Foradil Combi capsules with powder for inhalation 12/400 mcg 120 pcs. (budesonide, Formoterol)

Release form

Set of capsules with powder for inhalation.



packaging 120 pcs

Pharmacological action

Foradil Combi is a combined bronchodilator containing topical corticosteroids and selective beta2-adrenostimulator, which exhibit an additive effect in reducing the frequency of exacerbations of bronchial asthma.

Budesonide - inhaled GCS, in recommended doses it has an anti-inflammatory effect (has a lower frequency of side effects than systemic GCS).

Formoterol is a selective beta2-adrenergic receptor agonist, causing relaxation of the smooth muscles of the bronchi in patients with reversible airway obstruction. The bronchodilator effect occurs quickly, within 1-3 minutes after inhalation, and persists for 12 hours after single dose inhalation.

Adding formoterol to budesonide reduces the severity of symptoms of bronchial asthma, improves bronchial function and reduces the frequency of exacerbations of the disease.

The effect on the function of the bronchi corresponds to that of the combination of the single drugs budesonide and formoterol and exceeds the effect of one budesonide. The drug has good tolerance.

Indications

Bronchial asthma:

- insufficiently controlled by the administration of short-acting inhaled corticosteroids and beta2-agonists as therapy on demand

- adequately controlled by long-acting inhaled corticosteroids and beta2-agonists.

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

Contraindications

- lactation (breastfeeding)

- active pulmonary tuberculosis

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

- children's age up to 6 years of sensitivity to other component of the drug.

Special instructions

Inhalation powder containing budesonide and formoterol in a ratio of 80 / 4.5 mcg / 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

Formoterol fumarate dihydrate, budesonide

Excipients: lactose monohydrate.

Side effects

Adverse reactions observed in clinical trials are distributed according to the 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, tremor sometimes - agitation, anxiety, 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 using formoterol in clinical practice, the following changes in laboratory results were noted: hypokalemia, hyperglycemia, prolongation 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 with 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 anti-inflammatory drugs, antidepressants and other anti-inflammatory drugs , 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.

Concurrent use of xanthine derivatives, GCS 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 any emergency causes are required to use such a combination of drugs.

- 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: Formoterol overdose is thought to lead to the effects of excess beta2-adrenomimetics such as nausea, vomiting, headache, tremor, drowsiness, palpitations, tachycardia, ventricular arrhythmias, metabolic acidosis, hypokalemia.

Treatment: Supportive and symptomatic therapy is indicated. In serious cases, hospitalization is required. The use of beta-blockers may be considered, but only if extreme caution is observed and with careful medical control, as well. the use of such agents can cause bronchospasm.

Budesonide

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

Storage conditions

At a temperature not exceeding 25 ° C.

Shelf life

2 years.

Active ingredient

Bromge xin, Gufenesin, Formoterol set

Terms and conditions

prescription

Dosage form

capsules

Prescribing

Prescribing

Adults as prescribed by a doctor, Children prescribed by a doctor

Novartis Farma Stein AG, Switzerland



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