- Indications and Usage This nasal spray is indicated for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in adult and pediatric patients 12 years of age and older who have had an inadequate response to either nasal antihistamines or nasal corticosteroids alone.
- Dosage and Administration Recommended Dosage: The recommended dosage for patients 12 years and older is 1 spray in each nostril twice daily. Administration: The spray is for intranasal use only. Shake the bottle well immediately before using. Before the first use, prime the pump by spraying 6 sprays into the air away from the face. If the spray has not been used for more than 7 days, prime with 1 spray. Proper Technique: Keep the head slightly tilted down. Insert the tip into one nostril, close the opposite nostril, and press down on the pump while breathing in gently through the nose. Wipe the nozzle with a clean tissue and replace the dust cap.
- Mechanism of Action Azelastine: An antihistamine that selectively blocks H1 receptors, preventing the effects of histamine released during allergic reactions. Fluticasone: A corticosteroid that binds to cytosolic glucocorticoid receptors, inhibiting the release of multiple inflammatory mediators to reduce inflammation, congestion, and nasal symptoms.
- Safety and Warnings Nasal Septal Perforation: Ulcers and perforation of the nasal septum have been reported with intranasal corticosteroids. Ocular Effects: Long-term use may increase the risk of glaucoma, cataracts, and increased intraocular pressure. Hypersensitivity: Rare cases of anaphylaxis, angioedema, and bronchospasm have been reported. Adrenal Insufficiency: Systemic absorption of corticosteroids can lead to adrenal suppression, particularly with high doses.
- Adverse Reactions and Clinical Research Common Adverse Reactions: The most frequently reported adverse reactions include somnolence, nasal irritation, epistaxis, headache, and dysgeusia (bitter taste). Clinical Research: Clinical trials have demonstrated that this combination provides superior symptom relief compared to placebo in patients with SAR and PAR.
- Drug Interactions CYP3A4 Inhibitors: Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase the systemic exposure of fluticasone propionate, potentially increasing the risk of systemic corticosteroid side effects. CNS Depressants: Concomitant use with other drugs causing sedation may potentiate the somnolence associated with azelastine.
- Pharmaceutical Information Composition: Each actuation delivers 137 μg of azelastine hydrochloride and 50 μg of fluticasone propionate. Appearance: The suspension is white to off-white. Storage: Store at controlled room temperature (20°C to 25°C). Do not freeze or expose to excessive heat.
Dymista Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray
Brand Name: 迪敏思 ®（Dymista®）
Generic Name: Azelastine Hydrochloride and Fluticasone Propionate
Strength: Each spray delivers 137 μg azelastine hydrochloride and 50 μg fluticasone propionate, 120 sprays per bottle/box
Manufacturer: Cipla Limited
Marketing Authorization Holder: Viatris Healthcare GmbH
Approval Date in China: July 27, 2023
Registration Number: 国药准字HJ20230090
Storage: Store tightly closed at room temperature, protect from direct sunlight and freezing. Keep out of reach of children. Refer to the full package insert for detailed storage specifications.
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