Azelastine Hydrochloride
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
There is limited information regarding Azelastine Hydrochloride Patient Counseling Information in the drug label.
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
There is limited information regarding Azelastine Hydrochloride Brand Names in the drug label.
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.