AZELASTINE HYDROCHLORIDE- azelastine spray, metered

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

A-S Medication Solutions

Via di somministrazione:

NASAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

Product: 50090-3833 NDC: 50090-3833-0 30 mL in a BOTTLE, SPRAY / 1 in a CARTON

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

AZELASTINE HYDROCHLORIDE- AZELASTINE 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, 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.