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Dymista

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Dymista

Indications
Dosage
How Supplied

INDICATIONS

Dymista Nasal Spray is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 12 years of age and older who require treatment with both azelastine hydrochloride and fluticasone propionate for symptomatic relief.

DOSAGE AND ADMINISTRATION

Dosing Information

The recommended dose of Dymista Nasal Spray, 137 mcg/50 mcg, is 1 spray per nostril twice daily for seasonal allergic rhinitis. Each spray contains 137 mcg of azelastine hydrochloride and 50 mcg of fluticasone propionate (137 mcg/50 mcg).

Administer Dymista Nasal Spray by the intranasal route only.

Important Administration Instructions

Shake the bottle gently before each use.

Priming

Prime Dymista Nasal Spray before initial use by releasing 6 sprays or until a fine mist appears. When Dymista Nasal Spray has not been used for 14 or more days, reprime with 1 spray or until a fine mist appears. Avoid spraying Dymista Nasal Spray into the eyes. If sprayed in the eyes, flush eyes with water for at least 10 minutes.

HOW SUPPLIED

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. Dymista Nasal Spray should be shaken gently before each use and primed with 6 sprays before the initial use or with 1 spray after a non-use period of 14 days. 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 medicated sprays have been used.

Dymista 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° - 25°C (68° - 77°F). [See USP Controlled Temperature] Protect from light. Do not store in the freezer or refrigerator.

Manufactured by: Cipla Ltd. Goa, India. Distributed by: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4123. Revised: 8/2012

Last reviewed on RxList: 9/13/2012
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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