Dulera inhalers contain a combination of formoterol and mometasone. Formoterol is a long-acting bronchodilator that relaxes muscles in the airways to improve breathing. Mometasone is a steroid. It prevents the release of substances in the body that cause inflammation.
Dulera inhalers are used as a maintenance treatment for asthma in adults and children who are at least 12 years old. Dulera is not for use in treating an asthma or bronchospasm attack.
Dulera may also be used for purposes not listed in this medication guide.
Important information
Formoterol may increase the risk of asthma-related death. Use only the prescribed dose of Dulera, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits of using a Dulera inhaler.
Dulera will not work fast enough to treat an asthma attack. Use only a fast acting inhalation medicine for an asthma attack. Tell your doctor if it seems like your asthma medications don"t work as well.
Before using Dulera
You should not use Dulera if you are allergic to formoterol (Foradil, Perforomist, Symbicort) or mometasone (Asmanex).
To make sure Dulera is safe for you, tell your doctor if you have:
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an active infection of any kind;
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heart disease;
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liver disease;
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low bone mineral density;
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glaucoma or cataracts;
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epilepsy or other seizure disorder;
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diabetes;
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pheochromocytoma (tumor of the adrenal gland);
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a thyroid disorder; or
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a history of aneurysm (a weakened or damaged blood vessel that could tear and cause severe bleeding).
FDA pregnancy category C. It is not known whether Dulera will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
See also: Pregnancy and breastfeeding warnings (in more detail)
It is not known whether formoterol and mometasone passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Mometasone can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using Dulera.
Do not give Dulera to a child younger than 12 years old without the advice of a doctor.
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 of osteoporosis.
How should I use Dulera?
Dulera comes with patient instructions for safe and effective use, and directions for priming the inhaler device. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Formoterol may increase the risk of asthma-related death. Use only the prescribed dose of Dulera, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits of using Dulera.
Dulera will not work fast enough to treat an asthma attack. Use only a fast acting inhalation medicine for an asthma attack.
Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack.
Shake the Dulera inhaler canister well before each use. Remove the cap from the mouthpiece before placing the inhaler in your mouth.
To reduce the chance of developing a yeast infection in your mouth, rinse with water after using the inhaler. Do not swallow.
It may take up to 1 week before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 1 week of treatment.
If you need surgery, tell the surgeon ahead of time that you are using Dulera.
If you also use a steroid medication, you should not stop using Dulera suddenly. Follow your doctor"s instructions about tapering your dose.
Asthma is often treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor"s advice.
Store Dulera at room temperature away from moisture and heat.
Store the 60-inhalation canister upright with the mouthpiece down, or on its side. Keep the medicine canister away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture or burn an empty inhaler canister.
Do not try to clean or take apart the Aerolizer device. Throw it away when your capsules run out. Always use the new device provided with the medication when you get your prescription refilled.
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 at 1-800-222-1222.
Dulera dosing information
Usual Adult Dose of Dulera for Asthma -- Maintenance:
The recommended starting dosages for formoterol-mometasone treatment are based on prior asthma therapy.
For previous therapy of medium dose inhaled corticosteroids: 5 mcg-100 mcg 2 inhalations twice daily. Maximum recommended daily dose: 20 mcg-400 mcg.
For previous therapy of high dose inhaled corticosteroids: 5 mcg-200 mcg 2 inhalations twice daily. Maximum recommended daily dose: 20 mcg-800 mcg.
Formoterol-mometasone should be administered as two inhalations twice daily every day (morning and evening) by the orally inhaled route. Shake well prior to each inhalation.
Usual Pediatric Dose of Dulera for Asthma -- Maintenance:
The recommended starting dosages for formoterol-mometasone treatment are based on prior asthma therapy.
12 years of age and older:
For previous therapy of medium dose inhaled corticosteroids: 5 mcg-100 mcg 2 inhalations twice daily. Maximum recommended daily dose: 20 mcg-400 mcg.
For previous therapy of high dose inhaled corticosteroids: 5 mcg-200 mcg 2 inhalations twice daily. Maximum recommended daily dose: 20 mcg-800 mcg.
Formoterol-mometasone should be administered as two inhalations twice daily every day (morning and evening) by the orally inhaled route. Shake well prior to each inhalation.
What should I avoid?
Do not use a second form of formoterol (such as Foradil, Perforomist, or Symbicort) or use another similar long-acting inhaled bronchodilator (LABA) such as salmeterol (Advair, Serevent) or arformoterol (Brovana).
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 Dulera.
Dulera side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Dulera: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have:
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sores or white patches in your mouth or throat;
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wheezing, choking, or other breathing problems after using this medication;
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blurred vision, eye pain, or seeing halos around lights;
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changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist);
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chest pain, fast or pounding heartbeats, tremors, restless feeling, seizure;
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low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling;
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high blood sugar (increased thirst, increased urination, hunger, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss); or
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worsening asthma symptoms.
Common Dulera side effects may include:
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headache;
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runny or stuffy nose, sinus pain
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dry mouth, sore throat; or
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hoarseness or deepened voice.
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.
See also: Side effects (in more detail)
What other drugs will affect Dulera?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Dulera, especially:
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heart or blood pressure medication--carvedilol, labetalol, nadolol, penbutolol, propranolol, sotalol, timolol; or
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glaucoma medications used in the eyes (ophthalmic)--carteolol, levobunolol, metipranolol, timolol.
This list is not complete. Other drugs may interact with Dulera, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
