In a large clinical study, more patients with asthma who used salmeterol experienced severe episodes of asthma that had to be treated in a hospital or caused death than patients with asthma who did not use salmeterol. If you have asthma, use of salmeterol may increase the risk that you will develop serious or fatal asthma problems. There is not enough information available to tell whether inhaling fluticasone with salmeterol increases, decreases, or does not change this risk.
Your doctor will only prescribe fluticasone and salmeterol if your asthma is so severe that two medications are needed to control it.You will never use salmeterol alone; you must always use it along with another asthma controller medication such as fluticasone. Children and teenagers who need to be treated with salmeterol will probably be treated with a combination product that combines salmeterol and another medication such as fluticasone in a single inhaler to make it easier for them to use both medications as prescribed.
Because of the risks of using salmeterol, you should only use fluticasone and salmeterol as long as both medications are needed to bring your asthma symptoms under control. Once your asthma is controlled, your doctor will probably tell you to stop using salmeterol but continue using fluticasone or another asthma medication. Your doctor will probably prescribe a different inhaler that contains only one medication to use instead of the fluticasone and salmeterol combination inhaler.
Do not use fluticasone and salmeterol if you have asthma that is quickly getting worse. Tell your doctor if you have had many severe asthma attacks or if you have ever been hospitalized because of asthma symptoms. If you have any of the following signs of worsening asthma, call your doctor immediately:
Talk to your doctor about the risks of using this medication.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with fluticasone and salmeterol and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) or the manufacturer's website to obtain the Medication Guide.
The combination of fluticasone and salmeterol is used to prevent wheezing, shortness of breath, and breathing difficulties caused by asthma and chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema). Fluticasone is in a class of medications called steroids. It works by reducing swelling in the airways. Salmeterol is in a class of medications called long-acting beta-agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.
The combination of fluticasone and salmeterol comes as a powder to inhale by mouth using a specially designed inhaler. It is usually used twice a day, in the morning and evening, about 12 hours apart. Use fluticasone and salmeterol at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use fluticasone and salmeterol exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
Talk to your doctor about how you should take your other oral or inhaled medications for asthma during your treatment with salmeterol and fluticasone inhalation. If you were using a short-acting beta agonist inhaler such as albuterol (Proventil, Ventolin) on a regular basis, your doctor will probably tell you to stop using it regularly but to continue to use it to treat sudden attacks of asthma symptoms. Follow these directions carefully. Do not change the way you use any of your medications or stop taking any of your medications without talking to your doctor.
Do not use fluticasone and salmeterol during an attack of asthma or COPD. Your doctor will prescribe a short-acting inhaler to use during attacks.
Fluticasone and salmeterol inhalation controls asthma and COPD but does not cure these conditions. It may take a week or longer before you feel the full benefit of fluticasone and salmeterol. Continue to use fluticasone and salmeterol even if you feel well. Do not stop using fluticasone and salmeterol without talking to your doctor. If you stop using fluticasone and salmeterol inhalation, your symptoms may return.
Before you use fluticasone and salmeterol inhalation for the first time, ask your doctor, pharmacist, or respiratory therapist to show you how to use the inhaler. Practice using your inhaler while he or she watches.
To use the inhaler, follow these steps:
Never exhale into the inhaler, take the inhaler apart, or wash the mouthpiece or any part of the inhaler. Keep the inhaler dry. Do not use the inhaler with a spacer.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before using fluticasone and salmeterol,
Talk to your doctor about eating grapefruit or drinking grapefruit juice while taking this medication.
Skip the missed dose and continue your regular dosing schedule. Do not inhale a double dose to make up for a missed one.
Fluticasone and salmeterol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of the following side effects, call your doctor immediately:
Fluticasone and salmeterol may cause children to grow more slowly. Your child's doctor will monitor your child's growth carefully. Talk to your child's doctor about the risks of giving this medication to your child.
Fluticasone and salmeterol may increase the risk that you will develop glaucoma, cataracts, or osteoporosis. You will probably need to have regular eye exams and bone tests during your treatment with fluticasone and salmeterol. Talk to your doctor about the risks of using this medication.
Fluticasone and salmeterol may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from sunlight, excess heat and moisture (not in the bathroom). Throw away the inhaler 1 month after you remove it from the foil overwrap or after every blister has been used (when the dose indicator reads 0), whichever comes first. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
Keep all appointments with your doctor and your eye doctor.
Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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