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Fluticasone Propionate/Salmeterol DISKUS should be administered as 1 inhalation twice daily by the orally inhaled route only. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis. More frequent administration or a greater number of inhalations (more than 1 inhalation twice daily) of the prescribed strength of Fluticasone Propionate/Salmeterol DISKUS is not recommended as some patients are more likely to experience adverse effects with higher doses of salmeterol. Patients using Fluticasone Propionate/Salmeterol DISKUS should not use additional LABA for any reason. [See Warnings and Precautions ( 5.3 , 5.12 ).] For oral inhalation only. ( 2 ) Treatment of asthma in patients aged 12 years and older: 1 inhalation of Fluticasone Propionate/Salmeterol DISKUS inhalation powder 100/50 mcg, Fluticasone Propionate/Salmeterol DISKUS inhalation powder 250/50 mcg, and Fluticasone Propionate/Salmeterol DISKUS inhalation powder 500/50 mcg twice daily. Starting dosage is based on asthma severity. ( 2.1 ) Treatment of asthma in patients aged 4 to 11 years: 1 inhalation of Fluticasone Propionate/Salmeterol DISKUS inhalation powder 100/50 mcg twice daily. ( 2.1 ) Maintenance treatment of COPD: 1 inhalation of Fluticasone Propionate/Salmeterol DISKUS inhalation powder 250/50 mcg twice daily. ( 2.2 ) 2.1 Asthma…

Use of LABA may result in the following: Serious asthma-related events – hospitalizations, intubations, death [see Warnings and Precautions ( 5.1 )] Cardiovascular and central nervous system effects [see Warnings and Precautions ( 5.12 )] Systemic and local corticosteroid use may result in the following: Candida albicans infection [see Warnings and Precautions ( 5.4 )] Pneumonia in patients with COPD [see Warnings and Precautions ( 5.5 )] Immunosuppression [see Warnings and Precautions ( 5.6 )] Hypercorticism and adrenal suppression [see Warnings and Precautions ( 5.8 )] Reduction in bone mineral density [see Warnings and Precautions ( 5.13 )] Growth effects [see Warnings and Precautions ( 5.14 )] Glaucoma and cataracts [see Warnings and Precautions ( 5.15 )] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most common adverse reactions (incidence ≥3%) include: Asthma: Upper respiratory tract infection or inflammation, pharyngitis, dysphonia, oral candidiasis, bronchitis, cough, headaches, nausea and vomiting. ( 6.1 ) COPD: Pneumonia, oral candidiasis, throat irritation, dysphonia, viral respiratory infections, headaches, musculoskeletal pain. ( 6.2 ) To report…

The use of Fluticasone Propionate/Salmeterol DISKUS is contraindicated in the following conditions: Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required [see Warnings and Precautions ( 5.2 )]. Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate, salmeterol, or any of the excipients [see Warnings and Precautions ( 5.11 ), Adverse Reactions ( 6.3 ), Description ( 11 )] . Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures. ( 4 ) Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate, salmeterol, or any of the excipients. ( 4 )

No human overdosage data has been reported for fluticasone propionate/salmeterol DISKUS. Fluticasone Propionate/Salmeterol DISKUS contains both fluticasone propionate and salmeterol; therefore, the risks associated with overdosage for the individual components described below apply to Fluticasone Propionate/Salmeterol DISKUS. Treatment of overdosage consists of discontinuation of Fluticasone Propionate/Salmeterol DISKUS together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. Cardiac monitoring is recommended in cases of overdosage. 10.1 Fluticasone Propionate Chronic overdosage of fluticasone propionate may result in signs/symptoms of hypercorticism [see Warnings and Precautions ( 5.8 )] . Inhalation by healthy volunteers of a single dose of 4,000 mcg of fluticasone propionate inhalation powder or single doses of 1,760 or 3,520 mcg of fluticasone propionate CFC inhalation aerosol was well tolerated. Fluticasone propionate given by inhalation aerosol at dosages of 1,320 mcg twice daily for 7 to 15 days to healthy human volunteers was also well tolerated. Repeat oral doses up to 80 mg daily for 10 days in healthy volunteers and repeat oral doses up to 20 mg daily for 42 days in subjects were well tolerated. Adverse…

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

Fluticasone propionate/salmeterol DISKUS has been used concomitantly with other drugs, including short-acting beta 2 -agonists, methylxanthines, and intranasal corticosteroids, commonly used in patients with asthma or COPD without adverse drug reactions [see Clinical Pharmacology ( 12.2 )] . No formal drug interaction trials have been performed with fluticasone propionate/salmeterol DISKUS. Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid and cardiovascular effects. ( 7.1 ) Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of salmeterol on vascular system. ( 7.2 ) Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. ( 7.3 ) Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non–potassium-sparing diuretics may worsen with concomitant beta-agonists. ( 7.4 ) 7.1 Inhibitors of Cytochrome P450 3A4 Fluticasone propionate and salmeterol, the individual components of Fluticasone Propionate/Salmeterol DISKUS, are substrates of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with Fluticasone Propionate/Salmeterol DISKUS is not recommended because increased systemic corticosteroid and increased cardiovascular adverse effects may occur. Ritonavir Fluticasone Propionate: A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations [see Clinical Pharmacology ( 12.3 )] . During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression. Ketoconazole Fluticasone Propionate: Coadministration of orally inhaled fluticasone propionate (1,000 mcg) and ketoconazole (200 mg once daily) resulted in a 1.9-fold increase in plasma fluticasone propionate exposure and a 45% decrease in plasma cortisol area under the curve (AUC), but had no effect on urinary excretion of cortisol. Salmeterol: In a drug interaction trial in 20 healthy subjects, coadministration of inhaled salmeterol (50 mcg twice daily) and oral ketoconazole (400 mg once daily) for 7 days resulted in greater systemic exposure to salmeterol (AUC increased 16-fold and C max increased 1.4-fold). Three (3) subjects were withdrawn due to beta 2 -agonist side effects (2 with prolonged QTc and 1 with palpitations and sinus tachycardia). Although there was no statistical effect on the mean QTc, coadministration of salmeterol and ketoconazole was associated with more frequent increases in QTc duration compared with salmeterol and placebo administration. 7.2 Monoamine Oxidase Inhibitors and Tricyclic Antidepressants Fluticasone Propionate/Salmeterol DISKUS should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of salmeterol, a component of Fluticasone Propionate/Salmeterol DISKUS, on the vascular system may be potentiated by these agents. 7.3 Beta-adrenergic Receptor Blocking Agents Beta-blockers not only block the pulmonary effect of beta-agonists, such as salmeterol, a component of Fluticasone Propionate/Salmeterol DISKUS, but may also produce severe bronchospasm in patients with asthma or COPD. Therefore, patients with asthma or COPD should not normally be treated with beta-blockers. However, under certain circumstances, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents for these patients; cardioselective beta-blockers could be considered, although they should be administered with caution. 7.4 Non–Potassium-Sparing Diuretics The ECG changes and/or hypokalemia that may result from the administration of non–potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, such as salmeterol, a component of Fluticasone Propionate/Salmeterol DISKUS, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of Fluticasone Propionate/Salmeterol DISKUS with non–potassium-sparing diuretics.