Astelin
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Astelin® Nasal Spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing, and nasal pruritus in adults and children 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis, such as rhinorrhea, nasal congestion and postnasal drip in adults and children 12 years and older.
History
There is currently no drug history available for this drug.
Other Information
Astelin® (azelastine hydrochloride) Nasal Spray, 137 micrograms (mcg), is an antihistamine 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 C22H24CIN3O•HCl with the following chemical structure:
Astelin® Nasal Spray contains 0.1% azelastine hydrochloride in an aqueous solution at pH 6.8 ± 0.3. It also contains benzalkonium chloride (125 mcg/mL), edetate disodium, hypromellose, citric acid, dibasic sodium phosphate, sodium chloride, and purified water.
After priming, each metered spray delivers a 0.137 mL mean volume containing 137 mcg of azelastine hydrochloride (equivalent to 125 mcg of azelastine base). The bottle can deliver 200 metered sprays.
Sources
Astelin Manufacturers
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Physicians Total Care, Inc.
![Astelin (Azelastine Hydrochloride) Spray, Metered [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Astelin | Physicians Total Care, Inc.
Seasonal Allergic RhinitisThe recommended dose of Astelin® Nasal Spray in adults and children 12 years and older with seasonal allergic rhinitis is one or two sprays per nostril twice daily. The recommended dose of Astelin® Nasal Spray in children 5 years to 11 years of age is one spray per nostril twice daily.
Vasomotor RhinitisThe recommended dose of Astelin® Nasal Spray in adults and children 12 years and older with vasomotor rhinitis is two sprays per nostril twice daily.
Before initial use, the delivery system should be primed with 4 sprays or until a fine mist appears. When 3 or more days have elapsed since the last use, the pump should be reprimed with 2 sprays or until a fine mist appears.
CAUTION: Avoid spraying in the eyes.
Directions for Use: Illustrated patient instructions for proper use accompany each package of Astelin® Nasal Spray.
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Meda Pharmaceuticals Inc.
Astelin | Meda Pharmaceuticals Inc.
2.1 Seasonal Allergic RhinitisThe recommended dosage of Astelin Nasal Spray in adults and adolescent patients 12 years and older with seasonal allergic rhinitis is one or two sprays per nostril twice daily. The recommended dosage of Astelin Nasal Spray in pediatric patients 5 years to 11 years of age is one spray per nostril twice daily.
2.2 Vasomotor RhinitisThe recommended dosage of Astelin Nasal Spray in adults and adolescent patients 12 years and older with vasomotor rhinitis is two sprays per nostril twice daily.
2.3 Important Administration InstructionsAdminister Astelin Nasal Spray by the intranasal route only.
Priming: Prime Astelin Nasal Spray before initial use by releasing 4 sprays or until a fine mist appears. When Astelin Nasal Spray has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears. Avoid spraying Astelin Nasal Spray into the eyes.
![Astelin (Azelastine Hydrochloride) Spray, Metered [Meda Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=46b2ddff-d40a-43ac-b027-4fac9fc2f4b9&name=astelin-08.jpg)
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