DYMISTA Nasal spray, suspension Ref.[115137] Active ingredients: Azelastine Fluticasone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2023  Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Product name and form

Dymista Nasal Spray

137 micrograms/50 micrograms per actuation

Nasal Spray, Suspension

Azelastine/Fluticasone

37 micrograms/50 micrograms per actuation

Nasal Spray, Suspension

Pharmaceutical Form

Nasal spray, suspension.

White, homogeneous suspension.

Qualitative and quantitative composition

Each g of suspension contains 1000 micrograms azelastine hydrochloride and 365 micrograms fluticasone propionate.

One actuation (0.14 g) delivers 137 micrograms azelastine hydrochloride (= 125 micrograms azelastine) and 50 micrograms fluticasone propionate.

Excipient with known effect: One actuation (0.14 g) delivers 0.014 mg benzalkonium chloride.

For the full list of excipients, see section 6.1.

Active Ingredient

Azelastine, a phthalazinone derivative is classified as a potent long-acting anti-allergic compound with selective H1 antagonist properties. An additional anti-inflammatory effect could be detected after topical ocular administration. Data from in vivo (pre-clinical) and in vitro studies show that azelastine inhibits the synthesis or release of the chemical mediators known to be involved in early and late stage allergic reactions e.g. leukotriene, histamine, PAF and serotonin.

Fluticasone has anti-inflammatory and vasoconstrictive features. Fluticasone given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in a reduction of both symptoms and exacerbations of asthma, with a lower incidence and severity of adverse effects than those observed when corticosteroids are administered systemically.

List of Excipients

Disodium edetate
Glycerol
Microcrystalline cellulose
Carmellose sodium
Polysorbate 80
Benzalkonium chloride
Phenylethyl alcohol
Purified water

Pack sizes and marketing

Type I amber glass bottle fitted with a spray pump, a nasal polypropylene applicator (actuator) and a dust cap, containing 6.4 g (at least 28 actuations) and 23 g (at least 120 actuations) suspension.

Pack sizes:

1 bottle with 6.4 g suspension in 10 ml bottles (at least 28 actuations), 1 bottle with 23 g suspension in 25 ml bottles (at least 120 actuations).

Multipacks containing 64 g (10 bottles with 6.4 g) nasal spray, suspension Multipacks containing 69 g (3 bottles with 23 g) nasal spray, suspension.

Not all pack sizes may be marketed.

Marketing authorization holder

Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 46302/0162

01/2013

Drugs

Drug Countries
DYMISTA Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Lithuania, Malta, Mexico, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States

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