País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
AZELASTINE HYDROCHLORIDE (UNII: 0L591QR10I) (AZELASTINE - UNII:ZQI909440X)
A-S Medication Solutions
NASAL
PRESCRIPTION DRUG
Azelastine hydrochloride (HCl) nasal spray, 0.1% 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. None. Risk Summary Limited data from post-marketing experience over decades of use with azelastine HCl nasal spray, 0.1% 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 HCl 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 (MR
Product: 50090-3833 NDC: 50090-3833-0 30 mL in a BOTTLE, SPRAY / 1 in a CARTON
Abbreviated New Drug Application
AZELASTINE HYDROCHLORIDE- AZELASTINE SPRAY, METERED A-S MEDICATION SOLUTIONS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AZELASTINE HYDROCHLORIDE NASAL SPRAY SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AZELASTINE HYDROCHLORIDE NASAL SPRAY. AZELASTINE HYDROCHLORIDE NASAL SPRAY, FOR INTRANASAL USE INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE Azelastine HCl nasal spray, 0.1% is an H -receptor antagonist 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. (1) DOSAGE AND ADMINISTRATION For intranasal use only. (2.3) Seasonal allergic rhinitis: Pediatric patients 5 to 11 years of age: 1 spray per nostril twice daily. (2.1) Adults and adolescents 12 years of age and older: 1 or 2 sprays per nostril twice daily. (2.1) Vasomotor rhinitis: 2 sprays per nostril twice daily in adults and adolescents 12 years of age and older. (2.2) Prime azelastine HCl nasal spray, 0.1% before initial use and when it has not been used for 3 or more days. (2.3) DOSAGE FORMS AND STRENGTHS Azelastine HCl nasal spray, 0.1%: 137 mcg of azelastine HCl, USP in each 0.137 mL spray. (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking azelastine HCl nasal spray, 0.1%. (5.1) Alcohol and other central nervous system (CNS) depressants: Avoid concurrent use with azelastine HCl nasal spray, 0.1% because further decreased alertness and impairment of CNS performance may occur. (5.1) ADVERSE REACTIONS The most common adverse reactions (≥2% incidence) are: bitter taste, headache, somnolence, dysesthesia, rhinitis, nasal burning, pharyngitis, epistaxis, sinusitis, paroxysmal sneezing, nausea, dry mouth, fatigue, dizziness, and weight increase. Leer el documento completo