Drug Notebook

FDA Alerts

    Fluticasone Propionate in Fixed Combination with Salmeterol
  • Possible increase in asthma-related death in patients receiving long-acting β2-adrenergic bronchodilators, including salmeterol, in addition to usual asthma therapy.
  • Reserve use of fixed combination with salmeterol for patients with asthma whose disease is inadequately controlled with other asthma controller therapy (e.g., low to medium dosage of inhaled corticosteroids) or whose disease severity warrants treatment with 2 maintenance therapies. (See Acute Exacerbations of Asthma or COPD under Cautions).

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fluticasone
(floo TIK a zone)

What is fluticasone inhalation?
Fluticasone is a steroid. It prevents the release of substances in the body that cause inflammation. Fluticasone inhalation is used to prevent asthma attacks. It will not treat an asthma attack that has already begun. Fluticasone may also be used for other purposes not listed in this medication guide.

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What are the possible side effects of fluticasone inhalation?

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:

  • weakness, tired feeling, nausea, loss of appetite, weight loss;

  • wheezing or breathing problems after using this medication;

  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;

  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist);

  • worsening asthma symptoms.

Less serious side effects may include:

  • headache;

  • dryness in your mouth, nose, or throat;

  • white patches or sores inside your mouth or on your lips;

  • stuffy nose, sinus pain, cough; or

  • hoarseness or deepened voice.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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How should I use fluticasone inhalation?
Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. Do not use fluticasone inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use another, faster-acting inhalation medication to treat an asthma attack.

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What is the most important information I should know about fluticasone inhalation?
Do not use fluticasone inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use another, faster-acting inhalation medication to treat an asthma attack. Contact your doctor if your asthma symptoms do not improve after using fluticasone inhalation for 2 weeks. Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack.

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What happens if I miss a dose?
Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

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What other drugs will affect fluticasone inhalation?
If you are also using a bronchodilator (a drug that opens the airways to improve breathing), use it first before using the fluticasone inhaler. This will allow more fluticasone to reach your lungs. Bronchodilators include albuterol (Proventil, Ventolin), pirbuterol (Maxair), bitolterol (Tornalate), and others. Before using fluticasone inhalation, tell your doctor if you are using any of the following drugs: amiodarone (Cordarone); HIV medicines such as ritonavir (Norvir, Kaletra); certain antibiotics such as ketoconazole (Nizoral), itraconazole (Sporanox), clarithromycin (Biaxin), erythromycin (E-Mycin, Ery-Tab, E.E.S.), or;

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Fluticasone for inhalation has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity when corticosteroids are administered orally or potent steroids are applied topically. Fluticasone has been shown to be teratogenic when administered subcutaneously at high doses to mice. There are no controlled data in human pregnancy. Fluticasone is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

There are no data on the excretion of fluticasone into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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Who should NOT use this medication?

  • Primary treatment of severe acute asthmatic attacks or status asthmaticus when intensive measures (e.g., oxygen, parenteral bronchodilators, IV corticosteroids) are required.
  • Known hypersensitivity to fluticasone propionate or any ingredient in the formulation.

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. An overdose of fluticasone inhalation is not expected to produce life-threatening symptoms.

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What should I discuss with my healthcare provider before using fluticasone inhalation?
Before using this medication, tell your doctor if you have been sick or had an infection of any kind. You may not be able to use fluticasone inhalation until you are well. FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether fluticasone passes into breast milk or if it could harm a nursing baby. Do not use fluticasone inhalation without telling your doctor if you are breast-feeding a baby.

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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