Azelastine Hydrochloride

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Azelastine Hydrochloride
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: Deepika Beereddy, MBBS [2]

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Overview

Azelastine Hydrochloride is an anti-asthmatic agent that is FDA approved for the treatment of allergic rhinitis. Common adverse reactions include bitter taste, nasal discomfort, epistaxis, headache, sneezing, fatigue, somnolence, and upper respiratory infection.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Allergic Rhinitis

  • ASTEPRO Nasal Spray 0.1% and 0.15% is indicated for the relief of the symptoms of seasonal and perennial allergic rhinitis in patients 6 years of age and older.
  • DOSAGE
  • Seasonal Allergic Rhinitis
  • In adults and adolescents 12 years of age and older, the recommended dose of ASTEPRO Nasal Spray 0.1% and 0.15% is 1 or 2 sprays per nostril twice daily. ASTEPRO Nasal Spray 0.15% may also be administered as 2 sprays per nostril once daily.
  • Perennial Allergic Rhinitis
  • In adults and adolescents 12 years of age and older, the recommended dose of ASTEPRO Nasal Spray 0.15% is 2 sprays per nostril twice daily.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Allergic Rhinitis

  • ASTEPRO Nasal Spray 0.1% and 0.15% is indicated for the relief of the symptoms of seasonal and perennial allergic rhinitis in patients 6 years of age and older.
  • Dosing
  • Seasonal Allergic Rhinitis
  • In children 6 to 11 years of age, the recommended dose of ASTEPRO Nasal Spray 0.1% and 0.15% is 1 spray per nostril twice daily.
  • Perennial Allergic Rhinitis
  • In children 6 to 11 years of age, the recommended dose of ASTEPRO Nasal Spray 0.1% and 0.15% is 1 spray per nostril twice daily.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Azelastine Hydrochloride Contraindications in the drug label.

Warnings

There is limited information regarding Azelastine Hydrochloride Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Azelastine Hydrochloride Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Azelastine Hydrochloride Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Azelastine Hydrochloride Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Azelastine Hydrochloride in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Azelastine Hydrochloride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Azelastine Hydrochloride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Azelastine Hydrochloride in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Azelastine Hydrochloride in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Azelastine Hydrochloride in geriatric settings.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

There is limited information regarding Azelastine Hydrochloride Administration in the drug label.

Monitoring

There is limited information regarding Azelastine Hydrochloride Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Azelastine Hydrochloride and IV administrations.

Overdosage

There is limited information regarding Azelastine Hydrochloride overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Azelastine Hydrochloride Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Azelastine Hydrochloride Mechanism of Action in the drug label.

Structure

There is limited information regarding Azelastine Hydrochloride Structure in the drug label.

Pharmacodynamics

There is limited information regarding Azelastine Hydrochloride Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Azelastine Hydrochloride Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Azelastine Hydrochloride Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Azelastine Hydrochloride Clinical Studies in the drug label.

How Supplied

There is limited information regarding Azelastine Hydrochloride How Supplied in the drug label.

Storage

There is limited information regarding Azelastine Hydrochloride Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

See FDA-approved patient labeling (Patient Information and Instructions for Use).

Activities Requiring Mental Alertness

  • Somnolence has been reported in some patients taking ASTEPRO Nasal Spray. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery after administration of ASTEPRO Nasal Spray.

Concurrent Use of Alcohol and other Central Nervous System Depressants

  • Concurrent use of ASTEPRO Nasal Spray with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur'

Common Adverse Reactions

  • Patients should be informed that the treatment with ASTEPRO Nasal Spray may lead to adverse reactions, most common of which include bitter taste, nasal discomfort, epistaxis, headache, sneezing, fatigue, somnolence, and respiratory infection.

Priming

  • Patients should be instructed to prime the pump before initial use and when ASTEPRO Nasal Spray has not been used for 3 or more days.

Keep Spray Out of Eyes

  • Patients should be instructed to avoid spraying ASTEPRO Nasal Spray into their eyes.

Keep Out of Children’s Reach

  • Patients should be instructed to keep ASTEPRO Nasal Spray out of the reach of children. If a child accidentally ingests ASTEPRO Nasal Spray, seek medical help or call a poison control center immediately.

Precautions with Alcohol

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

Brand Names

Astelin, Astelin Ready-Spray, Optivar, Astepro

Look-Alike Drug Names

There is limited information regarding Azelastine Hydrochloride Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

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

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