DYMISTA- azelastine hydrochloride and fluticasone propionate spray, metered

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Meda Pharmaceuticals Inc.

INN (International Name):

AZELASTINE HYDROCHLORIDE

Sammensætning:

AZELASTINE HYDROCHLORIDE 137 ug

Indgivelsesvej:

NASAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

DYMISTA 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 DYMISTA 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 DYMISTA 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 DYMISTA are not available; however, studies are available with its individual components, azelastine hydrochloride and fluticasone propionate. In animal reproduction studies, there was no evidence of fetal harm in animals at oral doses of azelastine hydrochloride approximately 10 times the clinical daily dose. Oral administration of azelast

Produkt oversigt:

How Supplied: DYMISTA nasal spray (NDC 0037-0245-23) 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. DYMISTA 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.

Autorisation status:

New Drug Application

Produktets egenskaber

DYMISTA- AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE SPRAY,
METERED
MEDA PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DYMISTA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DYMISTA.
DYMISTA (AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE) NASAL
SPRAY
INITIAL U.S. APPROVAL: 2012
RECENT MAJOR CHANGES
Indications and Usage (1) 04/2021
INDICATIONS AND USAGE
DYMISTA contains 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
•
•
•
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 MEDA PHARMACEUTICALS
INC. AT 1-888-
939-6478 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 8/2022
®
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 DYMISTA. (5.1)
Avoid concurrent use of alcohol or other central nervous system (CNS)
depressants with DYMISTA
because further decreased alertness and impairment of CNS performance
may occur. (5.1)
Epistaxis, nasal ulcerations, nasal septal perforation, impaired wound
healing, _Candida albicans_
infection: Monitor patients periodically for signs of adverse effects
on the nasal mucosa. Avoid use in
patients with recent nasal ulc