AZELASTINE HCL NASAL- azelastine hcl spray

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Padagis Israel Pharmaceuticals Ltd

INN (International Name):

AZELASTINE HYDROCHLORIDE

구성:

AZELASTINE HYDROCHLORIDE 205.5 ug

관리 경로:

NASAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Azelastine HCl nasal spray, 0.15% is indicated for the relief of the symptoms of seasonal allergic rhinitis in patients 6 years of age and older and perennial allergic rhinitis in patients 6 years of age 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 4 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 180 times and higher than the maximum recommended human daily intranasal dose (MRHDID) of 1.644 mg. However, the relevance of these findings in animals to pregn

제품 요약:

Azelastine HCl nasal spray, 0.15% is supplied as a 30-mL package (NDC 45802-026 -83) 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 violet safety clip and a violet plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). The 30-mL bottle contains 45 mg (1.5 mg/mL) of azelastine hydrochloride, USP. After priming [see Dosage and Administration (2.3) ], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 205.5 mcg of azelastine hydrochloride, USP. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays for the 30-mL bottle have been used, even though the bottle is not completely empty. The bottle should be discarded after 200 sprays have been used. Azelastine HCl nasal spray, 0.15% should not be used after the expiration date “EXP” printed on the medicine label and carton. Storage: Store upright at controlled room temperature 20° to 25°C (68° to 77°F). Protect from freezing.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

AZELASTINE HCL NASAL- AZELASTINE HCL SPRAY
PADAGIS ISRAEL PHARMACEUTICALS LTD
----------
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 HCl nasal spray, 0.15% is an H -receptor antagonist
indicated for the relief of the symptoms of:
(1)
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Nasal spray solution available in one dosage strength: (3)
•
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
The most common adverse reactions (≥2% incidence) are: pyrexia,
dysgeusia, nasal discomfort, epistaxis,
headache, sneezing, fatigue, somnolence, upper respiratory infection,
cough, rhinalgia, vomiting, otitis
media, contact dermatitis, and oropharyngeal pain (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PERRIGO AT
1-866-634-9120 OR FDA AT 1-
800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
1
Seasonal allergic rhinitis in patients 6 years of age and older. (1.1)
Perennial allergic rhinitis in patients 6 years of age and older.
(1.1)
For intranasal use only (2.3).
Seasonal allergic rhinitis:
▪
▪
_6 to 11 years:_ azelastine HCl nasal spray, 0.15%: 1 spray per
nostril twice daily (2.1)
_Adults and adolescents 12 years of age and older:_
o
o
azelastine HCl nasal spray, 0.15%: 1 or 2 sprays per nostril twice
daily (2.1), or
azelastine HCl nasal spray, 0.15%: 2 sprays per nostril once daily
(2.1)
Perennial allergic rhinitis:
▪
▪
_6 to 11 years_: azelastine HCl nasal spray, 0.15%: 1 spray per
nostril twice daily (2.2)
_Adults and adolescents 12 years of age and older_: azelastine HCl
nasal spray, 0.15%: 2 sprays
per nostril twice daily (2.2)
Prime azelastine HCl nasal spray, 0.15% befor