AZELASTINE HYDROCHLORIDE spray, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Apotex Corp.

INN (International Name):

AZELASTINE HYDROCHLORIDE

Composition:

AZELASTINE HYDROCHLORIDE 205.5 ug

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Azelastine hydrochloride 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 nasal spray 0.15% 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

Product summary:

Azelastine hydrochloride nasal spray 0.15% is supplied as a 30 mL package (NDC 60505-0848-5) 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 safety clip and a 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. 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. 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 0.15% should not be used after the expiration date “EXP” printed on the medicine label and carton. Storage Store upright at 20°C to 25°C (68°F to 77°F) [see USP controlled room temperature]. Protect from freezing.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AZELASTINE HYDROCHLORIDE- AZELASTINE HYDROCHLORIDE SPRAY, METERED
APOTEX CORP.
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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 hydrochloride nasal spray 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 hydrochloride nasal spray 0.15%: 1 spray per
nostril twice daily (2.1)
_Adults and adolescents 12 years of age and older:_
Azelastine hydrochloride nasal spray, 0.15%: 1 or 2 sprays per nostril
twice daily (2.1), or
Azelastine hydrochloride nasal spray 0.15%: 2 sprays per nostril once
daily (2.1)
Perennial allergic rhinitis:
6 to 11 years: Azelastine hydrochloride nasal spray 0.15%: 1 spray per
nostril twice daily (2.2)
_Adults and adolescents 12 years of age and older:_
Azelastine hydrochloride nasal spray 0.15%: 2 sprays per nostril twice
daily (2.2)
Prime azelastine hydrochloride nasal spray 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 hydrochloride nasal spray, 0.15% (with sweetener): 205.5
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 spray (5.1)
Avoid concurrent use of alcohol and other central nervous system (CNS)
depressants: with azelastine
hydrochloride nasal spra