A budesonide, glycopyrrolate, and formoterol inhaler (Breztri Aerosphere) combines 3 medicines into 1 inhaler and is used as a long-term treatment for COPD (chronic obstructive pulmonary disease) in adults. The 3 medicines are:

• an inhaled corticosteroid (ICS) medicine (budesonide)
• an anticholinergic medicine (glycopyrrolate)
• a long-acting beta₂-adrenergic agonist (LABA) medicine (formoterol).

Budesonide, glycopyrrolate, and formoterol gained FDA approval under the brand name Breztri Aerosphere on July 23, 2020. There is no generic.

How do budesonide, glycopyrrolate, and formoterol work together?

The 3 ingredients in a budesonide, glycopyrrolate, and formoterol inhaler have different mechanisms of action and work together to help control COPD symptoms.

• Budesonide decreases lung inflammation, which can lead to breathing problems.
• Glycopyrrolate blocks the neurotransmitter acetylcholine in the lungs, allowing the airways to relax and widen, making breathing easier.
• Formoterol activates beta2-adrenergic receptors on the smooth muscle cells in the airways, allowing the airways to widen, making breathing easier. Formoterol has a long-lasting effect, typically lasting 12 hours or more, which provides sustained symptom relief throughout the day for COPD patients.

Clinical trials have not been done using a budesonide, glycopyrrolate, and formoterol for asthma, and this inhaler is not approved for asthma, only for COPD. 

This inhaler should not be used to relieve sudden breathing problems and will not replace a rescue inhaler, such as albuterol. If you do not have a rescue inhaler, talk to your healthcare provider.

Budesonide, glycopyrrolate, and formoterol side effects

The most common side effects of a budesonide, glycopyrrolate, and formoterol inhaler are:

• upper respiratory tract infections (such as sinusitis) or the flu
• lung infections (such as pneumonia)
• back pain
• oral thrush. Wash your mouth out with water and spit out after using the inhaler to help prevent this
• joint pain or muscle spasms
• headache
• high blood sugar levels
• a cough or hoarseness
• gastrointestinal effects such as diarrhea or nausea
• signs of a urinary tract infection including painful and frequent urination
• difficulty sleeping
• feeling anxious
• heart palpitations.

Tell your healthcare provider about any side effect that bothers you or does not go away.

Serious side effects and warnings

A budesonide, glycopyrrolate, and formoterol inhaler can cause the following serious side effects.

Fungal infections in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using your budesonide, glycopyrrolate, and formoterol inhaler to help reduce your chance of getting thrush.

Pneumonia. People with COPD have a higher chance of getting pneumonia. Budesonide, glycopyrrolate, and formoterol Aerosphere may increase your chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms:

• an increase in sputum production
• change in the color of your mucus
• fever
• chills
• increased cough
• increased breathing problems.

A weakened immune system and an increased chance of getting infections (immunosuppression). Budesonide, glycopyrrolate, and formoterol may make it harder for your immune system to fight infections.

Reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an ICS (such as budesonide, glycopyrrolate, and formoterol inhaler). During this transition period, when your body is under stress from fever, trauma (such as a car accident), infection, surgery, or worse COPD symptoms, adrenal insufficiency can get worse and may cause death.
Symptoms of adrenal insufficiency include:

• feeling tired
• lack of energy
• weakness
• nausea and vomiting
• low blood pressure (hypotension).

Sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after using your budesonide, glycopyrrolate, and formoterol inhaler, stop using it and call your healthcare provider right away.

Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction after using your budesonide, glycopyrrolate, and formoterol inhaler:

• rash
• hives
• swelling of your face, mouth, and tongue
• breathing problems.

Budesonide, glycopyrrolate, and formoterol may affect your heart. Tell your healthcare provider immediately if your blood pressure increases or you develop a fast or irregular heartbeat or chest pain after using this inhaler.

Budesonide, glycopyrrolate, and formoterol may affect your nervous system. Tell your healthcare provider immediately if you develop a tremor or if you find yourself more anxious or nervous after using this inhaler.

Bone thinning or weakness (osteoporosis). Budesonide, glycopyrrolate, and formoterol may reduce your bone density and cause thinning or weakness.

Budesonide, glycopyrrolate, and formoterol may cause new or worsened eye problems including acute narrow-angle glaucoma and cataracts. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include:

• eye pain or discomfort
• nausea or vomiting
• blurred vision
• seeing halos or bright colors around lights
• red eyes.

If you have these symptoms, call your healthcare provider right away before taking another dose.

Urinary retention. People who take budesonide, glycopyrrolate, and formoterol inhaler may develop new or worsening urinary retention. Symptoms of urinary retention may include:

• • difficulty urinating
  • urinating frequently
  • painful urination
  • urination in a weak stream or drips

If you have these symptoms of urinary retention, stop taking budesonide, glycopyrrolate, and formoterol Aerosphere and call your healthcare provider right away before taking another dose.

Changes in laboratory blood values, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia) have been reported after using a Budesonide, glycopyrrolate, and formoterol inhaler. Low levels of potassium may cause symptoms of muscle spasm, muscle weakness, or abnormal heart rhythm.

These are not all the possible side effects of budesonide, glycopyrrolate, and formoterol. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects.

Before taking

A budesonide, glycopyrrolate, and formoterol inhaler should not be used in children because clinical trials have not been conducted in children, and it is not known if this medicine is safe and effective in this age group.

Do not use a budesonide, glycopyrrolate, and formoterol inhaler if you are allergic to budesonide, glycopyrrolate, formoterol, or any of the other ingredients in you’re inhaler. See “What are the ingredients in Breztri Aerosphere?” at the end of this page for a complete list of ingredients.

Before using budesonide, glycopyrrolate, and formoterol Aerosphere, tell your healthcare provider about all of your medical conditions, including if you:

• have heart problems
• have high blood pressure
• have seizures
• have thyroid problems
• have diabetes
• have liver problems
• have kidney problems
• have weak bones (osteoporosis)
• have an immune system problem
• have eye problems such as glaucoma or cataracts. Using a budesonide, glycopyrrolate, and formoterol inhaler may make your glaucoma worse
• have prostate or bladder problems, or problems passing urine. Using a budesonide, glycopyrrolate, and formoterol inhaler may make these problems worse
• have a viral, bacterial, parasitic, or fungal infection
• are exposed to chickenpox or measles
• are pregnant, or plan to become pregnant. It is not known if budesonide, glycopyrrolate, and formoterol inhaler may harm your unborn baby
• are breastfeeding. It is not known if the medicines in budesonide, glycopyrrolate, and formoterol inhaler pass into your breast milk and if they can harm your baby. You and your healthcare provider should decide if you will take budesonide, glycopyrrolate, and formoterol inhaler while breastfeeding.

How should I use budesonide, glycopyrrolate, and formoterol inhaler?

A budesonide, glycopyrrolate, and formoterol inhaler is used as 2 puffs in the morning and 2 puffs in the evening.

• to improve symptoms of COPD for better breathing and to reduce the number of flare-ups (the worsening of your COPD symptoms for several days).

• Before using budesonide, glycopyrrolate, and formoterol inhaler, make sure your healthcare provider has taught you how to use the inhaler and that you understand how to use it correctly.
• Use this medicine exactly as your healthcare provider tells you to use it. Do not use it more often than prescribed.
• Use 2 inhalations of budesonide, glycopyrrolate, and formoterol inhaler, 2 times each day (2 puffs in the morning and 2 puffs in the evening).
• Do not take more than 2 inhalations of this inhaler 2 times each day.
• If a dose (2 puffs) is missed, it should be taken as soon as possible and the next dose should be taken at the usual time. Do not take more than one dose to make up for a forgotten dose.
• Rinse your mouth with water and spit the water out after each dose (2 puffs). Do not swallow the water. This will help to reduce the chance of getting a fungus infection (thrush) in the mouth and throat.
• If you take too much budesonide, glycopyrrolate, and formoterol inhaler, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.
• Do not spray the budesonide, glycopyrrolate, and formoterol inhaler into your eyes. If it gets in your eyes, rinse them well with water. If redness continues, call your healthcare provider.
• Do not use other medicines that contain a LABA or an anticholinergic for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA or anticholinergic-containing medicines.
• Do not change or stop any medicines used to control or treat your breathing problems. Your healthcare provider will change your medicines as needed.
• A budesonide, glycopyrrolate, and formoterol inhaler will not relieve sudden breathing problems and you should not take extra doses to relieve sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
• Call your healthcare provider or get emergency medical care right away if:
  • your breathing problems get worse.
  • you need to use your rescue inhaler more often than usual.
  • your rescue inhaler does not work as well to relieve your symptoms.

What other drugs will affect budesonide, glycopyrrolate, and formoterol?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Budesonide, glycopyrrolate, and formoterol inhaler and certain other medicines may interact with each other. This may cause serious side effects.

Especially tell your healthcare provider if you take:

• anticholinergics (including tiotropium, ipratropium, aclidinium, and umeclidinium)
• other LABAs (including salmeterol, formoterol, arformoterol tartrate, vilanterol, olodaterol, and indacaterol)
• atropine
• antifungal or anti-HIV medicines.

Budesonide, glycopyrrolate, and formoterol should not be used with other combination inhalers, such as Trelegy . Budesonide, glycopyrrolate, and formoterol may be used with rescue inhalers, such as albuterol.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

Budesonide, glycopyrrolate, and formoterol inhaler storage

Store your budesonide, glycopyrrolate, and formoterol inhaler at room temperature between 68ºF to 77ºF (20ºC to 25ºC). Keep in a dry place away from heat and sunlight. Keep the inhaler in its unopened foil pouch and only open when ready to use.

Do not use or store your budesonide, glycopyrrolate, and formoterol inhaler near heat or a flame. Temperatures above 120ºF (49ºC) may cause the canister to burst.

Do not throw the canister into a fire or an incinerator. Do not put a hole in the canister.

Throw away the budesonide, glycopyrrolate, and formoterol inhaler 3 months after you open the foil pouch (for the 120-inhalation canister), or 3 weeks after you open the foil pouch (for the 28-inhalation canister), or when the dose indicator reaches zero “0”, whichever comes first.

Budesonide and formoterol combination is used to help control the symptoms of asthma and improve lung function. It is used when a patient’s asthma has not been controlled sufficiently on other asthma medicines, or when a patient’s condition is so severe that more than one medicine is needed every day.

Budesonide and formoterol combination is also used as long-term maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. This medicine helps improve and reduce the number of flare-ups of the symptoms of COPD.

Inhaled budesonide belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It works by preventing inflammation (swelling) in the lungs that causes an asthma attack.

Formoterol belongs to the family of medicines known as long-acting bronchodilators. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, and trouble breathing by increasing the flow of air through the bronchial tubes.

This medicine is available only with your doctor’s prescription.

Before using budesonide and formoterol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Symbicort Aerosphere® inhaler in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Symbicort® inhaler in children 6 years of age and older. However, safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Symbicort Aerosphere® inhaler in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Symbicort® inhaler in the elderly. However, elderly patients with heart problems may require special caution when receiving budesonide and formoterol combination.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Cisapride
• Desmopressin
• Dronedarone
• Levoketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• Rotavirus Vaccine, Live
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Aceclofenac
• Acemetacin
• Adagrasib
• Alfuzosin
• Amineptine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amtolmetin Guacil
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Aspirin
• Astemizole
• Atazanavir
• Atenolol
• Azithromycin
• Balofloxacin
• Bedaquiline
• Belzutifan
• Bemetizide
• Bemiparin
• Bendroflumethiazide
• Benzthiazide
• Besifloxacin
• Betaxolol
• Bisoprolol
• Boceprevir
• Bromfenac
• Bufexamac
• Bumetanide
• Buprenorphine
• Bupropion
• Buserelin
• Carteolol
• Carvedilol
• Celecoxib
• Celiprolol
• Ceritinib
• Chloroquine
• Chlorothiazide
• Chlorpromazine
• Chlorthalidone
• Choline Salicylate
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clonixin
• Clopamide
• Clothiapine
• Clozapine
• Cobicistat
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Cyclopenthiazide
• Cyclosporine
• Cyclothiazide
• Dabrafenib
• Darunavir
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexibuprofen
• Dexketoprofen
• Dexmedetomidine
• Diazoxide
• Dibenzepin
• Diclofenac
• Diflunisal
• Dipyrone
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Droxicam
• Duvelisib
• Ebastine
• Efavirenz
• Encorafenib
• Enoxacin
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Esmolol
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Etozolin
• Etrasimod
• Famotidine
• Fedratinib
• Felbamate
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Fexinidazole
• Fingolimod
• Flecainide
• Fleroxacin
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Flumequine
• Fluoxetine
• Flurbiprofen
• Foscarnet
• Fosnetupitant
• Fosphenytoin
• Fostemsavir
• Furosemide
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibuprofen
• Ibutilide
• Idelalisib
• Iloperidone
• Imipramine
• Indapamide
• Indinavir
• Indomethacin
• Inotuzumab Ozogamicin
• Isocarboxazid
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Ketoprofen
• Ketorolac
• Labetalol
• Lapatinib
• Larotrectinib
• Lefamulin
• Lenacapavir
• Lenvatinib
• Leuprolide
• Levobunolol
• Levofloxacin
• Linezolid
• Lofepramine
• Lofexidine
• Lomefloxacin
• Lopinavir
• Lorlatinib
• Lornoxicam
• Loxoprofen
• Lumacaftor
• Lumefantrine
• Lumiracoxib
• Lutetium Lu 177 Dotatate
• Macimorelin
• Mavacamten
• Meclofenamate
• Mefenamic Acid
• Mefloquine
• Melitracen
• Meloxicam
• Methacholine
• Methadone
• Methotrimeprazine
• Methyclothiazide
• Methylene Blue
• Metipranolol
• Metolazone
• Metoprolol
• Metronidazole
• Mifepristone
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moricizine
• Morniflumate
• Moxifloxacin
• Nabumetone
• Nadifloxacin
• Nadolol
• Nadroparin
• Nafarelin
• Naproxen
• Nebivolol
• Nefazodone
• Nelfinavir
• Nepafenac
• Netupitant
• Niflumic Acid
• Nilotinib
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nirmatrelvir
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Olutasidenib
• Omaveloxolone
• Ondansetron
• Opipramol
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxaprozin
• Oxprenolol
• Oxyphenbutazone
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Papaverine
• Parecoxib
• Paroxetine
• Pasireotide
• Pazopanib
• Pazufloxacin
• Pefloxacin
• Penbutolol
• Pentamidine
• Perphenazine
• Phenelzine
• Phenobarbital
• Phenylbutazone
• Piketoprofen
• Pimavanserin
• Pindolol
• Pipamperone
• Piretanide
• Piroxicam
• Pirtobrutinib
• Pitolisant
• Polythiazide
• Ponesimod
• Posaconazole
• Pranoprofen
• Primidone
• Probucol
• Procainamide
• Procarbazine
• Prochlorperazine
• Proglumetacin
• Promethazine
• Propafenone
• Propranolol
• Propyphenazone
• Proquazone
• Protriptyline
• Prulifloxacin
• Quetiapine
• Quinethazone
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Rasagiline
• Relugolix
• Ribociclib
• Risperidone
• Ritlecitinib
• Ritonavir
• Rofecoxib
• Rufloxacin
• Safinamide
• Salicylic Acid
• Salsalate
• Saquinavir
• Sargramostim
• Selegiline
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Sodium Salicylate
• Solifenacin
• Somatrogon-ghla
• Sorafenib
• Sotalol
• Sparfloxacin
• Sulindac
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tenoxicam
• Tetrabenazine
• Tianeptine
• Tiaprofenic Acid
• Timolol
• Tocilizumab
• Tolfenamic Acid
• Tolmetin
• Tolterodine
• Toremifene
• Torsemide
• Tosufloxacin
• Tranylcypromine
• Trazodone
• Trichlormethiazide
• Triclabendazole
• Trimipramine
• Triptorelin
• Trofinetide
• Valdecoxib
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Xipamide
• Zotepine
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Auranofin
• Erythromycin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma attack, acute or
• Bronchospasm (difficulty with breathing), acute or
• COPD flare-up—Should not be used in patients with these conditions.

• Cataracts or
• Diabetes or
• Glaucoma or
• Heart or blood disease or
• Heart rhythm problems (eg, arrhythmia) or
• Hypertension (high blood pressure) or
• Hyperglycemia (high blood sugar) or
• Hypokalemia (low potassium in the blood) or
• Immune system problem (eg, Churg-Strauss syndrome) or
• Ketoacidosis (high ketones in the blood) or
• Osteoporosis, history of or
• Seizures or
• Thyroid problems—Use with caution. May make these conditions worse.

• Chickenpox (including recent exposure) or
• Herpes simplex (virus) infection of the eye or
• Infections (eg, virus, bacteria, or fungus) or
• Measles (including recent exposure) or
• Tuberculosis, active or history of—Can reduce the body’s ability to fight off these infections.

• Electrolyte imbalance or
• Infection (eg, gastroenteritis) or
• Stress or
• Surgery or
• Trauma—Supplementary oral corticosteroids may be needed. Check with your doctor.
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper use of budesonide and formoterol

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Do not stop using this medicine without telling your doctor. To do so may make your condition worse.

Inhaled fluticasone and salmeterol is used to prevent asthma attacks and treat chronic obstructive pulmonary disease (COPD). It is not used to relieve an asthma attack that has already started. For relief of an asthma attack that has already started, you should use another medicine. If you do not have another medicine to use for an attack or if you have any questions about this, check with your doctor.

This medicine comes with a patient information leaflet or patient instructions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor or pharmacist to show you what to do. Also, ask your doctor to check regularly how you use the inhaler to make sure you are using it properly.

In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor.

When you use the Symbicort® inhaler for the first time, or if you have not used it for 7 days or longer, or if the inhaler has been dropped, it may not deliver the right amount of medicine with the first inhalation. Therefore, before using the inhaler, prime it by spraying the medicine 2 times into the air away from the face, and shaking it well for 5 seconds before each spray.

To use the Symbicort® inhaler:

• Take the inhaler out of the moisture-protective foil pouch before you use it for the first time.
• Do not use the inhaler for this medicine with any other medicine.
• Prime the inhaler before use by shaking the inhaler well for 5 seconds and then releasing a test spray. Once again, shake the inhaler and release a second test spray.
• Breathe out to the end of a normal breath (exhale). Do not breathe into the inhaler.
• Put the mouthpiece fully into your mouth and close your lips around it. Do not block the mouthpiece with your teeth or tongue.
• While pressing down firmly and fully on the grey top of the inhaler, breathe in through your mouth as deeply as you can until you have taken a full deep breath.
• Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath for as long as you can up to 10 seconds before breathing out slowly. This gives the medicine time to settle in your airways and lungs.
• Release your finger from the grey top and then turn your head away from the inhaler. Breathe out slowly to the end of a normal breath. Do not breathe into the inhaler.
• Shake the inhaler again for 5 seconds and take the second inhalation following exactly the same steps you used for the first inhalation.
• Replace the mouthpiece cover after using the medicine.
• Gargle and rinse your mouth with water after each dose. This will help prevent hoarseness, throat irritation, and infection in the mouth. Do not swallow the water after rinsing.
• Clean the inhaler every 7 days by wiping the mouthpiece with a dry cloth. Do not put the inhaler into water or try to take it apart. However, you must use a new inhaler with each refill of your medicine.

The dose counter at the top of the Symbicort® inhaler will turn yellow when the inhaler has 20 or fewer doses left. Throw the inhaler when it reaches 0, or if it has been 3 months since you last opened the foil pouch.

When you use the Symbicort Aerosphere® inhaler for the first time, it may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, prime it by spraying the medicine 4 times into the air away from the face, and shaking it well before each spray. If you have not used it for 7 days or longer or if you’ve dropped it, re-prime by spraying the medicine 2 times into the air away from the face, and shaking it well before each spray.

To use the Symbicort Aerosphere® inhaler:

• This medicine comes in a sealed foil pouch. Do not open the foil pouch until you are ready to use a dose of this medicine.
• Once opened, remove the inhaler from the pouch.
• Take the cap off the mouthpiece. Check the mouthpiece to make sure it is clear.
• Press the center of the dose indicator all the way down and release it. You may hear a soft click from the dose indicator as it counts down during use.
• To inhale this medicine, breathe out fully and try to get as much air out of your lungs as possible. Put your lips tightly around the mouthpiece and breathe in quickly and deeply until the canister stops moving in the actuator and a puff of medicine has been released.
• Remove the inhaler from your mouth and hold your breath for as long as is comfortable, and then breathe out slowly through your nose.
• Rinse your mouth with water after each dose. This will help prevent infection in the mouth. Do not swallow the water after rinsing.
• Clean the actuator at least once a week with warm water for 30 seconds. Shake off the excess water. Let the actuator air-dry overnight. Do not let the canister get wet.

The dose display window of the Symbicort Aerosphere® inhaler will turn red when the inhaler has 20 or fewer doses left. Throw the inhaler when it reaches 0, or if it has been 3 months since you last opened the foil pouch.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For inhalation dosage form (aerosol):
  • For preventing an asthma attack:
    • Adults and children 12 years of age and older—Two puffs in the morning and another 2 puffs in the evening. Each inhalation contains 80 or 160 micrograms (mcg) of budesonide and 4.5 mcg of formoterol.
    • Children 6 to 11 years of age—Two puffs in the morning and another 2 puffs in the evening. Each inhalation contains 80 mcg of budesonide and 4.5 mcg of formoterol.
    • Children younger than 6 years of age—Use and dose must be determined by your child’s doctor.
  • For treatment and prevention of worsening attacks of COPD:
    • Adults—Two puffs in the morning and another 2 puffs in the evening. Each inhalation contains 160 micrograms (mcg) of budesonide and 4.8 mcg of formoterol.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the inhaler with the mouthpiece down.

Precautions while using budesonide and formoterol

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

Although this medicine decreases the number of asthma episodes, it may increase the chances of a severe asthma attack when they do occur. Be sure to read about these risks in the patient information leaflet and talk to your doctor about any questions or concerns that you have.

This medicine should not be used if you are having a sudden COPD attack, or if symptoms of COPD attack has already started. Your doctor will give you a short-acting inhaler to use for this condition. If the short-acting inhaler is not working, tell your doctor right away.

Tell your doctor if you are also using any other medicine for your COPD. Your doctor may want you to use it only during a severe COPD attack. Follow your doctor’s instructions on how you should take your medicine.

Talk to your doctor or get medical care right away if:

• Your symptoms do not improve after using this medicine for a few days or if they become worse.
• Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often.

Do not use this medicine together with other inhaled medicines for COPD, including arformoterol (Brovana®), formoterol (Foradil®, Perforomist®), indacaterol (Arcapta® Neohaler®), olodaterol, salmeterol (Serevent®), or vilanterol.

Do not change your dose or stop using your medicine without first asking your doctor.

You may get infections more easily while using this medicine. Tell your doctor right away if you or your child have been exposed to someone with chickenpox or measles.

This medicine may cause fungus infection of the mouth or throat (thrush). Tell your doctor right away if you or your child have white patches in the mouth or throat, or pain when eating or swallowing.

Patients with COPD may be more likely to have pneumonia when taking this medicine. Check with your doctor if you start having increased sputum (spit) production, change in sputum color, fever, chills, increased cough, or an increase in breathing problems.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you or your child have more than one of these symptoms while you are using this medicine: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

This medicine may cause paradoxical bronchospasm, which may be life-threatening. Check with your doctor right away if you or your child are having a cough, difficulty with breathing, or wheezing.

If you or your child develop a skin rash, hives, or any allergic reaction to this medicine, check with your doctor right away.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.

This medicine may cause children to grow more slowly than usual. Talk to your child’s doctor if you have any concerns.

This medicine may cause heart or blood vessel problems, including heart rhythm problems. Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain.

Call your doctor right away if blurred vision, difficulty in reading, seeing halos around lights, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may affect blood sugar and potassium levels. If you notice a change in the results of your blood or urine sugar or potassium tests or if you have any questions, check with your doctor.

Your doctor may want you to carry a medical identification (ID) card stating that you or your child are using this medicine and that you may need additional medicine during times of emergency, a severe asthma attack or other illness, or unusual stress.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of budesonide and formoterol

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Body aches or pain
• chest tightness
• chills
• cough
• difficulty with breathing
• ear congestion
• fever
• headache
• loss of voice
• muscle aches
• pain or tenderness around the eyes and cheekbones
• sneezing
• sore throat
• stuffy or runny nose
• unusual tiredness or weakness

Less common

• Bladder pain
• bloody or cloudy urine
• congestion
• cough producing mucus
• diarrhea
• difficult, burning, or painful urination
• dryness of the throat
• fast, irregular, pounding, or racing heartbeat or pulse
• frequent urge to urinate
• general feeling of discomfort or illness
• hoarseness
• joint pain
• loss of appetite
• lower back or side pain
• nausea
• noisy breathing
• shakiness in the legs, arms, hands, or feet
• shivering
• sore mouth or tongue
• stomach pain
• sweating
• tender, swollen glands in the neck
• trembling or shaking of the hands or feet
• trouble with sleeping
• trouble with swallowing
• voice changes
• vomiting
• white patches in the mouth or on the tongue

Rare

• Blurred vision
• confusion
• decreased urine
• dizziness or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• enlarged pupils
• fainting
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• increased sensitivity of the eyes to light
• increased sweating, possibly with fever or cold, clammy skin
• increased thirst
• increased urination
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• muscle cramps
• nervousness
• numbness or tingling in the hands, feet, or lips
• pounding in the ears
• seizures
• severe chest pain
• severe headache
• slow, fast, pounding, or irregular heartbeat or pulse
• stiff or sore neck
• unexplained weight loss

Incidence not known

• Blindness
• decreased vision
• eye pain
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• tearing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Arm, back, or jaw pain
• chest pain or discomfort
• darkening of the skin
• drowsiness
• mental depression
• rapid, deep breathing
• restlessness
• skin rash
• stomach cramps

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Stomach discomfort

Less common

• Belching
• difficulty with moving
• heartburn
• indigestion
• muscle spasms or stiffness
• pain in the arms or legs
• stomach upset
• swollen joints

Rare

• Bad, unusual, or unpleasant (after) taste
• change in taste
• deep or fast breathing with dizziness
• fear
• hives or welts, itching skin
• irritability
• large, flat, blue, or purplish patches in the skin
• numbness in the feet, hands, and around the mouth
• redness of the skin

Breo Ellipta inhalation powder contains a combination of fluticasone and vilanterol. Fluticasone is a steroid that prevents the release of substances in the body that cause inflammation. Vilanterol is a bronchodilator that works by relaxing muscles in the airways to improve breathing.

Breo Ellipta is a once-daily combination medicine used to treat asthma or COPD (chronic obstructive pulmonary disease), it helps improve breathing, reduce COPD flare-ups, and help prevent and control asthma symptoms. For asthma, it can be used by patients 5 years and older.

Breo Ellipta is not used to treat sudden, severe symptoms of COPD or asthma and does not replace a rescue inhaler

Vilanterol, when used alone, may increase the risk of death in people with asthma. However, this risk is not increased when fluticasone and vilanterol are used together as a combination product.

Warnings

Breo Ellipta is not a rescue medicine. It will not work fast enough to treat an asthma or bronchospasm attack.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Breo Ellipta may interact with other medicines and this may cause serious side effects. Tell your healthcare provider if you take antifungal or anti-HIV medicines.

Before taking this medicine

You should not use Breo Ellipta if you are allergic to fluticasone, vilanterol, or milk proteins.

Fluticasone can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

To make sure Breo Ellipta is safe for you, tell your doctor if you have:

• glaucoma or cataracts;
• a weak immune system;
• heart disease, high blood pressure;
• liver disease;
• a thyroid disorder;
• a seizure;
• diabetes;
• any type of infection (bacterial, fungal, viral, or parasitic); or
• osteoporosis.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk.

Tell your doctor if you are pregnant. It is not known whether Breo Ellipta will harm an unborn baby. However, having untreated or uncontrolled asthma during pregnancy may cause complications such as low birth weight, premature birth, or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating asthma may outweigh any risks to the baby.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Breo Ellipta is not approved for use by anyone younger than 4 years old.

How should I use Breo Ellipta?

Use Breo Ellipta inhalation powder exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Breo Ellipta is not a rescue medicine for asthma or bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

Breo Ellipta is a powder that comes with a special inhaler device preloaded with blister packs containing measured doses of the medicine. The device opens and loads a blister of Breo Ellipta each time you use the inhaler. Follow the patient instructions provided with the inhaler device.

Use the medicine at the same time each day, and not more than once in a 24-hour period.

Your dose needs may change due to surgery, illness, stress, or a recent asthma attack. Do not change your Breo Ellipta dose or dosage schedule without your doctor’s advice.

Always rinse out your mouth with water after using the inhaler device, to help prevent thrush (a fungal infection in the mouth or throat).

While using Breo Ellipta, your doctor will need to check your lung function on a regular basis. Your vision and your bone mineral density may also need to be checked.

Once your asthma is under control, your doctor may want you to stop using Breo Ellipta. Keep all follow-up appointments and do not stop using the medicine unless your doctor tells you to.

Store Breo Ellipta at room temperature away from moisture, heat, and light. Keep the inhaler device in the sealed foil tray until ready to start using it.

Throw the inhaler device away 6 weeks after you have taken it out of the foil pouch, or if the dose indicator shows a zero, whichever comes first.

Breo Ellipta Dosage Information

Maintenance treatment of COPD: 1 actuation of 100/25 mcg once daily administered by oral inhalation.

Maintenance treatment of asthma in adult patients aged 18 years and older: 1 actuation of 100/25 mcg or 200/25 mcg once daily administered by oral inhalation.

Maintenance treatment of asthma in pediatric patients aged 12 to 17 years: 1 actuation of 100/25 mcg once daily administered by oral inhalation.

Maintenance treatment of asthma in pediatric patients aged 5 to 11 years: 1 actuation of 50/25 mcg once daily administered by oral inhalation.

Breo Ellipta is available as

• 50 mcg fluticasone furoate and 25 mcg vilanterol (50/25 mcg) per actuation
• 100 mcg fluticasone furoate and 25 mcg vilanterol (100/25 mcg) per actuation
• 200 mcg fluticasone furoate and 25 mcg vilanterol (200/25 mcg) per actuation

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include chest pain, fast heart rate, and feeling shaky or short of breath.

Long term use of an inhaled steroid can lead to glaucoma, cataracts, thinning skin, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using Breo Ellipta?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using a steroid such as fluticasone.

Breo Ellipta side effects

Get emergency medical help if you have signs of an allergic reaction to Breo Ellipta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medicine;
• chest pain, fast or pounding heartbeats, pounding in your neck or ears;
• sores or white patches in your mouth and throat, pain when swallowing;
• fever, chills, cough with yellow or green mucus;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights.
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor;
• low potassium level – leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or
• signs of a hormonal disorder – worsening tiredness or muscle weakness, feeling light-headed, nausea, vomiting.

Common Breo Ellipta side effects may include:

• headache, back pain, joint pain;
• fever, flu symptoms;
• increased blood pressure;
• runny or stuffy nose, sore throat, cough; or
• a hoarse voice.

What is fluticasone and salmeterol inhalation?

Fluticasone and salmeterol inhalation is a steroid and bronchodilator combination medicine that is used to prevent asthma attacks. It is also used to prevent flare-ups or worsening of chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and/or emphysema.

In people with COPD, fluticasone and salmeterol is for long-term treatment. In people with asthma, fluticasone and salmeterol is for short-term treatment until symptoms are well controlled with with other medicines.

Advair Diskus is for use in adults and children who are at least 4 years old. Advair HFA and AirDuo Respiclick are for use in adults and children who are at least 12 years old.

Fluticasone and salmeterol may also be used for purposes not listed in this medication guide.

Fluticasone and salmeterol side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Fluticasone and salmeterol may cause serious side effects. Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medicine;
• fever, chills, cough with mucus, feeling short of breath;
• chest pain, fast or irregular heartbeats, severe headache, pounding in your neck or ears;
• tremors, nervousness;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• signs of thrush (a fungal infection)–sores or white patches in your mouth or throat, trouble swallowing;
• high blood sugar–increased thirst, increased urination, dry mouth, fruity breath odor;
• low potassium level–leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or
• signs of a hormonal disorder–worsening tiredness or weakness, feeling light-headed, nausea, vomiting.

Fluticasone can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

Common side effects of fluticasone and salmeterol may include:

• headache, muscle pain, bone pain, back pain;
• nausea, vomiting;
• thrush, throat irritation;
• ongoing cough, hoarseness or deepened voice;
• cold symptoms such as stuffy nose, sneezing, sore throat; or
• ear infection (in a child)–fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Fluticasone and salmeterol is not a rescue medicine. It will not work fast enough to treat an asthma or bronchospasm attack.

Seek medical attention you have worsening breathing problems, or if you think your medications are not working as well.

Before taking this medicine

You should not use fluticasone and salmeterol if you are allergic to fluticasone or salmeterol, or:

• if you have a severe allergy to milk proteins; or
• if you are having an asthma attack or severe COPD symptoms.

Fluticasone can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

Tell your doctor if you have ever had:

• glaucoma or cataracts;
• heart disease or high blood pressure;
• a seizure;
• diabetes;
• a food or drug allergy;
• a weak immune system;
• any type of infection (bacterial, fungal, viral, or parasitic);
• osteoporosis;
• a thyroid disorder; or
• liver or kidney disease.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough  vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk.

Tell your doctor if you are pregnant. It is not known whether this medicine will harm an unborn baby. However, having untreated or uncontrolled asthma during pregnancy may cause complications such as low birth weight, premature birth, or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating asthma may outweigh any risks to the baby.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Do not give this medicine to a child without medical advice.

How should I use fluticasone and salmeterol?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Using too much of this medicine can cause life-threatening side effects.

Fluticasone and salmeterol is not a rescue medicine for asthma or bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

 Advair Diskus is a powder form of fluticasone and salmeterol that comes with a special inhaler device pre-loaded with blister packs containing measured doses of the medicine.  Advair HFA and AirDuo Respiclick each come in a canister that is used with an actuator inhaler device.

Use the medicine at the same time each day. Use only the inhaler device provided with your medication.

Shake the Advair HFA inhaler for at least 5 seconds before each spray.

Do not allow a young child to use this medicine without help from an adult.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Rinse your mouth with water without swallowing after each use of your inhaler.

Your dose needs may change due to surgery, illness, stress, or a recent asthma attack. Do not change your medication dose or schedule without your doctor’s advice.

If you also use an oral steroid medication, you should not stop using it suddenly. Follow your doctor’s instructions about tapering your dose.

If you use a peak flow meter at home, tell your doctor if your numbers are lower than normal.

Your vision and your bone mineral density may need to be checked often.

Store your medicine at room temperature, away from moisture, heat, and sunlight. Avoid high heat, such as open flame or in a car on a hot day. Carefully follow all storage and disposal directions provided with your medicine.

Once your asthma is under control, your doctor may want you to stop using this medicine. Do not stop using the medicine unless your doctor tells you to.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include chest pain, fast heart rate, and feeling shaky or short of breath.

Long term use of an inhaled steroid can lead to glaucoma, cataracts, thinning skin, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using fluticasone and salmeterol?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using a steroid such as fluticasone.

Do not use a second inhaled bronchodilator unless your doctor tells you to. This includes formoterol (Perforomist, Symbicort, Bevespi, Dulera), arformoterol (Brovana), indacaterol (Arcapta), olodaterol (Striverdi,  Stiolto Respimat), salmeterol (Serevent), or vilanterol (Anoro Ellipta, Breo Ellipta, Trelegy Ellipta).

What other drugs will affect fluticasone and salmeterol?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

• antifungal medicine; or
• medicine to treat HIV or AIDS.

What is Advair Diskus?

Advair Diskus inhalation is a steroid and bronchodilator combination medicine that is used to prevent asthma attacks. It is also used to prevent flare-ups or worsening of chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and/or emphysema.

In people with COPD, Advair Diskus is for long-term treatment. In people with asthma, Advair Diskus is for short-term treatment until symptoms are well controlled with with other medicines.

Advair Diskus is for use in adults and children who are at least 4 years old. Advair HFA and AirDuo Respiclick are for use in adults and children who are at least 12 years old.

Advair Diskus may also be used for purposes not listed in this medication guide.

Advair Diskus side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Advair Diskus may cause serious side effects. Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medicine;
• fever, chills, cough with mucus, feeling short of breath;
• chest pain, fast or irregular heartbeats, severe headache, pounding in your neck or ears;
• tremors, nervousness;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• signs of thrush (a fungal infection)–sores or white patches in your mouth or throat, trouble swallowing;
• high blood sugar–increased thirst, increased urination, dry mouth, fruity breath odor;
• low potassium level–leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or
• signs of a hormonal disorder–worsening tiredness or weakness, feeling light-headed, nausea, vomiting.

Fluticasone can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

Common side effects of Advair Diskus may include:

• headache, muscle pain, bone pain, back pain;
• nausea, vomiting;
• thrush, throat irritation;
• ongoing cough, hoarseness or deepened voice;
• cold symptoms such as stuffy nose, sneezing, sore throat; or
• ear infection (in a child)–fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

Advair Diskus is not a rescue medicine. It will not work fast enough to treat an asthma or bronchospasm attack.

Seek medical attention you have worsening breathing problems, or if you think your medications are not working as well.

Before taking this medicine

You should not use Advair Diskus if you are allergic to fluticasone or salmeterol, or:

• if you have a severe allergy to milk proteins; or
• if you are having an asthma attack or severe COPD symptoms.

Fluticasone can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

Tell your doctor if you have ever had:

• glaucoma or cataracts;
• heart disease or high blood pressure;
• a seizure;
• diabetes;
• a food or drug allergy;
• a weak immune system;
• any type of infection (bacterial, fungal, viral, or parasitic);
• osteoporosis;
• a thyroid disorder; or
• liver or kidney disease.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk.

Tell your doctor if you are pregnant. It is not known whether this medicine will harm an unborn baby. However, having untreated or uncontrolled asthma during pregnancy may cause complications such as low birth weight, premature birth, or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating asthma may outweigh any risks to the baby.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Do not give this medicine to a child without medical advice.

How should I use Advair Diskus?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Using too much of this medicine can cause life-threatening side effects.

Advair Diskus is not a rescue medicine for asthma or bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

Advair Diskus is a powder form of fluticasone and salmeterol that comes with a special inhaler device pre-loaded with blister packs containing measured doses of the medicine. Advair HFA and AirDuo Respiclick each come in a canister that is used with an actuator inhaler device.

Use the medicine at the same time each day. Use only the inhaler device provided with your medication.

Shake the Advair HFA inhaler for at least 5 seconds before each spray.

Do not allow a young child to use this medicine without help from an adult.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Rinse your mouth with water without swallowing after each use of your inhaler.

Your dose needs may change due to surgery, illness, stress, or a recent asthma attack. Do not change your medication dose or schedule without your doctor’s advice.

If you also use an oral steroid medication, you should not stop using it suddenly. Follow your doctor’s instructions about tapering your dose.

If you use a peak flow meter at home, tell your doctor if your numbers are lower than normal.

Your vision and your bone mineral density may need to be checked often.

Store your medicine at room temperature, away from moisture, heat, and sunlight. Avoid high heat, such as open flame or in a car on a hot day. Carefully follow all storage and disposal directions provided with your medicine.

Once your asthma is under control, your doctor may want you to stop using this medicine. Do not stop using the medicine unless your doctor tells you to.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention

Overdose symptoms may include chest pain, fast heart rate, and feeling shaky or short of breath.

Long term use of an inhaled steroid can lead to glaucoma, cataracts, thinning skin, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using Advair Diskus?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using a steroid such as fluticasone.

Do not use a second inhaled bronchodilator unless your doctor tells you to. This includes formoterol (Perforomist, Symbicort, Bevespi, Dulera), arformoterol (Brovana), indacaterol (Arcapta), olodaterol (Striverdi, Stiolto Respimat), salmeterol (Serevent), or vilanterol (Anoro Ellipta, Breo Ellipta, Trelegy Ellipta).

What other drugs will affect Advair Diskus?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

• antifungal medicine; or
• medicine to treat HIV or AIDS.