Astepro (Azelastine Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

Allergic Rhinitis

ASTEPRO Nasal Spray 0.1% and 0.15% is indicated for the relief of the symptoms of seasonal and perennial allergic rhinitis in patients 6 years of age and older.

DOSAGE AND ADMINISTRATION

Seasonal Allergic Rhinitis

In children 6 to 11 years of age, the recommended dose of ASTEPRO Nasal Spray 0.1% and 0.15% is 1 spray per nostril twice daily.

In adults and adolescents 12 years of age and older, the recommended dose of ASTEPRO Nasal Spray 0.1% and 0.15% is 1 or 2 sprays per nostril twice daily. ASTEPRO Nasal Spray 0.15% may also be administered as 2 sprays per nostril once daily.

Perennial Allergic Rhinitis

In children 6 to 11 years of age, the recommended dose of ASTEPRO Nasal Spray 0.1% and 0.15% is 1 spray per nostril twice daily.

In adults and adolescents 12 years of age and older, the recommended dose of ASTEPRO Nasal Spray 0.15% is 2 sprays per nostril twice daily.

Important Administration Instructions

Administer ASTEPRO Nasal Spray by the intranasal route only.

Priming: Prime ASTEPRO Nasal Spray before initial use by releasing 6 sprays or until a fine mist appears. When ASTEPRO Nasal Spray has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears. Avoid spraying ASTEPRO Nasal Spray into the eyes.

DOSAGE FORMS AND STRENGTHS

ASTEPRO Nasal Spray is a nasal spray solution. Each spray of ASTEPRO Nasal Spray 0.1% delivers a volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride. Each spray of ASTEPRO Nasal Spray 0.15% delivers a volume of 0.137 mL solution containing 205.5 mcg of azelastine hydrochloride.

HOW SUPPLIED/STORAGE AND HANDLING

ASTEPRO (azelastine hydrochloride) Nasal Spray 0.1% is supplied as a 30-mL package 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 (2.3)], 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.

ASTEPRO (azelastine hydrochloride) Nasal Spray 0.15% is supplied as a 30-mL package (NDC 0037-0243-30) 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). The 30-mL bottle contains 45 mg (1.5 mg/mL) of azelastine hydrochloride. After priming [see Dosage and Administration (2.3)], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 205.5 mcg of azelastine hydrochloride. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays for the 30-mL bottle have been used, even though the bottle is not completely empty. The bottle should be discarded after 200 sprays have been used.

ASTEPRO Nasal Spray should not be used after the expiration date “EXP” printed on the medicine label and carton.

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