uses
What is Dulera used for?Dulera (mometasone/formoterol) is commonly used as a controller (maintenance) inhaler for asthma.Dulera may also be used for other conditions as determined by your healthcare provider.How does Dulera work (mechanism of action)?People with asthma have ongoing airflow problems in the lungs. Dulera contains two medicines. Mometasone reduces swelling or inflammation in the lungs. Formoterol relaxes the muscles around the airways. This can help to make it easier to breathe.How is Dulera supplied (dosage forms)?Brand and other namesDuleraDosage forms and strengths50 mcg/5 mcg per actuation inhalation aerosol100 mcg/5 mcg per actuation inhalation aerosol200 mcg/5 mcg per actuation inhalation aerosolHow should I store Dulera?Dulera should be stored with the cap covering the mouthpiece, at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place away from sunlight and heat. It may burst if exposed to temperatures over 120 F (49 C). Dulera inhalers that contain 60 puffs should be stored with the mouthpiece pointing down or the inhaler on its side. There are no special storage requirements for Dulera inhalers that contain 120 puffs.
how to use
spray that is inhaled
drug interactions
Does Dulera interact with foods or drinks?There are no known interactions between Dulera and foods or drinks.It is unknown if drinking alcohol will affect Dulera.Does Dulera interact with other medicines (drug interactions)?Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.In particular, make sure that you discuss if you are using any of the following before using Dulera.A beta-blocker, such as metoprolol (Lopressor), atenolol (Tenormin), or propranolol (Inderal LA), which is a medicine that may be used for certain heart conditions or to reduce blood pressureA diuretic, also called a water pill, which is a medicine used to reduce edema (fluid retention) and blood pressureA long-acting beta-2 agonist (LABA), such as salmeterol (Serevent), formoterol (Perforomist), arformoterol (Brovana), or olodaterol (Striverdi), which is an inhaled medicine used for asthma or COPDA medicine for HIV or AIDSA monoamine oxidase inhibitor (MAOI) within the past two weeks, which is a medicine usually used for depression or Parkinson’s diseaseA tricyclic antidepressant within the past two weeks, such as amitriptyline, nortriptyline, or protriptyline, even if it is not used for depressionMedicines within the past two weeks that can cause QT prolongation, which is a dangerous heart rhythm problemClarithromycin, which is a medicine used for bacterial infectionsAn antifungal medicine, such as ketoconazole, itraconazole (Sporanox, Tolsura), posaconazole (Noxafil), or voriconazole (Vfend) which is a medicine used for fungal infectionsTheophylline (Theo-24, Elixophyllin), which is a medicine for asthma or certain other breathing problemsPentoxifylline (Trental), which is a medicine to improve blood flowSome other medicines may alter the blood levels of Dulera. Tell your healthcare provider about all medicines that you take or have recently taken.This may not be a complete list of medicines that can interact with Dulera. Always check with your healthcare provider.
side effects
What are the most common side effects of Dulera?The most common side effects of Dulera are listed below. Tell your healthcare provider if you have any of these side effects that bother you.Infection in the nose or throat, sore throat, or common cold symptomsInflammation or swelling of the lining of the sinusesHeadacheThere may be other side effects of Dulera that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.What are the serious side effects of Dulera?While less common, the most serious side effects of Dulera are described below, along with what to do if they happen.Severe Allergic Reactions. Dulera may cause allergic reactions, which can be serious. Stop using Dulera and get help right away if you have any of the following symptoms of a serious allergic reaction.Breathing problems or wheezingRacing heartFever or general ill feelingSwollen lymph nodesSwelling of the face, lips, mouth, tongue, or throatTrouble swallowing or throat tightnessItching, skin rash, or pale red bumps on the skin called hivesNausea or vomitingDizziness, feeling lightheaded, or faintingStomach crampsJoint painReduced Adrenal Function. Long-term use of Dulera can cause your body’s adrenal glands to stop making as much cortisol (the stress hormone). This is known as adrenal insufficiency. This is especially a concern if you have been taking a corticosteroid by mouth, such as prednisone, and you stop it and switch to Dulera. Adrenal insufficiency can get worse if your body is under stress because of fever, surgery, or trauma. Tell your healthcare provider if you have any of the following symptoms of adrenal insufficiency.Nausea and vomitingWeakness, tiredness, or lack of energyLow blood pressureSudden Breathing Problems. Dulera may cause the muscles around your airways to tighten (bronchospasm) right after you use it, instead of relaxing these muscles. In some cases, this can be serious. Stop using Dulera and contact your healthcare provider right away if your breathing gets worse instead of better right after using Dulera.Glaucoma or Cataracts. Dulera may increase pressure inside the eye and cause or worsen narrow-angle glaucoma, which can lead to blindness. It may also increase the risk of cataracts. Tell your healthcare provider right away if you have any of the following symptoms of glaucoma.Loss of visionEye pain or rednessSevere headache or vomitingSeeing bright, colorful circles around lights (vision halos)Heart Effects. Dulera may increase your risk of certain effects on the heart, such as raising your heart rate, blood pressure, or causing an abnormal heart rhythm (arrhythmia). If you measure your blood pressure and the top number (systolic) is 180 mm Hg or higher or the bottom number (diastolic) is 120 mm Hg or higher, get medical attention right away. Also call your healthcare provider or get medical attention right away if you have chest pain, a fast or irregular heartbeat, or if you feel your heartbeat more than usual.Increased Blood Sugar. Dulera may increase your blood sugar levels. Talk to your healthcare provider about how to maintain healthy blood sugar levels.Oral Thrush. Dulera can cause a fungal infection in your mouth and throat, a condition known as oral thrush or oral candidiasis. To help prevent thrush, rinse your mouth with water and spit out the water (do not swallow it) after each dose of Dulera. Contact your healthcare provider if you notice any of the following symptoms of oral thrush. Cracking in the corners of the mouthLoss of tasteRed or white patches in the mouth or throatRaised white spots in the mouth or throatWeak Bones. Using Dulera for a long time may cause the bones to become weaker, leading to reduced bone density (osteopenia). It may also cause a more serious condition called osteoporosis, which can cause bones to break (or fracture) more easily. Your healthcare provider may monitor your bone density while you are using Dulera.Infection. Dulera can increase the risk of infections, including serious infections. Call your healthcare provider if you have any of the following symptoms.Cough or coughing up bloodFever, sweats, chills, or muscle achesShortness of breathDiarrhea or stomach painWeight lossLow Potassium Level (Hypokalemia). Dulera can cause a low potassium level, which can be serious and may lead to death. Your healthcare provider may check your potassium levels, especially if you take certain other medicines. Keep all appointments to have your blood checked. Call your healthcare provider if you have any of the following symptoms of a low potassium level.WeaknessUnusual tirednessMuscle cramps or twitchingConstipationNervous System Effects. Dulera may cause nervous system effects, including tremor or nervousness. Contact your healthcare provider right away if you develop these symptoms.Slow Growth. In people who are still growing, such as children and adolescents, Dulera may slow down growth. Keep all appointments for your healthcare provider to monitor growth rate.
overdose and misseddose
What should I do if I accidentally use too much Dulera?If you or someone else has used too much Dulera, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.What should I do if I miss a dose of Dulera?If you miss a dose, skip the missed dose. Use your next dose as you normally would. Do not use double or extra doses.Â
warnings and Precautions
Who should not use Dulera?Allergies to Ingredients. People who are allergic to any of the following should not use Dulera.DuleraMometasoneFormoterolAny of the ingredients in the specific product dispensedYour pharmacist can tell you all of the ingredients in Dulera.Sudden Asthma Symptoms. Unless your healthcare provider tells you to, do not use Dulera to treat a sudden worsening of symptoms, such as from an asthma attack. Ask your healthcare provider if you are not sure which medicine to use for quick relief of symptoms. What should I know about Dulera before using it?Do not use Dulera unless it has been prescribed to you by a healthcare provider. Use it as prescribed. Using Dulera more often than prescribed may increase the risk of serious side effects.Do not share Dulera with other people, even if they have the same condition as you. It may harm them.Ask your pharmacist or other healthcare provider to show you how to correctly prime, use, and clean Dulera. Follow the “Instructions for Use†that comes with your Dulera before using it for the first time and whenever you are not sure how to use it. The medicine needs to be primed so you get the correct dose. You also need to shake Dulera well before each spray.Keep Dulera out of the reach of children.After using Dulera, rinse your mouth out with water and spit the water out. This helps lower your chance of getting a fungal infection in your mouth or throat, called oral thrush.Do not stop using or change your Dulera dose without talking to your healthcare provider first.What should I tell my healthcare provider before using Dulera?Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Dulera is right for you.In particular, make sure that you discuss any of the following.Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.Any allergies, including to medicines or foodsAn infection, a history of immune system problems or severe infections, or if you have been exposed to chickenpox or measlesDiabetes or high blood sugarEye problems, such as glaucoma or cataractsHeart problems, including arrhythmiasHigh blood pressureHistory of bone conditions, such as osteomalacia, osteopenia, or osteoporosis, or if you are at risk for weak bones, such as if you use tobacco or are inactive for a long period of timeLiver problemsSeizuresThyroid problemsPlanned surgeryPheochromocytoma (an adrenal gland tumor)Aneurysm (a bulging in the wall of an artery)Other Medicines and Supplements. Dulera may interact with other medicines and supplements. Before using Dulera, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.Pregnancy. It is not known if or how Dulera could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should use Dulera while you are pregnant or trying to get pregnant.Breastfeeding. It is not known if Dulera passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should use Dulera while breastfeeding.How can I get more information about Dulera?For more information about Dulera, you can visit the manufacturer’s website at www.dulera.com or call them at 844-674-3200.
about
Dulera is a spray that you inhale to help manage asthma symptoms. It reduces inflammation and relaxes the muscles around your airways to make it easier to breathe. Common side effects include sore throat or common cold symptoms. Notify your healthcare provider right away if your breathing gets worse instead of better after using Dulera.