Important Safety Information

  • ASTEPRO (azelastine hydrochloride) Nasal Spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older
  • The most commonly reported adverse events were dose related (1 and 2 sprays per nostril respectively) and included bitter taste (6%-7%), epistaxis (2%-3%), headache (1%-3%), nasal discomfort (0%-1%), fatigue (0%-2%), and somnolence (1%-2%)
  • Avoid engaging in hazardous occupations requiring complete mental alertness when taking ASTEPRO Nasal Spray
  • Avoid concurrent use of alcohol or other central nervous system depressants with ASTEPRO Nasal Spray
  • Significant improvement in TNSS in as early as 30 minutes2,3
    • In one placebo-controlled study of 284 SAR patients conducted over 2 weeks, ASTEPRO administered 2 sprays per nostril bid demonstrated an onset of action vs placebo vehicle at 30 minutes and sustained efficacy vs placebo through the end of the 2-week study period.2
    • In a second study of 343 SAR patients conducted over 2 weeks, ASTEPRO administered 2 sprays per nostril bid demonstrated an onset of action vs placebo vehicle at 240 minutes and sustained efficacy vs placebo through the end of the 2-week study period.3

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

1 ASTEPRO package insert. Somerset, NJ: Meda Pharmaceuticals Inc; 2008.
2 Data on file. Study MP430. Meda Pharmaceuticals Inc.
3 Data on file. Study MP438. Meda Pharmaceuticals Inc.