Bufomix Easyhaler, powder for inhalation dosed 160 mcg/4.5 mcg/dose inhaler 120 doses— Made in Finland — Free Delivery

Brand: ORION PHARMA
Product Code: Bufomix Easyhaler
Availability: In Stock

$35.74

Description

Indications

Bufomix Easyhaler is indicated for the regular treatment of BA when the use of a combination (inhaled corticosteroids and long-acting β2-adrenergic receptor agonists) is appropriate: for patients who cannot achieve adequate control with inhaled corticosteroids and short-acting β2-adrenergic receptor agonists, used "as needed ", Or for patients who have already achieved adequate control when using both inhaled corticosteroids and long-acting β2-adrenergic receptor agonists.

Application

Dosage. Bufomix Easyhaler is not indicated for the initial treatment of BA. the doses of the bufomix Easyhaler components are selected individually and adjusted depending on the severity of the disease. this should be taken into account not only at the beginning of the use of combined preparations, but also when adjusting the maintenance dose. if the patient needs a combination of doses that differ from those available in the combined inhaler, appropriate doses of β2-adrenergic receptor agonists and / or corticosteroids should be prescribed in separate inhalers.

The dose should be titrated to the lowest dose that effectively controls the symptoms of the disease. Patients need to regularly undergo repeated examinations by the doctor who prescribed the preparation so that the dose of Bufomix Easyhaler remains optimal. After long-term symptom control has been achieved with the lowest recommended dose, symptom control should be attempted with an inhaled corticosteroid alone.

The patient should be warned to keep a separate fast acting bronchodilator with him at all times as a lifesaving device.

Recommended doses

Adults: 1-2 inhalations, 2 times a day. Some patients may need up to 4 inhalations 2 times a day (maximum dose).

Children aged 12-17 years: 1-2 inhalations, 2 times a day.

Children under 12 years of age: Bufomix Easyhaler is not recommended for children under 12 years of age.

Usually, after achieving control over the symptoms of the disease when using the preparation 2 times a day, the dose is titrated to the lowest effective dose, up to the use of the preparation Bufomix Easyhaler 1 time per day, when, according to the doctor, the patient needs maintenance therapy with a long-acting bronchodilator.

The need for more frequent use of a separate fast-acting bronchodilator indicates a deterioration in the patient's condition and the need to revise BA treatment.

Special categories of patients. There are no specific dosage requirements for elderly patients.

There are no data on the use of the preparation Bufomix Easyhaler in patients with hepatic or renal insufficiency. Since budesonide and formoterol are predominantly eliminated from the body by hepatic metabolism, increased exposure can be expected in patients with severe liver cirrhosis.

Mode of application. For inhalation.

How to use Bufomix Easyhaler correctly

The inhaler is controlled by the inhaled air stream. This means that when the patient inhales air through the mouthpiece, the substance enters the respiratory tract along with the inhaled air.

1. Remove the protective cap from the Easyhaler mouthpiece.

2. Shake the inhaler 3-5 times in an upright position.

3. To release the 1st dose of the preparation, place the Easyhaler between the thumb and forefinger and press the inhaler once. A click will be heard when pressed.

4. Take a full breath, grasp the mouthpiece tightly with your lips and inhale deeply, holding your breath for 5-10 seconds.

5. If more than 1 dose is prescribed, repeat steps 2, 3 and 4.

6. Close the Easyhaler mouthpiece with a protective cap.

7. The counter of doses on the inhaler helps to control the number of remaining doses of the preparation. The counter switches every 5 doses. A red zone on the counter means there are 20 doses left in Easyhaler.

It is important to draw the patient's attention to the following:

You must carefully read the instructions for medical use.

After opening the laminated bag, it is recommended to store the device in a protective container to protect it from shocks and to ensure reliable operation of the device.

Shake off the device and activate it before each inhalation.

Inhale through the mouthpiece actively and deeply enough to ensure that the optimal dose of the substance is delivered to the lungs.

Do not exhale through the mouthpiece as this will reduce the delivered dose. If this does happen, you need to tap the inhaler on the surface of the table or on the palm to remove the powder from the mouthpiece, and then repeat the procedure for taking the preparation.

Do not operate the device more than 1 time without inhaling the powder. If this does happen, the patient needs to tap the inhaler on the table surface or on the palm to remove the powder from the mouthpiece, and then repeat the procedure for taking the preparation.

Always wear a dust cap and close the lid of the protective container after using the inhaler to prevent accidental spraying of powder from the device (which could lead to either an overdose or inhalation of an insufficient amount of the preparation with subsequent use of the inhaler).

Rinse your mouth with water after inhaling the prescribed dose to minimize the risk of developing oral candidiasis. If oral candidiasis occurs, patients should rinse their mouth with water after inhalation “as needed”.

Clean the mouthpiece regularly with a dry cloth. Do not use water for cleaning, as the powder is hygroscopic.

Replace the Bufomix Easyhaler inhaler when zero appears on the counter, even if a certain amount of powder is still visible inside the device.

Contraindications

Hypersensitivity to budesonide, formoterol, or lactose (which contains small amounts of milk protein).

Side effects

Since Bufomix Easyhaler contains both budesonide and formoterol, patients may experience side effects similar to these two substances. after the simultaneous administration of two compounds, there was no increase in the frequency of adverse reactions. the most common preparation-related adverse events correspond to the pharmacologically predictable side effects of β2-agonist treatment. these are phenomena such as tremors and heart palpitations, which are usually mild and disappear after a few days.

Below, by organ systems and the frequency of development, are the adverse reactions associated with formoterol. The frequency is determined on the following scale: very often (1/10), often (1/100 to 1/10), infrequently (1/1000 to 1/100), rarely (1/10000 to 1/1000), very rarely (1/10 000), unknown (the frequency cannot be established from the available data).

Infectious and parasitic diseases: often - oropharyngeal candidiasis.

From the immune system: rarely - immediate or delayed hypersensitivity reactions such as rash, urticaria, pruritus, dermatitis, angioedema and anaphylactic reaction.

From the endocrine system: very rarely - Cushing's syndrome, suppression of the function of the adrenal cortex, growth retardation, reduced bone mineral density.

From the side of metabolism and nutrition: rarely - hypokalemia; very rarely - hyperkalemia.

From the side of the psyche: infrequently - aggression, psychomotor hyperactivity, anxiety, sleep disturbances; very rarely - depression, behavior changes (mainly in children).

From the nervous system: often - headache, tremor; infrequently - dizziness; very rarely - taste disturbance.

From the side of the organ of vision: very rarely - cataract and glaucoma.

From the side of the cardiovascular system: often - accelerated heartbeat; infrequently - tachycardia; rarely - arrhythmia, for example atrial fibrillation, supraventricular tachycardia, extrasystole; very rarely - angina pectoris, lengthening of the Q – Tc interval, fluctuations in blood pressure.

From the respiratory system, chest and mediastinal organs: often - moderate irritation in the throat, cough, hoarseness; rarely - bronchospasm.

From the digestive system: infrequently - nausea.

On the part of the skin and subcutaneous tissue: infrequently - bruising.

Musculoskeletal and connective tissue disorders: infrequently - muscle cramps.

Oropharyngeal candidiasis is caused by preparation deposition. The patient should be advised to rinse the mouth with water after each dose to minimize the risk. Oropharyngeal candidiasis usually responds to topical antifungal treatment and does not require withdrawal of inhaled corticosteroids.

As with other types of inhalation therapy, paradoxical bronchospasm can rarely develop, affecting 1 in 10,000 patients. In this case, the patient immediately after taking the dose increases wheezing and shortness of breath. Paradoxical bronchospasm responds to rapid-acting inhaled bronchodilators, and patients with this disorder should be treated urgently. It is necessary to immediately stop taking the preparation Bufomix Easyhaler, examine the patient and, if necessary, prescribe alternative therapy.

The systemic consequences of taking inhaled corticosteroids can develop, in particular, with the use of high doses for a long time. These effects are much less likely than those of oral corticosteroids. Possible systemic effects include Cushing's syndrome, Cushing's appearance, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, and glaucoma. Increased susceptibility to infections and impaired ability to adapt to stress may develop. These effects are likely to depend on dose, time of exposure, concomitant or prior use of steroids, and individual sensitivity.

Treatment with β2-agonists can lead to increased levels of insulin, free fatty acids, glycerol and ketone bodies in the blood.

Reporting suspected adverse reactions. It is important to report a suspicion of adverse reactions after receiving a marketing authorization for a medicinal product. This allows you to constantly monitor the benefit / risk ratio of the preparation. Health professionals are requested to report suspected adverse reactions through the national reporting system.

special instructions

It is recommended to gradually reduce the dose when discontinuing the preparation and not to abruptly discontinue the preparation.

If patients find that treatment is ineffective, or it becomes necessary to exceed the highest recommended dose of Bufomix Easyhaler, they should consult a doctor. A sudden and progressive deterioration in asthma control is potentially life-threatening, so the patient should undergo immediate medical examination. In such a case, consideration should be given to the need to intensify corticosteroid therapy (eg, a course of oral corticosteroids) or antibiotic treatment if infection is present.

Patients should be warned to keep their rescue inhaler with them at all times.

Patients should be reminded to take the maintenance dose of Bufomix Easyhaler as prescribed, even in the absence of symptoms. The prophylactic use of Bufomix Easyhaler, for example before exercise, has not been studied. For this purpose, an additional fast-acting bronchodilator should be used.

Once AD symptoms are under control, consideration should be given to gradually reducing the dose of Bufomix Easyhaler. It is important to see patients regularly as the dose is reduced. Use the lowest effective dose of Bufomix Easyhaler.

You should not start treatment with Bufomix Easyhaler in case of exacerbations, significant deterioration or severe complication of asthma.

During treatment with Bufomix Easyhaler, serious adverse events and exacerbations associated with asthma may occur. Patients should be advised of the need to continue treatment and at the same time see a doctor if BA symptoms are not controlled or worsen after starting to take Bufomix Easyhaler.

As with other types of inhalation therapy, there is a risk of developing paradoxical bronchospasm. In this case, the patient immediately after taking the dose increases wheezing and shortness of breath. If the patient develops paradoxical bronchospasm, it is necessary to immediately stop taking the preparation Bufomix Easyhaler, examine the patient and, if necessary, prescribe alternative therapy. Paradoxical bronchospasm responds to rapid-acting inhaled bronchodilators, and patients with this disorder should be treated urgently.

The systemic consequences of taking inhaled corticosteroids can develop, in particular, with the use of high doses for a long time. These effects are much less likely than those of oral corticosteroids. Possible systemic effects include Cushing's syndrome, Cushingoid appearance, adrenal suppression, stunted growth in children and adolescents, decreased bone mineral density, cataracts, glaucoma, and much less often, various psychological and behavioral abnormalities, including psychomotor hyperactivity, sleep disturbances, anxiety, depression or aggressiveness (especially in children).

Consideration should be given to the potential effect on bone density, especially in patients taking high doses for a long time and concomitantly with risk factors for osteoporosis. Long-term studies of inhaled budesonide in children with average daily doses of 400 mcg (metered dose) or in adults with daily doses of 800 mcg (metered dose) have not shown a significant effect on bone mineral density. There is no information available on the effects of high doses.

If there is reason to suspect that the function of the adrenal cortex will deteriorate due to prior systemic steroid therapy, care should be taken when transferring patients to therapy with Bufomix Easyhaler.

The benefits of inhaled budesonide therapy usually minimize the need for oral steroids, however, patients who switch from oral steroids are at risk of decreased adrenal reserve over time. Recovery can take a long time after stopping oral steroid therapy. In this case, you need to regularly monitor the function "hypothalamus - pituitary gland - adrenal cortex".

Long-term treatment with high-dose inhaled corticosteroids can lead to clinically significant suppression of the function of the adrenal cortex. Therefore, during stressful periods, such as severe infections and elective surgery, additional systemic corticosteroid treatment should be considered. A rapid decrease in the dose of steroids can provoke an acute insufficiency of the function of the adrenal cortex. Symptoms that can be seen in acute adrenal insufficiency include anorexia, abdominal pain, weight loss, fatigue, headache, nausea, vomiting, decreased consciousness, seizures, hypotension, and hypoglycemia.

Treatment with additional systemic steroids or inhaled budesonide should not be stopped abruptly.

When switching from oral preparations to Bufomix Easyhaler, a general low systemic effect of steroids is noted, which can lead to the appearance of allergic or arthritic symptoms such as rhinitis, eczema, muscle and joint pain. In this case, you need to start a specific treatment. A general insufficient effect of GCS should be suspected if, in some cases, symptoms such as fatigue, headache, nausea and vomiting appear. In such cases, it is sometimes required to temporarily increase the dose of oral corticosteroids.

In order to reduce the risk of developing oral candidiasis, patients should thoroughly rinse the oral cavity with water after inhaling a maintenance dose. In case of the appearance of oral candidiasis, patients should rinse the oral cavity with water also after inhalation "as needed".

Simultaneous treatment with itraconazole, ritonavir, or other potent CYP 3A4 inhibitors should be avoided. If this is not possible, the intervals between dosing should be as long as possible. Supportive care is not recommended for patients using potent CYP 3A4 inhibitors.

Bufomix Easyhaler should be used with caution in patients with thyrotoxicosis, pheochromocytoma, diabetes mellitus, untreated hypokalemia, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disease, such as cardiovascular disease.

Caution should be exercised when treating patients with an extended Q – Tc interval. Formoterol itself can cause prolongation of the Q – Tc interval.

In patients with active or inactive pulmonary tuberculosis, fungal and viral infections in the respiratory tract, the need and dose of inhaled corticosteroids should be reassessed.

When treated with β2-adrenergic receptor agonists in high doses, potentially life-threatening hypokalemia can develop. The hypokalemic effect of β2-adrenergic receptor agonists can be enhanced by simultaneous treatment with β2-adrenoceptor agonists and preparations that can cause hypokalemia or enhance the hypokalemic effect, such as xanthine derivatives, steroids and diuretics. Particular care should be taken in unstable asthma, in the case of inconsistent use of rescue bronchodilators, in acute severe asthma, since the associated risk is increased by hypoxia, as well as in other conditions when the risk of hypokalemia increases. In these cases, it is recommended to monitor serum potassium levels.

In patients with diabetes mellitus, it is recommended to carry out additional monitoring of the concentration of glucose in the blood.

Bufomix Easyhaler contains approximately 4 mg of lactose per 1 inhalation. Usually this amount does not cause problems for individuals with lactose intolerance. The excipient lactose contains small amounts of milk proteins that can cause allergic reactions.

Use during pregnancy and lactation

Pregnancy. There are no clinical data on the effect of Bufomix Easyhaler or concomitant treatment with formoterol and budesonide on pregnancy. Animal development studies of the embryo / fetus have not demonstrated any additional effect of the combination.

There are insufficient data on the use of formoterol in pregnant women. Formoterol has caused side effects in animals during reproductive studies at very high levels of systemic exposure.

Data on approximately 2000 pregnancy cases studied did not show an increased teratogenic risk associated with the use of inhaled budesonide. In animal studies, GCS has been shown to cause malformations. This is unlikely in people who are receiving the recommended doses.

Animal studies have also shown that excessive amounts of perinatal glucocorticoids increase the risk of intrauterine growth retardation, cardiovascular disease in adults, irreversible changes in glucocorticoid receptor density, neurotransmitter turnover and behavior at concentrations below the teratogenic dose range.

During pregnancy, Bufomix Easyhaler should be used only if the expected benefit outweighs the potential risk. The lowest effective dose of budesonide needed to maintain adequate asthma control should be used.

Lactation. Budesonide passes into breast milk. However, at therapeutic doses, no effect on the breastfed baby is expected. It is not known whether formoterol passes into breast milk. Small amounts of formoterol are found in the breast milk of animals. The use of the preparation Bufomix Easyhaler in women who are breastfeeding should be considered only if the expected benefit to the mother outweighs the possible risk to the fetus.

Children. Bufomix Easyhaler is not recommended for children under 12 years of age.

Regular growth measurements are recommended in children receiving long-term inhaled corticosteroid therapy. If growth slows down, the treatment regimen should be revised in order to reduce the dose of inhaled corticosteroid to the minimum, ensuring effective control of asthma. The benefits of corticosteroid treatment against the risk of growth suppression should be carefully weighed. In addition, it is necessary to refer the patient to a pediatric pulmonologist.

Some evidence from long-term studies suggests that most children and adolescents treated with inhaled budesonide eventually reach their target height as they get older. At the same time, initially a slight temporary decrease in growth was noted (by about 1 cm). In general, it occurs within 1 year of treatment.

The ability to influence the reaction rate when driving or operating other mechanisms.

In case of dizziness, tremors, convulsions during treatment, do not drive vehicles or operate machinery.

Interactions

Pharmacokinetic interactions

Potent inhibitors of CYP 3A4 (ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone, and HIV protease inhibitors) are likely to increase plasma levels of budesonide, so their concomitant use should be avoided. If this is not possible, the intervals between doses of these preparations should be as long as possible. Supportive care is not recommended for patients using potent CYP 3A4 inhibitors.

A potent inhibitor of CYP 3A4, ketoconazole at a dose of 200 mg once a day increases plasma levels of budesonide, administered simultaneously orally (single dose of 3 mg), on average by 6 times. When ketoconazole was taken 12 hours after budesonide, the concentration on average increased only 3-fold, indicating that separate administration can reduce the increase in plasma levels. Some data indicate that there may be a significant increase in plasma levels of budesonide (an average of 4 times) when taken simultaneously with inhaled budesonide (1000 mcg single dose) itraconazole at a dose of 200 mg 1 time per day.

Pharmacodynamic interactions. Β-adrenergic receptor blockers can weaken the effect of formoterol. Therefore, Bufomix Easyhaler should not be used together with β-adrenergic receptor blockers (including eye drops) unless there is a compelling reason for this.

Concomitant treatment with quinidine, disopyramide, procainamide, phenothiazine, antihistamines (terfenadine) and tricyclic antidepressants can lengthen the Q – Tc interval and increase the risk of ventricular arrhythmia.

In addition, levodopa, levothyroxine, oxytocin, and alcohol can worsen the heart's tolerance to β2-sympathomimetics.

Concomitant treatment with monoamine oxidase inhibitors, including preparations with similar properties, such as furazolidone and procarbazine, can cause hypertensive reactions.

The risk of developing arrhythmias increases with anesthesia with halogenated hydrocarbons.

The simultaneous use of other β-adrenergic or anticholinergic preparations may enhance the bronchodilatory effect.

Hypokalemia can increase the tendency to cardiac arrhythmias in patients treated with digitalis glycosides.

No interactions of budesonide and formoterol with any other preparations used to treat AD have been noted.

Overdose

Symptoms an overdose of formoterol may be accompanied by symptoms that usually occur with an overdose of β2-adrenergic receptor agonists: tremor, headache, palpitations. in some cases, symptoms such as tachycardia, hyperglycemia, hypokalemia, prolongation of the q – tc interval, arrhythmia, nausea and vomiting were reported. supportive and symptomatic treatment is indicated. a dose of 90 μg, taken within 3 hours, was safe in patients with acute bronchial obstruction.

In acute overdose of budesonide, even with excessive doses, clinical problems are not expected. With chronic use of excessive doses, GCS effects may appear, such as hypercortisolism and suppression of the function of the adrenal cortex.

If therapy with Bufomix Easyhaler must be discontinued due to an overdose of formoterol, the provision of appropriate therapy with inhaled corticosteroids should be considered.

Storage conditions

Before opening the laminated package, the preparation does not require special storage conditions.

After opening the laminated bag, store at a temperature not exceeding 25 ° C, protected from moisture.

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