Azelastine (Azelastine Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

Azelastine Hydrochloride 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.

DOSAGE AND ADMINISTRATION

Seasonal Allergic Rhinitis

The recommended dose of Azelastine Hydrochloride 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 Azelastine Hydrochloride Nasal Spray in children 5 years to 11 years of age is one spray per nostril twice daily.

Vasomotor Rhinitis

The recommended dose of Azelastine Hydrochloride 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 Azelastine Hydrochloride Nasal Spray.

HOW SUPPLIED

Azelastine Hydrochloride Nasal Spray, 137 mcg, (NDC 51525-0294-3) is supplied as a package containing 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. Patient instructions are also provided. The spray pump unit consists of a nasal spray pump fitted with a blue safety clip and a blue plastic dust cover.

The Azelastine Hydrochloride Nasal Spray, 137 mcg, bottle contains 30 mg (1 mg/mL) of azelastine hydrochloride. Each spray delivers a mean of 0.137 mL solution containing 137 mcg of azelastine hydrochloride.

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

U.S. Patent D447,419.