Azelastine Hydrochloride Spray label

Azelastine Hydrochloride Spray

Azelastine Hydrochloride Spray Recall

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Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Allergic Rhinitis

Azelastine Hydrochloride 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.

History

There is currently no drug history available for this drug.

Other Information

Azelastine Hydrochloride Nasal Spray 0.1%, 137 micrograms (mcg), is an antihistamine formulated as a metered-spray solution for intranasal administration. Azelastine Hydrochloride Nasal Spray 0.15%, 205.5 micrograms (mcg), is formulated as a metered-spray solution for intranasal administration.

Azelastine hydrochloride occurs as a white, almost odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.37. It is sparingly soluble in water, methanol, and propylene glycol and slightly soluble in ethanol, octanol, and glycerine. It has a melting point of about 225°C and the pH of a saturated solution is between 5.0 and 5.4. Its chemical name is (±)-1-(2H)-phthalazinone,4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride. Its molecular formula is C22H24ClN3O•HCl with the following chemical structure:

Azelastine Hydrochloride Nasal Spray 0.1% contains 0.1% azelastine hydrochloride in an isotonic aqueous solution containing sorbitol, sucralose, hypromellose, sodium citrate, edetate disodium, benzalkonium chloride (125 mcg/mL), and purified water (pH 6.4).

After priming [see Dosage and Administration (2.3)], each metered spray delivers a 0.137 mL mean volume containing 137 mcg of azelastine hydrochloride (equivalent to 125 mcg of azelastine base). The 30-mL (net weight 30 gm of solution) bottle provides 200 metered sprays.

Azelastine Hydrochloride Nasal Spray 0.15% contains 0.15% azelastine hydrochloride in an isotonic aqueous solution containing sorbitol, sucralose, hypromellose, sodium citrate, edetate disodium, benzalkonium chloride (125 mcg/mL), and purified water (pH 6.4).

After priming [see Dosage and Administration (2.3)], each metered spray delivers a 0.137 mL mean volume containing 205.5 mcg of azelastine hydrochloride (equivalent to 187.6 mcg of azelastine base). The 30-mL (net weight 30 gm of solution) bottle provides 200 metered sprays.

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Azelastine Hydrochloride Spray Recall

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Azelastine Hydrochloride Spray Manufacturers

Wallace Pharmaceuticals Inc.
No Recall
Azelastine Hydrochloride Spray | Wallace Pharmaceuticals Inc.
2.1 Seasonal Allergic Rhinitis
     In children 6 to 11 years of age, the recommended dose of Azelastine Hydrochloride 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 Azelastine Hydrochloride Nasal Spray 0.1% and 0.15% is 1 or 2 sprays per nostril twice daily. Azelastine Hydrochloride Nasal Spray 0.15% may also be administered as 2 sprays per nostril once daily.
2.2 Perennial Allergic Rhinitis
     In children 6 to 11 years of age, the recommended dose of Azelastine Hydrochloride 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 Azelastine Hydrochloride Nasal Spray 0.15% is 2 sprays per nostril twice daily.
2.3 Important Administration Instructions
     Administer Azelastine Hydrochloride Nasal Spray by the intranasal route only.

     Priming: Prime Azelastine Hydrochloride Nasal Spray before initial use by releasing 6 sprays or until a fine mist appears. When Azelastine Hydrochloride Nasal Spray has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears. Avoid spraying Azelastine Hydrochloride Nasal Spray and into the eyes.
Perrigo New York Inc
No Recall
Azelastine Hydrochloride Spray | Perrigo New York Inc
2.1 Seasonal Allergic Rhinitis
In children 6 to 11 years of age, the recommended dose of Azelastine Hydrochloride 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 Azelastine Hydrochloride Nasal Spray 0.1% and 0.15% is 1 or 2 sprays per nostril twice daily. Azelastine Hydrochloride Nasal Spray 0.15% may also be administered as 2 sprays per nostril once daily.
2.2 Perennial Allergic Rhinitis
In children 6 to 11 years of age, the recommended dose of Azelastine Hydrochloride 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 Azelastine Hydrochloride Nasal Spray 0.15% is 2 sprays per nostril twice daily.
2.3 Important Administration Instructions
Administer Azelastine Hydrochloride Nasal Spray by the intranasal route only.

Priming: Prime Azelastine Hydrochloride Nasal Spray before initial use by releasing 6 sprays or until a fine mist appears. When Azelastine Hydrochloride Nasal Spray has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears. Avoid spraying Azelastine Hydrochloride Nasal Spray into the eyes.
Physicians Total Care, Inc.
No Recall
Azelastine Hydrochloride Spray | Physicians Total Care, Inc.
Seasonal Allergic Rhinitis
The recommended dose of azelastine hydrochloride nasal solution 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 solution 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 solution 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 solution.
Sun Pharma Global Fze
No Recall
Azelastine Hydrochloride Spray | Penleigh Irving Ltd
There is currently no dosage information available for this product. We apologize for any inconvenience.
Apotex Corp.
No Recall
Azelastine Hydrochloride Spray | Apotex Corp.
2.1 Seasonal Allergic Rhinitis
The recommended dosage of azelastine hydrochloride 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 azelastine hydrochloride nasal spray in pediatric patients 5 years to 11 years of age is one spray per nostril twice daily.
2.2 Vasomotor Rhinitis
The recommended dosage of azelastine hydrochloride nasal spray in adults and adolescent patients 12 years and older with vasomotor rhinitis is two sprays per nostril twice daily.
2.3 Important Administration Instructions
Administer azelastine hydrochloride nasal spray by the intranasal route only.

Priming
Prime azelastine hydrochloride nasal spray before initial use by releasing 4 sprays or until a fine mist appears. When azelastine hydrochloride nasal spray has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears. Avoid spraying azelastine hydrochloride nasal spray into the eyes.
Wallace Pharmaceuticals Inc.
No Recall
Azelastine Hydrochloride Spray | Wallace Pharmaceuticals Inc.
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.
Apotex Corp.
No Recall
Azelastine Hydrochloride Spray | Apotex Corp.
2.1 Seasonal Allergic Rhinitis
In adults and adolescents 12 years of age and older, the recommended dose of azelastine hydrochloride nasal solution (nasal spray), 0.15% is 1 or 2 sprays per nostril twice daily. Azelastine hydrochloride nasal solution (nasal spray), 0.15% may also be administered as 2 sprays per nostril once daily.

Pediatric use information for patients ages 6 to 11 years of age for treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis is approved for Meda Pharmaceuticals’ azelastine hydrochloride nasal spray product. However, due to Meda Pharmaceuticals’ marketing exclusivity rights, this drug product is not labeled with that pediatric information.
2.2 Perennial Allergic Rhinitis
In adults and adolescents 12 years of age and older, the recommended dose of azelastine hydrochloride nasal solution (nasal spray), 0.15% is 2 sprays per nostril twice daily.

Pediatric use information for patients ages 6 to 11 years of age for treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis is approved for Meda Pharmaceuticals’ azelastine hydrochloride nasal spray product. However, due to Meda Pharmaceuticals’ marketing exclusivity rights, this drug product is not labeled with that pediatric information.
2.3 Important Administration Instructions
Administer azelastine hydrochloride nasal solution (nasal spray) by the intranasal route only.

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