August 31, 2015
Recommended Topic Related To:

Astepro

"In the largest, most comprehensive, nationwide study to examine the prevalence of allergies from early childhood to old age, scientists from the National Institutes of Health report that allergy prevalence is the same across different regions "...

Astepro




Indications
Dosage
How Supplied

INDICATIONS

Allergic Rhinitis

ASTEPRO Nasal Spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older.

DOSAGE AND ADMINISTRATION

Seasonal Allergic Rhinitis

Children 2 to 5 Years Of Age

ASTEPRO 0.1%, 1 spray per nostril twice daily.

Children 6 to 11 Years Of Age

ASTEPRO 0.1% or ASTEPRO 0.15%, 1 spray per nostril twice daily.

Adults and Adolescents 12 Years Of Age and Older

ASTEPRO 0.1% or ASTEPRO 0.15%, 1 or 2 sprays per nostril twice daily. ASTEPRO 0.15% may also be administered as 2 sprays per nostril once daily.

Perennial Allergic Rhinitis

Children 6 Months to 5 Years Of Age

ASTEPRO 0.1%, 1 spray per nostril twice daily.

Children 6 to 11 Years Of Age

ASTEPRO 0.1% or ASTEPRO 0.15%, 1 spray per nostril twice daily.

Adults and Adolescents 12 Years Of Age and Older

ASTEPRO 0.15%, 2 sprays per nostril twice daily.

Important Administration Instructions

Administer ASTEPRO by the intranasal route only.

Priming

Prime ASTEPRO before initial use by releasing 6 sprays or until a fine mist appears. When ASTEPRO has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears.

Avoid spraying ASTEPRO into the eyes.

HOW SUPPLIED

Dosage Forms And Strengths

ASTEPRO is a nasal spray solution available in two dosage strengths:

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

Storage And Handling

ASTEPRO (azelastine hydrochloride) 0.1% nasal spray 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) 0.15% nasal spray 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 should not be used after the expiration date “EXP” printed on the medicine label and carton.

Storage

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

Manufactured by: Meda Pharmaceuticals, Somerset, NJ 08873-4120. Revised: 2/2015

Last reviewed on RxList: 3/5/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Allergies & Asthma

Improve treatments & prevent attacks.