Astepro

Side effects of Astepro nasal spray include:

• fever
• unusual taste (bitter or sweet)
• nose pain or discomfort
• nosebleeds
• headache
• fatigue
• sleepiness
• sneezing

Talk to your doctor about any side effect that is bothersome or that does not go away. 

This is not a complete list of Astepro side effects. Ask your doctor or pharmacist for more information.

Before receiving Astepro, tell your doctor:

• about all of your medical conditions
• if you are allergic to any ingredient in Astepro
• if you are pregnant or breastfeeding

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Use Astepro exactly as prescribed. Follow the directions on your prescription bottle carefully.

Seasonal nasal allergies:

• 2 to 5 years: Astepro (azelastine) 0.1%: 1 spray per nostril twice daily
• 6 to 11 years: Astepro 0.1% or Astepro 0.15%: 1 spray per nostril twice daily
• Adults and adolescents 12 years of age and older: Astepro 0.1% or Astepro 0.15%: 1 or 2 sprays per nostril twice daily OR Astepro 0.15%: 2 sprays per nostril once daily 

Year-round (perennial) nasal allergies:

• 6 months to 5 years: Astepro 0.1%: 1 spray per nostril twice daily
•  6 to 11 years: Astepro 0.1% or Astepro 0.15%: 1 spray per nostril twice daily
•  Adults and adolescents 12 years of age and older: Astepro 0.15%: 2 sprays per nostril twice daily 

You should not use this medicine if you are allergic to azelastine.

To make sure azelastine is safe for you, tell your doctor about all of your medical conditions.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether azelastine nasal passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

To use the nasal spray:

• Blow your nose gently. Keep your head upright and insert the tip of bottle into one nostril. Press your other nostril closed with your finger. Breathe in quickly and gently spray the medicine into your nose. Then use the spray in your other nostril.

• Do not blow your nose for at least a few minutes after using the nasal spray.

• If the spray gets in your eyes or mouth or on your skin, rinse with water.

• If the nasal spray has not been used for longer than 3 days, prime it by spraying up to 6 sprays into the air, away from your face, until a fine mist appears.

Avoid getting this medicine in your eyes or mouth.

Do not allow a young child to use azelastine nasal without help from an adult.

Call your doctor if your symptoms do not improve, or if they get worse.

Store at room temperature in an upright position, away from moisture and heat. Keep the dust cover on the spray nozzle when not in use. Do not allow this medicine to freeze.

Throw away this medicine after you have used 200 sprays, even if there is still medicine left in the bottle.

An overdose of azelastine nasal is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol with this medicine can cause side effects.

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

Stop using azelastine and call your doctor at once if you have:

• worsening allergy symptoms; or

• signs of an ear infection (fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child).

Common side effects may include:

• drowsiness, tired feeling;

• fever;

• unusual taste in your mouth;

• sneezing, nasal irritation, nosebleeds;

• headache;

• cold symptoms such as stuffy nose, sneezing, cough, sore throat;

• vomiting;

• ear infection; or

• skin rash.

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.

• If you have an allergy to azelastine or any other part of Astepro (azelastine (nasal)).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

None.

Use of Astepro 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 0.1%

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 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 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.

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 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 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.

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.

Astepro 0.15%

The safety data described below reflect exposure to Astepro 0.15% in 2114 patients (6 months of age and older) with seasonal or perennial allergic rhinitis from 10 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 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 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 0.15% one spray per nostril twice daily. In a 4-week clinical trial, 95 patients (59 males and 36 females) ages 6 months to 5 years of age with seasonal and/or perennial allergic rhinitis were treated with Astepro 0.15% one spray per nostril twice daily. The racial distribution for the 10 clinical trials was 79% white, 14% 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 0.15% or placebo once or twice daily. Overall, adverse reactions were more common in the Astepro 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 0.15% in the seasonal and perennial allergic rhinitis controlled clinical trials.

In the above trials, somnolence was reported in <1% of patients treated with Astepro 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 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 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 0.15% and 17 patients (7%) treated with mometasone nasal spray discontinued from the trial due to adverse events.

Children 6 months to 11 years of age

See summary under Astepro 0.1%

Postmarketing Experience

During the post approval use of Astepro 0.1% and Astepro 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, 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.

Astepro Nasal Spray may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Before using Astepro, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Astepro.

Drinking alcohol can increase certain side effects of Astepro. Call your doctor if your symptoms do not improve, or if they get worse while using Astepro. Stop using this medicine and call your doctor at once if you have fast or uneven heartbeats, tightness in your chest, or if you feel short of breath.