Formisonide-native powder 160mcg + 4.5mcg/dose #120

Formisonide-native instruction for use

You can buy Formisonide-native here

pharmachologic effect

Formisonide-native is a combined preparation that contains formoterol and budesonide, which have different mechanisms of action and show an additive effect on the severity of symptoms of asthma (BA), improving lung function and reducing the frequency of exacerbations of bronchial asthma and chronic obstructive pulmonary disease (COPD).
The special properties of budesonide and formoterol make it possible to use their combination in the treatment of bronchial asthma at the same time as maintenance therapy and for relief of seizures, or as maintenance therapy.
Budesonide - glucocorticosteroid (GCS), after inhalation in recommended doses, 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. With the appointment of inhaled budesonide, there is a lower incidence of serious adverse effects than with systemic GCS. Budesonide reduces the swelling of bronchial mucosa, mucus production, sputum formation and airway hyperreactivity. The exact mechanism of the anti-inflammatory effect of GCS is unknown.
Formoterol is a selective β2-adrenomimetic (selective β 2 -adrenoreceptor agonist), causes rapid and prolonged relaxation of bronchial smooth muscles in patients with reversible airway obstruction.
The bronchodilator effect is dose-dependent, occurs within 1-3 minutes after inhalation and is maintained for at least 12 hours after taking a single dose.
The effect of the Formisonide-native drug on lung function is consistent with the combination of budesonide and formoterol monotherapy and exceeds the effect of a single budesonide.

Indications

- Bronchial asthma, as maintenance therapy and for relief of seizures (insufficiently controlled by the use of inhaled glucocorticosteroids and short-acting β2-adrenomimetics as on-demand therapy, or adequately controlled by inhaled GCS and long-acting β2-adrenomimetics);
- chronic obstructive pulmonary disease (symptomatic therapy in patients with severe COPD with FEV1 <50% of the estimated calculated level and with repeated exacerbations in the anamnesis, in the presence of severe symptoms of the disease, despite therapy with long-acting bronchodilators).

Contraindications

    Children under 6 years of age (for doses of 80 μg + 4.5 μg and 160 μg + 4.5 μg)
    Children under 12 years of age (for a dosage of 320 μg + 9 μg)
    Lactation.
    Hypersensitivity and / or intolerance to any of the components of the drug.
    Rare hereditary diseases, such as lactose intolerance, lactase deficiency or glucose-galactose malabsorption.
If you have one of these diseases, always consult a doctor before using the drug. Observance of extreme caution in the use of Formoterol-native preparation (especially in terms of dose reduction) and careful monitoring of patients is required in the presence of the following concomitant diseases: IHD; heart rhythm disturbances and conduction, especially AV blockade III degree; severe heart failure; idiomatic hypertrophic subaortic stenosis; severe degree of arterial hypertension; aneurysm of any localization; pheochromocytoma; ketoacidosis; hypertrophic obstructive cardiomyopathy; thyrotoxicosis; known or suspected prolongation of the QTc interval (QT corrected> 0.44 sec). Considering the hyperglycemic effect characteristic of beta2-adrenomimetics, in patients with diabetes mellitus taking formoterol-native, an additional regular monitoring of the concentration of glucose in the blood is recommended.

Application in pregnancy and lactation

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

Pregnancy

During pregnancy Formisonide-native should be used only when the benefits of using the drug exceed the potential risk to the fetus. The lowest effective dose of budesonide needed to maintain adequate control of asthma symptoms should be used.

Lactation

Inhaled budesonide is excreted in breast milk, however, when applied in therapeutic doses, no effect on the child was noted. It is not known whether formoterol passes into the breast milk of women, so Formisonide-native can be prescribed during breast-feeding only if the expected benefit to the mother is greater than any possible risk to the child.

special instructions

It is recommended to gradually reduce the dose of the drug before discontinuing treatment and it is not recommended to abruptly cancel treatment.
Dosages of 80 + 4.5 μg / dose and 320 + 9 μg / dose are not intended for the treatment of patients with severe bronchial asthma.
Formisonide-native is not intended for initial selection of therapy at the first stages of treatment of bronchial asthma and COPD.
If the effectiveness of therapy is inadequate or if the maximum recommended dose of Formisonide-native is exceeded, it is necessary to revise the treatment tactics.
An increase in the frequency of bronchodilators as an emergency medicine indicates a worsening of the course of the underlying disease and is the basis for reviewing the tactics of treating bronchial asthma.
An unexpected and progressive deterioration in the management of symptoms of bronchial asthma or COPD is potentially life threatening and requires urgent medical intervention. In this situation, one should consider the possibility of increasing the dose of GCS, that is, the administration of a course of oral GCS or treatment with antibiotics in case of infection.
Patients should always carry emergency medications: Formisonide-native (for patients with bronchial asthma who use Formisonide for maintenance therapy and for the management of seizures) or short-acting β2-adrenomimetics (for patients using Formisonide-only for maintenance therapy).
It should be explained to the patient that it is necessary to regularly take a maintenance dose of Formisonide-native in accordance with the selected therapy, even in those cases when there are no symptoms of the disease.
Inhalation of the drug Formisonide-native (80 + 4.5 mcg / dose and 160 + 4.5 mcg / dose) for relief of attacks should be performed only when symptoms occur, but the drug is not indicated for regular preventive use, i.e. before exercise. In such cases, the use of a single short-acting β2-adrenomimetic is indicated.
If the symptoms of bronchial asthma are controlled, you can gradually reduce the dose of the drug Formisonide-native, while it is important to monitor the condition of patients. The lowest effective dose should be given (see section "Dosage and Administration").
Treatment with the drug Formisonide-native should not be started during the period of exacerbation of bronchial asthma.
As with any other inhalation drug, paradoxical bronchospasm may occur with an immediate increase in wheezing after taking a dose of Formisonide-native. In this case, it is necessary to stop therapy with the drug Formisonide-native, review the tactics of treatment and, if necessary, prescribe an alternative therapy.
When taking any inhaled glucocorticosteroids, especially when taking high doses of drugs for a long period of time, a systemic effect may occur. The manifestation of systemic action is less likely in inhalation therapy than with oral GCS. Possible systemic effects include suppression of adrenal function, reduction of bone mineral density, cataract and glaucoma.
Because of the potential effect of inhaled glucocorticosteroids on the bone mineral density, special attention should be paid to patients taking the drug at 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 (metered dose) did not show a significant effect on bone mineral density. There is no data on the effect of high doses of the drug on the bone mineral density.
If there is reason to believe that against the background of previous systemic therapy of GCS, adrenal function was disrupted, precautions should be taken when transferring patients to Formisonide-native.
Inhaled therapy with budesonide usually minimizes the need for oral glucocorticosteroids, but patients who stop oral GCS therapy may have a long history of adrenal insufficiency. Patients who in the past needed urgent high-dose GCS or received long-term treatment with high-dose inhaled glucocorticosteroids may also be at this risk group. One should remember about the possibility of residual disturbance of adrenal function in such patients in extreme cases and any situations that can cause stress (including during surgical interventions). In such situations it is necessary to provide adequate treatment for SCS. Depending on the degree of adrenal insufficiency, specialist consultation may be required before the recommended procedures are performed.
Possible development of candidal infection of the oral cavity. To reduce the risk, patients are advised to rinse the mouth thoroughly with water after each inhalation of the drug. With the development of candidal infection of the oral cavity, it is possible to perform local antifungal therapy without stopping the treatment with the Formisonide-native drug.
Special precautions should be taken in patients with unstable bronchial asthma using short-acting β2-adrenomimetics to relieve attacks with exacerbation of severe bronchial asthma. the risk of hypokalemia increases with hypoxia and other conditions, when the likelihood of developing symptoms of hypokalemic action increases. In such cases it is recommended to monitor the potassium content in the blood serum.
During the treatment period it is necessary to control the concentration of glucose in the blood in patients with diabetes mellitus.
Use of formoterol in a dose exceeding 54 mcg / day (over 12 inhalations of Formisonide-native in doses of 80 + 4.5 mcg or 160 + 4.5 mcg or more than 6 inhalations in a dose of 320 + 9 mcg) can lead to positive results tests for doping.

Features of the drug during its cancellation

Because of the risk of developing an exacerbation, the sudden discontinuation of Formisonide-native drug should be avoided, the dose of the drug should be gradually reduced under the supervision of a doctor.

Dosing and Administration

The drug is not intended for oral administration. The dose of Formoterol-native is selected individually depending on the needs of the patient. Use the smallest dose that provides a therapeutic effect. When the symptoms of bronchial asthma are controlled against the background of Formoterol-native therapy, it is necessary to consider the possibility of a gradual decrease in the dose of the drug. Reduction in the dose of Formoterol-native is carried out under regular medical supervision of the patient's condition.
The drug is a capsule with powder for inhalation, which should be used only with a special device - inhaler "Inhaler CDM®", which is included in the package. Bronchial asthma Dose of formoterol-native for regular maintenance therapy (12-24 μg 1-2 capsules) 2 times / day Formoterol-native should be used only as an adjunct to inhaled glucocorticosteroids Do not exceed the maximum recommended dose of the preparation 48 μg / day (contents of 4 caps.) Given that the maximum daily dose of Formoterol-native is 48 μg, 12-24 μg / day can be optionally applied to relieve the symptoms of bronchial asthma. In the application of additional doses of the drug Formoterol-native ceases to be episodic (for example, it becomes more frequent than 2 days a week), it may indicate a worsening of the course of bronchial asthma, it is necessary to see a doctor .. Against the background of exacerbation of bronchial asthma should not begin treatment with Formoterol- native or change the dosage of the drug Formoterol-native should not be used to stop acute attacks of bronchial asthma.Preventing bronchospasm caused by physical exertion or the inevitable exposure to izve of the allergen should be used Formoterol-native dose of 12 mcg (contents of 1 caps.) 15 minutes before the alleged contact with the allergen or before the load. Additional inhalations of the drug should not be carried out within the next 12 hours. Prevention of severe bronchospasm. Patients with severe bronchospasm in the anamnesis may need a single inhalation in a dose of 24 mcg (2 capsules). COPD The dose of Formotrol-native for regular maintenance therapy of COPD is 12-24 μg (1-2 capsules content) 2 times / day.
Teenagers (12-17years old):
Formisonide-native 80 μg + 4.5 μg and 160 μg + 4.5 μg 1-2 inhalations twice daily
Formisonide-native 320 μg + 9 μg 1 inhalation twice daily
Children over 6 years of age:
Formisonide-native 80 μg + 4.5 μg 1-2 inhalations twice a day.

Side effects of Formisonide-native

Against the background of co-administration of budesonide and formoterol, there was no increase in incidence of adverse reactions.
Undesired reactions are distributed according to the 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 - rhinopharyngitis, nasal congestion, sinusitis, upper respiratory tract infection, bronchitis, oropharyngeal candidiasis (candidiasis of the oral and laryngeal mucosa).
Violations from the immune system: rarely - anaphylactic reactions, including angioedema (edema of Quincke); bronchospasm, including paradoxical.
Disorders from the endocrine system: rarely - hypokalemia; very rarely - hyperglycemia, symptoms of systemic glucocorticosteroid effects (including hypocorticism, hypercorticism.
Disorders of the psyche: infrequently - psychomotor agitation, anxiety, anxiety, dizziness, sleep disturbances; very rarely - depression, behavioral disorders, aggressive behavior, nervousness, taste disorders.
Disorders from the central nervous system: often - a headache.
Disorders from the side of the organ of vision: very rarely - cataract, glaucoma (with prolonged use of high doses), increased intraocular pressure.
Heart disorders: often - palpitations; infrequently - tachycardia; rarely - arrhythmias, including atrial fibrillation, supraventricular tachycardia, extrasystole; very rarely - angina pectoris, atrial and ventricular tachyarrhythmia.
Disorders from the vessels: very rarely - changes in blood pressure (arterial hypotension, arterial hypertension).
Disturbances from the respiratory system, chest and mediastinal organs: often - irritation in the throat, cough, hoarseness; rarely - dysphonia, (disappearing after discontinuing therapy or reducing the dose of the drug).
Disorders from the gastrointestinal tract: often - discomfort in the stomach, rarely - vomiting, very rarely - nausea, dysphagia (impaired swallowing).
Disorders from the skin and subcutaneous tissues: infrequent - bruising, rarely - hives, itching, dermatitis, rash, very rarely - redness of the skin of the face.
Disorders from the musculoskeletal and connective tissue: often - tremor, infrequently - muscle cramps; rarely - osteoporosis (reduction of bone mineral density), back pain.
The systemic effect of inhaled glucocorticosteroids can be observed when taking the drug in high doses for a long time.
The use of β2-adrenomimetics can lead to an increase in the blood levels of insulin, free fatty acids, glycerol, ketone derivatives.
If any of the side effects indicated in the manual are aggravated or you notice any other manifestations not listed in the instructions, inform your doctor.

Drug Interactions

With the simultaneous intake of ketoconazole at a dose of 200 mg once a day and budesonide at a dose of 3 mg, the concentration of budesonide in plasma increases by an average of 6 times. When taking ketoconazole 12 hours after taking budesonide, the concentration of the latter in the plasma increases on average by 3 times. Information on this interaction with budesonide with inhalation administration is not available, but a noticeable increase in the concentration of budesonide in the blood plasma should be expected.
It is not recommended to administer Formisonide-native as maintenance therapy and to relieve seizures for patients receiving potent CYP3A4 inhibitors, as there is no data for recommendations for dose selection, the above combination of drugs should be avoided. If it is impossible to avoid using a combination of these drugs, then the intervals between their methods should be maximized. You should also consider the possibility of reducing the dose of budesonide.
Formisonide-native should not be given concomitantly with β-blockers (including eye drops), since they can weaken or inhibit the action of formoterol, in addition to forced cases.
With the simultaneous use of the drug Formisonide-native and quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), monoamine oxidase (MAO) inhibitors and tricyclic antidepressants, the QTC interval and the risk of ventricular arrhythmias may increase.
Levodopa, levothyroxine sodium, oxytocin and ethanol can reduce the tolerance of the heart muscle to β2-adrenomimetics.
With the simultaneous administration of the drug Formisonide-native inhibitors of monoamine oxidase (MAO), as well as drugs with similar properties, it is possible to increase blood pressure.
When anesthetized with preparations of halogenated hydrocarbons against the background of the use of the drug Formisonide-native, there is an increased risk of arrhythmias in patients.
With concurrent administration of the drug Formisonide-native and other β-adrenomimetic agonists, it is possible to increase the side effect of formoterol.
The hypokalemic effect of β2-adrenomimetics can be enhanced by simultaneous administration of xanthine derivatives, mineral derivatives of GCS and diuretics. Hypokalemia increases the predisposition to the development of arrhythmias in patients taking cardiac glycosides.
Methandienone, estrogens strengthen the action of budesonide.
No interaction of budesonide with other medications used to treat bronchial asthma was noted.

Overdose

Symptoms: with acute overdose of budesonide, which is part of the drug Formisonide-native, no clinically significant symptoms are expected. With chronic administration of budesonide in excessive doses, the systemic effect of SCS may be manifested.
In case of an overdose of formoterol, tremors, nervousness, insomnia, headache, dizziness, palpitations, tachycardia, angina pectoris, changes in blood pressure, metabolic acidosis, in some cases hyperglycemia, hypokalemia, QTC interval prolongation, arrhythmias, nausea, increased nervous excitability, muscle spasms.
Treatment: supportive and symptomatic treatment is indicated.

Storage conditions

In the dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.
Shelf life - 2 years.

Conditions of leave from pharmacies

To buy Formisonide-native you don't need a prescription.