Astepro
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Uses
ASTEPRO Nasal Spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older.
History
There is currently no drug history available for this drug.
Other Information
ASTEPRO (azelastine hydrochloride) 0.1% nasal spray is an antihistamine (H1 receptor antagonist) formulated as a metered-spray solution for intranasal administration. ASTEPRO (azelastine hydrochloride) 0.15% nasal spray is an antihistamine (H1 receptor antagonist) formulated as a metered-spray solution for intranasal administration.
Azelastine hydrochloride occurs as a white, almost odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.37. It is sparingly soluble in water, methanol, and propylene glycol and slightly soluble in ethanol, octanol, and glycerine. It has a melting point of about 225°C and the pH of a saturated solution is between 5.0 and 5.4. Its chemical name is (±)-1-(2H)-phthalazinone,4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride. Its molecular formula is C22H24ClN3O•HCl with the following chemical structure:
ASTEPRO 0.1% contains 0.1% azelastine hydrochloride in an isotonic aqueous solution containing sorbitol, sucralose, hypromellose, sodium citrate, edetate disodium, benzalkonium chloride (125 mcg/mL), and purified water (pH 6.4). After priming [see Dosage and Administration (2.3)], each metered spray delivers a 0.137 mL mean volume containing 137 mcg of azelastine hydrochloride (equivalent to 125 mcg of azelastine base). The 30-mL (net weight 30 gm of solution) bottle provides 200 metered sprays.
ASTEPRO 0.15% contains 0.15% azelastine hydrochloride in an isotonic aqueous solution containing sorbitol, sucralose, hypromellose, sodium citrate, edetate disodium, benzalkonium chloride (125 mcg/mL), and purified water (pH 6.4). After priming [see Dosage and Administration (2.3)], each metered spray delivers a 0.137 mL mean volume containing 205.5 mcg of azelastine hydrochloride (equivalent to 187.6 mcg of azelastine base). The 30-mL (net weight 30 gm of solution) bottle provides 200 metered sprays.
Sources
Astepro Manufacturers
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Meda Pharmaceuticals Inc.
![Astepro (Azelastine Hydrochloride) Spray, Metered [Meda Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Astepro | Meda Pharmaceuticals Inc.
2.1 Seasonal Allergic RhinitisChildren 2 to 5 years of age: ASTEPRO 0.1%, 1 spray per nostril twice daily.
Children 6 to 11 years of age: ASTEPRO 0.1% or ASTEPRO 0.15%, 1 spray per nostril twice daily.
Adults and adolescents 12 years of age and older: ASTEPRO 0.1% or ASTEPRO 0.15%, 1 or 2 sprays per nostril twice daily. ASTEPRO 0.15% may also be administered as 2 sprays per nostril once daily.
2.2 Perennial Allergic RhinitisChildren 6 months to 5 years of age: ASTEPRO 0.1%, 1 spray per nostril twice daily.
Children 6 to 11 years of age: ASTEPRO 0.1% or ASTEPRO 0.15%, 1 spray per nostril twice daily.
Adults and adolescents 12 years of age and older: ASTEPRO 0.15%, 2 sprays per nostril twice daily.
2.3 Important Administration InstructionsAdminister ASTEPRO by the intranasal route only.
Priming: Prime ASTEPRO before initial use by releasing 6 sprays or until a fine mist appears. When ASTEPRO has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears.
Avoid spraying ASTEPRO into the eyes.
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