Universal reference book for medicines
Product name: FOSTER (FOSTER)

Active substance: beclometasone, formoterol

Type: Anti-inflammatory and bronchodilator drug

Manufacturer: Chiesi Pharmaceuticals (Germany)
Composition, form of production and packaging
Aerosol for inhalation dosage
1 dose

beclomethasone dipropionate 100 μg

formoterol fumarate 6 mcg

120 doses - aerosol aluminum cylinders (1) - packs of cardboard.

180 doses - aerosol aluminum cylinders (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

Foster contains beclomethasone dipropionate and formoterol, which have different mechanisms of action and exhibit an additive effect in reducing the frequency of exacerbations of bronchial asthma.

Beclomethasone dipropionate - inhaled glucocorticosteroids, at recommended doses has anti-inflammatory effect, reduces the symptoms of bronchial asthma and reduces the frequency of exacerbations of the disease, while it has a lower incidence of side effects than systemic GCS.

Formoterol is a selective agonist?
2- adrenoreceptors, which causes relaxation of the smooth muscles of the bronchi in patients with reversible airway obstruction.Broncholytic action occurs rapidly, within 1-3 min after inhalation, and persists for 12 h after inhalation of a single dose.
Addition of formoterol to beclomethasone dipropionate reduces the severity of symptoms of bronchial asthma, improves the function of external respiration (FVD) and reduces the frequency of exacerbations of the disease.

In the course of the clinical study, it was shown that the effect on FVD of a fixed Foster combination corresponds to that of a combination of beclomethasone dipropionate and formoterol monopreparations and exceeds the action of one beclomethasone dipropionate.

PHARMACOKINETICS

The pharmacokinetic parameters for the respective drugs were comparable after the administration of beclomethasone dipropionate (BDP) and formoterol in the form of monopreparations and as part of the combined preparation.

For beclomethasone dipropionate, when administered as a combined AUC preparation for its active metabolite beclomethasone-17-monopropionate and the C maxvalue in the plasma is somewhat lower, and absorption is faster than that of the beclomethasone dipropionate mono drug.

For formoterol, when administered as a combined preparation, Cmax in plasma coincided with that for monotherapy, and the systemic effect was slightly higher than that of monotherapy.

No data were obtained regarding the pharmacokinetic or pharmacodynamic interaction between BDP and formoterol: BDP under the action of esterase is converted to the active metabolite beclomethasone-17-monopropionate (B-17 MP).

Inhaled BDP is rapidly absorbed by the lungs;
its absorption is preceded by intensive conversion of BDP into its active metabolite, beclomethasone-17-monopropionate (B-17 MP). Systemic bioavailability (B-17 MP) is ensured by 36% at the expense of the lungs, and also due to absorption by the gastrointestinal organs of the swallowed part of the inhalation dose. The bioavailability of the swallowed BDP is negligible, however, the pre-system BDP conversion in B-17 MP leads to the fact that 41% of BDP is absorbed by the body in the form of B-17 MP. There is an almost linear increase in systemic action with an increase in the inhalation dose. Absolute bioavailability after inhalation is about 2% and 62% of the nominal dose in relation to the unchanged BDP u and B-17 MP, respectively.
Binding to plasma proteins is quite high.

Metabolism

BJP is characterized by a very high rate of clearance from the large circle of circulation due to the action of esterase, which is present in most tissues.
The main product of BDP metabolism is the active metabolite B-17 MP. Less active metabolites are beclomethasone 21 monopropionate (B-21 MP) and beclomethasone (BOH), which are also formed as a result of metabolism, but their role in systemic exposure to the BDP is very low.
Excretion

The main part of the BDP is excreted with the feces in the form of polar metabolites.
Renal excretion of the BDP and its metabolites is negligible. T 1/2 BDP and B-17 MP are 0.5 and 2.7 h, respectively.
Pharmacokinetics in special clinical cases

Hepatic insufficiency does not lead to a change in the pharmacokinetic properties and safety profile of the BDP due to the fact that the latter undergoes rapid metabolism to the polar metabolites B-21 MP, BOH and B-17 MP by enzymes present in the gastrointestinal tract, lungs and liver.

The pharmacokinetic properties of BDP in patients with renal insufficiency have not been studied.
Taking into account that both BDP and its metabolites with urine are practically not allocated, there are no grounds to assume an increase in the systemic effect of the drug on the body of patients suffering from renal insufficiency.
Formoterol

Suction and distribution

Inhaled formoterol is absorbed in the lungs and the digestive tract.
Part of the inhalation dose that is swallowed depends on the type of inhalation device. and inhalation techniques. So when using a multi-dose metered-dose inhaler, it can be up to 90%. Therefore, the swallowed fraction should be taken into account in the inhalation route of administration of the preparation.
At least 65% of the oral dose of fmoterol is absorbed through the gastrointestinal tract, with 70% of this volume being subjected to pre-systemic metabolism.
C max ofunchanged formoterol in blood plasma is observed during 0.5-1 h after oral administration. The connection with plasma proteins in formoterol is 61-64%, while the affinity for albumin is 34%. In the range of therapeutic doses of saturation, affinity is not observed. With oral administration, T 1/2 is 2-3 hours. When inhaled with 12-96 μg of formoterol fumarate, the absorption of formoterol is linear.
Metabolism

The metabolism of formoterol is carried out, in particular, by direct conjugation of the phenol hydroxyl group.

Conjugates of glucuronic acid are not active.
The second significant way of metabolism of formoterol is O-dimethylation by means of conjugation at the level of the phenol-2-hydroxyl group. Cytochrome P450 of the enzymes CYP2D6, CYP2C9, CYP2C19 participates in the O-demeterelation of formoterol. There is reason to believe that the metabolism of formoterol is mainly carried out in the liver. Formoterol does not inhibit CYP450 enzymes at therapeutically significant concentrations.
Excretion

Total renal excretion of formoterol after inhalation of a single dose through a metered powder inhaler increases linearly in the dose range of 12-96 μg.
The excretion rates of unchanged and total formoterol, on average, are 8% and 25%, respectively. Based on measurements of plasma concentrations of formoterol after its single inhalation at a dose of 120 μg, T 1/2 was determined in 12 healthy volunteers, which was 10 hours. The ratio of (R, R) - and (S, S) enantiomers of the unchanged drug in renal excretion is 40% and 60%, respectively. The relative ratio of these 2 indices does not change in the range of dosages being investigated; There is no evidence of the accumulation of one enantiomer relative to another after taking, a second dose.
In healthy volunteers, after oral administration (40-80 μg), 6-10% of the dose was detected in the urine as an unchanged drug;
8% of the dose was present as glucuronides.
Only 67% of the oral dose of formoterol is excreted by the kidneys (mainly in the form of metabolites), the rest of the dose - through the intestine.
The renal clearance of formoterol is 150 ml / min.
INDICATIONS

Basic therapy of bronchial asthma involving the appointment of combination therapy (inhaled GCS and long-acting β2-adrenomimetic):

- Patients, symptoms of the disease, which are not adequately controlled by inhaled GCS and?
2- adrenomimetics of short action;
- Patients receiving effective maintenance doses of inhaled glucocorticosteroids and?
2 -adrenomimetics of long-acting.
DOSING MODE

Foster is not intended for the initial treatment of bronchial asthma.
Selection of the dose of drugs that make up Foster, occurs individually and depending on the severity of the disease. This need to be taken into account not only at the beginning of treatment with combined preparations, but also with a change in the maintenance dose of the drug. In the event that individual patients require a different combination of doses of active components than in Foster, should be prescribed?2- adrenomimetics and / or GCS in separate inhalers.
For adults and teenagers over 12 years: 1-2 inhalations 2 times / day.
Patients should be under constant monitoring by a physician for an adequate dose of Foster.The dose should be reduced to the lowest, against which the optimal control of symptoms of bronchial asthma remains. When full control over the symptoms of bronchial asthma is achieved against the background of the minimum recommended dose of the drug, the next step is to try the appointment of monotherapy with inhaled glucocorticosteroids.
There is no need for a special dose selection for elderly patients .

There is no evidence of Foster receiving patients with renal or hepatic insufficiency .

Instructions for use of the inhaler.

The patient should be taught how to use the inhaler correctly and periodically check the technique of inhalation.

Before the first use of the inhaler or after 3 days or more after a break in its use, the first dose must be sprayed into the air to ensure that it works.

1. Take the inhaler with your thumb and index finger.

2. Remove the protective cap from the inhaler mouthpiece.

3. Take the mouthpiece into your mouth, tightly wrapping it around your lips, and completely exhale through your nose.

4. Draw a long deep breath while pressing the end of the can with your index finger.

5. After inhalation, hold your breath as long as possible.
Then take the mouthpiece out of your mouth and continue to breathe normally.
To obtain a second dose: holding the inhaler in an upright position, wait about 30 seconds and then repeat steps 3 through 5.

After use, tightly close the mouthpiece with a protective cap.

Performing steps 3 and 4, you can not hurry.
Start inhaling as slowly as possible, just before pressing the inhaler valve.
If the gas partially escapes from the top of the inhaler or from the corners of the patient's mouth, repeat the sequence from step 3.

Patients with weak hands are more comfortable to keep the inhaler with both hands.
Therefore, the upper part of the inhaler should be held by two index fingers, and its lower part by the thumbs.
After inhalation, rinse your mouth with water.

To maintain the purity of the mouthpiece, it is recommended to wash it with warm water as it gets dirty.

There are no clinical data on the use of Foster with a spacer;
so the recommended dosage of the drug is given taking into account the fact that an inhaler without a spacer with a standard activator is used.
It should be borne in mind that when using Foster with a spacer, it may be necessary to adjust the dose.

SIDE EFFECT

Foster contains beclomethasone dipropionate and formoterol fumarate, and therefore one should expect that it can cause side effects characteristic of these components.
There is no evidence that their simultaneous use causes additional side effects.
Side effects associated with the use of beclomethasone dipropionate and formoterol as a fixed combination (Foster) are presented below.

From the side of the central nervous system: often - a headache.

On the part of the respiratory system: often - the hoarseness of the voice;
less often - rhinitis, dysphonia, cough, mild irritation in the throat, bronchospasm.
From the cardiovascular system: less often - palpitations, lengthening of the QT interval, change in the ECG.

From the musculoskeletal system: tremor, muscle cramps.

From the hemopoietic system: granulocytopenia, an increase in the number of platelets.

From the digestive system: dry mouth, burning sensation in the lips, dysphagia, indigestion, diarrhea.

From the immune system: allergic dermatitis;
increase in C-reactive protein.
Metabolic disorders: hypokalemia.

Infections: pharyngitis, influenza, candidiasis of the oral mucosa, pharynx and esophagus, vaginal candidiasis, gastroenteritis, sinusitis.

Among the most common side effects associated with taking formoterol, typical for beta 2 -adrenomimetics such as hypokalemia, headache, tremor, palpitation, cough, muscle cramps, lengthening of the QTc interval are described.

Side effects, typical for beclomethasone dipropionate: Candidiasis of the mucous membrane of the oral cavity and pharynx, irritation in the throat.

Like other inhaled drugs, Foster can cause a paradoxical bronchospasm.

Other side effects of formoterol include thrombocytopenia, angioedema, hyperglycemia, increased insulin levels, free fatty acids, glycerol and ketone derivatives, sleep disorders, hallucinations, fatigue, anxiety, changes in taste (dysgeusia), tachycardia, tachyarrhythmia, ventricular extrasystole, angina pectoris, atrial fibrillation, arterial hypertension, arterial hypotension, exacerbation of bronchial asthma, dyspnea, nausea, pruritus, skin rash, urticaria, hyperhidrosis
, Myalgia, nephritis, peripheral edema.
Systemic effects of GCS (including beclomethasone dipropionate) occur when high doses are prescribed for a long time.
These include: suppression of adrenal function, reduction of bone mineral density, growth retardation in children and adolescents, glaucoma and cataracts.
Hypersensitivity reactions include: itching, skin rash, erythema and swelling of the eyes, face, lips and throat.

CONTRAINDICATIONS

- children's age till 12 years;

- Hypersensitivity to the components of the drug.

Precautions: pregnancy, lactation, pulmonary tuberculosis, fungal, viral or bacterial respiratory infections, thyrotoxicosis, pheochromocytoma, diabetes mellitus, uncontrolled hypokalemia, idiopathic hypertrophic subaortic stenosis, grade III AV blockade, severe arterial hypertension, aneurysm of any site or other severe cardiovascular diseases (acute myocardial infarction, ischemic heart disease, tachyarrhythmia, asthma, chronic heart failure, elongated QT interval (reception formsTerol may cause lengthening QT c) interval.

PREGNANCY AND LACTATION

There are no clinical data on the use of Foster during pregnancy.
In the course of animal studies, embryotoxic or teratogenic effects were not identified.
In pregnancy, Foster should be used only when the benefits of using the drug exceed the potential risk to the fetus.
It is recommended to prescribe a minimum dose, which provides effective control of symptoms of bronchial asthma.
There is no data on the penetration of Foster into the breast milk of women.
Foster may be prescribed to lactating women only if the expected therapeutic effect for the mother exceeds the potential risk for the child.
APPLICATION FOR FUNCTIONS OF THE LIVER

There is no evidence of Foster receiving patients with renal insufficiency .

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

There is no evidence of Foster receiving patients with hepatic insufficiency .

APPLICATION FOR CHILDREN

Contraindicated in children under 12 years.

APPLICATION IN ELDERLY PATIENTS

There is no need for a special dose selection for elderly patients .

SPECIAL INSTRUCTIONS

If patients have comorbid conditions such as IHD, myocardial infarction, exacerbation of the course of arterial hypertension, cardiac rhythm disturbances, chronic heart failure, diabetes mellitus, prostatic hypertrophy, glaucoma, caution should be exercised when choosing a dose of Foster.

Precautions should be observed in the treatment of patients with an extended QT c interval (QTc> 0.44 seconds).
Reception of formoterol may cause an extension of the QTc interval. Foster can be used in patients with tachyarrhythmia only with special precautions, such as ECG monitoring.
Special precautions should be taken in patients with unstable bronchial asthma who use short-acting bronchodilators to relieve attacks with exacerbation of severe bronchial asthma.
risk
the development of hypokalemia increases against a background of hypoxia and other conditions, when the likelihood of developing hypokalemic effects increases.
In such cases it is recommended to monitor the potassium content in the serum.
Inhaling high doses of formoterol can lead to increased blood glucose levels.
During the treatment period, the concentration of glucose in the blood should be monitored in patients with diabetes mellitus. If anesthesia is planned
preparations of halogenated hydrocarbons, it is necessary to warn the patient not to use Foster for 12 hours before the onset of anesthesia.

As with the appointment of other GCS, the need to apply and dose of Foster in patients with active or inactive forms of pulmonary tuberculosis, fungal, viral or bacterial infections of the respiratory system should be reviewed.

Because of the risk of developing an exacerbation, Foster's treatment can not be abruptly stopped, the dose of the drug should be reduced gradually and under the supervision of the doctor.

When patients are already taking this course of treatment (inhaled or oral glucocorticosteroids), it must be continued without any changes, even if symptoms improve.

Preservation of symptoms of bronchial asthma or the need to increase the dose of Foster may indicate a worsening of the course of bronchial asthma and the need to review treatment.
For relief of acute episodes of bronchospasm, patients are advised to carry a beta 2 -adrenomimetiki short-acting.
Foster treatment should not be given in acute asthma.
As with any other inhalation therapy, paradoxical bronchospasm may occur with immediate
gain wheezing after receiving the dose. In this connection, it is necessary to stop Foster therapy, to reconsider the tactics of treatment and, if necessary, appoint an alternative therapy.
Any inhaled GCS can cause systemic effects, especially with prolonged use in high doses;
it should be noted, however, that the likelihood of such symptoms are much lower than in the treatment of oral corticosteroids. Possible systemic effects include suppression of adrenal function, growth retardation in children and adolescents, reduction of bone mineral density, cataract and glaucoma. Considering the above, the dose of inhaled corticosteroids should be titrated to the minimum, which will ensure the continuation of effective control.
In chronic taking excessive doses of beclomethasone dipropionate can manifest its systemic action: it may be a significant inhibition of adrenocortical until adrenal crisis. Adrenal crisis manifested anorexia, abdominal pain, weight loss, fatigue, headache, nausea, vomiting, hypotension, hypoglycemia, accompanied by confusion and / or convulsions. Situations that can serve as a triggering factor of acute adrenal crisis include trauma, surgery, infection or
rapid decrease of the incoming dose beclomethasone Foster. In chronic overdose it is recommended to control the backup function of the adrenal cortex.
If there is reason to believe that against the background of previous systemic therapy SCS was disturbed adrenal function, precautions should be taken when transferring patients to treatment Foster.
The advantages of inhalation therapy are generally minimize the need for receiving oral corticosteroids, but the patients discontinuing therapy with oral corticosteroids for a long time can be maintained insufficient adrenal function. Patients who last needed urgently high doses of corticosteroids or to give long-term treatment with inhaled corticosteroids at high doses, may also be in this risk.
It is necessary to provide for the appointment of additional corticosteroids during periods of stress or surgery.
It is recommended to instruct the patient about the need to rinse the mouth with water after inhalation maintenance doses in order to prevent the risk of developing candidiasis of the oral mucosa and pharynx.
The balloon is under pressure: do not expose to high temperatures Do not pierce, do not burn even empty. Use within 3 months of application.
OVERDOSE

Symptoms: overdose arise typical for beta 2 -adrenomimetikov symptoms associated formoterol, such as nausea, vomiting, headache, tremor, sleepiness, palpitations, tachycardia, ventricular fibrillation, elongation QTc interval, metabolic acidosis, hypokalemia, hyperglycemia.
Treatment: symptomatic treatment. In severe cases, hospitalization. It may be considered the use of cardioselective beta blockers subject caution, since the use of these agents can cause bronchospasm. It is necessary to monitoring the level of potassium in the blood plasma.
Inhaled doses of beclomethasone dipropionate higher than recommended may cause a temporary depression of adrenocortical function. it does not usually require taking some extraordinary measures, because in most cases normal adrenal function is recovered in a few days. It is recommended to control the level of cortisol in the blood plasma.
In chronic taking excessive doses of beclomethasone dipropionate can manifest its systemic action: it may be a significant inhibition of adrenocortical until adrenal crisis. Acute adrenal crisis manifested hypoglycemia accompanied by confusion and / or convulsions. Situations that can serve as a triggering factor of acute adrenal crisis include trauma, surgery, infection or rapid dose reduction is part of the Foster beclomethasone. In chronic overdose it is recommended to control the backup function of the adrenal cortex.
DRUG INTERACTION

Beta-adrenergic receptors may attenuate the effect of formoterol. Foster should not be administered simultaneously with beta-blockers (including eye drops) unless required cases.
Foster a joint reception and other beta-adrenergic drugs may increase the side effects of formoterol.
Foster and co-administration of quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), MAO inhibitors and tricyclic antidepressants may lengthen QTc interval and increase the risk of ventricular arrhythmias.
In addition, levodopa, levothyroxine, oxytocin and alcohol can reduce the tolerance of the heart muscle to beta 2 -adrenomimetikam.
Co-administration of monoamine oxidase inhibitors and drugs with similar properties such as furazolidone and procarbazine, may cause increased blood pressure.
There is an increased risk of arrhythmias in patients with general anesthesia halogenated hydrocarbons drugs.
As a result of beta 2 -adrenomimetikov may occur hypokalemia which may be aggravated by concomitant medication xanthine derivatives, mineral derivatives of corticosteroids, diuretics. Hypokalemia may enhance susceptibility to the development of arrhythmias in patients receiving cardiac glycosides.
Because the content of a small amount of ethanol possible interaction manifestation in patients with increased sensitivity, taking disulfiram or metronidazole.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

Store the drug at a temperature of + 2 ° -8 ° C, protected from the sun location away from the heater.
Do not freeze. Keep out of the reach of children.
Shelf life - 18 months.
Do not use after the date shown on the package.
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