Universal reference book for medicines
Product name: FORADIL® COMBI (FORADIL COMBI)

Active substance: budesonide, formoterol

Type: Anti-inflammatory and bronchodilator drug

Manufacturer: NOVARTIS PHARMA (Switzerland) manufactured by NOVARTIS FARMACEUTICA (Spain)
Composition, form of production and packaging

A set of capsules with powder for inhalation.

Capsules with powder for inhalation are transparent colorless, size No. 3, labeled "CG" on the lid and "FXF" on the body or "CG" on the body and "FXF" on the lid with black ink;
contents of capsules - easily flowing powder of white color.
1 caps.

formoterol fumarate dihydrate 12 μg

Excipients: lactose monohydrate - up to 25 mg.

The composition of the capsule shell: gelatin 100% - 49 mg.

Capsules with powder for inhalation are hard gelatinous, size 3, with a cap of light pink color and a colorless transparent body, with an image and an inscription "BUDE 200", the contents of the capsules are white powder.

1 caps.

budesonide 200 μg

Excipients: lactose monohydrate - 24.77 mg.

The composition of the shell capsule shell: iron oxide red (E172) - 0.086%, titanium dioxide (E171) - 2%, water - 15%, gelatin - 83%.

The composition of the shell of the capsule body: water - 14.5%, gelatin - 85.5%.

40 pcs.
(10 pcs with formoterol in 3 blisters and 10 pcs with budesonide in 1 blister) - blisters (4) complete with device for inhalations (airlaser) - packs of cardboard.
60 pcs.
(10 pcs with formoterol in 3 blisters and 10 pcs with budesonide in 3 blisters) - blisters (6) complete with device for inhalations (airlaser) - packs of cardboard.
90 pcs.
(10 pcs with formoterol in 3 blisters and 10 pcs with budesonide in 6 blisters) - blisters (9) complete with device for inhalations (airlaser) - packs of cardboard.
150 pcs.
(10 pcs with formoterol in 3 blisters and 10 pcs with budesonide in 12 blisters) - blisters (15) complete with device for inhalations (airlaser) - packs of cardboard.
70 pcs.
(10 pcs with formoterol in 6 blisters and 10 pcs with budesonide in 1 blister) - blisters (7) complete with device for inhalations (aerolaser) - packs of cardboard.
90 pcs.
(10 pcs with formoterol in 6 blisters and 10 pcs with budesonide in 3 blisters) - blisters (9) complete with device for inhalations (airlaser) - packs of cardboard.
120 pcs.
(10 pcs with formoterol in 6 blisters and 10 pcs with budesonide in 6 blisters) - blisters (12) complete with device for inhalation (aerolaser) - packs of cardboard.
180 pcs.
(10 pcs with formoterol in 6 blisters and 10 pcs with budesonide in 12 blisters) - blisters (18) complete with device for inhalation (airlaser) - packs of cardboard.
A set of capsules with powder for inhalation.

Capsules with powder for inhalation are transparent colorless, size No. 3, labeled "CG" on the lid and "FXF" on the body or "CG" on the body and "FXF" on the lid with black ink;
contents of capsules - easily flowing powder of white color.
1 caps.

formoterol fumarate dihydrate 12 μg

Excipients: lactose monohydrate - up to 25 mg.

The composition of the capsule shell: gelatin 100% - 49 mg.

Capsules with powder for inhalation are hard gelatinous, size 3, with a pink lid and a colorless transparent body, with an image and an inscription "BUDE 400", the contents of the capsules are white powder.

1 caps.

budesonide 400 μg

Excipients: lactose monohydrate - 24.54 mg.

The composition of the shell capsule cover: iron oxide red (E172) - 0.12%, iron oxide black (E172) - 0.075%, dye crimson (ponso 4R) - 0.04%, titanium dioxide (E171) - 2.46%, water 14.5%, gelatin - 82.8%.

The composition of the shell of the capsule body: water - 14.5%, gelatin - 85.5%.

40 pcs.
(10 pcs with formoterol in 3 blisters and 10 pcs with budesonide in 1 blister) - blisters (4) complete with device for inhalations (airlaser) - packs of cardboard.
60 pcs.
(10 pcs with formoterol in 3 blisters and 10 pcs with budesonide in 3 blisters) - blisters (6) complete with device for inhalations (airlaser) - packs of cardboard.
90 pcs.
(10 pcs with formoterol in 3 blisters and 10 pcs with budesonide in 6 blisters) - blisters (9) complete with device for inhalations (airlaser) - packs of cardboard.
150 pcs.
(10 pcs with formoterol in 3 blisters and 10 pcs with Budesonide in 12 blisters) - blisters (15) complete with device for inhalations (airlaser) - packs of cardboard.
70 pcs.
(10 pcs with formoterol in 6 blisters and 10 pcs with budesonide in 1 blister) - blisters (7) complete with device for inhalations (aerolaser) - packs of cardboard.
90 pcs.
(10 pcs with formoterol in 6 blisters and 10 pcs with budesonide in 3 blisters) - blisters (9) complete with device for inhalations (airlaser) - packs of cardboard.
120 pcs.
(10 pcs with formoterol in 6 blisters and 10 pcs with budesonide in 6 blisters) - blisters (12) complete with device for inhalation (aerolaser) - packs of cardboard.
180 pcs.
(10 pcs with formoterol in 6 blisters and 10 pcs with budesonide in 12 blisters) - blisters (18) complete with device for inhalation (airlaser) - packs of cardboard.
A set of capsules with powder for inhalation.

Capsules with powder for inhalation are transparent colorless, size No. 3, labeled "CG" on the lid and "FXF" on the body or "CG" on the body and "FXF" on the lid with black ink;
the content of the capsules is a free flowing powder of white color.
1 caps.

formoterol fumarate dihydrate 12 μg

Excipients: lactose monohydrate - up to 25 mg.

The composition of the capsule shell: gelatin 100% - 49 mg.

Capsules with powder for inhalation are hard gelatinous, size 3, with a cap of light pink color and a colorless transparent body, with an image and an inscription "BUDE 200", the contents of the capsules are white powder.

1 caps.

budesonide 200 μg

Excipients: lactose monohydrate - 24.77 mg.

The composition of the shell capsule shell: iron oxide red (E172) - 0.086%, titanium dioxide (E171) - 2%, water - 15%, gelatin - 83%.

The composition of the shell of the capsule body: water - 14.5%, gelatin - 85.5%.

40 pcs.
(10 pcs with formoterol in 3 blisters and 10 pcs with budesonide in 1 blister) - blisters (4) complete with device for inhalations (airlaser) - packs of cardboard.
60 pcs.
(10 pcs with formoterol in 3 blisters and 10 pcs with budesonide in 3 blisters) - blisters (6) complete with device for inhalations (airlaser) - packs of cardboard.
90 pcs.
(10 pcs with formoterol in 3 blisters and 10 pcs with budesonide in 6 blisters) - blisters (9) complete with device for inhalations (airlaser) - packs of cardboard.
150 pcs.
(10 pcs with formoterol in 3 blisters and 10 pcs with budesonide in 12 blisters) - blisters (15) complete with device for inhalations (airlaser) - packs of cardboard.
70 pcs.
(10 pcs with formoterol in 6 blisters and 10 pcs with budesonide in 1 blister) - blisters (7) complete with device for inhalations (airlaser) - packs of cardboard.
90 pcs.
(10 pcs with formoterol in 6 blisters and 10 pcs with budesonide in 3 blisters) - blisters (9) complete with device for inhalations (airlaser) - packs of cardboard.
120 pcs.
(10 pcs with formoterol in 6 blisters and 10 pcs with budesonide in 6 blisters) - blisters (12) complete with device for inhalation (aerolaser) - packs of cardboard.
180 pcs.
(10 pcs with formoterol in 6 blisters and 10 pcs with budesonide in 12 blisters) - blisters (18) complete with device for inhalation (airlaser) - packs of cardboard.
A set of capsules with powder for inhalation.

Capsules with powder for inhalation are transparent colorless, size No. 3, labeled "CG" on the lid and "FXF" on the body or "CG" on the body and "FXF" on the lid with black ink;
contents of capsules - easily flowing powder of white color.
1 caps.

formoterol fumarate dihydrate 12 μg

Excipients: lactose monohydrate - up to 25 mg.

The composition of the capsule shell: gelatin 100% - 79 mg.

Capsules with powder for inhalation are hard gelatinous, size 3, with a pink lid and a colorless transparent body, with an image and an inscription "BUDE 400", the contents of the capsules are white powder.

1 caps.

budesonide 400 μg

Excipients: lactose monohydrate - 24.54 mg.

The composition of the shell capsule cover: iron oxide red (E172) - 0.12%, iron oxide black (E172) - 0.075%, dye crimson (ponso 4R) - 0.04%, titanium dioxide (E171) - 2.46%, water 14.5%, gelatin - 82.8%.

The composition of the shell of the capsule body: water - 14.5%, gelatin - 85.5%.

40 pcs.
(10 pcs with formoterol in 3 blisters and 10 pcs with budesonide in 1 blister) - blisters (4) complete with device for inhalations (airlaser) - packs of cardboard.
60 pcs.
(10 pcs with formoterol in 3 blisters and 10 pcs with budesonide in 3 blisters) - blisters (6) complete with device for inhalations (airlaser) - packs of cardboard.
90 pcs.
(10 pcs with formoterol in 3 blisters and 10 pcs with budesonide in 6 blisters) - blisters (9) complete with device for inhalations (airlaser) - packs of cardboard.
150 pcs.
(10 pcs with formoterol in 3 blisters and 10 pcs with Budesonide in 12 blisters) - blisters (15) complete with device for inhalations (airlaser) - packs of cardboard.
70 pcs.
(10 pcs with formoterol in 6 blisters and 10 pcs with budesonide in 1 blister) - blisters (7) complete with device for inhalations (aerolaser) - packs of cardboard.
90 pcs.
(10 pcs with formoterol in 6 blisters and 10 pcs with budesonide in 3 blisters) - blisters (9) complete with device for inhalations (airlaser) - packs of cardboard.
120 pcs.
(10 pcs with formoterol in 6 blisters and 10 pcs with budesonide in 6 blisters) - blisters (12) complete with device for inhalation (aerolaser) - packs of cardboard.
180 pcs.
(10 pcs with formoterol in 6 blisters and 10 pcs with budesonide in 12 blisters) - blisters (18) complete with device for inhalation (airlaser) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

The drug with anti-inflammatory and bronchodilator effect.

Formoterol

A selective agonist?
2- 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 min) and persists for 12 hours after inhalation. When the drug is used in therapeutic doses, the effect on the cardiovascular system is minimal and is noted only in rare cases.
It inhibits the release of histamine and leukotrienes from mast cells.
In animal experiments, some of the anti-inflammatory properties of formoterol have been shown, such as the ability to inhibit the development of edema and the accumulation of inflammatory cells.
Clinical studies have shown that the drug effectively prevents bronchospasm caused by inhaled allergens, physical activity, cold air, histamine or methacholine.
As the bronchodilator effect of formoterol remains pronounced within 12 hours after inhalation, the administration of the drug 2 times / day for prolonged maintenance therapy 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 COPD of stable course, formoterol causes a rapid onset of bronchodilator effect and improvement of quality of life parameters.

Budesonide

Budesonide is a GCS for inhalation, with little or no systemic effect.
Like other inhaled corticosteroids, budesonide exerts pharmacological effects through interaction with intracellular glucocorticoid receptors.
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 metabolic products of arachidonic acid-cyclic endoperoxides and prostaglandins. It prevents the accumulation of neutrophils, reduces inflammation and cytokine production, inhibits the migration of macrophages, reduces the intensity of infiltration and granulation processes, the formation of a chemotaxis substance (which explains the effectiveness of "late" allergy reactions); inhibits the release of mast cells from inflammatory mediators (immediate allergic reaction). Increases the number of "active"? -adrenoceptors, restores the patient's response to bronchodilators, reducing the frequency of their use, reduces the swelling of the bronchial mucosa, the production of mucus, the formation of sputum and reduces the hyperreactivity of the airways. Increases mucociliary transport.
The therapeutic effect of the drug in patients requiring treatment with GCS, develops on average within 10 days after the initiation 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 the hyperreactivity of the bronchi and prevents exacerbations of the disease.
PHARMACOKINETICS

Formoterol

Suction

After a single inhalation of formoterol fumarate at a dose of 120 μg to healthy volunteers, formoterol was rapidly absorbed into the plasma, C max formoterol in plasma was 266 pmol / L and was achieved within 5 min after inhalation.
In patients with COPD who received formoterol at a dose of 12 μg or 24 μg 2 times / day for 12 weeks, the plasma concentrations of formoterol, measured at 10 minutes, 2 hours and 6 hours after inhalation, were in the ranges 11.5-25.7 pmol / L and 23.3-50.3 pmol, respectively.
In studies that studied the total excretion of formoterol and its (R, R) - and (S, S) enantiomers in urine, it was shown that the amount of formoterol in the systemic blood flow increases in proportion to the amount of inhaled dose (12-96 μg).

After inhalation application of formoterol at a dose of 12 μg or 24 μg 2 times / day for 12 weeks, excretion of unchanged formoterol in urine in patients with bronchial asthma increased by 63-73%, and in COPD patients by 19-38%.
This indicates a certain cumulation of formoterol in the plasma after multiple inhalations. In this case, there was no greater accumulation of one of the enantiomers of formoterol compared to others after repeated inhalations.
Just as it was reported for other drugs used as inhalants, most of the formoterol used with the inhaler will be swallowed and then absorbed from the digestive tract.When 80 μg of 3 H-labeled formoterol was administered to the two healthy volunteers, at least 65% of formoterol was absorbed.

Distribution

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

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

Metabolism

The main way of metabolism of formoterol is direct conjugation with glucuronic acid.
Another way of metabolism is O-demethylation followed by glucuronization.
Minor metabolic pathways include conjugation of formoterol with sulfate followed by deforming.
A variety of isoenzymes are involved in the process of glucuronization (UGT1A1, 1A3, 1A6, 1A7, 1A8, 1A9, 1A10, 2B7 and 2B15) and O-demethylation of formoterol (CYP2D6, CYP2C19, CYP2C9, CYP2A6), which implies a low probability of drug interaction by inhibiting any anti- or isoenzyme, taking part in the metabolism of formoterol. In therapeutic concentrations, formoterol does not inhibit the isoenzymes of the cytochrome P450 system.
Excretion

In patients with bronchial asthma and COPD who received formoterol fumarate at a dose of 12 μg or 24 μg 2 times / day for 12 weeks, approximately 10% or 7%, respectively, was detected in the urine as unchanged formoterol.
The calculated fractions 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.
The active substance and its metabolites are completely eliminated from the body: 70% by the kidneys, 30% through the intestine.
The renal clearance of formoterol is 150 ml / min. T 1/2 is 2-3 hours.
In healthy volunteers, the final T 1/2 of formoterol from the plasma after a single inhalation at a dose of 120 μg is 10 hours;
The final T 1/2 (R, R) - and (S, S) -enantiomers calculated from excretion in the urine were 13.9 hours and 12.3 hours, respectively.
Pharmacokinetics in special clinical cases

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

The pharmacokinetics of formoterol in elderly patients aged 65 years and older have not been studied.

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

In clinical studies in children in urine was determined about 6% of unchanged formoterol.

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

Budesonide

Suction

Budesonide is rapidly and completely absorbed after inhalation, with C max in the blood plasma achieved immediately after use.
After inhalation budesonide taking into account the sedimentation of the drug on the mucous membrane of the oropharynx absolute bioavailability is 73%. Absolute bioavailability when taking the drug inside is ± 10%.
Distribution

V d is 3 l / kg.
Binding to plasma proteins - 88%. The systemic clearance of the inhaled drug is 0.5 l / min. In experimental studies, budesonide accumulated in the spleen, lymph nodes, thymus gland, adrenal cortex, reproductive organs and bronchi, and also penetrated the placental barrier.
Metabolism

Budesonide is not metabolized in the lungs.
After absorption, the drug is almost completely (about 90%) metabolized in the liver with the formation of several inactive metabolites (biological activity is 100 times less than budesonide), including 6? -hydroxybudesonide and 16? -hydroxprednisolone (systemic clearance 1.4 l / min) .Budesonide has a high systemic clearance - 84 l / h and the short T 1/2 -. 2.8 h main path budesonide hepatic metabolism via CYP3A4 P450 isoenzyme system may be affected by inhibitors or inducers of CYP3A4.
Excretion

T 1/2 -. 2-2.8 hours is derived through the intestine as metabolites - 10% kidney - 70%.
Pharmacokinetics in special clinical cases

Plasma concentrations of budesonide increased in patients with liver disease.
The pharmacokinetics of budesonide in children and adolescents has not been studied. However, data on other inhaled formulations comprising budesonide, suggest that clearance of budesonide in children above 3 years old about 50% higher compared with adult patients.
INDICATIONS

Bronchial asthma:
- insufficiently controlled reception inhaled corticosteroids and beta 2 -agonists short acting as therapies on demand;
- adequately controlled with inhaled corticosteroids and beta 2 agonists long-acting.
Chronic obstructive pulmonary disease (COPD) (with proven efficacy of corticosteroids).
DOSING MODE

Formoterol and budesonide are intended for administration by inhalation. The formulations are capsules with powder for inhalation, which should be used only with a special device - aerolayzera which included in the package.
Formoterol and budesonide should be administered individually, the lowest effective dose.
Upon reaching the control of asthma symptoms during therapy with formoterol, it is necessary to consider a gradual reduction in dose. Reducing the dose of formoterol is carried out under regular medical supervision of the patient. Against the background of acute asthma should not start treatment formoterol or change the dosage of the drug. Formoterol should not be used for the relief of acute asthma attacks.
When administering to a patient via inhalation therapy devices, it is necessary to pick up gradually (titrate) the dose to doses sufficient to maintain therapeutic effect.
Budesonide + formoterol
Adult
Pre inhaled beta-agonists dilates the bronchi, budesonide improves the flow of the respiratory tract and enhances its therapeutic effect. Therefore, for maintenance treatment of asthma and COPD is performed first inhalation formoterol, then - budesonide inhalation.
1. The dose of formoterol for regular maintenance therapy is 12-24 g (1-2 contents capsules) 2 times / day. Do not exceed the maximum recommended dose for adults of the drug (48 mg / day).
Considering that the maximum daily dose of 48 micrograms of formoterol, optionally additionally be applied 12-24 mg / day to alleviate symptoms of asthma. If the need for application of additional doses of the drug ceases to be an ad hoc (for example, becomes more than 2 days a week), the patient should be encouraged to consult with a physician for treatment of the revision, because it may indicate a potentially serious course of the disease.
2. Minimum dose per capsule is 200 mg. The drug is not administered, if the application requires a single dose of less than 200 micrograms. In adult patients with mild asthma treatment can begin in the minimal effective dose of 200 mg / day.
Supportive budesonide dose for adult patients amounts to 400-800 mg / day in 2 divided doses (200-400 mg 2 times / day).
During exacerbation of asthma during transfer from oral to inhaled corticosteroids or at lower doses of oral corticosteroids budesonide can be administered in a dose of 1600 mg / day in 2-4 doses.
Children aged 6 years and older
Pre inhaled beta-agonists dilates the bronchi, budesonide improves the flow of the respiratory tract and enhances its therapeutic effect. Therefore, for maintenance treatment of asthma inhalation formoterol is performed first, and then - after inhalation of budesonide.
1. The dose of formoterol for regular maintenance therapy is 12 mg 2 times / day. The maximum recommended dose is 24 mg / day.
2. Treatment of children with mild bronchial asthma begin with a dose of 200 mg / day. Budesonide dose for regular maintenance therapy is 100-200 micrograms 2 times / day. If necessary, the dose of budesonide may be increased to a maximum of - 800 mg / day.
Due to the lack of clinical experience in children under 6 years of budesonide should not be used in this age group.
Patients with impaired renal function

the need dose correction data in patients with impaired renal function is not obtained. Based on the pharmacokinetics of budesonide for ingestion is unlikely that these patients may clinically significant systemic exposure to the drug.
Patients with impaired hepatic function

The need dose correction data in patients with impaired liver function is not obtained. But Budesonide is metabolized primarily in the liver. Therefore, the drug should be used with caution in patients with severe hepatic impairment. In patients with mild or moderate hepatic impairment is unlikely a significant change in exposure to the drug, taking into account the pharmacokinetic parameters for the oral budesonide.
Elderly patients (over 65 years)
Data on the necessity of correction of the dose in patients over 65 years of age, compared to younger patients, is not obtained.
The rules of the inhalation
In order to ensure proper use of drugs, a doctor or other medical professional should show the patient how to use an inhaler; explain to the patient that use of the capsule with the powder to be inhaled only via aerolayzera; warn the patient that the capsules are only for inhalation use and not intended for ingestion. In children and adolescents inhaled budesonide and formoterol should be under adult supervision. You must ensure that the child is properly performing inhalation technique.
It is important that the patient understand that due to the destruction of a gelatin capsule small pieces of gelatin as a result of inhalation can be caught in the mouth or throat. In order to reduce this phenomenon to a minimum, do not pierce the capsule more than 1 times.
Remove the capsule from the blister pack immediately before use.
Rinsing the mouth with water after inhalation of budesonide can prevent irritation of the mouth and pharynx, and reduce the risk of systemic adverse events.
There are anecdotal reports of patients accidentally swallowed the drug capsules whole. The majority of cases are not related to adverse events. The health worker should explain to the patient how to use the drug, especially if after the inhalation of the patient is not breathing comes improvement.
Instructions for use aerolayzera
1. Remove the cap from the aerolayzera.
2. Firmly hold aerolayzer the base and turn the mouthpiece in the direction of the arrow.
3. Place the capsule in a cell located at the base aerolayzera (it has a capsule shape). Keep in mind that removing the capsule from the blister pack is necessary immediately prior to inhalation.
4. Turn the mouthpiece close aerolayzer.
5. Hold aerolayzer in the upright position once the end of the press to the blue button having laterally aerolayzera. Then let them go.
At this stage, by puncturing it may break the capsule, whereby the small pieces of gelatin can get into the mouth or throat. Since gelatin is edible, it does not cause any harm. In order that the capsule did not collapse completely, it should fulfill the following requirements: the capsule is not pierced more than once; to comply with the storage rules; remove the capsule from the blister until immediately prior to inhalation.
6. Make full exhalation.
7. Take the mouthpiece into your mouth and gently tilt the head back. Firmly grasp the mouthpiece lips and make a quick, uniform, maximally deep breath. In this case, the patient should hear the characteristic rattling noise generated by the rotation of the capsule and powder spraying. If the characteristic sound was not, then you need to open aerolayzer and see what happened to the capsule. Maybe she's 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 taps on the sides aerolayzera button.
8. If inhaled characteristic sound is heard, it is necessary to hold your breath as long as possible. At the same time, remove the mouthpiece from the mouth. Then exhale. Open aerolayzer and see whether remains of the capsule powder. If the capsule was powder, re-do the steps described in paragraphs 6-8.
9. After the inhalation procedure aerolayzer open, remove the empty capsule, close mouthpiece and close aerolayzer cap.
To remove residual powder should wipe the mouthpiece and cell dry cloth. You can also use a soft brush.
SIDE EFFECT

Adverse reactions, noted in clinical studies are distributed in accordance with the frequency of occurrence. The following criteria are used to assess the frequency: very common (1/10?); common (1/100, <1/10?);
infrequently (? 1/1000, <1/100); rarely (? 1/10 000, <1/1000); very rarely (<1/10 000), including individual messages.Within each group, adverse reactions are distributed in decreasing order of importance.
Formoterol
Allergic reactions: very rarely - hypersensitivity reactions, such as hypotension, urticaria, angioneurotic edema, pruritus, rash.
On the part of the psyche: seldom - agitation, anxiety, irritability, insomnia.
From the nervous system: often - headache, tremor;
infrequently - dizziness; very seldom - taste disturbances.
Cardio-vascular system: often - palpitations; rarely - tachycardia; very rarely - peripheral edema.
The respiratory system: rarely - bronchospasm, including paradoxical, irritation of the mucous membrane of the pharynx and larynx.
From the digestive system: infrequently - dryness of the oral mucosa; very rarely - nausea.
On the part of the musculoskeletal system: rarely - muscle spasm, myalgia.
Adverse reactions according to post-marketing observations when assigning formoterol (Foradil)
Laboratory and instrumental data:hypokalemia, hyperglycemia, lengthening the interval QT (during ECG), increased blood pressure (including hypertension).
The respiratory system: cough.
Skin and subcutaneous tissue disorders: rash.
Cardio-vascular system: angina, heart rhythm disorders, including atrial fibrillation, ventricular extrasystoles, tachyarrhythmia.
Budesonide is
part of the endocrine system: rarely - inhibition of the function of the adrenal cortex, Cushing's syndrome, hypercortisolism, growth retardation in children and adolescents.
From a sight organ: seldom - cataract, glaucoma.
Allergic reactions:rarely - hypersensitivity reactions, rash, urticaria, angioedema, pruritus, contact dermatitis (a reaction of delayed-type hypersensitivity IV).
On the part of the psyche: postmarketing surveillance - psychomotor hyperactivity, sleep disorders, anxiety, depression, aggressive behavior, conduct disorder (especially in children).
On the part of the musculoskeletal system: rarely - a decrease in bone mineral density.
The respiratory system: often - cough; rarely - paradoxical bronchospasm, candidiasis of the oral mucosa and throat, irritated throat, hoarseness, disappearing after cessation of therapy budesonide or reducing the dose.
The three-year clinical study in the application of 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%, p <0.001 and p <0.01 respectively).
CONTRAINDICATIONS

- the period of lactation (breastfeeding);

- an active pulmonary tuberculosis;
- hereditary galactose intolerance, severe lactase deficiency and malabsorption syndrome, glucose-galactose;
- children's age till 6 years;

- Hypersensitivity to formoterol, budesonide, or any other component of the formulation.
Formoterol
Compliance with special care when using formoterol (especially in terms of reduction of dose) and careful monitoring of patients required under the following concomitant diseases: coronary artery disease; disorders of heart rhythm and conduction, especially AV-block III degree; severe chronic heart failure; idiopathic subvalvular aortic stenosis; hypertrophic obstructive cardiomyopathy, aortic aneurysm; hyperthyroidism; known or suspected lengthening the interval QT (QT corrected> 0.44 s), hypokalemia, hypocalcemia, and pheochromocytoma.
Given hyperglycemic effect inherent beta-adrenergic agonist, including formoterol, in diabetic patients it is recommended additional regular control of blood glucose concentration.
Budesonide
Since budesonide is not effective, the drug should not be for the relief of acute bronchospasm designate as primary therapy in status asthmaticus or other acute asthmatic conditions.
Caution must be careful when applying budesonide in patients with inactive pulmonary tuberculosis, fungal, bacterial and viral infections of the respiratory tract, liver cirrhosis, glaucoma. Also, given the possibility of fungal disease, caution should be prescribed the drug for bronchiectasis and pneumoconiosis.
Formoterol and budesonide capsules contain lactose.
PREGNANCY AND LACTATION

Formoterol
Security application Foradil Combi in pregnancy and lactation has not yet been established.
Application of pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus. Formoterol, as well as other beta 2 -adrenomimetiki can slow down the process of childbirth as a result of tocolytic action (relaxing effect on the smooth muscles of the uterus).
It is not known whether formoterol is excreted in breast milk in humans. During the reception, Foradil Combi breastfeeding should be discontinued.
Budesonide
In experimental studiesanimal revealed a possible teratogenic effects of corticosteroids on the fetus. Information about budesonide teratogenicity or reproductive toxicity in the presence of the drug when used in humans, no.
Application of pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus. When the need for care
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