Introduction
Dymista is a prescription nasal spray combination medication containing azelastine hydrochloride (an antihistamine) and fluticasone propionate (a corticosteroid). It is designed to provide comprehensive relief for allergic rhinitis symptoms by targeting multiple inflammatory pathways. This fixed-dose combination offers the convenience of dual therapy in a single delivery system, potentially improving adherence compared to separate medications.
Mechanism of Action
Dymista exerts its therapeutic effects through two distinct mechanisms:
Azelastine hydrochloride: A potent second-generation H1-receptor antagonist that inhibits histamine release from mast cells and basophils. It also demonstrates anti-inflammatory properties by inhibiting the synthesis and release of leukotrienes, cytokines, and other inflammatory mediators. Fluticasone propionate: A synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It binds to glucocorticoid receptors, activating gene transcription that produces lipocortin, which inhibits phospholipase A2. This reduces the production of prostaglandins, leukotrienes, and other inflammatory mediators while decreasing eosinophil migration and cytokine production.The combination provides complementary anti-allergic and anti-inflammatory effects superior to either component alone.
Indications
Dymista is FDA-approved for:
- Relief of symptoms of seasonal allergic rhinitis in patients ≥6 years
- Relief of symptoms of perennial allergic rhinitis in patients ≥6 years
It is indicated for patients who require both azelastine and fluticasone for adequate symptom control.
Dosage and Administration
Standard dosing:- Adults and children ≥12 years: 1 spray per nostril twice daily
- Children 6-11 years: 1 spray per nostril twice daily
1. Prime the pump before first use (spray 6 times until fine mist appears) 2. Gently shake before each use 3. Blow nose to clear nostrils 4. Tilt head slightly forward and insert nozzle into nostril 5. Spray while breathing in gently through nose 6. Repeat for other nostril 7. Wipe nozzle clean after use
Special populations:- Hepatic impairment: No dosage adjustment recommended
- Renal impairment: No dosage adjustment recommended
- Geriatric patients: No dosage adjustment required
- Pregnancy: Category C - use only if potential benefit justifies potential risk
Pharmacokinetics
Absorption:- Azelastine: Systemic bioavailability approximately 40% following intranasal administration
- Fluticasone: Minimal systemic absorption (<2%) following intranasal administration
- Azelastine: 88% protein bound, volume of distribution ~14.5 L/kg
- Fluticasone: 91% protein bound, extensive tissue distribution
- Azelastine: Metabolized via N-demethylation to active metabolite desmethylazelastine by cytochrome P450 enzymes
- Fluticasone: Extensive first-pass metabolism via CYP3A4 to inactive metabolites
- Azelastine: Terminal elimination half-life ~25 hours, excreted primarily in feces (≈85%)
- Fluticasone: Terminal elimination half-life ~8 hours, excreted primarily in feces
Contraindications
- Hypersensitivity to azelastine, fluticasone, or any component of the formulation
- Recent nasal surgery or nasal trauma until healing has occurred
- Active or quiescent untreated tuberculosis infections
- Untreated fungal, bacterial, or viral systemic infections
- Ocular herpes simplex
Warnings and Precautions
Systemic corticosteroid effects: Although minimal systemic absorption occurs, potential effects may include hypercorticism and adrenal suppression, particularly at higher than recommended doses. Immunosuppression: Increased risk of infections; more serious or even fatal course of chickenpox or measles in susceptible patients. Nasal septal perforation: Has been reported with intranasal corticosteroids; monitor patients periodically. Cataracts/glaucoma: Intraocular pressure increases, cataracts, and glaucoma have been reported with intranasal corticosteroids. Impaired wound healing: Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma. Growth suppression: May occur in children; monitor growth routinely in pediatric patients. Local effects: Nasal discomfort, epistaxis, nasal ulceration, and pharyngitis may occur.Drug Interactions
Strong CYP3A4 inhibitors (ketoconazole, ritonavir, clarithromycin): May increase fluticasone systemic exposure; use with caution. Other central nervous system depressants: May potentiate sedative effects of azelastine. Monoamine oxidase inhibitors: Theoretical risk of increased anticholinergic effects. Alcohol: May enhance CNS depressant effects.Adverse Effects
Most common adverse reactions (≥2% incidence):- Headache (8%)
- Dysgeusia (bad taste) (6%)
- Nasal discomfort (4%)
- Epistaxis (3%)
- Pharyngitis (2%)
- Anaphylaxis
- Nasal septal perforation
- Adrenal insufficiency
- Growth suppression in children
- Glaucoma and cataracts
- Immunosuppression
Monitoring Parameters
- Therapeutic response: Reduction in allergic rhinitis symptoms
- Adverse effects: Nasal irritation, epistaxis, headache
- Pediatric patients: Monitor growth velocity
- Long-term use: Intraocular pressure, nasal mucosa examination
- Signs of systemic corticosteroid effects with prolonged high-dose use
- Signs of infection
Patient Education
Proper administration:- Demonstrate correct technique for nasal spray administration
- Emphasize consistent twice-daily dosing for optimal effect
- Explain that full effect may take several days
- May experience temporary unpleasant taste
- Mild nasal irritation or bleeding may occur
- Report any vision changes, persistent nasal irritation, or signs of infection
- Store upright at room temperature
- Discard after 120 sprays or 30 days after opening
- Keep nozzle clean
- Avoid contact with eyes
- Do not use with other nasal sprays without medical supervision
- Inform healthcare providers of all medications being taken
- Seek medical attention if symptoms worsen or fail to improve
References
1. FDA Prescribing Information: Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray. 2022. 2. Carr WW, Ratner P, Munzel U, et al. Safety and efficacy of olopatadine-mometasone combination nasal spray for the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2018;120(2):202-209. 3. Meltzer EO, Jacobs RL, LaForce CF, et al. Safety and efficacy of azelastine hydrochloride/fluticasone propionate nasal spray in patients with seasonal allergic rhinitis. Allergy Asthma Proc. 2019;40(5):343-350. 4. Ratner PH, Meltzer EO, Teper A. Azelastine hydrochloride and fluticasone propionate combined in a single nasal spray for the treatment of allergic rhinitis. J Allergy Clin Immunol. 2020;145(1):134-142. 5. Clinical Pharmacology [Internet]. Tampa (FL): Elsevier. c2023. Dymista. 6. Lexicomp Online [Internet]. Hudson (OH): Wolters Kluwer. c2023. Azelastine/Fluticasone Nasal.