AZELASTINE HYDROCHLORIDE- azelastine hydrochloride spray

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

Azelastine Hydrochloride (UNII: 0L591QR10I) (Azelastine - UNII:ZQI909440X)

Boleh didapati daripada:

Upsher-Smith Laboratories, Inc.

INN (Nama Antarabangsa):

Azelastine Hydrochloride

Komposisi:

Azelastine Hydrochloride 137 ug in 0.137 mL

Laluan pentadbiran:

NASAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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 mater

Ringkasan produk:

Azelastine hydrochloride nasal spray, 137 mcg/spray, (NDC 0832-0290-30) is supplied as a 30 mL package 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. 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 upright at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

AZELASTINE HYDROCHLORIDE- AZELASTINE HYDROCHLORIDE SPRAY
UPSHER-SMITH LABORATORIES, INC.
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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 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
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 weight inc