How does this medication work? What will it do for me?
This medication contains two active ingredients that are used to treat asthma and chronic obstructive pulmonary disease (COPD). The two active ingredients are salmeterol and fluticasone. Salmeterol belongs to a group of medications called bronchodilators. These medications relax the muscles in the walls of the small air passages in the lung, keeping the air passage open and making it easier to breathe. Fluticasone belongs to a group of medications known as corticosteroids. Corticosteroids reduce inflammation in the lungs and help reduce the swelling and irritation in the walls of the small air passages in the lungs. This helps open the airways and improve breathing.
The inhaled powder for the Diskus can be utilized to treat asthma and COPD, however the inhaled aerosol should only be utilized to treat asthma.
It is important to remember that salmeterol - fluticasone is intended for long-term relief and is not intended for immediate relief. Inhalers that contain "reliever" medications with fast action (e.g., salbutamol, terbutaline) will still be needed while using this medication.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
A pressurized metered-dose inhaler (MDI) consisting of an aluminum canister with a metering valve. Each canister is fitted into the supplied purple actuator/adaptor. A dust cap is fitted over the actuator's mouthpiece when not in use. It delivers 25 µg salmeterol (as the xinafoate salt) and 125 µg fluticasone propionate per actuation. Nonmedicinal ingredient: HFA-134a (1,1,1,2-tetrafluoroethane). It contains no excipients. Formats of 120 doses.
A pressurized metered-dose inhaler (MDI) consisting of an aluminum canister with a metering valve. Each canister is fitted into the supplied purple actuator/adaptor. A dust cap is fitted over the actuator's mouthpiece when not in use. It delivers 25 µg salmeterol (as the xinafoate salt) and 250 µg fluticasone propionate per actuation. Nonmedicinal ingredient: HFA-134a (1,1,1,2-tetrafluoroethane). It contains no excipients. Formats of 120 doses.
How should I use this medication?
The usual recommended dose for adults and children 12 yearsof age and older is two inhalations of the appropriate strength (as decided by your doctor) twice daily. Gargle with water after each use to prevent hoarseness and thrush of the mouth and throat.
Read the package insert or speak with your pharmacist for instructions on how to use the inhaler properly. If you have difficulties there are products that can be used with the inhaler to improve how well it works.
To make sure the medication remains effective, it is very important to use it regularly twice a day, exactly as prescribed by your doctor, even when you are not experiencing symptoms of asthma. To prevent side effects, do not use this medication more often than prescribed.
Many things can affect the dose of medication that a person needs, such as the severity of the condition, body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
If you miss a dose of this medication, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature with the cover on tight, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not use this medication if you:
- are allergic to salmeterol, fluticasone, or any ingredients of the medication
- are allergic to lactose or milk (Diskus only)
- have abnormal rapid heart rhythms known as tachyarrhythmias
- have status asthmaticus or are experiencing an asthma attack
- have untreated fungal, bacterial, or tuberculous infections of the lungs
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- body aches or pains
- disturbed sleep
- mouth, tongue, or throat irritation
- muscle cramps or pain
- spinning sensation
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- behavior changes (e.g., agitation, anxiety, or irritability)
- fast or irregular heartbeat
- increased bruising
- increased frequency of infections
- persistent pain and/or limited motion of joints or limbs
- pins and needles or numbness of arms or legs, sinus pain and congestion, worsening breathing problems (Churg-Strauss Syndrome)
- rounded face
- signs of low potassium levels in the blood (e.g., weakness, fatigue, muscle cramps, irregular heartbeat)
- slowed growth (children and adolescents)
- sores, ulcer, or white patches in the mouth or throat (thrush)
- symptoms of adrenal insufficiency (tiredness, headache, nausea, vomiting, muscle or joint pain)
- symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
- symptoms of increased pressure in the eyes (e.g., decreased or blurred vision, eye pain, red eye, swelling of the eye)
- symptoms of pneumonia (e.g., fever or chills, shortness of breath, fatigue, chest pain, cough)
- vision changes (blurred vision)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- a severe allergic reaction (e.g., hives; difficulty breathing; or swelling of the face, mouth, or tongue; difficulty swallowing, breathing, or speaking)
- skin rash or hives all over the body
- wheezing or difficulty breathing immediately after inhaling the medication
- worsening asthma symptoms even after using your reliever medication
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Asthma: When used for alone for asthma treatment, salmeterol has been linked to an increase in asthma-related deaths. Salmeterol - fluticasone should only be used when a regular inhaled corticosteroid (e.g., fluticasone) and a fast acting "reliever" medication (e.g., salbutamol) do not adequately control your symptoms.
If you start developing asthma symptoms, be sure to use your reliever medication for rapid relief of your asthma symptoms. It is very important that you have your reliever medication with you at all times. If you experience worsening symptoms or your reliever medications are not as effective as usual, contact your doctor or seek medical attention immediately.
Blood Pressure: Salmeterol can cause blood pressure to increase, particularly at higher doses. If you have high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Diabetes: Both fluticasone and salmeterol may cause an increase in blood sugar levels. If you have diabetes, you may find it necessary to monitor your blood sugar more frequently while using this medication. If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Eye problems: If you are at risk of developing glaucoma or cataracts, have your eyes checked by your doctor before starting long-term treatment with this medication. You should have your eyes monitored at regular intervals while using this medication.
Growth effects: Long-term use of corticosteroids, including inhaled forms such as this medication, may slow the growth of children and adolescents. It is important to use the lowest effective dose for managing asthma symptoms. Talk to your doctor if you have any concerns.
Heart rhythm: Beta-agonists such as salmeterol can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death.
Salmeterol can cause a fluttering of the heartbeat (atrial fibrillation) or rapid heart beat, increased blood pressure, chest pain and decreased oxygen reaching the heart muscle.
If you are at risk for heart rhythm problems (e.g., people with heart failure, angina, low potassium or magnesium levels), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Infections: Corticosteroids, such as fluticasone, can reduce your body's ability to fight infections and may hide signs of infection that is developing. Infections such as chickenpox and measles can be more serious in people taking medications such as fluticasone. If you are exposed to someone with chickenpox or measles, contact your doctor.
Inhalation-induced bronchospasm: Inhaled forms of medications may cause spasms of the airways, which make breathing difficult. If you experience this problem when using salmeterol - fluticasone, stop using this medication immediately. Speak to your doctor if you experience any problems with breathing while taking this or other inhaled medication.
Oral hygiene: Adequate oral hygiene, such as rinsing your mouth with water after using this medication, helps reduce the chances of developing a yeast infection of the mouth or throat (thrush). If you develop symptoms of thrush, such as white patches in your mouth, contact your doctor.
Osteoporosis: Long-term use of corticosteroids, including inhaled corticosteroids such as fluticasone, may increase the risk of bone loss and osteoporosis. If your doctor recommends that you use this medication for a lengthy period of time, talk to your doctor about supplements and strategies to slow down and reduce bone loss.
Steroid medication use: If you have taken oral steroid medications over the last several months or are still taking oral corticosteroids, consult with your doctor before using this medication. In times of stress or during a severe asthma attack, your doctor may want you to start your oral steroid medication again.
Stopping medication: Do not stop this medication abruptly, as this may cause your condition to get worse. When this medication is stopped, it should be stopped gradually as directed by your doctor.
Thyroid disease: People who have an over-active thyroid gland may be more sensitive to the effects of salmeterol - fluticasone. If you have thyroid disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Worsening symptoms: If you find you need to use your short-acting "rescue" inhaler more often or if your condition seems to worsen, call your doctor. If you have not been given instructions beforehand, contact your doctor immediately about what to do if any of the following situations occur (they may be signs of seriously worsening asthma):
- decreased effectiveness of short-acting, inhaled bronchodilators such as salbutamol, terbutaline, or fenoterol (less than 4 hours of relief)
- need for more inhalations than usual of short-acting, inhaled bronchodilators
- peak flow meter showing results in the below-normal range
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking salmeterol - fluticasone, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of the Diskus form of this medication have not been established for children less than 4 years of age. The safety and effectiveness of the inhaler form of this medication have not been established for children less than 12 years of age.
What other drugs could interact with this medication?
There may be an interaction between salmeterol - fluticasone and any of the following:
- amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
- anti-psychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzepine, quetiapine, risperidone)
- "azole" antifungals (e.g., fluconazole, itraconazole, ketoconazole, voriconazole)
- beta-blocker medications (e.g., propranolol, metoprolol, atenolol, labetalol)
- beta2-agonists (e.g., salbutamol, terbutaline, formoterol, indacaterol)
- decongestant cold medications (e.g., phenylephrine, pseudoephedrine)
- decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
- diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
- grapefruit juice
- HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delaviridine, efavirenz, etravirine, nevirapine)
- HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
- macrolide antibiotics (e.g., clarithromycin, erythromycin)
- monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
- protein kinase inhibitors (e.g., lapatinib, pazopanib, sunitinib)
- quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin, sparfloxacin)
- selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
- serotonin antagonists (anti-emetics; granisetron, ondansetron)
- theophyllines (e.g., aminophylline, oxtriphylline, theophylline)
- tricylic antidepressants (e.g. amitriptyline, clomipramine, desipramine)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
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