Version May 2024
Note: For patients with mucous crusting, rinsing with saline nasal spray before administration can remove mucous crusting and improve nasal coating (Ref). If nasal obstruction is so severe that sprays cannot penetrate, consider concomitant use of an intranasal decongestant for up to 5 days (Ref).
Allergic rhinitis, seasonal: Intranasal: 1 spray (azelastine 137 mcg/fluticasone 50 mcg) per nostril twice daily.
Nonallergic rhinitis (off label): Intranasal: 1 spray (azelastine 137 mcg/fluticasone 50 mcg) per nostril twice daily (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling. Alternatively, it has been recommended that no dosage adjustment is necessary (Dymista Canadian product labeling). Fluticasone undergoes extensive first-pass metabolism; use with caution.
Refer to adult dosing.
(For additional information see "Azelastine and fluticasone: Pediatric drug information")
Allergic rhinitis, seasonal:
Children 4 to 5 years: Limited data available; efficacy not established: Intranasal: 1 spray (137 mcg azelastine/50 mcg fluticasone) per nostril twice daily was evaluated in 61 patients as part of a larger pediatric trial, data did not fully establish efficacy; safety profile similar to older children (NCT01915823, 2014)
Children ≥6 years and Adolescents: Intranasal: 1 spray (137 mcg azelastine/50 mcg fluticasone) per nostril twice daily
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reactions/percentages reported with combination product; also see individual agents.
1% to 10%:
Central nervous system: Headache (2%)
Gastrointestinal: Dysgeusia (4%)
Respiratory: Epistaxis (4%; frequency and severity may be increased in children)
<1%, postmarketing, and/or case reports: Abnormality in thinking, ageusia, altered sense of smell, anaphylactoid reaction, anaphylaxis, angioedema, anosmia, anxiety, application site irritation, atrial fibrillation, blurred vision, bronchospasm, burning sensation, cataract, chest pain, confusion, conjunctivitis, cough, diarrhea, dizziness, drowsiness, drug tolerance, dry nose, dry throat, dyspnea, erythema, eye irritation, facial edema, facial swelling, fatigue, generalized ache, glaucoma, hoarseness, hypersensitivity reaction, hypertension, increased heart rate, increased intraocular pressure, insomnia (initial), muscle spasm, nasal discomfort, nasal obstruction, nasal septum perforation, nasal sores, nausea, nervousness, pain, palpitations, paresthesia, pruritus, restlessness, sedation, skin rash, sore throat, swelling of eye, therapeutic response unexpected, throat irritation, tongue edema, urinary retention, urticaria, vertigo, visual disturbance, voice disorder, vomiting, weight loss, wheezing, xerophthalmia
There are no contraindications listed in the US labeling.
Canadian labeling: Hypersensitivity to azelastine, fluticasone, or any component of the formulation; untreated fungal, bacterial, or tuberculosis infections of the respiratory tract.
Concerns related to adverse effects:
• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Pediatric patients may be more susceptible to systemic toxicity. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Patients receiving ≥20 mg per day of prednisone (or equivalent) may be most susceptible. Concurrent use of ritonavir (and potentially other strong inhibitors of CYP3A4) may increase fluticasone levels and effects on HPA suppression.
• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
• Delayed wound healing: Avoid nasal corticosteroid use in patients with recent nasal septal ulcers, nasal surgery, or nasal trauma until healing has occurred.
• Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Exposure to chickenpox or measles should be avoided.
• Infections: Corticosteroids should be used with caution, if at all, in patients with ocular herpes simplex, tuberculosis (TB) infection (latent TB), and/or TB reactivity, in patients with untreated fungal, viral, or bacterial infections, or systemic viral or parasitic infections.
• Local nasal effects: Nasal septal perforation, nasal ulceration, epistaxis, and localized Candida albicans infections of the nose and/or pharynx may occur. Monitor patients periodically for adverse nasal effects.
• Ocular disease: Increased intraocular pressure, open-angle glaucoma, and cataracts have occurred with intranasal corticosteroid use; use with caution in patients with a history of increased intraocular pressure, cataracts, and/or glaucoma. Consider routine eye exams in chronic users or in patients who report visual changes.
Special populations:
• Pediatric: Avoid using higher than recommended dosages; suppression of linear growth (ie, reduction of growth velocity), reduced bone mineral density, or hypercortisolism (Cushing syndrome) may occur; titrate to lowest effective dose. Reduction in growth velocity may occur when corticosteroids are administered to pediatric patients, even at recommended doses via intranasal route (monitor growth).
In a small pediatric study of fluticasone use conducted over 1 year, no statistically significant effect on growth velocity or clinically relevant changes in bone mineral density or HPA axis function were observed in children 3 to 9 years of age receiving fluticasone propionate nasal spray (200 mcg/day; n=56) versus placebo (n=52); effects at higher doses or in susceptible pediatric patients cannot be ruled out.
Dymista 23 g bottles contain 120 metered sprays.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Nasal:
Dymista: Azelastine hydrochloride 0.1% [137 mcg/spray] and fluticasone propionate 0.037% [50 mcg /spray] (23 g) [contains benzalkonium chloride, edetate (edta) disodium, polysorbate 80]
Generic: Azelastine hydrochloride 137 mcg and fluticasone propionate 50 mcg per spray (23 g)
Yes
Suspension (Azelastine-Fluticasone Nasal)
137-50 mcg/ACT (per gram): $8.91 - $9.90
Suspension (Dymista Nasal)
137-50 mcg/ACT (per gram): $10.94
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Nasal:
Dymista: Azelastine hydrochloride 137 mcg and fluticasone propionate 50 mcg per spray (6.4 g, 23 g) [contains benzalkonium chloride, edetate (edta) disodium, polysorbate 80]
Generic: Azelastine hydrochloride 137 mcg and fluticasone propionate 50 mcg per spray (6.4 g, 23 g)
For intranasal administration only. Prime pump (press 6 times until fine spray appears) prior to first use. If ≥14 days have elapsed since last use, then reprime pump with 1 spray or until a fine mist appears. Shake bottle gently before using. Blow nose to clear nostrils. Keep head tilted downward when spraying. Insert applicator tip 1/4 to 1/2 inch into nostril, keeping bottle upright, and close off the other nostril. Breathe in through nose. While inhaling, press pump to release spray. After each use, wipe the spray tip with a clean tissue or cloth and replace cap. Clean spray pump unit and dust cap at least 1 time each week in warm water and allow to completely dry before placing back on bottle. Avoid spraying directly into nasal septum, eyes or mouth. Discard after 120 medicated sprays have been used, even if bottle is not completely empty. The 10 mL bottle [Canadian product] should be discarded after 28 medicated sprays have been used. Avoid contact with eyes; flush eyes with water for ≥10 minutes with accidental contact.
For intranasal administration only. Prime pump (press 6 times or until fine spray appears) prior to first use. If 14 or more days have elapsed since last use, then reprime pump with 1 spray or until a fine mist appears. Shake bottle gently before using. Blow nose to clear nostrils. Keep head tilted downward when spraying. Insert applicator tip 1/4 to 1/2 inch into nostril, keeping bottle upright, and close off the other nostril. Breathe in through nose. While inhaling, press pump to release spray. After each use, wipe the spray tip with a clean tissue or cloth and replace cap. Avoid spraying directly into nasal septum, eyes, or mouth. If accidental contact with eyes; flush eyes with water for ≥10 minutes. Discard after 120 medicated sprays have been used (do not count initial priming sprays), even if bottle is not completely empty.
Seasonal allergic rhinitis: Relief of symptoms of seasonal allergic rhinitis in adults and pediatric patients ≥6 years of age.
Nonallergic rhinitis
Refer to individual components.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
CNS Depressants: Azelastine (Nasal) may enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination
CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Fluticasone (Nasal). Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Fluticasone (Nasal). Risk X: Avoid combination
Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Nirmatrelvir and Ritonavir: May increase the serum concentration of Fluticasone (Nasal). Management: Use of nasal fluticasone together with a strong CYP3A4 inhibitor is not recommended. Consider an alternative nasal corticosteroid, when possible. Risk D: Consider therapy modification
Refer to individual monographs.
It is not known if azelastine or fluticasone are present in breast milk following nasal administration.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
Growth (adolescents and children); signs/symptoms of HPA axis suppression/adrenal insufficiency; possible eosinophilic conditions (including eosinophilic granulomatosis with polyangiitis [formerly known as Churg-Strauss]); glaucoma and/or cataracts especially in patients with a change in vision; infection; adverse nasal effects (eg, nasal septal perforation, nasal ulceration, epistaxis, localized Candida albicans infections)
Azelastine competes with histamine for H1receptor sites on effector cells and inhibits the release of histamine and other mediators involved in the allergic response; when used intranasally, reduces hyper-reactivity of the airways; increases the motility of bronchial epithelial cilia, improving mucociliary transport.
Fluticasone belongs to a group of corticosteroids which utilizes a fluorocarbothioate ester linkage at the 17 carbon position; extremely potent vasoconstrictive and anti-inflammatory activity.
See individual agents.
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