Dulera (mometasone furoate/formoterol fumarate)

Dulera is a combination of inhaled drugs that is used to treat asthma. In patients with asthma, the smaller airways (bronchioles) through which air moves in and out of the lungs can be narrowed by accumulation of mucus, spasm of the muscles that surround these airways, or swelling of the lining of the airways due to inflammation. Airway narrowing leads to symptoms of shortness of breath, wheezing, cough, and congestion. Medications used in treating asthma include those that open airways, called bronchodilators, and those that reduce inflammation.

Dulera contains a combination of formoterol, a long acting beta-2 adrenergic agonist (LABA) bronchodilator, and mometasone furoate, an anti-inflammatory corticosteroid. Beta-2 agonists are medications that attach to beta-2 receptors on the smooth muscle cells that surround the airways, causing the muscle cells to relax and open the airways. Mometasone furoate is a synthetic (man-made) corticosteroid of the glucocorticoid family which is related to the natural hormone, cortisol or hydrocortisone, produced by the adrenal glands. Glucocorticoid steroids have potent anti-inflammatory actions. In people with asthma, the suppression of inflammation within the airways reduces the swelling caused by inflammation that narrows the airways. At the same time, production of mucus is reduced.

When used in lower doses, very little inhaled mometasone furoate is absorbed into the body and side effects are infrequent. When higher doses are used, mometasone furoate is absorbed and may cause side effects elsewhere in the body. The FDA approved Dulera in June, 2010.

What brand names are available for mometasone furoate and formoterol fumarate ?

Dulera

Is Dulera available as a generic drug?

No

Do I need a prescription for Dulera?

Yes

WARNING

• Dulera should not be used for treatment of acute asthmatic attacks.
• Use of long acting agents like formoterol, an active ingredient in Dulera, may increase the risk of asthma-related death. Therefore, Dulera should only be used in patients whose asthma is uncontrolled by other agents, including long-term asthma-controlling medications such as an inhaled corticosteroid.
• Dulera may cause bronchospasm.

The recommended dose is 2 inhalations twice daily of 100 mcg/5 mcg or 200 mcg/5 mcg.

The following drugs may increase the levels of mometasone in the body by reducing the breakdown of mometasone by liver enzymes. This may increase the side effects of Dulera. These drugs include:

• ritonavir (Norvir)
• atazanavir (Reyataz)
• clarithromycin (Biaxin)
• indinavir (Crixivan)
• itraconazole (Sporanox)
• ketoconazole
• nelfinavir (Viracept)
• telithromycin (Ketek)

Monoamine oxidase inhibitors (for example, tranylcypromine) and tricyclic antidepressants (for example, amitriptyline [Endep]) may increase the effect of formoterol on the heart and blood pressure. Since Dulera contains formoterol, it should not be used with or within two weeks of discontinuing monoamine oxidase inhibitors or tricyclic antidepressants.

Beta blockers block the therapeutic effects of beta2-agonists, such as formoterol, a component of Dulera, and may produce severe bronchospasm in patients with asthma. Therefore, patients with asthma should not be treated with beta blockers.

Use during pregnancy has not been adequately evaluated. Dulera harmed the fetus in animal reproductive studies.

It is not known whether components of Dulera are secreted in breast milk. Other medications in this class are secreted into breast milk. It is not known whether the small amounts of Dulera components that may appear in breast milk have an effect on the infant.

What preparations of Dulera mometasone furoate and formoterol fumarate are available?

Aerosol: 100/5 mcg per spray; 200/5 mcg per spray

How should I keep Dulera mometasone furoate and formoterol fumarate stored?

Mometasone should be kept at room temperature, between 15 C and 30 C (59 F and 86 F). It should be shaken well before each use.