Budesonide - instructions for use, reviews, analogs and forms of release (powder for inhalation Ishihler, aerosol, solution Nativ in the nebulizer) a hormonal drug for the treatment of bronchial asthma in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Budesonide. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Budesonide in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues Budesonide in the presence of existing structural analogues.Use for the treatment of bronchial asthma and ulcerative colitis in adults, children, as well as in pregnancy and lactation. Composition of the hormonal drug.

Budesonide - Glucocorticosteroid agent (SCS). With inhalation application has anti-inflammatory, antiallergic and antiexcadative effect, which leads to a decrease in bronchial obstruction. The mechanism of action is to inhibit the release of inflammatory mediators and allergies, as well as to reduce the reactivity of the airways to their action. In the process of treatment, the function of breathing improves, the severity and frequency of dyspnea, attacks of suffocation, coughing significantly decrease. The maximum clinical effect develops after 1-2 weeks of therapy.

The exact mechanism of action of budesonide in the treatment of ulcerative colitis is not fully established. Budesonide inhibits many inflammatory processes, including cytokine production, activation of inflammatory infiltrate cells, and expression of adhesive molecules on endothelial and epithelial cells. In doses that clinically correspond to prednisolone,budesonide causes significantly less suppression of the hypothalamic-pituitary-adrenal axis and has less effect on inflammatory markers.

Data from clinical pharmacological and pharmacokinetic studies indicate that the mechanism of action of budesonide upon ingestion is based on local action in the intestine.

Composition

Budesonide (budesonide) + auxiliary substances.

Pharmacokinetics

When inhaled into the bronchioles penetrates 30-35% of the dose. Bioavailability when entering the lung is about 73%. 25-30% fall into the digestive tract. Bioavailability in the oral route of administration is 10.7%. Budesonide is rapidly excreted from the body. After ingestion in a special dosage form, approximately 90% of budesonide is metabolized by "first passage" through the liver and only about 10% is systemic accessibility. Binding to plasma proteins is 85-90% on average. Budesonide undergoes extensive biotransformation in the liver with the formation of metabolites with low glucocorticoid activity. Glucocorticoid activity of the main metabolites (6beta-hydroxybudesonide and 16alpha-hydroxyprednisolone),does not exceed 1% of the activity of budesonide itself. The metabolism of budesonide is predominantly mediated by CYP3A isoenzymes. The rate of excretion of budesonide is limited by the degree of absorption.

Indications

• A bronchial asthma requiring maintenance therapy with glucocorticoids;
• for induction of remission in patients with mild or moderate active ulcerative colitis.

Forms of release

Powder for inhalation dosed Ishihler 200 mcg.

Aerosol is dosed (sometimes mistakenly called a spray).

Solution for inhalation budesonide Nativ in the nebulizer.

Other dosage forms, whether it be a suspension for inhalations, tablets or capsules, at the time of publication of the drug in the Directory did not exist.

Instructions for use and dosage

Powder or aerosol for inhalation

Inhalation, the dose is set individually, depending on the degree of severity. Adults - 1-2 doses (forte) 2 times a day. The highest daily dose is 1.6 mg.

Children - 1-2 doses (mite) 2 times a day. The highest daily dose is 0.4 mg.

Solution for inhalation

Inhalation.

The dosage of Budesonide-native must be individual. The initial dose in adults for the treatment of bronchial asthma and COPD is 1-2 mg per day. The dose with maintenance treatment is 0.5-4 mg per day.

After receiving the effect, the dose is reduced to the minimum effective dose necessary to maintain a stable state. In some cases, the dose of the drug may be increased in patients in whom treatment is necessary to achieve a rapid therapeutic effect.

If the patient took the GCS orally, the transfer to treatment with Budesonide Nativ should be done with a stable state of health of the patient, for 10-14 days combine inhalation and reception of GCS inside.

Within 10 days, it is recommended to take high doses of budesonide-native against the background of taking oral GCS in a selected dose. In the future, the dose of oral GCS should be gradually reduced (for example, 2.5 mg of prednisolone) to the lowest possible level. In many cases, it is possible to completely abandon the administration of oral GCS. There are no data on the use of budesonide in patients with renal insufficiency or liver dysfunction. Since the excretion of budesonide occurs due to biotransformation in the liver, an increase in the duration of action of the drug in patients with severe hepatic cirrhosis can be expected. When appointing patients with cirrhosis of the liver requires more careful observation.

Children older than 16 years - the initial dose of 0.25-0.5 mg per day. If necessary, the dose may be increased to 1 mg per day. The maintenance dose is 0.25-2 mg per day.

The drug is used with a nebulizer. The bottle contains 1 single dose.

Instructions for using the nebulizer

Open the vial with the drug. Fill the nebulizer through the top hole with the required amount of the drug. Nebulization should be performed in accordance with the instructions for the type of nebulizer used.

The volume of budesonide solution delivered to the patient's lungs by a nebulizer is variable and depends on several factors, including the following:

• time of inhalation;
• fill level of the camera;
• technical characteristics of the nebulizer;
• the ratio of volume upon inspiration / expiration and the patient's breathing volume;
• the use of a mouthpiece or mask.

Note:

1. After each inhalation, rinse your mouth with water.
2. If the patient uses a mask, he should make sure that when the mask is inhaled, the mask fits tightly to the face. After inhalation, wash face.

Cleaning

The nebulizer chamber should be cleaned after each use.

The nebulizer chamber and the mouthpiece or mask are washed with warm water, using a mild detergent or in accordance with the manufacturer's instructions.

Side effect

• irritation of mucous membranes of pharynx, oral cavity, nose;
• candidiasis;
• bronchospasm;
• allergic exanthema;
• red stria;
• petechia;
• ecchymosis;
• steroid acne;
• delayed healing of wounds;
• contact dermatitis;
• aseptic necrosis of bone (femur and head of humerus);
• glaucoma;
• cataract;
• depressive syndrome;
• irritability;
• euphoria;
• discomfort in the stomach;
• duodenal ulcer;
• pancreatitis;
• Cushing's syndrome;
• moonlike face;
• obesity of the trunk;
• decreased glucose tolerance;
• diabetes;
• insufficiency of adrenal cortex function;
• growth retardation in children;
• violation of the secretion of sex hormones (eg, amenorrhea, hirsutism, impotence);
• sodium retention with edema formation;
• increased release of potassium;
• arterial hypertension;
• increased risk of thrombosis;
• vasculitis (withdrawal syndrome after long-term therapy);
• violation of the immune response (eg, increased risk of infection).

Contraindications

• hypersensitivity to budesonide;
• cirrhosis of the liver;
• infectious diseases of the intestine;
• lactation period (breastfeeding);
• children and adolescents up to 7 years;
• hypersensitivity to budesonide.

Application in pregnancy and lactation

In the form of inhalations, the use of budesonide during pregnancy is possible when the intended benefit to the mother exceeds the potential risk to the fetus. If it is necessary to use during the lactation period, breastfeeding should be stopped, due to the lack of data on the isolation of budesonide with breast milk.

Contraindicated oral administration during pregnancy and lactation (breastfeeding).

Use in children

The effectiveness and safety of the drug in children under the age of 7 years has not been studied.

special instructions

For inhalation use

With caution apply in patients with pulmonary tuberculosis, as well as with chicken pox.

Budesonide is not intended for relief of acute attacks of asthma in bronchial asthma. It is not recommended for intermittent disease.

Replacement of systemic glucocorticosteroid funds by inhalation is carried out gradually.

The effectiveness and safety of budesonide in children under the age of 7 years has not been studied.

For oral administration

Use with caution in patients with diagnosed disorders of liver and kidney function, with diabetes mellitus, arterial hypertension, gastrointestinal diseases, osteoporosis, glaucoma or cataracts, with concomitant verified mental disorders or in the presence of mental illness in first-degree relatives.

The use of budesonide can lead to an exacerbation of the inflammatory response in patients with an infectious pathology, a decrease in the immune response to vaccines.

Drug Interactions

Cimetidine and Omeprazole have no clinically significant effect on the pharmacokinetics of budesonide when taken orally. However, under the influence of cimetidine, a slowdown in the metabolism of budesonide in the liver is possible.

Budesonide is characterized by lower systemic bioavailability compared to other GCS, so the drug interaction may be less pronounced than many other drugs in this class.

The risk of drug interactions may be increased in the elderly and in patients with impaired renal or hepatic function.

Analogues of medicinal product Budesonide

Structural analogs for the active substance:

• Apulein;
• Benacap;
• Benacorte;
• Benarin;
• Budenit;
• Budenofalk;
• Budesonid Ishihyler;
• Budesonide Nativ;
• Budiere;
• Budostere;
• Cortiment;
• Novopulmon E Novolayzer;
• Pulmicort;
• Pulmicort Turbuhaler;
• Tafen nasal;
• Tafen Novolayzer.

Analogues on the curative effect (funds for the treatment of bronchial asthma):

• Ambroxol;
• Aminophylline;
• Arthromax;
• Ascoril;
• Asthmopent;
• Atrovent;
• Acetylcysteine;
• ATSTS;
• Beklazone;
• Beclomethasone;
• Bechotide;
• Benacorte;
• Berodual;
• Berotek;
• Bromhexine;
• Broncholitin;
• Ventolin;
• Hydrocortisone;
• Histaglobin;
• Dexazone;
• Dexamethasone;
• Josette;
• Diprospan;
• Zaditen;
• Intal;
• Carbactin;
• Ketotifen;
• Clemastine;
• Clenbuterol;
• Cortisone;
• Cromolyn;
• Lazolvan;
• Oxys Turbuhaler;
• Platyphylline;
• Plibékot;
• Polyoxidonium;
• Polcortolone;
• Prednisolone;
• Salbutamol;
• Salmeterol;
• Seretid;
• Seredid Multidisk;
• Symbicort Turbuhaler;
• Solutan;
• Theotard;
• Theophylline;
• Triamcinolone;
• Fenoterol;
• Fluimucil;
• Fluidite;
• Formoterol;
• Foradyl;
• Fortecortin;
• Haliksol;
• Erbisol;
• Erespal;
• Eufillin;
• Eufilong.

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