AZELASTINE HYDROCHLORIDE spray, metered

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Wallace Pharmaceuticals 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. 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 m

제품 요약:

Azelastine Hydrochloride Nasal Spray, 137 mcg is supplied as a 30-mL package (NDC 51525-0224-3) 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 blue safety clip and a blue 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 at controlled room temperature 20° to 25°C (68° to 77°F). Protect from freezing.

승인 상태:

New Drug Application Authorized Generic

제품 특성 요약

AZELASTINE HYDROCHLORIDE- AZELASTINE HYDROCHLORIDE SPRAY, METERED
WALLACE PHARMACEUTICALS 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
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION
•
•
•
•
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
•
•
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.
(6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT WALLACE PHARMACEUTICALS
INC. AT 1-800-619-6344 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm (8.1)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 1/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Seasonal Allergic Rhinitis
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)
1
For intranasal use only (2.3)
Seasonal allergic rhinitis:
o
o
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 Az