Treatment and prevention of signs and symptoms of seasonal and perennial allergic rhinitis. Treatment of signs and symptoms of nasal polyps.
Composition:
1 dose of nasal spray contains 32 μg or 64 μg budesonide.
Action:
Glucocorticosteroid for nasal use with a strong local anti-inflammatory effect and low systemic effect after topical administration. After administration to the nose, Budesonide is absorbed through the mucosa of the nasal cavity and to some extent through the mucous membrane of the gastrointestinal tract. The systemic availability of budesonide is 33% of the intranasal dose of the drug. Budesonide shows increased systemic exposure in children. Budesonide kinetics at doses of clinical significance are proportional to the dose. With proteins, it is 85-90% bound. It is eliminated by metabolic processes, mainly involving the CYP3A4 enzyme. Over 90% of the dose undergoes rapid and intense first-pass metabolism through the liver. Metabolites are mainly excreted in the urine.
Contraindications:
Hypersensitivity to budesonide or other components of the drug.
Precautions:
Inhaled corticosteroids, in particular high-dose use for prolonged periods, may cause systemic effects. In children receiving nasal corticosteroids at the recommended doses, growth inhibition was observed - it is recommended to systematically control the growth of children. If growth is released, treatment should be revised to reduce the nasal corticosteroid dose, if possible, to the lowest dose to maintain effective symptom control. You should also consider referring the patient to the pediatrician. In addition, treatment with nasal corticosteroids at higher doses than recommended may result in clinically significant suppression of adrenal function. If higher doses are prescribed than recommended, during the periods of stress or before the planned surgery, additional corticosteroids with general effects should be considered. In the case of bacterial or fungal infections of the nasal mucosa, the drug should be administered only on condition of simultaneous antibacterial or antifungal treatment. During long-term continuous treatment, regular (eg every 6 months) regular monitoring of the nasal mucosa. Hepatic impairment affects the pharmacokinetics of corticosteroids; in the case of severe hepatic impairment, it may be necessary to consider systemic effects. It is not recommended for patients with nosebleeds, mouth sores, nose and eye infection, nose ulcers, in cases of recent surgery or nasal injuries until full recovery. Special care should be taken in patients with active or latent pulmonary tuberculosis and in patients with fungal and viral respiratory tract infections. The drug contains potassium sorbate, which can cause skin irritation (eg contact dermatitis).
Pregnancy and lactation:
The results of the research and experience after the marketing did not show an increased risk of general congenital malformations associated with the use of budesonide in inhaled or nasal form in early pregnancy. The use of budesonide during pregnancy requires an assessment of the relationship between the benefit for the mother and the risk for the fetus. Budesonide is excreted in human milk. However, budesonide used in therapeutic doses should not have any effect on the breastfed child. Budesonide can be used during breastfeeding.
Side effects:
Common: Injection site reactions such as irritation of the nasal mucosa, small amounts of bloody secretion, nosebleeds (immediately after use). Uncommon: hypersensitivity reactions of immediate or delayed type (urticaria, rash, pruritus, dermatitis, angioneurotic edema). Rarely; glaucoma, cataracts (with long-term treatment); osteoporosis (with long-term treatment); suppression of adrenal function and delayed growth in children. Very rare: ulceration of the nasal mucosa, nasal septum perforation; dysphonia.
Dosage:
Intranasally. The dose should be determined individually.The lowest dose that provides effective symptom control should be sought. The duration of treatment should be limited to the period of exposure to the allergen and depend on the type and specificity of the allergen. To achieve full therapeutic effect, regular use of the drug is essential. Allergic mucositis. Adults and children> 6 years: the recommended starting dose is 256 μg, once a day - in the morning or in 2 divided doses, in the morning and in the evening.Tafen Nasal 32 μg: 4 doses of 32 μg to each nostril once a day, in the morning or 2 doses (64 μg) for each nostril twice daily, in the morning and in the evening.Tafen Nasal 64 μg: 2 doses of 64 μg for each nostril once a day, in the morning or one dose (128 μg) for each nostril twice daily, in the morning and in the evening. Treatment of seasonal allergic rhinitis should be started as far as possible before the patient is exposed to allergens. Sometimes, additional treatment may be needed to relieve allergy symptoms in the eyes. The desired clinical effect occurs within approx. 1-2 weeks. After this time, the lowest dose should be chosen, which ensures that the symptoms disappear. Do not expect to increase the effectiveness of treatment at doses greater than 256 μg. Nasal polyps. Adults and children> 6 years: the recommended starting dose is 256 μg, once a day - in the morning or in two divided doses, in the morning and in the evening.Tafen Nasal 32 μg: 4 doses of 32 μg to each nostril once a day, in the morning or 2 doses (64 μg) for each nostril twice daily, in the morning and in the evening.Tafen Nasal 64 μg: 2 doses of 64 μg for each nostril once a day, in the morning or one dose (128 μg) for each nostril twice daily, in the morning and in the evening. Children should be treated under the supervision of an adult. After obtaining the desired clinical effect, the lowest dose should be chosen, which ensures that the symptoms disappear.