Fluticasone and Salmeterol

Fluticasone/salmeterol is a prescription medication used to treat asthma and COPD. It is a single product containing 2 medications: fluticasone and salmeterol. Fluticasone belongs to a class of medications called steroids. These work by reducing swelling in the airways. Salmeterol belongs to a class of drugs called long-acting beta-agonists (LABAs). These work by relaxing and opening air passages in the lungs, making it easier to breathe.

This medication comes in an inhaler form and is typically used twice a day, in the morning and evening, about 12 hours apart.

Common side effects of fluticasone/salmeterol include upper respiratory tract infection, throat irritation, hoarseness and voice changes, and thrush in the mouth or throat.

Fluticasone/salmeterol can also cause drowsiness. Do not drive or operate heavy machinery until you know how fluticasone/salmeterol affects you.

Fluticasone/salmeterol is a prescription medication used to treat asthma and chronic obstructive pulmonary disease (COPD). The condition COPD is a group of lung diseases that includes chronic bronchitis and emphysema.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information

Take this medication exactly as prescribed by your doctor.  Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of fluticasone/salmeterol Diskus for the treatment of asthma in people 4 years of age and older is 1 inhalation twice a day, in the morning and evening, about 12 hours apart.

The recommended dose of fluticasone/salmeterol Diskus for the treatment of COPD in adults is 1 inhalation twice a day, in the morning and evening, about 12 hours apart.

The recommended dose of fluticasone/salmeterol HFA for the treatment of asthma in people 12 years of age and older is 2 inhalation twice a day, in the morning and evening, about 12 hours apart.

Black Box Warning: Asthma-related death

Long-acting beta2-adrenergic agonists (LABA), such as salmeterol, one of the active ingredients in fluticasone/salmeterol, increase the risk of asthma-related death. A US trial showed an increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 subjects treated for 28 weeks on salmeterol versus 3 out of 13,179 subjects 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. 

When treating patients with asthma, only prescribe fluticasone/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 a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue fluticasone/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 fluticasone/salmeterol for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.

 

Serious side effects have been reported with fluticasone/salmeterol including the following:

• increased risk of death from asthma problems. People with asthma who take long-acting beta2 adrenergic agonist (LABA) medicines, such as salmeterol (one of the medicines in fluticasone/salmeterol), have an increased risk of death from asthma problems.
• pneumonia. People with COPD have a higher chance of getting pneumonia. Fluticasone/salmeterol may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms: increase in mucus production, change in mucus color, fever, chills, increased cough, and increased breathing problems.
• immunosuppression. Fluticasone/salmeterol may increase the chance of getting infections.
• adrenal insufficiency. Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones.  This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an inhaled steroid (such as fluticasone/salmeterol). When your body is under stress such as from fever, trauma (such as a car accident), infection, surgery, or worse COPD symptoms, adrenal insufficiency can get worse and may cause death.  Symptoms of adrenal insufficiency include the following: feeling tired, lack of energy, weakness, nausea and vomiting, and low blood pressure.
• thrush. Fluticasone/salmeterol can cause a fungal infection in your mouth or throat.  It is important to rinse your mouth with water without swallowing after using fluticasone/salmeterol to help reduce your chance of getting thrush.
• sudden breathing problems immediately after inhaling your medicine. Call your healthcare provider if breathing problems worsen over time while using fluticasone/salmeterol.
• serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction: rash, hives, swelling of your face, mouth, and tongue, and breathing problems.
• effects on the heart. fluticasone/salmeterol can cause increased blood pressure, a fast or irregular heartbeat, and chest pain.
• effects on the nervous system. Fluticasone/salmeterol can cause a tremor and nervousness.
• osteoporosis. Fluticasone/salmeterol can cause bone thinning or weakness.
• slowed growth in children. A child's growth should be checked often.
• glaucoma and cataracts. Fluticasone/salmeterol can cause eye problems. It is important to have regular eye exams while using fluticasone/salmeterol.
• changes in laboratory blood values. Fluticasone/salmeterol can cause changes in your sugar, potassium, and certain types of white blood cells.

Fluticasone/salmeterol can cause drowsiness. Do not drive or operate heavy machinery until you know how fluticasone/salmeterol affects you.

Do not take fluticasone/salmeterol in the following situations:

• are allergic to fluticasone/salmeterol or to any of its ingredients
• have a severe allergy to milk proteins
• treatment of a sudden attack of asthma or COPD

Serious side effects have been reported with fluticasone/salmeterol.  See the "Drug Precautions" section.

Common side effects of fluticasone/salmeterol include the following:

• upper respiratory tract infection
• throat irritation
• hoarseness and voice changes
• thrush in your mouth or throat
• bronchitis
• cough
• headache
• nausea
• vomiting
• viral respiratory infections
• muscle and bone pain

This is not a complete list of fluticasone/salmeterol side effects.  Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects.  You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medications you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.  Especially tell your doctor if you take:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone
• monoamine oxidase inhibitors such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)
• tricyclic antidepressants such as trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)
• beta blockers such as metoprolol (Toprol XL, Lopressor), carvedilol (Coreg), bisoprolol (Zebeta), betaxolol (Kerlone), nebivolol (Bystolic), propranolol (Inderal)
• non-potassium-sparing diuretics such as bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide, HCTZ), metolazone (Zaroxolyn), torsemide (Demadex)

This is not a complete list of fluticasone/salmeterol drug interactions.  Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Fluticasone/salmeterol falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if fluticasone/salmeterol crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using fluticasone/salmeterol.