AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE spray, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AZELASTINE HYDROCHLORIDE (UNII: 0L591QR10I) (AZELASTINE - UNII:ZQI909440X), FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)

Available from:

Mylan Pharmaceuticals Inc.

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Azelastine hydrochloride and fluticasone propionate nasal spray is indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older. None. Limited data from postmarketing experience with azelastine hydrochloride and fluticasone propionate nasal spray in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. The individual components of azelastine hydrochloride and fluticasone propionate nasal spray have been marketed for decades. While the data regarding the use of nasal preparations of fluticasone propionate in pregnancy are limited, data from clinical studies of inhaled fluticasone propionate do not indicate an increased risk of adverse maternal or fetal outcomes. Animal reproduction studies with azelastine hydrochloride and fluticasone propionate nasal spray are not available; however, studies are available with its individual components, azelastine hydrochloride and

Product summary:

How Supplied: Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray (NDC 0378-3458-23) is supplied as an amber glass bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump with a white nasal adapter and clear plastic dust cap. Each bottle contains a net fill weight of 23 g and will deliver 120 metered sprays after priming [see Dosage and Administration (2.2)] . After priming [see Dosage and Administration (2.2)] , each spray delivers a suspension volume of 0.137 mL as a fine mist, containing 137 mcg of azelastine hydrochloride and 50 mcg of fluticasone propionate (137 mcg/50 mcg). The correct amount of medication in each spray cannot be assured before the initial priming and after 120 sprays have been used, even though the bottle is not completely empty. The bottle should be discarded after 120 sprays have been used. Azelastine hydrochloride and fluticasone propionate nasal spray should not be used after the expiration date “EXP” printed on the bottle label and carton. Storage: Store upright with the dust cap in place at controlled room temperature 20°C to 25°C (68°F to 77°F). [See USP Controlled Temperature] Protect from light. Do not store in the freezer or refrigerator.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE- AZELASTINE
HYDROCHLORIDE AND FLUTICASONE PROPIONATE SPRAY, METERED
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AZELASTINE
HYDROCHLORIDE AND FLUTICASONE PROPIONATE NASAL SPRAY SAFELY AND
EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR AZELASTINE HYDROCHLORIDE AND
FLUTICASONE
PROPIONATE NASAL SPRAY.
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE NASAL SPRAY
INITIAL U.S. APPROVAL: 2012
RECENT MAJOR CHANGES
Indications and Usage (1) 04/2021
INDICATIONS AND USAGE
Azelastine hydrochloride and fluticasone propionate nasal
spraycontains an H -receptor antagonist and a
corticosteroid, and is indicated for the relief of symptoms of
seasonal allergic rhinitis in adult and pediatric
patients 6 years of age and older. (1)
DOSAGE AND ADMINISTRATION
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•
•
DOSAGE FORMS AND STRENGTHS
Nasal spray: 137 mcg of azelastine hydrochloride and 50 mcg of
fluticasone propionate in each spray. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
ADVERSE REACTIONS
The most common adverse reactions (≥ 2% incidence) are: dysgeusia,
epistaxis, and headache. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-
RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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•
1
Recommended dosage: 1 spray per nostril twice daily (2.1)
For nasal use only. (2.2)
Prime before initial use and when it has not been used for 14 or more
days. (2.2)
Somnolence: Avoid engaging in hazardous occupations requiring complete
mental alertness such as
driving or operating machinery when taking azelastine hydrochloride
and fluticasone propionate nasal
spray. (5.1)
Avoid concurrent use of alcohol or other central nervous system (CNS)
depressants with azelastine
hydrochloride and fluticasone propionate nasal spray because further
decreased alertness and
impairment of CNS performance may occur. (5.1)
Epistaxis, nasal ulc