Index of drugs

Relief of symptoms of seasonal and perennial allergic rhinitis of moderate to severe severity, if the use of other nasally administered preparations containing only antihistamine or glucocorticosteroid is considered insufficient.

1 dose of spray contains 137 μg of azelastine hydrochloride (= 125 μg of azelastine) and 50 μg of fluticasone propionate. The preparation contains benzalkonium chloride.

The preparation contains azelastine hydrochloride and fluticasone propionate - substances with different mechanisms of action, showing a synergistic effect in the relief of symptoms of allergic rhinitis with conjunctivitis. Fluticasone propionate is a synthetic trifluoride corticosteroid with a strong anti-inflammatory effect. Azelastine is a selective H receptor antagonist_1, has stabilizing properties of mast cells and anti-inflammatory; inhibits the synthesis or release of mediators associated with the early and late phase of allergic reactions. Reduction of nasal allergy symptoms is observed within 15 minutes after administration. After nasal administration, the maximum plasma concentration of azelastine occurred on average after 0.5 hours and fluticasone on average after 1 hour. After administration, the fluticasone systemic exposures were approximately 50% higher than with the commercially available fluticasone spray formulation. nose. The level of systemic exposure to azelastine was comparable after administration of the preparation and commercially available azelastine nasal spray. Fluticasone propionate is 91% bound to plasma proteins, azelastine is 80-90% bound. In addition, both compounds have a broad therapeutic index, so the phenomenon of displacement of one drug by the other is unlikely. Fluticasone propionate is rapidly removed from the systemic circulation, mainly as a result of metabolic changes occurring in the liver to an inactive carboxylic acid metabolite with the participation of CYP3A4. Azelastine is metabolised to N-desmethylazelastine with the participation of various CYP isoenzymes mainly CYP3A4, CYP2D6 and CYP2CM9. The main route of elimination of fluticasone propionate is the excretion of the drug and its metabolites in the bile. T_0,5 in the elimination phase of azelastine, after a single dose administration, it is about 20-25 h for azelastine and about 45 h for the therapeutically active metabolite N-desmetylaZelastine. The compound is mainly excreted in faeces.

Hypersensitivity to the active substances or to any of the excipients.

Due to the risk of systemic side effects of corticosteroids, fluticasone propionate should not be used concomitantly with ritonavir unless the potential benefit to the patient outweighs the risk. Systemic corticosteroids administered intranasally are possible, especially when used in high doses over a longer period (the likelihood of their occurrence is significantly lower than in the case of oral corticosteroids). Caution should be exercised in patients with severe liver disease. Treatment with intranasal corticosteroids in doses higher than recommended may lead to clinically significant suppression of adrenal function. If anything indicates that the medicine has been used at higher than recommended doses, consideration should be given to including additional corticosteroids generally administered during periods of stress or during elective surgery. Adolescent control of growth is recommended for adolescents who have long-term use of intranasal corticosteroids. If the rate of growth is checked, the treatment should be revised for the possibility of reducing the dose of intranasal corticosteroid to the smallest dose allowing for effective symptom control. In patients with a change in vision or in the past, elevated intraocular pressure, glaucoma and / or cataracts are recommended for close monitoring. If there is any reason to believe that you have adrenal insufficiency, caution should be exercised when changing therapy with steroids generally given to Dymista.In patients with tuberculosis, with untreated infection of any type, or after a recent surgery or a recent injury to the nose or mouth, the possible risks to the potential benefit of treatment with the preparation should be determined. Nasal infection should be treated with antibacterial or antifungal agents; however, they do not constitute a special contraindication for treatment with the preparation. It is not recommended for use in children under 12 years of age because its safety and efficacy in this age group has not been established. The preparation contains benzalkonium chloride, which may cause irritation of the nasal mucosa and bronchospasm. Avoid contact with the eyes.

It can be used during pregnancy and breastfeeding only if the potential benefits justify a potential risk to the fetus or newborn / infant.

Very often: nosebleeds. Common: headache, taste disturbance (unpleasant taste), unpleasant smell. Uncommon: discomfort in the nasal cavity (including irritation, burning itching), sneezing, dry nasal cavity, cough, dry throat, irritation of the throat. Rare: dry mouth. Very rare: hypersensitivity (including anaphylactic reactions, angioedema - swelling of the face or tongue and rash, bronchospasm), dizziness, drowsiness (drowsiness, drowsiness), glaucoma, increased intraocular pressure, cataracts, perforation of the nasal septum, mucosal erosion , nausea, rash, pruritus, urticaria, fatigue (fatigue, exhaustion), weakness. Systemic effects of some nasal corticosteroids may occur, especially when used in high doses for prolonged periods. There are reports of inhibition of growth in children receiving intranasal corticosteroids - in adolescents it is also possible to inhibit growth. In rare cases, the occurrence of osteoporosis has been observed when glucocorticoids have been administered intranasally for a long time.

Intranasally. Adults and adolescents from 12 years: 1 dose sprayed in each nostril twice daily (morning and evening). No dosage adjustment is required in elderly patients. There are no data on the use of patients with impaired renal or hepatic function. The preparation can be used for a long time. The duration of treatment should correspond to the period of exposure to allergens.