Seasonal allergic rhinitis. All-year allergic or non-allergic rhinitis. Symptomatic treatment of nasal polyps. Prevention of nasal polyps after removal.
Composition:
1 dose of nasal spray contains 32 μg or 64 μg micronized budesonide. In addition, 1 dose contains 0.06 mg of potassium sorbate.
Action:
Glucocorticoid with a strong local anti-inflammatory effect, for nasal use. It probably inhibits inflammatory mediators and a cytokine-dependent immune response. It reduces over-reactivity and inhibits the inflow of eosinophils. It does not significantly affect the basic plasma cortisol concentration or response to ACTH stimulation. The Budesonide strength, measured as affinity to the glucocorticoid receptor, is 15-fold greater than the potency of prednisolone. Bioavailability is 33% of the metered dose. The maximum concentration in the blood occurs after 0.7 h. It is 90% bound to plasma proteins. Metabolism occurs in the liver and urinary excretion. Patients with severe hepatic impairment may reduce excretion and increase bioavailability.
Contraindications:
Hypersensitivity to budesonide or any of the ingredients.
Precautions:
Particularly cautiously used in patients with fungal infection of the nose, herpes infection and tuberculosis. Special care should be taken when switching from general to intranasal treatment due to the risk of hypothalamic-pituitary-adrenal axis dysfunction. In these patients, oral glucocorticosteroids should be considered in situations of stress exposure, eg before planned surgical procedures or in the event of an injury. Due to the content of potassium sorbate, the preparation may cause local skin reactions (eg contact dermatitis).
Pregnancy and lactation:
During pregnancy and breastfeeding, use only if the anticipated benefit to the mother outweighs the potential risk to the fetus or fed child. The preparation should be used in the lowest possible dose and in the shortest possible time.
Side effects:
Common: local irritation, low nasal discharge with a slightly bloody nose, nosebleed. Rare: angioneurotic edema, urticaria, rash, dermatitis, pruritus, hypersensitivity reactions (urticaria, rash, dermatitis, angioneurotic edema, pruritus), ulceration of the nasal mucosa, perforation of the nasal septum. Long-term use of high doses may cause systemic symptoms such as suppression of the hypothalamic-pituitary-adrenal axis and (or) slowing of growth in children.
Dosage:
Intranasally. Adults and children> 6 years.Inflammation of the nasal mucosa: initially 256 μg / day, which means 128 μg for each nostril once a day (in the morning) or 64 μg for each nostril twice daily (morning and evening). After improvement, the dose should be reduced to the lowest dose needed to control the symptoms of the disease. A dose of 32 μg, given in the morning to each nostril, may be sufficient for some patients. In some patients, symptoms are relieved within 5-7 hours of starting treatment. Full effect of the drug is achieved after a few days of treatment, in rare cases after 2 weeks. If possible, treatment of seasonal allergic rhinitis should be started before exposure to allergens. In case of increased nasal mucosal edema, it may be necessary to administer a vasoconstrictor.Symptomatic treatment of nasal polyps and their prevention after polypectomy: 256 μg / day, used once daily (in the morning) or in 2 divided doses (morning and evening). After improvement, the dose should be reduced to the least sufficient to control the symptoms of the disease.
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