Frequently Asked Questions for Patients About ASTEPRO® (azelastine HCI) Nasal Spray 0.15%

Q: What is ASTEPRO 0.15%?

A: ASTEPRO 0.15% is an antihistamine nasal spray that provides relief from the symptoms of seasonal and indoor (year-round) allergies, including nasal congestion, itchy nose, runny nose, and sneezing, without added decongestants like pseudoephedrine.

Q: What are the benefits of an antihistamine nasal spray?

A: It provides relief of nasal allergy symptoms, without added decongestants like pseudoephedrine.

Q: What should be known about decongestants?

A: Decongestants such as pseudoephedrine should be used with caution in patients with a history of irregular heartbeat, glaucoma, diabetes, high blood pressure, overactive thyroid, and urinary dysfunction.

Q: How does ASTEPRO 0.15% work?

A: ASTEPRO 0.15% relieves symptoms by blocking the effects of histamine. Histamine is the primary cause of seasonal allergy symptoms such as sneezing; itchy, runny nose; and nasal congestion. Seasonal and indoor allergens cause symptoms by activating the body's immune system. The immune system produces antibodies (proteins in the blood intended to protect the body from invaders) that cause the release of histamine from specialized cells called mast cells.

Q: What is the recommended dosing for ASTEPRO 0.15%?

A: The FDA-approved dose for seasonal allergies is 2 sprays per nostril once a day or 1 or 2 sprays into each nostril, twice a day, as prescribed by your doctor. The FDA-approved dose for indoor allergies is 2 sprays per nostril twice a day.

Q: Can children take ASTEPRO 0.15%?

A: ASTEPRO 0.15% is indicated for patients with seasonal allergies or indoor allergies who are 12 years of age and older.

Q: Does ASTEPRO 0.15% have side effects?

A: Yes. The most common side effects with ASTEPRO 0.15% are generally mild and include bitter taste, nasal discomfort, nosebleeds, and sneezing.

Q: Is original ASTEPRO still commercially available?

A: No. ASTEPRO 0.15%, 205.5 mcg, is the only form of ASTEPRO available.

Q: ASTEPRO 0.15% is made by the same company that makes original ASTEPRO and ASTELIN. Are the products interchangeable?

A: ASTELIN, original ASTEPRO, and ASTEPRO 0.15% are not interchangeable. They have different indications and dosing schedules.

Q: Does the incidence of bitter taste increase with the higher concentration of azelastine found in ASTEPRO 0.15%?

A: No. In clinical trials, the incidence of bitter taste was 6% for ASTEPRO 0.15% and 7% for original ASTEPRO when dosed 2 sprays per nostril twice daily.

Q: Who should not use ASTEPRO 0.15%?

A: If you are allergic to ASTEPRO 0.15%, ASTELIN, azelastine, or any of its components, do not use ASTEPRO 0.15%.

Q: Does ASTEPRO 0.15% contain pseudoephedrine?

A: No. ASTEPRO 0.15% does not contain pseudoephedrine or any other added decongestant. Some other antihistamines are used in combination with a decongestant such as pseudoephedrine, which can cause restlessness and sleep difficulties. Pseudoephedrine should be used with caution if you have certain conditions such as diabetes, enlarged prostate, heart or blood vessel disease, high blood pressure, or overactive thyroid.

Q: Does ASTEPRO 0.15% contain a steroid?

A: No. Unlike some other prescription nasal sprays, ASTEPRO 0.15% is steroid-free.

Q: What is sucralose?

A: Sucralose is a non-caloric sweetener made from sugar. It is about 600 times sweeter than sugar and is used in more than 4000 products worldwide. It is used in a wide variety of products, including beverages, baked goods, and desserts. Sucralose has been approved by the FDA for use in ASTEPRO 0.15%.

Q: What is sorbitol?

A: Sorbitol, also known as glucitol, has many uses in prescription products as well as in foods such as "sugarfree" mints, gum, etc .

Q: Has sucralose been studied for safety in people with diabetes?

A: Studies have shown that sucralose may be used in both diabetic and non-diabetic patients.

 

Indication

ASTEPRO® (azelastine HCl) Nasal Spray 0.15% is indicated for the relief of the symptoms of seasonal and perennial allergic rhinitis in patients 12 years of age and older.

Important Risk Information

  • Avoid engaging in hazardous occupations requiring complete mental alertness when taking ASTEPRO Nasal Spray 0.15%
  • Avoid concurrent use of alcohol or other central nervous system depressants with ASTEPRO Nasal Spray 0.15%
  • In clinical studies, the most commonly reported adverse reactions, when dosed at 2 sprays per nostril once or twice daily, respectively, included bitter taste (4%, 6%), nasal discomfort (4%, 3%), epistaxis (2%, 1%), and sneezing (1%, 2%)
  • Pregnancy Category C: Based on animal data, may cause fetal harm
    Please see full Prescribing Information
    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

    For more information about ASTEPRO Nasal Spray 0.15%, call Meda Pharmaceuticals Inc. at 1-800-526-3840.