budesonide, Formoterol | Formisonide-native powder for inhalation dosage 160 mcg + 4.5 mcg / dose 60 pcs.

Release form

Dosage 160 mcg + 4.5 mcg: hard capsules No. 3, transparent, colorless, with a slightly yellowish tinge.

Indications

· Bronchial asthma, as a maintenance therapy and for relieving seizures (insufficiently controlled with inhaled corticosteroids and 2 short-acting adrenergic agonists as on-demand therapy, or adequately controlled by inhaled corticosteroids and long-acting 2-adrenergic agonists).

· Chronic obstructive pulmonary disease (COPD), as symptomatic therapy in patients with COPD with post-bronchodilation FEV1 <70% of those due and history of exacerbations, despite regular therapy with bronchodilators.

Contraindications

· Hypersensitivity to budesonide, formoterol, or inhaled lactose.

· Lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

· Children under 6 years of age (for dosages of 80 mcg + 4.5 mcg and 160 mcg + 4.5 mcg).

· Children under 12 years of age (for dosage of 320 mcg + 9 mcg).

Precautions

Pulmonary tuberculosis (active or inactive form), fungal, viral or bacterial infections of the respiratory system, thyrotoxicosis, pheochromocytoma, diabetes mellitus, decreased adrenal cortex function, uncontrolled hypokalemia, hypertrophic obstructive cardiomyopathy, idiopathic hypertrophic subaortic stenosis, severe arterial hypertension, any cardiovascular disease or other diseases of the heart, or any serious cardiovascular disease severe tachyarrhythmia or heart failure), lengthening of the QT interval (taking formoterol can cause lengthening of QTc-interval).

Use during pregnancy and lactation

There are no clinical data on the use of the drug FormisonideВ®-native or the combined use of budesonide and formoterol in pregnancy.

Pregnancy. During pregnancy, FormisononВ®-native should be used only in cases where the benefit of using the drug exceeds the potential risk to the fetus. The lowest effective dose of budesonide necessary to maintain adequate control of the symptoms of bronchial asthma should be used.

Breastfeeding period. Inhaled budesonide is excreted in breast milk, however, when used in therapeutic doses, no effect on the baby was noted. It is not known whether formoterol passes into breast milk of women. FormisonideВ®-native can be prescribed to women during breastfeeding only if the expected benefit to the mother is greater than any possible risk to the baby.

Special instructions

It is recommended to gradually reduce the dose of the drug before stopping treatment and it is not recommended to abruptly cancel the treatment.

Dosages 80 + 4.5 mcg / dose and 320 + 9 mcg / dose are not intended for the treatment of patients with severe bronchial asthma.

Formisonide®-native is not intended for the initial selection of therapy in the early stages of treatment of bronchial asthma.

In case of insufficient effectiveness of therapy or exceeding the maximum recommended doses of Formisonon®-native, treatment tactics should be reviewed.

An increase in the frequency of administration of bronchodilators as emergency drugs indicates a worsening of the course of the underlying disease and serves as a basis for reviewing the tactics of treating bronchial asthma. An unexpected and progressive deterioration in the control of symptoms of bronchial asthma or COPD is a potentially life-threatening condition and requires urgent medical attention. In this situation, consider increasing the dose of glucocorticosteroids, i.e. prescribing a course of oral glucocorticosteroids or antibiotic treatment in case of infection. Patients are advised to always have emergency drugs with them: Formisonide®-native (for patients with bronchial asthma who use Formisonide®-native for maintenance therapy and for relieving seizures) or short-acting β-2-adrenergic agonists (for all patients who use Formisonide®-native for maintenance therapy only).

The patient should be advised of the need for regular administration of a maintenance dose of Formisonid®-native in accordance with the selected therapy, even in cases where there are no symptoms of the disease. Inhalations of the drug Formisonide®-native (80 + 4.5 μg / dose and 160 + 4.5 μg / dose) for relieving seizures should be carried out only if symptoms occur, but are not indicated for regular prophylactic use, i.e. before physical exertion. In such cases, the use of a separate short-acting 2-adrenergic agonist is indicated.

If the symptoms of bronchial asthma are manageable, you can gradually reduce the dose of Formisonide®-native, while it is important to constantly monitor the condition of patients. The lowest effective dose should be prescribed (see section "Dosage and Administration"). Treatment with Formisonon®-native should not be started during an exacerbation or significant deterioration of the course of bronchial asthma.

During therapy with Formisonon®-native, exacerbations and the development of serious adverse events associated with bronchial asthma may occur. Patients should continue treatment, but seek medical help if there is no control over the symptoms of bronchial asthma or if the condition worsens after the start of therapy.

Clinical trials of the use of a combination of budesonide and formoterol in patients with COPD with prebronchodilation FEV1> 50% of the due and with postbronchodilation FEV1 <70% of the due are absent (see

Pharmacodynamics section).

As with any other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after taking a dose of Formisonide®-native. In this case, you should stop therapy with Formisonid®-native, reconsider the treatment tactics and, if necessary, prescribe alternative therapy.

Systemic effects may occur with any inhaled glucocorticosteroid, especially when taking high doses over a long period of time. The manifestation of a systemic effect is less likely with inhalation therapy than with oral glucocorticosteroids. Possible systemic effects include suppression of adrenal function, stunted growth in children and adolescents, decreased bone mineral density, cataracts and glaucoma. It is recommended to regularly monitor the growth of children who receive glucocorticosteroid therapy in an inhaled form for a long time. In case of established growth retardation, therapy should be reviewed to reduce the dose of inhaled glucocorticosteroid. It is necessary to carefully evaluate the ratio of the benefits of glucocorticosteroid therapy to the possible risk of stunting. When choosing therapy, it is recommended to consult a pediatric pulmonologist. Based on limited research data on long-term use of glucocorticosteroids, it can be assumed that most children and adolescents receiving inhaled budesonide therapy ultimately achieve normal adult growth rates. However, a slight short-term growth retardation was reported mainly in the first year of treatment. Due to the potential effect of inhaled glucocorticosteroids on bone mineral density, special attention should be paid to patients taking high doses of the drug for a long period with risk factors for osteoporosis. Studies of the long-term use of inhaled budesonide in children at an average daily dose of 400 mcg (metered dose) or adults at a daily dose of 800 mcg (metered dose) have not shown a noticeable effect on bone mineral density. There is no data on the effect of high doses of the combination of budesonide and formoterol on bone mineral density.

If there is reason to believe that adrenal function has been impaired against previous systemic glucocorticosteroid therapy, precautions should be taken when transferring patients to treatment with Formisonide®-native.

The benefits of budesonide inhalation therapy generally minimize the need for oral glucocorticosteroids, but patients who stop oral glucocorticosteroid therapy may have insufficient adrenal function for a long time. Patients who in the past needed urgent administration of high doses of glucocorticosteroids or received long-term treatment with high-dose inhaled glucocorticosteroids, may also be in this risk group. It is necessary to provide for the additional administration of glucocorticosteroids during stress or surgery.

It is recommended that the patient is instructed to rinse his mouth with water after inhalation of maintenance doses in order to prevent the risk of candidiasis of the oral mucosa and pharynx. It is also necessary to rinse your mouth with water after inhalation to relieve symptoms in case of candidiasis of the oral mucosa and pharynx.

Precautions should be observed when treating patients with an extended

QTc interval. Formoterol may cause a prolonged QTc interval.

The need for use and dose of inhaled glucocorticosteroid in patients with active or inactive forms of pulmonary tuberculosis should be reviewed fungal, viral or bacterial infections of the respiratory system.

When co-administered with 2-adrenergic agonists with drugs that can cause or enhance the hypokalemic effect, for example, xanthine derivatives, steroids or diuretics, the hypokalemic effect of 2-adrenergic agonists may be enhanced. Special precautions should be taken in patients with unstable bronchial asthma who use short-acting bronchodilator for relieving seizures during exacerbation of severe bronchial asthma, since the risk of hypokalemia increases against hypoxia and in other conditions, when the likelihood of developing a hypokalemic effect increases. In such cases, it is recommended that serum potassium levels be monitored. Reception by patients with acute bronchial obstruction of formoterol at a dose of 90 mcg for 3 hours is safe. During the treatment period, the concentration of glucose in the blood in patients with diabetes should be monitored.

Formisonide®-native contains lactose (<1 mg / inhalation). Typically, this amount does not cause problems in patients with lactose intolerance. Clinical studies and meta-analyzes have shown that the use of inhaled glucocorticosteroids for COPD can increase the risk of pneumonia. However, the absolute risk when using budesonide is small. A meta-analysis of 11 double-blind studies involving 10,570 patients with COPD did not show a statistically significant increase in the risk of pneumonia in patients receiving budesonide (including in combination with formoterol), compared with patients receiving therapy without budesonide (placebo or formoterol). The incidence of a serious adverse event of pneumonia was 1.9% per year with therapy including budesonide, and 1.5% per year with therapy without budesonide. The combined risk ratio when comparing therapy involving budesonide with therapy without budesonide was 1.15 (965% confidence interval (CI): 0.83, 1.57). The combined risk ratio when comparing budesonide / formoterol with formoterol or placebo was 1.00 (95% CI: 0.69, 1.44).

A causal relationship between the development of pneumonia and the use of drugs containing budesonide has not been established.

Effect on the ability to drive vehicles and mechanisms

There is no data on the effect of the drug Formisonide®-native on the ability to drive vehicles and mechanisms. However, in case of the development of adverse reactions such as dizziness, tremors, muscle cramps, etc., one should refrain from driving vehicles and mechanisms, as well as from engaging in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Ingredients

Active ingredient:

160 Ојg +

4.5 Ојg

Budesonide

0.02 mg

Lactose monohydrate

up to 12.0 mg

Capsule:

dye car stranded

-

dye chlorophyllin-copper

-

sodium and potassium

T ipromelloza

100%

Dosage and administration of

Bronchial asthma

Formisonideέnative is not intended for the initial treatment of bronchial asthma with intermittent and mild persistent course. The selection of the dose of active substances that are part of the drug Formisonideέnative is carried out individually and depending on the severity of the disease. This must be taken into account not only at the beginning of treatment with combined drugs, but also when changing the maintenance dose of the drug.

In the event that individual patients require a different combination of doses of active substances than in Formisonideέnative, separate? 2-adrenergic agonists and / or GCS in separate inhalers should be prescribed.

The dose should be reduced to the lowest, against which optimal control of symptoms of bronchial asthma is maintained. Patients should be under the constant supervision of a doctor to adequately select the dose of Formisonidέnative. When achieving complete control over the symptoms of bronchial asthma against the background of the minimum recommended dose of the drug, at the next stage, you can try the appointment of monotherapy with inhaled glucocorticosteroids.

There are two approaches to prescribing therapy with Formisonideέnative:

A. Formisonideέnative as maintenance therapy: Formisonideέnative is prescribed for continuous maintenance therapy in combination with a separate short-acting? 2-adrenergic agonist for relieving seizures.

B. Formisonideέnative as maintenance therapy and for relieving seizures: Formisonideέnative is prescribed both for continuous maintenance therapy and on demand when symptoms occur.

A. Formisonideέnative as maintenance therapy: The patient must always have a separate inhaler with a short-acting? 2-adrenergic agonist to relieve seizures. Adults (18 years and older):

Formisonideέnative 80 mcg + 4.5 mcg and 160 mcg + 4.5 mcg

1-2 inhalations 2 times a day. If necessary, it is possible to increase the dose to 4 inhalations twice a day.

Children over 6 years of age:

Formisonideέnative 80 mcg + 4.5 mcg 1-2 inhalations twice a day.

After achieving optimal control over the symptoms of bronchial asthma when using the drug twice a day, it is recommended to titrate the dose to the minimum effective up to taking the drug once a day in cases where, according to the doctor, the patient needs maintenance therapy in combination with a long bronchodilator actions.

An increase in the frequency of use of short-acting? 2-adrenergic agonists is an indicator of worsening overall disease control and requires a review of anti-asthma therapy.

Formisonideέnative 320 mcg + 9 mcg

Formisonidέnative 320 mcg + 9 mcg is not recommended for children under 12 years of age due to lack of clinical data. Formiconideέnative 320 mcg + 9 mcg is intended for maintenance therapy only.

B. Formisonideέnative as maintenance therapy and for relieving seizures: Formisonideέnative is prescribed both for continuous maintenance therapy and on demand when symptoms occur.

Formisonideέnative can be prescribed both as a continuous maintenance therapy and as an on-demand therapy for seizures. The patient must always have Formisononέnative with him to stop attacks.

Formisonideέnative as a supportive therapy and for relieving seizures is especially indicated for patients with:

- lack of control over asthma and the need for frequent use of drugs to relieve

attacks - the presence of a history of exacerbations of bronchial asthma requiring medical intervention.

Careful monitoring of dose-dependent side effects in patients using a large number of inhalations to relieve seizures is required.

Adults and adolescents (12 years of age and older):

Formisonideέnative 80 mcg + 4.5 mcg and 160 mcg + 4.5 mcg

Recommended dose for maintenance treatment 2 inhalations per day, 1 inhalation is used in the morning and evening, or 2 inhalations once only in the morning or only in the evening. For some patients, a maintenance dose of Formisonideέnative 160 ?g + 4.5 ?g 2 inhalations twice a day may be prescribed. If symptoms occur, 1 additional inhalation is necessary. With a further increase in symptoms within a few minutes, 1 additional inhalation is prescribed, but no more than 6 inhalations for stopping 1 attack.

Usually, more than 8 inhalations per day are not required, but you can increase the number of inhalations to 12 per day for a short time. Patients receiving more than 8 inhalations per day are advised to seek medical attention to review therapy.

Children under 12 years of age:

Formisonideέnative as a supportive therapy and for relieving seizures is not recommended for children and adolescents.

COPD

Adults (18 years of age and older): Formisonideέnative 160 mcg + 4.5 mcg 2 inhalations twice daily.

Formisonideέnative 320 mcg + 9 mcg

1 inhalation twice daily.

Use in special patient groups

There is no need for special dose selection for elderly patients. There is no data on the use of the drug Formisonideέnative in patients with liver failure. Since budesonide and formoterol are excreted mainly by the kidneys with the participation of hepatic metabolism, in patients with severe cirrhosis of the liver, a slowdown in the elimination rate of the drug can be expected.

Children under 6 years of age: Formisonideέnative is not recommended for children under 6 years of age.

Inhaler CDMΠInhaler Instructions for Use

In order to ensure proper use of the drug, Formisonideέnative should only be used with the Inhaler CDMΠdevice. Capsules are for inhalation use only and are not intended to be swallowed.

Remove the capsule from the cell packaging immediately before use.

Inhaler CDMΠInhaler Instructions for Use

ԉnhaler CDMΔ is a single dose inhaler that allows you to dose and inhale the drug in very small doses. Formisonideέnative enters the patientӳ respiratory tract along with airflows when an active breath is taken through the mouthpiece.

Inhaler CDMΠis very easy to use. When using it, follow the step-by-step instructions below:

Remove the transparent cap from the Inhaler CDMΠdevice, as shown in fig. 1.

Hold the device firmly with one hand, with the index and thumb of the other hand, open the capsule compartment as shown in fig. 2. To do this, press the ԐRESSԠwith the index finger in the movable part of the CDMΠInhaler inhaler, moving the compartment in the opposite direction.

Holding the device with one hand, insert the capsule with the drug into the compartment slot (Fig. 3).

Make sure the capsule is correctly inserted into the slot (fig. 4).

While holding the Inhaler CDMΠin an upright position, close the compartment by pushing the thumb in the opposite direction as far as it will go until you hear a click (Fig. 5).

Hold the Inhaler CDMΠdevice vertically (fig. 6).

Bring the device into working condition, as shown in fig. 7. To do this, press the mouthpiece with force so that the arrow on the case disappears beyond the boundaries of the lower part of the device to the upper line. Then release the mouthpiece to return it to its original position. Thus, you will pierce the capsule, opening access to the drug in the lumen of the mouthpiece.

Warning: Because of the destruction of the capsule, small pieces of gelatin as a result of inhalation can get into the mouth or throat. In order to minimize this phenomenon, do not puncture the capsule more than 1 time.

Caution: exhale before inhalation (Fig. 8). Do not exhale through the mouthpiece!

Gently squeeze the mouthpiece of the Inhaler CDMΠdevice with your teeth, grip it tightly with your lips and take a deep and strong breath through your mouth (Fig. 9). You will hear a vibrating sound inside the capsule compartment made by the capsule as the drug rotates and disperses.

Caution: the mouthpiece must not be chewed and clenched with teeth!

Do not press the mouthpiece when inhaled. This may block the movement of the capsule. Hold your breath for approximately 10 seconds or longer as much as possible.

Remove the inhaler from the mouth. Breathe out slowly. Then breathe normally. Repeat steps 8ֹ again to ensure that you are breathing in a dose.

After inhalation, open the capsule compartment (Fig. 2), remove the empty capsule and then close it as shown in Fig. 5.

Caution:

When inhaling, try not to cover the openings located on the sides of the mouthpiece. This can interfere with the free movement of air inside the inhaler, thereby reducing the dispersion of the contents of the capsule.

Always close the CDMΠInhaler tightly with a cap after use to keep

clean.

Regularly (once a week), clean the mouthpiece from the outside with a dry cloth.

Side effects

There was no increase in the incidence of adverse reactions with the combined administration of budesonide and formoterol.

The most common adverse reactions associated with taking the drug are adverse events pharmacologically expected for β2-adrenergic agonists, such as tremors and palpitations, usually have a moderate severity and disappear a few days after the start of treatment. During the use of budesonide for COPD, bruising and pneumonia occurred at a frequency of 10% and 6%, respectively, compared with 4% and 3% in the placebo group (p <0.001 and p <0.01, respectively).

Adverse reactions are distributed according to frequency of occurrence. The following criteria were used to estimate the frequency: very often (> 1/10), often (from 1/100 to 1/10), infrequently (from 1/1000 to 1/100), rarely (from 1/10000 to 1/1000), very rarely (<1 / 10000), (including individual messages).

Infectious and parasitic diseases: often - candidiasis of the oral mucosa and pharynx.

Immune system disorders: rarely, immediate and delayed hypersensitivity reactions (e.g., dermatitis, exanthema, urticaria, pruritus, angioedema, anaphylactic reaction).

Disorders of the endocrine system: very rarely - signs or symptoms of systemic glucocorticosteroid effects (including adrenal hypofunction).

Mental disorders: very rarely - depression, behavioral disorders (mainly in children). Disorders from the central nervous system: often - headache infrequently - psychomotor agitation, anxiety, nausea, dizziness, sleep disturbances are very rare - taste disturbance.

Heart disorders: often - palpitations infrequently - tachycardia rarely

- arrhythmias, including atrial fibrillation, supraventricular tachycardia, extrasystole very rarely - angina pectoris.

Vascular disorders: very rarely - fluctuations in blood pressure.

Disorders of the respiratory system, chest and mediastinal organs: often

- cough, hoarseness, mild irritation in the throat rarely - bronchospasm.

Disorders of the skin and subcutaneous tissue: infrequently - bruising.

Disorders of the musculoskeletal and connective tissue: often tremors,

infrequently, muscle cramps.

Metabolism and nutritional disorders: rarely - hypokalemia very rarely -

hyperglycemia.

The systemic effect of inhaled glucocorticosteroids can be observed with the use of high doses of the drug for a long time.

The use of? 2-adrenergic agonists can lead to an increase in blood levels of insulin, free fatty acids, glycerol, and ketone derivatives.

Drug interaction

Taking 200 mg of ketoconazole once a day increases the plasma concentration of oral budesonide (single dose of 3 mg) when used together, on average, 6 times. When prescribing ketoconazole 12 hours after taking budesonide, the concentration of the latter in plasma increases on average 3 times. Information on such an interaction with budesonide during inhalation is not available, however, a noticeable increase in the concentration of budesonide in blood plasma should be expected. Since there are no data for dose recommendations, the above combination of drugs should be avoided. If this is not possible, the time interval between the appointment of ketoconazole and budesonide should be maximized. Consideration should also be given to reducing the dose of budesonide in

plasma. The use of the drug Formisonide®-native as maintenance therapy and for relieving seizures in patients receiving powerful CPY3A4 inhibitors is not recommended.

? -adrenergic receptor blockers may attenuate the effects of formoterol. Formisonide®-native should not be prescribed simultaneously with? -Adrenoblockers (including eye drops), except in forced cases.

Co-administration of the drug Formisonide®-native and quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), monoamine oxidase inhibitors (MAOs) and tricyclic antidepressants can extend the QTc interval and increase the risk of ventricular arrhythmias.

In addition, levodopa, levothyroxine, oxytocin, and alcohol may decrease heart muscle tolerance to? 2-adrenergic agonists.

Co-administration of MAO inhibitors, as well as drugs with similar properties, such as furazolidone and procarbazine, can cause high blood pressure. There is an increased risk of arrhythmias in patients during general anesthesia with halogenated hydrocarbon preparations.

With the combined use of the drug Formisonide®-native and other? -adrenergic drugs, an increase in the side effect of formoterol is possible.

As a result of the use of? 2-adrenergic agonists, hypokalemia may occur, which may be aggravated with concomitant treatment with xanthine derivatives, mineral derivatives of glucocorticosteroids or diuretics. Hypokalemia may increase the predisposition to the development of arrhythmias in patients taking cardiac glycosides. No interaction of budesonide and formoterol with other drugs used to treat bronchial asthma has been observed.

Overdose

Symptoms of an overdose of formoterol: tremor, headache, palpitations. In some cases, the development of tachycardia, hyperglycemia, hypokalemia, lengthening of the QTc interval, arrhythmia, nausea and vomiting were reported. Supportive symptomatic treatment may be prescribed.

If it is necessary to discontinue the drug Formisonide®-native due to an overdose of formoterol, which is part of the combined preparation, the appointment of an appropriate glucocorticosteroid should be considered.

Treatment: supportive and symptomatic. Reception by patients with acute bronchial obstruction of formoterol at a dose of 90 mcg for 3 hours is safe.

Overdose of budesonide: with acute overdose of budesonide, even in significant doses, no clinically significant effects are expected. With chronic excessive doses, the systemic effects of glucocorticosteroids may occur, such as hypercorticism and suppression of adrenal function.

Storage Conditions

In a dark place at a temperature not exceeding 25 РC.

Keep out of the reach and sight of children.

Term hodnosty

2 years

Active ingredient

budesonide, Formoterol

Terms leave from

pharmacies by prescription

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