Pronunciation:

for-MOE-ter-ol FUE-ma-rate, moe-MET-a-sone FURE-oh-ate

Brand Names:

• Dulera

Dosage Forms:

• Aerosol Powder

Classifications:

Therapeutic—

Antiasthma, Anti-Inflammatory/Bronchodilator Combination

Pharmacologic—

Formoterol

Uses of This Medicine:

Mometasone and formoterol is a combination of two medicines that are used to treat 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. This medicine will not relieve an asthma attack that has already started.

Mometasone 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 adrenergic bronchodilators. Adrenergic bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

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

Before Using This Medicine:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of mometasone and formoterol combination in children 5 years of age and older. However, safety and efficacy have not been established in children younger than 5 years of age.

Older adults—

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

Other 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
• 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
• Adagrasib
• Alfuzosin
• Amineptine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Aspirin
• Astemizole
• Atazanavir
• Atenolol
• Azithromycin
• Bedaquiline
• Bemetizide
• Bemiparin
• Bendroflumethiazide
• Benzthiazide
• Betaxolol
• Bisoprolol
• Bumetanide
• Buprenorphine
• Buserelin
• Carbamazepine
• Carteolol
• Carvedilol
• Celiprolol
• Ceritinib
• Chloroquine
• Chlorothiazide
• Chlorpromazine
• Chlorthalidone
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clopamide
• Clothiapine
• Clozapine
• Cobicistat
• Cosyntropin
• Crizotinib
• Cyclobenzaprine
• Cyclopenthiazide
• Cyclothiazide
• Dabrafenib
• Darunavir
• Dasatinib
• Degarelix
• Delamanid
• Desflurane
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Dextroamphetamine
• Diazoxide
• Dibenzepin
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Esmolol
• Ethacrynic Acid
• Ethinyl Estradiol
• Etozolin
• Etrasimod
• Famotidine
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Furosemide
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Givinostat
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Indapamide
• Inotuzumab Ozogamicin
• Isocarboxazid
• Isoflurane
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Labetalol
• Landiolol
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levobunolol
• Levofloxacin
• Linezolid
• Lisdexamfetamine
• Lofepramine
• Lofexidine
• Lonafarnib
• Lumefantrine
• Lutetium Lu 177 Dotatate
• Macimorelin
• Mavorixafor
• Mefloquine
• Melitracen
• Methacholine
• Methadone
• Methotrimeprazine
• Methyclothiazide
• Methylene Blue
• Metipranolol
• Metolazone
• Metoprolol
• Metronidazole
• Mifepristone
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moricizine
• Moxifloxacin
• Nadolol
• Nadroparin
• Nafarelin
• Nebivolol
• Nelfinavir
• Nilotinib
• Nirmatrelvir
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Opipramol
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxprenolol
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Penbutolol
• Pentamidine
• Perphenazine
• Phenelzine
• Phenobarbital
• Pimavanserin
• Pindolol
• Pipamperone
• Piretanide
• Pitolisant
• Polythiazide
• Ponesimod
• Posaconazole
• Primidone
• Probucol
• Procainamide
• Procarbazine
• Prochlorperazine
• Promethazine
• Propafenone
• Propranolol
• Protriptyline
• Quetiapine
• Quinethazone
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Rasagiline
• Relugolix
• Revumenib
• Ribociclib
• Rilpivirine
• Risperidone
• Ritonavir
• Safinamide
• Sargramostim
• Selegiline
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Somatrogon-ghla
• Sorafenib
• Sotalol
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tianeptine
• Timolol
• Tolterodine
• Toremifene
• Torsemide
• Tranylcypromine
• Trazodone
• Trichlormethiazide
• Triclabendazole
• Trimipramine
• Triptorelin
• Upadacitinib
• 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
• Ketoconazole

Other interactions—

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Angina (severe chest pain) or
• Bone problems (eg, osteoporosis), or history of or
• Cataracts, or history of or
• Glaucoma, or history of or
• Heart or blood vessel disease (eg, aneurysm) or
• Heart rhythm problems (eg, arrhythmia) or
• Hypertension (high blood pressure) or
• Hypokalemia (low potassium in the blood) or
• Pheochromocytoma (adrenal gland problem) or
• Seizures or
• Thyroid problems—Use with caution. May make these conditions worse.

• Asthma attack, acute—Should not be used in patients with this condition.

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

• Diabetes or
• Hyperglycemia (high glucose in the blood) or
• Ketoacidosis (high ketones in the blood)—Blood sugar levels may increase.

• Infection or
• Stress or
• Surgery or
• Trauma—Oral corticosteroids may be needed during these periods. 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 This Medicine:

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop taking this medicine without telling your doctor. To do so may increase the chance of side effects.

This medicine is used with a special inhaler and usually comes with patient directions or a Medication Guide. 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.

When you use the inhaler for the first time, or if you have not used it for 5 days or longer, it may not deliver the right amount of medicine with the first puff. 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.

How to use this medicine:

• Take the inhaler out of the carton before you use it for the first time.
• Do not use the inhaler for this medicine with any other medicine.
• Remove the cap from the mouthpiece of the actuator.
• Do not remove the canister from the actuator.
• Prime the inhaler before use by shaking the inhaler well and then releasing 4 test sprays.
• To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. 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 blue top of the inhaler, breathe in through your mouth as deeply as you can until you have taken a full deep breath.
• Repeat these steps for the next puff, starting with shaking the inhaler.
• 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.

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 puff contains 100 or 200 micrograms (mcg) of mometasone and 5 mcg of formoterol. Your doctor may increase your dose as needed. However, the dose is usually not more than 800 mcg of mometasone and 20 mcg of formoterol per day.
    • Children 5 to 11 years of age—Two puffs in the morning and another 2 puffs in the evening. Each puff contains 50 mcg of mometasone and 5 mcg of formoterol. Your doctor may increase your dose as needed. However, the dose is usually not more than 200 mcg of mometasone and 20 mcg of formoterol per day.
    • Children younger than 5 years of age—Use and dose must be determined by your child's doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

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 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.

When you store the inhaler, make sure to always place the mouthpiece down.

Precautions While Using This Medicine:

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 and to check for any unwanted effects that may be caused by this medicine. You may need to have your eyes checked at regular visits. Be sure to keep all appointments.

Although this medicine decreases the number of asthma episodes, it may increase the chances of a severe asthma episode when they do occur. Talk to your doctor or pharmacist about any questions or concerns that you have.

You or your child should not use this medicine if your asthma attack has already started or if you already have a severe asthma attack. Your doctor may prescribe another medicine (eg, a short-acting inhaler) for you to use in case of an acute asthma attack. Call your doctor immediately for instructions.

Do not use any other asthma medicine or medicine for breathing problems without talking to your doctor. This medicine should not be used with arformoterol (Brovana®), budesonide/formoterol (Symbicort®), formoterol (Foradil®, Perforomist®), or salmeterol (Serevent®) inhalers.

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

• Your or your child's symptoms do not improve after using this medicine for 1 week 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 (eg, you use 1 whole canister of your short-acting inhaler in 8 weeks time, or you need to use 4 or more inhalations of your short-acting inhaler for 2 or more days in a row).
• You or your child have a significant decrease in your peak flow when measured as directed by your doctor.

Your doctor may want you to carry a medical identification 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.

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 have white patches in the mouth or throat, or pain when eating or swallowing.

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 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.

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 This Medicine:

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:

Less common

Cough

fever

headache

muscle aches

pain or tenderness around the eyes and cheekbones

sore throat

stuffy or runny nose

tightness of the chest

troubled breathing

unusual tiredness or weakness

Rare

Sore mouth or tongue

white patches in the mouth or on the tongue

Incidence not known

Blindness

blurred vision

cough or hoarseness

creamy white, curd-like patches in the mouth or throat

darkening of the skin

decreased vision

diarrhea

dizziness

eye pain

fainting

fever or chills

loss of appetite

lower back or side pain

mental depression

nausea or vomiting

pain when eating or swallowing

painful or difficult urination

skin rash

tearing

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:

Less common

Voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.