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brand flovent hfa 220 mcg inhaler

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Uses

Bronchospasm

Asthma

Fluticasone propionate is used for the long-term prevention of bronchospasm in patients with asthma. The fixed combination of fluticasone propionate and salmeterol xinafoate is used only in patients with asthma who have not responded adequately to long-term asthma controller therapy, such as inhaled corticosteroids, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a long-acting β2-adrenergic agonist. Once asthma control is achieved and maintained, the patient should be assessed at regular intervals and therapy should be stepped down (e.g., discontinuance of fluticasone propionate in fixed combination with salmeterol xinafoate), if possible without loss of asthma control, and the patient should be maintained on long-term asthma controller therapy, such as inhaled corticosteroids. Fluticasone propionate in fixed combination with salmeterol xinafoate should not be used in patients whose asthma is adequately controlled on low or medium dosage of inhaled corticosteroids.(See Asthma-related Death under Warnings/Precautions: Warnings, in Cautions.)

Orally inhaled fluticasone propionate alone or combined with salmeterol xinafoate should not be used for the primary treatment of severe acute asthmatic attacks or status asthmaticus when intensive measures (e.g., oxygen, parenteral bronchodilators, IV corticosteroids) are required. Fluticasone propionate oral inhalation is not a bronchodilator, and patients should be warned that the drug alone or in fixed combination with salmeterol xinafoate should not be used for rapid relief of bronchospasm.

Mild Persistent Asthma

Drugs for asthma may be categorized as relievers (e.g., bronchodilators taken as needed for acute symptoms) or controllers (principally inhaled corticosteroids or other anti-inflammatory agents taken regularly to achieve long-term control of asthma). In the stepped-care approach to antiasthmatic drug therapy, current asthma management guidelines and most clinicians recommend initiation of a controller drug such as an anti-inflammatory agent, preferably a low-dose orally inhaled corticosteroid (e.g., 88-264, 88-176, or 176 mcg of fluticasone propionate [or its equivalent] daily via a metered-dose inhaler in adolescents and adults, children 5-11 years of age, or children 4 years of age or younger, respectively) as first-line therapy for persistent asthma (e.g., patients with daytime symptoms of asthma more than twice per week, but less than once daily, and nocturnal symptoms of asthma 3-4 times per month), supplemented by as-needed use of a short-acting, inhaled β2-agonist.

Moderate Persistent Asthma

According to current asthma management guidelines, therapy with a long-acting β2-agonist such as salmeterol or formoterol generally is recommended in adults and adolescents who have moderate persistent asthma and daily asthma symptoms that are inadequately controlled following addition of low-dose inhaled corticosteroids to as-needed inhaled β2-agonist treatment. However, the National Asthma Education and Prevention Program (NAEPP) recommends that the beneficial effects of long-acting inhaled β2-agonists should be weighed carefully against the increased risk (although uncommon) of severe asthma exacerbations and asthma-related deaths associated with daily use of such agents. Current asthma management guidelines also state that an alternative, but equally preferred option for management of moderate persistent asthma that is not adequately controlled with a low dosage of inhaled corticosteroid is to increase the maintenance dosage to a medium dosage (e.g., exceeding 264 but not more than 440 mcg of fluticasone propionate [or its equivalent] daily via a metered-dose inhaler in adults and adolescents).

In children 5-11 years of age with moderate persistent asthma that is not controlled with a low dosage of an inhaled corticosteroid, a long-acting inhaled β2-agonist (i.e., salmeterol, formoterol), a leukotriene modifier (i.e., montelukast, zafirlukast), or extended-release theophylline (with appropriate monitoring) may be added to low-dose inhaled corticosteroid therapy; another preferred option according to current asthma management guidelines is to increase the maintenance dosage of the inhaled corticosteroid to a medium dosage (e.g., exceeding 176 but not more than 352 mcg of fluticasone propionate [or its equivalent] daily via a metered-dose inhaler). In infants and children 4 years of age or younger with moderate persistent asthma that is not controlled by a low dosage of an inhaled corticosteroid, the only preferred option is to increase the maintenance dosage of the inhaled corticosteroid to a medium dosage (e.g., exceeding 176 but not more than 352 mcg of fluticasone propionate [or its equivalent] daily via a metered-dose inhaler).

Severe Persistent Asthma

Maintenance therapy with an inhaled corticosteroid at medium or high dosages (e.g., exceeding 440 mcg of fluticasone propionate [or its equivalent] daily in adults and adolescents or 352 mcg of the drug daily in children 5-11 years of age via a metered-dose inhaler) and adjunctive therapy with a long-acting inhaled β2-agonist is the preferred treatment according to current asthma management guidelines for adults and children 5 years of age or older with severe persistent asthma (i.e., continuous daytime asthma symptoms, nighttime symptoms 7 times per week). In infants and children 4 years of age or younger with severe asthma, maintenance therapy with an inhaled corticosteroid at medium or high dosages (e.g., exceeding 352 mcg of fluticasone propionate or its equivalent daily via a metered-dose inhaler) and adjunctive therapy with either a long-acting inhaled β2-agonist or montelukast is the only preferred treatment according to current asthma management guidelines.

Poorly Controlled Asthma

If asthma symptoms in patients with moderate to severe asthma are very poorly controlled (i.e., at least 2-3 exacerbations per year requiring oral corticosteroids), a short course of an oral corticosteroid (3-10 days) may be added to gain prompt control of asthma. Regular use of oral corticosteroids as add-on therapy in adults and children 5 years of age or older with severe asthma who are inadequately controlled with high-dose inhaled corticosteroid, intermittent oral corticosteroid therapy, and a long-acting inhaled β2-agonist bronchodilator is suggested, based on consensus and clinical experience. A short (2-week) course of oral corticosteroids may be considered to confirm clinical response prior to implementing long-term therapy with these agents. Once long-term oral corticosteroid therapy is initiated, the lowest possible effective dosage (i.e., alternate-day or once-daily administration) should be used, and the patient should be monitored carefully for adverse effects. Once asthma is well-controlled, repeated attempts should be made to reduce the oral corticosteroid dosage. Use of orally inhaled fluticasone propionate as adjunctive therapy in patients who require chronic administration of systemic corticosteroids to control asthma symptoms may permit a reduction in dosage or discontinuance of systemic corticosteroids. When used in recommended dosages in responsive patients, fluticasone propionate oral inhalation may permit control of asthmatic symptoms with less suppression of hypothalamic-pituitary-adrenal (HPA) function than therapeutically equivalent oral dosages of prednisone. For additional details on the stepped-care approach to drug therapy in asthma, and see .

Clinical Experience with Fluticasone Propionate

Well-controlled clinical studies have shown that oral inhalation of fluticasone propionate relieves symptoms of bronchial asthma (cough, dyspnea, wheezing) and improves pulmonary function. Although substantial improvement may occur within the first day of therapy, optimum symptomatic relief may require at least 1-2 weeks of continuous fluticasone propionate oral inhalation therapy. In corticosteroid-dependent patients, use of fluticasone propionate oral inhalation therapy may permit a substantial reduction in the daily maintenance dosage of the systemic corticosteroid and gradual discontinuance of corticosteroid maintenance dosages.

In several randomized, double-blind, placebo-controlled clinical trials in adults or children with mild to severe persistent asthma, fluticasone propionate (50, 100, 250, 500, or 1000 mcg twice daily) powder for oral inhalation produced greater improvement in pulmonary function (e.g., mean percent change from baseline in forced expiratory volume in 1 second [FEV1] or morning or evening peak expiratory flow [PEF]) than placebo. Data from an open-label extension study in pediatric patients (4-11 years of age) with mild to moderate persistent asthma indicate that fluticasone propionate (100 mcg twice daily or 200 mcg once daily) maintained improvement in lung function for up to 1 year.

In several randomized, double-blind, placebo-controlled clinical trials in patients with mild to severe asthma, fluticasone propionate (100, 250, or 500 mcg) in fixed combination with salmeterol xinafoate (50 mcg as salmeterol) for oral inhalation produced greater improvement in most indices of pulmonary function (e.g., mean percent change from baseline in FEV1, morning FEV1, or PEF) than either drug alone and similar efficacy as concurrent therapy with both agents given separately. Additional randomized, double-blind, comparative trials in patients with mild to moderate persistent asthma who were not optimally controlled with their current antiasthma therapy, the fixed combination of fluticasone propionate 90, 230, or 460 mcg twice daily and salmeterol (42 mcg twice daily) with a hydrofluoroalkane propellant (HFA) for oral inhalation via a metered-dose inhaler (Advair HFA) produced greater improvement in indices of pulmonary function (e.g., mean percent change from baseline in FEV1 or morning and evening PEF) than either drug alone.

Chronic Obstructive Pulmonary Disease

Fluticasone propionate in fixed combination with salmeterol xinafoate as the inhalation powder (Advair Diskus) is used for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Fluticasone propionate in fixed combination with salmeterol xinafoate as the inhalation powder (Advair Diskus) also is used to reduce exacerbations of COPD in patients with a history of such exacerbations. Fluticasone propionate in fixed combination with salmeterol xinafoate is not indicated for the relief of acute bronchospasm.

In several randomized, double-blind, placebo-controlled studies of 6 or 12 months' duration in patients with COPD, orally inhaled fluticasone propionate (250 or 500 mcg twice daily) in fixed combination with salmeterol (50 mcg twice daily) as the inhalation powder produced greater improvement in lung function (defined as predose and postdose FEV1) than either drug alone or placebo. The improvement in lung function with fluticasone propionate 500 mcg and salmeterol 50 mcg in fixed combination was similar to that observed with fluticasone propionate 250 mcg and salmeterol 50 mcg in fixed combination. In two randomized, double-blind studies of 12 months' duration in patients with COPD, orally inhaled fluticasone propionate (250 mcg twice daily) in fixed combination with salmeterol (50 mcg twice daily) as the inhalation powder produced a greater reduction in the annual incidence of moderate/severe COPD exacerbations and exacerbations requiring treatment with oral corticosteroids compared with salmeterol alone. No studies have been conducted to directly compare the efficacy of fluticasone propionate 250 mcg and salmeterol 50 mcg in fixed combination with fluticasone propionate 500 mcg and salmeterol 50 mcg in fixed combination in reducing exacerbations; however, in clinical studies, the reduction in exacerbations observed with fluticasone propionate 500 mcg and salmeterol 50 mcg in fixed combination was not greater than the reduction in exacerbations observed with fluticasone propionate 250 mcg and salmeterol 50 mcg in fixed combination. In a double-blind, placebo-controlled study of 3 years' duration in patients with COPD, orally inhaled fluticasone propionate (500 mcg) in fixed combination with salmeterol (50 mcg) as the inhalation powder did not improve all-cause mortality compared with either drug alone or placebo. Fluticasone propionate 250 mcg and salmeterol 50 mcg in fixed combination twice daily is the only recommended dosage for the treatment of COPD; an efficacy advantage of the higher dosage of the fixed combination (500 mcg of fluticasone propionate and 50 mcg of salmeterol) over the lower dosage (250 mcg of fluticasone propionate and 50 mcg of salmeterol) has not been established.

Other Uses

Fluticasone also has been administered as oral tablets (formulation currently not commercially available in the US) in the management of ulcerative colitis, Crohn's disease, and celiac sprue.

Dosage and Administration

General

Dosage of fluticasone propionate alone or in fixed combination with salmeterol xinafoate should be adjusted carefully according to individual requirements and response. The recommended initial and maximum dosages of fluticasone propionate for oral inhalation are based on previous asthma therapy. The recommended initial dosage of the inhalation powder preparation containing fluticasone propionate in fixed combination with salmeterol (Advair Diskus) is based on the patient's asthma severity, and the recommended initial dosage of the inhalation aerosol containing fluticasone propionate in fixed combination with salmeterol (Advair HFA) is based on the patient's current asthma therapy. The lowest effective dosage of fluticasone should be achieved, particularly in children, since inhaled corticosteroids have the potential to affect growth.

Administration

Fluticasone propionate alone and in fixed combination with salmeterol is administered as a microcrystalline suspension by oral inhalation using an oral aerosol inhaler with hydrofluoroalkane (HFA; non-chlorofluorocarbon) propellant or as the inhalation powder using the Diskus device that delivers the drug from foil-wrapped blisters. Fluticasone propionate in fixed combination with salmeterol xinafoate is also administered as an inhalation powder using the Diskus device that delivers the drugs from foil-wrapped blisters.

Oral Inhalation via Aerosol Inhaler

The fluticasone propionate HFA inhalation aerosol canister should be shaken well for 5 seconds immediately prior to use. The fluticasone propionate HFA aerosol canister should be used only with the supplied actuator (inhaler). The aerosol inhaler should be actuated 4 times prior to the initial use of fluticasone propionate. In addition, the inhaler should be shaken well for 5 seconds and actuated once prior to use if it has not been used for longer than 1 week or if the inhaler has been dropped. Patients should exhale slowly and completely and place the mouthpiece of the inhaler well into the mouth with lips closed around it. Patients should inhale slowly and deeply through the mouth while actuating the inhaler. Patients should hold their breath for up to 10 seconds, withdraw the mouthpiece from the mouth, and then exhale slowly. Subsequent actuations of the aerosol inhaler should be performed 30 seconds after the previous inhalation. Following each treatment, the patient should rinse the mouth thoroughly. The inhaler should be cleaned at least once a week after the evening dose by removing the mouthpiece cap from the inhaler and washing the mouthpiece with moistened cotton; the actuator should be allowed to air-dry overnight. When the dose counter on the inhaler reads ''020'', the patient should contact the pharmacy for a refill or consult their clinician to determine whether a refill is needed. The inhaler should be discarded when the dose counter reads ''000''. The canister should never be immersed in water to determine the amount of drug remaining in the canister (''float test'').

Fluticasone propionate/salmeterol inhalation aerosol (Advair HFA) should only be used with the actuator provided with the product. Before each inhalation, the inhaler must be shaken well for 5 seconds. The aerosol inhaler should be test sprayed 4 times into the air (away from the face) before initial use, and shaken well for 5 seconds before each spray. If the inhaler has not been used for more than 4 weeks or if the inhaler was dropped, the inhaler should be test sprayed twice into the air (away from the face) and shaken well for 5 seconds before each spray.

The cap covering the mouthpiece should be removed; the strap on the cap will stay attached to the actuator. The patient should look for foreign objects inside the inhaler prior to use and verify that the canister is fully inserted into the actuator. After exhaling as completely as possible, the patient should place the mouthpiece of the inhaler well into the mouth and close the lips firmly around it. Then the patient should inhale slowly and deeply through the mouth while actuating the inhaler. The patient should remove the mouthpiece from the mouth and hold the breath for as long as possible, up to 10 seconds, and then exhale normally. It is recommended that 30 seconds should elapse between inhalations. Rinsing the mouth thoroughly after inhalation of fluticasone propionate/salmeterol inhalation aerosol and spitting out the water are advised. The opening for the spray of the metal canister should be wiped dry with a dry cotton swab and the mouthpiece should be wiped clean with a dampened tissue at least once a week after the evening dose. The actuator should be allowed to air-dry overnight. When the dose counter on the inhaler reads ''020,'' the patient should contact the pharmacy for a refill or consult their clinician to determine whether a refill is needed. The inhaler should be discarded when the dose counter reads ''000.'' The counter should never be altered or removed from the canister.

Oral Inhalation via Dry Powder Inhaler

The oral inhalation powder of fluticasone propionate alone or in fixed combination with salmeterol xinafoate is administered using a special preloaded oral inhaler (Diskus). To obtain optimal benefit, the patient should be given a copy of the patient instructions or medication guide provided by the manufacturer with Flovent Diskus or Advair Diskus, respectively. Children should use Flovent Diskus or Advair Diskus under adult supervision as instructed by a clinician. The patient should hold the Diskus device in one hand, put the thumb of the other hand on the thumbgrip, and push the thumbgrip until the mouthpiece appears and snaps into position. The lever on the Diskus should then be depressed in a direction away from the patient while the inhaler is held in a level, horizontal position until a click is heard; the lever pierces the foil blister and releases the powdered drug into an exit port. To avoid releasing and wasting additional doses of the drug, the patient should not tilt or close the Diskus device, play with the lever, or advance the lever more than once at this point. A dose counter will advance each time the lever is depressed.

Before inhaling the dose, the patient should exhale as completely as possible; the patient should not exhale into the Diskus device because pressure from the exhalation will interfere with proper inhaler operation. The patient should then place the mouthpiece of the inhaler between the lips and inhale deeply and quickly through the inhaler with a steady, even breath; pressure from the inhalation will disperse drug from the exit port into the air stream created by the patient's inhalation. The patient should remove the inhaler from the mouth, hold his or her breath for a few seconds (i.e., 10 seconds), and then exhale slowly. While patients may or may not taste or feel a dose of drug delivered from the Diskus device, they should be instructed not to use an extra dose even if they do not perceive that the dose has been delivered. Rinsing the mouth after inhalation of fluticasone propionate alone or in fixed combination with salmeterol is advised. The Diskus device may be closed and reset for the next dose by sliding the thumbgrip towards the patient as far as it will go. The inhaler should not be washed but should be stored in a dry place away from direct heat or sunlight. The Flovent Diskus inhaler should be discarded when every blister has been used (when the dose indicator reads ''0'') or 6 weeks after removal from its foil overwrap pouch. The Advair Diskus inhaler should be discarded when every blister has been used or 1 month after removal from its foil overwrap pouch, whichever comes first. The inhaler should not be taken apart.

Dosage

Unless otherwise stated, the dose of fluticasone propionate administered as an aerosol via metered-dose inhaler with a hydrofluoroalkane (HFA) propellant is expressed as the amount of drug delivered from the actuator of the inhaler per metered spray; the dose of fluticasone propionate (and of salmeterol in the combination preparation Advair) administered as an oral inhalation powder is expressed as the nominal (labeled) dose contained in each foil-wrapped blister. The manufacturer states that spacer devices should not be used with Advair or Flovent Diskus.

Each actuation of the commercially available fluticasone propionate HFA oral inhalation aerosol labeled as containing 44, 110, or 220 mcg of fluticasone propionate per metered spray delivers 50, 125, or 250 mcg from the valve, respectively, and 44, 110, or 220 mcg from the actuator, respectively. The 10.6-g (labeled as containing 44 mcg of fluticasone propionate) or 12-g canister (labeled as containing 110 or 220 mcg of fluticasone propionate) delivers 120 metered sprays of fluticasone propionate.

Each actuation of the oral aerosol inhaler containing the fixed combination of fluticasone propionate and salmeterol xinafoate delivers 50, 125, or 250 mcg of fluticasone propionate and 25 mcg of salmeterol from the valve. Dosages of fluticasone propionate and salmeterol in the fixed-combination inhalation aerosol are expressed in terms of drug delivered from the mouthpiece; each actuation of the inhaler delivers 45, 115, or 230 mcg of fluticasone propionate and 21 mcg of salmeterol from the mouthpiece. The commercially available inhalation aerosol of fluticasone propionate in fixed combination with salmeterol delivers 60 or 120 metered sprays per 8- or 12-g canister, respectively.

With commercially available fluticasone propionate inhalation powder (Flovent Diskus, Advair Diskus) delivered via the Diskus device, the amount of drug delivered to the lungs depends on factors such as the patient's inspiratory flow. Using standardized in vitro testing at a flow rate of 60 L per minute for 2 seconds, the Flovent Diskus labeled as containing 50, 100, or 250 mcg of fluticasone propionate delivers 46, 94, or 235 mcg of fluticasone propionate, respectively. In adults with obstructive lung disease and severely compromised lung function (FEV1 20-30% of predicted), mean peak inspiratory flow through the Diskus device was 82.4 L/minute. In children 4 and 8 years of age with asthma, mean peak inspiratory flow through the Diskus device was 70 and 104 L/minute, respectively. Using standardized in vitro testing at a flow rate of 60 L per minute for 2 seconds, the Advair Diskus device delivered 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol per activation from a Diskus labeled as containing 100, 250, or 500 mcg of fluticasone propionate and 50 mcg of salmeterol, respectively. In adults with obstructive lung disease and severely compromised lung function (FEV1 20-30% of predicted), mean peak inspiratory flow through the Diskus device was 82.4 L/minute for Advair. In adults and adolescents with asthma, mean peak inspiratory flow through the Diskus device was 122.2 L/minute. In a group of children 4 years of age, mean peak inspiratory flow through the Advair Diskus device averaged 75.5 L/minute; in children 8 years of age, mean peak inspiratory flow averaged 107.3 L/minute.

Asthma

Fluticasone Propionate

Safety and efficacy of fluticasone propionate dosages exceeding those recommended by the manufacturer have not been established.

When the fluticasone propionate HFA oral inhalation aerosol is used, the initial, maintenance, and maximum dosage in children 4-11 years of age is 88 mcg twice daily. The recommended initial dosage of fluticasone propionate for adults and adolescents 12 years of age or older who previously were receiving bronchodilators alone is 88 mcg twice daily; the maximum recommended dosage is 440 mcg twice daily. In adults and adolescents 12 years of age or older who previously were receiving inhaled corticosteroids, the recommended initial dosages of fluticasone propionate, using the HFA oral inhalation aerosol, are 88-220 mcg twice daily; the maximum recommended dosage is 440 mcg twice daily. Initial dosages exceeding 88 mcg twice daily should be considered in patients with poorer asthma control or in those who were receiving inhaled corticosteroids at the higher end of the dosing range. In adults and adolescents 12 years of age or older who previously were receiving oral corticosteroids, the recommended initial and maximum dosage of fluticasone propionate, using the HFA oral inhalation aerosol, is 440 and 880 mcg twice daily, respectively. If control of asthma is inadequate after 2 weeks of therapy at the initial dosage, replacing the current strength with a higher strength may provide additional asthma control.

When fluticasone propionate inhalation powder is administered via the Diskus device, the recommended initial dosage of fluticasone propionate in adults and adolescents 12 years of age or older who previously were receiving bronchodilators alone is 100 mcg twice daily; the maximum recommended dosage is 500 mcg twice daily. In adults and adolescents 12 years of age or older who previously were receiving inhaled corticosteroids, the recommended initial dosage of fluticasone propionate using the inhalation powder (administered via a Diskus) is 100-250 mcg twice daily; the maximum recommended dosage is 500 mcg twice daily. Initial dosages exceeding 100 mcg twice daily should be considered in patients with poorer asthma control or in those who were receiving inhaled corticosteroids at the higher end of the dosing range. In adults and adolescents 12 years of age or older who previously were receiving oral corticosteroids, the recommended initial dosage of fluticasone propionate using the powdered drug is 500-1000 mcg twice daily (administered via the Diskus device); the maximum recommended dosage for the Diskus device is 1000 mcg twice daily.

When the fluticasone propionate inhalation powder is administered via the Diskus device in children 4 to younger than 12 years of age who previously were receiving bronchodilators alone or with inhaled corticosteroids, the recommended initial dosage of fluticasone propionate is 50 mcg twice daily; the recommended maximum dosage is 100 mcg twice daily. Initial dosages exceeding 50 mcg twice daily should be considered in children with poorer asthma control or in those who were receiving inhaled corticosteroids at the higher end of the dosing range. Because patient responses may vary, pediatric patients previously maintained on fluticasone propionate inhalation powder administered via the Diskhaler (50 or 100 mcg twice daily) may require dosage adjustments upon transfer to the drug administered via the Diskus device.

Conversion to Orally Inhaled Therapy in Patients Receiving Systemic Corticosteroids

When orally inhaled corticosteroids are administered to patients receiving systemic corticosteroids, the patient's asthma should be reasonably stable before treatment with the oral inhalation begins. Initially, fluticasone propionate inhalation powder is given concurrently with the maintenance dosage of the systemic corticosteroid. The manufacturer suggests that in patients who were receiving prior oral corticosteroid therapy, reduction of oral corticosteroid dosage should be initiated at least 1 week after starting fluticasone propionate oral inhalation and decrements usually should not exceed 2.5-5 mg of prednisone (or its equivalent) each week. Once oral corticosteroids are discontinued and symptoms of asthma have been controlled, the dosage of fluticasone propionate should be titrated to the lowest effective level. The inability to decrease the dosage of oral corticosteroids during systemic corticosteroid withdrawal may indicate the need to increase the dosage of fluticasone propionate up to a maximum of 1000 mcg twice daily. The manufacturer of the oral inhalation powder containing fluticasone propionate in fixed combination with salmeterol (Advair Diskus) states that patients requiring oral corticosteroids should be withdrawn slowly from systemic corticosteroid use after transferring to fluticasone propionate in fixed combination with salmeterol inhalation powder. The manufacturer also states that prednisone dosage reduction may be accomplished by reducing the daily dosage of prednisone by 2.5 mg on a weekly basis during therapy with the oral inhalation powder containing fluticasone propionate in fixed combination with salmeterol. The oral inhalation aerosol containing fluticasone propionate in fixed combination with salmeterol (Advair HFA) should not be used to transfer patients from systemic corticosteroid therapy.Particular care is needed in gradually withdrawing systemic corticosteroids following long-term therapy, since death has occurred in some individuals in whom systemic corticosteroids were withdrawn too rapidly.(See Withdrawal of Systemic Corticosteroid Therapy under Warnings/Precautions: Warnings, in Cautions.)

Fluticasone Propionate/Salmeterol Fixed-combination Therapy

In asthmatic patients 4-11 years of age who are inadequately controlled on an inhaled corticosteroid, the recommended dosage of the commercially available inhalation powder preparation containing fluticasone propionate in fixed combination with salmeterol (Advair Diskus) is 100 mcg of fluticasone propionate and 50 mcg of salmeterol (1 inhalation) twice daily, given approximately 12 hours apart (morning and evening).

In asthmatic patients 12 years of age or older, the recommended initial dosage of the commercially available inhalation powder preparation containing fluticasone propionate in fixed combination with salmeterol (Advair Diskus) is based on the patient's asthma severity. The dosage of the inhalation powder fixed-combination preparation is 100, 250, or 500 mcg of fluticasone propionate and 50 mcg of salmeterol (1 inhalation) twice daily, given approximately 12 hours apart (morning and evening). The maximum recommended dosage of fluticasone propionate in fixed combination with salmeterol is 500 mcg of fluticasone propionate and 50 mcg of salmeterol twice daily. The manufacturer states that administration of the inhalation powder containing fluticasone propionate in fixed combination with salmeterol more frequently than twice daily or exceeding 1 inhalation twice daily is not recommended.

In asthmatic patients 12 years of age or older, the recommended initial dosage of the inhalation aerosol containing fluticasone propionate in fixed combination with salmeterol (Advair HFA) is based on the patient's current asthma therapy. The dosage of the inhalation aerosol fixed-combination preparation is 90, 230, or 460 mcg of fluticasone propionate and 42 mcg of salmeterol (2 inhalations) twice daily, given approximately 12 hours apart (morning and evening). The maximum recommended dosage of fluticasone propionate is 460 mcg in fixed combination with 42 mcg of salmeterol (2 inhalations) twice daily. The manufacturer states that administration of the inhalation aerosol containing fluticasone propionate in fixed combination with salmeterol more frequently than twice daily or exceeding 2 inhalations twice daily is not recommended.

If control of asthma is inadequate after 2 weeks of therapy at the initial dosage, replacing the current strength of the fixed combination with a higher strength (higher strengths contain higher dosages of fluticasone propionate only) may provide additional asthma control. Patients receiving the fixed combination of fluticasone propionate and salmeterol twice daily should not use additional salmeterol or other long-acting β2-adrenergic agonists (e.g., formoterol) for any reason, including the treatment of asthma or prevention of exercise-induced bronchospasm. Patients also should be advised not to discontinue fluticasone propionate in fixed combination with salmeterol without medical supervision, as symptoms may recur after treatment discontinuance. If a previously effective dosage of fluticasone propionate in fixed combination with salmeterol fails to provide adequate improvement in asthma control, the therapeutic regimen should be reevaluated and additional therapeutic options should be considered (e.g., increasing the strength of the fixed combination [higher strengths contain higher dosages of fluticasone propionate only], adding additional inhaled corticosteroids, initiating systemic corticosteroids). The manufacturer warns that therapy with the fixed combination of fluticasone propionate and salmeterol should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma. and also

Chronic Obstructive Pulmonary Disease

Fluticasone Propionate/Salmeterol Fixed-combination Therapy

For maintenance therapy of COPD, the recommended dosage of fluticasone propionate in fixed combination with salmeterol (Advair Diskus) in adults is 250 mcg of fluticasone propionate and 50 mcg of salmeterol (1 inhalation) twice daily, given approximately every 12 hours (morning and evening). If shortness of breath occurs between doses, an inhaled, short-acting β2-agonist should be used for immediate relief. Higher dosages of salmeterol in fixed combination with fluticasone propionate (e.g., 500 mcg of fluticasone propionate and 50 mcg of salmeterol twice daily) do not result in additional benefit and are not recommended. Patients receiving fluticasone propionate in fixed combination with salmeterol should not use additional salmeterol or other long-acting β2-agonists (e.g., arformoterol, formoterol) for any reason, including the treatment of COPD.

Special Populations

The following information addresses dosage of fluticasone propionate in special populations. When fluticasone propionate is used in fixed combination with salmeterol, dosage requirements for salmeterol should be considered.

Dosage of fluticasone propionate HFA inhalation aerosol in geriatric patients should be selected with caution, reflecting the greater frequency of decreased hepatic function, presence of coexisting conditions, or other drug therapies in such patients. Dosage adjustments based solely on age are not recommended in geriatric patients receiving fluticasone propionate inhalation powder alone or fluticasone propionate inhalation powder or aerosol in fixed combination with salmeterol.

Cautions

Contraindications

Primary treatment of severe acute asthmatic attacks or status asthmaticus when intensive measures (e.g., oxygen, parenteral bronchodilators, IV corticosteroids) are required.

Fluticasone propionate in fixed combination with salmeterol is contraindicated as primary treatment of status asthmaticus or other acute episodes of asthma or chronic obstructive pulmonary disease (COPD) when intensive measures are required.

Known hypersensitivity to fluticasone propionate or any ingredient (e.g., milk protein) in the formulation.

When fluticasone propionate is used in fixed combination with salmeterol, contraindications associated with salmeterol should be considered.

Warnings/Precautions

Warnings

Use of Fixed Combinations

When preparations containing fluticasone propionate in fixed combination with salmeterol are used, the usual cautions, precautions, and contraindications associated with salmeterol should be considered. Cautionary information applicable to specific populations (e.g., pregnant or nursing women, individuals with hepatic or renal impairment, geriatric patients) should be considered for each drug in the fixed combination.

Asthma-related Death

Long-acting β2-adrenergic agonists, such as salmeterol, a component of Advair Diskus and Advair HFA, increase the risk of asthma-related death. Data from a large (approximately 26,000 patients), placebo-controlled study (Salmeterol Multi-center Asthma Research Trial [SMART]) evaluating the safety of salmeterol in patients with asthma showed an increase in asthma-related deaths in those receiving the drug. Results of a post hoc analysis revealed a statistically significant greater risk of asthma-related deaths or life-threatening experiences with salmeterol therapy in African-American patients and in patients not receiving concomitant inhaled corticosteroid therapy (53% of study patients) compared with placebo. In addition, available data from controlled clinical trials suggest that long-acting β2-adrenergic agonists increase the risk of asthma-related hospitalization in pediatric and adolescent patients.

Therefore, in the treatment of asthma, the fixed combination of fluticasone propionate and salmeterol xinafoate is used only in patients who have not responded adequately to long-term asthma controller therapy, such as inhaled corticosteroids, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a long-acting β2-adrenergic agonist.(See Asthma under Uses: Bronchospasm.)

Withdrawal of Systemic Corticosteroid Therapy

The fixed combination of fluticasone propionate and salmeterol xinafoate as the inhalation aerosol (Advair HFA) should not be used for transferring patients from systemic corticosteroid therapy. In patients being switched from systemic corticosteroids to orally inhaled fluticasone propionate, systemic corticosteroid therapy should be withdrawn gradually and patients should be monitored during dosage reduction for objective signs of adrenal insufficiency (e.g., hypotension, fatigue, lassitude, weakness, nausea, vomiting) since a life-threatening exacerbation of asthma or adrenal insufficiency could occur. Lung function (FEV1 or morning PEF), adjunctive β2-adrenergic agonist use, and asthma symptoms should be carefully monitored during withdrawal of systemic corticosteroid therapy.In most patients, several months are required for total recovery of HPA function following withdrawal of systemic corticosteroid therapy. Patients who have been previously maintained on a corticosteroid dosage equivalent to 20 mg or more of prednisone daily may be most susceptible to adrenal insufficiency, particularly when systemic corticosteroids have been almost completely withdrawn. Corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, fatigue, lassitude, depression) may occur. Acute adrenal insufficiency may occur during exposure to trauma, surgery, or infection (particularly gastroenteritis or other conditions associated with acute electrolyte loss). Clinicians should be alert for the potential for eosinophilia, vasculitic rash, worsening of pulmonary symptoms, cardiac complications, and/or neuropathy consistent with Churg-Strauss syndrome; or unmasking of conditions previously controlled by systemic corticosteroid therapy (e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions).

Immunosuppressed Patients

Patients who become immunosuppressed while receiving corticosteroids have increased susceptibility to infections compared with healthy individuals, and certain infections (e.g., varicella [chickenpox], measles) can have a more serious or even fatal outcome in such patients, particularly in children. Patients receiving corticosteroids who are potentially immunosuppressed should be warned of the risk of exposure to certain infections (e.g., chickenpox, measles) and of the importance of obtaining medical advice if such exposure occurs. Such patients should take particular care to avoid exposure to these infections. If exposure to varicella (chickenpox) or measles occurs in susceptible patients, administration of varicella zoster immune globulin (VZIG) or pooled immune globulin (IG), respectively, should be considered. If chickenpox develops, treatment with an antiviral agent should be considered. For additional information, and also

Bronchospasm

As with other inhaled drugs for asthma, bronchospasm may occur, resulting in an immediate increase in wheezing following oral inhalation of fluticasone propionate. If bronchospasm occurs, appropriate treatment (e.g., use of a short-acting β2-adrenergic agonist) should be instituted immediately and fluticasone propionate therapy should be discontinued.

Acute Exacerbations of Asthma or Chronic Obstructive Pulmonary Disease

Therapy with the fixed combination of fluticasone propionate and salmeterol xinafoate should not be initiated in patients with substantially worsening or acutely deteriorating asthma or acute symptoms of chronic obstructive pulmonary disease (COPD). Failure to respond to a previously effective dosage of fluticasone propionate in fixed combination with salmeterol xinafoate may indicate substantially worsening asthma or COPD that requires reevaluation. If inadequate control of symptoms persists with supplemental β2-agonist bronchodilator therapy (i.e., if there is a need to increase the dose or frequency of administration of the short-acting bronchodilator) or an appreciable decrease in lung function (e.g., peak expiratory flow [PEF]) occurs, prompt reevaluation of asthma therapy is required; however, extra/increased doses of salmeterol or other long-acting inhaled β2-agonists (e.g., formoterol) should not be used in such situations or for any indication. Such reevaluation may include increasing the strength of the fixed combination (higher strengths contain higher dosages of fluticasone propionate only), adding additional inhaled corticosteroid, or initiating systemic corticosteroids. Patients should not increase the frequency of administration of the fixed combination.

Sensitivity Reactions

Anaphylactic reactions, including reactions in patients with severe milk protein allergy, have been reported very rarely. Cutaneous hypersensitivity reactions also have been reported rarely.

General Precautions

Infections

Localized candidal infections of the pharynx have been reported in patients receiving orally inhaled fluticasone propionate therapy. When infection occurs, appropriate local or systemic treatment of the infection may be necessary and/or discontinuance of orally inhaled fluticasone propionate therapy may be required. Inhaled corticosteroid therapy should be used with extreme caution, if at all, in patients with clinical or asymptomatic Mycobacterium tuberculosis infections of the respiratory tract; untreated fungal, bacterial, or parasitic infections; or ocular herpes simplex or untreated systemic viral infections. Clinicians should remain vigilant for the possible development of pneumonia in patients with COPD who are receiving the inhalation powder preparation containing fluticasone propionate in fixed combination with salmeterol (Advair Diskus), since the clinical features of pneumonia and COPD exacerbations frequently overlap. Lower respiratory tract infections, including pneumonia, have been reported in patients with COPD following the administration of inhaled corticosteroids, including fluticasone propionate and the inhalation powder preparation containing fluticasone propionate in fixed combination with salmeterol (Advair Diskus).

Ophthalmic Effects

Glaucoma, increased intraocular pressure, and cataracts rarely have been reported in patients receiving orally inhaled corticosteroids, including fluticasone propionate; regular eye examinations should be considered.

Systemic Corticosteroid Effects

Administration of higher than recommended dosages of orally inhaled fluticasone propionate may result in manifestations of hypercorticism and suppression of HPA function. If such changes occur, the dosage of fluticasone propionate should be reduced slowly, consistent with accepted procedures for reducing corticosteroid dosage and management of asthma symptoms. Particular care should be taken in monitoring patients postoperatively or during periods of stress for evidence of inadequate adrenal response.

Musculoskeletal Effects

Long-term use of orally inhaled corticosteroids may affect normal bone metabolism, resulting in a loss of bone mineral density. In a 2-year study in adults with asthma, orally inhaled fluticasone propionate was not associated with appreciable changes in lumbar spine bone mineral density. The manufacturer of fluticasone propionate in fixed combination with salmeterol states that use of this preparation can pose additional risks in patients with major risk factors for decreased bone mineral density, such as tobacco use, advanced age, sedentary lifestyle, poor nutrition, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, corticosteroids). Since patients with chronic obstructive pulmonary disease (COPD) often have multiple risk factors for reduced bone mineral density, assessment of bone mineral density is recommended prior to initiation of therapy and periodically thereafter. If appreciable reductions in bone mineral density are seen and use of fluticasone propionate and salmeterol in fixed combination is considered to be important for the patient's COPD therapy, use of agents to treat or prevent osteoporosis should be strongly considered.

Specific Populations

Pregnancy

Category C.

Lactation

While it is not known whether fluticasone propionate is distributed into milk in humans, the drug is distributed into milk in rats. Since other corticosteroids are distributed into milk, caution is advised if fluticasone propionate is administered in nursing women. The manufacturer of Flovent Diskus, Flovent HFA, Advair Diskus, and Advair HFA (containing fluticasone propionate and salmeterol xinafoate) state that since no data from controlled trials are available on the use of these preparations in nursing women, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and efficacy of fluticasone propionate inhalation aerosol or powder alone in children younger than 4 years of age have not been established. Safety and efficacy of the inhalation powder containing fluticasone propionate in fixed combination with salmeterol (Advair Diskus) in children younger than 4 years of age have not been established. Safety and efficacy of the inhalation aerosol containing fluticasone propionate in fixed combination with salmeterol (Advair HFA) in children younger than 12 years of age have not been established. Use of the inhalation powder containing fluticasone propionate in children 4-11 years of age is supported by data from several clinical trials. Use of fluticasone propionate inhalation aerosol or the inhalation powder containing fluticasone propionate in fixed combination with salmeterol (Advair Diskus) in children 4-11 years of age is supported by data from several clinical trials and by extrapolation of efficacy data from older patients. The adverse effect profile of Flovent HFA in pediatric patients (4-11 years of age) generally is similar to that observed in adolescents and adults.

Use of corticosteroids or inadequate control of chronic diseases (e.g., asthma) may lead to suppression of growth in children and adolescents. Therefore, children receiving prolonged therapy with orally inhaled fluticasone propionate should be monitored periodically (e.g., via stadiometry) for possible adverse effects on growth and development. The benefits of corticosteroid therapy should be weighed against the possibility of growth suppression and the risks associated with alternative therapies. Children should be maintained on the lowest possible dosage of fluticasone propionate that controls asthma symptoms.

Geriatric Use

Although no overall differences in safety and efficacy of orally inhaled fluticasone propionate alone or fluticasone proprionate in fixed combination with salmeterol as the inhalation aerosol (Advair HFA) were observed relative to younger adults, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out. Experience with the inhalation powder containing fluticasone propionate in fixed combination with salmeterol (Advair Diskus) in those 65 years of age or older with asthma is insufficient to determine whether geriatric patients respond differently than younger patients. In clinical studies evaluating the inhalation powder containing fluticasone propionate in fixed combination with salmeterol for COPD, patients 65 years of age or older experienced a higher incidence of serious adverse effects compared with those younger than 65 years of age, although the distribution of adverse effects was similar in the two groups. Dosage of fluticasone propionate HFA inhalation aerosol in geriatric patients should be selected with caution, reflecting the greater frequency of decreased hepatic function, presence of coexisting conditions, or other drug therapies in such patients. Dosage adjustments based solely on age are not recommended in geriatric patients receiving fluticasone propionate inhalation powder alone or fluticasone propionate inhalation powder or aerosol in fixed combination with salmeterol.

Common Adverse Effects

Adverse effects occurring in more than 3% of patients older than 12 years of age receiving fluticasone propionate HFA oral inhalation aerosol in controlled clinical trials include upper respiratory tract infection, headache, throat irritation, upper respiratory inflammation, sinusitis/sinus infection, candidiasis (including oral candidiasis), cough, hoarseness/dysphonia, and bronchitis. Adverse effects reported in clinical trials with fluticasone propionate HFA inhalation aerosol in pediatric patients (4-11 years of age) generally were similar to those observed in adolescents and adults.

Adverse effects occurring in more than 3% of patients receiving fluticasone propionate oral inhalation powder in controlled clinical trials include upper respiratory tract infection, throat irritation, sinusitis/sinus infection, upper respiratory inflammation, rhinitis, viral respiratory infection, cough, bronchitis, oral candidiasis, nausea and vomiting, GI discomfort and pain, viral GI infection, musculoskeletal pain, muscle injury, headache, fever, and viral infection.

Drug Interactions

The following information addresses potential interactions with fluticasone propionate. When fluticasone propionate is used in fixed combination with salmeterol, interactions associated with salmeterol should be considered. No formal drug interaction studies have been performed to date with the fixed-combination preparations containing fluticasone propionate and salmeterol.

Drugs Affecting Hepatic Microsomal Enzymes

Since fluticasone propionate is metabolized in the liver by the cytochrome P-450 (CYP) 3A4 isoenzyme, concomitant use of drugs that affect cytochrome P-450 hepatic microsomal enzymes could alter the metabolism of fluticasone.

Cushing's syndrome and adrenal suppression have been reported during postmarketing experience in patients receiving concomitant therapy with fluticasone propionate and ritonavir, a highly potent CYP3A4 inhibitor. Concomitant use of ritonavir and fluticasone propionate is not recommended unless the potential benefit is considered to outweigh the risk of systemic corticosteroid adverse effects.

Administration of a single 1-mg dose of orally inhaled fluticasone propionate in healthy individuals receiving ketoconazole (200 mg once daily to steady state) increased mean plasma fluticasone concentrations, resulting in a depression of certain indices of HPA-axis function (as determined by a reduction in area under the plasma cortisol concentration-time curve [AUC]). Care should be exercised when fluticasone propionate is used concomitantly with long-term ketoconazole or other potent isoenzyme CYP3A4 inhibitors.

Concomitant use of fluticasone propionate (500 mcg twice daily) and erythromycin (333 mg 3 times daily) did not affect fluticasone propionate pharmacokinetics.

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