Roflumilast
Chronic Obstructive Pulmonary Disease
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Drug Status
Government Approvals
US(FDA), UK(BNF)
WHO Essential Medicine
NO
Known Teratogen
NO
Pharmaceutical Class
Phosphodiesterase 4 Inhibitor
Controlled Drug Substance
No
Roflumilast
Summary
Roflumilast is used for the maintenance treatment of severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis in adults. It's used to reduce the risk of COPD exacerbations but is not a bronchodilator and should not be used for acute bronchospasm relief.
Roflumilast works by inhibiting an enzyme called phosphodiesterase 4 (PDE4) that's involved in the inflammatory process in the lungs. This inhibition leads to a decrease in inflammation, helping to improve lung function in patients with COPD.
The usual daily dose of Roflumilast for adults is 500 micrograms (mcg) taken once daily. It should be taken with or without food at the same time each day.
Common side effects of Roflumilast include diarrhea, weight loss, nausea, headache, and insomnia. Serious adverse effects include psychiatric events such as depression and suicidal thoughts. If you experience these side effects, you should report them to your healthcare provider immediately.
Roflumilast is contraindicated in patients with moderate to severe liver impairment. It's also associated with psychiatric adverse reactions, including suicidal thoughts and behavior, and weight loss. It should be used with caution in those with a history of depression or liver disease.
Indications and Purpose
How does Roflumilast work?
Roflumilast works by inhibiting the enzyme phosphodiesterase 4 (PDE4), which leads to an increase in intracellular cyclic AMP levels. This results in reduced inflammation in the lungs, helping to manage symptoms of COPD and prevent exacerbations.
Is Roflumilast effective?
Roflumilast has been shown to reduce the rate of COPD exacerbations in clinical trials, particularly in patients with severe COPD associated with chronic bronchitis. It improves lung function and reduces inflammation in the airways, contributing to its effectiveness in managing COPD symptoms.
What is Roflumilast?
Roflumilast is used to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis. It works by inhibiting phosphodiesterase 4 (PDE4), leading to decreased inflammation in the lungs. This helps improve lung function and reduce symptoms.
Directions for Use
For how long do I take Roflumilast?
Roflumilast is typically used as a long-term treatment for chronic obstructive pulmonary disease (COPD) to reduce the risk of exacerbations. It is not a cure for COPD, so it is usually taken continuously as prescribed by a healthcare provider.
How do I take Roflumilast?
Roflumilast should be taken once daily, with or without food, at the same time each day. There are no specific food restrictions while taking this medication, but it is important to follow your healthcare provider's instructions.
How long does it take for Roflumilast to start working?
Roflumilast may take several weeks to achieve its full effect. Patients should continue taking the medication as prescribed, even if they do not notice immediate improvements, and consult their healthcare provider for regular evaluations.
How should I store Roflumilast?
Store Roflumilast tablets at room temperature, between 68° to 77°F (20° to 25°C). Keep the medication in its original container, tightly closed, and out of reach of children. Avoid storing it in the bathroom to prevent exposure to moisture.
What is the usual dose of Roflumilast?
The usual daily dose for adults is one 500 micrograms (mcg) tablet taken once a day, with or without food. Roflumilast is not recommended for use in children as its safety and effectiveness have not been established in pediatric patients.
Warnings and Precautions
Can I take Roflumilast with other prescription drugs?
Roflumilast's effectiveness may be reduced by strong cytochrome P450 enzyme inducers like rifampicin, phenobarbital, carbamazepine, and phenytoin. Concurrent use with these drugs is not recommended. CYP3A4 inhibitors may increase Roflumilast exposure, requiring careful consideration of risks and benefits.
Can Roflumilast be taken safely while breastfeeding?
Roflumilast and its metabolites are likely excreted in human milk, and there is a potential risk to the breastfed infant. Therefore, Roflumilast should not be used by women who are breastfeeding.
Can Roflumilast be taken safely while pregnant?
There are no randomized clinical studies of Roflumilast in pregnant women. Animal studies have shown some reproductive toxicity, so Roflumilast is not recommended during pregnancy. Women of childbearing potential should use effective contraception while taking this medication.
Is it safe to exercise while taking Roflumilast?
Roflumilast is not known to limit the ability to exercise. It is used to manage COPD symptoms, which may help improve exercise tolerance by reducing exacerbations. However, if you experience any unusual symptoms during exercise, consult your healthcare provider.
Is Roflumilast safe for the elderly?
Roflumilast can be used in elderly patients without dosage adjustment. However, elderly patients may be more sensitive to side effects, such as sleep disorders. Regular monitoring by a healthcare provider is recommended to ensure safe and effective use of the medication.
Who should avoid taking Roflumilast?
Roflumilast is contraindicated in patients with moderate to severe liver impairment. It may cause psychiatric events, including depression and suicidal thoughts, and weight loss. Patients should be monitored for these side effects, and the medication should not be used for acute bronchospasm relief.
