Classes
DEA Class; Rx, OTC
Common Brand Names; Astelin Nasal Spray, Astepro, Astepro Allergy, Children’s Astepro Allergy
- Allergy, Intranasal;
- Antihistamines, Intranasal
azelastine ophthalmic (Rx)
- Classes: Antihistamines, Ophthalmic
Description
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
Indications
Indicated for
- Seasonal Allergic Rhinitis
- Perennial Allergic Rhinitis
- Vasomotor Rhinitis
- Allergic Conjunctivitis
Contraindications
Documented hypersensitivity
Adverse Effects
- 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%)
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
NOTE: Do not exceed recommended dosage limits for the specific product prescribed; the following are general guidelines:
4 nasal sprays/day per nostril; 2 ophthalmic drops/day per affected eye.
4 nasal sprays/day per nostril; 2 ophthalmic drops/day per affected eye.
4 nasal sprays/day per nostril; 2 ophthalmic drops/day per affected eye.
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.
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.
Safety and efficacy have not been established.
How supplied
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])
