AZELASTINE HYDROCHLORIDE- azelastine hydrochloride spray, metered

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

AZELASTINE HYDROCHLORIDE (UNII: 0L591QR10I) (AZELASTINE - UNII:ZQI909440X)

Disponible desde:

A-S Medication Solutions

Vía de administración:

NASAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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. Pregnancy Category C: There are no adequate and well-controlled clinical studies in pregnant women. Azelastine hydrochloride has been shown to cause developmental toxicity in mice, rats, and rabbits. Azelastine Hydrochloride Nasal Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Teratogenic Effects: In mice, azelastine hydrochloride caused embryo-fetal death, malformations (cleft palate; short or absent tail; fused, absent or branched ribs), delayed ossification, and decreased fetal weight at approximately 170 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 ma

Resumen del producto:

Product: 50090-2538 NDC: 50090-2538-0 200 SPRAY, METERED in a BOTTLE, SPRAY

Estado de Autorización:

New Drug Application Authorized Generic

Ficha técnica

AZELASTINE HYDROCHLORIDE- AZELASTINE HYDROCHLORIDE SPRAY, METERED
A-S MEDICATION SOLUTIONS
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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 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 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, dizziness, and we