Applies to the following strength(s): 500 mcg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Chronic Obstructive Pulmonary Disease - Maintenance
To reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations: 500 mcg orally once a day, with or without food
Renal Dose Adjustments
No adjustment recommended.
Liver Dose Adjustments
Mild liver impairment (Child-Pugh A): Data not available; the risk-benefit of administering roflumilast to patients with this degree of liver impairment should be considered
Moderate to severe liver impairment (Child-Pugh B or C): Contraindicated
Roflumilast is not a bronchodilator and should not be used for the relief of acute bronchospasm.
An increase in psychiatric adverse reactions has been reported with roflumilast. Before use, prescribers should carefully weigh the risks and benefits of roflumilast therapy in patients with a history of depression and/or suicidal thoughts or behavior. Patients, their caregivers, and families should be advised to contact their healthcare provider if insomnia, anxiety, depression, suicidal thoughts, or other mood changes develop or worsen. If such events occur, prescribers should carefully evaluate the risks and benefits of continuing roflumilast therapy.
Weight loss was common during clinical trials. Patients treated with roflumilast should have their weight monitored regularly. If unexplained or clinically significant weight loss occurs, weight loss should be evaluated, and discontinuation of roflumilast should be considered.
Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).
Data not available
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Other brands: Daliresp