Budesonide-Nativ solution for inhalation of 0.25 mg ml N10
Condition: New product
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Active ingredients
Budesonide
Release form
Solution
Composition
Active ingredient: budesonide 0.25 mg / ml. Excipients: methyl parahydroxybenzoate (nipagin) - 0.5 mg, succinic acid - 1.5 mg, disodium edetate (Trilon B) - 0.5 mg, macrogol 400 (polyethylene oxide-400) - 350 mg, propylene glycol - 200 mg, water purified - up to 1 ml.
Pharmacological effect
Synthetic glucocorticosteroid (GCS) for local use, has anti-inflammatory, anti-allergic and immunosuppressive effects. Increases the production of lipomodulin, which is an inhibitor of phospholipase A, inhibits the release of arachidonic acid, inhibits the synthesis of products of the metachism of arachidonic acid - cyclic endoperexia and prostaglandins (Pg). Warns neutrophil marginal accumulation, reduces inflammatory exudation and cytokine production, inhibits macrophage migration, reduces the intensity of infiltration processes, the formation of chemotaxis substance, and inhibits the release of inflammatory mediators from mast cells. Increases the number of "active" beta-adrenergic receptors, restores the bronchial response to bronchodilators, reducing the frequency of their use, reduces swelling of the mucous membrane of the bronchi, mucus production, sputum formation and reduces airway hyperreactivity. Improves mucociliary transport. It is well tolerated with long-term treatment, it does not possess mineralocorticosteroid activity, and in recommended doses it has almost no systemic effect. The therapeutic effect begins several hours after inhalation. The maximum therapeutic effect develops only a few days after the administration of therapeutic doses of inhaled budesonide, on average, 5-7 days. Inhalation of budesonide can prevent an attack of bronchial asthma, but does not stop acute bronchospasm.
Indications
Bronchial asthma (BA), requiring maintenance treatment of GCS, chronic obstructive pulmonary disease (COPD).
Contraindications
Hypersensitivity to drug components, children's age up to 16 years.
Use during pregnancy and lactation
Caution should be exercised during periods of pregnancy and lactation.The purpose of the drug is rational if the benefits of its use for the mother outweigh the potential risk to the fetus or child. Data on the allocation of budesonide with breast milk are not available.
Dosage and administration
The dosage of the drug "Budesonide-native" must be individualized. The initial dose in adults for the treatment of asthma and COPD is 1 to 2 mg per day. The dose for maintenance treatment is 0.5-4 mg per day. After obtaining the effect, the dose is reduced to the minimum effective dose necessary to maintain a stable state. In some cases, in patients whose treatment requires the achievement of a rapid therapeutic effect, the dose of the drug may be increased. If the patient has taken GCS orally, the transfer to the treatment with Budesonide-native should be carried out with a stable state of health of the patient, for 10-14 days they combine inhalation and taking GCS orally. For 10 days, it is recommended to take high doses of Budesonide-Native while taking oral glucocorticosteroids in the appropriate dose. In the future, the dose of oral glucocorticosteroids should be gradually reduced (for example, 2.5 mg of prednisolone) to the lowest possible level. In many cases, it is possible to completely refuse to take oral glucocorticosteroids. There is no data on the use of budesonide in patients with renal insufficiency or abnormal liver function. Since the elimination of budesonide occurs due to biotransformation in the liver, an increase in the duration of the drug's action in patients with severe liver cirrhosis can be expected. Children older than 16 years: initial dose of 0.25-0.5 mg / day. If necessary, the dose can be increased to 1 mg / day. Maintenance dose is 0.25-2 mg / day. When prescribing to patients with cirrhosis of the liver requires more careful monitoring. The drug is used with a nebulizer. The bottle contains 1 single dose.
Side effects
Often (> 1/100): cough, dry mouth, hoarseness, dysphonia, irritation of the mucous membranes of the oral cavity and pharynx, candidal stomatitis, dryness of the pharyngeal mucosa, headache, nausea. Rarely (less than 1/1000): formation of bruises or thinning of the skin, unpleasant taste sensations, paradoxical bronchospasm (for prophylaxis - a combination of inhalations with beta2-adrenomimetics), esophageal candidiasis. High doses of the drug can lead to the development of systemic side effects of depletion of the adrenal cortex, hyperglycemia, arterial hypertension.
special instructions
Often (> 1/100): cough, dry mouth, hoarseness, dysphonia, irritation of the mucous membranes of the oral cavity and pharynx, candidal stomatitis, dryness of the pharyngeal mucosa, headache, nausea. Rarely (less than 1/1000): formation of bruises or thinning of the skin, unpleasant taste sensations, paradoxical bronchospasm (for prophylaxis - a combination of inhalations with beta2-adrenomimetics), esophageal candidiasis. High doses of the drug can lead to the development of systemic side effects of depletion of the adrenal cortex, hyperglycemia, arterial hypertension.