Azelastine Hydrochloride .5 mg/mL
azelastine hydrochloride · SOLUTION/ DROPS · Sandoz Inc
Azelastine Hydrochloride is a solution/ drops containing azelastine hydrochloride at .5 mg/mL, taken intraocular. Manufactured by Sandoz Inc.
Key Facts
- Brand Name
- Azelastine Hydrochloride
- Generic Name
- azelastine hydrochloride
- NDC Code (Product)
61314-308- Manufacturer
- Sandoz Inc
- Strength
- .5 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- INTRAOCULAR
- Marketing Status
- Application #
- ANDA202305
- Marketing Start
- 03/21/2013
Recall History
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Mylan Pharmaceuticals Inc.
Defective Container: Potential for broken glass in the neck area of the glass bottles.
Mylan Pharmaceuticals Inc.
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Roxane Laboratories, Inc.
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Azelastine hydrochloride nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. Azelastine hydrochloride nasal spray is an H1-receptor antagonist indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For intranasal use only ( 2.3 ) Seasonal allergic rhinitis: Pediatric patients 5 to 11 years of age: 1 spray per nostril twice daily ( 2.1 ) Adults and adolescents 12 years of age and older: 1 or 2 sprays per nostril twice daily ( 2.1 ) Vasomotor rhinitis: 2 sprays per nostril twice daily in adults and adolescents 12 years of age and older ( 2.2 ) Prime azelastine hydrochloride nasal spray before initial use and when it has not been used for 3 or more days ( 2.3 ) 2.1 Seasonal Allergic Rhinitis The recommended dosage of azelastine hydrochloride nasal spray in adults and adolescent patients 12 years and older with seasonal allergic rhinitis is one or two sprays per nostril twice daily. The recommended dosage of azelastine hydrochloride nasal spray in pediatric patients 5 years to 11 years of age is one spray per nostril twice daily. 2.2 Vasomotor Rhinitis The recommended dosage of azelastine hydrochloride nasal spray in adults and adolescent patients 12 years and older with vasomotor rhinitis is two sprays per nostril twice daily. 2.3 Important Administration Instructions Administer azelastine hydrochloride nasal spray by the intranasal route only. Primin…
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Central Nervous System Depressants Concurrent use of azelastine hydrochloride nasal spray with alcohol or other central nervous system depressants should be avoided because reductions in alertness and impairment of central nervous system performance may occur [see Warnings and Precautions ( 5.1 )].
Adverse Reactions
6 ADVERSE REACTIONS Use of azelastine hydrochloride nasal spray has been associated with somnolence [see Warnings and Precautions ( 5.1 )]. The most common adverse reactions (≥2% incidence) are: bitter taste, headache, somnolence, dysesthesia, rhinitis, nasal burning, pharyngitis, epistaxis, sinusitis, paroxysmal sneezing, nausea, dry mouth, fatigue, dizziness, and weight increase. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex CORP. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice. Seasonal Allergic Rhinitis Azelastine hydrochloride nasal spray Two Sprays Per Nostril Twice Daily Adverse experience information for azelastine hydrochloride nasal spray is derived from six placebo- and active- controlled, 2-day to 8-week clinical trials which included 391 patients, 12 years of age and older, with seasonal allergic rhinitis who received azelastine hydrochloride nasal spray…
Frequently Asked Questions
What is Azelastine Hydrochloride used for?
Azelastine Hydrochloride contains azelastine hydrochloride. It is a solution/ drops taken intraocular. Consult your doctor for specific uses.
Is Azelastine Hydrochloride a controlled substance?
Azelastine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Azelastine Hydrochloride?
The generic name for Azelastine Hydrochloride is azelastine hydrochloride. There are 6 other brand versions of azelastine hydrochloride.
What is the NDC code for Azelastine Hydrochloride .5 mg/mL?
The NDC (National Drug Code) for Azelastine Hydrochloride .5 mg/mL is 61314-308, listed by Sandoz Inc.
Other Azelastine Brands
See all →- Azelastine Hydrochloride and Fluticasone Propionate137 ug/10480-2157
- AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE137 ug/145802-066
- AZELASTINE HYDROCHLORIDE.5 mg/mL60505-0578
- AZELASTINE HYDROCHLORIDE205.5 ug/158602-020
- Azelastine hydrochloride and Fluticasone propionate137 ug/160505-0953
- AZELASTINE HYDROCHLORIDE137 ug/159651-214
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)