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Astelin

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Astelin

Indications
Dosage
How Supplied

INDICATIONS

Astelin Nasal Spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.

DOSAGE AND ADMINISTRATION

Seasonal Allergic Rhinitis

The 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.

Vasomotor Rhinitis

The 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.

Important Administration Instructions

Administer 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.

HOW SUPPLIED

Dosage Forms And Strengths

Astelin Nasal Spray is a nasal spray solution. Each spray of Astelin Nasal Spray delivers a volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride.

Storage And Handling

Astelin (azelastine hydrochloride) Nasal Spray, 137 mcg is supplied as a 30-mL package (NDC 0037-0241-30) delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump fitted with a blue safety clip and a blue plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). Each bottle contains 30 mg (1 mg/mL) of azelastine hydrochloride. After priming [see DOSAGE AND ADMINISTRATION], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays have been used, even though the bottle is not completely empty. The bottle should be discarded after 200 sprays have been used. Astelin Nasal Spray should not be used after the expiration date “EXP” printed on the medicine label and carton.

Storage

Store at controlled room temperature 20° to 25°C (68° to 77°F). Protect from freezing.

Manufactured by: MEDA Pharmaceuticals Somerset, NJ 08873-4120. Revised: 10/2014

Last reviewed on RxList: 12/1/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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