AZELASTINE HYDROCHLORIDE spray, metered

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Amneal Pharmaceuticals LLC

प्रशासन का मार्ग:

NASAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 post-marketing experience over decades of use with azelastine HCl 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 HCl 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 pregnant women was consi

उत्पाद समीक्षा:

Azelastine HCl nasal spray, 0.15% is supplied as a 30 mL package (NDC 65162-706-84) 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 or clear 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 HCl, 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 HCl, 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) [see USP Controlled Room Temperature]. Protect from freezing.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

AZELASTINE HYDROCHLORIDE- AZELASTINE HYDROCHLORIDE SPRAY, METERED
AMNEAL PHARMACEUTICALS LLC
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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
RECENT MAJOR CHANGES
Indications and Usage (1) 06/2021
Dosage and Administration, Recommended Dosage for
Seasonal Allergic Rhinitis (2.1) 06/2021
Dosage and Administration, Recommended Dosage for
Perennial Allergic Rhinitis (2.2) 06/2021
INDICATIONS AND USAGE
Azelastine hydrochloride (HCl) nasal spray, 0.15% is an H -receptor
antagonist indicated for the relief of
the symptoms of:
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)
DOSAGE AND ADMINISTRATION
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:_
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% before initial use and when it
has not been used for 3 or
more days. (2.3)
DOSAGE FORMS AND STRENGTHS
Nasal spray solution available in one dosage strength:
Azelastine HCl nasal spray 0.15%: 205.5 mcg of azelastine HCl, USP 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 operatin