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Advair Diskus

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Advair Diskus

ADVAIR DISKUS 100/50
(fluticasone propionate 100 mcg and salmeterol 50 mcg) Inhalation Powder

ADVAIR DISKUS 250/50
(fluticasone propionate 250 mcg and salmeterol 50 mcg) Inhalation Powder

ADVAIR DISKUS 500/50
(fluticasone propionate 500 mcg and salmeterol 50 mcg) Inhalation Powder

FOR ORAL INHALATION

WARNING

ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA), such as salmeterol, one of the active ingredients in ADVAIR DISKUS (fluticasone propionate) ®, increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of salmeterol (SEREVENT® Inhalation Aerosol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 patients treated for 28 weeks on salmeterol versus 3 deaths out of 13,179 patients on placebo). Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients.

Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS (fluticasone propionate) for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g. discontinue ADVAIR DISKUS (fluticasone propionate) ) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use ADVAIR DISKUS (fluticasone propionate) for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids. [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

ADVAIR DISKUS 100/50 (fluticasone propionate) , ADVAIR DISKUS (fluticasone propionate) 250/50, and ADVAIR DISKUS 500/50 are combinations of fluticasone propionate and salmeterol xinafoate.

One active component of ADVAIR DISKUS is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3­oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure:

Fluticasone Propionate Structural Formula Illustration

Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol.

The other active component of ADVAIR DISKUS (fluticasone propionate) is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2­naphthoic acid salt of salmeterol. The chemical name of salmeterol xinafoate is 4-hydroxy-α1­[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2­naphthalenecarboxylate, and it has the following chemical structure:

Salmeterol Xinafoate Structural Formula Illustration

Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4 •C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water.

ADVAIR DISKUS 100/50 (fluticasone propionate) , ADVAIR DISKUS (fluticasone propionate) 250/50, and ADVAIR DISKUS (fluticasone propionate) 500/50 are specially designed plastic devices containing a double-foil blister strip of a powder formulation of fluticasone propionate and salmeterol xinafoate intended for oral inhalation only. Each blister on the double-foil strip within the device contains 100, 250, or 500 mcg of microfine fluticasone propionate and 72.5 mcg of microfine salmeterol xinafoate salt, equivalent to 50 mcg of salmeterol base, in 12.5 mg of formulation containing lactose (which contains milk proteins). Each blister contains 1 complete dose of both medications. After a blister containing medication is opened by activating the device, the medication is dispersed into the airstream created by the patient inhaling through the mouthpiece.

Under standardized in vitro test conditions, ADVAIR DISKUS delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per blister from ADVAIR DISKUS 100/50 (fluticasone propionate) , 250/50, and 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult patients with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through a DISKUS® inhalation device was 82.4 L/min (range: 46.1 to 115.3 L/min).

Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) patients with asthma inhaling maximally through the DISKUS device show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric patients with asthma inhaling maximally through the DISKUS device show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old patient set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old patient set (N = 20).

The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.

What are the possible side effects of fluticasone and salmeterol (Advair Diskus, Advair HFA)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • bronchospasm (wheezing, chest tightness, trouble breathing);
  • fast or uneven heart beats, restless feeling, tremor;
  • fever, chills, stabbing chest pain, cough with yellow or green mucus;
  • blurred vision, eye pain, or seeing halos around lights;
  • white patches or sores inside your...

Read All Potential Side Effects and See Pictures of Advair Diskus »

What are the precautions when taking fluticasone propionate (Advair Diskus)?

Before using this product, tell your doctor or pharmacist if you are allergic to fluticasone or salmeterol; or if you have any other allergies. This product may contain inactive ingredients (such as lactose, milk proteins), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/past infections (such as tuberculosis, herpes), high blood pressure, bone loss (osteoporosis), heart disease (such as chest pain, heart attack, irregular heartbeat), overactive thyroid (hyperthyroidism), diabetes, eye problems (such as cataracts, glaucoma), seizures, liver disease.

Salmeterol may cause a condition that affects the heart rhythm (QT...

Read All Potential Precautions of Advair Diskus »

Last reviewed on RxList: 1/24/2011
This monograph has been modified to include the generic and brand name in many instances.

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