AZELASTINE HYDROCHLORIDE spray, metered

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

RPK Pharmaceuticals, Inc.

Οδός χορήγησης:

NASAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Product: 53002-2279 NDC: 53002-2279-1 200 SPRAY, METERED in a BOTTLE, SPRAY / 1 in a BOX

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

AZELASTINE HYDROCHLORIDE - AZELASTINE HYDROCHLORIDE SPRAY, METERED
RPK PHARMACEUTICALS, INC.
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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