Astepro

What Is Asterpro?

Astepro (azelastine hydrochloride) Nasal Spray is an antihistamine used for the relief of the symptoms of seasonal and perennial allergic rhinitis in patients 12 years of age and older.

What Are Side Effects of Asterpro?

Side effects of Astepro include:

• a bitter taste in the mouth,
• headache,
• drowsiness,
• dizziness,
• dry mouth,
• sore throat,
• sores or burning in your nose,
• weight gain,
• nausea,
• nosebleed,
• cough,
• sneezing,
• runny nose,
• sore throat, or
• eye redness.

Dosage for Asterpro

Astepro is available in strengths of 137 and 205.5 micrograms per spray. The recommended dose of Astepro Nasal Spray is 1 or 2 sprays per nostril twice daily for seasonal allergic rhinitis. Astepro Nasal Spray may also be administered as 2 sprays per nostril once daily.

What Drugs, Substances, or Supplements Interact with Asterpro?

Astepro may interact with other medicines that make you sleepy (such as cold or allergy medicines, narcotic pain medicines, sleeping pills, muscle relaxers, and medicines for seizures, depression, or anxiety), or cimetidine. Tell your doctor all medications and supplements you use.

Asterpro During Pregnancy or Breastfeeding

Astepro Nasal Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because many drugs are excreted in human milk, caution should be excercised when Astepro Nasal Spray is administered to a nursing woman. Consult your doctor before breastfeeding.

Additional Information

Our Astepro (azelastine hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Astepro Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects may include:

• bitter taste in your mouth;
• drowsiness, tiredness;
• headache, dizziness;
• sneezing, nasal irritation, nosebleeds;
• nausea, dry mouth; or
• weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Astepro (Azelastine Hydrochloride Nasal Spray)

 

Astepro Professional Information

SIDE EFFECTS

The following clinically significant adverse reaction is described elsewhere in the labeling:

• 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.

The safety data described below reflect exposure to ASTEPRO 0.1% in 975 patients 6 months of age and older from 4 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 0.1% one or two sprays per nostril daily. In the 12month, 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 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 0.1% one spray per nostril twice daily. In a 4-week clinical trial, 96 patients (51 males and 45 females) ages 6 months to 5 years of age with seasonal and/or perennial allergic rhinitis were treated with ASTEPRO 0.1% one spray per nostril twice daily. The racial and ethnic distribution for the 4 clinical trials was 80% white, 11% black, 8% 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 0.1%, Astelin Nasal Spray or placebo twice daily; or 2 sprays per nostril of ASTEPRO 0.1%, Astelin Nasal Spray, or placebo twice daily. Overall, adverse reactions were more common in the ASTEPRO 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 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 0.1% in Adult and Adolescent Patients with Seasonal Allergic Rhinitis

	1 spray twice daily			2 sprays twice daily
	ASTEPRO 0.1% (N=139)	Astelin Nasal Spray (N=137)	Vehicle Placebo (N=137)	ASTEPRO 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 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 12month 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 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 0.1%, ASTEPRO 0.15% or placebo, one spray per nostril twice daily. Overall, adverse events were similar in the ASTEPRO 0.15% group (24%), ASTEPRO 0.1% group (26%) and the placebo group (24%). Overall, less than 1% of the combined ASTEPRO 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 0.1% or ASTEPRO 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 0.1% or ASTEPRO 0.15% in Children 6 to 11 Years of Age with Perennial Allergic Rhinitis

	1 spray twice daily
	ASTEPRO 0.1% (N=166)	ASTEPRO 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%)

Children 6 Months To 5 Years

In a 4-week clinical trial, 191 patients ages 6 months to 5 years with either seasonal and/or perennial allergic rhinitis were treated with either ASTEPRO 0.1% or ASTEPRO 0.15% one spray per nostril twice daily. The most frequently (≥2%) reported adverse reactions were pyrexia, cough, epistaxis, sneezing, dysgeusia, rhinalgia, upper respiratory infection, vomiting, otitis media, contact dermatitis, and oropharyngeal pain. Overall, adverse events were slightly higher in the ASTEPRO 0.15% group (28%) compared to ASTEPRO 0.1% group (21%). Focused nasal examinations were performed and showed no incidence of nasal mucosal ulceration at any time point during the study. No patients had reports of nasal septal perforation. Overall, less than 3% of the combined ASTEPRO groups discontinued due to adverse events.

Postmarketing Experience

During the post approval use of ASTEPRO, 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, atrial fibrillation, blurred vision, chest pain, confusion, disturbance or loss of sense of smell and/or taste, dizziness, dyspnea, facial swelling, hypertension, involuntary muscle contractions, nasal burning, nausea, nervousness, palpitations, paresthesia, parosmia, pruritus, rash, sneezing, insomnia, sweet taste, tachycardia, 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, facial edema, paroxysmal sneezing, tolerance, urinary retention, and xerophthalmia.

DRUG INTERACTIONS

Central Nervous System Depressants

Concurrent use of ASTEPRO 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].

Read the entire FDA prescribing information for Astepro (Azelastine Hydrochloride Nasal Spray)