AZELASTINE spray, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ascend Laboratories, LLC

INN (International Name):

AZELASTINE HYDROCHLORIDE

Composition:

AZELASTINE HYDROCHLORIDE 137 ug

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Azelastine HCl 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. Risk Summary Limited data from postmarketing experience over decades of use with Azelastine HCl Nasal Spray 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 recommended human daily intranasal dose (MRHDID) of 1.096 mg. How

Product summary:

Azelastine HCl Nasal Spray , 137 mcg is supplied as a 30-mL package (NDC 67877-477-50)  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 transparent 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, 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 137 mcg of azelastine hydrochloride, USP. 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 HCl 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AZELASTINE - AZELASTINE SPRAY, METERED
ASCEND LABORATORIES, 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
INDICATIONS AND USAGE
Azelastine HCl 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:
o Pediatric patients 5 to 11 years of age: 1 spray per nostril twice
daily (2.1)
o 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 HCl Nasal Spray before initial use and when it has
not been used for 3 or more days
(2.3)
DOSAGE FORMS AND STRENGTHS
Azelastine HCl Nasal Spray: 137 mcg of azelastine hydrochloride, 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 operating machinery when taking Azelastine HCl Nasal Spray.
(5.1)
Alcohol and other central nervous system (CNS) depressants: Avoid
concurrent use with Azelastine
HCl Nasal Spray 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,
sinusitis, paroxysmal sneezing, nausea, dry
mouth, fatigue, dizziness, and weight increase. (6.1)
TO REPORT SUSPECTED ADVERSE