Recommended Topic Related To:

Dymista

"The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflam"...

Dymista

DYMISTA
(azelastine hydrochloride and fluticasone propionate) Nasal Spray

DRUG DESCRIPTION

Dymista (azelastine hydrochloride and fluticasone propionate) nasal spray is formulated as a white, uniform metered-spray suspension for intranasal administration. It is a fixed dose combination product containing an antihistamine (H1 receptor antagonist) and a corticosteroid as active ingredients.

Azelastine hydrochloride active ingredient occurs as a white, odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.37. It is sparingly soluble in water, methanol, and propylene glycol and slightly soluble in ethanol, octanol, and glycerin. It has a melting point of 225°C and the pH of 5.2. Its chemical name is (±)-1-(2H)-phthalazinone,4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride. Its molecular formula is C22H24ClN3O•HCl with the following chemical structure:

Azelastine hydrochloride Structural Formula Illustration

Fluticasone propionate active ingredient is a white powder with a melting point of 273°C, a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Fluticasone propionate is a synthetic corticosteroid having the chemical name S-(fluoromethyl)-6α,9-difluoro-11β,-17-dihydroxy-16α-methyl-3-oxoandrosta1,4-diene-17β-carbothioate, 17-propionate, and the following chemical structure:

Fluticasone propionate Structural Formula Illustration

Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg contains 0.1% solution of azelastine hydrochloride and 0.037% suspension of micronized fluticasone propionate in an isotonic aqueous suspension containing glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, phenylethyl alcohol (2.5 mg/g), edetate disodium, benzalkonium chloride (0.1 mg/g), polysorbate 80, and purified water. It has a pH of approximately 6.0.

After priming [see DOSAGE AND ADMINISTRATION], each metered spray delivers a 0.137 mL mean volume of suspension containing 137 mcg of azelastine hydrochloride (equivalent to 125 mcg of azelastine base) and 50 mcg of fluticasone propionate. The 23 g bottle provides 120 metered sprays, after priming.

What are the possible side effects of azelastine and fluticasone nasal (Dymista)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe or ongoing nosebleeds;
  • noisy breathing, runny nose, or crusting around your nostrils;
  • redness, sores, or white patches in your mouth or throat;
  • fever, chills, weakness, nausea, vomiting, flu symptoms;
  • any wound that will not heal; or
  • blurred vision, eye pain, or seeing halos...

Read All Potential Side Effects and See Pictures of Dymista »

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

A A A

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

Improve treatments & prevent attacks.