Azelastine nasal spray for seasonal allergic and vasomotor rhinitis

Azelastine hydrochloride nasal spray is an antihistamine nasal spray approved for relieving symptoms of seasonal allergic rhinitis in adults and children aged 5 years and older, and for treating vasomotor rhinitis symptoms in adults and adolescents 12 years and older.

This nasal spray is used to treat nasal symptoms such as sneezing, runny or itchy nose caused by seasonal allergic rhinitis in adults and children 5 years and older. It is also approved to treat symptoms of vasomotor rhinitis, a non-allergic nasal condition, in adults and adolescents 12 years and older.

Azelastine hydrochloride

Azelastine hydrochloride works by blocking H1 histamine receptors in the nasal passages. Histamine is a chemical involved in allergic and inflammatory responses; by blocking its effects, azelastine reduces nasal symptoms like itching, sneezing, and congestion associated with allergic and vasomotor rhinitis.

Seasonal allergic rhinitis

• Adults and adolescents (12 years and older): 1 or 2 sprays per nostril twice daily.
• Children (5 to 11 years): 1 spray per nostril twice daily.

Vasomotor rhinitis

• Adults and adolescents (12 years and older): 2 sprays per nostril twice daily.

Administration instructions

• For intranasal use only.
• Prime the spray before first use by releasing 4 sprays or until a fine mist appears.
• If not used for 3 or more days, reprime with 2 sprays until a fine mist appears.
• Avoid spraying into the eyes.

None reported.

Somnolence and mental alertness

Some patients experience drowsiness when using azelastine nasal spray. Avoid hazardous activities requiring full alertness, such as driving or operating machinery, while using this product.

Use with CNS depressants

Concurrent use with alcohol or other central nervous system depressants can increase drowsiness and impair mental and motor skills. Such combinations should be avoided.

Common side effects (occurring in 2% or more of patients)

• Bitter taste (up to about 20%)
• Headache (around 8–15%)
• Somnolence (3–11.5%)
• Nasal burning
• Pharyngitis (sore throat)
• Paroxysmal sneezing
• Dry mouth
• Nausea
• Rhinitis
• Fatigue
• Dizziness
• Epistaxis (nosebleed)
• Weight increase (reported in some adult patients)

Less common side effects (<2%)

Includes cardiovascular (flushing, hypertension, tachycardia), dermatologic (contact dermatitis, eczema), digestive (constipation, gastroenteritis), musculoskeletal, neurological, psychological, respiratory, special senses, urogenital, and general symptoms such as allergic reactions, back pain, and viral infections.

Postmarketing reports

Rarely reported effects include anaphylaxis, nasal sores, facial edema, muscle contractions, loss or disturbance of smell and taste, tolerance, urinary retention, and vision abnormalities.

Co-administration with alcohol or other central nervous system depressants should be avoided as it may cause increased drowsiness and decreased mental alertness.

Pregnancy

Limited human data have not identified risks of miscarriage, birth defects, or other adverse outcomes associated with azelastine nasal spray. Animal studies at high oral doses showed developmental toxicity, but these doses were much higher than human intranasal doses. The significance of these findings to humans is uncertain.

Lactation

There are no data on azelastine presence in human milk. Breastfed infants should be monitored for signs of milk rejection possibly related to the bitter taste of the drug. Consider the benefits of breastfeeding along with the clinical need for treatment.