AZELASTINE HYDROCHLORIDE spray, metered

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Breckenridge Pharmaceutical, Inc.

INN (International Adı):

AZELASTINE HYDROCHLORIDE

Kompozisyon:

AZELASTINE HYDROCHLORIDE 137 ug in 0.137 mL

Uygulama yolu:

NASAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 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 (MRHDID) of 1.096

Ürün özeti:

Azelastine Hydrochloride Nasal Spray, 0.1% (137 mcg/spray) is supplied as a 30-mL package (NDC 51991-814-03) delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump fitted with a white safety clip and a white plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). Each bottle contains 30 mg (1 mg/mL) of azelastine hydrochloride. After priming [see Dosage and Administration (2.3) ], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays have been used, even though the bottle is not completely empty. The bottle should be discarded after 200 sprays have been used. Azelastine Hydrochloride Nasal Spray should not be used after the expiration date "EXP" printed on the medicine label and carton. Storage: Store between 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature]. Protect from freezing.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

AZELASTINE HYDROCHLORIDE- AZELASTINE HYDROCHLORIDE SPRAY, METERED
BRECKENRIDGE PHARMACEUTICAL, 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, FOR INTRANASAL USE
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
mout