Condition2=====
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


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


<!--Contraindications-->
|contraindications=* Azelastine hydrochloride ophthalmic solution is contraindicated in persons with known or suspected [[hypersensitivity]] to any of its components.
|contraindications=* Condition1
|warnings=* Azelastine hydrochloride ophthalmic solution is for ocular use only and not for injection or oral use.
 
<!--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.
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} 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=====
<!--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.
=====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-->
|drugInteractions=* Drug
:* Description


<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''


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* Intravenous
* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.


* Description
<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.


<!--Overdosage-->
|overdose====Acute Overdose===
|overdose====Acute Overdose===


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<!--Clinical Studies-->
<!--Clinical Studies-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
|howSupplied=*
|howSupplied=* Azelastine Hydrochloride Ophthalmic Solution, 0.05% is supplied as follows: 6 mL (NDC# 60505-0578-4) solution in a translucent 11 mL HDPE container with a LDPE dropper tip, and a white HDPE screw cap.
|storage=* Store UPRIGHT at 20º-25ºC (68º-77ºF).
|packLabel=<!--Patient Counseling Information-->
|packLabel=<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


<!--Precautions with Alcohol-->
 
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


<!--Brand Names-->
 
|brandNames=* AZELASTINE HYDROCHLORIDE®<ref>{{Cite web | title=azelastine hydrochloride solution/ drops|url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=77a33738-ffcf-221c-1562-780418882e5d }}</ref>
|brandNames=* AZELASTINE HYDROCHLORIDE®<ref>{{Cite web | title=azelastine hydrochloride solution/ drops|url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=77a33738-ffcf-221c-1562-780418882e5d }}</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>

Revision as of 16:55, 6 May 2015

Azelastine (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

Azelastine (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

For the treatment of itching of the eye associated with allergic conjunctivitis.

Dosage

  • The recommended dose is one drop instilled into each affected eye twice a day.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

  • Azelastine hydrochloride ophthalmic solution is contraindicated in persons with known or suspected hypersensitivity to any of its components.

Warnings

  • Azelastine hydrochloride ophthalmic solution is for ocular use only and not for injection or oral use.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Azelastine (ophthalmic) in the drug label.

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Azelastine (ophthalmic) in women who are pregnant.
Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

Template:Px
Azelastine (ophthalmic)
Systematic (IUPAC) name
(RS)-4-[(4-chlorophenyl)methyl]-2- (1-methylazepan-4-yl)-phthalazin-1-one
Identifiers
CAS number 58581-89-8
ATC code R01AC03 R06AX19 (WHO), S01GX07 (WHO)
PubChem 2267
DrugBank DB00972
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 381.898 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability 40% (intranasal)
Metabolism ?
Half life 22 hours
Excretion ?
Therapeutic considerations
Pregnancy cat.

C(US)

Legal status

Rx Only (US)

Routes intranasal, ocular

Mechanism of Action

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

  • Azelastine Hydrochloride Ophthalmic Solution, 0.05% is supplied as follows: 6 mL (NDC# 60505-0578-4) solution in a translucent 11 mL HDPE container with a LDPE dropper tip, and a white HDPE screw cap.

Storage

  • Store UPRIGHT at 20º-25ºC (68º-77ºF).

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

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

Brand Names

  • AZELASTINE HYDROCHLORIDE®[1]

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

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

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