Norton (Waterford) Limited, Ireland
Adults are prescribed by a doctor, nursing mothers, pregnant by a doctor, children on prescription
The powder for inhalation dose of white or off-white color, with no visible lumps and inclusions.
1 delivered dose: budesonide (micronized) – 160 ug
of formoterol fumarate dihydrate (micronized) – 4.5 ug
Other ingredients: lactose monohydrate – 5 mg
Slow learner, bronchospasm, asthma
Asthma (insufficiently controlled receiving inhaled corticosteroids and β2-agonists short-acting or adequately controlled with inhaled corticosteroids and β2-adrenostimulyatorov long acting);
Chronic obstructive pulmonary disease (symptomatic therapy in patients with severe chronic obstructive pulmonary disease – FEV1
Hypersensitivity to budesonide, formoterol or inhaled lactose;
Children under 18 years of age.
With care: pulmonary tuberculosis (active or inactive form); fungal, viral or bacterial respiratory infection, hyperthyroidism, pheochromocytoma, diabetes, uncontrolled hypokalemia, idiopathic hypertrophic subaortic stenosis, severe hypertension, aneurysm of any location or other severe cardiovascular disease (ischemic heart disease, tachyarrhythmia or cardiac failure, severe) lengthening the interval QT (reception formoterol can cause elongation of QTc-interval), lactose intolerance, lactase deficiency or glucose-gala ktoznaya malabsorption.
On the background of a joint appointment of the two drugs was no increase in the incidence of adverse reactions. The most common adverse reactions associated with administration of the drug are such pharmacologically expected for β2-agonists unwanted side effects like tremor, and palpitations. Symptoms are usually mild severity and tested a few days after the start of treatment. During the 3-year clinical study of budesonide in COPD application on the skin and bruising occurred pneumonia at 10 and 6% respectively, while in the placebo group – with a frequency of 4 and 3% (p
The frequency is defined as follows: very often (≥1 / 10); commonly (≥1 / 100,
On the part of the immune system: rarely – immediate hypersensitivity reactions and delayed-type (rash, hives, itching, dermatitis, angioedema and anaphylactic reaction)
From the endocrine system: very rarely – Cushing’s syndrome, adrenal suppression, growth retardation, decreased bone mineral density
On the part of metabolism and nutrition: rarely – hypokalemia; very rarely – hyperglycemia, signs or symptoms of systemic GKS- effects (including hypofunction of the adrenal glands)
On the part of the psyche: rarely – excitement, agitation, anxiety, sleep disorders; very rarely – depression, behavioral disorders
Systemic action of inhaled corticosteroids may occur at high doses for a prolonged time. Use of β2-agonists may lead to an increase in blood levels of insulin, free fatty acids, glycerol and ketone derivatives.
How to accept, acceptance rate and dosage
The drug DuoResp Spiromaks not intended for the initial treatment of bronchial asthma and intermittent mild persistent flow. Selection dose preparations comprising the drug DuoResp Spiromaks occurs individually and depending on the severity of the disease. This should be considered not only at the beginning of combination therapies, but when you change the maintenance dose of the drug.
In the event that individual patients require different doses of a combination of active components than in Preparation DuoResp Spiromaks should assign β2-adrenoceptor agonists and / or SSC in separate inhalers.
Patients should see your doctor regularly to monitor the optimal dose DuoResp Spiromaks. The dose should be reduced to the lowest against which retained optimal control of asthma symptoms. 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 until dosing one time per day, in cases where, in the judgment of the physician, the patient requires supportive therapy in combination with a bronchodilator long-acting .
adults (18 years and older): preparation DuoResp Spiromaks 160 / 4.5 ug / dose in a maintenance therapy 1-2 inhalation 2 times per day. If necessary, the dose may be increased to 4 inhalations 2 times per day. The patient must always carry a separate inhaler with β2-agonists short action for relief of attacks. Increasing the frequency of use of β2-agonists short-acting is an indicator of the deterioration of the overall control of the disease and requires a review of anti-asthma therapy.
The drug DuoResp Spiromaks 160 / 4.5 mg / dose as a maintenance therapy and cupping. DuoResp Spiromaks drug may be administered either as a constant maintenance therapy as well as on-demand treatment with seizure occurs. As a maintenance therapy and cupping especially indicated for patients:
– with inadequate asthma control and the need for frequent use of drugs for relief of attacks;
– a history of bronchial asthma exacerbations requiring medical intervention
It takes careful control of dose-related side effects in patients using a large number of inhalations for relief of attacks. The recommended dose for maintenance therapy – 2 inhalations per day, taken no 1 inhalation in the morning and in the evening or 2 inhalations once – only in the morning or in the evening. For some patients can be assigned supporting DuoResp Spiromaks dose 160 / 4.5 mg / dose of 2 inhalations 2 times per day. If you have any symptoms should occur, the appointment of 1 additional inhalation. With further increase of the symptoms within a few minutes is assigned a further 1 additional inhalation, but not more than 6 inhalations for relief 1 attack. Not normally required destination more than 8 inhalations per day, but you can increase the number of inhalations to 12 inhalations a day for a short time.
Patients receiving more than 8 inhalations per day, it is recommended to seek medical help for the revision of care.
The drug DuoResp Spiromaks 320/9 ug / dose. 1 inhalation 2 times a day. If necessary, the dose may be increased to 2 inhalations 2 times a day.
After achieving optimal control of asthma symptoms in patients receiving the drug, 2 times a day, may be reduced to the smallest effective dose, up to a once a day.
Adults (18 years and older): DuoResp Spiromaks 160 / 4.5 mcg / dose is 2 inhalations of the drug 2 times a day. DuoResp Spiromaks 320/9 mg / 1 dose of the inhalation formulation 2 times a day.
Special groups of patients
There is no need for a special selection of doses for elderly patients.
There are no data on the admission of the drug DuoResp Spiromaks patients with renal or hepatic insufficiency. Since budesonide and formoterol are derived primarily by the kidneys, with the participation of hepatic metabolism, the patients with severe cirrhosis of the liver can be expected to slow the speed of elimination of the drug.
Receiving 200 mg ketoconazole 1 time per day increases in the plasma concentration of oral budesonide (3 mg single dose) at their joint assignment, an average 6-fold.
When assigning ketoconazole at 12 h after administration of budesonide concentration in plasma increased the latter, on average 3-fold. Information about such interactions with inhaled budesonide is not available, but you should expect a marked increase in plasma concentrations of the drug. Since the data for the dose recommendation for the selection are not available, to avoid the above combination of drugs. If possible, the time intervals between administration of ketoconazole and budesonide should be maximized. You should also consider reducing the dose of budesonide. Other potent inhibitors of CYP3A4, probably also can greatly increase the concentration of budesonide in the plasma. Blockers β2-adrenergic receptor may attenuate the action of formoterol. A combination of formoterol + budesonide should not be administered concurrently with β- blockers (including eye drops) unless required cases.
Co-administration of the combination formoterol + budesonide and quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), MAO inhibitors and tricyclic antidepressants can prolong QT interval and increase the risk of ventricular arrhythmias.
In addition, levodopa, levothyroxine, oxytocin and alcohol can reduce the tolerance of the heart muscle to β2-adrenoceptor agonists.
The simultaneous use of MAO inhibitors and drugs with similar properties such as furazolidone and procarbazine, may cause increased blood pressure. There is an increased risk of arrhythmias in patients with general anesthesia halogenated hydrocarbons drugs.
When applied simultaneously combination formoterol + budesonide and other β-adrenergic drugs may increase the side effects of formoterol. As a result of β2-agonists may occur hypokalemia which may be exacerbated by the concomitant treatment of xanthine derivatives, corticosteroids or diuretics. Hypokalemia may enhance susceptibility to the development of arrhythmias in patients receiving cardiac glycosides.
There was no interaction between formoterol and budesonide with other drugs used to treat asthma.
It is recommended to gradually reduce the dose before stopping treatment is not recommended rapidly cancel treatment.
The drug DuoResp Spiromaks 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 interval QT.
Increased frequency receiving bronchodilators as emergency drugs indicates worsening of the underlying disease and serves as a basis for revising tactics treatment of bronchial asthma.
Sudden and progressive deterioration in control of asthma symptoms or COPD is potentially life-threatening condition and requires immediate medical intervention. In this situation, should consider the possibility of increasing doses of corticosteroids or addition of systemic anti-inflammatory therapy, such course of oral corticosteroids or antibiotic treatment in case of infection attachment. Patients are advised to always carry emergency medications (β2-agonists short-acting). Should pay attention to the patient’s need for regular ingestion DuoResp Spiromaks in accordance with the selected dose even in the absence of symptoms.
Treatment with DuoResp Spiromaks should not be initiated during an exacerbation or significant worsening of asthma.
As with any other inhalation therapy, paradoxical bronchospasm may occur with increased wheezing immediate postdose formulation. In this connection should be discontinued therapy with DuoResp Spiromaks reconsider the tactics of treatment and, if necessary, appoint an alternative therapy. Systemic effects may occur at any reception of inhaled corticosteroids, particularly when high doses of drugs over a long period of time. Manifestation of systemic effects are less likely during inhalation therapy than with oral corticosteroids. Possible systemic effects include adrenal suppression, decrease in bone mineral density, cataract and glaucoma.
Based on the limited research data on chronic administration of corticosteroids, it can be assumed that the majority of children and adolescents receiving therapy with inhaled budesonide ultimately achieve normal adult rate of growth. However, the reported low (about 1 cm), short growth delay, mainly in the first year of treatment.
Because of the potential actions of inhaled corticosteroids on bone mineral density should be given special consideration in patients taking high doses over a long period with the presence of risk factors for osteoporosis. Studies prolonged use of inhaled budesonide in children at an average daily dose of 400 micrograms (metered dose) or adults in a daily dose of 800 micrograms (metered dose) showed a significant effect on BMD. No data on the effect of high doses of the drug DuoResp Spiromaks on BMD.
If there is reason to believe that against the background of previous systemic therapy SCS was disturbed adrenal function, should take precautions when transferring patients to treatment with DuoResp Spiromaks. Advantages budesonide inhalation therapy are generally minimize the need for use of oral steroids, but patients discontinuing therapy with oral corticosteroids for a long time can be maintained insufficient adrenal function.
Patients who last in urgent need of high doses of corticosteroids or to give long-term treatment with inhaled corticosteroids at high doses, may also be in this risk. It is necessary to provide for the appointment of additional corticosteroids during periods of stress or surgery. Recommended instruct the patient about the need to rinse the mouth with water after inhalation to prevent development of candidiasis of the oral mucosa.
It is necessary to take precautions when treating patients with an extended QTc-interval.
Acceptance of formoterol may cause elongation QTc- interval. Should review the need for, and dose of inhaled corticosteroids in patients with active or inactive forms of pulmonary tuberculosis, fungal, viral or bacterial infections of the respiratory system. When coadministered β2-agonists with drugs that may induce or enhance the hypokalemic effect, e.g. xanthine derivatives, steroids or diuretics may increase gipokaliemicheskogo effect β2-agonists. It is necessary to take special precautions in patients with unstable asthma patients treated with short-acting bronchodilators, for removal during exacerbation episodes of severe asthma, because the risk of hypokalemia increased by hypoxia and in other conditions when the increased likelihood of developing gipokaliemicheskogo effect. In such cases it is advisable to control the content of potassium in serum. During treatment should monitor the concentration of blood glucose in patients with diabetes.
Effects on ability to drive and mehanizmami.Preparat DuoResp Spiromaks does not affect the ability to drive and use machines. May have little influence in the manifestation of side effects. Caution should be exercised when driving and mechanisms due to the possibility of side effects.
The symptoms: tremor, headache, palpitations. In some cases, it was reported on the development of tachycardia, hyperglycemia, hypokalemia, prolongation QTc-interval, arrhythmia, nausea and vomiting. If necessary, the withdrawal of the drug DuoResp Spiromaks due to overdose of formoterol, which is part of a combined preparation, should consider the appointment of the relevant SSC.
Treatment: supportive and symptomatic. Receiving patients with acute bronchial obstruction formoterol in a dose of 90 mg for 3 hours safe.
In acute overdose, even in large doses, it is not expected clinically significant effects. In chronic receiving excessive doses can manifest systemic effects of corticosteroids, such as hypercortisolism and adrenal suppression.
Powder for inhalation