Azelastine (ophthalmic): Difference between revisions

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

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Revision as of 16:55, 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

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


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 atom Template:OrganicBox atom Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox atom Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox atom Template:OrganicBox Template:OrganicBox atom Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template: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

A® — B®^[2]

Drug Shortage Status

Price

References

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

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

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[1] "azelastine hydrochloride solution/ drops".

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

[1]

[2]

@@ Line 13: / Line 13: @@
 <!--FDA-Labeled Indications and Dosage (Adult)-->
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+|fdaLIADAdult===Indications==
+For the treatment of [[itch|itching]] of the eye associated with allergic [[conjunctivitis]].
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-<!--Pediatric Indications and Dosage-->
 <!--FDA-Labeled Indications and Dosage (Pediatric)-->
-|fdaLIADPed======Condition1=====
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-<!--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====
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-<!--Clinical Trials Experience-->
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-=====Body as a Whole=====
-=====Cardiovascular=====
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-=====Special Senses=====
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-<!--Postmarketing Experience-->
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-=====Special Senses=====
-=====Urogenital=====
-=====Miscellaneous=====
-<!--Drug Interactions-->
-|drugInteractions=* Drug
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-<!--Use in Specific Populations-->
-|useInPregnancyFDA=* '''Pregnancy Category'''
 |useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
@@ Line 269: / Line 68: @@
 * Intravenous
 |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
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-|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
-<!--Overdosage-->
 |overdose====Acute Overdose===
@@ Line 360: / Line 155: @@
 <!--Clinical Studies-->
 |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-->
 |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.
-<!--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>
 |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>

Azelastine (ophthalmic): Difference between revisions

Revision as of 16:55, 6 May 2015

Disclaimer

Overview

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Dosage

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

Acute Overdose

Signs and Symptoms

Management

Chronic Overdose

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

Navigation menu

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