Dymista® Nasal Spray (Azelastine/Fluticasone)

Dymista® is an innovative combination nasal spray that brings together two well-established active ingredients in one product: azelastine (a topical antihistamine) and fluticasone propionate (a nasal corticosteroid).

In clinical studies, Dymista® was significantly more effective than fluticasone nasal spray or azelastine nasal spray used alone. It relieves both nasal congestion (through the corticosteroid) and sneezing, itching, and runny nose (through the antihistamine).

Dymista® is recommended for moderate to severe allergic rhinitis when a nasal corticosteroid or an antihistamine alone is not sufficient.

Dymista® combines two different mechanisms of action:

1. Azelastine (antihistamine):

• Blocks H1 histamine receptors locally in the nasal mucosa
• Rapid onset of action (within 15 minutes)
• Additionally inhibits the release of inflammatory mediators
• Also works in non-allergic rhinitis

2. Fluticasone propionate (corticosteroid):

• Strong anti-inflammatory effect in the nasal mucosa
• Reduces swelling of the mucosa (decongestion)
• Inhibits eosinophil infiltration
• Full effect after a few days of regular use

Synergistic effect:

• The combination works faster than fluticasone alone
• Stronger overall effect than either individual component
• Azelastine speeds up the onset of action of fluticasone
• Superior symptom control compared with monotherapy in studies

Dymista® is suitable for:

• Adults and adolescents aged 12 years and older
• Moderate to severe allergic rhinitis
• When a nasal corticosteroid or antihistamine alone is not sufficient
• Seasonal and perennial allergic rhinitis

Especially recommended for:

• Severe hay fever symptoms with nasal congestion AND sneezing/itching
• Patients who do not respond adequately to monotherapy
• When both a rapid and a long-lasting effect are desired
• Allergy to several types of pollen (longer season)

Not suitable:

• Children under 12 years of age
• Hypersensitivity to azelastine or fluticasone
• Acute sinus infection without medical treatment

Adults and adolescents aged 12 years and older:

• 1 spray per nostril twice daily (morning and evening)

Per spray:

• 137 µg azelastine hydrochloride
• 50 µg fluticasone propionate

Total daily dose:

• 548 µg azelastine hydrochloride + 200 µg fluticasone propionate

Available pack size:

• 23 ml nasal spray (approx. 120 sprays)

Duration of use:

• Throughout the entire pollen season or as needed
• Regular use for optimal effect
• Long-term use: medical monitoring recommended

How to use:

• Gently blow your nose
• Shake the bottle vigorously (at least 5 seconds)
• Insert the nozzle into one nostril, pointing slightly away from the nasal septum
• Breathe in gently while spraying
• Repeat for the other nostril
• Do not blow your nose directly after use

Important notes:

• Use twice daily (morning and evening)
• Before first use: pump 6 times until an even mist appears
• If not used for > 7 days: pump 1 time until a mist appears
• Clean the spray tip regularly with warm water
• Do not spray into the eyes

Taste: Azelastine can cause a bitter taste if the spray gets into the throat. Tilt your head slightly forward when spraying.

Dymista® must not be used in cases of:

• Hypersensitivity to azelastine, fluticasone, or any of the other ingredients

Caution in cases of:

• Severe hepatic impairment
• Concomitant therapy with ritonavir or strong CYP3A4 inhibitors
• Active tuberculosis
• Systemic fungal infections
• Nasal septal ulcers or nasal surgery
• Glaucoma (intraocular pressure)
• Cataract (clouding of the lens)
• Children and adolescents (growth monitoring)

Pregnancy and breastfeeding: Insufficient data for the combination. Should only be used after a strict benefit-risk assessment. Systemic absorption is low.

Very common (10% or more):

• Nosebleeds (epistaxis)

Common (1–10%):

• Bitter taste (due to azelastine, if the spray runs into the throat)
• Headache
• Unpleasant smell

Uncommon (0.1–1%):

• Nasal irritation or dryness
• Sneezing directly after use

Very rare:

• Nasal septum perforation (with long-term use, very rare)
• Hypersensitivity reactions
• Somnolence (drowsiness due to azelastine)
• Nausea

Note: The bitter taste is the most common reason for stopping treatment. It can be minimized by correct application technique (head slightly forward, do not breathe in too strongly).

Caution with:

• Ritonavir and strong CYP3A4 inhibitors (increased systemic fluticasone exposure)
• Other nasal corticosteroids (additive cortisol suppression)
• CNS depressants (theoretical enhancement of azelastine sedation)
• Alcohol (slight enhancement of the sedative effect of azelastine possible)

No relevant interaction with:

• Oral antihistamines (but usually not necessary in combination with Dymista®)
• Oral cortisone preparations
• Antibiotics

Note: Systemic absorption of both active ingredients from Dymista® is low, so systemic interactions are unlikely.