Dulera Inhaler

Generic Name: formoterol and mometasone (for MOE ter ol and moe MET a sone)
Brand Name: Dulera

What is Dulera?

Dulera Inhalers contains a combination formoterol and mometasone. Formoterol is a long-acting bronchodilator that relaxes muscles in the airways to improve breathing. Mometasone is a corticosteroid. It prevents the release of substances in the body that cause inflammation.

Dulera is 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 Dulera

Do not use Dulera to treat an asthma attack that has already begun. It will not work fast enough. Use only a fast acting inhalation medication. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks.

Video: Asthma

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.

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:

• tuberculosis;

• an active infection of any kind;

• herpes infection of the eye;

• heart disease;

• liver disease;

• low bone mineral density;

• glaucoma or cataracts;

• epilepsy or other seizure disorder;

• diabetes; or

• a thyroid disorder.

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: Dulera 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 this medication, and do not use it for longer than your doctor recommends. Talk with your doctor about your individual risks and benefits of using Dulera.

Do not use Dulera to treat an asthma attack that has already begun. It will not work fast enough. Use only a fast-acting inhalation medication.

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 Dulera as directed and tell your doctor if your symptoms do not improve after 1 week of treatment.

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.

If you also use a steroid medication, you should not stop using Dulera suddenly. Follow your doctor's instructions about tapering your dose.

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.

Store Dulera at room temperature away from moisture and heat.

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.

What should I avoid while using Dulera?

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:

• sores or white patches in your mouth or throat;

• wheezing, choking, or other breathing problems after using this medication;

• blurred vision, eye pain, or seeing halos around lights;

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist);

• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling;

• chest pain, fast or pounding heartbeats, tremors, restless feeling, seizure;

• increased thirst or hunger, urinating more than usual; or

• worsening asthma symptoms.

Common Dulera side effects may include:

• headache;

• runny or stuffy nose, sinus pain

• dry mouth, sore throat; or

• 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: Dulera side effects (in more detail)

What other drugs will affect Dulera?

Many drugs can interact with Dulera. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Dulera, especially:

• imatinib;

• isoniazid;

• nefazodone;

• theophylline;

• an antibiotic--clarithromycin, telithromycin;

• antifungal medication--itraconazole, ketoconazole, posaconazole, voriconazole;

• diet pills, cold medicine, or a stimulant medication (such as Adderall or Ritalin);

• heart or blood pressure medication--atenolol, carvedilol, labetalol, metoprolol, nadolol, nebivolol, nicardipine, propranolol, quinidine, sotalol, and others; or

• hepatitis C medications--boceprevir, telaprevir;

• HIV/AIDS medication--atazanavir, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir;

• an MAO inhibitor--isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, tranylcypromine.

This list is not complete and many other drugs can interact with Dulera. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

• Your pharmacist can provide more information about Dulera.