Azelastine Hydrochloride

AZELASTINE HYDROCHLORIDE- azelastine hydrochloride spray, metered
Roxane Laboratories, Inc.

1 INDICATIONS AND USAGE

Azelastine Hydrochloride Nasal Solution (Nasal Spray) is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.

2 DOSAGE AND ADMINISTRATION

2.1Seasonal Allergic Rhinitis

The recommended dose of azelastine hydrochloride nasal solution in adults and adolescent patients 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 pediatric patients 5 years to 11 years of age is one spray per nostril twice daily.

2.2Vasomotor Rhinitis

The recommended dose of azelastine hydrochloride nasal solution 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 solution by the intranasal route only.

Priming: Prime azelastine hydrochloride nasal solution before initial use by releasing 4 sprays or until a fine mist appears. When azelastine hydrochloride nasal solution 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 into the eyes.

3 DOSAGE FORMS AND STRENGTHS

Azelastine hydrochloride nasal solution is a nasal spray solution. Each spray of azelastine hydrochloride nasal solution delivers a volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride.

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Somnolence in Activities Requiring Mental Alertness

In clinical trials, the occurrence of somnolence has been reported in some patients taking azelastine hydrochloride nasal solution [see Adverse Reactions (6.1)]. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as operating machinery or driving a motor vehicle after administration of azelastine hydrochloride nasal solution. Concurrent use of azelastine hydrochloride nasal solution with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur [see Drug Interactions (7.1)].

6 ADVERSE REACTIONS

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Use of azelastine hydrochloride nasal solution has been associated with somnolence [see Warnings and Precautions (5.1)].

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice.

Seasonal Allergic Rhinitis

Azelastine Hydrochloride Nasal Solution Two Sprays Per Nostril Twice Daily

Adverse experience information for azelastine hydrochloride nasal solution is derived from six placebo- and active-controlled, 2-day to 8-week clinical trials which included 391 patients, 12 years of age and older, with seasonal allergic rhinitis who received azelastine hydrochloride nasal solution at a dose of 2 sprays per nostril twice daily. In placebo-controlled efficacy trials, the incidence of discontinuation due to adverse reactions in patients receiving azelastine hydrochloride nasal solution and vehicle placebo was 2.2% and 2.8%, respectively.

Table 1 contains adverse reactions that were reported with frequencies ≥2% in the azelastine hydrochloride nasal solution 2 sprays per nostril twice daily treatment group and more frequently than placebo.

Table 1: Adverse Reactions Reported in ≥2% Incidence in Placebo-Controlled Trials in Patients with Seasonal Allergic Rhinitis [n(%)]

Adverse Reaction

Azelastine HCl Nasal Solution (n=391)

Vehicle Placebo (n=353)

Bitter Taste

77 (19.7%)

2 (0.6%)

Headache

58 (14.8%)

45 (12.7%)

Somnolence

45 (11.5%)

19 (5.4%)

Nasal Burning

16 (4.1%)

6 (1.7%)

Pharyngitis

15 (3.8%)

10 (2.8%)

Paroxysmal Sneezing

12 (3.1%)

4 (1.1%)

Dry Mouth

11 (2.8%)

6 (1.7%)

Nausea

11 (2.8%)

4 (1.1%)

Rhinitis

9 (2.3%)

5 (1.4%)

Fatigue

9 (2.3%)

5 (1.4%)

Dizziness

8 (2.0%)

5 (1.4%)

Epistaxis

8 (2.0%)

5 (1.4%)

Weight Increase

8 (2.0%)

0 (0.0%)

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