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fluticasone and salmeterol oral inhaler (cont.)

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

PREGNANCY: Adequate studies of fluticasone or inhaled salmeterol during pregnancy have not been done. Fluticasone use during pregnancy should be avoided unless the potential benefit justifies the potential but unknown risk to the fetus. In some, but not all, pregnant animal models exposure to very high doses of oral salmeterol has led to offspring with birth defects. The concentrations of salmeterol in the blood after these very high doses, however, were much higher than the concentrations observed after inhalation. Salmeterol inhalation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

NURSING MOTHERS: It is not known if fluticasone propionate is secreted in breast milk. Other medications in the same class as fluticasone propionate are secreted into breast milk, but it is not known whether the small amounts that may appear in the milk have effects on nursing infants. In rats, salmeterol is excreted in milk. Therefore, caution should be exercised when salmeterol is administered to nursing women.

SIDE EFFECTS: Upper respiratory tract infections occur in 20%-25% of patients using Advair Diskus. Headaches occur in about 1 in 8 patients who use it. Other potential adverse events include nausea, vomiting, diarrhea, mouth or throat candidiasis, and musculoskeletal pain. Use of long acting agents like salmeterol, an active ingredient in Advair Diskus, may increase the risk of asthma-related death. Therefore Advair Diskus should only be used in patients uncontrolled by other agents.

Reference: FDA Prescribing Information


Last Editorial Review: 7/27/2006




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