Description
Release form
Capsules with powder for inhalation.
Packing
120 pcs.
Pharmacological action
FORADIL COMBI
– a drug with anti-inflammatory and bronchodilator effects.
Formoterol is a selective agonist 2 -adrenoreceptors. It has a bronchodilatory effect in patients with both reversible and irreversible airway obstruction. The action of the drug occurs rapidly (within 1-3 minutes) and persists 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.
Inhibits the release of histamine and leukotrienes from mast cells. Animal experiments have shown some anti-inflammatory properties of formoterol, such as the ability to inhibit the development of edema and the accumulation of inflammatory cells.
In studies in humans, Foradil Combi has been shown to effectively prevent bronchospasm caused by inhaled allergens, exercise, cold air, histamine, or methacholine. Since the bronchodilating effect of Foradil Combi remains pronounced for 12 hours after inhalation, maintenance therapy, in which Foradil Combi is prescribed 2 times / day., 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), a stable course of formoterol causes a rapid onset of 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. It increases the production of lipocortin, which is an inhibitor of phospholipase A2, inhibits the release of arachidonic acid, inhibits the synthesis of arachidonic acid metabolism products – cyclic endoperoxides and prostaglandins. Prevents marginal accumulation of neutrophils, 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). It increases the number of active -Adrenoreceptors, restores the patient s reaction to bronchodilators, allowing them to be reduced in frequency, reduces swelling of the bronchial mucosa, mucus production, sputum formation and reduces airway hyperresponsiveness. Increases mucociliary transport.
The therapeutic effect of the drug in patients requiring treatment for corticosteroids 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.
Contraindications
Lactation (breastfeeding).
Active pulmonary tuberculosis.
Hereditary galactose intolerance, severe lactase deficiency and impaired glucose-galactose absorption syndrome.
Children under 6 years old.
Hypersensitivity to formoterol, budesonide, or any other component of the drug.
Special instructions
Powder for inhalation containing budesonide and formoterol in a ratio of 80 / 4.5 μg / dose is not indicated for patients with severe bronchial asthma.
Not intended for the initial selection of therapy in the early stages of treatment of bronchial asthma.
A gradual reduction in the dose of the drug is recommended before discontinuation of treatment.
An increase in the frequency of taking bronchodilators for emergency care indicates a worsening of the underlying disease and is the basis for reviewing the treatment of bronchial asthma.
To minimize the possibility of developing a fungal infection of the oropharynx, rinse your mouth with water after each inhalation.
There is no data on the use of the drug for the relief of acute attacks of bronchial asthma. Patients should be strictly advised to have medicines for emergency care at all times.
Treatment should not be started during an exacerbation of bronchial asthma.
As with any other inhalation therapy, paradoxical bronchospasm may occur (in this case, treatment tactics should be reviewed and alternative therapy prescribed if necessary).
The manifestation of a systemic effect during inhalation therapy is less likely than when using oral corticosteroids. However, it can occur when taking any inhaled GCS, especially when using high doses for a long period of time (it is very important to use the lowest effective dose of inhaled GCS, which provides optimal control of symptoms of bronchial asthma).
Doctors need to carefully monitor the growth of children and adolescents who take GCS in any dosage form for a long time, and evaluate the relationship between the benefits of GCS therapy and the possible risk of stunting.
In the event that adrenal function was impaired during previous systemic therapy with corticosteroids, precautions should be taken when transferring patients to inhaled treatment with the drug (in patients who discontinue therapy with oral corticosteroids, insufficient adrenal function may persist for a long time). In stressful situations, it is always necessary to remember the possibility of residual adrenal dysfunction in such patients.
There is no clinical data on the use of the drug or the combined use of formoterol and budesonide during pregnancy. In pregnant women, the drug should be used only if the expected benefit to the mother outweighs the potential risk to the fetus, while the lowest effective dose of budesonide necessary to maintain adequate control of symptoms of bronchial asthma should be used.
It is not known whether formoterol or budesonide passes into breast milk of women (the drug can be prescribed to lactating women only if the expected benefit to the mother is greater than any possible risk to the baby).
During treatment, it is recommended to monitor the concentration of K + in the blood serum, as well as glucose in patients with diabetes.
Contains lactose (less than 1 mg / dose). Typically, this amount does not cause problems in patients with lactose intolerance.
Composition of
In 1 capsule with formoterol inhalation powder contains:
Active ingredients: formoterol fumarate dihydrate.
Excipients: lactose monohydrate.
In 1 capsule with powder for inhalation of budesonide contains:
Active ingredients: budesonide
Excipients: lactose monohydrate.
Side effects
Adverse reactions observed in clinical studies distributed according to frequency of occurrence. The following criteria were used to estimate the frequency: very often (? 1/10) often (from? 1/100, <1/10) sometimes (? 1/1000, <1/100) rarely (? 1/10 000, <1 / 1000) is very rare (<1/10 000), including single messages. Within each group, adverse events are distributed in decreasing order of importance. – Formoterol Allergic reactions: very rarely – hypersensitivity reactions such as arterial hypotension, urticaria, angioedema, itching, exanthema. From the side of the central nervous system: often – headache, tremors sometimes – agitation, anxiety, increased irritability, insomnia, dizziness. From the cardiovascular system: often – palpitations sometimes – tachycardia is very rare – peripheral edema. From 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 have been identified with the use of other dosage forms, which include formoterol: cough and rash. When applying formoterol in clinical practice, the following changes in laboratory results were noted: hypokalemia, hyperglycemia, lengthening of the QT interval (during ECG). – Budesonide From the endocrine system: rarely – suppression of adrenal cortex function, Cushing’s syndrome, hypercorticism, growth retardation in children and adolescents. From the side 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: a decrease in bone mineral density. From the respiratory system: often – cough rarely – paradoxical bronchospasm, candidiasis of the mucous membrane of the oral cavity and larynx, pharyngeal irritation, dysphonia, which disappears after discontinuation of budesonide therapy or a decrease in the dose of the drug. In a three-year clinical study using budesonide in patients with COPD, an increase in the incidence of subcutaneous hematomas (10%) and pneumonia (6%) was observed compared with the placebo group (4% and 3%, with p <0. 001 and p Drug Interactions – Formoterol Formoterol (like other beta2-adrenostimulants) should be used with caution in patients receiving drugs such as quinidine, disopyramide, procainamide, phenothiazines, antihistamines, other inhibitors, M inhibitors and other inhibitors , which are known to extend the QT interval, because in these cases, the effect of adrenostimulants on the cardiovascular system may be enhanced. When using drugs that can extend the QT interval, the risk of ventricular arrhythmias increases. The simultaneous use of other sympathomimetic drugs can lead to aggravation of side effects of formoterol. The simultaneous use of xanthine derivatives, corticosteroids, or diuretics may enhance the potential hypokalemic effect of beta2-adrenergic agonists. Hypokalemia may increase the predisposition to the development of cardiac arrhythmias in patients receiving digitalis preparations. Beta-blockers can weaken the effect of formoterol. In this regard, formoterol should not be used in conjunction with beta-blockers (including eye drops), unless the use of such a combination of drugs does not force any emergency reasons. – Budesonide Use of the drug together with CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, ritonavir, nelfinavir, amiodarone, clarithromycin) can lead to a decrease in budesonide metabolism and an increase in its systemic concentration. When prescribing budesonide along with CYP3A4 inhibitors, adrenal cortex function should be regularly monitored and, if necessary, change the dose of budesonide. When using budesonide together with drugs that induce CYP3A4 (for example, rifampicin, phenobarbital, phenytoin), an increase in the metabolism of budesonide and a decrease in its systemic concentration are possible. Methandrostenolone, estrogens enhance the effect of budesonide. Overdose – Formoterol Symptoms: an overdose of formoterol can presumably lead to phenomena characteristic of the excessive action of other beta2-adrenergic agonists, such as nausea, vomiting, headache, tremor, drowsiness, palpitations, tachycardia, ventricular arrhythmias, metabolic acidosis, hypokalemia, hyperglycemia. Treatment: supportive and symptomatic therapy is indicated. In severe cases, hospitalization is required. The use of beta-blockers may be considered, but only subject to extreme caution and under close medical supervision, as the use of such drugs can cause bronchospasm. – Budesonide 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. In case of an overdose of budesonide, treatment can be continued in doses sufficient to maintain a therapeutic effect. Storage conditions At a temperature not exceeding 25 ° C. Expiration 2 years. active substance Budesonide, Formoterol set Dosage form capsule Prescription Children prescribed by a doctor, Pregnant women prescribed by a doctor, Adults prescribed by a doctor, Children over 6 years old Novartis Farma Stein AG, Switzerland