Fluticasone and Salmeterol (Inhalation)

Overview

Asthma attacks in certain patients can sometimes be so severe that one medicine alone is not effective to treat the symptoms. When inhaled, Fluticasone and Salmeterol effectively relieve severe asthma. The medication is typically used after other asthma medicines failed to work. Chronic Obstructive Pulmonary Disease (COPD) is another condition treated with the combination drug.

Fluticasone is, by itself, one of the most potent inhaled steroid medicines, used to prevent inflammation. Salmeterol is a long-acting bronchodilator that increases airflow to the lungs. Together, they provide powerful relief.

In treating symptoms of severe asthma, the medicine is inhaled through an inhaler device. It makes breathing better by relaxing the muscles in the airways and preventing bronchial and lung inflammation. It works similarly in the treatment of Chronic Obstructive Pulmonary Disease (COPD), improving breathing and lung functions. Both asthma and COPD patients are relieved of various symptoms, such as shortness of breath and wheezing.

The medicine is for preventative care rather than for treating active asthmatic or COPD attacks. While it works well as a long-term treatment for COPD, it is more of a quick and effective, short-term treatment for severe asthma.

Once symptoms are under control in asthma patients, the medicine need not be used.

Fluticasone and Salmeterol combination drug is supplied to patients by doctor's prescription only. It is sold in the US under various brand names, including Advair, Advair Diskus, Advair Diskus 25050, Advair HFA, and Advair HFA 4521.

Conditions Treated

  • Severe Asthma
  • Obstructive Pulmonary Disease (COPD)

Type Of Medicine

  • Inhaled corticosteroid
  • Long-acting Beta-Agonist (LABA) Bronchodilator

Side Effects

Like other prescription medicines, Fluticasone and Salmeterol have a list of side effects. Some of these side effects may be serious or even life-threatening. For example, the medicine may worsen a patient's asthma or cause death. Some patients may also develop serious infections, pneumonia, or a possibly life-threatening condition called paradoxical bronchospasm.

For these reasons, you should use the medicine carefully and pay close attention to the side effects you may experience during treatment. Some side effects are expected; others are not and may require immediate medical attention.

This medicine is effective in reducing the number of asthma attacks. However, it may increase the risk of a severe asthma attack. Call your doctor right away if you experience any of the following signs that your asthma is getting worse:

  • Your symptoms of asthma do not improve or get worse after you have been regularly using Fluticasone and Salmeterol inhalation for seven days.
  • You need emergency medical care for your asthma.
  • The device that you use to test your breathing at home gives you results that show your breathing problems are getting worse.
  • You need to use your short-acting inhaler more often or you need to use more puffs than you did before.
  • You need two or more puffs per day of your short-acting inhaler for at least two days in a row.
  • The short-acting inhaler that you use to treat symptoms of sudden asthma attacks no longer works as well as it did in the past.
  • Within eight weeks you finish one canister of (200 inhalations) of your short-acting inhaler.

Fluticasone and Salmeterol may also cause a possibly life-threatening condition known as paradoxical bronchospasm. When this happens, your wheezing or breathing will worsen. Stop using the medicine and call your doctor right away if you experience one or more of the following symptoms of paradoxical bronchospasm:

  • Difficulty breathing
  • Wheezing
  • Shortness of breath
  • Cough

Also speak with your doctor right away if you experience any of the following side effects:

More commonly occur

  • Eye pain
  • Stools that are black or tarry
  • Blindness
  • Redness, rash or itching of the skin
  • A sensation of numbness, tingling, burning or pain in the arms, hands, legs or feet
  • Cough
  • Fever
  • Headache
  • Wheezing
  • Blurred vision
  • Sore throat
  • Hives or welts
  • Chills
  • Shortness of breath
  • Large, hive-like swelling of the face, lips, eyelids, throat, tongue, legs, feet, hands, or sex organs
  • Stabbing pain in the arms or legs
  • Fast heartbeat
  • Breathing that sounds noisy
  • Swelling of the throat, tongue or face
  • Difficulty swallowing or breathing
  • A sensation of pins and needles sticking you
  • Decreased vision
  • Swollen glands
  • Nausea or vomiting
  • Tearing of the eyes
  • White spots, sores or ulcers in the mouth or on the lips
  • Unusual bleeding or bruising
  • Pain or difficulty urinating

Incidence unknown

  • Irritability
  • Flushed, dry skin
  • Pain in the stomach or abdomen
  • Bruising
  • Fractures
  • Decrease in height
  • Breath odor that smells fruity
  • Problems with moving
  • Dizziness
  • Hair growth on the face of females
  • Unexplained weight loss
  • Mental depression
  • Fainting
  • Large, flat, bluish or purplish patches on the skin
  • Heartbeat that is irregular, slow, fast or pounding
  • Irregular pulse
  • Darkening of the skin
  • Increased hunger
  • Unusual tiredness or weakness
  • Menstrual irregularities (including heavy menstrual bleeding)
  • Backache
  • Muscle wasting
  • Pain in the arms, legs, back or ribs
  • Loss of sexual ability or desire
  • Joint pain
  • Sweating
  • Diarrhea
  • Increase in urine output
  • Excess thirst
  • Troubled breathing
  • Weight gain
  • Full or round face, neck or trunk
  • Stiffness or pain in the muscle

The following side effects may occur, but do not usually require medical attention. They tend to go away on their own as the body gets used to the medicine. If any of them occur and become bothersome, worsen or do not go away, tell your doctor.

More commonly occur

  • Hoarseness
  • Choking
  • Sneezing
  • Congestion
  • Change in the sound of your voice
  • Dryness of the throat
  • Runny nose
  • Pain or aches about the body
  • High-pitched noise while breathing
  • Trouble with swallowing

Less commonly occur

  • Stuffy nose
  • Flu-like symptoms
  • Cough (with mucus)
  • Irritation or inflammation of the eye
  • Muscle pain
  • Tenderness or pain around the eyes and cheekbones
  • Sleep disorders
  • White patches on the tongue or in the mouth or throat

One or more of these side effects may occur, but not all of them may occur at once in one single patient. Some patients may experience other side effects not listed here.

Check with your doctor if you notice any unusual effect that becomes bothersome or does not go away. You can ask your doctor or health care professional about ways to prevent or reduce side effects.

You may also call the FDA at 1-800-FDA-1088 to report side effects.

Dosage

Fluticasone and Salmeterol are two different medicines combined to create a single drug. It is supplied as aerosol liquid, aerosol powder or disk. It is necessary for patients to use the medicine every day and on time to prevent asthma or COPD attacks.

Dosage usually varies from one patient to the other. Take your dose as directed and follow all other directions given to you by your doctor or pharmacist.

Dosage and other directions can be found on the prescription label. Dosage information usually includes the strength of your dose, time between each dose and the length of time you should use the medicine.

The following is only a recommended dosage guide. You should stick to the dosage directions given to you by your doctor or pharmacist.

Dosage with aerosol for inhalation:

Treatment for preventing asthma attacks

Adults, teenagers and children aged 12 years and older: Take two puffs of the medicine in the morning. Take two more puffs in the evening. Carefully take your dose at least every 12 hours.

Children 12 years of age or younger: Treatment with the aerosol form of this combination medication must be determined by a doctor.

Dosage with powder for inhalation:

Treatment for preventing asthma attacks

Adults, teenagers, and children aged four years and older: Take one inhalation once in the morning. Take another inhalation once in the evening. Carefully take your dose at least every 12 hours.

Children four years of age or younger: Treatment with the powdered form of this combination medication must be determined by a doctor.

Treatment of Chronic Obstructive Pulmonary Disease (COPD):

Adults: Take one inhalation (250/50) once in the morning. Take another inhalation once in the evening. Carefully take your dose at least every 12 hours.

Children: Treatment with the powdered form of this combination medication must be determined by a doctor.

Your doctor is likely to stop your treatment of Salmeterol once your asthma symptoms are under control. You will continue to use Fluticasone or another asthma medication, as prescribed by your doctor, or you may be prescribed a different inhaler containing a single medication, which you will use instead of the inhaler containing Fluticasone and Salmeterol.

In addition, your doctor will prescribe a short-acting inhaler for you to use for treating asthma or COPD during an attack. This is necessary because a Fluticasone and Salmeterol combination inhaler cannot be used to treat these attacks once they start.

Using the Fluticasone and Salmeterol inhaler (Advair HFA)

If you are not sure how to use the inhaler device, ask your doctor, pharmacist or healthcare professional to show you. The following guide may also be helpful.

  • Keep the inhaler in the pouch it comes in until immediately before use
  • When ready to use, take the inhaler out of the pouch.
  • Remove the cap on the inhaler and check to make sure the mouthpiece is clean.
  • To prime the inhaler before the first use, shake it well then activate it by spraying it four times.
  • Before you inhale the medicine, try to get as much air as possible out of your lungs by breathing out fully.
  • Position the mouthpiece fully into your mouth. Use your lips to firmly hold it in position. Be careful to not block the mouthpiece with either your teeth or tongue.
  • Press down the top of the inhaler fully, then take a full, deep breath through your mouth. This should deliver your medicine.
  • Allow 30 seconds to go by and then repeat the same steps to take the next puff. Ensure you shake the inhaler first.
  • Gargle and rinse your mouth with water after each dose to prevent throat irritation, infection or hoarseness.
  • Always replace the cover onto the mouthpiece each time you are finished using the inhaler.
  • The digital indicator on the inhaler will show you the number of doses you have remaining, counting from 20 down to 0. This way you will know when your supply of medicine is running low.
  • Carefully dispose of the inhaler once the count reaches 000. At this point, the inhaler device may not deliver the right amount of medicine.
  • The inhaler is provided for you to inhale only Fluticasone and Salmeterol; it should not be used to inhale other medicines.

It is possible for the Advair HFA inhaler to not deliver the correct amount of medicine on the first puff. This sometimes occurs if the inhaler has fallen or has not been used for a week or more.

For it to work effectively, the inhaler needs to be primed. Do this by spraying the medicine about four times into the air, avoiding your face. Thereafter, shake the medicine well for about five seconds before you take each spray.

Missed dose

If you missed a dose of the inhaled medicine, take it as soon as possible. However, if it is time to take the next dose, skip the missed dose and take the next dose on time. An extra dose should not be taken to make up for a missed dose.

Overdose

Call your doctor, 911 or the local poison control center at 1-800-222-1222 if you overdose on this drug. If the patient collapses or is not breathing, call 911.

The following are symptoms of an overdose. Other symptoms not included in the list may occur. Seek medical attention right away.

  • Feeling lightheaded
  • Seizures
  • Chest pain
  • Dizziness
  • Fainting
  • Confusion
  • Pain or tightness in the chest
  • Seizures
  • Blurred vision
  • Irregular, fast or pounding heartbeat
  • Nervousness
  • High blood pressure (hypertension)
  • Loss of appetite
  • Headache
  • Mood changes
  • Uncontrollable shaking of a part of the body
  • Cramps or weakness of the muscle
  • Dry mouth
  • Tremors
  • Decrease in urine amount
  • Sudden sweating
  • Nausea
  • Numbness or tingling of the lips, feet or hands
  • Extreme tiredness
  • A general feeling of illness or discomfort
  • Lack of energy
  • Difficulty falling or staying asleep

Interactions

If you are taking other medicines or have certain medical problems, Fluticasone and Salmeterol may interact with one or more of them. The medicine may also interact with foods or certain substances.

Because of the potential for adverse interaction, certain medications are not recommended to be used together, but there are times when it cannot be avoided. If, to maintain your health, you must use one or more of other medicines, your doctor may take necessary precautions when treating you.

Ensure you let your doctor know if you are using any of the following listed medicines. They are mentioned in this guide because they have the potential to cause significant adverse interaction with Fluticasone and Salmeterol. Other medicines not listed here may also cause adverse interactions, some of which may be significant. Based on the medications you may be taking, your doctor may need to take caution in treating you to avoid adverse interaction.

The following medicines are not recommended to be used with this combination medication. Your doctor may decide against treating you with this medication or change one or more or the other medicines you take.

  • Posaconazole
  • Fluconazole

It is usually not recommended for patients to use the combination treatment with any of the following medicines. In certain cases, it may be required to do so in spite of the risks involved.

In cases where this cannot be avoided, your doctor may change your dose or how often you use one or more of your medicines.

  • Dofetilide
  • Quinine
  • Amiodarone
  • Nelfinavir
  • Apomorphine
  • Tetrabenazine
  • Atazanavir
  • Iloperidone
  • Azithromycin
  • Boceprevir
  • Ibutilide
  • Fingolimod
  • Bupropion
  • Ceritinib
  • Perflutren Lipid Microsphere
  • Ciprofloxacin
  • Amprenavir
  • Clozapine
  • Darunavir
  • Arsenic Trioxide
  • Dasatinib
  • Methadone
  • Ritonavir
  • Clarithromycin
  • Domperidone
  • Bemiparin
  • Droperidol
  • Fosamprenavir
  • Cobicistat
  • Procainamide
  • Gemifloxacin
  • Nadroparin
  • Disopyramide
  • Citalopram
  • Halofantrine
  • Nilotinib
  • Sodium Phosphate, Dibasic
  • Chloroquine
  • Haloperidol
  • Idelalisib
  • Granisetron
  • Indinavir
  • Dolasetron
  • Itraconazole
  • Ketoconazole
  • Lapatinib
  • Alfuzosin
  • Sorafenib
  • Lopinavir
  • Asenapine
  • Lumefantrine
  • Tipranavir
  • Flecainide
  • Nefazodone
  • Chlorpromazine
  • Norfloxacin
  • Octreotide
  • Lumacaftor
  • Ondansetron
  • Paritaprevir
  • Nelfinavir
  • Pixantrone
  • Telithromycin
  • Sodium Phosphate
  • Mefloquine
  • Trazodone
  • Conivaptan
  • Posaconazole
  • Dasabuvir
  • Telavancin
  • Prochlorperazine
  • Ofloxacin
  • Trifluoperazine
  • Promethazine
  • Quinidine
  • Propafenone
  • Saquinavir
  • Ombitasvir
  • Sodium Phosphate, Monobasic
  • Mifepristone
  • Vardenafil
  • Solifenacin
  • Astemizole
  • Ranolazine
  • Telaprevir
  • Paliperidone
  • Sunitinib
  • Toremifene
  • Voriconazole
  • Gatifloxacin

There is a risk of increased side effects if this medicine is used with the following medicines. If using them together is the best treatment for your health, your doctor may change your dose or how often you use either one.

  • Erythromycin

Other interactions

Food, alcohol, and tobacco

Some medicines may or may not be taken with food. In some cases, certain foods should be avoided near the time of taking a dose of a medicine to avoid interaction. Other substances, such as alcohol and tobacco, may also cause adverse interactions. Your doctor will caution you on the use of foods, alcohol and tobacco, if necessary.

The following food may cause an interaction. It has been included in this guide due to its potential to cause a significant interaction. Your doctor may adjust your dose or give you special instructions about the use of this food during treatment.

  • Grapefruit juice

Other medical problems

The presence of other medical problems in patients taking Fluticasone and Salmeterol may cause adverse interaction with this medicine. You must tell your doctor about any other medical problems you have. Using the combination medicine in patients with the following conditions may worsen those conditions.

  • Bronchospasm (severe difficulty breathing)
  • Milk protein allergy (severe)
  • Asthma attack (acute)
  • COPD flare-ups

The medicine should be used with caution in patients with any of the following conditions, to avoid making the condition worse.

  • Heart disease
  • Low potassium in the blood (hypokalemia)
  • Blood vessel disease (such as Churg-Strauss syndrome)
  • Ketoacidosis (high ketones level in the blood)
  • Bone problems (such as osteoporosis)
  • High blood pressure (hypertension)
  • Cataracts
  • Glaucoma
  • Diabetes
  • Heart rhythm problems (such as arrhythmia)
  • Seizures (or history of)
  • Hyperthyroidism (overactive thyroid)

Also, use with caution where patients have the following conditions. Slow removal of the medicine from their body may increase side effects.

  • Liver disease

Inhaled Fluticasone can weaken the immune system, making it difficult for the body to fight off the following infections:

  • Infections (bacterial, viral, or fungal)
  • Herpes simplex (virus) infection of the eye
  • Tuberculosis (active or history of)
  • Chickenpox (including recent exposure)
  • Measles

Your doctor may need to prescribe supplementary oral corticosteroids for the following conditions:

  • Surgery
  • Trauma
  • Infection
  • Stress

Warnings

Do not use Fluticasone and Salmeterol unless it was prescribed for treating your asthma or COPD symptoms.

Salmeterol can worsen asthma or even cause death if it is used continuously. It is not known whether Fluticasone prevents this risk. Your doctor will consider your medical history and the potential risks and benefits involved before treating you. Fluticasone and Salmeterol may not be right for you if your asthma continues to quickly worsen. If your doctor decides to treat you, Fluticasone and Salmeterol combination will be prescribed for you, but never Salmeterol alone.

Do not use this medicine if you are allergic to it. Tell your doctor if you have had an unusual or allergic reaction to Fluticasone and Salmeterol, or any of its ingredients. Also, tell your doctor if there are other medicines that you are allergic to. If you or your child develop an allergic reaction or have symptoms like hives or skin rash, stop taking the medicine and call your doctor right away. You should let your doctor know if you are allergic to certain foods, dyes, preservatives, or animals.

Other medicines may cause interactions with Fluticasone and Salmeterol. If you take or plan to take prescription or non-prescription medicines, vitamins, or nutritional or herbal supplements, make sure you tell your doctor.

Do not use the medicine if you are pregnant or may be pregnant. Adequate studies have not been done to determine if using it during pregnancy may cause harm to an unborn baby. Your doctor must determine if the medicine is safe for you based on the potential risks and benefits of using it.

Do not use the combination medicine if you are breastfeeding. There is no specific information available that suggests the medicine can pass through breast milk and harm a breastfeeding infant. However, due to a potential risk of harm to an infant, your doctor will decide whether the medicine is safe for you.

The safety and efficacy of using the medicine in children depend on a child's age. Do not let your child use this medicine unless the doctor has determined that treatment with it is safe. Your doctor may need to monitor your child's growth closely, because Fluticasone and Salmeterol tend to slow growth in children. Tell your doctor if your child's growth slows while they are taking this medicine.

If you are an elderly patient, tell your doctor if you have blood vessel problems. Your doctor will decide if the medicine is safe for you, and should treat you with caution to avoid a significant interaction with this medical condition.

Use this medicine only to prevent attacks of asthma or COPD. It cannot treat these conditions once they have already started. Do not use this medication to treat COPD attacks or sudden breathing problems. Your doctor should prescribe a short-acting inhaler for you to use during these attacks.

Do not take less or more of the medicine than you were directed to take by your doctor or pharmacist. Using it for a long period or using too much of it may increase the risk of developing adrenal gland problems.

Let your doctor know if you or your child experience one or more of the symptoms of adrenal gland problems. They include nausea, dizziness, diarrhea, loss of appetite, mental depression, fainting, darkening of the skin, unusual tiredness or weakness, vomiting and skin rash.

Do not stop taking the medicine even if you feel better or your symptoms go away, unless your doctor tells you to. Stopping may cause the symptoms of asthma or COPD to come back.

You should not have a medical or dental surgery or procedure unless you first tell the person doing the procedure that you are taking this medication.

Tell your doctor if you or your child's symptoms do not get better after one week of using the medication. You should stop using the medicine and call your doctor right away if your wheezing gets worse.

Stop using the medicine and call your doctor right away if you experience signs of paradoxical bronchospasm, a possibly life-threatening condition.

Certain medical conditions may affect or be affected by the medicine. Tell your doctor if you have or had many severe asthma attacks or have had to be hospitalized due to asthma symptoms.

You may be at a higher risk of contracting measles or chicken pox due to taking this medication. Let your doctor know if you've never had measles or chicken pox or received vaccination for them. Your doctor may tell you to get vaccinated to prevent these infections. Avoid contact with people who are sick, especially if they have measles or chickenpox. Call your doctor right away if you were exposed to these infections or experience any of their symptoms.

Rinse your mouth with room-temperature water after taking each dose of the medicine. This may help to prevent your throat from becoming hoarse, irritated or infected. Avoid swallowing the water while rinsing your mouth.

Tell your doctor right away if you develop symptoms of a fungal infection of the throat or mouth (thrush), which has symptoms including white patches in the throat or mouth and pain when you swallow or eat.

Call your doctor if you are a COPD patient using this medicine and show signs of pneumonia, such as breathing problems, excess sputum (spit), change in color of your sputum, chills, excess coughing or fever.

If you have heart disease or diabetes, this medicine may affect potassium or blood or urine sugar levels in your body. Tell your doctor if you notice a change in your potassium or blood or urine sugar test results, whichever applies to you.

Use this medicine with care. Avoid spraying it in your eyes. If this happens, rinse your eyes immediately with cool water.

Do not use other medicines for asthma, COPD, or other breathing problems before talking to your doctor.

You should not use Fluticasone and Salmeterol inhaler with other inhalers containing a combination of budesonide and formoterol.

Always carry your medical identification card with you if one was issued to you by your doctor. The card will state that you are using this medicine. It should also include other important health information, such any additional medicine you may need during a severe asthma attack, for unusual stress, or other illness.

Keep your appointments for regular follow-ups with your doctor or lab. Your doctor will need to monitor you for side effects and will check your eyes to make sure you are not developing any eye problems, such as cataract or glaucoma. Your doctor will also check for developing bone problems, such as osteoporosis.

Storage

Keep the medicine in its original package until you are ready to use it.

You should store the canister containing Fluticasone and Salmeterol away from heat, moisture, and direct light. Keep from freezing. This medicine should not be stored in a car. This may expose it to extremely hot or cold temperatures that can make the medicine no longer proper for use.

Keep out of the reach of children.

Throw away medicine that is expired or no longer needed. You should not dent, damage or poke holes in the canister, or toss it into a fire. You may ask your healthcare professional or local waste disposal agency how to safely dispose of it.

Summary

Fluticasone and Salmeterol are two different medicines combined to create a single drug. It is used for treating symptoms of asthma and Chronic Obstructive Pulmonary Disease (COPD).

It comes in a powder or aerosol form and can be safely and effectively used in the treatment of adults and children of certain ages.

A doctor's decision to prescribe this combination medication usually only comes after determining that the patient's asthma is too severe to be treated with one medication. The medication is also prescribed when others failed to work.

The medicine is designed to be used only for preventing attacks of asthma and COPD symptoms. It will not work if used to treat active asthmatic or COPD attacks. This means that patients usually need to use another medicine to treat sudden asthma or COPD attacks or treat attacks that are already active.

The medicine works well as a long-term treatment for COPD patients, but not for asthma patients. This is because it is intended for quick and effective relief of severe asthma. Once it is under control, treatment may be stopped.

It is a usual practice for a doctor to stop a patient's treatment with Salmeterol but allow the continued use of Fluticasone. This is done to prevent serious side effects and a potentially fatal outcome.

Notwithstanding its ability to provide quick and effective relief for asthma and good long-term benefits for COPD patients, this drug may increase the risk of severe asthma attacks. It may also cause other medical problems and has a long list of potentially serious side effects. These effects may require urgent medical attention.

The medicine is shown to cause slow growth in children being treated with it. Elderly patients are also at risk for more side effects and their health may be adversely affected if they have blood vessel problems.

The use of Fluticasone and Salmeterol may cause paradoxical bronchospasm, a condition that can be life-threatening. This is in addition to the potential for it to weaken the immune system, thus exposing patients to the risk of contracting bacterial, viral or fungal infections. COPD patients are also at risk of developing pneumonia.

It could take a week or more before the medicine becomes fully effective. As long as patients carefully follow the directions for use and monitor their body's response to the drug, they usually get the desired relief from their symptoms.