Foradil combi

Use during pregnancy and breastfeeding

Formoterol
The safety of using Foradil Combi during pregnancy and lactation has not yet been established.

Use during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus. Formoterol, as well as other beta2-agonists, can slow down the process of labor due to its tocolytic effect (relaxing effect on the smooth muscles of the uterus).

It is not known whether formoterol is excreted into breast milk in humans. Breastfeeding should be stopped while taking Foradil Combi.

Budesonide

Experimental studies on animals revealed a possible teratogenic effect of GCS on the fetus. There is no data on the teratogenic effect of budesonide or on the presence of reproductive toxicity in the drug when used in humans.

Use during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus. If it is necessary to carry out GCS therapy during pregnancy, it is preferable to prescribe them in the form of inhalations, because GCS for inhalation have less systemic effect compared to oral GCS.

It is not known whether budesonide is excreted into breast milk in humans.

Fertility

There is no data on the effect of the drug on fertility. Experimental studies on animals did not reveal any effect on fertility with oral formoterol and subcutaneous administration of budesonide.

Use for liver dysfunction

There are no data on the need for dose adjustment in patients with impaired liver function. But budesonide is metabolized mainly in the liver. Therefore, the drug should be used with caution in patients with severe liver dysfunction. In patients with mild or moderate hepatic impairment, drug exposure is unlikely to be significantly altered based on the pharmacokinetic parameters of oral budesonide.

Use for renal impairment

There are no data available on the need for dose adjustment in patients with impaired renal function. Based on the pharmacokinetics of oral budesonide, it is unlikely that clinically significant systemic exposure to the drug is possible in these patients.

Use in children

Contraindication: children under 6 years of age.

Use in elderly patients

There is no data available on the need to adjust the dose of the drug in patients over 65 years of age, compared with younger patients.

special instructions

Formoterol

It has been shown that the use of formoterol improves the quality of life of patients with COPD.

Formoterol belongs to the class of long-acting beta2-agonists. Another long-acting beta2-agonist, salmeterol, was associated with an increased incidence of asthma-related deaths (13 of 13,176 patients) compared with placebo (3 of 13,179 patients). Clinical studies have not been conducted to assess the incidence of deaths associated with bronchial asthma during the use of formoterol.

Anti-inflammatory therapy

In patients with asthma, formoterol should be used only as an adjunctive treatment when symptoms are insufficiently controlled on inhaled corticosteroid monotherapy or when the disease is severe and requires the use of an inhaled corticosteroid and a long-acting β2-adrenergic agonist. Formoterol should not be co-administered with other long-acting β2-adrenergic agonists.

When prescribing formoterol, it is necessary to assess the condition of patients regarding the adequacy of the anti-inflammatory therapy they receive. After starting treatment with formoterol, patients should be advised to continue anti-inflammatory therapy without changes, even if improvement is noted.

To relieve an acute attack of bronchial asthma, short-acting beta2-adrenergic receptor agonists should be used. If the condition suddenly worsens, patients should seek medical help immediately.

Severe exacerbations of bronchial asthma

In clinical studies, with the use of formoterol, there was a slight increase in the incidence of severe exacerbations of bronchial asthma compared to placebo, especially in children 6-12 years of age.

In placebo-controlled clinical studies in patients receiving formoterol for 4 weeks, there was an increase in the incidence of severe exacerbations of bronchial asthma (0.9% with a dosage regimen of 10-12 mcg 2 times a day, 1.9% with a dosage regimen of 10-12 mcg 2 times a day, 1.9% with a dosage regimen of 24 mcg 2 times a day days) compared to the placebo group (0.3%), especially in children 6-12 years old.

In two large controlled clinical trials involving 1095 adults and children 12 years of age and older, severe asthma exacerbations (requiring hospitalization) were more common in patients receiving formoterol 24 mcg twice daily (9/271, 3.3%) , compared with the groups of formoterol at a dose of 12 mcg 2 times / day (1/275, 0.4%), placebo (2/277, 0.7%) and albuterol (2/272, 0.7%).

When formoterol was used for 16 weeks, another large clinical trial of 2085 adults and adolescents did not find an increase in the incidence of severe asthma exacerbations with increasing formoterol dosage. However, in this study, the incidence of severe exacerbations was higher in the formoterol group (with a dosage regimen of 24 mcg 2 times / day - 2/527, 0.4%, with 12 mcg 2 times / day - 3/527, 0.6%) compared with placebo (1/517, 0.2%). In the open-label phase of this study, when using formoterol at a dose of 12 mcg 2 times a day (if necessary, patients could use up to two additional doses of the drug), the incidence of severe exacerbations of bronchial asthma was 1/517, 0.2%.

In a 52-week, multicenter, randomized, double-blind clinical trial that included 518 children aged 6 to 12 years, the incidence of severe asthma exacerbations was higher with formoterol 24 mcg twice daily (11/171, 6.4 %), 12 mcg 2 times / day (8/171, 4.7%) compared with placebo (0/176, 0.0%).

However, the results of the above clinical studies do not allow us to quantify the incidence of severe exacerbations of bronchial asthma in different groups.

Hypokalemia

Therapy with beta2-agonists, including formoterol, may result in potentially serious hypokalemia. Hypokalemia may increase susceptibility to the development of arrhythmias.

Because this effect of the drug can be enhanced by hypoxia and concomitant treatment; special caution should be observed in patients with severe bronchial asthma. In these cases, regular monitoring of serum potassium concentration is recommended.

Paradoxical bronchospasm

As with other inhalation therapy, the possibility of developing paradoxical bronchospasm should be taken into account. If it occurs, the drug should be discontinued immediately and alternative treatment should be prescribed.

Impact on the ability to drive vehicles and operate machinery

Patients who experience dizziness or other central nervous system disorders while using the drug formoterol should refrain from driving vehicles or operating machinery during the period of using the drug.

Budesonide

To ensure that budesonide reaches the lungs, it is important to instruct patients to correctly inhale the drug in accordance with the instructions for use.

Patients should be informed that the drug is not intended to relieve attacks, but for regular daily preventive use even in the absence of symptoms of bronchial asthma.

If paradoxical bronchospasm develops, you should immediately stop using budesonide, assess the patient's condition and, if necessary, prescribe therapy with other drugs. Paradoxical bronchospasm must be immediately relieved with a short-acting beta2-agonist. Patients should always have a short-acting beta2-agonist inhaler available to relieve acute exacerbations of bronchial asthma.

Patients should be informed about the need to consult a doctor if their condition worsens (increased need for short-acting bronchodilators, increased attacks of shortness of breath). In such cases, it is necessary to examine the patient and consider the possibility of increasing the dose of inhaled or oral GCS.

To reduce the risk of developing candidal infections of the oral cavity and pharynx, the patient should thoroughly rinse his mouth with water after each inhalation of the drug. With the development of candidal infection of the oral cavity and pharynx, local antifungal therapy can be performed without stopping treatment with budesonide.

In case of exacerbation of bronchial asthma, the dose of budesonide should be increased or, if necessary, a short course of systemic corticosteroids should be administered and/or antibiotic therapy should be prescribed if infection develops.

It is necessary to regularly monitor the growth dynamics of children and adolescents receiving long-term therapy with inhaled corticosteroids. If growth is delayed, the need to reduce the dose of inhaled corticosteroids (prescribed in the minimum effective dose) and refer the child for consultation to an allergist should be considered. The long-term consequences of growth retardation (impact on final adult height) in children receiving therapy with inhaled corticosteroids have not been studied.

There has been no adequate study of the possibility of compensating for growth retardation in children after discontinuation of therapy with oral corticosteroids.

Budesonide usually has no effect on adrenal function. However, in some patients, with long-term use at recommended daily doses, systemic effects of budesonide may be observed.

When prescribing inhaled corticosteroids in high doses or over a long period of time, systemic adverse reactions may develop (however less frequently than when using oral corticosteroids), such as suppression of adrenal function, hypercortisolism/Cushing's syndrome, growth retardation in children and adolescents, decreased mineral bone density, hypersensitivity reactions, cataracts, glaucoma and, less commonly, a number of behavioral disorders, including psychomotor hyperactivity, sleep disturbances, agitation, depression or aggression (especially in children).

Patients with hormone-independent bronchial asthma

In patients with hormone-independent bronchial asthma, the therapeutic effect of budesonide develops on average within 10 days after the start of treatment. At the beginning of budesonide therapy in patients with increased bronchial secretion, oral corticosteroids can be added to the drug inhalations in a short course (lasting about 2 weeks).

Patients with hormone-dependent bronchial asthma

When switching from oral corticosteroids to inhaled budesonide, patients should be in a relatively stable condition. During the first 10 days, high doses of budesonide are prescribed in combination with previously used oral corticosteroids at the same dose. Then the daily dose of oral corticosteroids begins to be gradually reduced (2.5 mg every month in terms of prednisolone) to the minimum possible level. Treatment with corticosteroids, including budesonide, should not be abruptly interrupted.

The patient's condition should be carefully monitored in the first months after transition until the hypothalamic-pituitary-adrenal axis has recovered sufficiently to provide an adequate response to stressful situations (for example, trauma, surgery, or severe infection). The function of the hypothalamic-pituitary-adrenal system should be regularly monitored.

In some cases, patients with reduced adrenal cortex function may need additional administration of GCS for oral administration during stressful situations. This category of patients is recommended to always carry a warning card with them, which should indicate that in stressful situations they need additional systemic administration of GCS.

When transferring patients from systemic corticosteroids to inhaled budesonide therapy, reactions such as allergic rhinitis, eczema, lethargy, pain in muscles and joints, and sometimes nausea and vomiting, which were previously suppressed by taking systemic corticosteroids, may occur. Treatment of these reactions should be carried out with antihistamines or local corticosteroids.

Impact on the ability to drive vehicles and operate machinery

There is no data on the effect of budesonide on the ability to drive vehicles and operate machinery. A negative effect of the drug on the ability to drive vehicles and operate machinery is unlikely.

Foradil, 30 pcs., 12 mcg, capsules with powder for inhalation, complete with Aerolyzer inhaler

Inhalation.

Intended for inhalation use in adults and children 5 years and older. The drug is not intended for oral administration.

The dose of the drug is selected individually, depending on the needs of the patient. The lowest dose that provides a therapeutic effect should be used. When control of bronchial asthma symptoms is achieved during therapy with Foradil, it is necessary to consider the possibility of gradually reducing the dose of the drug. The dose reduction is carried out under regular medical supervision of the patient's condition.

The drug is a powder for inhalation, which should be used only with the help of a special device - an aerolyzer - which is included in the package.

Adults

For bronchial asthma

the dose of the drug for regular maintenance therapy is 12–24 mcg (contents 1–2 capsules) 2 times a day.

The drug Foradil should be used only as an additional therapy to inhaled corticosteroids.

The maximum recommended dose of the drug for adults (48 mcg/day) should not be exceeded. Considering that the maximum daily dose of Foradil is 48 mcg, if necessary, an additional 12–24 mcg/day can be used to relieve the symptoms of bronchial asthma.

If the need for 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 a doctor about reviewing therapy, because this may indicate a worsening of bronchial asthma.

Against the background of exacerbation of bronchial asthma, you should not start treatment with Foradil or change the dosage. The drug Foradil should not be used to relieve acute attacks of bronchial asthma.

To prevent bronchospasm caused by physical activity or unavoidable exposure to a known allergen,

15 minutes before the expected contact with the allergen or before the load, 12 mcg of the drug (contents of 1 capsule) should be inhaled.

Patients with a history of severe bronchospasm may require inhalation of the contents of 2 caps for prevention. (24 mcg).

For COPD

the dose of the drug for regular maintenance therapy is 12–24 mcg (contents 1–2 capsules) 2 times a day.

Children 5 years and older

The maximum recommended dose of the drug is 24 mcg/day.

For bronchial asthma

The dose of the drug for regular maintenance therapy is 12 mcg 2 times a day. The drug Foradil should be used only as an additional therapy to inhaled corticosteroids.

In children aged 5 to 12 years, it is recommended to use combination drugs containing inhaled corticosteroids and a long-acting beta2-adrenergic receptor agonist, unless it is necessary to use them separately.

To prevent bronchospasm caused by physical activity or unavoidable exposure to a known allergen,

15 minutes before the expected contact with the allergen or before the load, 12 mcg of the drug (contents of 1 capsule) should be inhaled.

Instructions for inhalation

To ensure proper use of the drug, a doctor or other health care professional must show the patient how to use the inhaler; explain to the patient that capsules with powder for inhalation should only be used using an aerosolizer; Warn the patient that the capsules are for inhalation use only and are not intended to be swallowed.

Children should use the drug under adult supervision.

It is important that the patient understands that due to the breakdown of the gelatin capsule, small pieces of gelatin may enter the mouth or throat as a result of inhalation. In order to minimize this phenomenon, you should not pierce the capsule more than once. The capsule should be removed from the blister pack immediately before use (see “Instructions for use of the aerolizer”). There are isolated reports of patients accidentally swallowing capsules of the drug whole. Most of these cases are not associated with the development of adverse events. The healthcare professional should explain to the patient how to use the drug correctly, especially if the patient does not experience improvement in breathing after inhalation.

Elderly patients (over 65 years old).

There is no evidence to support the need to use the drug at a different dose in patients over 65 years of age compared to younger patients.

Instructions for using the aerolizer

1. It is necessary to remove the cap from the aerolizer.

2. Hold the aeralizer 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 must be remembered that you need to remove the capsule from the blister pack immediately before inhalation.

4. Turn the mouthpiece to close the aerolyzer.

5. Holding the aerolizer in a strictly vertical position, press the blue buttons on the sides of the aerolizer all the way once. Then release them.

Note.

At this stage, if the capsule is pierced, it may break, causing small pieces of gelatin to enter the mouth or throat. Since gelatin is edible, it will not cause any harm. To ensure that the capsule does not collapse completely, the following requirements must be met: do not pierce the capsule more than once; follow storage rules; remove the capsule from the blister only immediately before inhalation.

6. It is necessary to exhale completely.

7. You should take the mouthpiece into your mouth and tilt your head back slightly. Cover the mouthpiece tightly with your lips and take a quick, even, as deep breath as possible. There should be a characteristic rattling sound created by the rotation of the capsule and spraying of the powder. If there is no characteristic sound, then you should open the aerolizer and see what happened to the capsule. It may be stuck in the cell. In this case, you need to carefully remove the capsule. Under no circumstances should you try to release the capsule by repeatedly pressing the buttons on the sides of the aerolizer.

8. If a characteristic sound occurs when inhaling, you must hold your breath as long as possible. At the same time, remove the mouthpiece from your mouth. Then exhale. Open the aerolizer and see if there is any powder left in the capsule. If there is powder left in the capsule, repeat the steps described in steps 6–8.

9. After completing the inhalation procedure, you must open the aerolizer, remove the empty capsule, close the mouthpiece and the aerolizer with the cap.

Airizer care:

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

Foradil caps spor d/ing 12 mcg/dose No. 30 + d/ing device

Compound

Active substance: formoterol - 12 mcg. Excipients: lactose - up to 25 mg.

Pharmacokinetics

The therapeutic range of doses of formoterol is from 12 mcg to 24 mcg 2 times a day. Data on the pharmacokinetics of formoterol were obtained in healthy volunteers after inhalation of formoterol in doses above the recommended range and in patients with COPD after inhalation of formoterol in therapeutic doses.

Suction

After a single inhalation of formoterol fumarate at a dose of 120 mcg to healthy volunteers, formoterol was rapidly absorbed into the plasma, the Cmax of formoterol in plasma was 266 pmol/l and was achieved within 5 minutes after inhalation. In patients with COPD who received formoterol at a dose of 12 or 24 mcg 2 times / day for 12 weeks, plasma formoterol concentrations measured 10 minutes, 2 hours and 6 hours after inhalation were in the ranges of 11.5-25.7 pmol/l and 23.3 -50.3 pmol, respectively.

In studies that examined the total urinary excretion of formoterol and its (R,R)- and (S,S)-enantiomers, it was shown that the amount of formoterol in the systemic circulation increases in proportion to the size of the inhaled dose (12-96 mcg).

After inhaled use of formoterol at a dose of 12 or 24 mcg 2 times a day for 12 weeks, the urinary excretion of unchanged formoterol in patients with bronchial asthma increased by 63-73%, and in patients with COPD - by 19-38%. This indicates some accumulation of formoterol in plasma after repeated inhalations. However, there was no greater accumulation of one of the enantiomers of formoterol compared to the others after repeated inhalations.

As has been reported for other inhaled medicinal products, the majority of formoterol administered by inhalation will be swallowed and subsequently absorbed from the gastrointestinal tract. When 80 mcg of 3H-labeled formoterol was administered orally to two healthy volunteers, at least 65% of the formoterol was absorbed.

Distribution

The binding of formoterol to plasma proteins is 61-64% (primarily, binding to albumin is 34%).

In the concentration range observed after administration of the drug in therapeutic doses, saturation of binding sites is not achieved.

Metabolism

The main route of metabolism of formoterol is direct glucuronidation. Another metabolic pathway is o-demethylation followed by glucuronidation.

Minor metabolic pathways include conjugation of formoterol with sulfate followed by deformylation. Multiple isoenzymes are involved in the process of glucuronidation (UGT1A1, 1A3, 1A6, 1A7, 1A8, 1A9, 1A10, 2B7 and 2B15) and O-demethylation (CYP2D6, 2C19, 2C9, 2A6) of formoterol, which suggests a low likelihood of drug interaction through inhibition of any or an isoenzyme involved in the metabolism of formoterol. At therapeutic concentrations, formoterol does not inhibit isoenzymes of the cytochrome P450 system.

Removal

In patients with bronchial asthma and COPD who received formoterol fumarate at a dose of 12 or 24 mcg 2 times a day for 12 weeks, approximately 10% or 7%, respectively, was determined in the urine as unchanged formoterol. The calculated proportions of (R,R)- and (S,S)-enantiomers of unchanged formoterol in urine are 40% and 60%, respectively, after a single dose of formoterol (12-120 μg) in healthy volunteers and after single and repeated doses of formoterol in patients with bronchial asthma. asthma.

The active substance and its metabolites are completely eliminated from the body; about 2/3 of the dose administered orally is excreted in the urine, and 1/3 in feces. The renal clearance of formoterol is 150 ml/min.

In healthy volunteers, the final T1/2 of formoterol from plasma after a single inhalation at a dose of 120 mcg is 10 hours; the final T1/2 of (R,R)- and (S,S)-enantiomers, calculated from urinary excretion, were 13.9 and 12.3, respectively.

Pharmacokinetics in special clinical situations

Floor

After correction for body weight, the pharmacokinetic parameters of formoterol in men and women do not differ significantly.

Elderly patients

The pharmacokinetics of formoterol in elderly patients has not been studied.

Pediatrics

In a clinical study in children aged 5-12 years with asthma who received formoterol fumarate at a dose of 12 or 24 mcg 2 times / day for 12 weeks, excretion of unchanged formoterol in urine increased by 18-84% compared with the corresponding indicator. measured after the first dose.

In clinical studies in children, about 6% unchanged formoterol was detected in the urine.

Patients with impaired liver and/or kidney function

The pharmacokinetics of formoterol in patients with impaired liver and/or renal function have not been studied.

Indications for use

prevention and treatment of bronchospasm in patients with bronchial asthma as an addition to therapy with inhaled corticosteroids;
prevention of bronchospasm caused by inhaled allergens, cold air or physical activity as an addition to therapy with inhaled corticosteroids;
prevention and treatment of bronchial obstruction in patients with COPD, in the presence of both reversible and irreversible bronchial obstruction, chronic bronchitis and emphysema.

Contraindications

children under 5 years of age;
lactation period (breastfeeding);
hypersensitivity to the components of the drug.

Particular caution when using Foradil (especially in terms of dose reduction) and careful monitoring of patients is required in the presence of the following concomitant diseases: IHD; disturbances of heart rhythm and conduction, especially AV blockade of the third degree; severe heart failure; idiopathic hypertrophic subaortic stenosis; severe arterial hypertension; aneurysm; pheochromocytoma; hypertrophic cardiomyopathy; known or suspected prolongation of the QTc interval (QT corrected >0.44 sec).

Considering the hyperglycemic effect characteristic of beta2-adrenergic agonists, additional regular monitoring of blood glucose concentrations is recommended in patients with diabetes mellitus taking Foradil.

Directions for use and doses

The drug Foradil is intended for inhalation use in adults and children aged 5 years and older. The drug is not intended for oral administration. The dose of the drug is selected individually depending on the needs of the patient. The smallest one that provides a therapeutic effect should be used.

When control of bronchial asthma is achieved during therapy with Foradil, it is necessary to consider the possibility of gradually reducing the dose of the drug. Reducing the dose of Foradil is carried out by regular medical monitoring of the patient's condition.

The drug is an inhalation powder that should be used only with the help of a special device - an Aerolyzer, which is included in the package.

Adults

For bronchial asthma, the dose of the drug for regular maintenance therapy is 12-24 mcg (contents of 1-2 capsules) 2 times a day.

The drug Foradil should be used only as an additional therapy to inhaled GCTs; The maximum recommended dose of the drug for adults (48 mcg/day) should not be exceeded.

If necessary, an additional 12-24 mcg/day can be used. If the need for 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 a doctor about reviewing treatment, because this may indicate a worsening of the underlying disease.

Considering that the maximum daily dose of Foradil is 48 mcg, if necessary, an additional 12-24 mcg/day can be used to relieve the symptoms of bronchial asthma. If the need for 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 a doctor about reviewing therapy, because this may indicate a worsening of bronchial asthma.

In order to prevent bronchospasm caused by physical activity or inevitable exposure to a known allergen, the contents of 1 capsule (12 mcg) should be inhaled 15 minutes before expected contact with the allergen or before exercise. Patients with severe bronchial asthma may require a single dose of 24 mcg.

For chronic obstructive pulmonary disease, the dose of the drug for regular maintenance therapy is 12-24 mcg (contents of 1-2 capsules) 2 times a day.

Children aged 5 years and older

The maximum recommended dose of the drug is 24 mcg/day.

For bronchial asthma, the dose of the drug for regular maintenance therapy is 12 mcg 2 times a day. The drug Foradil should be used only as an additional therapy to inhaled corticosteroids.

In order to prevent brochospasm caused by physical activity or inevitable exposure to a known allergen, the contents of 1 capsule (12 mcg) should be inhaled 15 minutes before expected contact with the allergen or before exercise.

Instructions for inhalation

Rules for inhalation

To ensure proper use of the drug, a doctor or other health care professional must show the patient how to use the inhaler; Explain to the patient that capsules with powder for inhalation should be used only with the help of an Aerolyzer; Warn the patient that the capsules are for inhalation use only and are not intended to be swallowed.

Children should use the drug under adult supervision.

Elderly patients (over 65 years old)

There is no evidence to support the need to use the drug at a different dose in patients over 65 years of age compared to younger patients.

Remove the capsule from the blister pack immediately before use.

There are isolated reports of patients accidentally swallowing capsules of the drug whole. Most of these cases are not associated with the development of adverse events. The medical professional should explain to patients how to use the drug correctly, especially if the patient does not experience improvement in breathing after inhalation.

Instructions for use of the Aerolyzer

1. Remove the cap from the Aerolyzer.

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 Aerolyzer (it has the shape of a capsule). It should be remembered that you need to remove the capsule from the blister pack immediately before inhalation.

4. Turn the mouthpiece and close the Aerolizer.

5. Holding the Aerolyzer in a strictly vertical position, press all the way down on the blue buttons located on the sides of the Aerolyzer once. Then release them.

At this stage, if the capsule is pierced, it may break, causing small pieces of gelatin to enter the mouth or throat. Since gelatin is edible, it does not cause any harm. To ensure that the capsule does not collapse completely, the following requirements must be met: do not pierce the capsule more than once; follow storage rules; remove the capsule from the blister only immediately before inhalation.

6. Exhale completely.

7. Place the mouthpiece in your mouth and tilt your head back slightly. Cover the mouthpiece tightly with your lips and take a quick, even, as deep breath as possible. In this case, the patient should hear a characteristic rattling sound created by the rotation of the capsule and spraying of the powder. If there was no characteristic sound, then you need to open the Aerolizer and see what happened to the capsule. It may be stuck in the cell. In this case, you need to carefully remove the capsule. Under no circumstances should you try to release the capsule by repeatedly pressing the buttons on the sides of the Aerolyzer.

8. If a characteristic sound is heard when inhaling, you should hold your breath as long as possible. At the same time, remove the mouthpiece from your mouth. Then exhale. Open the Aerolyzer and see if there is any powder left in the capsule. If there is powder left in the capsule, repeat the steps described in steps 6-8.

9. After completing the inhalation procedure, open the Aerolizer, remove the empty capsule, close the mouthpiece and close the Aerolizer with the cap.

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

Storage conditions

Store out of the reach of children at a temperature not exceeding 25°C, protect from moisture.

Best before date

2 years. The drug should not be used after the expiration date.

special instructions

Patients with hypersensitivity to lactose should note that the drug contains lactose.

Foradil belongs to the class of long-acting beta2-adrenergic receptor agonists. Another long-acting beta2-adrenergic agonist (salmeterol) was associated with an increased incidence of asthma-related deaths (13 of 13,176 patients) compared with placebo (3 of 13,179 patients). Clinical studies have not been conducted to assess the incidence of deaths associated with bronchial asthma during the use of Foradil.

It has been shown that the use of Foradil improves the quality of life of patients with COPD.

Anti-inflammatory therapy

In patients with bronchial asthma, Foradil should be used only as an additional treatment in cases of insufficient control of symptoms during monotherapy with inhaled corticosteroids or in severe forms of the disease requiring the use of a combination of inhaled corticosteroids and a long-acting beta2-adrenergic agonist. The drug should not be used with other long-acting beta2-adrenergic receptor agonists. When prescribing Foradil, it is necessary to assess the condition of patients regarding the adequacy of the anti-inflammatory therapy they receive. After starting treatment with Foradil, patients should be advised to continue anti-inflammatory therapy without changes, even if improvement is noted.

To relieve an acute attack of bronchial asthma, beta2-adrenergic receptor agonists should be used. If the condition suddenly worsens, patients should seek medical help immediately.

Severe exacerbations of bronchial asthma

Hypokalemia

Therapy with beta2-agonists, including Foradil, may result in the development of potentially serious hypokalemia. Hypokalemia may increase the risk of developing arrhythmias. Because this effect of the drug can be enhanced by hypoxia and concomitant treatment; special caution should be observed in patients with severe bronchial asthma. In these cases, regular monitoring of serum potassium concentration is recommended.

Paradoxical bronchospasm

Description

Bronchodilator drug - beta2-adrenergic agonist.

Dosage form

Capsules with powder for inhalation are transparent, colorless, size No. 3, marked “CG” on the cap and “FXF” on the body or “CG” on the body and “FXF” on the cap in black ink; The contents of the capsules are an easily flowing white powder.

Use in children

Contraindicated: children under 5 years of age.

For bronchial asthma, the dose of the drug for regular maintenance therapy is 12 mcg 2 times a day. The drug Foradil should be used only as an additional therapy to inhaled corticosteroids.

Pharmacodynamics

Selective β2-adrenergic receptor agonist. It has a bronchodilator effect in patients with both reversible and irreversible airway obstruction. The effect of the drug occurs quickly (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 observed only in rare cases.

Foradil 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 vitro animal studies have shown that racemic formoterol and its (R,R)- and (S,S)-enantiomers are highly selective β2 receptor agonists. The (S,S) enantiomer was 800-1000 times less active than the (R,R) enantiomer and did not adversely affect the tracheal smooth muscle activity of the (R,R) enantiomer. There has been no pharmacological evidence of benefit from using one of these two enantiomers over the racemic mixture.

In human studies, Foradil has been shown to be effective in preventing bronchospasm caused by inhaled allergens, exercise, cold air, histamine or methacholine. Since the bronchodilator effect of Foradil remains pronounced for 12 hours after inhalation, maintenance therapy, in which Foradil is prescribed 2 times a 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 stable chronic obstructive pulmonary disease (COPD), formoterol, used in the form of inhalation using an Aerolyzer device in doses of 12 mcg or 24 mcg 2 times a day, causes a rapid onset of a bronchodilator effect, which lasts for at least 12 hours and is accompanied by subjective improvement in terms of quality of life parameters.

Side effects

Adverse reactions are distributed according to frequency of occurrence. The following criteria were used to assess frequency: very often (>1/10): often (from >1/100, <1/10); uncommon (>1/1000, <1/100): rare (>1/10000, <1/1000); very rare (<1/10000), including isolated reports.

From the immune system: very rarely - hypersensitivity reactions, such as decreased blood pressure, urticaria, angioedema, itching, rash.

Mental disorders: infrequently - agitation, anxiety, increased excitability, insomnia.

From the nervous system: often - headache, tremor; infrequently - dizziness; very rarely - taste disturbances.

From the side of the heart: often - palpitations; infrequently tachycardia; very rarely - peripheral edema.

From the respiratory system, chest and mediastinal organs: infrequently - bronchospasm, including paradoxical.

General disorders and disorders at the injection site: uncommon - irritation of the mucous membrane of the pharynx and larynx.

From the gastrointestinal tract: infrequently - dry oral mucosa; very rarely - nausea.

From the musculoskeletal and connective tissue side: infrequently - muscle spasm, myalgia.

According to lost marketing observations, when prescribing the drug Foradil, the following adverse reactions were noted, the frequency of which, due to the small number of patients, was considered “frequency unknown”:

Laboratory and instrumental data: hypokalismia and hyperglycemia, prolongation of the QT interval on the electrocardiogram, increased blood pressure (including arterial hypertension).

From the respiratory system, chest and mediastinum: cough.

From the skin and subcutaneous tissues: rash.

From the heart: angina pectoris, cardiac arrhythmia (including atrial fibrillation, ventricular extrasystoles, tachyarrhythmia).

In clinical studies, formoterol showed a slight increase in the incidence of serious exacerbations of asthma compared to placebo. However, the results of the above clinical studies do not allow us to quantify the incidence of serious exacerbations of bronchial asthma in different groups.

If any of the side effects indicated in the instructions get worse, you notice any other side effects not listed in the instructions, tell your doctor.

Use during pregnancy and breastfeeding

The safety of using Foradil during pregnancy and lactation has not yet been established.

The use of the drug during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus. Formoterol, as well as other beta2-agonists, can slow down the process of labor due to its tocolytic effect (relaxing effect on the smooth muscles of the uterus).

It is not known whether formoterol is excreted into breast milk in humans. Breastfeeding should be stopped while taking Foradil.

There is no data on the effect of the drug on fertility. Studies in experimental animals have shown no effect on fertility with oral formoterol.

Interaction

Foradil, as well as other beta2-agonists, should be prescribed with caution to patients receiving drugs such as quinidine, disopyramide, procainamide, phenothiazines, antihistamines, MAO inhibitors, tricyclic antidepressants, as well as other drugs that are known to they prolong the QT interval because in these cases, the effect of adrenergic stimulants on the cardiovascular system may be enhanced. When using drugs that can prolong the QT interval, the risk of ventricular arrhythmias increases.

The simultaneous use of other sympathomimetic drugs may lead to worsening of the side effects of Foradil.

The simultaneous use of xanthine derivatives, corticosteroids or diuretics may enhance the potential hypokalemic effect of beta2-agonists.

Patients receiving anesthesia using hydrocarbons have an increased risk of developing arrhythmia,

Beta blockers may weaken the effect of Foradil. In this regard, Foradil should not be used in conjunction with beta-blockers (including eye drops), unless the use of such a combination of drugs is forced by any emergency reasons.

Overdose

Symptoms: an overdose of Foradil can presumably lead to phenomena characteristic of the excessive action of other beta2-agonists, such as nausea, vomiting, headache, tremor, drowsiness, palpitations, tachycardia, ventricular arrhythmias, metabolic acidosis, hypokalemia, hyperglycemia, increased or decreased blood pressure , nervousness, convulsions, muscle cramps, dry mouth, dizziness, weakness, anxiety. As with all inhaled sympathomimetics, an overdose of Foradil can cause cardiac arrest and death.

Treatment: maintenance and symptomatic therapy is indicated. In serious cases, hospitalization is necessary.

The use of beta blockers may be considered, but only with extreme caution and under close medical supervision, as the use of such drugs may cause bronchospasm. Monitoring of cardiac indicators is recommended.

Impact on the ability to drive vehicles and operate machinery

Patients who experience dizziness or other central nervous system disorders while using the drug Foradil should refrain from driving vehicles or operating machinery while using the drug.

Directions for use and doses

Inhalation.

Intended for inhalation use in adults and children 5 years and older. The drug is not intended for oral administration.

The drug is a powder for inhalation, which should be used only with the help of a special device - an aerolyzer - which is included in the package.

Adults

For bronchial asthma, the dose of the drug for regular maintenance therapy is 12–24 mcg (contents 1–2 capsules) 2 times a day.

The drug Foradil should be used only as an additional therapy to inhaled corticosteroids.

In order to prevent bronchospasm caused by physical activity or inevitable exposure to a known allergen, 12 mcg of the drug (contents of 1 capsule) should be inhaled 15 minutes before expected contact with the allergen or before exercise.

Patients with a history of severe bronchospasm may require inhalation of the contents of 2 caps for prevention. (24 mcg).

For COPD, the dose of the drug for regular maintenance therapy is 12–24 mcg (contents 1–2 capsules) 2 times a day.

Children 5 years and older

The maximum recommended dose of the drug is 24 mcg/day.

For bronchial asthma, the dose of the drug for regular maintenance therapy is 12 mcg 2 times a day. The drug Foradil should be used only as an additional therapy to inhaled corticosteroids.

Instructions for inhalation

Children should use the drug under adult supervision.

Elderly patients (over 65 years old). There is no evidence to support the need to use the drug at a different dose in patients over 65 years of age compared to younger patients.

Instructions for using the aerolizer

1. It is necessary to remove the cap from the aerolizer.

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

4. Turn the mouthpiece to close the aerolyzer.

5. Holding the aerolizer in a strictly vertical position, press the blue buttons on the sides of the aerolizer all the way once. Then release them.

Note. At this stage, if the capsule is pierced, it may break, causing small pieces of gelatin to enter the mouth or throat. Since gelatin is edible, it will not cause any harm. To ensure that the capsule does not collapse completely, the following requirements must be met: do not pierce the capsule more than once; follow storage rules; remove the capsule from the blister only immediately before inhalation.

6. It is necessary to exhale completely.

9. After completing the inhalation procedure, you must open the aerolizer, remove the empty capsule, close the mouthpiece and the aerolizer with the cap.

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