Treatment of: seasonal and perennial allergic rhinitis and nasal polyps in adults and children over 6 years of age; non-allergic rhinitis in adults.
Composition:
1 dose of nasal spray contains 50 μg of micronized budesonide.
Action:
Glucocorticosteroid for nasal use with a strong local anti-inflammatory effect. The product reduces the severity of the symptoms of allergic rhinitis, inhibits the early and late phase of the allergic reaction and reduces inflammatory changes in the upper respiratory tract. In addition, Budesonide has been shown to constrict blood vessels, reduce the amount of plasma in the extracellular space and reduce inflammatory edema. After intranasal administration 20% of the dose reaches the systemic circulation, the maximum plasma concentration occurs within 0.7 h. Symptoms of the disease decrease within 2-3 days after administration. Systemic bioavailability of budesonide is low because 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 ingredients of the preparation.
Precautions:
Particularly cautiously use in patients whose general corticosteroid therapy is replaced by nasal treatment due to the risk of adrenal insufficiency. Special care should be taken in patients with viral or mycotic infection in the nose, in patients with pulmonary tuberculosis and in patients with bronchial asthma (rapid reduction in the dose of oral corticosteroids may cause severe exacerbation of the disease). The preparation should be used with caution in patients who have recently undergone nasal or nasal surgery (the preparation inhibits wound healing). In patients with severe hepatic impairment (cirrhosis) or patients with hypothyroidism, the systemic effects of budesonide may be increased. In children receiving nasal corticosteroids at the recommended doses, growth disorders have been reported. It is recommended to regularly measure the growth in children who have been on long-term treatment with nasal corticosteroids. If growth slows down, treatment should be re-evaluated and dose reduction should be considered to the smallest one that controls the symptoms of the disease. The propylene glycol and p-hydroxybenzoic acid esters in the preparation may cause skin irritation, allergic reactions and bronchospasm.
Pregnancy and lactation:
During pregnancy and breastfeeding, use only if the benefits for the mother outweigh the potential risk to the fetus or the fed baby. Infants whose mothers used budesonide during pregnancy should be carefully observed for symptoms of adrenal insufficiency. If long-term use of the drug is necessary, breastfeeding should be discontinued.
Side effects:
Common: nosebleed, irritation of the mucous membrane of the nose and throat, coughing, sneezing, dry mouth, indigestion. Uncommon: nausea, contact dermatitis, urticaria, rash, pruritus, angioneurotic edema. Rare: increased intraocular pressure, glaucoma. Very rare: perforation of the nasal septum, ulceration of the nasal mucosa. Patients using high doses of nasal budesonide for a long time or in particularly sensitive patients may experience symptoms of excessive secretion of adrenocortical hormones.
Dosage:
Adults and children over 6 years: the initial dose is 400 μg per day, ie: 2 doses of 50 μg to each nostril twice a day. The maintenance dose is 200 μg per day ie: 1 dose of 50 μg to each nostril twice a day or 2 doses (100 μg) to each nostril once a day in the morning. The lowest effective maintenance dose to control the symptoms of the disease should be determined.
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