Frequently Asked Questions for Physicians 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 seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) symptoms, including nasal congestion, without an added decongestant like pseudoephedrine.
Q:What are the benefits of an antihistamine nasal spray?
A: It provides relief from nasal allergy symptoms, including nasal congestion, without an added decongestant like pseudoephedrine. It has been shown to begin to work in as early as 30 to 45 minutes.
Q:What should be known about decongestants?
A: Decongestants such as pseudoephedrine should be used with caution in patients with a history of cardiac arrhythmia, glaucoma, diabetes, hypertension, hyperthyroidism, 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 perennial allergens cause symptoms by activating the body's immune system. The immune system produces antibodies that cause the release of histamine from mast cells.
Q:How quickly does ASTEPRO 0.15% work?
A: Clinical studies indicated that ASTEPRO 0.15% can provide rapid relief in as early as 30 to 45 minutes.
Q:What is the recommended dosage for ASTEPRO 0.15%?
A: The FDA-approved dose for seasonal allergic rhinitis is 2 sprays per nostril QD, or 1 or 2 sprays per nostril BID, as prescribed by your doctor. The FDA-approved dose for perennial allergic rhinitis is 2 sprays per nostril BID.
Q:Can children take ASTEPRO 0.15%?
A: ASTEPRO 0.15% is indicated for patients with seasonal allergic rhinitis or perennial allergic rhinitis 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 ASTEPRO 0.15% available on electronic prescribing systems?
A: ASTEPRO 0.15% should be loaded into all major prescribing systems, but this may vary by software provider. It may be necessary to update or synchronize the system.
Q:Is original ASTEPRO still commercially available?
A: No. ASTEPRO 0.15%, 205.5 mcg, is the only ASTEPRO formulation available.
Q:Why is original ASTEPRO no longer available?
A: After completing a comprehensive review of the ASTEPRO family of products, Meda Pharmaceuticals decided to discontinue the manufacturing, distribution, and marketing of original ASTEPRO, 137 mcg. ASTEPRO 0.15%, 205.5 mcg, offers a combination of benefits that makes it different from other antihistamines. Meda will continue to manufacture, distribute, and market ASTEPRO 0.15%.
Q:ASTEPRO 0.15% is made by the same company that makes original ASTEPRO and ASTELIN. Are the products interchangeable?
A: ASTEPRO 0.15%, original ASTEPRO, and ASTELIN are not interchangeable. They have different indications and dosing schedules.
Q:Has the volume of the spray plume in ASTEPRO 0.15% been changed from that of original ASTEPRO and/or ASTELIN?
A: No. The volume of the spray plume has not changed in ASTEPRO 0.15% as compared with original ASTEPRO and ASTELIN.
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 BID.
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 noncaloric 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 nondiabetic patients.
