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Astepro

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Astepro

Astepro

INDICATIONS

Allergic Rhinitis

ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.1% and 0.15% is indicated for the relief of the symptoms of seasonal and perennial allergic rhinitis in patients 12 years of age and older.

DOSAGE AND ADMINISTRATION

Seasonal Allergic Rhinitis

The recommended dose of ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.1% and 0.15% is 1 or 2 sprays per nostril twice daily for seasonal allergic rhinitis. ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.15% may also be administered as 2 sprays per nostril once daily.

Perennial Allergic Rhinitis

The recommended dose of ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.15% for perennial allergic rhinitis is 2 sprays per nostril twice daily.

Important Administration Instructions

Administer ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray by the intranasal route only.

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

HOW SUPPLIED

Dosage Forms And Strengths

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

Storage And Handling

ASTEPRO (azelastine hydrochloride) Nasal Spray 0.1% (NDC 0037-0242-30) 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], 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], 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 (azelastine hydrochloride nasal spray) Nasal Spray 0.1% and 0.15% 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.

Manufactured by: MEDA Pharmaceuticals Meda Pharmaceuticals Inc. Somerset, NJ 08873-4120. Revised 11/10

Last reviewed on RxList: 3/10/2011
This monograph has been modified to include the generic and brand name in many instances.

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