Astelin

What Is Astelin?

Astelin (azelastine hydrochloride) Nasal Spray is an antihistamine that prevents sneezing, itching, runny nose, and other nasal symptoms of allergies. Astelin Nasal Spray is available in generic form.

What Are Side Effects of Astelin?

Common side effects of Astelin Nasal Spray include:

• bitter taste in the mouth,
• drowsiness,
• dizziness,
• sores or a burning feeling inside the nose,
• nosebleeds,
• dry mouth,
• sore throat,
• sneezing fits,
• cough,
• runny nose,
• nausea,
• weight gain,
• muscle aches,
• headache, and
• red eyes.

Other side effects of Astelin Nasal Spray include:

• strange feelings on the skin (e.g., pins and needles, crawling sensation).

Many people using Astelin Nasal Spray do not have serious side effects.

Dosage for Astelin

The recommended dose of Astelin Nasal Spray in adults and children 12 years and older with seasonal allergic rhinitis is one or two sprays per nostril twice daily. The recommended dose of Astelin in children 5 years to 11 years of age is one spray per nostril twice daily. For vasomotor rhinitis, the dose is two sprays per nostril twice daily.

What Drugs, Substances, or Supplements Interact with Astelin?

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

Astelin During Pregnancy and Breastfeeding

Astelin should be used only when prescribed during pregnancy. It is not known whether this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

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

 

Astelin 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.

Call your doctor at once if you have signs of an ear infection:

• ear pain or full feeling;
• drainage from the ear;
• trouble hearing; or
• fever.

Common side effects may include:

• drowsiness, tiredness;
• a bitter taste in your mouth;
• mouth or throat pain;
• nasal pain or discomfort, nosebleeds;
• cold symptoms such as stuffy nose, sneezing, cough, sore throat;
• fever, headache;
• vomiting; or
• skin itching around your nose.

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 Astelin (Azelastine Hydrochloride)

 

Astelin Professional Information

SIDE EFFECTS

Use of Astelin 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.

Seasonal Allergic Rhinitis

Astelin Nasal Spray Two Sprays Per Nostril Twice Daily

Adverse experience information for Astelin Nasal Spray 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 Astelin Nasal Spray 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 Astelin Nasal Spray and vehicle placebo was 2.2% and 2.8%, respectively.

Table 1 contains adverse reactions that were reported with frequencies ≥ 2% in the Astelin Nasal Spray 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 (%)]

	Astelin Nasal Spray 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%)

Astelin Nasal Spray One Spray Per Nostril Twice Daily

Adverse experience information for Astelin Nasal Spray at a dose of one spray per nostril twice daily is derived from two placebo-controlled 2-week clinical studies which included 276 patients 12 years of age and older with seasonal allergic rhinitis. The incidence of discontinuation due to adverse reactions in patients receiving Astelin Nasal Spray and vehicle placebo was 0.0% and 0.8%, respectively. Bitter taste was reported in 8.3% of patients compared to none in the placebo group. Somnolence was reported in 0.4% of patients compared to none in the placebo group.

A total of 176 patients 5 to 11 years of age were exposed to Astelin Nasal Spray at a dose of 1 spray each nostril twice daily in 3 placebo-controlled studies. In these studies, adverse reactions that occurred more frequently in patients treated with Astelin Nasal Spray than with placebo, and that were not represented in the adult adverse reactions table above include rhinitis/cold symptoms (17.0% vs. 9.5%), cough (11.4% vs. 8.3%), conjunctivitis (5.1% vs. 1.8%), and asthma (4.5% vs. 4.1%).

Adverse Reactions < 2% in Astelin Nasal Spray One or Two Sprays Per Nostril Twice Daily

The following reactions were observed infrequently ( < 2% and exceeding placebo incidence) in patients who received Astelin Nasal Spray dosed at 1 or 2 sprays per nostril twice daily in U.S. clinical trials.

Cardiovascular: flushing, hypertension, tachycardia.

Dermatological: contact dermatitis, eczema, hair and follicle infection, furunculosis, skin laceration.

Digestive: constipation, gastroenteritis, glossitis, ulcerative stomatitis, vomiting, increased SGPT, aphthous stomatitis, diarrhea, toothache.

Metabolic and Nutritional: increased appetite.

Musculoskeletal: myalgia, temporomandibular dislocation, rheumatoid arthritis.

Neurological: hyperkinesia, hypoesthesia, vertigo.

Psychological: anxiety, depersonalization, depression, nervousness, sleep disorder, thinking abnormal. Respiratory: bronchospasm, coughing, throat burning, laryngitis, bronchitis, dry throat, nocturnal dyspnea, nasopharyngitis, nasal congestion, pharyngolaryngeal pain, sinusitis, nasal dryness, paranasal sinus hypersecretion, post nasal drip.

Special Senses: conjunctivitis, eye abnormality, eye pain, watery eyes, taste loss.

Urogenital: albuminuria, amenorrhea, breast pain, hematuria, increased urinary frequency.

Whole Body: allergic reaction, back pain, herpes simplex, viral infection, malaise, pain in extremities, abdominal pain, pyrexia.

Vasomotor Rhinitis

Adverse experience information for Astelin Nasal Spray is derived from two placebo-controlled clinical studies which included 216 patients 12 years and older with vasomotor rhinitis who received Astelin Nasal Spray at a dose of 2 sprays per nostril twice daily for up to 28 days. The incidence of discontinuation due to adverse reactions in patients receiving Astelin Nasal Spray and vehicle placebo was 2.8% and 2.9%, respectively.

The following adverse reactions were reported with frequencies ≥ 2% in the Astelin Nasal Spray treatment group and more frequently than placebo.

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

	Astelin Nasal Spray N = 216	Vehicle Placebo N = 210
Bitter Taste	42 (19.4%)	5 (2.4%)
Headache	17 (7.9%)	16 (7.6%)
Dysesthesia	17 (7.9%)	7 (3.3%)
Rhinitis	12 (5.6%)	5 (2.4%)
Epistaxis	7 (3.2%)	5 (2.4%)
Sinusitis	7 (3.2%)	4 (1.9%)
Somnolence	7 (3.2%)	2 (1.0%)

Reactions observed infrequently ( < 2% and exceeding placebo incidence) in patients who received Astelin Nasal Spray (2 sprays/nostril twice daily) in U.S. clinical trials in vasomotor rhinitis were similar to those observed in U.S. clinical trials in seasonal allergic rhinitis.

In controlled trials involving nasal and oral azelastine hydrochloride formulations, there were infrequent occurrences of hepatic transaminase elevations.

Postmarketing Experience

During the post approval use of Astelin Nasal Spray, 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: anaphylaxis, application site irritation, atrial fibrillation, chest pain, confusion, dyspnea, facial edema, involuntary muscle contractions, nasal sores, palpitations, paresthesia, parosmia, pruritus, rash, disturbance or loss of sense of smell and/or taste, tolerance, urinary retention, vision abnormal and xerophthalmia.

Read the entire FDA prescribing information for Astelin (Azelastine Hydrochloride)