Foradil combi capsules 12mcg/200 mcg №120

Composition

Formoterol fumarate dihydrate, Budesonide

Excipients: lactose monohydrate.

Packing

120 pieces

Mechanism of action

FORADIL COMBI - a drug with anti-inflammatory and bronchodilatory effects.

Selective agonist β₂-adrenoreceptors. It has a bronchodilator effect in patients with both reversible and irreversible airway obstruction. The action of the drug occurs quickly (within 1-3 minutes) and lasts for 12 hours after inhalation. When using the drug in therapeutic doses, the effect on the cardiovascular system is minimal and is noted only in rare cases.

Slows down the release of histamine and leukotrienes from mast cells. In animal experiments, some of the anti-inflammatory properties of formoterol were shown, such as the ability to inhibit the development of edema and the accumulation of inflammatory cells.

In studies conducted in humans, it is shown that Foradil Combi effectively prevents bronchospasm caused by inhaled allergens, exercise, cold air, histamine or methacholine.Since the bronchodilator effect of Foradil Kombi remains pronounced for 12 hours after inhalation, supportive therapy in which Foradil Combi prescribe 2, allows in most cases to provide the necessary control of bronchospasm in chronic lung diseases both during the day and at night.

In patients with chronic obstructive pulmonary disease (COPD) of a stable course, formoterol causes a rapid onset of a bronchodilator effect and an improvement in quality of life parameters.

Budesonide is a glucocorticosteroid (GCS) for inhalation use, with virtually no systemic effect. Budesonide has anti-inflammatory, anti-allergic and immunosuppressive effects. Increases the production of lipocortin, which is an inhibitor of phospholipase A2, inhibits the release of arachidonic acid, inhibits the synthesis of metabolites of arachidonic acid metabolism - cyclic endoperexia and prostaglandins. Warns neutrophil marginal accumulation, reduces inflammatory exudation and cytokine production, inhibits macrophage migration, reduces the severity of infiltration and granulation processes, the formation of chemotaxis substance (which explains the effectiveness in "late" allergy reactions); inhibits the release of inflammatory mediators from mast cells (immediate allergic reaction). Increases the number of "active" β-adrenergic receptors,restores the patient's response to bronchodilators, allowing them to reduce the frequency of their use, reduces swelling of the bronchial mucosa, mucus production, sputum formation and reduces airway hyperreactivity. Increases mucociliary transport.

The therapeutic effect of the drug in patients requiring treatment of GCS, develops on average within 10 days after the start of therapy. With regular use in patients with bronchial asthma, budesonide reduces the severity of chronic inflammation in the lungs, and thus improves pulmonary function, the course of bronchial asthma, reduces bronchial hyperreactivity and prevents exacerbations of the disease.

Indications and usage

Bronchial asthma:

- insufficiently controlled intake of inhaled corticosteroids and beta₂short-acting agonists as on-demand therapy;

- adequately controlled by inhaled corticosteroids and beta₂long-acting agonists.

Chronic obstructive pulmonary disease (COPD) (with proven efficacy of GCS).

Contraindications

- lactation period (breastfeeding);

- active pulmonary tuberculosis;

- hereditary intolerance to galactose, severe lactase deficiency and impaired glucose-galactose absorption syndrome;

- children's age up to 6 years;

- hypersensitivity to formoterol, budesonide or any other component of the drug.

Dosage and administration

Formoterol and budesonide are intended for inhalation use. Preparations are capsules with powder for inhalation, which should be used only with the help of a special device - an arolizer, which is included in the package.

Formoterol and budesonide should be administered individually, in the minimum effective dose.

When controlling the symptoms of bronchial asthma during therapy with formoterol, it is necessary to consider the possibility of gradually reducing the dose of the drug. Reducing the dose of formoterol is carried out under regular medical supervision of the patient. Against the background of exacerbation of asthma should not begin treatment with formoterol or change the dosage of the drug. Formoterol should not be used for relief of acute attacks of bronchial asthma.

When prescribing therapy to a patient using an inhalation device, one should gradually select (titrate) the dose of the drug to doses sufficient to maintain the therapeutic effect.

Foradil is intended for inhalation use. adults and children aged 6 and over. The drug is a powder for inhalation, used with a special device - airliner, which is included in the package.

Pre-inhalation of beta-adrenostimulyatorov expands the bronchi, improves the flow of budesonide into the respiratory tract and enhances its therapeutic effect.Therefore, for maintenance therapy of bronchial asthma and COPD, inhalation of formoterol is first carried out, then inhalation of budesonide.

1. The dose of formoterol for regular maintenance therapy is 12-24 μg (contents of 1-2 capsules) 2 times / day. Do not exceed the maximum recommended dose of the drug for adults (48 mg / day.).

Given that the maximum daily dose of formoterol is 48 μg, if necessary, you can additionally use 12-24 μg / day. to relieve symptoms of bronchial asthma. If the need to use additional doses of the drug ceases to be episodic (for example, it becomes more often than 2 days a week), the patient should be advised to consult with a doctor about the revision of therapy, as this may indicate a worsening course of the disease.

2. Maintenance dose of budesonide for adult patients is 400-800 mcg / day. in 2 doses (200-400 mg each 2 times / day).

With exacerbation of asthma during the transfer from oral GCS to inhaled or with a decrease in the dose of oral GCS, budesonide can be administered at a dose of 1600 mcg / day. in 2-4 receptions.

If the dose of budesonide (divided into several doses) is less than 400 mcg / day, there is no need to use the drug.

Pre-inhalation of beta-adrenostimulyatorov expands the bronchi, improves the flow of budesonide into the respiratory tract and enhances its therapeutic effect.Therefore, for the maintenance treatment of bronchial asthma, first inhalation of formoterol is carried out, then inhalation of budesonide.

1. The dose of formoterol for regular maintenance therapy is 12 mcg 2 times / day. The maximum recommended dose of the drug is 24 mg / day.

2. The dose of budesonide for regular maintenance therapy is 100-200 mcg 2 times / day. If necessary, the dose of budesonide can be increased to the maximum - 800 mg / day.

In order to ensure the correct use of drugs, a doctor or other medical professional must show the patient how to use the inhaler; explain to the patient that it is necessary to use capsules with powder for inhalation only with the help of an airliser; warn the patient that the capsules are intended for inhalation use only and are not intended for ingestion. In children and adolescents, inhaled budesonide and formoterol should be supervised by adults. It is necessary to make sure that the child correctly performs the inhalation technique. It is important for the patient to understand that, due to the destruction of the gelatin capsule, small pieces of gelatin can be inhaled through the mouth or throat as a result of inhalation. In order to minimize this phenomenon, one should not pierce the capsule more than 1 time.

Remove the capsule from the blister pack immediately before use.

Rinsing the mouth with water after inhalation of budesonide can prevent irritation of the mucous membranes of the mouth and pharynx, as well as reduce the risk of developing systemic adverse events.

Instructions for the use of aerolizer

one.Remove cap from aerolizer.

2. Hold the aerolizer firmly by the base and turn the mouthpiece in the direction of the arrow.

3. Place the capsule in the cell located at the base of the aerolizer (it has the shape of a capsule). It should be remembered that removing the capsule from a blister pack should be immediately prior to inhalation.

4. Turning the mouthpiece, close the aeolizer.

5. Holding the aerolizer in a strictly upright position, push the blue buttons on the sides of the aerolizer once to the end. Then let them go.

At this stage, when the capsule is punctured, it may collapse, as a result of which small pieces of gelatin can get into the mouth or throat. Since gelatin is edible, it causes no harm. In order for the capsule not to collapse completely, the following requirements should be fulfilled: do not pierce the capsule more than once; follow the rules of storage; remove the capsule from the blister only immediately prior to inhalation.

6. Make a full exhalation.

7. Take the mouthpiece in your mouth and slightly tilt your head back. Grip the mouthpiece tightly with your lips and take a quick, even, deep breath. In this case, the patient should hear the characteristic rattling sound created by rotating the capsule and spraying the powder. If there was no characteristic sound, then you need to open the airliner and see what happened to the capsule. Perhaps she was stuck in a cell. In this case, you need to carefully remove the capsule.In no case do not try to release the capsule by repeated pressing the buttons on the sides of the airliser.

8. If a characteristic sound is heard during inhalation, you should hold your breath as long as possible. At the same time, remove the mouthpiece from the mouth. Then exhale. Open the aeroliser and see if there is any powder remaining in the capsule. If powder remains in the capsule, repeat the steps described in paragraphs 6–8.

9. After the end of the inhalation procedure, open the airliner, take out the empty capsule, close the mouthpiece and close the aerializer with a cap.

To remove powder residues, wipe the mouthpiece and the cell with a dry cloth. You can also use a soft brush.

Allergic reactions: very rarely, hypersensitivity reactions, such as arterial hypotension, urticaria, angioedema, pruritus, exanthema.

From the side of the central nervous system: often - headache, tremor; sometimes - agitation, anxiety, irritability, insomnia, dizziness.

Since the cardiovascular system: often - a feeling of heartbeat; sometimes - tachycardia; very rarely - peripheral edema.

On the part of the respiratory system: sometimes - bronchospasm, including paradoxical, irritation of the mucous membrane of the pharynx and larynx.

From the digestive system: very rarely - nausea, taste disturbances.

From the musculoskeletal system: sometimes - muscle cramps, myalgia.

The following side effects were found when using other dosage forms, which include formoterol: cough and rash.

When using formoterol in clinical practice, the following changes in the results of laboratory tests were noted: hypokalemia, hyperglycemia, lengthening of the QT interval (when conducting an ECG).

On the part of the endocrine system: rarely - suppression of the function of the adrenal cortex, Cushing's syndrome, hypercorticism, growth retardation in children and adolescents.

On the part of the organ of vision: rarely - cataract, glaucoma.

Allergic reactions: rarely, hypersensitivity reactions, rash, urticaria, angioedema, pruritus.

From the side of the central nervous system: rarely, unusual behavior, including depression (described in children).

From the musculoskeletal system: decrease in bone mineral density.

On the part of the respiratory system: often cough; rarely - paradoxical bronchospasm, candidiasis of the mucous membrane of the oral cavity and larynx, pharynx irritation, dysphonia, disappearing after cessation of budesonide therapy or lowering the dose of the drug.

In a three-year clinical study with budesonide in patients with COPD, there was an increase in the incidence of subcutaneous hematomas (10%) and pneumonia (6%) compared with the placebo group (4% and 3%, with p <0.001 and p <0.01, respectively)

Symptoms: an overdose of formoterol presumably can lead to phenomena characteristic of the excess action of other beta₂-adrenomimetikov, such as nausea, vomiting, headache, tremor, drowsiness, palpitations, tachycardia, ventricular arrhythmias, metabolic acidosis, hypokalemia, hyperglycemia.

Treatment: shown to support and symptomatic therapy. In serious cases, hospitalization is necessary. The use of beta-blockers can be considered, but only under the condition of extreme caution and under close medical supervision, since the use of such funds can cause bronchospasm.

Budesonide has low acute toxicity. A single inhalation of a large amount of the drug can lead to a temporary suppression of the function of the hypothalamic-pituitary-adrenal system, which does not require emergency therapy. With an overdose of budesonide, treatment can be continued in doses sufficient to maintain a therapeutic effect.

At temperatures not above 25 ° C.