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Seroflo inhaler is a combined oral drug. It contains salmeterol and fluticasone propionate. Salmeterol prevents the bronchospasm symptoms, fluticasone propionate improves lung function and prevents disease exacerbation.Buy Now
Seroflo Inhaler is a combined bronchodilating agent. It contains beta2-selective adrenomimetic + local glucocorticosteroid.
Mechanism of action
Seroflo Inhaler is a combined drug that contains two active ingredients: fluticasone and salmeterol. These medicinal substances belong to different classes (synthetic fluorinated glucocorticosteroid and long-acting selective β2-adrenergic receptor agonist). They both have different mechanisms of action.
Fluticasone is a synthetic glucocorticosteroid (GCS) for topical use. When administered by inhalation in recommended doses, it has a pronounced anti-inflammatory and antiallergic effect in the lungs. It contributes to a decrease in clinical symptoms, a decrease in the frequency of exacerbations of bronchial asthma. Fluticasone propionate does not cause the undesirable effects that are found with systemic administration of corticosteroids.
The pharmacological action of fluticasone is achieved due to the ability to bind to glucocorticoid receptors of target cells, including epithelial cells of the respiratory tract.
Fluticasone inhibits the influx of mast cells, eosinophils, lymphocytes, macrophages, neutrophils, reduces the production and release of inflammatory mediators and other biologically active substances (including histamine, prostaglandins, leukotrienes and cytokines) involved in the formation of allergen-specific sensitization. As a result, capillary permeability decreases. The exudation disappears, the secretion of mucus by the mucous glands decreases, the patency of the bronchial tree is restored.
Salmeterol is a selective long-acting (up to 12 hours) β2-adrenergic receptor agonist with a long side chain that binds to the outer domain of the receptor.
Seroflo Inhaler is indicated as a basic therapy for bronchial asthma, when it is advisable to use a combination of a long-acting β2-adrenergic agonist with inhaled GCS:
- patients with insufficient control of the disease on the background of constant monotherapy with inhaled GCS with periodic use of a short-acting β2-adrenomimetic;
- patients with adequate disease control during therapy with inhaled corticosteroids and a long-acting β2-adrenomimetic agent;
- as a starting maintenance therapy for patients with persistent bronchial asthma in the presence of indications for the appointment of GCS to take the disease under control;
- for maintenance therapy in chronic obstructive pulmonary disease (COPD) and FEV1 value <60% of the proper values (before inhalation of the bronchodilator) and repeated exacerbations in the history, in which severe symptoms persist despite regular bronchodilator therapy.
- Hypersensitivity to one or more drug components;
- Children under 4 years of age.
Be careful in the following cases:
- acute or latent tuberculosis;
- fungal, viral or bacterial infections;
- pheochromocytoma, thyrotoxicosis, hypothyroidism;
- uncontrolled hypokalemia;
- uncontrolled arterial hypertension, coronary heart disease, idiopathic hypertrophic subaortic stenosis, arrhythmias such as supraventricular tachycardia and extrasystole, ventricular extrasystole, atrial fibrillation;
- any inhaled GCS can cause systemic effects, especially with prolonged use in high doses. Therefore, the drug should be used with caution in cataracts, glaucoma, osteoporosis.
There are very rare reports of an increase in the concentration of glucose in the blood plasma, therefore, patients with diabetes should use Seroflo Inhaler with caution.
Pregnancy and lactation
Impact on fertility
Animal studies have not shown any effect of fluticasone propionate or salmeterol xinafoate on male and female fertility.
Pregnant women can be prescribed the drug only if the intended benefit to the mother outweighs the potential risk to the fetus. When conducting studies of reproductive toxicity in animals with the introduction of salmeterol and fluticasone, both individually and in combination, the effect on the fetus of excessive systemic concentrations of active β2-adrenomimetic and glucocorticosteroid was revealed.
The concentration of salmeterol and fluticasone propionate in the blood plasma after inhalation in therapeutic doses is extremely low, therefore their concentration in breast milk should also be low. This is confirmed by studies on animals, in whose milk low concentrations of salmeterol and fluticasone propionate were determined.
It is possible to prescribe the drug to lactating women only if the intended benefit to the mother outweighs the potential risk to the child.
Mode of application and dosage
Seroflo Inhaler is intended for inhalation.
Adults and children over 12 years old
- 25 mcg / 50 mcg: 2 inhalation doses 2 times a day;
- 25 mcg / 125 mcg: 2 inhalation doses 2 times a day;
- 25 mcg / 250 mcg: 2 inhalation doses 2 times a day.
Children from 4 to 12 years old: 25 mcg / 50 mcg: 2 inhalation doses 2 times a day.
Chronic obstructive pulmonary disease (COPD)
- 25 mcg / 125 mcg: 2 inhalation doses 2 times a day;
- Seroflo Inhaler 25 mcg / 250 mcg: 2 inhalation doses 2 times a day.
The drug is prescribed in the minimum effective dose to control the disease symptoms.
When the effect is achieved by using the drug 2 times a day, it is advisable to reduce the dose to the minimum effective or switch to a lower dosage, the frequency of use is 1 time per day. The dose of fluticasone in the form chosen should be appropriate for the severity of the disease.
To achieve the optimal effect, the drug is used regularly, even in the absence of bronchial asthma and COPD symptoms. The doctor sets the course of treatment and the dose of the drug individually. The physician should regularly evaluate the effectiveness of the patient’s treatment.
There is no need for dose adjustment in elderly patients and in patients with liver and kidney pathology.
- The cardiovascular system: myocardial ischemia, infrequently – palpitations, tachycardia, atrial fibrillation; rarely – arrhythmia, including ventricular premature beats, supraventricular tachycardia and extrasystole.
- The nervous system: often – headache; infrequently – tremor.
- The immune system: infrequently – skin reactions of hypersensitivity, shortness of breath; rarely – anaphylactic reactions, angioedema (mainly edema of the face and oropharynx), bronchospasm, allergic rhinitis and conjunctivitis.
- The respiratory system: nosebleeds, nasal congestion, dryness of the mucous membranes of the nasal cavity, laryngitis; often – hoarseness and/or dysphonia; infrequently – throat irritation; rarely – paradoxical bronchospasm.
- The gastrointestinal tract: irritation of the mucous membranes of the oropharynx, change in taste, hyposalivation, infections of the gastrointestinal tract, damage to hard tissues of the teeth, abdominal pain, increased gas production, constipation, hemorrhoids.
- The skin: hemorrhages, eczema, dermatitis, dermatoses; infrequently – bruising.
- The musculoskeletal system: muscle cramps, pain in bones and joints; often – muscle spasms, arthralgia.
- Infections and infestations: urinary tract infections, respiratory infections, other bacterial and viral infections; often – candidiasis of the oral cavity and pharynx, pneumonia (in patients with COPD); rarely – esophageal candidiasis.
- The endocrine system: rarely – Cushing’s syndrome, cushingoid symptoms, inhibition of adrenal function, growth retardation in children and adolescents, decreased bone mineral density.
- Metabolic and nutritional disorders: infrequently – hyperglycemia; very rarely – hypokalemia.
- Mental disorders: infrequently – anxiety, sleep disturbances; rarely – changes in behavior, including increased activity and irritability (especially in children).
Under normal conditions, after the drug inhalation, low plasma concentrations of salmeterol and fluticasone are achieved, however, potential interaction with other substrates or inhibitors of the CYP3A4 isoenzyme cannot be excluded.
The use of non-selective and selective beta-blockers in patients with bronchial asthma should be avoided due to the risk of developing bronchospasm. The use of Seroflo Inhaler together with beta-blockers is permissible only in the presence of strict indications.
Combined use with other agents containing β2-adrenergic receptor agonists can lead to increased effects.
When studying 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 (increase in Cmax by 1.4 times and AUC by 15 times). This can lead to a prolongation of the QTc interval. Be autious when co-administration of strong CYP3A4 inhibitors (eg, ketoconazole) and salmeterol.
Xanthine derivatives, GCS and diuretics increase the risk of hypokalemia (especially in patients with exacerbation of bronchial asthma, hypoxia).