Benodil suspension for inhalation 0.25mg/ml 2ml No. 20

Benode contains a potent non-halogenated GCS - budesonide, intended for the treatment of bronchial asthma in patients for whom the use of inhalers with compressed air atomization of medicinal substances or in the form of a dry powder dosage form is ineffective or impractical.

Benode is also recommended for use in infants and children with croup (a complication of acute viral upper respiratory tract infection, also known as laryngotracheobronchitis or false croup), which is an indication for hospitalization.

Composition

Active ingredient: budesonide;

1 ml of suspension for nebulization contains 0.25 mg or 0.5 mg of budesonide;

Excipients: sodium chloride, sodium citrate, sodium edetate, polysorbate 80, citric acid, water for injections.

Contraindication

Hypersensitivity to budesonide or any other ingredient of the drug.

Method of application

The drug is intended for use by spraying through a compressor-type nebulizer.

Application features

Pregnant women

The administration of budesonide during pregnancy requires careful weighing of the benefits to the woman against the risk to the fetus.

Children

Benode should be used in children aged 6 months and older according to indications.

Drivers

Benode has no or negligible influence on the ability to drive and use machines.

Overdose

Benode contains 0.1 mg/ml sodium edetate, which has been shown to cause bronchoconstriction at levels above 1.2 mg/ml. Acute overdose of Benodeil, even at excessive doses, is unlikely to be a clinically significant problem. Symptoms of acute budesonide intoxication are unknown. In acute overdose, suppression of the hypothalamic-pituitary-adrenal axis may occur. In cases of chronic overdose, atrophy of the adrenal cortex may develop. Signs and symptoms of hypercorticism may occur. Stress adaptation disorders may also occur.

Treatment of overdose. In case of chronic overdose, emergency treatment is not required. Continued inhalation therapy with Benode in the recommended dose is accompanied by restoration of the function of the hypothalamic-pituitary-adrenal system within 1-2 days.

During stress, there may be a need for "GCS protection" - additional administration of a high dose of hydrocortisone.

In the event of adrenal cortical atrophy, the patient should be classified as steroid-dependent and a maintenance dose of systemic corticosteroids should be prescribed.

Benode contains 0.1 mg/ml sodium B, which has been shown to cause bronchospasm at concentrations above 1.2 mg/ml.

Side effects

Description of selected adverse reactions: Oropharyngeal candidiasis occurs as a result of exposure to drug residues. Rinsing the mouth with water after each use of the drug minimizes this risk.

As with any inhalation therapy, paradoxical bronchospasm may develop very rarely.

Interaction

Limited data on a similar interaction with high doses of inhaled budesonide show that with simultaneous use of itraconazole at a dose of 200 mg once a day, the administration of inhaled budesonide (single dose of 1000 μg) leads to a significant increase in the concentration of the substance in the blood plasma (on average 4 times).

Storage conditions

Store in the original packaging at a temperature not exceeding 30 ° C. Keep out of the reach of children.

An opened container should be used within 12 hours.

After opening the envelope, the containers contained therein should be used within 3 months.

Shelf life - 3 years.