Buy DuoResp Spiromax powder 320 mcg + 9 mcg/dose 60 doses of 1 pc.

Budesonide, Formoterol

Brand Norton (Waterford) Limited

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Available since: 2019-09-19

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Clinical Pharmacology

The drug DuoResp Spiromax contains formoterol and budesonide, which have different mechanisms of action and have an additive effect in reducing the frequency of exacerbations of bronchial asthma and COPD.

The special properties of budesonide and formoterol make it possible to use their combination at the same time to relieve seizures or as maintenance therapy for bronchial asthma.

Budesonide

Budesonide - GCS, which after inhalation has a fast (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. The appointment of inhaled budesonide has a lower incidence of serious adverse effects than with the use of systemic corticosteroids. Reduces the severity of bronchial mucous edema, mucus production, sputum formation and airway hyperreactivity.

Formoterol

Formoterol - selective β agonist₂-adrenergic receptors, which, after inhalation, causes a quick and long-lasting relaxation of the smooth muscles of the bronchi in patients with reversible airway obstruction. Bronchodilatory dose-dependent effect occurs quickly, within 1-3 minutes after inhalation and lasts for at least 12 hours after taking a single dose.

Budesonide + Formoterol

Bronchial asthma. Adding formoterol to budesonide reduces the severity of asthma symptoms, improves bronchial function and reduces the frequency of exacerbations of the disease.

The effect of the drug DuoResp Spiromax on the function of the bronchi corresponds to the effect of the combination of monodrugs budesonide and formoterol and exceeds the effect of one budesonide. In all cases, β was used to relieve seizures.₂- short-acting adrenostimulator. There was no decrease in anti-asthma effect over time. The drug is well tolerated.

Clinical efficacy as maintenance therapy and for relief of seizures (for dosage 160 / 4,5 only). During the observation of 4447 patients receiving budesonide / formoterol as a maintenance therapy and to relieve seizures for 6 to 12 months, there was a statistically and clinically significant decrease in the number of severe exacerbations, an increase in the time before the first exacerbation compared with the combination formoterol + budesonide or budesonide as maintenance therapy and β₂-adrenostimulator for relief of seizures. There was also effective control over the symptoms of the disease, pulmonary function, and a reduction in the frequency of inhalations for the relief of seizures. There was no development of tolerance to the prescribed therapy. After inhalation of budesonide / formoterol, relief of symptoms (withdrawal of bronchospasm) occurred as quickly and effectively as after treatment with salbutamol and formoterol.

COPD Patients with severe COPD while taking the drug DuoResp Spiromax showed a significant decrease in the frequency of exacerbations of the disease compared with patients who received only formoterol or placebo as therapy (the average frequency of exacerbations was 1.4 compared with 1.8-1.9 in the group placebo / formoterol). There were no differences between taking DuoResp Spiromax and formoterol on the OFB value.₁.

Indications

Bronchial asthma (inadequately controlled by inhaled GCS and β₂short-acting adrenostimulators or adequately controlled by inhaled GCS and β₂-adrenal stimulants for long periods);

Chronic obstructive pulmonary disease (symptomatic therapy in patients with severe chronic obstructive pulmonary disease - FEV₁

Composition

Powder for inhalation dosed white or almost white in color, without visible lumps and inclusions; The metering indicator window should show # 120.

	1 delivered dose
budesonide (micronized)	320 mcg
formoterol fumarate dihydrate (micronized)	9 mcg

Excipients: lactose monohydrate - 10 mg.

Budesonide, Formoterol is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
DuoResp Spiromax	Norton (Waterford) Limited	Ireland	powder
Formisonide Native	Nativa	Russia	powder
Symbicort Turbuhaler	AstraZeneca	UK	powder

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Dosage and Administration

Inhalation.

Bronchial asthma

The drug DuoResp Spiromax is not intended for the initial treatment of bronchial asthma intermittent and mild persistent course. Selection of the dose of drugs that make up the drug DuoResp Spiromaks, occurs individually and depending on the severity of the disease. This should be considered not only when starting treatment with combined preparations, but also when changing the maintenance dose of the preparation.

In the event that individual patients require a different combination of doses of active ingredients than in DuoResp Spiromax, β should be prescribed.₂- adrenomimetics and / or corticosteroids in separate inhalers.

Patients should regularly visit the doctor to control the optimal dose of DuoResp Spiromax. The dose should be reduced to the lowest, against which the optimal control of the symptoms of bronchial asthma is maintained. After achieving optimal control of asthma while taking the drug 2 times a day, it is recommended to titrate the dose to the minimum effective, up to taking the drug 1 time a day, in cases where, according to the doctor, the patient requires maintenance therapy in combination with a long-acting bronchodilator .

Adults (18 years and older): DuoResp Spiromax 160 / 4.5 mcg / dose as maintenance therapy 1–2 inhalations 2 times a day. If necessary, you can increase the dose to 4 inhalations 2 times a day. The patient must constantly carry with him a separate inhaler with β₂short-acting adrenostimulator for relief of seizures. Increase the frequency of use of β₂short-acting adrenostimulants are indicative of a deterioration in overall disease control and require revision of anti-asthma therapy.

The drug DuoResp Spiromax 160 / 4.5 mcg / dose as maintenance therapy and for the relief of seizures. The drug DuoResp Spiromax can be prescribed both as a permanent maintenance therapy, and as an on-demand therapy in the event of seizures. As a maintenance therapy and for the relief of seizures, it is especially indicated for patients:

- with insufficient control over bronchial asthma and the need for frequent use of drugs for the relief of attacks;

- 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. The recommended dose for maintenance therapy is 2 inhalations per day, taken no 1 inhalation 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 DuoResp Spiromax 160 / 4.5 μg / dose 2 inhalation 2 times a day may be prescribed. If symptoms occur, 1 additional inhalation is necessary. With further increase of symptoms within a few minutes, another 1 additional inhalation is prescribed, but not more than 6 inhalations for stopping 1 attack. Usually, no more than 8 inhalations per day are required, but you can increase the number of inhalations to 12 inhalations per day for a short time.

Patients who receive more than 8 inhalations per day are recommended to seek medical help to review the therapy.

The drug DuoResp Spiromaks 320/9 mg / dose. 1 inhalation 2 times a day. If necessary, you can increase the dose to 2 inhalations 2 times a day.

After achieving optimal control of symptoms of bronchial asthma while taking the drug 2 times a day, the dose may be reduced to the lowest effective, up to once a day.

COPD

Adults (18 years and older): DuoResp Spiromax 160 / 4.5 μg / dose 2 inhalations of the drug 2 times a day.DuoResp Spiromax 320/9 mcg / dose 1 inhalation of the drug 2 times a day.

Special patient groups

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

There is no data on taking the drug DuoResp Spiromax patients with renal or hepatic insufficiency. Since budesonide and formoterol are excreted mainly by the kidneys, with the participation of hepatic metabolism, in patients with severe cirrhosis of the liver, one can expect a slower rate of elimination of the drug.

Adverse reactions

Against the background of co-administration of the two drugs, there was no increase in the incidence of adverse reactions. The most frequent adverse reactions associated with taking the drug are those pharmacologically expected for β₂-adrenergic undesirable side effects, like tremor and heart palpitations. Symptoms usually have a moderate degree of severity and pass a few days after the start of treatment. During a 3-year clinical study on the use of budesonide in COPD, skin bruising and pneumonia occurred at 10 and 6%, respectively, while in the placebo group, at 4 and 3% (p

Frequency is defined as follows: very often (≥1 / 10); often (≥1 / 100,

On the part of the immune system: rarely - immediate and delayed type hypersensitivity reactions (rash, urticaria, pruritus, angioedema dermatitis and anaphylactic reaction).

On the part of the endocrine system: very rarely - Cushing's syndrome, adrenal suppression, growth retardation, a decrease in BMD.

Metabolism and nutrition: rarely - hypokalemia; very rarely, hyperglycemia, signs or symptoms of systemic GCS effects (including adrenal hypofunction).

On the part of the psyche: infrequently - agitation, psychomotor agitation, anxiety, sleep disturbances; very rarely - depression, behavior disorders.

Systemic effects of inhaled corticosteroids can occur when taking high doses for an extended period of time. Application β₂α-adrenomimetics can lead to an increase in blood insulin, free fatty acids, glycerol and ketone derivatives.

Contraindications

Hypersensitivity to budesonide, formoterol or inhaled lactose;

Children's age up to 18 years.

With care: pulmonary tuberculosis (active or inactive form); fungal, viral or bacterial infections of the respiratory system, thyrotoxicosis, pheochromocytoma, diabetes mellitus, uncontrolled hypokalemia, idiopathic hypertrophic subaortic stenosis, severe arterial hypertension, aneurysm of any location or other severe cardiovascular diseases (ischemic heart disease (ischemic heart diseases), I have no heartbeat, I have no heartbeat, I do not need to have heart failure, I have no heart failure, I don't have heart failure, I don't have heart failure, I don't have a heartbeat, I don't have to suffer from heart failure, I don't have to get aneurysm, or I have other severe cardiovascular diseases , prolongation of the QT interval (ingestion of formoterol may cause prolongation of the QTc interval), lactose intolerance, deficiency of lactase or glucose Whose malabsorption.

Drug interactions

Taking 200 mg of ketoconazole 1 time per day increases the plasma concentration of oral budesonide (single dose of 3 mg) when administered together, an average of 6 times.

With the appointment of ketoconazole 12 hours after taking budesonide, the plasma concentration of the latter increased, on average, 3 times. There is no information about such interaction with inhaled budesonide, however, a significant increase in plasma concentration of the drug should be expected. Since there are no data for recommendations on dose selection, the above combination of drugs should be avoided. If possible, the time intervals between the appointment of ketoconazole and budesonide should be maximized. You should also consider reducing the dose of budesonide. Other potent inhibitors of CYP3A4 may also significantly increase the concentration of budesonide in plasma. Β blockers₂-adrenergic receptors may weaken the action of formoterol.The combination of formoterol + budesonide should not be administered concurrently with β-blockers (including eye drops), except in forced cases.

Combined use of the combination formoterol + budesonide and quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), MAO inhibitors and tricyclic antidepressants can prolong the QT interval and increase the risk of ventricular arrhythmias.

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

The simultaneous 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 with general anesthesia with halogenated hydrocarbon preparations.

With the simultaneous use of a combination of formoterol + budesonide and other β-adrenergic drugs, the side effects of formoterol may be enhanced. As a result of applying β₂-adrenergicov can occur hypokalemia, which can be amplified with the concomitant treatment of xanthine derivatives, GCS or diuretics. Hypokalemia may increase susceptibility to the development of arrhythmias in patients taking cardiac glycosides.

The interaction of budesonide and formoterol with other drugs used to treat bronchial asthma was not observed.

Pregnancy and Lactation

There are no clinical data on the use of the drug DuoResp Spiromax or the joint use of formoterol and budesonide during pregnancy.

During pregnancy, DuoResp Spiromax should be used only in cases where the benefits of using the drug outweigh the potential risk to the fetus.

The smallest effective dose of budesonide necessary to maintain adequate control of the symptoms of bronchial asthma should be used.

Igylated budesonide is excreted in breast milk, however, when used in therapeutic doses, no effect on the child is noted. It is not known whether formoterol penetrates the breast milk of women. DuoResp Spiromax may be prescribed to nursing women 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 discontinuing treatment and it is not recommended to abruptly cancel treatment.

The drug DuoResp Spiromaks is not used for the initial selection of therapy in the early stages of the treatment of bronchial asthma.

Acceptance of formoterol may cause prolongation of the QT interval.

An increase in the frequency of taking bronchodilators as emergency medicine indicates a worsening of the course of the underlying disease and serves as a basis for revising 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 intervention. In this situation, you should consider increasing the dose of GCS or adding systemic anti-inflammatory therapy, such as a course of oral GCS or treatment with antibiotics in the event of infection. Patients are advised to keep emergency medications with them at all times (β₂short-acting adrenomimetics). The patient’s attention should be drawn to the need for regular intake of the drug DuoResp Spiromax in accordance with the selected dose, even in cases of no symptoms of the disease.

Treatment with DuoResp Spiromax should not be started during an exacerbation or a significant deterioration in the course of bronchial asthma.

As with any other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after taking a dose of the drug. In this connection, it is necessary to discontinue therapy with DuoResp Spiromax, reconsider the treatment tactics and, if necessary, prescribe alternative therapy. Systemic effects can occur when taking any inhaled GCS, especially when taking high doses of drugs over a long period of time. The manifestation of systemic action is less likely with inhalation therapy than with oral GCS. Possible systemic effects include suppression of adrenal function, decreased BMD, cataracts, and glaucoma.

Based on limited research data on long-term administration of GCS, it can be assumed that most children and adolescents receiving therapy with inhaled budesonide will eventually achieve normal growth rates for adults. At the same time, a slight (approximately 1 cm) short growth retardation was reported, mainly in the first year of treatment.

Due to the potential effect of inhaled GCS on BMD, special attention should be paid to patients taking high doses of the drug for a long period with the presence of risk factors for osteoporosis. Studies on 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) did not show a noticeable effect on BMD. There are no data regarding the action of high doses of the drug DuoResp Spiromax on BMD.

If there is reason to believe that, against the background of previous systemic treatment of GCS, the adrenal function was impaired, precautions should be taken when transferring patients to DuoResp Spiromax. The benefits of budesonide inhalation therapy, as a rule, minimize the need to take oral steroids, however, in patients who discontinue therapy with oral GCS, insufficient adrenal function may persist for a long time.

Patients who in the past needed emergency high-dose GCS or received long-term treatment with high-dose inhaled GCS may also be in this risk group. It is necessary to provide for the additional appointment of GCS in the period of stress or surgery. It is recommended that the patient be instructed to rinse the mouth with water after inhalation in order to prevent the development of oral mucosa candidiasis.

Care should be taken when treating patients with an extended QTc interval.

Acceptance of formoterol may cause prolongation of the QTc interval. The need for the use and dose of inhaled GCS in patients with active or inactive forms of pulmonary tuberculosis, fungal, viral or bacterial respiratory infections should be reconsidered. With a joint appointment of β₂-adrenomimetics with drugs that can cause or enhance the hypokalemic effect, such as xanthine derivatives, steroids or diuretics, may increase the hypokalemic effect of β₂- adrenomimetics. Special precautions should be taken in patients with unstable bronchial asthma who use short-acting bronchodilators to relieve seizures during exacerbation of severe asthma, since the risk of hypokalemia increases with hypoxia and in other conditions when the likelihood of a hypokalemic effect increases. In such cases, it is recommended to control the content of potassium in serum. During the treatment period, blood glucose concentration should be monitored in patients with diabetes mellitus.

Influence on the ability to drive vehicles and mechanisms. The drug DuoResp Spiromax does not affect the ability to drive vehicles and mechanisms. May have a slight effect in the manifestation of side effects. Care must be taken when driving vehicles and machinery in connection with the possibility of developing side effects.

Overdosage

Formoterol

Symptoms: tremor, headache, palpitations. In some cases, the development of tachycardia, hyperglycemia, hypokalemia, prolongation of the QTc interval, arrhythmia, nausea and vomiting have been reported. If it is necessary to cancel the drug DuoResp Spiromax due to an overdose of formoterol, which is part of the combined preparation, consideration should be given to administering the appropriate GCS.

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

Budesonide

In acute overdose, even in significant doses, no clinically significant effects are expected. In chronic intake of excessive doses, a systemic effect of corticosteroids, such as hypercorticism and adrenal suppression, may be manifested.