Dulera Inhaler

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

What Dulera?

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 inhalers are not for use in treating an asthma or bronchospasm attack.

Important information
Dulera will not work fast enough to treat an asthma attack. Use only a fast acting inhalation medicine for an asthma attack.

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Formoterol may increase the risk of asthma-related death or hospitalization. Use only the prescribed dose of Dulera, and follow all patient instructions for safe use.

Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

Before taking this medicine
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:

an active infection of any kind;
heart disease, high blood pressure;
liver disease;
low bone mineral density;
glaucoma or cataracts;
a seizure disorder;
diabetes;
pheochromocytoma (tumor of the adrenal gland);
a thyroid disorder; or
a history of aneurysm (a weakened or damaged blood vessel that could tear and cause severe bleeding).
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.

It is not known whether Dulera will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

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.

Do not give Dulera to a child younger than 12 years old without the advice of a doctor.

How should I use Dulera?
Dulera inhalers come 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.

Follow all directions on your prescription label. Do not use Dulera in larger or smaller amounts or for longer than recommended.

Formoterol may increase the risk of asthma-related death or hospitalization. Use only the prescribed dose of Dulera, and follow all patient instructions for safe use.

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.

Dulera inhalers will not work fast enough to treat an asthma attack. Use only a fast acting inhalation medicine for an asthma attack.

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.

Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well. An increased need for medication could be an early sign of a serious asthma attack.

Store Dulera inhalers at room temperature away from moisture and heat.

Store the 60-inhalation canister upright with the mouthpiece down, or on its side. Keep the Dulera 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.

Dulera dosing information
Usual Adult Dose of Dulera for Asthma -- Maintenance:

Two inhalations inhaled orally twice daily (morning and evening).

Each inhalation contains either 100 mcg or 200 mcg of mometasone with 5 mcg of formoterol.

Maximum Daily Dose: 800 mcg of mometasone; 20 mcg of formoterol

Comments:
-The starting dose should be determined based on patient's previous asthma therapy.
-Patients previously on inhaled medium dose corticosteroids should be started on the 100 mcg/5 mcg strength.
-Patients previously on inhaled high dose corticosteroids should be started on the 200 mcg/5 mcg strength.
-Not for use in treatment of acute bronchospasm.

Usual Pediatric Dose of Dulera for Asthma -- Maintenance:

For children 12 years of age and older:
Two inhalations inhaled orally twice daily (morning and evening).

Each inhalation contains either 100 mcg or 200 mcg of mometasone with 5 mcg of formoterol.

Maximum Daily Dose: 800 mcg of mometasone; 20 mcg of formoterol

Comments:
-The starting dose should be determined based on patient's previous asthma therapy.
-Patients previously on inhaled medium dose corticosteroids should be started on the 100 mcg/5 mcg strength.
-Patients previously on inhaled high dose corticosteroids should be started on the 200 mcg/5 mcg strength.
-Not for use in treatment of acute bronchospasm.

Use: Indicated for patients 12 years of age and older who have inadequate control on a long-term asthma control medication or whose disease severity requires initiation of an inhaled corticosteroid and long-acting beta2-adrenergic agonist

See also: Dosage Information (in more detail)

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 signs of an allergic reaction to Dulera: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Mometasone can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

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);
chest pain, fast or pounding heartbeats, tremors, restless feeling, seizure;
low potassium - leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;
high blood sugar - increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or
worsening asthma symptoms.
Common Dulera side effects may include:

headache;
runny or stuffy nose, sinus pain;
cough, sore throat; or
flu symptoms.
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?
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.

Many drugs can interact with formoterol and mometasone. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

an antibiotic - clarithromycin, telithromycin;
antifungal medicine - itraconazole, ketoconazole, posaconazole, voriconazole;
heart medication - nicardipine, quinidine; or
antiviral medicine to treat hepatitis C or HIV/AIDS - atazanavir, boceprevir, cobicistat, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir.
This list is not complete and many other drugs can interact with formoterol and mometasone. 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.