Azelastine Hcl Generic Name & Formulations
Mechanism of Action
Azelastine Hcl Indications
Azelastine Hcl Dosage and Administration
Azelastine Hcl Contraindications
Azelastine Hcl Boxed Warnings
Azelastine Hcl Warnings/Precautions
Somnolence inActivities Requiring Mental Alertness
Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking azelastine HCl nasal spray 0.1%.
Alcohol and other CNS depressants
Avoid concomitant use with alcohol and other CNS depressants due to the potential risk of further decreased alertness and impairment of CNS performance.
Limited data from post-marketing experience over decades of use with azelastine HCl nasal spray, 0.1% in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes.
Nursing Mother Considerations
There are no data on the presence of azelastine HCl in human milk, the effects on the breastfed infant, or the effects on milk production.
Monitor breastfed infants for signs of milk rejection.
Consider the developmental and health benefits of breastfeeding along with mother’s clinical need for azelastine HCl nasal spray, 0.1% and any potential adverse effects on the breastfed infant or from the underlying maternal condition.
Monitoring for Adverse Reactions: Monitor breastfed infants of lactating women treated with azelastine HCl nasal spray for possible signs of milk rejection related to the bitter taste of azelastine.
Safety and effectiveness of azelastine HCl nasal spray, 0.1% in pediatric patients below the age of 5 years with seasonal allergic rhinitis and in pediatric patients below the age of 12 years with vasomotor rhinitis have not been established.
Use caution in elderly patients, usually starting at the low end of the dosing range.
Azelastine Hcl Pharmacokinetics
Systemic bioavailability: approximately 40%.
Maximum plasma concentrations are achieved in 2 to 3 hours.
Steady-state volume of distribution: 14.5 L/kg.
88% plasma protein bound.
Half-life: 22 hours.
Azelastine Hcl Interactions
Azelastine Hcl Adverse Reactions
Azelastine Hcl Clinical Trials
Seasonal Allergic Rhinitis – Two Sprays Per Nostril Twice Daily
Approval was based on data from 3 placebo-controlled clinical trials evaluating the efficacy and safety of azelastine HCl nasal spray 0.1% in 322 patients with seasonal allergic rhinitis, including 55 pediatric patients aged 12 to 16 years. Patients received 2 sprays per nostril twice a day of either azelastine HCl nasal spray or placebo for up to 4 weeks.
Efficacy was based on the 12-hour reflective Total Symptom Complex (TSC) and Major Symptom Complex (MSC).
Azelastine HCl nasal spray showed a greater decrease in the MSC compared with placebo. In dose-ranging trials, there was a statistically significant decrease in symptoms in the azelastine arm compared with placebo within 3 hours after initial dosing and persisted over the 12-hour dosing interval.
Seasonal Allergic Rhinitis – One Spray Per Nostril Twice Daily
Approval was based on data from 2 placebo-controlled clinical trials evaluating the efficacy and safety of azelastine HCl nasal spray 0.1% in 275 patient with seasonal allergic rhinitis. Patients received 1 spray per nostril twice a day of either azelastine HCl nasal spray or placebo for up to 2 weeks.
Efficacy was based on the 12-hour reflective Total Nasal Symptom Score (rTNSS). The primary efficacy endpoint was the change from baseline to Day 14 in rTNSS.
Azelastine HCl nasal spray achieved a greater mean change in rTNSS at Day 14 from baseline compared with placebo.
Approval was based on data from 2 placebo-controlled clinical trials evaluating the efficacy and safety of azelastine HCl nasal spray 0.1% in 216 patients with vasomotor rhinitis. Patients received 2 sprays per nostril twice a day of azelastine HCl nasal spray or placebo for up to 4 weeks.
Azelastine HCl nasal spray 0.1% achieved a significantly greater decrease in symptom complex (rhinorrhea, post nasal drip, nasal congestion, sneezing) compared with placebo.
Azelastine Hcl Note
Azelastine Hcl Patient Counseling