Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
AZELASTINE HYDROCHLORIDE (UNII: 0L591QR10I) (AZELASTINE - UNII:ZQI909440X)
NuCare Pharmaceuticals,Inc.
NASAL
PRESCRIPTION DRUG
Azelastine hydrochloride 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. None. Risk Summary Limited data from postmarketing experience over decades of use with azelastine hydrochloride 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 (MRHD
Azelastine hydrochloride nasal solution 0.1% (nasal spray), 137 mcg/spray, (NDC 68071-2497-1) is supplied as a package containing 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. A leaflet of patient instructions is also provided. The spray pump unit consists of a nasal spray pump fitted with a safety clip and a plastic dust cover. The Azelastine hydrochloride nasal solution 0.1% (nasal spray), 137 mcg/spray, bottle contains 30 mg (1 mg/mL) of azelastine hydrochloride. Storage Store upright at 20ºC to 25ºC (68ºF to 77ºF) [See USP Controlled Room Temperature]. Protect from freezing. Keep bottle tightly closed and away from children.
Abbreviated New Drug Application
AZELASTINE HYDROCHLORIDE- AZELASTINE HYDROCHLORIDE SPRAY, METERED NUCARE PHARMACEUTICALS,INC. ---------- 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 INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE Azelastine hydrochloride nasal spray is an H1-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 spray before initial use and when it has not been used for 3 or more days ( 2.3) DOSAGE FORMS AND STRENGTHS Azelastine hydrochloride 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 spray. ( 5.1) Alcohol and other central nervous system (CNS) depressants: Avoid concurrent use with azelastine hydrochloride nasal spray 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, dizzi Les hele dokumentet