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Astepro

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Astepro

Side Effects
Interactions

SIDE EFFECTS

Use of ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray has been associated with somnolence [see WARNINGS AND PRECAUTIONS].

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.

ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.1%

The safety data described below reflect exposure to ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.1% in 713 patients 12 years of age and older from 2 clinical trials of 2 weeks to 12 months duration. In a 2-week, double-blind, placebo-controlled, and active-controlled (Astelin® Nasal Spray; azelastine hydrochloride) clinical trial, 285 patients (115 males and 170 females) 12 years of age and older with seasonal allergic rhinitis were treated with ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.1% one or two sprays per nostril daily. In the 12 month open-label, active-controlled (Astelin Nasal Spray) clinical trial, 428 patients (207 males and 221 females) 12 years of age and older with perennial allergic rhinitis and/or nonallergic rhinitis were treated with ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.1% two sprays per nostril twice daily. The racial and ethnic distribution for the 2 clinical trials was 82% white, 8% black, 6% Hispanic, 3% Asian, and < 1% other.

Adults and Adolescents 12 Years of Age and Older

In the two week clinical trial, 835 patients 12 years of age and older with seasonal allergic rhinitis were treated with one of six treatments: one spray per nostril of either ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.1%, Astelin Nasal Spray or placebo twice daily; or 2 sprays per nostril of ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.1%, Astelin Nasal Spray, or placebo twice daily. Overall, adverse reactions were more common in the ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.1% treatment groups (21-28%) than in the placebo groups (16-20%). Overall, less than 1% of patients discontinued due to adverse reactions and withdrawal due to adverse reactions was similar among the treatment groups.

Table 1 contains adverse reactions reported with frequencies greater than or equal to 2% and more frequently than placebo in patients treated with ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.1% in the controlled clinical trial described above.

Table 1: Adverse Reactions Reported in ≥ 2% Incidence in a Placebo-Controlled Trial of 2 Weeks' Duration with ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.1% in Adult and Adolescent Patients with Seasonal Allergic Rhinitis

  1 spray twice daily 2 sprays twice daily
ASTEPRO Nasal Spray 0.1%
(N=139)
Astelin Nasal Spray
(N=137)
Vehicle Placebo
(N=137)
ASTEPRO Nasal Spray 0.1%
(N=146)
Astelin Nasal Spray
(N=137)
Vehicle Placebo
(N=138)
Bitter Taste 8 (6%) 13 (10%) 2 (2%) 10 (7%) 11 (8%) 3 (2%)
Epistaxis 3 (2%) 8 (6%) 3 (2%) 4 (3%) 3 (2%) 0 (0%)
Headache 2 (1%) 5 (4%) 1 ( < 1%) 4 (3%) 3 (2%) 1 ( < 1%)
Nasal Discomfort 0 (0%) 3 (2%) 1 ( < 1%) 2 (1%) 6 (4%) 0 (0%)
Fatigue 0 (0%) 1 ( < 1%) 1 ( < 1%) 3 (2%) 3 (2%) 1 ( < 1%)
Somnolence 2 (1%) 2 (2%) 0 (0%) 3 (2%) 2 (1%) 0 (0%)

Long-Term (12 Month) Safety Trial

In the 12 month, open-label, active-controlled, long-term safety trial, 862 patients 12 years of age and older with perennial allergic and/or nonallergic rhinitis were treated with ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.1% two sprays per nostril twice daily or Astelin Nasal Spray two sprays per nostril twice daily. The most frequently reported adverse reactions were headache, bitter taste, epistaxis, and nasopharyngitis and were generally similar between treatment groups. Focused nasal examinations were performed and showed that the incidence of nasal mucosal ulceration in each treatment group was approximately 1% at baseline and approximately 1.5% throughout the 12 month treatment period. In each treatment group, 5-7% of patients had mild epistaxis. No patients had reports of nasal septal perforation or severe epistaxis. Twenty-two patients (5%) treated with ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.1% and 17 patients (4%) treated with Astelin Nasal Spray discontinued from the trial due to adverse events.

ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.15%

The safety data described below reflect exposure to ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.15% in 1858 patients (12 years of age and older) with seasonal or perennial allergic rhinitis from 8 clinical trials of 2 weeks to 12 months duration. In 7 double-blind, placebo-controlled clinical trials of 2 to 4 weeks duration, 1544 patients (560 males and 984 females) with seasonal or perennial allergic rhinitis were treated with ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.15% two sprays per nostril once or twice daily. In the 12 month open-label, active-controlled clinical trial, 466 patients (156 males and 310 females) with perennial allergic rhinitis were treated with ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.15% two sprays per nostril twice daily. Of these 466 patients, 152 had participated in the 4-week placebo-controlled perennial allergic rhinitis clinical trials. The racial distribution for the 8 clinical trials was 80% white, 13% black, 2% Asian, and 5% other.

Adults and Adolescents 12 Years of Age and Older

In the 7 placebo controlled clinical trials of 2 to 4 week duration, 2343 patients with seasonal allergic rhinitis and 540 patients with perennial allergic rhinitis were treated with two sprays per nostril of either ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.15% or placebo once or twice daily. Overall, adverse reactions were more common in the ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.15% treatment groups (16-31%) than in the placebo groups (11-24%). Overall, less than 2% of patients discontinued due to adverse reactions and withdrawal due to adverse reactions was similar among the treatment groups.

Table 2 contains adverse reactions reported with frequencies greater than or equal to 2% and more frequently than placebo in patients treated with ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.15% in the seasonal and perennial allergic rhinitis controlled clinical trials.

Table 2: Adverse Reactions with ≥ 2% Incidence in Placebo-Controlled Trials of 2 to 4 Weeks' Duration with ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.15% in Adult and Adolescent Patients With Seasonal or Perennial Allergic Rhinitis

  2 sprays twice daily 2 sprays once daily
ASTEPRO Nasal Spray 0.15 %
(N=523)
Vehicle Placebo
(N=523)
ASTEPRO Nasal Spray 0.15 %
(N=1021)
Vehicle Placebo
(N=816)
Bitter Taste 31 (6%) 5 (1%) 38 (4%) 2 ( < 1%)
Nasal Discomfort 18 (3%) 12 (2%) 37 (4%) 7 (1%)
Epistaxis 5 (1%) 7 (1%) 21 (2%) 14 (2%)
Sneezing 9 (2%) 1 ( < 1%) 14 (1%) 0 (0%)

In the above trials, somnolence was reported in < 1% of patients treated with ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.15% (11 of 1544) or vehicle placebo (1 of 1339).

Long-Term (12 Month) Safety Trial

In the 12 month, open-label, active-controlled, long-term safety trial, 466 patients (12 years of age and older) with perennial allergic rhinitis were treated with ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.15% two sprays per nostril twice daily and 237 patients were treated with mometasone nasal spray two sprays per nostril once daily. The most frequently reported adverse reactions ( > 5%) with ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.15% were bitter taste, headache, sinusitis, and epistaxis. Focused nasal examinations were performed and no nasal ulcerations or septal perforations were observed. In each treatment group, approximately 3% of patients had mild epistaxis. No patients had reports of severe epistaxis. Fifty-four patients (12%) treated with ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.15% and 17 patients (7%) treated with mometasone nasal spray discontinued from the trial due to adverse events.

Postmarketing Experience

During the post approval use of ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.1% and 0.15%, the following adverse reactions have been identified. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions reported include: abdominal pain, nasal burning, nausea, sweet taste, and throat irritation.

Additionally, the following adverse reactions have been identified during the post approval use of the Astelin brand of azelastine hydrochloride 0.1% nasal spray (total daily dose 0.55 mg to 1.1 mg). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions reported include the following: anaphylactoid reaction, application site irritation, atrial fibrillation, blurred vision, chest pain, confusion, dizziness, dyspnea, facial edema, hypertension, involuntary muscle contractions, nervousness, palpitations, paresthesia, parosmia, paroxysmal sneezing, pruritus, rash, disturbance or loss of sense of smell and/or taste, tachycardia, tolerance, urinary retention, and xerophthalmia.

Read the Astepro (azelastine hydrochloride nasal spray) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Central Nervous System Depressants

Concurrent use of ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray with alcohol or other central nervous system depressants should be avoided because reductions in alertness and impairment of central nervous system performance may occur [see WARNINGS AND PRECAUTIONS].

Erythromycin and Ketoconazole

Interaction studies investigating the cardiac effects, as measured by the corrected QT interval (QTc), of concomitantly administered oral azelastine hydrochloride and erythromycin or ketoconazole were conducted. Oral erythromycin (500 mg three times daily for 7 days) had no effect on azelastine pharmacokinetics or QTc based on analyses of serial electrocardiograms. Ketoconazole (200 mg twice daily for 7 days) interfered with the measurement of azelastine plasma concentrations on the analytic HPLC; however, no effects on QTc were observed [see CLINICAL PHARMACOLOGY].

Cimetidine

Cimetidine (400 mg twice daily) increased the mean Cmax and AUC of orally administered azelastine hydrochloride (4 mg twice daily) by approximately 65% [see CLINICAL PHARMACOLOGY].

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

Side Effects
Interactions
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