Dymista (azelastine HCl/fluticasone propionate)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Fluticasone propionate is a synthetic trifluorinated corticosteroid.
Azelastine is a histamine H1-receptor antagonist.
Azelastine is a histamine H1-receptor antagonist. Azelastine, a phthalazinone derivative, is structurally unrelated to other currently available antihistamines and has been characterized a selective H1-receptor antagonist. Although azelastine has been referred to as a second generation (''nonsedating'') antihistamine, adverse CNS effects (e.g., drowsiness) may occur with the drug, particularly at relatively high doses or when administered with CNS depressants (e.g., alcohol).
The desmethyl metabolite also possesses antihistaminic activity. In addition, azelastine inhibits other mediators (e.g., leukotrienes, platelet activating factor (PAF)) involved in allergic reactions. Azelastine may inhibit the accumulation of eosinophils at the site of allergic inflammation and prevent eosinophil degranulation.
Azelastine currently is commercially available in the US as azelastine hydrochloride nasal spray preparation, having a pH of approximately 6.8. When administered intranasally, approximately 40% of a dose reaches systemic circulation.
Azelastine also is commercially available as azelastine hydrochloride ophthalmic solution. Azelastine hydrochloride ophthalmic solution is a sterile solution of the drug in water for injection; the solution contains benzalkonium chloride as a preservative and also contains edetate disodium, hydroxypropyl methylcellulose, sorbitol, and sodium hydroxide. Azelastine hydrochloride ophthalmic solution has a pH of approximately 5-6.5 and an osmolarity of approximately 271-312 mOsml/L.
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information.
The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Fluticasone propionate nasal spray is used for symptomatic treatment of seasonal or perennial allergic rhinitis and also for perennial nonallergic rhinitis.
Generic name: azelastine HCl/fluticasone propionate
Pronunciation: (AY-ze-LAS-teen/floo-TIK-a-sone)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Dymista
Indications
The following indications are listed for Dymista:
- Seasonal Allergic Rhinitis
Also known as: Intermittent Allergic Rhinitis, Periodic Runny Nose, Seasonal Allergy.
Dosing
The nasal inhaler delivers about 50 mcg of fluticasone propionate per metered spray. The commercially available preparation delivers about 120 metered sprays per 16-g bottle; the container should be discarded after the labeled number of actuations have been used since the correct dose per inhalation cannot be assured if used for additional doses. Dosage of intranasal fluticasone propionate should be adjusted according to individual requirements and response; the lowest effective dosage should be used in order to minimize potential systemic effects of the drug. (See Cautions: Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression.) The maximum daily dosage of intranasal fluticasone propionate should not exceed 100 mcg in each nostril (total of 200 mcg daily).
The manufacturer preferentially labels the dosage and concentration of azelastine hydrochloride in terms of the hydrochloride salt.
Fluticasone propionate is administered by nasal inhalation using a metered-dose nasal spray pump. Patients should be instructed carefully in the use of the nasal spray pump, including the need to prime the pump prior to first use or after a period of nonuse (i.e., 1 week or more). To obtain optimum results, patients also should be given a copy of the patient instructions provided by the manufacturer.
Prior to administration of fluticasone propionate nasal spray, patients should clear their nasal passages; administration of a topical nasal decongestant about 5-15 minutes before intranasal corticosteroid administration may be useful during the first 2 or 3 days of therapy in patients with blocked nasal passages to ensure adequate penetration of the drug. Prior to initial use, the nasal inhaler must be primed. Patients should tilt the head slightly forward, insert the nasal adapter into one nostril, and point the tip of the adapter toward the inflamed nasal turbinates and away from the nasal septum. For maximum therapeutic effect and to ensure adequate penetration of the drug, patients should pump the drug into one nostril while holding the other nostril closed and should concurrently inspire through the nose. This procedure is then repeated for the other nostril. If sneezing occurs during drug administration, patients should wait until sneezing has stopped, then clear the nasal passages and repeat administration of the dose.
The manufacturer recommends cleaning of the nasal spray adapter and/or pump at least once weekly. After removing the nasal adapter and dust cap, these pieces should be rinsed in warm water and dried thoroughly. If the nasal adapter becomes clogged, the piece should be soaked in warm water; cleaning by inserting a sharp object into the piece is not recommended.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
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There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
There is no enhanced messaging for this drug.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
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No enhanced messaging available.
Fluticasone propionate nasal spray should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. Since adrenal insufficiency may occur in neonates born to women who received corticosteroids during pregnancy, these neonates should be monitored carefully for manifestations of this condition. Although there are no adequate and well-controlled studies to date using fluticasone propionate in pregnant women, fluticasone propionate has been shown to be teratogenic and embryotoxic in mice or rats when administered subcutaneously at daily dosages of 45 or 100 mcg/kg, respectively (approximately equivalent to 4 times the maximum recommended daily intranasal dosage in adults based on surface area). Observed fetal toxicity was characteristic of potent glucocorticoid compounds and included embryonic growth retardation, omphalocele, cleft palate, and retarded cranial ossification. Fetal weight reduction and cleft palate were observed in offspring of rabbits given fluticasone propionate 4 mcg/kg subcutaneously (less than the maximum recommended daily intranasal dosage in adults). Following oral administration of up to 300 mcg/kg (approximately 25 times the maximum recommended daily intranasal dosage in adults on a mcg/m2 basis) daily of fluticasone propionate in rabbits, the drug was not detected in plasma, and no maternal effects nor increased incidence of external, visceral, or skeletal fetal defects was detected. The low bioavailability and small distribution of fluticasone propionate across the placenta may account for the lack of teratogenicity; in rats and rabbits receiving oral fluticasone propionate dosages of 100 mcg/kg (590 mcg/m2) or 300 mcg/kg (3.6 mg/m2), respectively, less than 0.008% of the dose crossed the placenta. Long-term experience with the use of oral glucocorticoids suggests that rodents are more prone to teratogenic effects of glucocorticoids than humans. In addition, because there is a natural increase in glucocorticoid production during pregnancy, most women will require a lower exogenous glucocorticoid dose and many will not need glucocorticoid treatment during pregnancy.
Fluticasone propionate should be used with caution in nursing women, since it is not known whether the drug is distributed into milk in humans. Subcutaneous administration of tritiated fluticasone propionate to lactating rats (10 mcg/kg, less than the maximum recommended daily intranasal dosage in adults on a mcg/m2 basis) resulted in measurable radioactivity in both plasma and milk. Other corticosteroids are distributed into milk and in systemic amounts may cause adverse effects, such as growth suppression, in nursing infants.
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ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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