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Flovent Flixotide fluticasone 250mcg Susp 60D OnlyUSA&limit2

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Please consult your personal physician before taking any medication. INDICATIONS: Asthma: Flixotide ® has a pronounced anti-inflammatory effect in the lungs. It reduces symptoms and exacerbations of asthma in patients previously treated with bronchodilators alone or with other prophylactic therapy. Severe asthma requires regular medical assessment, it can cause death. Patients with severe asthma have constant symptoms and frequent exacerbations, with limited physical abilities and values ​​of peak expiratory flow (PEF) below 60% predicted with more than 30% variability, usually not returning entirely to normal after a bronchodilator. These patients require treatment with high-dose inhaled corticosteroids (see DOSAGE AND ADMINISTRATION) or oral. Sudden worsening of symptoms may require increased corticosteroid dosage which should be administered under medical supervision. Adults: Prophylactic treatment: - Mild asthma (PEF values ​​over 80% predicted less than 20% variability): Patients on more than one occasion requiring intermittent symptomatic medication, a bronchodilator to treat asthma. - Moderate asthma (PEF values ​​60-80% predicted with 20-30% variability): Patients requiring asthma medication regularly and patients with stable or progressive asthma under prophylactic treatment using currently available or only a bronchodilator. - Severe asthma (PEF values ​​less than 60% predicted with more than 30% variability): Patients with severe persistent asthma. By establishing inhaled fluticasone propionate, many patients who depend on systemic corticosteroids for adequate control of their symptoms, may significantly reduce or eliminate their requirement for oral corticosteroids. Child: Any child requiring preventive asthma medication, including patients not controlled on currently available prophylactic medication. Symptomatic treatment of chronic obstructive pulmonary disease (COPD): Clinical studies have shown that regular use of inhaled fluticasone propionate has favorable effects on lung function, reducing symptoms of COPD, the frequency and severity of exacerbations and the need for additional courses of oral corticosteroids. There is also a reduction in the rate of decline in health status. DRUG INTERACTIONS: Under normal circumstances, low concentrations of fluticasone propionate in plasma are reached after inhalation dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome P-450 3A4 in the gut and liver. It is therefore unlikely that in clinically significant drug interactions mediated by fluticasone propionate. A drug interaction study in healthy subjects demonstrated that ritonavir (an inhibitor of cytochrome P-450 highly potent 3A4) can significantly increase plasma concentrations of fluticasone propionate, resulting in markedly reduced serum cortisol concentrations. During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in characteristic side effects of systemic corticosteroids, including Cushing's syndrome and adrenal suppression. Therefore, concomitant use of fluticasone propionate and ritonavir should be avoided, unless the potential benefit to the patient outweighs the risk of the typical side effects of systemic corticosteroids. Studies have shown that other inhibitors of cytochrome P450 3A4 produce negligible (erythromycin) and slight increases (ketoconazole) in systemic exposure to fluticasone propionate, no apparent reductions in serum cortisol concentrations. However, caution is advised when administered concomitantly. LEGENDS OF PROTECTION Its sale requires a prescription. Exclusively for medical literature. Keep out of reach of children. DANGER-FLAMMABLE. Do not use near fire or flame. No smoke or flame switch where applicable. The package to the excessively hot sunlight or locations or puncture or incinerate Do not expose. Avoid contact with eyes. GLAXOSMITHKLINE MEXICO, SA de CV Reg No. 172M95, SSA IV PRECAUTIONS: The management of asthma should follow a stepwise program and patient response should be monitored clinically and by lung function tests. • The increased use of inhaled beta2-agonists, short-acting to control symptoms indicates deterioration of asthma control. Under these conditions, the patient's treatment plan should be reassessed. • Sudden and progressive deterioration in asthma control carries a potential risk to life, so it should be considered an increase in the dose of corticosteroid. In patients considered at risk, daily peak flow should be instituted. • Flixotide ® should not be used for the relief of acute asthma attacks, but for the long-term regular treatment. To relieve acute asthmatic symptoms, patients will require inhaled bronchodilator fast and short action. • Lack of response or acute exacerbations of asthma should be treated by increasing the dose of Flixotide ® and, if necessary, by administering a systemic steroid and / or antibiotic for infection. • There is an increased incidence of pneumonia reported in studies in patients with COPD receiving 500 mg Flixotide (see Adverse Reactions). Physicians should remain vigilant to the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap. • Systemic effects may occur with the use of inhaled corticosteroid, particularly at high doses prescribed for prolonged periods; the likelihood of these effects is much lower than with oral corticosteroids (see Manifestations and management of overdose or accidental ingestion). Possible effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. It is important that the dose of inhaled corticosteroid is scaled to the lowest effective dose to maintain control (see Adverse Reactions). • It is recommended to regularly monitor the height of children receiving prolonged treatment with inhaled corticosteroid. • Some individuals may exhibit increased susceptibility to the effects of inhaled corticosteroid that most of the patients. • The technique of inhaler use by patients should be verified to ensure that the actuation of the inhaler is synchronized with inspiration, ensuring the optimal delivery of the drug into the lungs. • The function and adrenal reserve usually remain within the normal range during treatment with the recommended doses of fluticasone propionate. The benefits of treatment with inhaled fluticasone propionate should minimize the need for oral steroids. However, for some time you can persist the possibility of adverse effects in patients with previous or intermittent administration of oral steroids. The extent of the adrenal impairment may require specialist advice before elective procedures. • Always keep in mind the possibility of impaired adrenal response in emergency and elective situations likely to produce stress, and should be considered appropriate treatment with corticosteroids (see Manifestations and management of overdose or accidental ingestion). • Due to the possibility of impaired adrenal response, patients are transferred to treatment with oral steroid treatment with inhaled fluticasone propionate should be treated with special care and adrenal function should be monitored regularly. • After the introduction of inhaled fluticasone propionate, systemic treatment discontinuation should be gradual and should advise patients to carry a steroid warning card indicating the possible need for additional treatment during periods of stress. • Similarly, replacement treatment with systemic steroids for inhalation therapy may unmask allergies such as rhinitis, eczema, previously controlled by the systemic drug. These entities should be treated symptomatically with antihistamines and / or topical preparations, including topical steroid. • Special care is needed in patients with active or quiescent pulmonary tuberculosis. • Treatment with fluticasone propionate should not be interrupted or discontinued abruptly. PRECAUTIONS IN RELATION TO EFFECTS Carcinogenesis, Mutagenesis, Impairment of Fertility: Toxicology has shown only those class effects, characteristic of potent corticosteroid, which only occur at doses well above those proposed for therapeutic use. So far carcinogenic, mutagenic, teratogenic, and any impairment of fertility are unknown.

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