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Seasonal Allergic Rhinitis
DYMISTA nasal spray is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 6 years of age and older who require treatment with both azelastine hydrochloride and fluticasone propionate for symptomatic relief.
DOSAGE AND ADMINISTRATION
The recommended dosage of DYMISTA is 1 spray in each nostril twice daily.
Important Administration Instructions
Administer DYMISTA by the intranasal route only.
Shake the bottle gently before each use.
Prime DYMISTA before initial use by releasing 6 sprays or until a fine mist appears. When DYMISTA has not been used for 14 or more days, reprime with 1 spray or until a fine mist appears.
Avoid spraying DYMISTA into the eyes. If sprayed in the eyes, flush eyes with water for at least 10 minutes.
Dosage Forms And Strengths
DYMISTA is a nasal spray suspension. Each spray delivers a volume of 0.137 mL suspension containing 137 mcg of azelastine hydrochloride and 50 mcg of fluticasone propionate (137 mcg/50 mcg).
Storage And Handling
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]. After priming [see DOSAGE AND ADMINISTRATION], 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.
Store upright with the dust cap in place at controlled room temperature 20° to 25°C (68° to 77°F). [See USP Controlled Temperature] Protect from light. Do not store in the freezer or refrigerator.
Distributed by: Meda Pharmaceuticals® Somerset, NJ 08873-4120. Rev. Feb 2015
Last reviewed on RxList: 3/9/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Dymista Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Allergies & Asthma
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