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

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: What are the indications and dosing regimens for ASTEPRO 0.15% compared with other nasal azelastine products?

A: ASTEPRO 0.15% is the first nasal antihistamine with an indication for seasonal allergic rhinitis (SAR) (once- or twice-daily dosing) and perennial allergic rhinitis (PAR) (twice-daily dosing). ASTEPRO is indicated for the relief of symptoms of SAR in patients 12 years of age and older and dosed BID.

Nasal Azelastine Products

SAR

PAR

Once Daily
(SAR)

BID
(PAR)

ASTEPRO 0.15%

X

X

X

X

Original ASTEPRO

X

 

 

X

 

Q: ASTEPRO 0.15% is made by the same company that makes original ASTEPRO and ASTELIN. Is ASTEPRO 0.15% interchangeable with original ASTEPRO and/or ASTELIN?

A: No. The products are NOT AB rated and therefore are not interchangeable. ASTEPRO 0.15% contains 205.5 mcg of azelastine HCI in each 0.137 mL spray. Original ASTEPRO and ASTELIN contain 137 mcg of azelastine HCI in each 0.137 mL spray. Furthermore, the products have different indications and dosing regimens. Do not substitute with another azelastine HCI formulation; please dispense ASTEPRO 0.15% as prescribed.

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

A: The FDA-recommended dosage for ASTEPRO 0.15% is 2 sprays per nostril once daily or 1 to 2 sprays per nostril BID in patients 12 years of age and older with SAR and 2 sprays per nostril BID in patients 12 years of age and older with PAR.

Q: What are the most commonly reported adverse events in the 2- to 4-week SAR and PAR trials with ASTEPRO 0.15%?

A: The most commonly reported adverse events when ASTEPRO 0.15% was dosed 2 sprays per nostril (once daily or twice daily, respectively) for SAR and PAR included bitter taste (4%, 6%), nasal discomfort (4%, 3%), epistaxis (2%, 1%), and sneezing (1%, 2%).

Q: What is the order number for ASTEPRO 0.15%?

A: The NDC number for ASTEPRO 0.15% is 0037-0243-30 and is supplied as one (30 mL) bottle, which contains 200 metered sprays.

 

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.