Frequently Asked Questions from
Healthcare Providers About ASTEPRO
FAQ about the Medication
FAQ about the Formulation, Device and Delivery
About the Medication
Q: Why are you bringing another azelastine product to the market?
A: The planning for ASTEPRO was initiated 10 years ago, in response to customer feedback regarding the tolerability of ASTELIN. During the clinical trials, we found that ASTEPRO provided powerful efficacy, rapid relief, in as early as 30 minutes, and improved tolerability for patients 12 years of age and older suffering from SAR.
Q: Is ASTEPRO available on electronic prescribing systems?
A: ASTEPRO should be loaded into all major systems, but this may vary by software provider. It may be necessary to update or synchronize the system.
Q: How is ASTEPRO different than ASTELIN?
A: ASTEPRO is an antihistamine nasal spray formulation that provides patients with powerful efficacy, rapid relief in as early as 30 minutes, and improved tolerability. ASTEPRO has a unique vehicle formulated with sucralose and sorbitol. ASTELIN has a saline-based vehicle. The active ingredient, azelastine, remains the same in both formulations; and it is the same strength-- 137mcg per spray.
Q: Are the indications the same?
A: No; however, there is some overlap – both ASTELIN and ASTEPRO Nasal Spray are an H1- receptor antagonist indicated for the relief of symptoms of SAR in patients 12 years and older. In addition, ASTELIN is indicated to treat SAR patients 5 years and older and non-allergic vasomotor rhinitis patients 12 years and older.
Q: Is ASTEPRO indicated for kids?
A: ASTEPRO is indicated for SAR patients 12 years of age and older.
Q: Are you now taking ASTELIN off the market?
A: No. ASTELIN remains on the market.
Q: Are the two products interchangeable?
A: ASTELIN and ASTEPRO are not interchangeable. They have different NDC numbers and indications. Therefore, each requires a separate prescription.
Q: Is the dosing regimen the same for ASTEPRO and ASTELIN?
A: The FDA recommended dose for both brands in patients with SAR 12 year of age and older is 1 or 2 sprays per nostril BID.
Q: Can I send the ASTELIN I have back to the wholesaler for credit?
A: ASTELIN will remain on the market and prescriptions will continue to be filled. The normal Meda return policy applies for ASTELIN Nasal Spray.
Q: What will happen to ASTELIN? Will you promote, sample, manufacture?
A: Yes, Meda continues to promote, sample and manufacture ASTELIN.
Q: What should patients know about ASTEPRO?
A: ASTEPRO is a unique nasal formulation that provides seasonal allergy patients with powerful and rapid nasal allergy symptom relief, in as early as 30 minutes, and it is well tolerated. Patients should review the instructions for the dosing and administration. Also, patients should be informed of warnings and potential side effects.
Q: What is the incidence of bitter taste with ASTEPRO?
A: In a pivotal clinical study, the incidence of reports of bitter taste for ASTEPRO two sprays per nostril BID was 7%. This means 93% of patients in the pivotal clinical study did not report bitter taste when taking ASTEPRO.
About the Formulation, Device, Delivery
Q: Has the volume of the spray plume in ASTEPRO been changed from that of ASTELIN?
A: No. The volume of the spray and the amount of active ingredient in each spray is 137 mcg.
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 4,000 products worldwide and is used in a wide variety of products, including beverages, baked goods and desserts. Sucralose was included in ASTEPRO as a taste-masking agent.
Q: What is sorbitol?
A: Sorbitol, also known as glucitol, has many uses in prescription products as well as foods such as "sugarfree" mints, gum, etc. Sorbitol maintains the isotenicity of ASTEPRO.
Q: Has sucralose studied for use in patients with diabetes?
A: Studies have shown that sucralose may be used in both normal and diabetic patients.
Q: What if someone is allergic to artificial sweeteners?
A: If you are allergic to Astepo, Astelin, Azelastine or any of its components do not use Astepro.
