Seretide Multidisc powder 50mcg/250mcg 60doses
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Seretide Multidisc user manualYou can buy Seretide Multidisc hereForm of release, composition and packagingThe powder for inhalation is dosed white or almost white.1 dose *salmeterol xinafoate micronized 72.5 μg,which corresponds ..
Seretide Multidisc user manual
You can buy Seretide Multidisc here
Form of release, composition and packaging
The powder for inhalation is dosed white or almost white.
1 dose *
salmeterol xinafoate micronized 72.5 μg,
which corresponds to a salmeterol content of 50 μg
fluticasone propionate micronized ** 250 μg
Excipients: lactose monohydrate - up to 12.5 mg.
The drug Seretide Multidisc is a combined preparation that contains salmeterol and fluticasone propionate, which have different mechanisms of action. Salmeterol prevents the appearance of symptoms of bronchospasm, fluticasone propionate improves pulmonary function and prevents the exacerbation of the disease. The drug Seretid Multidisc, because of the more convenient dosage regimen, can be an alternative for patients who simultaneously receive the β2-adrenoreceptor agonist and inhaled GCS from different inhalers.
Salmeterol is a selective long-acting (up to 12 h) β 2 -adrenoreceptor agonist having a long side chain that binds to the receptor's outer domain.
Pharmacological properties of salmeterol provide more effective protection against histamine-induced bronchoconstriction and longer bronchodilation (duration of at least 12 h) than short-acting β2-adrenoreceptor agonists.
In vitro studies have shown that salmeterol is a potent inhibitor of the release of human mediators of mast cells, such as histamine, leukotrienes and prostaglandin D2, from the human lungs and has an extended period of action.
Salmeterol depresses the early and late phases of the response to inhaled allergens. The inhibition of the late phase of the response persists for more than 30 hours after taking a single dose, while the bronchodilator effect is no longer present. Single administration of salmeterol weakens the hyperreactivity of the bronchial tree. This suggests that salmeterol in addition to bronchodilator activity has an additional effect, not associated with the expansion of bronchi, the clinical significance of which has not been established. This mechanism of action is different from the anti-inflammatory effect of GCS.
Fluticasone propionate belongs to the SCS group for topical application and, when inhaled at recommended doses, it has a pronounced anti-inflammatory and anti-allergic effect in the lungs, which leads to a decrease in clinical symptoms, a decrease in the frequency of exacerbations of bronchial asthma. Fluticasone propionate does not cause undesirable phenomena, which are observed with systemic intake of corticosteroids.
With prolonged use of inhalation fluticasone propionate, the daily secretion of hormones in the adrenal cortex remains within normal limits in both adults and children, even when using the maximum recommended doses. After transferring patients receiving other inhaled glucocorticosteroids to the administration of fluticasone propionate, the daily secretion of adrenal cortex hormones gradually improves, despite the previous and current recurrent use of oral steroids. This indicates the restoration of the adrenal function against the background of the inhalation application of fluticasone propionate. With prolonged use of fluticasone propionate, the reserve function of the adrenal cortex also remains within normal limits, as evidenced by a normal increase in cortisol production in response to appropriate stimulation (it should be borne in mind that the residual decrease in adrenal reserve caused by previous therapy may persist for a long time).
There is no evidence to suggest that when combined inhaled salmeterol and fluticasone propionate affect the pharmacokinetics of each other, and therefore the pharmacokinetic characteristics of each component of the Seredide Multidisc can be considered separately.
The study, conducted with the participation of 15 healthy volunteers who simultaneously received salmeterol (inhalation 50 μg 2 times / day) and inhibitor of the isoenzyme CYP3A4-ketoconazole (oral 400 mg once / day) for 7 days, showed a significant increase in salmeterol concentration in blood plasma (an increase in Cmax by 1.4 times and AUC by 15 times). There was no increase in salmeterol accumulation when taking repeated doses. In three patients, treatment was withdrawn because of the prolongation of the QTc interval or rapid heart rate with sinus tachycardia. In the remaining 12 patients, the simultaneous use of salmeterol and ketoconazole did not have a clinically significant effect on heart rate, potassium level in the blood, or the duration of the QTc interval (see the sections "With caution", "Special instructions", "Drug interactions").
Salmeterol acts locally in the lung tissue, so its content in the blood plasma is not an indicator of therapeutic effects. Data on its pharmacokinetics are very limited due to technical problems: when inhaled in therapeutic doses, its Cmax in plasma is extremely low (about 200 pg / ml and below). After regular inhalations of salmeterol in the blood, it is possible to detect hydroxynaphthoic acid, Css of which is about 100 ng / ml. These concentrations are 1000 times lower than Css observed in toxicity studies. No adverse effects were observed with prolonged regular use of Seretide Multidisc (for more than 12 months) in patients with airway obstruction.
Fluticasone propionate: the absolute bioavailability of inhalation fluticasone propionate in healthy people varies depending on the inhaler used, when a combination of salmeterol and fluticasone propionate is administered with a Multidisc inhaler it is 5.5%. In patients with bronchial asthma and COPD, lower concentrations of fluticasone propionate in blood plasma are observed. Systemic absorption occurs mainly through the lungs. At first it is faster, but then its speed slows down.
Part of the inhalation dose can be swallowed, but this part contributes minimal contribution to systemic absorption due to the low solubility of fluticasone propionate in water and due to its pre-systemic metabolism; bioavailability of the gastrointestinal tract is less than 1%. As the inhalation dose increases, a linear increase in the concentration of fluticasone propionate in the blood plasma is observed.
There is no data on the distribution of salmeterol.
Fluticasone propionate has a large Vd in the equilibrium state (about 300 L) and has a relatively high degree of binding to plasma proteins (91%).
The results of the in vitro study showed that salmeterol is extensively metabolized under the action of the CYP3A4 isoenzyme of the cytochrome P450 system to α-hydroxysalmeterol by aliphatic oxidation. In a study with repeated dosing of salmeterol and erythromycin, healthy volunteers lacked clinically significant changes in pharmacodynamic effects when taking 500 mg of erythromycin 3 times / day. However, the study of the interaction of salmeterol and ketoconazole showed a significant increase in the concentration of salmeterol in the blood plasma (see sections "Special instructions", "Drug interaction").
Fluticasone propionate is rapidly eliminated from the blood, mainly as a result of metabolism under the action of the CYP3A4 isoenzyme of the cytochrome P450 system to the inactive carboxyl metabolite. Caution should be exercised while using known inhibitors of CYP3A4 and fluticasone propionate, since in such situations it is possible to increase the content of the latter in plasma.
There is no data on salmeterol excretion.
The distribution of fluticasone propionate is characterized by rapid clearance from the plasma (1150 ml / min) and a final T1 / 2 of about 8 hours. The renal clearance of unchanged fluticasone propionate is negligible (<0.2%), a metabolite with urine displays less than 5% of the dose.
The drug is intended for regular treatment of bronchial asthma if combined therapy with long-acting beta2-adrenomimetic and inhaled corticosteroid is indicated:
- Patients with insufficient control of the disease against a background of continuous monotherapy with inhaled corticosteroids in the periodical use of short-acting beta2-adrenergics;
- patients with adequate disease control on the background of inhaled corticosteroid therapy and long-acting beta2-adrenomimetics;
- as a starting maintenance therapy in patients with persistent bronchial asthma in the presence of indications for the appointment of GCS to achieve control of the disease.
Seretide Multidisc is intended for maintenance therapy in patients with COPD with a value of FEV1 <60% of the proper values (before inhalation bronchodilator) and repeated exacerbations in the history, in which the expressed symptoms of the disease persist despite regular therapy with bronchodilators.
Contraindications for Seretide Multidisc
- hypersensitivity to the components of the drug;
- Children's age up to 4 years.
Like all other inhaled preparations containing GCS, Seretide Multidisc should be used with caution in patients with acute or latent pulmonary tuberculosis.
Seretide Multidisc should be given with caution in thyrotoxicosis.
The drug Seretide Multidisc should be used with caution in fungal, viral or bacterial infections of the respiratory system.
When taking any preparations of the group of sympathomimetics, especially when therapeutic doses are exceeded, it is possible to develop cardiovascular events such as an increase in systolic blood pressure and heart rate. For this reason, the drug Seretide Multidisc should be administered with caution to patients with cardiovascular diseases, incl. arrhythmias such as supraventricular tachycardia and extrasystole, ventricular extrasystole, atrial fibrillation.
All simpatomimeticheskie drugs in dosages exceeding the therapeutic, can cause a transient decrease in the level of potassium in the serum. Therefore, the drug Seretide Multidisc should be administered with caution to patients with hypokalemia.
The drug Seretide Multidisc should be used with caution in individuals with an allergic reaction to lactose and milk protein in the anamnesis, because they have a history of infection. residual amounts of protein may be included in the composition of lactose.
Any inhaled GCS can cause systemic effects, especially with prolonged use in high doses. Therefore, Seretide Multidisc should be used with caution in glaucoma, cataracts, osteoporosis (see section "Special instructions").
There are very rare reports of an increase in blood glucose, so patients with diabetes should use the drug Seretid Multidisc with caution (see section "Side effect").
The drug Seretide Multidisc is intended only for inhalations.
The patient should be informed that to obtain the optimal effect Seretide Multidisc should be used regularly, even in the absence of clinical symptoms of bronchial asthma and COPD.
The physician should regularly evaluate the effectiveness of the patient's treatment.
Determining the duration of the course of therapy and changing the dose of the drug is possible only on the advice of a doctor.
The dose of Seretide Multidisc should be reduced to the lowest dose, which provides effective control of symptoms.
If the drug Seretid Multidisc 2 times / day provides control over the symptoms, within the dose reduction to minimally effective it is possible to reduce the frequency of taking the drug up to 1 time / day.
The patient should be prescribed a form of Seretide Multidisc, which contains a dose of fluticasone propionate, corresponding to the severity of his disease.
If therapy with inhaled glucocorticosteroids does not provide adequate control over the disease, then their replacement with Seretide Multidisc in a dose therapeutically equivalent to that administered by GCS can improve the control of the course of bronchial asthma. In patients who can monitor the course of bronchial asthma solely with the help of inhaled glucocorticosteroids, their replacement with Seretide Multidisc can help reduce the dose of GCS necessary to control the course of asthma.
Adults and children 12 years and older: one inhalation (50 μg salmeterol and 100 μg fluticasone propionate) 2 times / day, or one inhalation (50 μg salmeterol and 250 μg fluticasone propionate) 2 times / day, or one inhalation (50 μg salmeterol and 500 μg fluticasone propionate) 2 times / day.
Children 4 years and older: one inhalation (50 μg salmeterol and 100 μg fluticasone propionate) 2 times / day.
At present, there is no data on the use of Seretide Multidisc in children under 4 years of age.
Chronic obstructive pulmonary disease (COPD)
For adult patients, the maximum recommended dose is 1 inhalation (50 μg salmeterol and 500 μg fluticasone propionate) 2 times / day. For this dosage of Seretide Multidisc, the reduction in mortality from any cause was demonstrated.
Special patient groups
There is no need to reduce the dose of Seretide Multidisc in elderly patients, as well as in patients with impaired renal or hepatic function.
Instructions for the use of the inhaler "Multidisc"
When you take out Seredid Multidisc out of the box, it is in the closed position.
The drug Seretide Multidisc contains 28 or 60 doses in the form of a powder. Each dose is measured and hygienically protected. No maintenance of the dose level is required, nor its additional filling.
The inhaler has an indicator, which, after the inhalation, shows the number of remaining doses. The numbers go in descending order from 60 to 0 or from 28 to 0. The numbers from 5 to 0 are red, warning that only a few doses remain in the inhaler. The appearance in the window of the digit 0 means that the inhaler is empty and unsuitable for further use.
For inhalation, perform five consecutive actions:
1. open the inhaler;
2. Press the lever;
3. inhale the dose of the drug;
4. close the inhaler;
5. Rinse your mouth.
How the inhaler works
When you turn the lever inhaler opens a small hole in the mouthpiece, one dose is ready for inhalation. When the inhaler closes, the lever automatically returns to its original position, thus remaining ready to receive the next required dose. The packaging protects the inhaler when not in use.
1. Open the inhaler. Hold the body with one hand, placing the thumb of the other hand in a special recess. To open the inhaler, press your thumb against yourself until you hear a click.
2. Press the lever. Hold the inhaler with a mouthpiece to your face. The inhaler can be held with your right or left hand. Push the lever in the direction from yourself to the stop until you hear a click. The inhaler is now ready for use. When you press the lever, another cell with powder for inhalation is opened. At the same time, the number of remaining doses decreases, which is indicated in the indicator window. Push the lever only before inhalation, otherwise it will lead to a waste of the drug.
3. Inhale the dose of the drug. Before inhalation, read this section carefully.
- Keep the inhaler at a certain distance from the mouth and make a deep exhalation without effort. Remember: you can never breathe out into the inhaler!
- Tightly grasp the mouthpiece with your lips. Take a uniform and deep breath through your mouth (not through your nose).
- Take the inhaler out of your mouth.
- Hold your breath for about 10 seconds or longer, as far as you can.
- Take a slow exhalation.
4. Close the inhaler. To close the inhaler, place your thumb in a special recess and push towards you until it clicks into place. The lever automatically returns to its original position. The inhaler is again ready for use.
5. Rinse your mouth. After using the inhaler, rinse the mouth with water and then spit it out.
Remember: store the inhaler dry. Keep it closed when not in use. Never breathe out into the inhaler. Turn the lever only when you are ready to take a dose. Do not exceed the prescribed dose. Keep the inhaler out of the reach of children.
Side effects of Seretide Multidisc
All the undesirable reactions presented below are characteristic for the active substances - salmeterol and fluticasone propionate alone. The profile of undesirable reactions of the drug Seretid Multidisc does not differ from the profile of undesirable reactions of its active substances.
The undesirable reactions presented below are listed in accordance with the damage to organs and organ systems and frequency of occurrence. Frequency of occurrence is defined as follows: very often (≥1 / 10), often (≥1 / 100 and <1/10), infrequently (≥1 / 1000 and <1/100), rarely (≥1 / 10,000 and < 1/1000), very rarely (<1/10 000, including individual cases). Frequency categories were formed on the basis of clinical trial data and post-registration surveillance.
Clinical Trials Data
Frequency of occurrence of undesirable reactions
Infectious and parasitic diseases: often - candidiasis of the mouth and pharynx, pneumonia (in patients with COPD); rarely - esophageal candidiasis.
On the part of the immune system: hypersensitivity reactions: infrequently - skin reactions of hypersensitivity, dyspnea, rarely - anaphylactic reactions.
On the part of the endocrine system: possible systemic effects (see section "Special instructions"): infrequently - cataract, rarely - glaucoma.
From the side of metabolism and nutrition: infrequently - hyperglycemia; very rarely - hypokalemia.
Disorders of the psyche: infrequently - anxiety, sleep disturbances; rarely - changes in behavior, incl. hyperactivity and irritability (especially in children).
From the nervous system: very often - a headache (see section "Special instructions"); infrequently - a tremor (see section "Special instructions").
From the side of the heart: infrequently - heart palpitations (see sections "With caution" and "Special instructions"), tachycardia, atrial fibrillation; rarely - arrhythmia, including ventricular extrasystole, supraventricular tachycardia and extrasystole.
From the respiratory system, chest and mediastinum: often - hoarseness of voice and / or dysphonia; infrequent - pharynx irritation.
From the skin and subcutaneous tissues: infrequently - bruising.
From the osteomuscular system and connective tissue: often - muscle spasms, arthralgia.
Frequency of occurrence of undesirable reactions
From the immune system: hypersensitivity reactions: rarely - angioedema (mainly, edema of the face and oropharynx), bronchospasm.
On the part of the endocrine system: possible systemic effects (see the section "Special instructions") rarely - Cushing's syndrome, cushingoid symptoms, oppression of adrenal function, growth retardation in children and adolescents, decrease in bone mineral density.
From the respiratory system, chest and mediastinum: rarely - a paradoxical bronchospasm (see section "Special instructions").
It is not recommended to administer the drug at doses exceeding those specified in the "Dosage regimen" section. It is very important to regularly review the patient's dosing regimen and reduce the dose to the lowest recommended dose, which provides effective symptom control.
The expected symptoms and signs of salmeterol overdose are typical for excessive beta2-adrenergic stimulation and include tremor, headache, tachycardia, increased systolic blood pressure and hypokalemia.
Acute overdose of fluticasone propionate with inhalation can provoke a temporary suppression of the hypothalamic-pituitary-adrenal system. Usually this does not require taking any emergency measures, since the normal function of the adrenal glands is restored within a few days.
When taking the drug at a dose higher than recommended for a long period of time, it is possible to significantly suppress the function of the adrenal cortex. Rare cases of acute adrenal crisis, which occurred mainly in children who received doses of the drug above recommended for a long time (several months or years), are described. Acute adrenal crisis is manifested by hypoglycemia, accompanied by confusion and / or convulsions. Situations that can serve as triggers for an acute adrenal crisis include trauma, surgery, infection, or any rapid reduction in the dose of the drug Seretide Multidisc Fluticasone Propionate.
There is no specific treatment for an overdose of salmeterol and fluticasone propionate. In case of an overdose, supportive therapy should be followed and the patient's condition monitored. In chronic overdose, it is recommended to monitor the reserve function of the adrenal cortex.
Because of the risk of developing bronchospasm, selective and nonselective beta-blockers should be avoided, unless they are extremely necessary for the patient.
In normal situations, inhalations of fluticasone propionate are accompanied by low plasma concentrations due to intensive metabolism during the "first passage" and high systemic clearance under the influence of the CYP3A4 isoenzyme of the cytochrome P450 system in the intestine and liver. Due to this, clinically significant interaction with the participation of fluticasone propionate is unlikely.
A study of drug interaction showed that ritonavir, a highly active inhibitor of the isoenzyme CYP3A4, can cause a dramatic increase in the concentration of fluticasone propionate in the plasma, resulting in a significant decrease in serum cortisol concentrations.
During post-registration observations, clinically significant drug interactions were reported in patients who simultaneously received fluticasone propionate (intranasally or by inhalation) and ritonavir. This interaction caused such side effects as Cushing's syndrome and suppression of adrenal function. Given this, simultaneous use of fluticasone propionate and ritonavir should be avoided, unless the potential benefit to the patient exceeds the risk of systemic side effects of GCS.
Studies have shown that other inhibitors of the CYP3A4 isoenzyme cause negligible (erythromycin) and insignificant (ketoconazole) increase in plasma fluticasone propionate, in which the serum cortisol concentrations are virtually unchanged. Nevertheless, caution should be exercised when using fluticasone propionate and strong inhibitors of CYP3A4 (eg, ketoconazole), since such combinations do not exclude the possibility of an increase in the concentration of fluticasone propionate in the plasma, which can potentially increase the systemic effects of fluticasone propionate.
When investigating the interaction of drugs, it was found that the use of ketoconazole as a concomitant systemic therapy significantly increases the concentration of salmeterol in the blood plasma (an increase of Cmax by 1.4 times and AUC by 15 times). This can lead to an elongation of the QTc interval. Caution should be exercised when co-administration of strong inhibitors of CYP3A4 (eg, ketoconazole) and salmeterol.
The derivatives of xanthine, GCS and diuretics increase the risk of hypokalemia (especially in patients with exacerbation of bronchial asthma, hypoxia). MAO inhibitors and tricyclic antidepressants increase the risk of developing side effects from the cardiovascular system.
The drug Seretide Multidisc is compatible with cromoglycic acid.
special instructions for Seretide Multidisc
The drug Seretide Multidisc is not intended to alleviate acute symptoms, because in such cases, a rapid and short-acting inhaled bronchodilator (eg, salbutamol) should be used. Patients should be informed that they always have at hand a drug to stop acute symptoms.
The combination of salmeterol and fluticasone propionate can be used for initial maintenance therapy in patients with persistent asthma (daily occurrence of symptoms or daily use of an agent for arresting seizures), if there is evidence of SCS administration and when determining their approximate dosage.
The more frequent use of short-acting bronchodilators to relieve symptoms indicates a worsening of disease control, and in such situations the patient should consult a doctor.
The sudden and increasing deterioration in the control of bronchial asthma poses a potential threat to life, and in such situations, the patient should also consult a doctor. The doctor should consider the possibility of prescribing a higher dose of GCS. If the used dose of Seretide Multidisc does not provide adequate control of the disease, then the patient should also consult a doctor.
Patients with asthma can not abruptly stop treatment with Seretide Multidisc because of the risk of developing an exacerbation, the dose of the drug should be reduced gradually under the supervision of a doctor.
In patients with COPD, the withdrawal of the drug may be accompanied by symptoms of decompensation and requires the supervision of a physician.
In clinical studies, data were obtained on the increase in the incidence of pneumonia in patients with COPD receiving Seretide Multidisc (see "Side effect"). Doctors should be aware of the possibility of developing pneumonia in COPD, as the clinical picture of pneumonia and exacerbations of COPD are often similar.
Any inhaled GCS can cause systemic effects, especially with prolonged use in high doses; it should be noted, however, that the likelihood of such symptoms is much lower than when treated with oral GCS (see "Overdose"). Possible systemic effects include Cushing's syndrome, cushingoid features, suppression of adrenal function, growth retardation in children and adolescents, reduction of bone mineral density, cataract and glaucoma. Therefore, in the treatment of bronchial asthma, it is important to reduce the dose to the lowest dose, which provides effective control of symptoms.
In emergency and planned situations that can cause stress, it is always necessary to remember the possibility of suppressing the adrenal glands and to be ready for use by the GCS (see section "Overdose").
When carrying out resuscitation measures or surgical interventions, it is required to determine the degree of adrenal insufficiency.
It is recommended to regularly measure the growth of children who receive long-term inhaled glucocorticosteroids.
Due to the possibility of suppression of the adrenal glands, patients transferred from oral GCS to inhalation therapy with fluticasone propionate should be treated with extreme caution and regularly monitor their function as the adrenal cortex. When transferring patients from taking systemic GCS to inhalation therapy, allergic reactions (for example, allergic rhinitis, eczema), which were suppressed by systemic GCS, may appear. In such situations it is recommended to carry out symptomatic treatment with antihistamines and / or topical preparations, incl. GCS for topical application.
After initiation of treatment with inhaled fluticasone propionate, systemic GCS should be discontinued gradually, and such patients should carry a special patient card containing an indication of the possible need for additional administration of SCS in stressful situations.
In patients with exacerbation of bronchial asthma, hypoxia, it is necessary to monitor the concentration of K + ions in the plasma.
There are very rare reports of an increase in blood glucose levels, and this should be remembered when assigning a combination of salmeterol and fluticasone propionate to diabetic patients (see the "Side effect" section).
During the post-marketing period, reports were received of a clinically significant drug interaction between fluticasone propionate and ritonavir leading to systemic effects of GCS, including Cushing's syndrome and suppression of adrenal function. Therefore, it is recommended that joint use of fluticasone propionate and ritonavir should be avoided, unless the potential benefit to the patient exceeds the risk associated with systemic effects of GCS (see "Drug Interactions").
A clinical study of the safety of salmeterol added to ongoing asthma therapy compared with placebo showed that the incidence of lethal outcomes due to bronchial asthma was higher in the salmeterol group. When taking salmeterol compared to placebo, the risk of serious unwanted reactions from the respiratory system or death in African-American patients is presumably higher than in other patients. The importance of pharmacogenetic factors or other causes is unknown. The effect associated with the use of GCS in this study has not been studied.
Like other inhaled drugs, the drug Seretid Multidisc can cause a paradoxical bronchospasm, manifested by the increase of dyspnea immediately after use. In this case, the short-acting inhaled bronchodilator should be immediately applied, the Seretide Multidisc should be canceled and, if necessary, an alternative therapy should be started.
There are reports of adverse events associated with the pharmacological action of beta2-antagonists, such as tremor, subjective palpitation and headache. However, these phenomena are of a short-term nature, and their severity decreases with regular therapy.
Impact on the ability to drive vehicles and manage mechanisms
In clinical trials, no evidence of the effect of the drug on the ability to drive vehicles and other mechanisms has been obtained, but side effects that the drug may cause should be considered.
Pregnancy and lactemia
There is no data on the effect on fertility in humans. In animal studies, the effects of fluticasone propionate or salmeterol xinafoate on the fertility of males or females have not been identified.
Data on the use of the drug in pregnant women are limited. Use during pregnancy is only permissible if the potential benefit to the mother exceeds the possible risk to the fetus.
According to the results of a retrospective study, there was no increased risk of serious congenital malformations (CVD) after exposure to fluticasone propionate during the first trimester of pregnancy compared with other inhaled corticosteroids.
When carrying out studies of reproductive toxicity in animals with the introduction of each component of the drug alone, and their combination, the effect on the fetus of excessive systemic concentrations of active beta2-adrenomimetic and GCS was revealed.
Extensive experience in the clinical use of drugs of this class indicates that with the use of therapeutic doses, the described effects are not clinically significant.
The concentration of salmeterol and fluticasone propionate in blood plasma after inhaling the drug in therapeutic doses is extremely low, so their concentration in breast milk should be the same low. This is confirmed by studies in animals in the milk of which low concentrations of the drug were determined. There are no related data on breast milk.
The use of the drug in the period of breastfeeding is permissible only if the potential benefit to the mother exceeds the possible risk for the child.
Application in childhood
It is recommended to monitor the growth dynamics of children who receive long-term inhaled glucocorticosteroids.
Contraindicated in children under the age of 4 years.
In case of violations of kidney function
In patients with impaired renal function, a dose reduction is not required.
With violations of liver function
In patients with impaired liver function, a dose reduction is not required.
Application in old age
There is no need to reduce the dose of the drug to elderly patients.
Conditions of leave from pharmacies
To buy Seretide Multidisc you don't need a prescription.
Terms and conditions of storage
The drug should be stored out of the reach of children at a temperature below 30 ° C. Shelf life - 2 years.
Do not use after the expiry date printed on the package.