Manufacturer:

Meda Pharmaceuticals

Pharmacological Class:

Antihistamine.

Active Ingredient(s):

Azelastine HCl 137mcg/spray; aqueous nasal spray; contains benzalkonium chloride.

Indication(s):

Seasonal allergic rhinitis.

Pharmacology:

Seasonal allergic rhinitis presents as an array of symptoms such as rhinorrhea, nasal congestion, sneezing, and itchy nose caused by sensitivity to seasonal pollens. Azelastine hydrochloride is an antihistamine that antagonizes H₁-receptor activity to relieve these symptoms by interfering with the inflammatory response to the allergens. The major active metabolite of azelastine hydrochloride, desmethylazelastine, also possesses H₁-receptor antagonist activity.

Clinical Trials:

A 2-week, randomized, multicenter, double-blind, placebo-controlled clinical trial was conducted to establish the safety and efficacy of Astepro nasal spray in the treatment of seasonal allergic rhinitis. In this study, 834 adult and adolescent patients 12–83 years of age with symptoms of seasonal allergic rhinitis were randomized to receive Astepro nasal spray, Astelin nasal spray, or vehicle nasal spray. Efficacy was assessed based on the 12-hour reflective total nasal symptom scores (rTNSS) (rhinorrhea, nasal congestion, sneezing, and nasal itching on a 0 to 3 severity scale [0=absent to 3=severe]) recorded by the patients in the morning (AM) and evening (PM). The primary efficacy endpoint was defined as the mean change from baseline of the summed AM and PM rTNSS for each day (maximum score =24) and averaged over the 2-week treatment period. At endpoint, Astepro nasal spray demonstrated a greater decrease in the summed AM and PM rTNSS compared to placebo and the difference was statistically significant.

Legal Classification:

Rx

Adults:

1 or 2 sprays in each nostril twice daily.

Children:

Not recommended.

Warnings/Precautions:

Avoid eyes, mouth. Pregnancy (Cat.C). Nursing mothers.

Interaction(s):

Potentiates CNS depression with alcohol, other CNS depressants. Serum levels increased by cimetidine. Caution with other antihistamines.

Adverse Reaction(s):

Bitter taste, epistaxis, headache, fatigue, somnolence.

How Supplied:

Spray—30mL (200 sprays)

Last Updated:

3/4/2009