Zelanex

Allergic rhinitis, vasomotor rhinitis.

Prime with 4 sprays before initial use; if idle for 3 days, reprime with 2 sprays

Allergic Rhinitis: Adults: 2 sprays per nostril twice daily.

Allergic Rhinitis: Children 5 years to 11 years of age: 1 spray into each nostril twice daily. Children >12 years: 2 sprays per nostril twice daily.

Known hypersensitivity to Azelastine Hydrochloride or any of its components.

Azelastine blocks histamine H1-receptor activity and inhibits release of inflammatory mediators from mast cells.

In clinical trials, the occurrence of somnolence has been reported in some patients taking Azelastine Hydrochloride Nasal Spray; due caution should therefore be exercised when driving a car or operating potentially dangerous machinery. Concurrent use of Azelastine Hydrochloride Nasal Spray with Alcohol or other CNS depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur. Lactation: Not known if excreted in breast milk; use caution

>10% Bitter taste (8-19.7%),Headache (8-14.8%),Somnolence (1-11.5%),Cold symptoms/rhinitis (2-17%),Cough (11%) 1-10% 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%) <1% Amenorrhea,Breast pain,Constipation,Contact dermatitis,Eczema,Flushing,Glossitis,Hyperkinesia,Hypertension,Tachycardia,Vertigo,Vomiting

Pregnancy 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 Animal data In animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose; oral administration to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 270 times and higher than maximum recommended human daily intranasal dose of 1.096 mg; relevance of these findings in animals to pregnant women considered questionable based upon high animal to human dose multiple Lactation There are no data on presence in human milk, effects on breastfed infant, or on milk production; breastfed infants should be monitored for signs of milk rejection during use by lactating women; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition