Formisonide powder for inhalation dosed 160mcg + 4.5mcg/dose, 60pcs

Composition

Composition for one dose: Active ingredients: Budesonide 160 mcg Formoterol Fumarate dihydrate 4.5 MCGM Auxiliary Substances: Sodium Benzoate 0.02 mg Lactose monohydrate up to 12.0 mgCapsule solid*Hypromellose up to 100%

Pharmacological action

Pharmacotherapeutic group: Combined bronchodilator (p2-selective adrenomimetic + local glucocorticosteroid)

ATX Code: R03AK07

Pharmacodynamics

Formisonide® contains budesonide and formoterol, which have different mechanisms of action and show an additive effect on reducing the frequency of exacerbations of bronchial asthma. The special properties of budesonide and formoterol make it possible to use their combination for the relief of attacks/symptoms with an anti-inflammatory effect, or as a supportive therapy for bronchial asthma. Budesonide. Budesonide is a glucocorticosteroid that, after inhalation, has a rapid (within a few hours) and dose-dependent anti-inflammatory effect on the respiratory tract, reducing the severity of symptoms and the frequency of exacerbations of bronchial asthma. When using inhaled budesonide, there is a lower incidence of serious adverse effects than when using systemic glucocorticosteroids. Reduces the severity of edema of the bronchial mucosa, mucus production, sputum formation and hyperreactivity of the respiratory tract. The exact mechanism of anti-inflammatory action of glucocorticosteroids is unknown. Formoterol. Formoterol is a selective beta-2-adrenergic agonist, which is inhaled and causes rapid and prolonged relaxation of bronchial smooth muscle in patients with reversible airway obstruction. The dose-dependent bronchodilator effect occurs within 1-3 minutes after inhalation and persists for at least 12 hours after taking a single dose. Clinical efficacy of the budesonide + formoterol combination as a maintenance therapy The addition of formoterol to budesonide reduces the severity of asthma symptoms, improves lung function and reduces the frequency of exacerbations of the disease. The effect of the combined drug budesonide+formoterol on lung function corresponds to the effect of a combination of monopreparations budesonide and formoterol and exceeds the effect of budesonide alone. In all cases, a short – acting beta-2-adrenostimulator was used to stop seizures. There was no decrease in the anti-asthmatic effect over time. The combined drug is well tolerated. Combination of budesonide and formoterol as maintenance therapy in combination with a short-acting beta-2-adrenostimulant. There was no decrease in the anti-asthmatic effect over time. The drug is well tolerated. The combined drug budesonide+formoterol as a maintenance therapy in combination with a short-acting beta-2-adrenostimulator for the relief of seizures was prescribed to patients aged 6 to 11 years for 12 weeks (two inhalations of 80/4.5 mcg / inhalation twice a day). Improvement of pulmonary function and good tolerability of therapy compared with the corresponding dose of budesonide were noted. Clinical efficacy of the combination of budesonide and formoterol as maintenance therapy and for the relief of attacks/symptoms During the follow-up of 4447 patients who received a combination of budesonide and formoterol as maintenance therapy and for the relief of attacks/symptoms with anti-inflammatory effects for 6 to 12 months, there was a statistically and clinically significant decrease in the number of severe exacerbations, an increase in the time period to the onset of the first exacerbation compared to the combination of budesonide in combination with formoterol or budesonide as a maintenance therapy and beta-2-adrenostimulator for the relief of seizures. There was also effective control of symptoms, pulmonary function, and a reduction in the frequency of prescribing inhalations to stop seizures. No tolerance to the prescribed therapy was detected. In patients who sought medical attention due to the development of an acute attack of bronchial asthma, after inhalation of a combination of budesonide and formoterol, relief of symptoms (relief of bronchospasm) occurred as quickly and effectively as after the appointment of salbutamol and formoterol. Chronic obstructive pulmonary disease (COPD)In two 12-month studies in patients with moderate and severe COPD (baseline: pre-bronchodilatory forced expiratory volume index for the first second (FEV 1)) There were no differences between the use of budesonide in combination with formoterol and formoterol for FEV 1.

Indications

-Bronchial asthma, to achieve overall disease control, including prevention and relief of symptoms, and reduce the risk of exacerbations. Formisonide® is suitable for the treatment of bronchial asthma of any severity, if it is advisable to use inhaled glucocorticosteroids. – Chronic obstructive pulmonary disease (COPD), as a symptomatic therapy in patients with COPD with post-bronchodilator FEV 1

Use during pregnancy and lactation

There are no clinical data on the use of Formisonide® or the combined use of budesonide and formoterol during pregnancy. Pregnancy. During pregnancy, Formisonide should only be used in cases where the benefits of the drug outweigh the potential risk to the fetus. The lowest effective dose of budesonide needed to maintain adequate control of asthma symptoms should be used. Breast-feeding period. Inhaled budesonide is excreted in breast milk, but when used in therapeutic doses, no effects on the child were observed. It is not known whether formoterol passes into the breast milk of women. Formisonide may only be prescribed to women who are breast-feeding if the expected benefit to the mother is greater than any possible risk to the child.

Contraindications

-Hypersensitivity to budesonide, formoterol or inhaled lactose. – Lactose intolerance, lactase deficiency, or glucose-galactase malabsorption. – Children under 12 years of age (for dosages of 160 mcg+4.5 mcg and 320 mcg + 9 mcg). With caution, tuberculosis of the lungs (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, aneurysm of any localization or other severe cardiovascular diseases (ischemic heart disease, tachyarrhythmia, or severe heart failure), prolongation of the QT interval (taking formoterol may cause prolongation of the QT interval).

Side effects

When budesonide and formoterol were co-administered, there was no increase in the incidence of adverse reactions.

Adverse reactions are distributed according to the frequency of occurrence. The following criteria are used to estimate the frequency: very common (>1/10), common (from 1/100 to 1/10), infrequent (from 1/1000 to 1/100), rare (from 1/10000 to 1/1000), very rare (>

Infectious and parasitic diseases: often – rhinopharyngitis, nasal congestion, sinusitis, upper respiratory tract infections, bronchitis, oropharyngeal candidiasis (candidiasis of the oral mucosa and larynx).

Immune system disorders: rarely – anaphylactic reactions, including angioedema (angioedema); bronchospasm, including paradoxical.

Endocrine system disorders: rarely-hypokalemia; very rarely-hyperglycemia, symptoms of systemic glucocorticoid effects (including hypocorticism, hypercorticism).

Mental disorders: infrequently-psychomotor agitation, anxiety, feelings of anxiety, dizziness, sleep disorders, very rarely-depression, behavioral disorders, aggressive behavior, nervousness, taste disorders.

Central nervous system disorders: often – headache.

Visual disturbances: very rarely – cataracts, glaucoma (with prolonged use of high doses), increased intraocular pressure.

Cardiac disorders: often-palpitations; infrequently-tachycardia; rarely-arrhythmias, including atrial fibrillation, supraventricular tachycardia, extrasystole; very rarely-angina, atrial and ventricular tachyarrhythmia.

Vascular disorders: very rarely-changes in blood pressure (arterial hypotension, arterial hypertension).

Respiratory, thoracic and mediastinal disorders: often-irritation in the throat, cough, hoarseness of voice; rarely-dysphonia (disappears after stopping therapy or reducing the dose of the drug).

Disorders of the gastrointestinal tract: often-stomach discomfort, rarely-vomiting, very rarely-nausea, dysphagia (swallowing disorders).

Skin and subcutaneous tissue disorders: infrequently – bruising, rarely-urticaria, itching, dermatitis, rash, very rarely-redness of the skin of the face.

Musculoskeletal and connective tissue disorders:often – tremor, infrequently-muscle cramps, rarely-osteoporosis (decreased bone mineral density), back pain.

The systemic effect of inhaled corticosteroids can be observed when taking the drug in high doses for a long time.

The use of p2-adrenomimetics can lead to an increase in the blood content of insulin, free fatty acids, glycerol, and ketone derivatives.

If any of the side effects listed in the instructions get worse or you notice any other symptoms that are not listed in the instructions, tell your doctor.

Interaction

Taking 200 mg of ketoconazole once a day increases the plasma concentration (a single oral dose of 3 mg) with their combined appointment, on average, by 6 times. When using ketoconazole 12 hours after taking budesonide, the plasma concentration of the latter increased, on average, by 3 times. There is no information about such an interaction with inhaled budesonide, however, a noticeable increase in the concentration of the drug in blood plasma should be expected. Since there are no data available for dose recommendations, the combination described above should be avoided. If this is not possible, the time interval between the use of ketoconazole and budesonide should be maximized. You should also consider reducing the dose of budesonide. Other potent SURZA 4 inhibitors are also likely to significantly increase the plasma concentration of budesonide. Formisonide® for the relief of seizures/symptoms with anti-inflammatory effects is not recommended in patients receiving powerful SURZA 4 inhibitors. Beta-adrenergic receptor blockers may weaken the effect of formoterol. Formisonide should not be administered concomitantly with ?- adrenoblockers (including eye drops), except in emergency cases. Concomitant use of Formisonide and quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), monoamine oxidase inhibitors (MAO), and tricyclic antidepressants may prolong the QT interval and increase the risk of ventricular arrhythmias. In addition, levodopa, levothyroxine, oxytocin, and alcohol may reduce heart muscle tolerance to beta-2-adrenomimetics. The combined use of MAO inhibitors, as well as drugs with similar properties, such as furazolidone and procarbazine, can cause an increase in blood pressure. There is an increased risk of arrhythmias in patients undergoing general anesthesia with halogenated hydrocarbons. When taking Formisonide and other agonists together ?- adrenergic medications may increase the side effect of formoterol. Hypokalemia may occur as a result of the use of beta-2-adrenomimetics, which may increase with concomitant treatment with xanthine derivatives, mineral derivatives of glucocorticosteroids or diuretics. Hypokalemia may increase the predisposition to arrhythmias in patients taking cardiac glycosides. There was no interaction of budesonide and formoterol with other drugs used for the treatment of bronchial asthma.

How to take, course of use and dosage

Selection of the dose of active substances that make up the drug Formisonide is carried out individually and depending on the severity of the disease. This should be taken into account not only when starting treatment with combined drugs, but also when changing the dose of the drug.

Bronchial asthma

Formisonide is not intended for the initial treatment of intermittent and mild persistent bronchial asthma.

In the event that individual patients require a different combination of Active ingredient doses than in Formisonide, p2-adrenomimetics and/or corticosteroids in separate inhalers should be prescribed separately.

Patients should visit their doctor regularly to monitor the optimal dosage of Formisonide. The dose should be reduced to the lowest level, against which optimal control of asthma symptoms is maintained. After achieving control of bronchial asthma when taking the drug 2 times a day, it is recommended to titrate the dose to the minimum effective, up to taking 1 inhalation per day, in cases where, in the opinion of the doctor, the patient needs maintenance therapy in combination with a long-acting bronchodilator. At the next stage, when complete control is achieved, you can try the appointment of monotherapy with inhaled glucocorticosteroids.

There are two approaches to prescribing Formisonide therapy for bronchial asthma:

A. As maintenance therapy: Formisonide is prescribed for permanent maintenance therapy in combination with a separate short-acting p2-adrenomimetic to stop seizures. As maintenance therapy and for the relief of seizures: Formisonide is prescribed both for continuous maintenance therapy and on demand when symptoms appear. As maintenance therapy: it is prescribed in combination with a separate short-acting p2-adrenomimetic to stop seizures. The patient should always have a separate inhaler with a short-acting P2-adrenomimetic to stop seizures.

An increase in the frequency of use of short-acting P2-adrenomimetics is an indicator of deterioration in overall disease control and requires a review of anti-asthmatic therapy.

As a maintenance therapy and for the relief of seizures, the drug is especially indicated for patients with insufficient control over bronchial asthma and the need for frequent use of drugs for the relief of seizures; with indications in the anamnesis of exacerbations of bronchial asthma that required medical intervention. The patient should always have Formisonide with them to stop seizures.

It is necessary to carefully monitor the occurrence of dose-dependent side effects in patients who use a large number of inhalations to stop seizures.

The recommended dose is 2 inhalations per day: 1 inhalation in the morning and evening, or 2 inhalations 1 time a day only in the morning or only in the evening. Some patients may be prescribed a maintenance dose of Formisonide 160 mcg + 4.5 mcg 2 inhalations 2 times a day. If symptoms of bronchial asthma occur,1 additional inhalation should be prescribed. With a further increase in symptoms within a few minutes, another 1 additional inhalation is prescribed, but no more than 6 inhalations to stop 1 attack.

Usually, you do not need to prescribe more than 8 inhalations per day, but you can increase the number of inhalations to 12 per day for a short time. In patients who use more than 8 inhalations per day, a review of therapy is recommended.

Chronic obstructive pulmonary disease: Recommended dose: 2 inhalations 2 times a day.

Special patient groups:

There are no data on the use of Formisonide b in patients with hepatic insufficiency. Since budesonide and formoterol are mainly excreted by the kidneys with the participation of hepatic metabolism, patients with severe cirrhosis of the liver can expect a slowdown in the rate of drug excretion.

There is no need for special selection of the drug dose for elderly patients.

Overdose

Symptoms of formoterol overdose: tremor, headache, rapid heartbeat. In some cases, tachycardia, hyperglycemia, hypokalemia, prolongation of the QT interval, arrhythmia, nausea and vomiting have been reported. Supportive symptomatic treatment may be prescribed. The use of formoterol at a dose of 90 mcg for 3 hours in patients with acute bronchial obstruction was safe. If it is necessary to discontinue Formisonide® due to an overdose of formoterol, which is part of the combined drug, the appointment of an appropriate glucocorticosteroid should be considered. Budesonide overdose: in acute overdose of budesonide, even at significant doses, no clinically significant effects are expected. If excessive doses are taken chronically, systemic effects of glucocorticosteroids may occur, such as hypercorticism and adrenal suppression. Treatment: supportive and symptomatic.

Special instructions

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

Formisonide is not intended for initial selection of therapy in the first stages of treatment of bronchial asthma and COPD.

In case of insufficient effectiveness of therapy or exceeding the maximum recommended doses of Formisonide, it is necessary to reconsider the treatment strategy.

An increase in the frequency of taking bronchodilators as emergency medications indicates a worsening of the course of the underlying disease and is the basis for reviewing the tactics of treatment of bronchial asthma. Unexpected and progressive deterioration in the control of symptoms of asthma or COPD is a potentially life-threatening condition and requires urgent medical intervention. In this situation, the possibility of increasing the dose of corticosteroids should be considered, i. e. the appointment of a course of oral corticosteroids or antibiotic treatment in case of infection. Patients should always carry emergency medications: Formisonide (for patients with asthma who use Formisonide for maintenance therapy and for the relief of seizures) or short-acting p2-adrenomimetics (for patients who use Formisonide only for maintenance therapy).

It is necessary to explain to the patient the need to regularly take a maintenance dose of Formisonide in accordance with the selected therapy, even in cases where there are no symptoms of the disease.Inhalation of the drug Formisonide for the relief of seizures should be carried out only when symptoms occur, but the use of the drug is not indicated for regular preventive use, i. e. before physical activity. In such cases, the use of a separate short-acting p2-adrenomimetic is indicated. If the symptoms of bronchial asthma can be controlled, you can gradually reduce the dose of Formisonide, while it is important to constantly monitor the condition of patients. The lowest effective dose should be prescribed (see section “Dosage and use”).

Treatment with Formisonide b should not be initiated during the period of acute bronchial asthma.

As with any other inhaled drug, paradoxical bronchospasm may occur with an immediate increase in wheezing after taking a dose of Formisonide. In this case, you should stop therapy with Formisonide, review the treatment strategy and, if necessary, prescribe alternative therapy.

When taking any inhaled corticosteroids, especially when taking high doses of drugs for a long period of time, a systemic effect may occur. Systemic effects are less likely to occur with inhaled therapy than with oral corticosteroids. Possible systemic effects include adrenal suppression, decreased bone mineral density, cataracts, and glaucoma.

Due to the potential effect of inhaled corticosteroids on bone mineral density, special attention should be paid to patients taking the drug in high doses for a long time with the presence of risk factors for osteoporosis. Studies of long-term use of inhaled budesonide in adults at a daily dose of 800 micrograms (measured dose) did not show a noticeable effect on bone mineral density. There are no data on the effect of high doses of the drug on bone mineral density.

If there is reason to believe that the adrenal function was impaired during previous systemic corticosteroid therapy, precautions should be taken when transferring patients to Formisonide.

Inhaled budesonide therapy generally minimizes the need for oral corticosteroids, but patients who discontinue oral corticosteroid therapy may experience long-term adrenal insufficiency. Patients who have previously needed urgent high-dose corticosteroids or received long-term treatment with inhaled corticosteroids at a high dose may also be at this risk. It is necessary to keep in mind the possibility of residual adrenal dysfunction in such patients in extreme cases and in any situations that can cause stress (including during surgical interventions). In such situations, adequate treatment of corticosteroids should be provided. Depending on the degree of adrenal dysfunction, you may need to consult a specialist before performing the recommended procedures.

It is possible to develop a candida infection of the oral cavity. To reduce the risk, patients are advised to rinse their mouth thoroughly with water after each inhalation of the drug. If a candida infection of the oral cavity develops, local antifungal therapy may be performed without discontinuing treatment with Formisonide. Special precautions should be taken in patients with unstable bronchial asthma who use short-acting P2-adrenomimetics to relieve seizures during exacerbation of severe bronchial asthma, since the risk of hypokalemia increases against the background of hypoxia and in other conditions where the likelihood of developing symptoms of hypokalemic action increases. In such cases, it is recommended to monitor the content of potassium in the blood serum.

During the treatment period, the blood glucose concentration should be monitored in patients with diabetes mellitus.

The use of formoterol in a dose exceeding 54 mcg / day (more than 12 inhalations of Formisonide in doses of 80+4.5 mcg or 160+4.5 mcg or more than 6 inhalations in a dose of 320+9 mcg) may lead to positive results of doping tests.

Features of the action of the drug when it is discontinued due to the risk of exacerbation, sudden withdrawal of the drug Formisonide should be avoided, the dose of the drug should be reduced gradually under the supervision of a doctor.

Influence on the ability to drive a car and other vehicles, to work with moving mechanismswith the development of such adverse reactions as tremor or muscle cramps, when using the drug Formisonide b, you should refrain from driving vehicles and operating mechanisms, as well as from engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions

In a dark place at a temperature not exceeding 25°C. Keep out of reach of children.

Shelf

life is 2 years. Do not use after the expiration date indicated on the package.

Active ingredient

Budesonide, Formoterol

Conditions of release from pharmacies

By prescription

Dosage form

powder for inhalation