- Flixotide 50 Inhaler, a pressurized container with a metering pump, which releases 50 μg fluticasone propionate each injection (dose). Each container contains 60 doses (sprays), 120 doses (sprays).
- Flixotide 250 Inhaler, a pressurized container with a metering pump, which released 250 μg fluticasone propionate each injection (dose). Each container contains 60 doses (sprays), 120 doses (sprays).
Flixotide 50 Inhaler
Adults - Control (therapeutic remission) at:
• Mild persistent form - patients need more frequent symptomatic bronchodilator therapy
• moderate form - patients who require regular anti-inflammatory treatment of bronchial asthma or in patients with unstable or progressive disease
• Severe - patients with severe chronic bronchial asthma. In many patients requiring treatment with systemic corticosteroids to control symptoms and reduce the dose or eliminate the need for oral corticosteroids.
Children - in need of anti-inflammatory treatment, including patients not controlled by the state of other products used for prevention.
Flixotide 250 Inhaler
Bronchial asthma - to achieve control (remission treatment) in adults with:
- Mild persistent form - patients need more frequent symptomatic bronchodilator therapy.
- Moderate form - patients who require regular anti-inflammatory treatment of bronchial asthma or in patients with unstable or progressive disease.
- Severe - patients with severe chronic bronchial asthma. In many patients requiring treatment with systemic corticosteroids to control symptoms and reduce the dose or eliminate the need for oral corticosteroids.
Chronic obstructive pulmonary disease (COPD)
Symptomatic treatment of COPD - its regular use leads to improvement of respiratory function, reduce the symptoms of COPD, reducing the frequency and severity of exacerbations and the need for additional oral corticosteroid.
Flixotide 50 Inhaler
Inhaled through the mouth. Important - used to control the disease and regardless of the presence or absence of symptoms, the drug must be taken regularly. The daily dose can be taken in two doses. Difficulties in coordination, can be administered using a volumetric chamber for inhalation.
Special patient groups
It is not necessary to change the dose in the elderly or in renal or hepatic impairment. Dosage in bronchial asthma - the effect is manifested 4 -7 days after beginning treatment. If no inhaled corticosteroids were administered before - a change in status after the first 24 hours. Caution in patients reporting to reduce the effect of bronchodilator fast or need a reception to honor prescriptions.
Dosage in adults and children over 16 years - 100 to 1000 mg twice daily.
The initial dose should be determined depending on the seriousness of the situation:
- A mild form of bronchial asthma: 100 to 250 mg twice daily.
- Moderate form of bronchial asthma: 250 to 500 mg twice daily.
- Severe bronchial asthma: 500 to 1000 mg twice daily.
The dose may be altered to control the situation or, depending on response and can be reduced to the minimum effective dose. Severe form of bronchial asthma - systematic assessment of the situation because of the risk of death. Необходим е прием на високи дози инхалаторен или перорален кортикостероид. A sudden deterioration may be necessary to increase the dose of corticosteroids. Described increasing the dose must be prescribed by a doctor.
Children over 4 years - 50 to 200 mg twice daily. In many cases - only 50 to 100 mg twice daily. Which do not adequately control - up to 200 mg twice daily. The starting dose for children is determined by the severity of disease. The dose may be adjusted to achieve adequate control or reduce to the minimum effective dose depending on response to therapy.
Children aged 1 to 4 years - 100 mg twice daily, administered through the use of child displacement chamber with facial mask. When young children have success in the therapy management of common manifestations or persistent symptoms of the disease. In young children the necessary doses are higher than those for older children. This is explained by a difficult penetration of the product in the airways due to the smaller diameter, more frequent use of the volumetric chamber for inhalation and mostly bow breathing in these patients.
Flixotide 250 Inhaler
Inhaled through the mouth only. Used to control the disease and regardless of the presence or absence of symptoms, the drug must be taken regularly. The effect of treatment occurs 4-7 day. If you have not received inhaled corticosteroids may occur a change in status after the first 24 hours. Dosage should be determined according to individual response. Account for failing bronchodilator effect of fast or need a reception to honor prescriptions.
Be taken in two doses. In patients with problems in coordination - can be applied using a volumetric chamber for inhalation.
Dosage in bronchial asthma
Dosage in adults and children over 16 years - 250 to 1000 mg twice daily.
The starting dose is determined by the gravity of the situation:
- A mild form of bronchial asthma - up to 250 mg twice daily.
- Moderate form of bronchial asthma - from 250 to 500 mg twice daily.
- Severe bronchial asthma - from 500 to 1000 mg twice daily.
The dose is changed to achieve control of the state or the individual response to therapy can be reduced to the minimum effective dose. For the approximate determination of the initial dose of Flixotide can serve half the daily dose of inhaled beclomethasone dipropionate or equivalent. Severe form - regular assessment of the situation because of the risk of death. If necessary - high doses of inhaled or oral corticosteroids. A sudden deterioration in the situation - with increasing dose.
Special populations - No change is needed in dosage in elderly patients or those with renal or hepatic impairment.
Dosage in COPD
Dosage in adults - 500 mg twice daily, regularly. Change in the state is established after 3 to 6 months. If not - clinical evaluation of the condition.
Hypersensitivity to any component of the product.
Treatment to follow a cascade program. Response can be controlled by clinical and functional respiratory tests. Increased use of inhaled fast? 2 agonists showed a worsening of bronchial asthma - changes to the plan of treatment. Sudden and progressive worsening of disease control may lead to death - to increase the dose of corticosteroids. At increased risk - daily monitoring of VED. Not used in controlling seizures. It is indicated for prolonged treatment. To curb the attacks - fast inhaled bronchodilators. In the absence of response to therapy or exacerbations of bronchial asthma - raising dosage and administration of systemic treatment with corticosteroids and / or antibiotics for an infection. You should check inhalation technique - a necessary synergy between inhalation and inhalation. This is of great importance for the proper distribution of drug in the lung. May develop side effects throughout the body, especially when taking high doses for long periods of time. Possible systemic effects include Cushing syndrome, symptoms similar to those seen in Cushing syndrome, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. It is important to accept the lowest therapeutic dose. Regular monitoring changes in growth in children receiving prolonged treatment. In most cases, adrenal function and reserve is maintained in reference limits. The change in status could lead to reducing the demand for oral corticosteroids. It is possible that the development of adverse reactions for some time as a result of intermitirashta oral corticosteroid therapy - clinical evaluation of impaired adrenal function. Urgent or elective surgery and treatments - the possibility of poor response from the Adrenal. When switching from oral to inhaled corticosteroid therapy - attention and regular monitoring of renal function. There is a potential for side effects of Adrenal response to therapy. It is recommended to gradually reduce the dose of oral corticosteroids. Patients carry a warning card for an additional dose of corticosteroid stress. This may lead to manifestation of allergic conditions masked as allergic rhinitis or eczema. The administration of systemic corticosteroids resulted in inhibition of their expression. It is recommended that symptomatic treatment with antihistamines and / or topical products, including topical corticosteroids. Treatment with fluticasone propionate be stopped gradually. Caution in active or latent pulmonary tuberculosis.
Clinically significant drug interactions are unlikely.
Ritonavir may increase the plasma concentrations of fluticasone propionate - a decrease of serum cortisol levels, resulting in systemic corticosteroid effects including Cushing syndrome and adrenal suppression function - concomitant use of fluticasone propionate and ritonavir should be avoided unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects.
Caution with concomitant use of fluticasone propionate with potent cytochrome P450 3A4 inhibitors (eg Erythromycin and Ketoconazole) - possible increase in systemic exposure to fluticasone.
Pregnancy and lactation
Pregnancy - apply only if the expected benefit of treatment of the mother is greater than the potential risk to the fetus.
Lactation - No studies have been conducted. After inhalation of fluticasone propionate at therapeutic doses are expected lower plasma concentrations.
Adverse drug reactions
Infections and infestations - Candidiasis of the mouth and throat. Rinsing the mouth with water after inhalation may reduce these events. It is treated with topical antifungal products.
Immune system disorders - hypersensitivity reactions: from the skin, angioedema (mainly of the person or oropharyngeal edema), respiratory symptoms (dyspnoea and / or bronchospasm) and anaphylactoid reactions.
Endocrine Disorders - Possible systemic effects: Cushing syndrome, symptoms similar to those seen in Cushing syndrome, suppression of adrenal function, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma.
Metabolism and Nutrition - Hyperglycaemia.
Psychiatric disorders - anxiety, sleep disturbances and behavioral changes, including hyperactivity and irritability (predominantly in children).
Abnormalities in the respiratory system, thorax and mediastinum - hoarseness of voice.
Rinsing the mouth with water after inhalation may reduce these events. Paradoxical bronchospasm with an increase in wheezing immediately after administration of dose - treat immediately with application of fast-acting inhaled bronchodilator. Taking fluticasone propionate inhaler should be discontinued. It is necessary to assess the patient's condition and need to consider alternative therapy.
Formulation and packaging
Contains a suspension of fluticasone propionate in an aluminum container, sealed with a metering pump - valve. Container is placed in a plastic device with spray nozzle, and handpiece protective cap. Pack sizes - 60 or 120 doses of inhaled.
Recommendations for use:
Checking inhalera - Before using metered dose inhaler for the first time or if your inhaler has not been used for one week, remove the cap of the flapper, which is placed in the mouth by gently grasp of both sides, shake and spray inhalera once in the air to make sure it works.
Using inhalera - Remove the cap of the flapper by carefully squeezing both sides and check the inside and outside if the flapper is clean.
- Shake inhalera
- Keep inhalera between the fingers and thumb, and place the thumb as a flapper.
- Exhale and then insert the flapper in your mouth between your teeth and close lips around it without biting him.
- As soon as you start breathing through your mouth, press the tip of inhalera to spray fluticasone propionate, as long and inhale deeply.
- While holding your breath, remove inhalera of mouth and remove your finger from the tip of inhalera. Hold your breath as you possible.
- If you need to take a greater number of doses inhalera hold up and wait half a minute, then repeat the action item 2 to item 6.
Flapper closes by strongly squeezing the cap. Perform as a slow action point 4, 5 and 6. It is important to begin to breathe as slowly as possible just before the enactment of inhalera. Practice in front of the mirror the first few times. If you see after inhalation of droplets or remove your inhaler on his lips should be adopted by the repeat item 2. If your doctor has given any instructions for use of inhalera, please observe them carefully. If something bothers you, do not interfere with or understand, ask your doctor.
Cleaning - Your inhaler should be cleaned at least once a week::
- Remove the metal from the plastic bottle of inhalera cap and remove the flapper, which is placed in the mouth.
- Rinse the plastic part with a flapper in hot water.
- Allow them to dry in a dry and warm place. Do not heat.
- Again positioned bottle and cap.
Water may appear weak or detergent solution such as those for washing bottles for feeding babies (ask your pharmacist for advice). Then it is recommended to rinse thoroughly with clean water before drying. Do not put metal in water bottle.
Especially for Flixotide 50 Inhaler - For children may need help in using inhalera. It is recommended that using an adult. Child should exhale as inhalerat used for inhalation. Make several attempts together. In older children and in patients with poor muscle strength of hands is recommended inhalerat be held with both hands. Both pointer should be placed on top of inhalera, while the two thumb are based on a flapper.
Method of allocation