Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
AZELASTINE HYDROCHLORIDE (UNII: 0L591QR10I) (AZELASTINE - UNII:ZQI909440X)
RPK Pharmaceuticals, Inc.
NASAL
PRESCRIPTION DRUG
Azelastine hydrochloride nasal solution (nasal spray), 0.1% (137 mcg per 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. None. Risk Summary Limited data from postmarketing experience over decades of use with azelastine hydrochloride nasal solution 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
Product: 53002-2279 NDC: 53002-2279-1 200 SPRAY, METERED in a BOTTLE, SPRAY / 1 in a BOX
Abbreviated New Drug Application
AZELASTINE HYDROCHLORIDE - AZELASTINE HYDROCHLORIDE SPRAY, METERED RPK PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AZELASTINE HYDROCHLORIDE NASAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AZELASTINE HYDROCHLORIDE NASAL SOLUTION. AZELASTINE HYDROCHLORIDE NASAL SOLUTION (NASAL SPRAY) INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE Azelastine hydrochloride nasal solution (nasal spray) 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 hydrochloride nasal solution before initial use and when it has not been used for 3 or more days (2.3) DOSAGE FORMS AND STRENGTHS Azelastine hydrochloride nasal solution (nasal spray): 137 mcg of azelastine hydrochloride 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 hydrochloride nasal solution. (5.1) Alcohol and other central nervous system (CNS) depressants: Avoid concurrent use with azelastine hydrochloride nasal solution 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 Belgenin tamamını okuyun