Azelastine/Fluticasone

DEA Class; Rx

Common Brand Names; Dymista

  • Allergy, Intranasal; 
  • Corticosteroids, Intranasal

Nasal combination of an H1-blocker antihistamine (azelastine) and a corticosteroid (fluticasone)
Used to treat seasonal allergic rhinitis in adult and pediatric patients 6 years and older
Combination primarily used for patients not responding to monotherapy, or those with initial severe symptoms

Indicated for the management of symptoms of seasonal allergies, including seasonal allergic rhinitis.

  • Dysgeusia (4%)
  • Headache (2%)
  • Epistaxis (2%)
  • Somnolence
  • Nasal effects (eg, nasal ulceration, nasal septal perforation)
  • Impaired wound healing
  • Candida albicans infection
  • Glaucoma
  • Cataracts
  • Immunosuppression and risk of infections
  • Hypothalamic-pituitary-adrenal (HPA) axis suppression

For intranasal use only

Avoid spraying directly into eyes; if drug is sprayed into eyes, flush with water for a minimum of 10 minutes

May cause somnolence; avoid operating heavy machinery or engaging in tasks that require mental alertness and coordination; caution patients against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as operating machinery or driving a motor vehicle after administration of drug

May cause glaucoma or cataractsNasal and inhaled corticosteroids may result in development of glaucoma and/or cataracts; close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts

Due to the potential reduction in growth velocity in children, patients must be monitored routinely

Limited data from postmarketing experience over decades of use in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes

There are no available data on presence of azelastine hydrochloride or fluticasone propionate in human milk, effects on breastfed infant, or on milk production

Adults

2 sprays/day per nostril.

Geriatric

2 sprays/day per nostril.

Adolescents

2 sprays/day per nostril.

Children

>= 6 years: 2 sprays/day per nostril.
< 6 years: Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

azelastine hydrochloride/fluticasone propionate

nasal spray

  • (137mcg/50mcg)/spray

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