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Astepro (Azelastine Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Use of ASTEPRO Nasal Spray has been associated with somnolence [see Warnings and Precautions (5.1)].

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.

ASTEPRO Nasal Spray 0.1%

The safety data described below reflect exposure to ASTEPRO Nasal Spray 0.1% in 879 patients 6 years of age and older from 3 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 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 Nasal Spray 0.1% two sprays per nostril twice daily. In a 4-week, double-blind, placebo-controlled clinical trial, 166 patients (101 males and 65 females) ages 6 to 11 years of age with perennial allergic rhinitis, with or without concomitant seasonal allergic rhinitis, were treated with ASTEPRO Nasal Spray 0.1% one spray per nostril twice daily. The racial and ethnic distribution for the 3 clinical trials was 81% white, 9% black, 5% Hispanic, 3% Asian, and 2% 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 Nasal Spray 0.1%, Astelin Nasal Spray or placebo twice daily; or 2 sprays per nostril of ASTEPRO Nasal Spray 0.1%, Astelin Nasal Spray, or placebo twice daily. Overall, adverse reactions were more common in the ASTEPRO 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 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 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 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 Nasal Spray 0.1% and 17 patients (4%) treated with Astelin Nasal Spray discontinued from the trial due to adverse events.

Children 6 to 11 years of age

In a 4 week clinical trial, 489 patients ages 6 to 11 years with perennial allergic rhinitis, with or without concomitant seasonal allergic rhinitis, were treated with either ASTEPRO Nasal Spray 0.1%, ASTEPRO Nasal Spray 0.15% or placebo one spray per nostril twice daily. Overall, adverse events were similar in the ASTEPRO Nasal Spray 0.15% group (24%), ASTEPRO Nasal Spray 0.1% group (26%) and the placebo group (24%). Overall, less than 1% of the combined ASTEPRO Nasal Spray groups discontinued due to adverse events.
Table 2 contains adverse reactions reported with frequencies greater than or equal to 2% and more frequently than placebo in children 6 to 11 years of age treated with ASTEPRO Nasal Spray 0.1% or 0.15% in the controlled trial described above.

Table 2. Adverse Reactions Reported in ≥2% Incidence in a Placebo-Controlled Trial of 4 Weeks’ Duration with ASTEPRO Nasal Spray 0.1% or ASTEPRO Nasal Spray 0.15% in Children 6 to 11 Years of Age with Perennial Allergic Rhinitis
  1 spray twice daily
ASTEPRO
Nasal Spray 0.1%
(N=166)
ASTEPRO
Nasal Spray
0.15%
(N=161)
Vehicle Placebo
(N=162)
Epistaxis 8 (5%) 7 (4%) 5 (3%)
Nasal Discomfort 1 (<1%) 7 (4%) 0 (0%)
Dysgeusia 4 (2%) 6 (4%) 1 (<1%)
Upper respiratory
infection
4 (2%) 4 (3%) 3 (2%)
Sneezing 3 (2%) 4 (3%) 2 (1%)

ASTEPRO Nasal Spray 0.15%

The safety data described below reflect exposure to ASTEPRO Nasal Spray 0.15% in 2019 patients (6 years of age and older) with seasonal or perennial allergic rhinitis from 9 clinical trials of 2 weeks to 12 months duration. In 8 double-blind, placebo-controlled clinical trials of 2 to 4 weeks duration, 1703 patients (646 males and 1059 females) with seasonal or perennial allergic rhinitis were treated with ASTEPRO Nasal Spray 0.15% one or 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 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. In a 4-week, double-blind, placebo-controlled clinical trial, 161 patients (87 males and 74 females) ages 6 to 11 years of age with perennial allergic rhinitis, with or without concomitant seasonal allergic rhinitis, were treated with ASTEPRO Nasal Spray 0.15% one spray per nostril twice daily. The racial distribution for the 9 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 Nasal Spray 0.15% or placebo once or twice daily. Overall, adverse reactions were more common in the ASTEPRO 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 3 contains adverse reactions reported with frequencies greater than or equal to 2% and more frequently than placebo in patients treated with ASTEPRO Nasal Spray 0.15% in the seasonal and perennial allergic rhinitis controlled clinical trials.

Table 3. Adverse Reactions with ≥2% Incidence in Placebo-Controlled Trials of 2 to 4 Weeks’ Duration with ASTEPRO 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 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 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 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 Nasal Spray 0.15% and 17 patients (7%) treated with mometasone nasal spray discontinued from the trial due to adverse events.

Children 6 to 11 years of age

See summary under ASTEPRO Nasal Spray 0.1%

Postmarketing Experience

During the post approval use of ASTEPRO 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.



REPORTS OF SUSPECTED ASTEPRO SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Astepro. The information is not vetted and should not be considered as verified clinical evidence.

Possible Astepro side effects / adverse reactions in 77 year old female

Reported by a consumer/non-health professional from United States on 2011-10-28

Patient: 77 year old female

Reactions: Blood Pressure Increased, Malaise, Dyspepsia, Heart Rate Increased, Chest Pain

Suspect drug(s):
Brovana
    Indication: Dyspnoea
    End date: 2011-04-25

Nasonex

Astepro

Advair Diskus 100/50
    Indication: Product Used FOR Unknown Indication

Spiriva

Albuterol
    Indication: Product Used FOR Unknown Indication

Allegra
    Dosage: 180mg per day
    Administration route: Oral
    Indication: Multiple Allergies
    Start date: 2011-04-01

Unspecified Treatment
    Indication: Dyspnoea
    End date: 2011-04-25



Possible Astepro side effects / adverse reactions in 65 year old female

Reported by a individual with unspecified qualification from United States on 2012-02-23

Patient: 65 year old female weighing 47.6 kg (104.8 pounds)

Reactions: Concussion, Fatigue, Syncope, Head Injury, Tachycardia, Dizziness, Somnolence, Loss of Consciousness

Adverse event resulted in: hospitalization

Suspect drug(s):
Astepro
    Dosage: 1644 mcg (822 mcg, 2 in 1 d), in, (822 mg, once daily iin pm), in
    Indication: Rhinitis Allergic
    Start date: 2011-12-01
    End date: 2011-12-01

Astepro
    Dosage: 1644 mcg (822 mcg, 2 in 1 d), in, (822 mg, once daily iin pm), in
    Indication: Rhinitis Allergic
    Start date: 2011-12-01
    End date: 2011-12-01

Other drugs received by patient: Allegra; Prilosec; Symbicort; Tazorac; Singulair; Nasonex (Mometasone); Evamist (Estradiol); Vagifem



Possible Astepro side effects / adverse reactions in 52 year old female

Reported by a consumer/non-health professional from United States on 2012-05-25

Patient: 52 year old female

Reactions: Tongue Ulceration, Glossitis, Swollen Tongue

Suspect drug(s):
Astepro
    Dosage: 2spr twice per day
    Indication: Sinusitis
    Start date: 2011-07-14
    End date: 2011-07-25

Veramyst
    Dosage: 2spr per day
    Indication: Sinusitis
    Start date: 2011-07-14
    End date: 2011-07-25

Other drugs received by patient: Singulair; Proair HFA



See index of all Astepro side effect reports >>

Drug label data at the top of this Page last updated: 2014-04-15

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