Seretide aerosol for inhalation 25mkg + 250mkg/dose 120doz

Aerosol inhalation dosed

Composition

1 dose contains salmeterol xinafoate (equivalent to salmeterol 25 μg) 36.3 μg, fluticasone propionate 250 μg

Packing

Bottle of 120 doses.

Mechanism of action

Seretide has anti-asthma, bronchodilatory, anti-inflammatory effect.

Indications and usage

Basic therapy of diseases associated with reversible airway obstruction (including bronchial asthma in children and adults) when it is appropriate to prescribe a combination therapy - a bronchodilator and a drug from the group of inhaled GCS:
- in patients receiving effective maintenance doses of agonists of long-acting β-adrenoreceptors and inhaled GCS;
- in patients who have symptoms of the disease during therapy with inhaled corticosteroids;
- in patients receiving regular treatment with bronchodilators and in need of inhaled GCS.
Maintenance therapy for COPD.

Contraindications

- children's age up to 4 years;
- hypersensitivity to the drug.
with caution the drug should be prescribed for pulmonary tuberculosis, fungal, viral or bacterial infections of the respiratory system,thyrotoxicosis, pheochromocytoma, diabetes mellitus, uncontrolled hypokalemia, idiopathic hypertrophic subaortic stenosis, uncontrolled arterial hypertension, arrhythmias, prolongation of the QT interval on the ECG, IHD, hypoxia of various genesis, a pattern, an aurora, a pattern, an aurora, an aurora, an anatom

Pregnancy and Breastfeeding

During pregnancy and lactation (breastfeeding) Seretide can be prescribed only if the intended benefit to the mother outweighs any possible risk to the fetus or child.

Dosage and administration

Seretide is intended for inhalation only.
To obtain the optimal effect, the drug should be used regularly, even in the absence of clinical symptoms of bronchial asthma and COPD.
The doctor sets the course of treatment and dose change individually.
The patient should be prescribed the drug in a dosage form that contains a dose of fluticasone propionate, corresponding to the severity of the disease.
The recommended doses for adults and children aged 12 years and older are 2 inhalations (25 mcg salmeterol and 50 mcg fluticasone propionate) 2 times / day, or 2 inhalations (25 mcg salmeterol and 125 mcg fluticasone propionate) 2 times / day, or 2 inhalation (25 mcg salmeterol and 250 mcg fluticasone propionate) 2 times / day.
For children aged 4 years and older, 2 inhalations are recommended (25 mcg salmeterol and 50 mcg fluticasone propionate) 2 times / day.
The dose of Seretide should be reduced to the minimum effective dose.
AtCOPD for adults, the maximum recommended dose is 2 inhalations (25 mcg salmeterol and 250 mcg fluticasone propionate) 2 times / day.
Elderly patients and patients with impaired liver or kidney function dose reduction is not required.

Adverse reactions

Since Seretide contains salmeterol and fluticasone propionate, its side effects are characteristic of each of these drugs. Their simultaneous use does not cause additional side effects.
Seretide may cause paradoxical bronchospasm.
Salmeterol
Cardiovascular: palpitations, headache (as a rule, transient, decrease with the continuation of therapy salmeterol); usually in predisposed patients - cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystole).
Gastrointestinal: rarely - abdominal pain, nausea, vomiting; in some cases - a violation of taste.
Allergic reactions: rash, angioedema.
Other: tremor, hypokalemia (as a rule, transient, decrease with the continuation of therapy salmeterol); rarely - arthralgia, nervousness, peripheral edema; in some cases - irritation of the mucous membrane of the oropharynx, painful muscle spasms.
Fluticasone Propionate
Respiratory: hoarseness, candidiasis of the mouth and pharynx.
Allergic reactions: skin manifestations, angioedema (mainly of the face and oropharynx), bronchospasm, Anaphylactic reactions.
Systemic reactions: It is theoretically possible to suppress adrenal function, growth retardation in children and adolescents, a decrease in bone mineral density, cataract and glaucoma.

Special notes

Seretide is intended for long-term treatment of the disease, and not for the relief of seizures. To relieve seizures, patients should be prescribed inhaled short-acting bronchodilators (for example, salbutamol), which patients are advised to always carry with them.
With the development of paradoxical bronchospasm, you should immediately apply a short-acting inhaled bronchodilator, cancel Seretide and begin, if indicated, alternative therapy.
Treatment of bronchial asthma is recommended in stages, monitoring the patient's clinical response to treatment and lung function. The patient must be taught to use the inhaler correctly.
The severity and frequency of coarsening of the voice and candidiasis can be reduced by rinsing the mouth with water after Seretide inhalation. When candidiasis is prescribed antifungal drugs for local use, continuing therapy with Seretide.
More frequent use of short-acting bronchodilators to relieve symptoms indicates a deterioration in the control of the disease, in such situations the patient should consult a doctor.
A sudden and progressive deterioration in the control of the bronchospastic syndrome represents a potential threat to life. In such situations, the need to control the doctor. If the applied dose of Seretide does not provide adequate control of the disease, then an additional administration of GCS may be required, and if the exacerbation is caused by an infection, then antibiotics are prescribed.
Because of the danger of aggravation, the sudden discontinuation of seretide should be avoided, the dose should be reduced gradually under the supervision of a physician.
When using any inhaled corticosteroids, it is possible to develop systemic effects (suppression of adrenal function, growth retardation in children and adolescents, decrease in bone mineral density, cataracts and glaucoma), especially with long-term use in high doses, but the likelihood of such effects is much lower than with treatment of oral forms of corticosteroids. Given this, the dose of inhaled corticosteroids should be titrated to the minimum, which ensures the maintenance of effective control.
In emergency and planned stressful situations, it is always necessary to remember about the possibility of suppressing the function of the adrenal glands and the emergence of the need to use GCS.
When conducting resuscitation or surgical interventions, determination of the degree of adrenal insufficiency is required.
In some patients, individual sensitivity to GCS for inhalation may be noted.
In connection with possible adrenal insufficiency, special care should be taken and the indicators of the function of the adrenal cortex should be regularly monitored when transferring patients taking GCS orally for fluticone propionate for inhalation. When transferring patients from taking systemic corticosteroids to inhalation therapy, allergic reactions can occur (for example, allergic rhinitis, eczema), which were previously suppressed by systemic corticosteroids. In such situations, it is recommended to carry out symptomatic treatment with antihistamines and / or topical preparations (including GCS for local use).
The abolition of systemic corticosteroids against the background of inhaled fluticasone propionate should be carried out gradually. Patients should carry a card indicating that they may need additional intake of GCS under various stressful situations.

Drug Interactions

The use of selective and non-selective beta-blockers should be avoided, unless it is really necessary and justified.
Even despite the very low concentration of salmeterol in the blood plasma, its interaction with other substrates and inhibitors of the CYP3A4 isoenzyme cannot be ruled out.
When fluticasone propionate is used in the form of inhalations, its plasma concentration is low due to intensive metabolism during the "first pass" through the liver under the influence of the CYP3A4 isoenzyme and high systemic clearance. Because of this, a clinically significant interaction with fluticasone propionate is unlikely.
Care must be taken with the simultaneous use of known inhibitors of CYP3A4 and fluticasone propionate, since in such situations it is possible to increase the content of the latter in plasma.
Ritonavir (a highly active inhibitor of the isoenzyme CYP3A4) can cause a significant increase in the concentration of fluticasone propionate in the blood plasma, as a result of which serum cortisol concentrations are significantly reduced. There are reports of clinically significant drug interactions in patients who simultaneously received fluticasone propionate and ritonavir, which was manifested by the development of Itsenko-Cushing syndrome and adrenal suppression. With this in mind, the simultaneous use of fluticasone propionate and ritonavir should be avoided, except in cases where the potential benefit of combination therapy for a patient exceeds the risk of developing systemic side effects of GCS.
Other inhibitors of the isoenzyme CYP3A4 cause a negligible (erythromycin) and a slight (ketoconazole) increase in the content of fluticasone propionate in the plasma, at which the concentration of serum cortisol remains practically unchanged. Despite this, caution is advised when using fluticasone propionate and strong CYP3A4 inhibitors (for example, ketoconazole) at the same time, since such combinations do not exclude the likelihood of increasing plasma concentration of fluticasone propionate.
With simultaneous use of Seretide, xanthine derivatives, GCS and diuretics increase the risk of hypokalemia (especially in patients with exacerbation of bronchial asthma, with hypoxia); MAO inhibitors and tricyclic antidepressants increase the risk of cardiovascular side effects.
Seretide is compatible with cromoglicic acid.

Symptoms: tremor, headache and tachycardia caused by the action of salmeterol; temporary suppression of the hypothalamic-pituitary-adrenal system, due to the action of fluticasone.
With prolonged inhalation of Seretide in excessively high doses, a marked inhibition of adrenal function is possible. There are rare reports of an acute adrenal crisis that occurs predominantly in children who receive Seretide in excessively high doses for a long time (several months or years). Acute adrenal crisis is manifested by hypoglycemia, accompanied by confusion and / or convulsions. The situations that can serve as trigger factors for acute adrenal crisis include trauma, surgery, infection, or a rapid reduction in the dose of fluticasone propionate, which is part of Seretide.
Treatment: symptoms caused by the action of salmeterol, should be stopped by the introduction of an antidote - a cardioselective beta-blocker. In those cases when it is necessary to discontinue Seretide due to an overdose of salmeterol contained in it, the patient should be given an appropriate replacement GCS.
Symptoms caused by the action of fluticasone propionate, usually do not require emergency treatment, since in most cases the normal function of the adrenal glands is restored within a few days. In chronic overdose, it is recommended to monitor the reserve function of the adrenal cortex.
In order to avoid overdose, patients should not take Seretide in doses higher than recommended. It is important to regularly evaluate the effectiveness of therapy and reduce the dose of Seretide to the minimum level that provides effective control of the symptoms of the disease.

In a dry, dark place at a temperature of no higher than 20 ° C.