Generic Name: Salmeterol + Fluticasone Brand Name(s): Generics only. No brands available.

Uses

What is Salmeterol + Fluticasone used for?

Salmeterol + Fluticasone is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). It contains 2 medications: fluticasone and salmeterol. Fluticasone belongs to a class of drugs known as corticosteroids. It works by reducing the irritation and swelling of the airways. Salmeterol belongs to the class of drugs known as long-acting beta agonists. It works by opening airways in the lungs to make breathing easier. Controlling symptoms of breathing problems can decrease time lost from work or school.

For asthma treatment, this product should only be used when breathing problems are not well controlled with one asthma-control medication (inhaled corticosteroid).

Before using this medication, it is important to learn how to use it properly. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.

How should I take Salmeterol + Fluticasone?

Use this device in a level, flat position. Inhale this medication by mouth as directed by your doctor, usually twice daily (in the morning and evening, 12 hours apart). You may or may not taste/feel the drug when you inhale. Either is normal. Do not exhale into the device.

Do not take the inhaler apart or wash the mouthpiece or any part of the device. Close the device after each use.

If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication, and use this drug last.

Gargle and rinse your mouth with water after each use of this medication to help prevent irritation and yeast infections (thrush) in the mouth and throat. Do not swallow the rinse water.

The dosage is based on your medical condition, age, and response to treatment.

Use this medication regularly in order to get the most benefit from it. This medication works best if used at evenly spaced intervals. To help you remember, use it at the same times each day. Do not increase your dose, use this medication more frequently, or stop using it without first consulting your doctor. Also, do not use other long-acting beta agonists while using this medication.

If you have been using a quick-relief inhaler (such as albuterol, also called salbutamol in some countries) on a regular daily schedule (such as 4 times daily), you must stop this schedule and only use the quick-relief inhaler as needed for sudden shortness of breath/asthma attacks. Consult your doctor for details.

If you are regularly using a different corticosteroid taken by mouth (such as prednisone), you should not stop using it unless directed by your doctor. You may have withdrawal symptoms if the drug is suddenly stopped. Some conditions (such as asthma, allergies) may become worse when the drug is suddenly stopped. To prevent withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness), your doctor may direct you to slowly lower the dose of your old medication after you begin using this product. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away. It may take 1 week or longer before you get the full benefit of this drug. Tell your doctor if your condition does not improve or if it worsens.

Learn which of your inhalers you should use every day (controller drugs) and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, worsening peak flow meter readings, waking up at night with trouble breathing, if you use your quick-relief inhaler more often (more than 2 days a week), or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.

How do I store Salmeterol + Fluticasone?

Salmeterol + Fluticasone is best stored at room temperature away from direct light and moisture. Store with the mouthpiece down.

Protect from heat or open flame. Do not puncture or burn even if it seems empty. To prevent drug damage, you should not store Salmeterol + Fluticasone in the bathroom or the freezer. There may be different brands of Salmeterol + Fluticasone that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Salmeterol + Fluticasone down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Salmeterol + Fluticasone?

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 (such as lactose, milk proteins), 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 rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using this product, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using this medication safely.

This medication may mask signs of infection. It can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses for a long time, it may be more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used a corticosteroid taken by mouth within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. Carry a warning card or medical ID bracelet that says you use (or have used) corticosteroid medications.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults with COPD may be at greater risk for pneumonia while using this drug. Older adults may also be more sensitive to the side effects of this drug, especially QT prolongation.

This medication may slow down a child’s growth if used for a long time, but poorly controlled asthma can also slow down growth. The effect on final adult height is unknown. See the doctor regularly so your child’s height can be checked.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Salmeterol + Fluticasone during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Salmeterol + Fluticasone. Salmeterol + Fluticasone is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Salmeterol + Fluticasone?

Hoarseness, throat irritation, headache, or stomach upset may occur. If any of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Infrequently, this medication may cause severe sudden worsening of breathing problems/asthma immediately after use. If you have sudden worsening of breathing, use your quick-relief inhaler and get medical help right away.

Tell your doctor right away if any of these unlikely but serious side effects occur: white patches on tongue/in mouth, signs of infection (such as fever, persistent sore throat), mental/mood changes (such as nervousness), trouble sleeping, vision problems (such as blurred vision), increased thirst/urination, muscle cramps, shaking (tremors).

Get medical help right away if any of these rare but seriouschest pain, fast/irregular heartbeat, severe dizziness, fainting, seizures.

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Salmeterol + Fluticasone?

A product that may interact with this drug is: aldesleukin.

Other medications can affect the removal of fluticasone and salmeterol from your body, which may affect how this product works. Examples include azole antifungals (such as ketoconazole), boceprevir, cobicistat, macrolide antibiotics (such as clarithromycin), HIV protease inhibitors (such as lopinavir, ritonavir), nefazodone, telithromycin, among others.

Salmeterol + Fluticasone may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Salmeterol + Fluticasone?

Salmeterol + Fluticasone may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Salmeterol + Fluticasone?

Salmeterol + Fluticasone may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Salmeterol + Fluticasone.

What is the dose of Salmeterol + Fluticasone for an adult?

Usual Adult Dose for Chronic Obstructive Pulmonary Disease – Maintenance

Fluticasone-salmeterol 250/50 mcg: 1 inhalation orally twice a day, approximately 12 hours apart

Comments:

-If shortness of breath occurs in the period between doses, use an inhaled, short-acting beta2-agonist for immediate relief.

-Fluticasone 250 mcg-salmeterol 50 mcg is the only approved dosage for the treatment of COPD; higher doses are not recommended, as advantage of the higher strength has not been demonstrated.

Uses: Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema; to reduce exacerbations of COPD in patients with a history of exacerbations

Usual Adult Dose for Asthma – Maintenance

Inhalation Powder:

-Fluticasone-salmeterol 100/50 mcg, 250/50 mcg, or 500/50 mcg: 1 inhalation orally twice a day

-Maximum dose: Fluticasone 500 mcg-salmeterol 50 mcg orally twice a day

Inhalation Aerosol:

-Fluticasone-salmeterol 45/21 mcg, 115/21 mcg, or 230/21 mcg: 2 inhalations orally twice a day

-Maximum dose: Fluticasone 230 mcg-salmeterol 31 mcg orally twice a day

Comments:

-Inhalations should be administered approximately 12 hours apart.

-Initial dose should be based on the patient’s asthma severity.

-If shortness of breath occurs in the period between doses, use an inhaled, short-acting beta2-agonist for immediate relief.

-Improvement in asthma control occurs within 30 minutes of beginning treatment; maximum benefit can take 1 week or longer.

-The inhalation dose can be increased if response does not improve after 2 weeks of therapy.

-If previously effective dose fails to improve asthma control, reevaluate treatment and consider additional therapies (e.g., adding additional inhaled or oral corticosteroid).

Uses: Treatment of asthma in 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

Liver Dose Adjustments

Use with caution.

Dose Adjustments

-Titrate to the lowest dose that maintains symptoms control.

-Once control of asthma is achieved and maintained, assess the patient regularly and step down therapy (e.g., discontinue this drug) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid.

-If asthma remains poorly controlled the total daily dose of the inhaled corticosteroid can be increased by administering a higher strength of this combination product.

-No adjustment is needed in geriatric patients.

Other Comments

Administration advice:

-Rinse mouth with water without swallowing after each inhalation to reduce the risk of oropharyngeal candidiasis.

-Increasing the recommended dose can increase the risk of adverse effects with higher doses of salmeterol.

-This drug should not be used with other products containing LABA.

-Prime the inhalation aerosol before using for the first time by releasing 4 sprays into the air away from the face, shaking well for 5 seconds before each spray. If the inhaler has not been used for more than 4 weeks or when it has been dropped, prime the inhaler again by releasing 2 sprays into the air away from the face, shaking well for 5 seconds before each spray.

General:

-Limitation of Use: This drug is not indicated for the relief of acute bronchospasm.

-This drug should not be used to relieve of acute symptoms; the use of short acting inhaled bronchodilator is recommended for these situations.

-Only the inhalation powder fluticasone 250 mcg-salmeterol 50 mcg is indicated for the treatment of COPD.

Monitoring:

-Ocular: Changes in vision, intraocular pressure, glaucoma, cataracts

-Pediatric: Growth

-Respiratory: Lung function tests, bronchospasm, signs and symptoms of pneumonia

Patient advice:

-This drug is not indicated relieve acute asthma symptoms or exacerbations of COPD and extra doses should not be used for that purpose.

-Patients should seek medical attention immediately if they experience decreasing effectiveness of inhaled, short-acting beta2-agonists; need for more inhalations than usual dose of inhaled, short-acting beta2-agonists; significant decrease in lung function.

-Therapy with this drug should not be discontinued without medical advice as symptoms may recur after discontinuation.

-Patients should consider regular eye exam.

What is the dose of Salmeterol + Fluticasone for a child?

Usual Pediatric Dose for Asthma – Maintenance

Inhalation Powder:

Less than 4 years: Not recommended.

4 years to 11 years:

-Fluticasone-salmeterol 100/50 mcg: 1 inhalation orally twice a day

12 years or older:

-Fluticasone-salmeterol 100/50 mcg, 250/50 mcg, or 500/50 mcg: 1 inhalation orally twice a day

-Maximum dose: Fluticasone 500 mcg-salmeterol 50 mcg orally twice a day

Inhalation Aerosol:

Less than 12 years: Use is not approved.

12 years and older:

-Fluticasone-salmeterol 45/21 mcg, 115/21 mcg, or 230/21 mcg: 2 inhalations orally twice a day

Comments:

-Inhalations should be administered approximately 12 hours apart.

-Initial dose should be based on the patient’s asthma severity.

-If shortness of breath occurs in the period between doses, use an inhaled, short-acting beta2-agonist for immediate relief.

-Improvement in asthma control occurs within 30 minutes of beginning treatment; maximum benefit can take 1 week or longer.

-The dose can be increased if response does not improve after 2 weeks of therapy.

-If previously effective dose fails to improve asthma control, reevaluate treatment and consider additional therapies (e.g., adding additional inhaled or oral corticosteroid).

Uses: Treatment of asthma in 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

Precautions

Inhalation Powder: Safety and efficacy have not been established in patients younger than 4 years.

Inhalation Aerosol: Safety and efficacy have not been established in patients younger than 12 years.

How is Salmeterol + Fluticasone available?

Salmeterol + Fluticasone is available in the following dosage forms and strengths:

  • Inhalation powder,
  • Inhalation aerosol.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Salmeterol + Fluticasone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: April 26, 2018 | Last Modified: April 26, 2018

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