budesonide, formoterol | Formidron vials, 50 ml pdf dffro dff28250f2f2f2f2 160 mcg + 4.5 mcg / dose 120 pcs.

Release form

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

Indications

· Bronchial asthma, as a maintenance therapy and for relieving seizures (not sufficiently controlled with inhaled corticosteroids and 2 short-acting adrenergic agonists as on-demand therapy, or adequately controlled by long-acting inhaled corticosteroids and 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).

Caution

Pulmonary tuberculosis (active or inactive), fungal, viral or bacterial infections of the respiratory system, thyrotoxicosis, pheochromocytoma, diabetes mellitus, decreased adrenal cortex function, uncontrolled hypokalemia, hypertrophic obstructive cardiomyopathy, severe cardiomyopathy, idiopathic hypertrophy, idiopathic hypertrophy, idiopathic hypertrophy, idiopathic hypertrophy aneurysm of any location or other severe cardiovascular disease (coronary heart disease, tachyarrhythmia or cardiac insufficiency NOSTA severe), lengthening the interval QT (reception formoterol can cause elongation 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 using Formisonide®-native for maintenance therapy and for relief of attacks) or 2-short-acting adrenergic agonists (for all patients using Formisonide®- native only for maintenance therapy).

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 the relief of 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 the long-term use of glucocorticosteroids, it can be assumed that most children and adolescents receiving inhaled budesonide therapy will 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 in patients discontinuing oral glucocorticosteroid therapy, insufficient adrenal function may persist for a long time. Patients who in the past needed emergency treatment with high doses of glucocorticosteroids or received long-term treatment with high-dose inhaled glucocorticosteroids may also be at risk. 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 the use and dose of inhaled glucocorticosteroid in patients with active or inactive forms of pulmonary tuberculosis, fungal, viral or bacterial infections of the respiratory system should be reviewed.

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 observed in patients with unstable bronchial asthma, using short-acting bronchodilator for relieving seizures in exacerbation of severe bronchial asthma, since the risk of developing hypokalemia increases with hypoxia and in other conditions, when the likelihood of developing a hypokalemia 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 drug contains lactose (

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 the event 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.

Composition

Active substance:

160 mcg +

4, 5 mcg

Budesonide

160 mcg

Formoterol fumarate dihydrate

4.5 mcg

Excipients:

Sodium benzoate

0.02 mg

Lactose monohydrate

up to 12.0 mg srld kpld

- sodium and potassium



G ipromellose

100%

Dosage and administration

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 that case if 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 separately.

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 Formisonidέnative:

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 daily.

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

Formisonideέnative 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 for continuous maintenance therapy, as well as 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 bronchial asthma and the need for frequent use of drugs for relieving

attacks - the presence in the 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 with your index finger on ԐRESSԠin 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).

Holding the Inhaler CDMΠupright, close the compartment by pushing your thumb backwards until it stops, 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.

Caution: Because of capsule disruption, small pieces of gelatin may be inhaled 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.

Warning:

When inhaling, try not to block 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 (

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)

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

mental disorders: very rarely - depression, behavioral disturbances (mainly in children) Violations of the central nervous system. Common - headache rarely - psychomotor agitation, anxiety, nausea, dizziness, sleep disturbances are very rare - a violation of taste.

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.

Metabolic 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 the content of free fatty insulin in the bloodacid, glycerol, ketone derivatives.

Drug Interactions

Taking 200 mg of ketoconazole once a day increases the plasma concentration of oral budesonide (single dose 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. There is no information on such interaction with budesonide when inhaled 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. Formiconide®-native should not be prescribed simultaneously with? -Adrenoblockers (including eye drops), except in forced cases.

Concomitant use of the drug Formisonide®-native and quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), monoamine oxidase inhibitors (MAOs) and tricyclic antidepressants can lengthen 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 formoterol overdose: tremors, headache, heart palpitations. In some cases, the development of tachycardia, hyperglycemia, hypokalemia, lengthening of the QTc interval, arrhythmia, nausea and vomiting. 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. In chronic use of excessive doses, systemic effects of glucocorticosteroids, such as hypercorticism and suppression of adrenal function, may occur.

Storage Conditions

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

Keep out of the reach and sight of children.

Prescription terms from

pharmacies Prescription

Form of Treatment

poroshok dlya ingalyatsiy

Appointment of

Adult on prescription, Children on prescription, Pregnant doctor prescribing

Indications

Bronchospasm, Low learning ability

Possible product names

Formisonide-native powder for inhalation dosage 160 mcg + 4.5 mcg / dose 120 pcs.

Nativ / Pharmstandard, Russia