Azelastine
Azelastine Prescribing Information
Azelastine HCl Nasal Spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.
- For intranasal use only ()
2.3 Important Administration InstructionsAdminister Azelastine HCl Nasal Spray by the intranasal route only
Priming: Prime Azelastine HCl Nasal Spray before initial use by releasing 4 sprays or until a fine mist appears. When Azelastine HCl Nasal Spray has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears. Avoid spraying Azelastine HCl Nasal Spray into the eyes. - Seasonal allergic rhinitis:
o Pediatric patients 5 to 11 years of age: 1 spray per nostril twice daily (
The recommended dosage of Azelastine HCl Nasal Spray in adults and adolescent patients 12 years and older with seasonal allergic rhinitis is one or two sprays per nostril twice daily. The recommended dosage of Azelastine HCl Nasal Spray in pediatric patients 5 years to 11 years of age is one spray per nostril twice daily.
o Adults and adolescents 12 years of age and older: 1 or 2 sprays per nostril twice daily (
The recommended dosage of Azelastine HCl Nasal Spray in adults and adolescent patients 12 years and older with seasonal allergic rhinitis is one or two sprays per nostril twice daily. The recommended dosage of Azelastine HCl Nasal Spray in pediatric patients 5 years to 11 years of age is one spray per nostril twice daily.
- Vasomotor rhinitis: 2 sprays per nostril twice daily in adults and adolescents 12 years of age and older ()
2.2 Vasomotor RhinitisThe recommended dosage of Azelastine HCl Nasal Spray in adults and adolescent patients 12 years and older with vasomotor rhinitis is two sprays per nostril twice daily.
- Prime Azelastine HCl Nasal Spray before initial use and when it has not been used for 3 or more days ()
2.3 Important Administration InstructionsAdminister Azelastine HCl Nasal Spray by the intranasal route only
Priming: Prime Azelastine HCl Nasal Spray before initial use by releasing 4 sprays or until a fine mist appears. When Azelastine HCl Nasal Spray has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears. Avoid spraying Azelastine HCl Nasal Spray into the eyes.
Azelastine HCl Nasal Spray is a nasal spray . Each spray of Azelastine HCl Nasal Spray delivers a volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride, USP.
Risk Summary Limited data from postmarketing experience over decades of use with Azelastine HCl Nasal Spray in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose. Oral administration of azelastine hydrochloride 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 the maximum recommended human daily intranasal dose (MRHDID) of 1.096 mg. However, the relevance of these findings in animals to pregnant women was considered questionable based upon the high animal to human dose multiple.
The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
In an embryo-fetal development study in mice dosed during the period of organogenesis, azelastine hydrochloride caused embryo-fetal death, structural abnormalities (cleft palate; short or absent tail; fused, absent or branched ribs), delayed ossification, and decreased fetal weight at approximately 300 times the maximum recommended human daily intranasal dose (MRHDID) in adults (on a mg/m2 basis at a maternal oral dose of 68.6 mg/kg/day), which also caused maternal toxicity as evidenced by decreased maternal body weight. Neither fetal nor maternal effects occurred in mice at approximately 15 times the MRHDID in adults (on a mg/m2 basis at a maternal oral dose of 3 mg/kg/day).
In an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 7 to 17, azelastine hydrochloride caused structural abnormalities (oligo-and brachydactylia), delayed ossification, and skeletal variations, in the absence of maternal toxicity, at approximately 270 times the MRHDID in adults (on a mg/m2 basis at a maternal oral dose of 30 mg/kg/day). Azelastine hydrochloride caused embryo-fetal death and decreased fetal weight and severe maternal toxicity at approximately 610 times the MRHDID (on a mg/m2 basis at a maternal oral dose of 68.6 mg/kg/day). Neither fetal nor maternal effects occurred at approximately 20 times the MRHDID (on a mg/m2 basis at a maternal oral dose of 2 mg/kg/day).
In an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation days 6 to 18, azelastine hydrochloride caused abortion, delayed ossification and decreased fetal weight and severe maternal toxicity at approximately 530 times the MRHDID in adults (on a mg/m2 basis at a maternal oral dose of 30 mg/kg/day). Neither fetal nor maternal effects occurred at approximately 5 times the MRHDID (on a mg/m2 basis at a maternal oral dose of 0.3 mg/kg/day).
In a prenatal and postnatal development study in pregnant rats dosed from late in the gestation period and through the lactation period from gestation day 17 through lactation day 21, azelastine hydrochloride produced no adverse developmental effects on pups at maternal doses up to approximately 270 times the MRHDID (on mg/m2 basis at a maternal dose of 30 mg/kg/day).
None.
- Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking Azelastine HCl Nasal Spray. ()
5.1 Somnolence in Activities Requiring Mental AlertnessIn clinical trials, the occurrence of somnolence has been reported in some patients taking Azelastine HCl Nasal Spray [
see Adverse Reactions]. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as operating machinery or driving a motor vehicle after administration of Azelastine HCl Nasal Spray. Concurrent use of Azelastine HCl Nasal Spray with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur [see Drug Interactions]. - Alcohol and other central nervous system (CNS) depressants: Avoid concurrent use with Azelastine HCl Nasal Spray because further decreased alertness and impairment of CNS performance may occur. ()
5.1 Somnolence in Activities Requiring Mental AlertnessIn clinical trials, the occurrence of somnolence has been reported in some patients taking Azelastine HCl Nasal Spray [
see Adverse Reactions]. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as operating machinery or driving a motor vehicle after administration of Azelastine HCl Nasal Spray. Concurrent use of Azelastine HCl Nasal Spray with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur [see Drug Interactions].