AZELASTINE HYDROCHLORIDE spray, metered

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

H.J. Harkins Company, Inc.

관리 경로:

NASAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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. 8.1 Pregnancy 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 als

제품 요약:

Azelastine Hydrochloride Nasal Spray, 0.1% (137 mcg/spray) 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. 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.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

AZELASTINE HYDROCHLORIDE- AZELASTINE HYDROCHLORIDE SPRAY, METERED
H.J. HARKINS COMPANY, INC.
----------
1222 AZELASTINE
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.
2.1 Seasonal Allergic Rhinitis
The recommended dosage of Azelastine Hydrochloride Nasal Spray in
adults and adolescent patients 12
years and older with seasonal allergic rhinitis is one or two sprays
per nostril twice daily. The
recommended dosage of Azelastine Hydrochloride Nasal Spray in
pediatric patients 5 years to 11 years
of age is one spray per nostril twice daily.
2.2 Vasomotor Rhinitis
The recommended dosage of Azelastine Hydrochloride Nasal Spray in
adults and adolescent patients 12
years and older with vasomotor rhinitis is two sprays per nostril
twice daily.
2.3 Important Administration Instructions
Administer Azelastine Hydrochloride Nasal Spray by the intranasal
route only.
Priming: Prime Azelastine Hydrochloride Nasal Spray before initial use
by releasing 4 sprays or until a
fine mist appears. When Azelastine Hydrochloride Nasal Spray has not
been used for 3 or more days,
reprime with 2 sprays or until a fine mist appears. Avoid spraying
Azelastine Hydrochloride Nasal
Spray into the eyes.
Azelastine Hydrochloride Nasal Spray is a nasal spray solution. Each
spray of Azelastine
Hydrochloride Nasal Spray delivers a volume of 0.137 mL solution
containing 137 mcg of azelastine
hydrochloride.
None.
5.1 Somnolence in Activities Requiring Mental Alertness
In clinical trials, the occurrence of somnolence has been reported in
some patients taking Azelastine
Hydrochloride Nasal Spray [see ADVERSE REACTIONS (6.1)]. Patients
should be cautioned against
engaging in hazardous occupations requiring complete mental alertness
and motor coordination such as
operating machinery or driving a motor vehicle after administration