Foradil capsules 12mkg №60 + inhaler

Indications and usage

- prevention and treatment of bronchospasm in patients with bronchial asthma as an adjunct to therapy with inhaled GCS;

- prevention of bronchospasm caused by inhaled allergens, cold air or exercise as a supplement to therapy with inhaled GCS;

- prevention and treatment of bronchial obstruction in patients with COPD, in the presence of both reversible and irreversible bronchial obstruction, chronic bronchitis and pulmonary emphysema.

The drug Foradil is intended for inhalation use in adults with children aged 5 years and older. The preparation is not intended for oral administration. The dose of the drug is selected individually depending on the needs of the patient. You should use the least to provide a therapeutic effect.

When achieving control of bronchial asthma during therapy with the drug Foradil it is necessary to consider the possibility of gradually reducing the dose of the drug. Reducing the dose of the drug Foradil spend regular medical monitoring of the patient.

The drug is a powder inhalation, which should be used only with a special device - Airliser, which is included in the package.

Adults

At bronchial asthma The dose of the drug for regular maintenance therapy is 12-24 μg (contents of 1-2 capsules) 2 times / day.

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

If necessary, you can additionally apply 12-24 mg / day. 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 a doctor for a review of treatment, since this may indicate worsening of the underlying disease.

Given that the maximum daily dose of the drug Foradil is 48 μg, if necessary, you can additionally use 12-24 μg / day to relieve the symptoms of bronchial asthma. If the need to apply
additional doses of the drug cease to be episodic (for example, it becomes more often than 2 days a week), should
recommend that the patient consult a physician for a review of therapy, because this may indicate a worsening course of bronchial asthma.

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

At chronic obstructive pulmonary disease The dose of the drug for regular maintenance therapy is 12-24 μg (contents of 1-2 capsules) 2 times / day.

Children aged 5 and over

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

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

In children from 5 to 12 years old, the use of combined preparations containing inhaled GCS and beta agonist is recommended.₂- long-acting adrenoreceptors, with the exception of cases of the need for their separate use.

With the aim of prevention of brophospasm caused by exercise or the inevitable exposure to a known allergen, 15 minutes before the intended contact with the allergen or before the load, the contents of 1 capsule (12 mcg) should be inhaled.

Inhalation Instructions

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

Inhalation rules

In order to ensure the correct use of the drug, the doctor or other medical professional must show the patient how to use the inhaler; explain to the patientthat capsules with powder for inhalation should be used only with the help of an airliser; warn the patient that the capsules are intended for inhalation use only, and are not intended to be swallowed.

Children should use the drug under adult supervision.

Elderly patients (over 65)

Data in favor of the need to use the drug in a different dose of patients older than 65 years compared with younger patients is not received.

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.

There are separate reports of patients accidentally swallowing capsules of the drug entirely. Most of these cases are not associated with the development of adverse events. The health care provider should explain to patients how to properly use the drug, especially if after inhalation the patient does not improve breathing.

Instructions for use Aerolizer

1. Remove the cap from the airliner.

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.

four.Turning the mouthpiece, close the airliner.

5. While holding the Aerolizer in a strictly vertical position, once to press the blue buttons on the sides of the Arolizer 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 break 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 Airliser 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 Aerolizer.

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 Airliser 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 Airliser, take out the empty capsule, close the mouthpiece and close the Airlizer cap.

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

Adverse reactions

Undesirable reactions 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); infrequently (> 1/1000, <1/100): rarely (> 1/10000, <1/1000); very rarely (<1/10000), including individual messages.

With side of the immune system: very rarely, hypersensitivity reactions such as a decrease in blood pressure, urticaria, angioedema, pruritus, rash.

Mental Disorders: infrequently - agitation, anxiety, irritability, insomnia.

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

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

On the part of the respiratory system, organs of the chest and mediastinum: infrequently - bronchospasm, including paradoxical.

General disorders and disorders at the site of administration: infrequently - 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: infrequently - muscle spasm, myalgia.

According to the results of lostmarketing observations when prescribing the drug Foradil, the following undesirable reactions were noted, the frequency of which, due to the small number of patients, was regarded as “frequency unknown”:

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

On the part of the respiratory system, organs of the chest and mediastinum: cough.

Skin and Subcutaneous Tissues: rash.

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

In clinical trials with the use of formoterol, there was a slight increase in the incidence of serious exacerbations of bronchial asthma compared with placebo. However, the results of the above clinical studies do not allow a quantitative assessment of the incidence of serious exacerbations of bronchial asthma in various groups.

If any of the side effects indicated in the instruction are aggravated, rot you have noticed any other side effects not indicated in the instruction, inform your doctor.

Contraindications

- children's age up to 5 years;

- lactation period (breastfeeding);

- hypersensitivity to the drug.

Compliance with the special caution with the use of Foradil (especially in terms of dose reduction) and careful monitoring of patients is required in the presence of the following comorbidities: IHD; heart rhythm disorders and
conduction, especially AV block III; severe heart failure ; idiopathic hypertrophic subaortic stenosis; severe arterial hypertension; aneurysm; pheochromocytoma; hypertrophic cardiomyopathy; known or suspected lengthening of the QTc interval (QT corrected> 0.44 s).

Given the hyperglycemic effect inherent in beta₂-adrenomimetikam, in patients with diabetes mellitus, receiving Foradil, additional regular monitoring of the concentration of glucose in the blood is recommended.

Use during pregnancy and lactation

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

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

It is not known whether formoterol is excreted in human breast milk. While taking Foradil, breastfeeding should be discontinued.

Data on the effect of the drug on fertility is not.Studies on experimental animals did not reveal any effect on fertility in oral administration of formoterol.

Use in children

Contraindicated: children under 5 years.

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

In children from 5 to 12 years old, the use of combined preparations containing inhaled GCS and beta agonist is recommended.₂- long-acting adrenoreceptors, with the exception of cases of the need for their separate use.

Use in elderly patients

Data in favor of the need to use the drug in a different dose of patients older than 65 years compared with younger patients is not received.

special instructions

Patients with hypersensitivity to lactose should take into account that the drug contains lactose.

Foradil belongs to the class of beta agonists₂- long-acting adrenoreceptors. Against the background of using another beta agonist₂- long-acting adrenoreceptors (salmeterol) showed an increase in the frequency of deaths associated with bronchial asthma (13 of 13176 patients) compared with placebo (3 of 13179 patients). Clinical studies to assess the incidence of deaths associated with bronchial asthma, while using Foradil, have not been conducted.

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

Anti-inflammatory therapy

In patients with asthma, Foradil should be used only as an additional treatment for
inadequate control of symptoms on the background of monotherapy with inhaled GCS or in severe form of the disease requiring the use of a combination of inhaled GCS and beta agonist₂- long-acting adrenoreceptors.
Do not use the drug with other beta agonists.₂- long-acting adrenoreceptors. When prescribing Foradil, it is necessary to assess the condition of the patients regarding the adequacy of the anti-inflammatory therapy they receive. After starting treatment with Foradil, patients should be advised to continue the anti-inflammatory therapy unchanged, even if improvement is noted.

Beta agonists should be used to relieve an acute attack of bronchial asthma.₂-adrenoreceptors. With a sudden deterioration, patients should immediately seek medical attention.

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 with placebo, especially in children 5–12 years old.

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 μg 2 times / day, 1.9% - with 24 μg 2 times / days) compared with the placebo group (0.3%), especially in children 5–12 years old.

Hypokalemia

Consequence of beta therapy₂-adrenomimetics, including Foradil, may be the development of potentially severe hypokalemia. Hypokalemia may increase the risk of arrhythmias. Since 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, it is recommended to regularly monitor the concentration of potassium in the serum.

Paradoxical bronchospasm

As with other inhalation therapy, the possibility of the development of paradoxical bronchospasm should be considered. If it occurs, discontinue the drug immediately and prescribe an alternative treatment.

Influence on ability to drive motor transport and / or work with mechanisms

Patients who have dizziness or other abnormalities on the part of the central nervous system on the background of using the drug Foradil should refrain from driving or working with mechanisms during the period of using the drug.

Overdose

Symptoms: an overdose of Foradil may presumably 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, increase or decrease in blood pressure,
nervousness, cramps, muscle cramps, dry mouth, dizziness, weakness, anxiety. As with all inhaled
sympathomimetics, with an overdose of the drug Foradil possible cardiac arrest and death.

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. Recommended monitoring of cardiac activity.

Drug interaction

Foradil, as well as other beta₂- adrenomimetics, should be carefully prescribed to patients receiving drugs such as quinidine, disopyramide, procainamide, phenothiazines, antihistamines, MAO inhibitors , tricyclic antidepressants, and other drugs that are known to prolong the QT interval, because . in these cases, the effect of adrenostimulyatorov on the cardiovascular system may increase. 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 the aggravation of the side effects of Foradil.

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

In patients receiving anesthesia with the use of hydrocarbons, increases the risk of developing arrhythmias,

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 not compelled by any extraordinary reasons.

Pharmacy sales terms

The drug is available on prescription.

Terms and conditions of storage

The drug should be protected from moisture. Keep out of reach of children at a temperature not exceeding 25 ° C, protect from moisture.