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Azelastine

    Brands

    DEA Class; Rx, OTC

    Common Brand Names; Astelin Nasal Spray, Astepro, Astepro Allergy, Children’s Astepro Allergy

    • Allergy, Intranasal; 
    • Antihistamines, Intranasal

    azelastine ophthalmic (Rx)

    Brand and Other Names:Optivar
    • Classes: Antihistamines, Ophthalmic
     

    Second-generation nasal and ophthalmic antihistamine (H1-blocker)
    Used nasally for allergic or vasomotor rhinitis and as an ophthalmic solution for itching related to allergic conjunctivitis
    Drowsiness rates with use are similar to placebo

    Indicated for

    • Seasonal Allergic Rhinitis
    • Perennial Allergic Rhinitis
    • Vasomotor Rhinitis
    • Allergic Conjunctivitis

    Documented hypersensitivity

    • Bitter taste (8-19.7%)
    • Headache (8-14.8%)
    • Somnolence (1-11.5%)
    • Cold symptoms/rhinitis (2-17%)
    • Cough (11%)
    • Nasal burning (4.1%)
    • Sneezing (3.1%)
    • Dry mouth (2.8%)
    • Nausea (2.8%)
    • Conjunctivitis (2-5%)
    • Asthma (5%)
    • Fatigue (2.3%)
    • Rhinitis (2.3%)
    • Pharyngitis (4%)
    • Dizziness (2%)
    • Weight increase (2%)
    • Myalgia (<2%)

    May cause CNS depression/drowsiness; use caution when performing tasks requiring mental alertness eg, operating heavy machinery

    Avoid administering concurrent CNS depressants that may add to somnolence

    Caution in premature newborns and neonates

    Limited data from postmarketing experience over decades of use in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes

    There are no data on presence in human milk, effects on breastfed infant, or on milk production

    NOTE: Do not exceed recommended dosage limits for the specific product prescribed; the following are general guidelines:

    Adults

    4 nasal sprays/day per nostril; 2 ophthalmic drops/day per affected eye.

    Geriatric

    4 nasal sprays/day per nostril; 2 ophthalmic drops/day per affected eye.

    Adolescents

    4 nasal sprays/day per nostril; 2 ophthalmic drops/day per affected eye.

    Children

    12 years: 4 sprays/day per nostril (205.5 mcg/spray); 2 ophthalmic drops/day per affected eye.
    6 to 11 years: 2 sprays/day per nostril (205.5 mcg/spray); 2 ophthalmic drops/day per affected eye.
    3 to 5 years: 2 sprays/day per nostril (137 mcg/spray); 2 ophthalmic drops/day per affected eye.
    1 to 3 years: 2 sprays/day per nostril (137 mcg/spray); the safety and efficacy of the ophthalmic drops have not been established.

    Infants

    6 to 12 months: 2 sprays/day per nostril (137 mcg/spray); the safety and efficacy of the ophthalmic drops have not been established.
    Less than 6 months: Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Azelastine hydrochloride

    nasal spray

    • 0.1% (137mcg/spray) (Astelin Nasal Spray [Rx]; Astepro [Rx], generic [Rx])
    • 0.15% (205.5mcg/spray) (Astepro Allergy [OTC]; generic [Rx])