AZELASTINE HYDROCHLORIDE spray, metered

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

AZELASTINE HYDROCHLORIDE

রচনা:

AZELASTINE HYDROCHLORIDE 137 ug

প্রশাসন রুট:

NASAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Azelastine hydrochloride nasal solution (nasal spray), 0.1% (137 mcg per 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. Risk Summary Limited data from postmarketing experience over decades of use with azelastine hydrochloride nasal solution 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 5 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 270 times and higher than the maximum

পণ্য সারাংশ:

Azelastine hydrochloride nasal solution (Nasal Spray), 0.1% (137 mcg per spray) is supplied as a 30 mL package (NDC 47335-779-91) 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 solution (nasal spray) should not be used after the expiration date "Exp" printed on the medicine label and carton. Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from freezing.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

AZELASTINE HYDROCHLORIDE - AZELASTINE HYDROCHLORIDE SPRAY, METERED
SUN PHARMACEUTICAL INDUSTRIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AZELASTINE HYDROCHLORIDE NASAL
SOLUTION SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR AZELASTINE HYDROCHLORIDE NASAL
SOLUTION.
AZELASTINE HYDROCHLORIDE NASAL SOLUTION (NASAL SPRAY)
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Azelastine hydrochloride nasal solution (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 solution before initial use and
when it has not been used for 3 or more days (2.3)
DOSAGE FORMS AND STRENGTHS
Azelastine hydrochloride nasal solution (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
solution. (5.1)
Alcohol and other central nervous system (CNS) depressants: Avoid
concurrent use with azelastine hydrochloride
nasal solution 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,