Azelastine

Azelastine HCl 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 HCl 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 )

• For intranasal use only Seasonal allergic rhinitis: o
• Pediatric patients 5 to 11 years of age: 1 spray per nostril twice daily o
• Adults and adolescents 12 years of age and older: 1 or 2 sprays per nostril twice daily Vasomotor rhinitis: 2 sprays per nostril twice daily
• In adults and adolescents 12 years of age and older Prime Azelastine HCl Nasal Spray before initial use and when it has not been used for 3 or more days Seasonal Allergic Rhinitis The recommended dosage of Azelastine HCl 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 HCl Nasal Spray
• In pediatric patients 5 years to 11 years of age is one spray per nostril twice daily
• Vasomotor Rhinitis The recommended dosage of Azelastine HCl Nasal Spray
• In adults and adolescent patients 12 years and older with vasomotor rhinitis is two sprays per nostril twice daily
• Important Administration Instructions Administer Azelastine HCl Nasal Spray by the intranasal route only
• Priming : Prime Azelastine HCl Nasal Spray before initial use by releasing 4 sprays or until a fine mist appears
• When Azelastine HCl Nasal Spray has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears
• Avoid spraying Azelastine HCl Nasal Spray into the eyes

Azelastine HCl Nasal Spray is a nasal spray. Each spray of Azelastine HCl Nasal Spray delivers a volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride, USP. Azelastine HCl Nasal Spray: 137 mcg of azelastine hydrochloride, USP in each 0.137 mL spray. ( 3 )

• The safety and effectiveness of Azelastine HCl Nasal Spray
• For the treatment of symptoms of seasonal allergic rhinitis have been established for patients 5 years and older [ see Adverse Reactions and Clinical Studies ]
• The safety and effectiveness of Azelastine HCl Nasal Spray
• For the treatment of vasomotor rhinitis have been established for patients 12 years and older [ see Adverse Reactions and Clinical Studies ]. …

Clinical trials of Azelastine HCl Nasal Spray did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. …

• See FDA-approved patient labeling (Patient Information and Instructions for Use)
• Activities Requiring Mental Alertness Somnolence has been reported in some patients taking Azelastine HCl Nasal Spray
• Caution patients against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery after administration of Azelastine HCl Nasal Spray [ see Warnings and Precautions ]. …

• None
• None

7.1 Central Nervous System Depressants Concurrent use of Azelastine HCl 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 ) ].

Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking Azelastine HCl Nasal Spray. ( 5.1 ) Alcohol and other central nervous system (CNS) depressants: Avoid concurrent use with Azelastine HCl Nasal Spray because further decreased alertness and impairment of CNS performance may occur. ( 5.1 ) 5.1 Somnolence in Activities Requiring Mental Alertness In clinical trials, the occurrence of somnolence has been reported in some patients taking Azelastine HCl Nasal Spray [ see Adverse Reactions ( 6.1 ) ]. …

Use of Azelastine HCl 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 Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

8.1 Pregnancy Risk Summary Limited data from postmarketing experience over decades of use with Azelastine HCl Nasal Spray in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose. …

There have been no reported overdosages with Azelastine HCl Nasal Spray. Acute overdosage by adults with this dosage form is unlikely to result in clinically significant adverse reactions, other than increased somnolence, since one bottle of Azelastine HCl Nasal Spray contains 30 mg of azelastine hydrochloride. Clinical trials in adults with single doses of the oral formulation of azelastine hydrochloride (up to 16 mg) have not resulted in increased incidence of serious adverse reactions. General supportive measures should be employed if overdosage occurs. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.