Generic equivalent of Azelastine Hydrochloride
2 SKUs available · Available to order · NABP accredited · DSCSA compliant
Azelastine hydrochloride is the generic equivalent of the brand-name drug Azelastine Hydrochloride. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Azelastine hydrochloride through Premier Pharma with same-day fulfillment on in-stock SKUs.
1 INDICATIONS AND USAGE Azelastine hydrochloride nasal solution (nasal spray), 0.1% (137 mcg per 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 solution (nasal spray) is an H 1 -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 )
6 ADVERSE REACTIONS Use of azelastine hydrochloride nasal solution 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 Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 o…
7 DRUG INTERACTIONS 7.1 Central Nervous System Depressants Concurrent use of azelastine hydrochloride nasal solution 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 ) ].
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 solution before initial use and when it has not been used for 3 or more days ( 2.3 )…
17 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 azelastine hydrochloride nasal solution. Caution patients against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery after administration of azelastine hydrochloride nasal solution [ see Warnings and Precautions ( 5.1 ) ]. Concurrent Use of Alcohol and other Central Nervous System Depressants Instruct patients…
Source: FDA. For professional use only. Not a substitute for prescribing information.
| Name | Status |
|---|---|
| AZELASTINE HCL OPHTHALMIC SOLUTION 0.05% 6 ML | 2-Day |
| AZELASTINE NASAL SOLUTION 1% 30 ML Sun Pharmaceutical Industries, Inc. | 2-Day |
Premier Pharma stocks 2 Azelastine hydrochloride SKUs — 0 currently in stock — available to licensed pharmacies, clinics, doctor's offices, and veterinary practices. Azelastine hydrochloride is the generic equivalent of Azelastine Hydrochloride. Create a free account to see live wholesale pricing and place orders with same-day fulfillment for in-stock items.
Premier Pharma carries Azelastine hydrochloride in .5 mg/mL, 137 ug/1 and SOLUTION/ DROPS, SPRAY, METERED. Available from manufacturers including Sun Pharmaceutical Industries, Inc..
Azelastine hydrochloride carries an FDA Orange Book TE code of AT. Therapeutically equivalent — topical product. Always verify substitution with the current Orange Book before dispensing.
Create a free Premier Pharma account to unlock live wholesale pricing, place orders, and track shipments — approval typically takes minutes for licensed pharmacies, clinics, doctor's offices, and veterinary practices.