budesonide/formoterol hfa inhaler (Symbicort)

Symbicort is a combination of inhaled drugs that is used to treat asthma and chronic obstructive pulmonary disease (COPD). In patients with asthma or COPD the smaller airways (bronchioles) through which air moves in and out of thelungs 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 or COPD include those that open airways, called bronchodilators, and those that reduce inflammation.

Symbicort contains a combination of formoterol, a long acting beta-2 adrenergic agonist (LABA) bronchodilator, and budesonide, 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. Budesonide 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 asthmatic patients and people with COPD, 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 budesonide is absorbed into the body and side effects are infrequent. When higher doses are used, budesonide is absorbed and may cause side effects elsewhere in the body. The FDA approved Symbicort in July 2006.

What brand names are available for budesonide/formoterol?

Symbicort

Is budesonide/formoterol available as a generic drug?

No

Do I need a prescription for budesonide/formoterol?

Yes

The most common side effects associated with Symbicort are:

• headache
• sinusitis
• common cold
• back pain
• vomiting
• stomach discomfort
• upper respiratory tract infection
• Oral fungal infections (candidiasis)

Higher doses of budesonide may cause suppression of the body's ability to make its own natural glucocorticoid in the adrenal gland. People with suppression of their adrenal glands (which can be diagnosed by a doctor) would need increased amounts of glucocorticoids, probably by the oral or intravenous route, during periods of high physical stress or acute illness when glucocorticoids are particularly important. Inhaled steroids may cause growth suppression, weaken the immune system, and may increase the risk of glaucoma, and cataracts.

Allergic reactions, including swelling of face, throat and tongue, as well as rash, hives, and breathing problems may occur.

The recommended dose is 2 inhalations twice daily of 80 mcg/4.5 mcg or 160 mcg/5 mcg strengths. The dose for treating COPD is 2 inhalations of 160/4.5 strength twice daily.

The following drugs may increase levels of budesonide in the body by reducing the breakdown of budesonide byliver enzymes. This may increase side effects of Symbicort.

• ritonavir (Norvir),
• atazanavir (Reyataz),
• clarithromycin (Biaxin),
• indinavir (Crixivan),
• itraconazole (Sporanox),
• ketoconazole,
• nelfinavir (Viracept), and
• 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 Symbicort 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 beta 2-agonists, such as formoterol, a component of Symbicort, 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. Symbicort harmed the fetus in animal reproductive studies.

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

What preparations of BUDESONIDE/FORMOTEROL-INHALATION are available?

Aerosol: 80/4.5 mcg per spray; 160/4.5 mcg per spray

How should I keep BUDESONIDE/FORMOTEROL-INHALATION stored?

Budesonide should be kept at room temperature, 20 C to 25 C (68 F to 77 F). It should be shaken well before each use.