What is the recommended dosage of Roflumilast (Daxas) for Chronic Obstructive Pulmonary Disease (COPD)?

From the Guidelines

The recommended dosage of Roflumilast (Daxas) for Chronic Obstructive Pulmonary Disease (COPD) is 500 micrograms (0.5 mg) taken once daily. This medication should be taken consistently at the same time each day, with or without food. Roflumilast is not intended for immediate relief of breathing problems or acute bronchospasm but works as a maintenance therapy to reduce the frequency of COPD exacerbations. It functions as a selective phosphodiesterase-4 (PDE4) inhibitor, which helps decrease inflammation in the lungs by preventing the breakdown of cyclic AMP, ultimately reducing airway inflammation associated with COPD 1.

The use of Roflumilast in patients with COPD, particularly those with chronic bronchitis and a history of exacerbations, has been supported by guidelines and studies, including those from the European Respiratory Society and American Thoracic Society 1. These guidelines suggest that Roflumilast can reduce the number of moderate or severe exacerbations per patient-year and increase time to next exacerbation, although it may also increase adverse events such as diarrhea, weight loss, and nausea 1.

Common side effects of Roflumilast may include:

• Diarrhea
• Weight loss
• Nausea
• Headache
• Back pain Patients should be monitored for mood changes or suicidal thoughts as these can occur with Roflumilast. The medication typically takes several weeks to reach its full therapeutic effect, so patients should continue taking it as prescribed even if they don't notice immediate improvement in their symptoms. It's also important to consider the patient's overall health status and potential interactions with other medications when prescribing Roflumilast 1.

From the FDA Drug Label

The maintenance dose for patients with COPD is one 500 mcg tablet per day, with or without food. Starting treatment with a dose of roflumilast tablet 250 mcg once daily for 4 weeks and increasing to roflumilast tablet 500 mcg once daily thereafter may reduce the rate of treatment discontinuation in some patients.

The recommended dosage of Roflumilast (Daxas) for Chronic Obstructive Pulmonary Disease (COPD) is:

• Starting dose: 250 mcg once daily for the first 4 weeks
• Maintenance dose: 500 mcg once daily thereafter 2

From the Research

Roflumilast Dosage for COPD

The recommended dosage of Roflumilast (Daxas) for Chronic Obstructive Pulmonary Disease (COPD) is:

• 500 μg daily, as stated in studies 3, 4, 5, 6

Efficacy and Safety

The efficacy and safety of Roflumilast have been evaluated in several studies, including:

• A study published in 2010, which found that Roflumilast 500 μg daily improved lung function and reduced exacerbations in patients with severe COPD 3
• A study published in 2014, which found that Roflumilast 500 μg daily was effective in reducing exacerbations and improving lung function in patients with COPD, especially those with chronic bronchitis and frequent exacerbations 4
• A study published in 2018, which compared the incidence of adverse effects and discontinuation rate between patients receiving 250 μg and 500 μg of Roflumilast, and found that the 250 μg dose was associated with a lower incidence of adverse effects and discontinuation 7

Adverse Effects

The most common adverse effects associated with Roflumilast are:

• Gastrointestinal upset, such as diarrhea and nausea 3, 4, 5, 6
• Headache 3, 4, 5, 6
• Weight loss 3, 4, 5
• Psychiatric events, such as insomnia and depression 5, 6