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Before we present the typical symptoms of asthma, we should dispel some common myths about this condition. This is best achieved by conducting a short true or false quiz.
ADVAIR® HFA 45/21
(fluticasone propionate 45 mcg and salmeterol 21 mcg*) Inhalation Aerosol
ADVAIR® HFA 115/21
(fluticasone propionate 115 mcg and salmeterol 21 mcg*) Inhalation Aerosol
ADVAIR® HFA 230/21
(fluticasone propionate 230 mcg and salmeterol 21 mcg*) Inhalation Aerosol
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:
Read All Potential Side Effects and See Pictures of Advair HFA »
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, 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 prolongation). QT prolongation can...
*As salmeterol xinafoate salt 30.45 mcg, equivalent to salmeterol base 21 mcg
For Oral Inhalation Only
WARNING
ASTHMA-RELATED DEATH
Long-acting beta2-adrenergic agonists, such as salmeterol, one of the active ingredients in ADVAIR HFA (fluticasone propionate and salmeterol) , 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 HFA (fluticasone propionate and salmeterol) 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 HFA (fluticasone propionate and salmeterol) ) 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 HFA (fluticasone propionate and salmeterol) for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids. (see WARNINGS).
ADVAIR HFA (fluticasone propionate and salmeterol) 45/21 Inhalation Aerosol, ADVAIR HFA (fluticasone propionate and salmeterol) 115/21 Inhalation Aerosol, and ADVAIR HFA (fluticasone propionate and salmeterol) 230/21 Inhalation Aerosol are combinations of fluticasone propionate and salmeterol xinafoate.
One active component of ADVAIR HFA (fluticasone propionate and salmeterol) is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure:
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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 HFA (fluticasone propionate and salmeterol) is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. The chemical name of salmeterol xinafoate is 4-hydroxy-α1-[[[6-(4phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2naphthalenecarboxylate, and it has the following chemical structure:
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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 HFA (fluticasone propionate and salmeterol) 45/21 Inhalation Aerosol, ADVAIR HFA (fluticasone propionate and salmeterol) 115/21 Inhalation Aerosol, and ADVAIR HFA (fluticasone propionate and salmeterol) 230/21 Inhalation Aerosol are pressurized metered-dose aerosol units fitted with a counter. ADVAIR HFA (fluticasone propionate and salmeterol) is intended for oral inhalation only. Each unit contains a microcrystalline suspension of fluticasone propionate (micronized) and salmeterol xinafoate (micronized) in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients.
After priming, each actuation of the inhaler delivers 50, 125, or 250 mcg of fluticasone propionate and 25 mcg of salmeterol in 75 mg of suspension from the valve. Each actuation delivers 45, 115, or 230 mcg of fluticasone propionate and 21 mcg of salmeterol from the actuator. Twenty-one micrograms (21 mcg) of salmeterol base is equivalent to 30.45 mcg of salmeterol xinafoate. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the device and inspiration through the delivery system.
Each 12-g canister provides 120 inhalations.
ADVAIR HFA (fluticasone propionate and salmeterol) should be primed before using for the first time by releasing 4 test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 4 weeks or when it has been dropped, prime the inhaler again by releasing 2 test sprays into the air away from the face, shaking well for 5 seconds before each spray.
This product does not contain any chlorofluorocarbon (CFC) as the propellant.
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:
Read All Potential Side Effects and See Pictures of Advair HFA »
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, 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 prolongation). QT prolongation can...
Last reviewed on RxList: 7/23/2010
This monograph has been modified to include the generic and brand name in many instances.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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