Active substanceSalmeterol + FluticasoneSalmeterol + Fluticasone
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  • Dosage form: & nbspcapsules with powder for inhalation
    Composition:

    One capsule contains: active substances: salmeterol xinafoate (in terms of salmeterol) 0,07264 mg (0,0500 mg) / 0,07264 mg (0,0500 mg) / 0,07264 mg (0,0500 mg); fluticasone propionate 0.1000 mg / 0.2500 mg / 0.5000 mg; Excipients: lactose monohydrate (Pharmacosis 125 M) 17.3671 mg / 17.2516 mg / 17.0591 mg, lactose monohydrate (Pharmacosis 150 M) 7.447 mg / 7.3396 mg / 7.3111 mg.

    Composition of gelatin capsule

    Capsules 50 + 100 mcg. CapDye Azorubin (E 122) 0.0001 mg, dye solar sunset yellow (E 110) 0.0150 mg, titanium dioxide (E 171) 0.2650 mg, gelatin 16.6039 mg, water 2.9000 mg, sodium lauryl sulfate 0.0160 mg, methyl parahydroxybenzoate 0.1600 mg, propyl parahydroxybenzoate 0.0400 mg. Housing: gelatin 25.3260 mg, water 4.3500 mg, sodium lauryl sulfate 0.0240 mg, methyl parahydroxybenzoate 0.2400 mg, propyl parahydroxybenzoate 0.0600 mg.

    Capsules 50 + 250 mcg. Cap(E 133) 0.0009576 mg, dye azorubin (E 122) 0.0023184 mg, dye sunset yellow (E 110) 0.0039200 mg, dye quinoline yellow (E 104) 0.0392 million mg, titanium dioxide (E 171) 0.196 million mg, gelatin 16.6544040 mg, water 3.0360000 mg, sodium lauryl sulfate 0.04 million mg, methyl parahydroxybenzoate sodium 0.0200000 mg, sodium propyl parahydroxybenzoate 0.0072000 mg. The housing, gelatin 25.3452000 mg, water 4.5540000 mg, sodium lauryl sulfate 0.0600000 mg, sodium methylparahydroxybenzoate 0.0300000 mg, sodium propyl parahydroxybenzoate 0.0108000 mg.

    Capsules 50 + 500 mcg. Cap(E 133) 0,0276 mg, azorubin (E 122) dye 0,0048 mg, dye sunset yellow (E 110) 0.0768 mg, titanium dioxide (E 171) 0.2999 mg, gelatin 16 , 4749 mg, water 2.9000 mg, sodium lauryl sulfate 0.0160 mg, methyl parahydroxybenzoate 0.1600 mg, propyl parahydroxybenzoate 0.0400 mg. Housing: gelatin 25.3260 mg, water 4.3500 mg, sodium lauryl sulfate 0.0240 mg, methyl parahydroxybenzoate 0.2400 mg, propyl parahydroxybenzoate 0.0600 mg.

    Composition of white ink (for capsules 50 + 100 μg and 50 + 500 μg): shellac 20-25%, ethanol 30-34%, isopropanol 3-6%, butanol 3-6%, propylene glycol 0.5-2%, titanium dioxide (E 171) 30-34%, polysorbate 80 0-1% .

    Composition of white ink (for capsules 50 + 250 μg): shellac 11-13%, ethanol 15-18%, isopropanol 15-18%, butanol 4-7%, propylene glycol 1-3%, sodium hydroxide 0.05-0.1%, povidone 10-13%, titanium dioxide ( E 171) 32-36%.

    Composition of black ink (for capsules 50 + 100 μg and 50 + 500 μg): shellac 20-24%, ethanol 30-34%, isopropanol 3-6%, butanol 3-5%, propylene glycol 0.5-2%, ferric oxide black oxide (E 172) 20-24%, water up to the required amount.

    Composition of black trait (for capsules 50 + 250 μg): shellac 24-27%, ethanol 23-26%, isopropanol 1-3%, butanol 1-3%, propylene glycol 3-7%, ammonia water 1-2%, potassium hydroxide 0.05-1.1%, water 15 -18%, ferric oxide black oxide (E 172) 24-28%.

    Description:

    Capsules 50 + 100 mcg. Hard gelatin capsules No. 3 with a light orange lid and a colorless transparent casing. On the cover in a circle with white ink printed "Seroflo-100 ", on the body in a circle in black ink printed logo "Cipla".

    Capsules 50 + 250 mcg. Hard gelatin capsules No. 3 with a dark yellow lid and a colorless transparent casing. On the cover in a circle with white ink printed "Seroflo-250", on the body in a circle in black ink printed logo "Cipla".

    Capsules 50 + 500 mcg. Hard gelatin capsules No. 3 with a greenish-gray lid and a colorless transparent casing. On the cover in a circle with white ink printed "Seroflo-500", on the body in a circle in black ink printed logo "Cipla".

    Each capsule is partially filled with white or almost white powder.
    Pharmacotherapeutic group:Bronchodilator combined (beta2-adrenomimetic selective + glucocorticosteroid local)
    ATX: & nbsp

    R.03.A.K   Sympathomimetics in combination with corticosteroids or other drugs, excluding anticholinergic drugs

    R.03.A.K.06   Salmeterol and fluticasone

    Pharmacodynamics:

    Mechanism of action

    The preparation SEROFLO is a combined preparation that contains salmeterol and fluticasone propionate, which possess 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 preparation SEROFLO, because of the more convenient dosage regimen, can be an alternative for patients who simultaneously receive the beta2-adrenoreceptor agonist and inhalation glucocorticosteroid (GCS) from different inhalers.

    Salmeterol is a selective long-acting (up to 12 h) beta2-adrenergic receptor 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 moreprolonged bronchodilation (duration not less than 12 hours) than short-acting beta2-adrenergic agonists.

    In vitro The research showed that salmeterol is a potent inhibitor of the release from the human lungs of the mediators of mast cells, such as histamine, leukotrienes and prostaglandin D2 and has a long period of validity.

    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 indicates that salmeterol in addition to bronchodilating activity has an additional effect, not associated with the expansion of bronchi, the clinical significance of which has not been finally established. This mechanism of action is different from the anti-inflammatory effect of GCS.

    Fluticasone propionate belongs to the group of GCS for topical application and when inhaled at recommended doses it has a pronounced anti-inflammatory and antiallergicaction in the lungs, which leads to reduction of clinical symptoms, reduction 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).

    Pharmacokinetics:

    There is no evidence that when combined inhalation salmeterol and fluticasone propionate affect the pharmacokinetics of each other, and therefore the pharmacokinetic characteristics of each component of the drug SEROFLO can be considered separately.

    A study conducted with the participation of 15 healthy volunteers who simultaneously received salmeterol (inhalation 50 μg twice daily) and an isoenzyme inhibitor CYP3A4 - ketoconazole (oral 400 mg once daily) for 7 days, showed a significant increase in salmeterol concentration in blood plasma (an increase in CmOh in 1,4 times and AUC in 15 times). There was no increase in salmeterol accumulation when taking repeated doses. In 3 patients the treatment was canceled because of the lengthening of the interval QTc or rapid heart rate with sinus tachycardia. In the remaining 12 patients, simultaneous use of salmeterol and ketoconazole did not have a clinically significant effect on heart rate, blood potassium level or interval duration QTc (see the sections "With caution", "Special instructions", "Interaction with other medicinal products").

    Suction. 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 maximum plasma concentration is extremely low (about 200 ng / ml and below). After regular inhalation with salmeterol, it is possible to detect hydroxynaphthoic acid in the blood, the equilibrium concentrations of which are about 100 ng / ml. These concentrations are 1000 times lower than the equilibrium concentrations observed in the toxicity studies. No adverse effects were observed with prolonged regular use of the drug (for more than 12 months) in patients with airway obstruction.

    Fluticasone propionate: the absolute bioavailability of a single dose inhalation fluticasone propionate in healthy people varies from about 5 to 11% of the nominal dose, depending on the inhaler used. In patients with bronchial asthma and chronic obstructive pulmonary disease (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 from 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.

    Distribution. There is no data on the distribution of salmeterol. Fluticasone propionate has a large volume of distribution in the equilibrium state (about 300 liters) and has a relatively high degree of binding to plasma proteins (91%).

    Metabolism. Results of the study in vitro showed that salmeterol Extensively metabolized by isoenzyme CYP3A4 cytochrome P450 systems to α-hydroxysalmeterol by aliphatic oxidation. In a study with repeated dosing of salmeterol and erythromycin, healthy volunteers did not have clinically significant changes in pharmacodynamic effects when taking 500 mg of erythromycin 3 times a 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", "Interaction with other medicinal products").

    Fluticasone propionate is rapidly eliminated from the blood, mainly as a result of metabolism under the action of the isoenzyme CYP3A4 the cytochrome P450 system to the inactive carboxyl metabolite. Caution should be exercised while using known inhibitors CYP3A4 and fluticasone propionate, since in such situations it is possible to increase the content of the latter in plasma.

    Excretion. 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 half-life 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.

    Indications:

    Treatment of bronchial asthma in patients who are shown combined therapy with long-acting beta2-adrenomimetic and inhaled glucocorticosteroid (GCS):

    - in patients with insufficient control of the disease against the background of continuous monotherapy with inhaled glucocorticosteroids in the periodical application of short-acting beta2-adrenomimetics;

    - in patients with adequate control of the disease on the background of inhaled glucocorticosteroids and long-acting beta2-adrenomimetics;

    - as a starting maintenance therapy in patients with persistent asthma (the daily occurrence of symptoms, the daily use of funds for rapid relief of symptoms) in the presence of indications for the use of GCS to achieve control of the disease.

    Supportive therapy for COPD and the value of FEV1 (volume of forced expiration 1) is less than 60% of the required values ​​(before bronchodilator inhalation) and repeated exacerbations in the history, in which the expressed symptoms of the disease persist despite regular therapy with bronchodilators.

    Contraindications:

    - Hypersensitivity to the components of the drug;

    - children under 4 years.

    Carefully:

    Like all other inhaled preparations containing GCS, the preparation of SEROFLO should be used with caution in patients with acute or latent pulmonary tuberculosis.The drug SEROFLO should be administered with caution in thyrotoxicosis.

    The drug SEROFLO should be used with caution in fungal, viral, as well as bacterial infections of the respiratory system.

    When taking any drugs from the group of sympathomimetics, especially when the therapeutic doses are exceeded, due to the fact that in these cases, the development of cardiovascular events such as an increase in systolic blood pressure and heart rate is possible. For this reason, the preparation SEROFLO should be administered with caution to patients suffering from cardiovascular diseases, including arrhythmias, such as supraventricular tachycardia and extrasystole, ventricular extrasystole, atrial fibrillation.

    All simpatomimeticheskie drugs in dosages exceeding therapeutic, can cause a transient decrease in serum potassium level, so the drug SEROFLO should be administered with caution to patients with hypokalemia.

    The drug SEROFLO should be used with caution in individuals with allergic reactions to lactose and milk protein in the anamnesis.Any inhaled GCS can cause systemic effects, especially with prolonged use in high doses. Therefore, the drug 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 SEROFLO with caution (see section "Side effects").

    Pregnancy and lactation:

    Pregnant and lactating women can be prescribed a drug only if the expected benefit to the mother exceeds any possible risk to the fetus or child. There is insufficient data on the use of salmeterol and fluticasone propionate in pregnancy and lactation.

    Pregnancy. Reproductive toxicity of the drug and its components was studied during preclinical studies. Excessive systemic concentration of active beta2-adrenomimetic and GCS affects the fetus.

    Extensive experience of clinical use of drugs of this class indicates that when used in therapeutic doses, the described effects are not clinically significant. Salmeterol and fluticasone propionate do not possess genotoxicity.

    Lactation. The concentration of salmeterol and fluticasone propionate in blood plasma after inhalation of 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 salmeterol and fluticasone propionate were measured. There is no data on the concentration of salmeterol and fluticasone propionate in breast milk of women during breastfeeding.

    Dosing and Administration:

    Inhalation. The preparation SEROFLO is intended for inhalation using individual inhalers for dry powders "Rotahaler" or "Revolaser". To obtain the optimal effect, the drug should be used regularly, even in the absence of clinical symptoms of bronchial asthma and chronic obstructive pulmonary disease.

    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 patient should be prescribed a medication that contains a dose of fluticasone propionate, corresponding to the severity of his illness.

    Dosage of the drug SEROFLO should be reduced to the lowest dose, which provides effective control of symptoms. If symptom control is provided by 2 inhalations of the drug SEROFLO per day, the minimum effective dose can be 1 inhalation per day.

    Bronchial asthma

    Adults and children over 12 years of age

    1 inhalation of the drug SROOFLO 50 + 100 μg (50 μg salmeterol and 100 μg fluticasone propionate) 2 times a day.

    1 inhalation of the drug SEROFLO 50 + 250 μg (50 μg salmeterol and 250 μg fluticasone propionate) 2 times a day.

    1 inhalation of the preparation SEROFLO 50 + 500 μg (50 μg salmeterol and 500 μg fluticasone propionate) 2 times a day.

    Children from 4 to 12 years old

    1 inhalation of the drug SROOFLO 50 + 100 μg (50 μg salmeterol and 100 μg fluticasone propionate) 2 times a day.

    Chronic obstructive pulmonary disease

    For adult patients, the maximum recommended dose is 1 inhalation of the preparation SEROFLO 50 + 500 μg (50 μg salmeterol and 500 μg fluticasone propionate) 2 times a day.

    In elderly patients and with impaired renal or hepatic function, dose adjustment is not required.

    Side effects:

    All the undesirable reactions presented below are characteristic for each of the active substances - salmeterol and fluticasone propionate alone.The safety profile of the preparation SEROFLO 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 <1/100), infrequently (≥1 / 1000 and <1/100), rarely (≥1 / 10000 and <1 / 1000), very rarely (<1/10000, including individual cases).

    Infections and infestations: often - candidiasis of the oral cavity and pharynx, pneumonia bronchitis (in patients with COPD); rarely - esophageal candidiasis.

    Immune system disorders: infrequently - dyspnea, skin reactions of hypersensitivity; rarely - anaphylactic reactions, angioedema, mainly edema of the face and oropharynx, bronchospasm.

    Disorders from the endocrine system: possible systemic effects (see the sections "With caution" and "Special instructions"): rarely - Cushing's syndrome, Cushing's symptoms, suppression of adrenal function, growth retardation in children and adolescents, decrease in bone mineral density.

    Disorders from the side of the organ of vision: infrequently - cataract; rarely - glaucoma.

    Disorders from the metabolism and nutrition: often - hypokalemia; very rarely - hyperglycemia.

    Disorders of the psyche: infrequently - anxiety, sleep disturbances; rarely - changes in behavior, including increased activity and irritability (especially in children).

    Impaired nervous system: very often - headache (see section "Special instructions"); infrequently: tremor (see section "Special instructions").

    Heart Disease: infrequent - a feeling of palpitations (see "With caution" and "Special instructions"), tachycardia, atrial fibrillation, angina pectoris; rarely - arrhythmia, including ventricular extrasystole, supraventricular tachycardia, extrasystole.

    Disturbances from the respiratory system, chest and mediastinal organs: often - hoarseness, voice and / or dysphonia, sinusitis; infrequent - pharynx irritation; rarely - paradoxical bronchospasm (see section "Special instructions").

    Disturbances from the skin and subcutaneous tissues: infrequently - bruises.

    Disorders from the musculoskeletal system and connective tissues: often - muscle spasms, arthralgia, myalgia.

    Disorders from the gastrointestinal tract: very rarely - dyspepsia, nausea.

    Children and teens

    It is theoretically possible to develop systemic reactions involving Cushing syndrome, Cushingoid symptoms, suppression of adrenal function, growth retardation in children and adolescents.Very rarely there may be anxiety, sleep disorders and behavioral disorders, including hyperactivity and irritability.

    Overdose:

    It is not recommended to administer the drug at doses exceeding those specified in the section "Method of administration and dose". It is important to regularly review the individual dosage regimen for the patient and reduce the dose to the lowest recommended dose, which provides effective control of the disease ("Mode of administration and dose").

    Symptoms. The expected symptoms and signs of an overdose of salmeterol 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 in doses above recommended for a long period time, a significant suppression of the function of the adrenal cortex is possible. 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 a rapid reduction in the dose of the active ingredient fluticasone propionate, which is part of the SROFLO drug.

    Treatment. 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.

    Interaction:

    Selective and nonselective beta-blockers should be avoided, except when they are extremely necessary for the patient due to the risk of developing bronchospasm.

    In normal situations, inhalations of fluticasone propionate are accompanied by low concentrations of it in the blood plasma due to intensive metabolism during "first passage" and high systemic clearance under the influence of isoenzyme CYP3A4 systems of cytochrome P450 in the intestine and liver. Due to this, clinically significant interactions involving fluticasone propionate are unlikely.

    The study of drug interactions showed that ritonavir (active isoenzyme inhibitor CYP3A4) can cause a sharp increase in the concentrations of fluticasone propionate in the blood plasma, resulting in a significant decrease in serum cortisol concentrations.

    There have been reports of clinically significant drug interactions in patients who simultaneously received fluticasone propionate and ritonavir. These interactions caused such side effects as Cushing's syndrome and suppression of adrenal function. Therefore, simultaneous use of fluticasone propionate and ritonavir should be avoided, unless the potential benefit to the patient outweighs the risk of systemic side effects of GCS.

    Other inhibitors of isoenzyme CYP3A4 (erythromycin, ketoconazole) can cause a slight increase in the level of fluticasone propionate in blood plasma, at which the concentrations of serum cortisol are practically not reduced. In spite of this, caution should be exercised while using fluticasone propionate and active inhibitors CYP3A4 (eg, ketoconazole), since in such cases the probability of increasing the concentration of fluticasone propionate in the blood plasma is not excluded.

    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 (an increase in CmOh in 1,4 times and AUC in 15 times). it can lead to lengthening of the interval QTc. Caution should be exercised when co-prescribing strong inhibitors of SURCA4 (eg, ketoconazole) and salmeterol.

    The derivatives of xanthine, GCS and diuretics increase the risk of hypokalemia (especially in patients with exacerbation of bronchial asthma, as well as hypoxia).

    MAO inhibitors and tricyclic antidepressants increase the risk of developing side effects from the cardiovascular system.

    Compatible with cromoglicic acid.

    Special instructions:

    Treatment of bronchial asthma is recommended to be carried out step by step, controlling the patient's clinical response to treatment and parameters of lung function. The patient needs to be taught how to use the inhaler correctly.

    The drug SEROFLO is not used for the treatment of asthmatic status or other acute attacks of bronchospasm, since in such cases, a rapid and short-acting inhaled bronchodilator should be used (for example, salbutamol). Patients should be informed that they always have on 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.

    More frequent use of short-acting bronchodilators for relief bronchospasm indicates a worsening of the course of the disease. In this case, the patient should consult a doctor.

    The sudden and increasing current of the bronchospasm syndrome poses a potential threat to life. Patients in this condition should be under the supervision of a physician.

    If the used dose of the drug SROROFLO does not provide adequate control of the disease, then the patient should also consult a doctor who may reconsider the treatment regimen.

    Because of the risk of developing an exacerbation of the disease, treatment with SROOFLO can not be abruptly stopped, the dose of the drug should be reduced gradually under the supervision of the doctor.

    In patients with COPD, the withdrawal of the drug may be accompanied by symptoms of decompensation and requires the supervision of a physician. Doctors should be aware of the possibility of developing pneumonia in patients with COPD receiving the drug, as the clinical picture of pneumonia and exacerbations of COPD are often similar.

    Any inhaled glucocorticosteroids can cause systemic effects, especially with prolonged use in high doses, however, the likelihood of such symptoms is much lower than when treated with oral GCS. 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.Given this, the dose of inhaled glucocorticosteroids should be reduced to the lowest dose, which can ensure the maintenance of effective treatment.

    It is recommended to regularly measure the growth of children who receive long-term inhaled glucocorticosteroids.

    In emergency situations that can cause stress, it is necessary to remember the possible suppression of adrenal function and the emergence of the need for systemic GCS.

    When carrying out resuscitation measures or surgical interventions in patients with bronchial asthma and severe COPD, it is necessary to monitor the indices of adrenal function.

    Due to the possibility of suppression of the function of the adrenal glands, patients transferred from the GCS for oral administration (systemic action) to inhalation therapy with fluticasone propionate (topical action) should be treated with extreme caution and regularly monitored 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 card containing an indication of the possible need for additional administration of SCS in stressful situations.

    When taking salmeterol, the risk of serious unwanted reactions in the treatment of bronchial asthma from the respiratory system or death in patients of African American origin is presumably higher than in other patients. The importance of pharmacogenetic factors or other causes is unknown. The effect of concomitant use of inhaled glucocorticosteroids on the risk of lethal outcomes in patients with bronchial asthma has not been studied.

    The drug SEROFLO, like other inhaled medications, can cause a paradoxical bronchospasm. In this case, a short-acting inhaled bronchodilator should be immediately applied, the preparation SEROFLO should be withdrawn and an alternative therapy should be started if there is evidence.

    There are reports of adverse events associated with the pharmacological action of beta2-agonists, such as tremor, subjective palpitation and headache. However, these phenomena are of a short-term nature, and their severity decreases with regular therapy.

    In patients with exacerbation of bronchial asthma, hypoxia, it is necessary to monitor the concentration of potassium in the blood plasma.

    There are very few reports of an increase in blood glucose, and this should be taken into account when appointing a combination of salmeterol and fluticasone propionate in patients with diabetes mellitus.

    To reduce the manifestations of such side effects of fluconazole propionate, like candidiasis of the oral and pharyngeal mucosa, hoarseness, it is necessary to rinse the mouth and throat with water after inhalation of the drug SEROFLO.

    Effect on the ability to drive transp. cf. and fur:

    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.

    Form release / dosage:

    Capsules with powder for inhalation 50 + 100 μg, 50 + 250 μg, 50 + 500 μg.

    Packaging:

    For 30 capsules in a bottle of HDPE white with a lid of LDPE with control of the first opening and engraving Cipla”.

    1 bottle together with instructions for medical use of the drug in a cardboard box.
    Storage conditions:

    Store at a temperature not exceeding 30 ° C.

    Keep out of the reach of children!

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-004244
    Date of registration:17.04.2017
    Expiration Date:17.04.2022
    The owner of the registration certificate:Cipla Ltd.Cipla Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspTeva Teva Israel
    Information update date: & nbsp12.05.2017
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